(177 days)
General Positioning Devices: The device is indicated to aid in supporting and positioning adult and pediatric patients undergoing radiation therapy including electron, photon treatments. The device is also used during image acquisition to support treatment planning. Devices include Couchtops, Cushions, Cushions, and Accessories. The following are other positioning devices:
Head. Neck. and Shoulders Device is indicated to aid in supporting, positioning, and/or immobilization of adult and pediatric patients undergoing radiation therapy of the head, brain, neck, and spine including radiosurgery and electron, photon, and proton treatments. The device is also used during image acquisition to support treatment planning. Devices include Overlays, Extensions, Thermoplastic Masks, and Cushions.
Support Garments: The device is indicated to aid in supporting adolescents undergoing radiation therapy including electron, photon treatments. The device is also used during image acquisition to support treatment planning. The device is not intended for use with patients under 12 years of age.
Breast Positioning Devices: The device is indicated to aid in supporting adult and adolescent patients undergoing radiation therapy of the breast and chest region including electron, photon treatments. The device is also used during image acquisition to support treatment planning. The device is not intended for use with patients under 12 years of age.
The CIVCO Positioning and Immobilization devices have been used for many years and were previously cleared under other 510(k) is to have these identical Class II products cleared for use in Proton Therapy environment.
The Head, Neck, and Shoulder Devices are used to treat cancer of the head, neck, brain and spine. Organs that are located in these anatomical regions are applicable.
The General Positioning Devices are used to treat cancer of the spine, thorax, breast, abdomen, pelvis and prostate. Organs that are located in these anatomical regions are applicable.
The Support Garments are used to treat cancer of the breast, thorax and abdominal area. Organs that are located in these anatomical regions are applicable.
The Breast Positioning Devices are used to treat cancer of the breast, thorax and abdominal area. Organs that are located in these anatomical regions are applicable.
The devices are intended for therapeutic treatment (including proton, photon, and electron beam therapy) and diagnostics (including CT and MR as indicated). The devices will be used in a variety of types of external beam radiation therapy including Intensity Modulated Proton Therapy (IMPT), Intensity Modulated Radiation Therapy (IMRT), Pencil Beam Proton Therapy (PBPT), Image Guided Radiation Therapy (IGRT), Volumetric Modulated Arc Therapy (VMAT), Stereotactic Radiosurgery (SRS), Stereotactic Radiotherapy (SRT), Stereotactic Body Radiation Therapy (SBRT), and Craniospinal Treatment.
The intended users of the devices are radiation oncology therapists, medical physicists, and oncologists. The provider selects the appropriate equipment based on a patient's individual clinical goals and unique constraints.
Thermoplastic mask, AccuForm Cushion, and Support Garment devices are single patient use. All devices are non-powered and static.
The subject devices are reusable or disposable as provided in product labeling, provided non-sterile, and are used in a healthcare facility/hospital. The devices are labeled for MR safety, as applicable.
This document is a 510(k) Pre-market Notification for medical devices, specifically Proton Positioning and Immobilization Devices. It is a submission to the FDA to demonstrate substantial equivalence to legally marketed predicate devices, primarily for the modified intended use/indications for use to include proton treatment and pediatric/adolescent use.
The document does not describe a study involving an algorithm or artificial intelligence (AI) with acceptance criteria in the traditional sense of a computer-aided diagnosis (CAD) or AI-driven diagnostic device. Instead, it describes non-clinical performance testing for physical medical devices. Therefore, many of the requested details about acceptance criteria, ground truth establishment, expert consensus, and multi-reader multi-case (MRMC) studies are not applicable to this type of device submission.
Here's an interpretation of the relevant information provided, framed as closely as possible to your request for acceptance criteria and study proof for a medical device:
Device Type: Physical Medical Devices (Positioning and Immobilization for Radiation Therapy)
Purpose of Submission: To expand the Indications for Use of existing, previously cleared devices to include proton treatment and pediatric/adolescent use.
1. Table of "Acceptance Criteria" (Performance Goals) and Reported Device Performance
Given that this is a 510(k) for physical positioning devices, the "acceptance criteria" are not quantitative performance metrics like sensitivity/specificity for an AI algorithm. Instead, they are functional performance goals related to the physical interaction with the proton beam and patient. The "reported device performance" is the confirmation that these functional goals are met.
| Acceptance Criteria (Performance Goal) | Reported Device Performance (Conclusion from Testing) |
|---|---|
| Primary Goal: Device will not perturb or impact the proton beam in a way that cannot be accounted for in the facility's proton treatment planning process. | Devices evaluated, including edge effects, were considered safe and effective for use with proton. The performance tests confirmed that these devices would not perturb or impact the proton beam in a way that cannot be accounted for in the proton treatment planning process. (No recognized threshold for proton attenuation; criteria based on non-perturbation given facility's planning capabilities). |
| Maintain safety and effectiveness with expanded use (proton treatment, pediatric/adolescent use). | The risk analysis confirmed the safety and effectiveness of similar devices used for pediatrics/adolescents and Proton Therapy, ensuring no new issues are raised. CIVCO devices were found to be safe and effective for use with adults, pediatrics, and/or adolescents in the Proton Therapy environment. |
| No additional biocompatibility issues with expanded use. | All devices are previously cleared and manufactured with the same or substantially equivalent material that was previously cleared, thus no additional biocompatibility testing is required. |
| Devices used in MRI environment maintain their MR safety. | Devices labeled for use in an MRI environment were previously cleared by predicate 510(k)s included in this submission. Therefore, no additional MR testing is required. |
| Mechanical function without software/electronics. | Confirmed: The devices are mechanical without the use of software or electronics. |
| Limited contact duration (<24 hours) for surface devices (skin). | Confirmed: The devices are intended for limited contact duration (<24 hours) for surface devices (skin). |
| Devices are non-sterile. | Confirmed: Devices are non-sterile. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify a quantitative "sample size" in terms of number of devices tested or number of patient images/cases. The testing appears to be conducted on representative devices from the product families concerned. It mentions "devices were selected for performance testing" and "devices were evaluated." For physical devices like these, performance testing often involves a small number of physical units to verify properties.
- Data Provenance: Not applicable in the sense of patient data. The "study" is a non-clinical, in-house performance evaluation and literature review. This is not retrospective or prospective patient data, but rather engineering-level testing of the device's interaction with a proton beam.
- Country of Origin: The non-clinical testing was performed by CIVCO (MEDTEC, Inc.), which is located in the USA (Orange City, Iowa).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This question is not directly applicable. The "ground truth" for these physical devices is established by physical measurements and engineering principles related to proton beam physics and material interactions, rather than expert interpretation of medical images.
The document states: "Because there is no recognized threshold for Proton attenuation, the criteria used for determining acceptable performance was to verify the part will not perturb or impact the proton beam in a way that cannot be accounted for in the facility's proton treatment planning process." This implies reliance on established physics and a facility's ability to plan around the device, rather than a clinical "truth" adjudicated by experts.
The intended users of the devices are mentioned as "radiation oncology therapists, medical physicists, and oncologists," implying their expertise is relevant for the clinical application but not for establishing the fundamental physical properties of the device materials.
4. Adjudication Method for the Test Set
Not applicable. This is not a study requiring adjudication of expert disagreement or clinical findings. Performance is assessed against physical properties and effects on proton beams.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging devices where human readers interpret medical images with and without AI assistance. The devices in this submission are physical positioning and immobilization tools, not diagnostic AI software.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Yes, in a conceptual sense, the "standalone" performance of the physical devices was assessed. The non-clinical testing evaluated the physical interaction of the devices with the proton beam independent of a "human-in-the-loop" clinical application, to ensure they meet the criteria of "not perturbing or impacting the proton beam in a way that cannot be accounted for in the facility's proton treatment planning process."
7. The Type of Ground Truth Used
The ground truth used is primarily physics-based experimental data related to proton beam attenuation and material properties, and engineering validation that the devices maintain their mechanical function and safety characteristics when exposed to a proton environment or used by various patient populations (pediatric/adolescent). The lack of a "recognized threshold for Proton attenuation" indicates that the "ground truth" for acceptable performance is framed by a facility's ability to integrate the device's known characteristics into their treatment planning.
8. The Sample Size for the Training Set
Not applicable. These are physical medical devices, not an AI algorithm, so there is no concept of a "training set" for model development.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no training set for an AI algorithm.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
MEDTEC, Inc. d/b/a "CIVCO Medical Solutions" and "CIVCO Radi % Ms. Alena Newgren Regulatory Specialist 140 1 8th Street SE ORANGE CITY IOWA 51041
June 29, 2018
Re: K180021
Trade/Device Name: Proton Positioning and Immobilization Devices Regulation Number: 21 CFR 892.5050 Regulation Name: Medical Charged-Particle Radiation Therapy System Regulatory Class: Class II Product Code: IYE Dated: December 22, 2017 Received: January 3, 2018
Dear Ms. Alena:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);
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Page 2 - Ms. Alena Newgren
and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Michael D.'Hara
For
Robert A. Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K180021
Device Name
General Positioning Devices; Head, Neck, and Shoulders Devices; Support Garments; Breast Positioning Devices
Indications for Use (Describe)
General Positioning Devices: The device is indicated to aid in supporting and positioning adult and pediatric patients undergoing radiation therapy including electron, photon treatments. The device is also used during image acquisition to support treatment planning. Devices include Couchtops, Cushions, Cushions, and Accessories. The following are other positioning devices:
Head. Neck. and Shoulders Device is indicated to aid in supporting, positioning, and/or immobilization of adult and pediatric patients undergoing radiation therapy of the head, brain, neck, and spine including radiosurgery and electron, photon, and proton treatments. The device is also used during image acquisition to support treatment planning. Devices include Overlays, Extensions, Thermoplastic Masks, and Cushions.
Support Garments: The device is indicated to aid in supporting adolescents undergoing radiation therapy including electron, photon treatments. The device is also used during image acquisition to support treatment planning. The device is not intended for use with patients under 12 years of age.
Breast Positioning Devices: The device is indicated to aid in supporting adult and adolescent patients undergoing radiation therapy of the breast and chest region including electron, photon treatments. The device is also used during image acquisition to support treatment planning. The device is not intended for use with patients under 12 years of age.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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Image /page/3/Picture/0 description: The image shows the CIVCO Radiotherapy logo. The logo is blue and features the word "CIVCO" in a stylized font, with a blue circle above the "V". Below the word "CIVCO" is the word "Radiotherapy" in a smaller, sans-serif font, also in blue. The logo is clean and modern, and the use of blue gives it a professional and trustworthy feel.
510(k) Summary
A. Submitter Information
| Submitter Name & Address: MEDTEC, Inc. d/b/a "CIVCO Medical Solutions" and"CIVCO Radiotherapy"1401 8th St. SEOrange City, IA 51041 | |
|---|---|
| Contact Person: | Alena Newgren, Regulatory SpecialistTelephone: 712-737-8688, Fax: 877-613-6300regulatory@civcort.com |
| Date Summary Prepared: | June 13, 2018 |
| Trade Name: | Proton Positioning and Immobilization Solutions |
| Common Name: | Head, Neck and Shoulders DevicesGeneral Positioning DevicesSupport GarmentsBreast Positioning Devices |
| Classification Names & | Medical charged-particle radiation therapy system(892.5050) |
| Numbers: | System, Nuclear Magnetic Resonance Imaging (892.1000) |
| Device Class: | Class II |
| Review Panels: | Radiology |
| Product Codes: | IYE, LNH |
B. Predicate Devices
The subject devices are substantially equivalent to the predicate devices in the following 510(k)s:
| Predicate Device: | Manufacturer |
|---|---|
| K973842: Carbon Fiber Conformal Couch Top | MEDTEC, Inc. |
| Reference Devices: | |
| K933227: Uni-Frame Head Immobilization System | |
| K080072: MRI Patient Positioning Devices | |
| K060737: Sinmed Positioning Devices | |
| K982624: Moldcare Head & Neck Cushion | |
| K935300: Vac-Lok Immobilization System | |
| K121284: Chabner XRT Garments | |
| K974703: Carbon Fiber Breast Board |
The purpose of this 510(k) is to modify the intended use/indications for use for the subject devices including specification of proton treatment and pediatric/adolescent use.
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Image /page/4/Picture/0 description: The image shows the logo for CIVCO Radiotherapy. The logo is blue and features the word "CIVCO" in a stylized font. The "V" in CIVCO has a blue circle above it. Below the word "CIVCO" is the word "Radiotherapy" in a smaller font.
D. Device Descriptions
This submission does not include in-vitro diagnostic devices.
The CIVCO Positioning and Immobilization devices have been used for many years and were previously cleared under other 510(k) is to have these identical Class II products cleared for use in Proton Therapy environment.
The Head, Neck, and Shoulder Devices are used to treat cancer of the head, neck, brain and spine. Organs that are located in these anatomical regions are applicable.
The General Positioning Devices are used to treat cancer of the spine, thorax, breast, abdomen, pelvis and prostate. Organs that are located in these anatomical regions are applicable.
The Support Garments are used to treat cancer of the breast, thorax and abdominal area. Organs that are located in these anatomical regions are applicable.
The Breast Positioning Devices are used to treat cancer of the breast, thorax and abdominal area. Organs that are located in these anatomical regions are applicable.
The devices are intended for therapeutic treatment (including proton, photon, and electron beam therapy) and diagnostics (including CT and MR as indicated). The devices will be used in a variety of types of external beam radiation therapy including Intensity Modulated Proton Therapy (IMPT), Intensity Modulated Radiation Therapy (IMRT), Pencil Beam Proton Therapy (PBPT), Image Guided Radiation Therapy (IGRT), Volumetric Modulated Arc Therapy (VMAT), Stereotactic Radiosurgery (SRS), Stereotactic Radiotherapy (SRT), Stereotactic Body Radiation Therapy (SBRT), and Craniospinal Treatment.
The intended users of the devices are radiation oncology therapists, medical physicists, and oncologists. The provider selects the appropriate equipment based on a patient's individual clinical goals and unique constraints.
Thermoplastic mask, AccuForm Cushion, and Support Garment devices are single patient use. All devices are non-powered and static. Detailed device specific descriptions are located in Section 11.
The subject devices are reusable or disposable as provided in product labeling, provided non-sterile, and are used in a healthcare facility/hospital. The devices are labeled for MR safety, as applicable. The following models are included in this submission:
www.civcort.com
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Image /page/5/Picture/0 description: The image shows the CIVCO Radiotherapy logo. The logo is in blue and features the word "CIVCO" in large, bold letters. The "V" in CIVCO has a light blue circle above it. Below the word "CIVCO" is the word "Radiotherapy" in a smaller, thinner font.
Table A. Head, Neck, and Shoulders Devices.
| DeviceFamily | Part No. | Device Name | Reference510(k) |
|---|---|---|---|
| Overlay | MTPT210002 | Type-S™ Overlay (Reusable non-sterile overlay with thermoplastic frame for use with Hitachi proton system) | K933227 |
| Overlay | MTMRHNTYPES | Type-S™ Overlay (Reusable non-sterile Type-S™ overlay with strap) | K080072 |
| ThermoplasticMask | MTAPUDMP | Disposable non-sterile head only FirmFit™ Thermoplastic (2.3mm) | K060737 |
| ThermoplasticMask | MTAPSDMP | Disposable non-sterile head neck, and shoulder FirmFit™ Thermoplastic (2.3mm) | |
| ThermoplasticMask | MTAPUDMPSG | Disposable non-sterile head only open face FirmFit™ Thermoplastic (2.3mm) | |
| Extension | MTPT210001 | Type-S™ Extension (Reusable non-sterile head extension for use with Hitachi proton system) | K933227 |
| Extension | MTIL6665 | Type-S Extension (Reusable non-sterile extension for use with Universal Couchtop Long Extension) | K973842 |
| Extension | MTIL6668 | SRS Posifix Extension (Reusable non-sterile SRS compatible extension for use with Universal Couchtop Long Extension) | K973842 |
| Cushion | MTACL1520 | AccuForm™ Cushion (15 x 20 cm) | |
| Cushion | MTACL2035 | AccuForm™ Cushion (20 x 35 cm) chamfered | |
| Cushion | MTACL2035HF | AccuForm™ Cushion (20 x 35 cm) chamfered, half fill | |
| Cushion | MTACL2045 | AccuForm™ Cushion (20 x 45 cm) | K982624 and |
| Cushion | MTACL4060 | AccuForm™ Cushion (40 x 60 cm) | K080072 |
| Cushion | MTACL6060 | AccuForm™ Cushion (60 x 60 cm) | |
| Cushion | MTACL14242 | AccuForm™ Cushion (20 x 25 cm) | |
| Cushion | MTACLTYPES1 | AccuForm™ Cushion (Types-S) | |
| Couchtop &Lok-Bar | MTIL6720 | IPPS™ Couchtop (Reusable non-sterile one piece couchtopwith Lok-Bar) | |
| MTIL6740 | Universal Couchtop (Reusable non-sterile couchtop with Lok-Bar, rectangular extension, and storage rack) | K973842 | |
| Extension | MTIL6660 | Rectangular Extension (Reusable non-sterile rectangularextension for use with Universal Couchtop Long Extension) | K973842 |
| Accessories(Hand Grips) | MTIL662501 | Patient Hand Grip (Reusable non-sterile SBRT Body Pro-Lok™ hand grip (right) for use with Universal Couchtop) | K973842 |
| MTIL662502 | Patient Hand Grip (Reusable non-sterile SBRT Body Pro-Lok™ hand grip (left) for use with Universal Couchtop) | ||
| Cushion(Vac-Lok) | MTVLG35FC | Vac-Lok ™ Cushion (Reusable, non-sterile, 70 x 100 cm, 35L,nylon bag with indexing safe for use in 1.5T and 3.0T MRenvironments) | K080072K935300 |
| Cushion(Combifix) | 151004 | Combifix™ (Reusable non-sterile Combifix™ baseplate with(2) elevation blocks, Feetfix™ bracket, Feetfix cushion, andKneefix™ cushion) | K060737 |
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Image /page/6/Picture/0 description: The image shows the CIVCO Radiotherapy logo. The logo is blue and features the word "CIVCO" in large, bold letters. A blue circle is above the V in CIVCO. Below the word "CIVCO" is the word "Radiotherapy" in a smaller, thinner font.
Table B. General Positioning Devices.
www.civcort.com
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Image /page/7/Picture/0 description: The image shows the CIVCO Radiotherapy logo. The logo is blue and features the word "CIVCO" in a stylized font, with a blue circle above the "V". Below the word "CIVCO" is the word "Radiotherapy" in a smaller, sans-serif font. The logo is clean and modern, and the blue color gives it a sense of trust and reliability.
Table C. Support Garments
| SupportGarments(Brassiere) | CRTBRA01 | Chabner XRT® Radiation Bra, Size 1 | |
|---|---|---|---|
| CRTBRA02 | Chabner XRT® Radiation Bra, Size 2 | ||
| CRTBRA03 | Chabner XRT® Radiation Bra, Size 3 | ||
| CRTBRA04 | Chabner XRT® Radiation Bra, Size 4 | ||
| CRTBRA05 | Chabner XRT® Radiation Bra, Size 5 | ||
| CRTBRA06 | Chabner XRT® Radiation Bra, Size 6 | K121284 | |
| CRTBRA07 | Chabner XRT® Radiation Bra, Size 7 | ||
| CRTBRA08 | Chabner XRT® Radiation Bra, Size 8 | ||
| CRTBRA09 | Chabner XRT® Radiation Bra, Size 9 | ||
| CRTEXT01 | Bra Extender |
Table D. Breast Positioning Devices
| Breastboard | MTM400 | C-Qual™ (Reusable non-sterile breastboard with head support and Monarch™ Overhead Arm Positioner) | K080072 |
|---|---|---|---|
| ------------- | -------- | --------------------------------------------------------------------------------------------------- | --------- |
E. Indications for Use/Intended Use Statements
General Positioning Devices:
The device is indicated to aid in supporting and positioning adult and pediatric patients undergoing radiation therapy including electron, photon, and proton treatments. The device is also used during image acquisition to support treatment planning. Devices include Couchtops, Lok-Bars, Extensions, Cushions, and Accessories. The following are other positioning devices:
Head, Neck, and Shoulder Devices:
The device is indicated to aid in supporting, positioning, and/or immobilization of adult and pediatric patients undergoing radiation therapy of the head, brain, neck, and spine including radiosurgery and electron, photon, and proton treatments. The device is also used during image acquisition to support treatment planning. Devices include Overlays, Extensions, Thermoplastic Masks, and Cushions.
www.civcort.com
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Image /page/8/Picture/0 description: The image shows the CIVCO Radiotherapy logo. The logo is in blue and features the word "CIVCO" in large, rounded letters. Above the "V" is a small, light blue circle. Below the word "CIVCO" is the word "Radiotherapy" in a smaller font.
Support Garments:
The device is indicated to aid in supporting adolescent and adult patients undergoing radiation therapy including electron, photon, and proton treatments. The device is also used during image acquisition to support treatment planning. The device is not intended for use with patients under 12 years of age.
Breast Positioning Devices:
The device is indicated to aid in supporting and positioning adult and adolescent patients undergoing radiation therapy of the breast and chest region including electron, photon, and proton treatments. The device is also used during image acquisition to support treatment planning. The device is not intended for use with patients under 12 years of age.
F. Comparison of Technological Characteristics
This 510(k) is being submitted only to add the Proton Intended Use and pediatric/adolescent use for these previously cleared devices.
| MTPT210002 | Type-S TM Overlay | ||
|---|---|---|---|
| Component/Parameter | Proposed Device | Predicate Device | Reference Device |
| 510k | K180021 | K973842 | K933227 |
| Intended Use/Indications forUse | The device is indicated to aidin supporting, positioning,and/or immobilization of adultand pediatric patientsundergoing radiation therapyof the head, brain, neck, andspine including radiosurgeryand electron, photon, andproton treatments. The deviceis also used during imageacquisition to supporttreatment planning. | The intended use ofthe MED-TEC, INC.Carbon FiberConformal Couch Topis to support and aid inpositioning a patientduring radiologic andother medicalprocedures. | The intended use of this device isto immobilize the head duringradiation therapy. |
| DesignFeatures | The Type-S Overlay is placedon top of the treatment tablevia Lok-Bar and allows forattachments of head or head,neck, and shouldersthermoplastic masks. TheOverlay also allows aheadrest to be used. The | The Couch Top isplaced onto thetreatment pedestal andincludes indexing foraccessories to beattached onto to allowfor patient positioningand immobilization. | The baseplate sets on thetreatment table and allows forattachments of head or head,neck, and shoulders thermoplasticmasks. The baseplate also allowsa headrest to be used. Thebaseplate is fitted with tworegistration pins that index to |
Head, Neck, and Shoulders Devices
www.civcort.com
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Image /page/9/Picture/0 description: The image shows the CIVCO Radiotherapy logo. The word "CIVCO" is in large, bold, blue letters, with a light blue circle above the V. Below the word "CIVCO" is the word "Radiotherapy" in a smaller font.
| Overlay has holes thatcorrespond to thermoplasticmask attachment pins. | corresponding holes in thethermoplastic frame to giveprecision repositioning. Fourswivel clamps allow quick lockdown and removal of thethermoplastic frame. | ||
|---|---|---|---|
| Principle ofOperation | Mechanical devices without the use of software or electronics. | ||
| Device BodyContactCategory | Limited contact duration (<24 hours) for surface devices (skin). | ||
| Sterility | N/A Devices are non-sterile |
| MTPT210001 | Type-S™ Extension | ||
|---|---|---|---|
| Component/Parameter | Proposed Device | Predicate Device | Reference Device |
| 510k | K180021 | K973842 | K933227 |
| Intended Use/Indications forUse | The device is indicated to aid in supporting, positioning, and/or immobilization of adult and pediatric patients undergoing radiation therapy of the head, brain, neck, and spine including radiosurgery and electron, photon, and proton treatments. The device is also used during image acquisition to support treatment planning. | The intended use of the MED-TEC, INC. Carbon Fiber Conformal Couch Top is to support and aid in positioning a patient during radiologic and other medical procedures. | The intended use of this device is to immobilize the head during radiation therapy. |
| DesignFeatures | The device attaches to the end of the treatment table via a cantilever lock and pin mechanism. The Extensions allows for the placement of a headrest and has corresponding holes for thermoplastic mask attachment of head only or head, neck, and shoulders. | The Couch Top is placed onto the treatment pedestal and includes indexing for accessories to be attached onto to allow for patient positioning and immobilization. | The baseplate sets on the treatment table and allows for attachments of head or head, neck, and shoulders thermoplastic masks. The baseplate also allows a headrest to be used. The baseplate is fitted with two registration pins that index to corresponding holes in the thermoplastic frame to give precision repositioning. Four swivel clamps allow quick lock down and removal of the thermoplastic frame. |
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Image /page/10/Picture/0 description: The image shows the logo for CIVCO Radiotherapy. The logo is in blue and features the word "CIVCO" in a bold, sans-serif font. A light blue circle is above the V. Below the word "CIVCO" is the word "Radiotherapy" in a smaller, sans-serif font.
| Principle ofOperation | Mechanical devices without the use of software or electronics. |
|---|---|
| Device BodyContactCategory | Limited contact duration (<24 hours) for surface devices (skin). |
| Sterility | N/A Devices are non-sterile |
| MTMRHNTYPES | Type-ST™ Overlay | ||
|---|---|---|---|
| Component/Parameter | Proposed Device | Predicate Device | Reference Device |
| 510k | K180021 | K973842 | K080072 |
| Intended Use/Indications for Use | The device is indicated to aid insupporting, positioning, and/orimmobilization of adult andpediatric patients undergoingradiation therapy of the head,brain, neck, and spine includingradiosurgery and electron, photon,and proton treatments. Thedevice is also used during imageacquisition to support treatmentplanning. | The intended use ofthe MED-TEC, INC.Carbon FiberConformal Couch Topis to support and aid inpositioning a patientduring radiologic andother medicalprocedures. | Patient PositioningDevices are used to aid inthe support andpositioning of patientsduring an MRI. |
| Design Features | The Overlay is attached to thetreatment couch top via Lok-Barand secured by a Velcro strap.The overlay is contoured to followthe anatomy of the head, neck,and shoulder region by a 'S'shape. The Overlay containsholes for thermoplastic mask toattach to in either head only orhead, neck, and shoulder style. Aheadrest can be placed on theOverlay for patient positioning andcomfort. | The Couch Top isplaced onto thetreatment pedestal andincludes indexing foraccessories to beattached onto to allowfor patient positioningand immobilization. | The device is attached tothe treatment pedestal viaLok-Bar and allowsattachment of otherpositioning andimmobilization devices orto be used stand-alone.The device allows aheadrest to be added andthermoplastic masks to beattached. |
| Principle ofOperation | Mechanical devices without the use of software or electronics. | ||
| Device BodyContact Category | Limited contact duration (<24 hours) for surface devices (skin). | ||
| Sterility | N/A Devices are non-sterile |
Corporate Office | 2301 Jones Boulevard | Coralville, IA 52241 | USA | office +1 (319) 248.6757 | info@civcort.com Global Sales Office | 1401 8º Street SE | Orange City, IA 51041 | USA | office +1 (712) 737.8688 | fax +1 (877) 613.6300
510(k) Summary – Page 8
{11}------------------------------------------------
Image /page/11/Picture/0 description: The image shows the logo for CIVCO Radiotherapy. The logo is in blue and features the word "CIVCO" in a stylized font. Above the V is a light blue circle. Below the logo is the word "Radiotherapy" in a smaller, sans-serif font.
| MTAPUDMPComponent/Parameter | Disposable non-sterile head only FirmFit™ Thermoplastic | Proposed Device | PredicateDevice | Reference Device | Reference Device |
|---|---|---|---|---|---|
| 510k | K180021 | K973842 | K080072 | K060737 | |
| Intended Use/Indications forUse | The device is indicatedto aid in supporting,positioning, and/orimmobilization of adultand pediatric patientsundergoing radiationtherapy of the head,brain, neck, and spineincluding radiosurgeryand electron, photon,and proton treatments.The device is also usedduring imageacquisition to supporttreatment planning. | The intended useof the MED-TEC,INC. Carbon FiberConformal CouchTop is to supportand aid inpositioning apatient duringradiologic andother medicalprocedures. | Patient PositioningDevices are used toaid in the support andpositioning of patientsduring an MRI. | Fixation and(re)positioning of thehead- and neck areaof the patient duringradiotherapy anddiagnostics. | |
| DesignFeatures | Thermoplastic Masksare composed of aframe, mask, and pushpins. The thermoplasticmask is submerged inheated water to soften.Once removed from thewater, the user quicklydries off the water andthen forms the maskaround the patient'shead and locks the pinsinto pinholes of theCouchtop, Extension,or Overlay. TheSnapFrame style allowsthe user to pull thesides down first andthen connect the topportion with the sides tomake a continuous U-shaped frame. | The Couch Top isplaced onto thetreatment pedestaland includesindexing foraccessories to beattached onto toallow for patientpositioning andimmobilization. | Thermoplastic Masksare composed of aframe, mask, andpush pins. Thethermoplastic mask issubmerged in heatedwater to soften. Onceremoved from thewater, the userquickly dries off thewater and then formsthe mask around thepatient's head andlocks the pins intopinholes of theCouchtop, Extension,or Overlay. | Thermoplastic Masksare composed of aframe, mask, andpush pins. Thethermoplastic mask issubmerged in heatedwater to soften. Onceremoved from thewater, the userquickly dries off thewater and then formsthe mask around thepatient's head andlocks the pins intopinholes of theCouchtop, Extension,or Overlay. | |
| Principle ofOperation | Mechanical deviceswithout the use ofsoftware or electronics. | Mechanicaldevices withoutthe use of | Mechanical deviceswithout the use ofsoftware orelectronics | Mechanical deviceswithout the use ofsoftware orelectronics | |
| software orelectronics. | |||||
| Device BodyContactCategory | Limited contact duration(<24 hours) for surfacedevices (skin). | Limited contactduration (<24hours) for surfacedevices (skin). | Limited contactduration (<24 hours)for surface devices(skin). | Limited contactduration (<24 hours)for surface devices(skin). | |
| Sterility | N/A Devices are non-sterile | N/A Devices arenon-sterile | N/A Devices are non-sterile | N/A Devices are non-sterile |
{12}------------------------------------------------
Image /page/12/Picture/0 description: The image shows the CIVCO Radiotherapy logo. The logo is in blue and consists of the word "CIVCO" in a sans-serif font, with a blue circle above the "V". Below the word "CIVCO" is the word "Radiotherapy" in a smaller sans-serif font, also in blue.
| MTAPSDMP | Disposable non-sterile head neck, and shoulder FirmFit™ Thermoplastic | |||
|---|---|---|---|---|
| Component/Parameter | Proposed Device | PredicateDevice | Reference Device | Reference Device |
| 510k | K180021 | K973842 | K080072 | K060737 |
| Intended Use/Indications forUse | The device is indicatedto aid in supporting,positioning, and/orimmobilization of adultand pediatric patientsundergoing radiationtherapy of the head,brain, neck, and spineincluding radiosurgeryand electron, photon,and proton treatments.The device is also usedduring imageacquisition to supporttreatment planning. | The intended useof the MED-TEC,INC. Carbon FiberConformal CouchTop is to supportand aid inpositioning apatient duringradiologic andother medicalprocedures. | The intended use ofthis device is toprovide an additionalaid to the fast andaccurate repeatpositioning of thepatient for radiation orother treatment. | Fixation and(re)positioning of thehead- and neck areaof the patient duringradiotherapy anddiagnostics. |
| DesignFeatures | Thermoplastic Masksare composed of aframe, mask, and pushpins. The thermoplasticmask is submerged inheated water to soften.Once removed from thewater, the user quicklydries off the water andthen forms the maskaround the patient'shead and locks the pinsinto pinholes of theCouchtop, Extension, orOverlay. TheSnapFrame style allowsthe user to pull the | The Couch Top isplaced onto thetreatment pedestaland includesindexing foraccessories to beattached onto toallow for patientpositioning andimmobilization. | Thermoplastic Masksare composed of aframe, mask, andpush pins. Thethermoplastic mask issubmerged in heatedwater to soften. Onceremoved from thewater, the userquickly dries off thewater and then formsthe mask around thepatient's head andlocks the pins intopinholes of theCouchtop, Extension,or Overlay. | Thermoplastic Masksare composed of aframe, mask, andpush pins. Thethermoplastic mask issubmerged in heatedwater to soften. Onceremoved from thewater, the userquickly dries off thewater and then formsthe mask around thepatient's head andlocks the pins intopinholes of theCouchtop, Extension,or Overlay. |
{13}------------------------------------------------
Image /page/13/Picture/0 description: The image shows the logo for CIVCO Radiotherapy. The logo is blue and features the word "CIVCO" in a stylized font, with a blue circle above the "V". Below the word "CIVCO" is the word "Radiotherapy" in a smaller, sans-serif font, also in blue. The logo is simple and modern, and the use of blue gives it a professional and trustworthy feel.
| sides down first andthen connect the topportion with the sides tomake a continuous U-shaped frame. | |||
|---|---|---|---|
| Principle ofOperation | Mechanical devices without the use of software or electronics. | ||
| Device BodyContactCategory | Limited contact duration (<24 hours) for surface devices (skin). | ||
| Sterility | N/A Devices are non-sterile |
| MTAPUDMPSG | Disposable non-sterile head only open face FirmFit™ Thermoplastic | |||
|---|---|---|---|---|
| Component/Parameter | Proposed Device | PredicateDevice | Reference Device | Reference Device |
| 510k | K180021 | K973842 | K982624 | K060737 |
| Intended Use/Indications forUse | The device isindicated to aid insupporting,positioning, and/orimmobilization of adultand pediatric patientsundergoing radiationtherapy of the head,brain, neck, and spineincluding radiosurgeryand electron, photon,and proton treatments.The device is alsoused during imageacquisition to supporttreatment planning. | The intended useof the MED-TEC,INC. Carbon FiberConformal CouchTop is to supportand aid inpositioning apatient duringradiologic andother medicalprocedures. | The intended use ofthis device is toprovide an additionalaid to the fast andaccurate repeatpositioning of thepatient for radiationor other treatment. | Fixation and(re)positioning of thehead- and neck areaof the patient duringradiotherapy anddiagnostics. |
| Design Features | Thermoplastic Masksare composed of aframe, mask, andpush pins. Thethermoplastic mask issubmerged in heatedwater to soften. Onceremoved from thewater, the user quicklydries off the water andthen forms the maskaround the patient'shead and locks the | The Couch Top isplaced onto thetreatmentpedestal andincludes indexingfor accessories tobe attached ontoto allow for patientpositioning andimmobilization. | ThermoplasticMasks arecomposed of aframe, mask, andpush pins. Thethermoplastic maskis submerged inheated water tosoften. Onceremoved from thewater, the userquickly dries off thewater and then | ThermoplasticMasks arecomposed of aframe, mask, andpush pins. Thethermoplastic maskis submerged inheated water tosoften. Onceremoved from thewater, the userquickly dries off thewater and then forms |
{14}------------------------------------------------
Image /page/14/Picture/0 description: The image shows the CIVCO Radiotherapy logo. The logo is in blue and features the word "CIVCO" in a stylized font. The "I" in CIVCO has a blue circle above it. Below the word "CIVCO" is the word "Radiotherapy" in a smaller font.
| pins into pinholes ofthe Couchtop,Extension, or Overlay.The SnapFrame styleallows the user to pullthe sides down firstand then connect thetop portion with thesides to make acontinuous U-shapedframe. | forms the maskaround the patient'shead and locks thepins into pinholes ofthe Couchtop,Extension, orOverlay. | the mask around thepatient's head andlocks the pins intopinholes of theCouchtop,Extension, orOverlay. | |
|---|---|---|---|
| Principle ofOperation | Mechanical devices without the use of software or electronics. | ||
| Device BodyContact Category | Limited contact duration (<24 hours) for surface devices (skin). | ||
| Sterility | N/A Devices are non-sterile |
| MTIL6665 | Type-S Extension | Predicate Device |
|---|---|---|
| Component/Parameter | Proposed Device | |
| 510k | K180021 | K973842 |
| Intended Use/Indications forUse | The device is indicated to aid in supporting, positioning, and/or immobilization of adult and pediatric patients undergoing radiation therapy of the head, brain, neck, and spine including radiosurgery and electron, photon, and proton treatments. The device is also used during image acquisition to support treatment planning. | The intended use of the MED-TEC, INC. Carbon Fiber Conformal Couch Top is to support and aid in positioning a patient during radiologic and other medical procedures. |
| DesignFeatures | The Type-S Extension attaches to the Couchtop junction outside of the treatment zone and is shaped so that it follows the contours of the patient's head, neck, and shoulder outline. Extensions do not require a support mechanism that needs to be moved or accounted for during planning and treatment. | The Couch Top is placed onto the treatment pedestal and includes indexing for accessories to be attached onto to allow for patient positioning and immobilization. |
| Principle ofOperation | Mechanical devices without the use of software or electronics. | |
| Device BodyContactCategory | Limited contact duration (<24 hours) for surface devices (skin). | |
| Sterility | N/A Devices are non-sterile |
{15}------------------------------------------------
Image /page/15/Picture/0 description: The image shows the CIVCO Radiotherapy logo. The logo is in blue and features the word "CIVCO" in a stylized font, with a blue circle above the "V". Below the word "CIVCO" is the word "Radiotherapy" in a smaller font.
| MTIL6668 | SRS Posifix Extension | |
|---|---|---|
| Component/Parameter | Proposed Device | Predicate Device |
| 510k | K180021 | K973842 |
| Intended Use/Indications forUse | The device is indicated to aid in supporting, positioning, and/or immobilization of adult and pediatric patients undergoing radiation therapy of the head, brain, neck, and spine including radiosurgery and electron, photon, and proton treatments. The device is also used during image acquisition to support treatment planning. | The intended use of the MED-TEC, INC. Carbon Fiber Conformal Couch Top is to support and aid in positioning a patient during radiologic and other medical procedures. |
| DesignFeatures | The Extension attaches to the Couchtop junction outside of the treatment zone and is shaped so that it follows the contours of the patient's head, neck, and shoulder outline. Extensions do not require a support mechanism that needs to be moved or accounted for during planning and treatment. | The Couch Top is placed onto the treatment pedestal and includes indexing for accessories to be attached onto to allow for patient positioning and immobilization. |
| Principle ofOperation | Mechanical devices without the use of software or electronics. | |
| Device BodyContactCategory | Limited contact duration (<24 hours) for surface devices (skin). | |
| Sterility | N/A Devices are non-sterile |
| MTACL1520 | AccuForm™ Cushion | |||
|---|---|---|---|---|
| Component/Parameter | Proposed Device | Predicate Device | Reference Device | ReferenceDevice |
| 510k | K180021 | K973842 | K080072 | K982624 |
| Intended Use/Indications forUse | The device is indicatedto aid in supporting,positioning, and/orimmobilization of adultand pediatric patientsundergoing radiationtherapy of the head,brain, neck, and spineincluding radiosurgeryand electron, photon,and proton treatments.The device is also usedduring image acquisitionto support treatmentplanning. | The intended use ofthe MED-TEC, INC.Carbon FiberConformal CouchTop is to supportand aid inpositioning a patientduring radiologicand other medicalprocedures. | Patient PositioningDevices are used toaid in the support andpositioning of patientsduring an MRI. | The intended useof this device is toprovide anadditional aid tothe fast andaccurate repeatpositioning of thepatient for radiationor other treatment. |
| DesignFeatures | AccuForm Cushions areactivated by a chemical | The Couch Top isplaced onto the | The device isattached to the | AccuFormCushions are |
{16}------------------------------------------------
Image /page/16/Picture/0 description: The image shows the logo for CIVCO Radiotherapy. The logo is in blue and consists of the word "CIVCO" in a rounded sans-serif font, with a small blue circle above the "V". Below the word "CIVCO" is the word "Radiotherapy" in a smaller, sans-serif font.
| reaction when water is | treatment pedestal | treatment pedestal via | activated by a | |
|---|---|---|---|---|
| introduced to the inside | and includes | Lok-Bar and allows | chemical reaction | |
| materials. After the | indexing for | attachment of other | when water is | |
| device has hardened it is | accessories to be | positioning and | introduced to the | |
| a custom fit to the patient | attached onto to | immobilization | inside materials. | |
| and can be used over | allow for patient | devices or to be used | After the device | |
| the course of treatment. | positioning and | stand-alone. The | has hardened it is | |
| immobilization. | device allows a | a custom fit to the | ||
| headrest to be added | patient and can be | |||
| and thermoplastic | used over the | |||
| masks to be attached. | course of | |||
| treatment. | ||||
| Principle ofOperation | Mechanical devices without the use of software or electronics. | |||
| Device BodyContactCategory | Limited contact duration (<24 hours) for surface devices (skin). | |||
| Sterility | N/A Devices are non-sterile |
| MTACL2035 | AccuForm™ Cushion | |||
|---|---|---|---|---|
| Component/Parameter | Proposed Device | Predicate Device | Reference Device | ReferenceDevice |
| 510k | K180021 | K973842 | K080072 | K982624 |
| Intended Use/Indications forUse | The device is indicatedto aid in supporting,positioning, and/orimmobilization of adultand pediatric patientsundergoing radiationtherapy of the head,brain, neck, and spineincluding radiosurgeryand electron, photon,and proton treatments.The device is also usedduring image acquisitionto support treatmentplanning. | The intended use ofthe MED-TEC, INC.Carbon FiberConformal CouchTop is to supportand aid inpositioning a patientduring radiologicand other medicalprocedures. | Patient PositioningDevices are used toaid in the support andpositioning of patientsduring an MRI. | The intended useof this device is toprovide anadditional aid tothe fast andaccurate repeatpositioning of thepatient for radiationor other treatment. |
| DesignFeatures | The Extension attachesto the Couchtop junctionoutside of the treatmentzone and is shaped sothat it follows thecontours of the patient'shead, neck, and | The Couch Top isplaced onto thetreatment pedestaland includesindexing foraccessories to beattached onto to | The device isattached to thetreatment pedestal viaLok-Bar and allowsattachment of otherpositioning andimmobilization | AccuFormCushions areactivated by achemical reactionwhen water isintroduced to theinside materials. |
{17}------------------------------------------------
Image /page/17/Picture/0 description: The image shows the CIVCO Radiotherapy logo. The logo is in blue and features the word "CIVCO" in a stylized font, with a blue circle above the "V". Below the word "CIVCO" is the word "Radiotherapy" in a smaller, sans-serif font.
| shoulder outline. | allow for patient | devices or to be used | After the device | |
|---|---|---|---|---|
| Extensions do notrequire a supportmechanism that needs tobe moved or accountedfor during planning andtreatment. | positioning andimmobilization. | stand-alone. Thedevice allows aheadrest to be addedand thermoplasticmasks to be attached. | has hardened it isa custom fit to thepatient and can beused over thecourse oftreatment. | |
| Principle ofOperation | Mechanical devices without the use of software or electronics. | |||
| Device BodyContactCategory | Limited contact duration (<24 hours) for surface devices (skin). | |||
| Sterility | N/A Devices are non-sterile |
| MTACL2035HF | AccuForm™ Cushion | |||
|---|---|---|---|---|
| Component/Parameter | Proposed Device | PredicateDevice | Reference Device | ReferenceDevice |
| 510k | K180021 | K973842 | K080072 | K982624 |
| Intended Use/Indications forUse | The device is indicatedto aid in supporting,positioning, and/orimmobilization of adultand pediatric patientsundergoing radiationtherapy of the head,brain, neck, and spineincluding radiosurgeryand electron, photon,and proton treatments.The device is also usedduring imageacquisition to supporttreatment planning. | The intended useof the MED-TEC,INC. Carbon FiberConformal CouchTop is to supportand aid inpositioning apatient duringradiologic and othermedicalprocedures. | Patient PositioningDevices are used toaid in the supportand positioning ofpatients during anMRI. | The intended useof this device is toprovide anadditional aid tothe fast andaccurate repeatpositioning of thepatient forradiation or othertreatment. |
| Design Features | The Extension attachesto the Couchtopjunction outside of thetreatment zone and isshaped so that itfollows the contours ofthe patient's head,neck, and shoulderoutline. Extensions donot require a supportmechanism that needsto be moved or | The Couch Top isplaced onto thetreatment pedestaland includesindexing foraccessories to beattached onto toallow for patientpositioning andimmobilization. | The device isattached to thetreatment pedestalvia Lok-Bar andallows attachment ofother positioning andimmobilizationdevices or to be usedstand-alone. Thedevice allows aheadrest to be addedand thermoplastic | AccuFormCushions areactivated by achemical reactionwhen water isintroduced to theinside materials.After the devicehas hardened it isa custom fit to thepatient and canbe used over the |
{18}------------------------------------------------
Image /page/18/Picture/0 description: The image shows the CIVCO Radiotherapy logo. The logo is in blue and features the word "CIVCO" in a stylized font. Above the V is a blue circle. Below the word "CIVCO" is the word "Radiotherapy".
| accounted for duringplanning and treatment. | masks to beattached. | course oftreatment. | |
|---|---|---|---|
| Principle ofOperation | Mechanical devices without the use of software or electronics. | ||
| Device BodyContact Category | Limited contact duration (<24 hours) for surface devices (skin). | ||
| Sterility | N/A Devices are non-sterile |
| MTACL2045 | AccuForm™ Cushion | |||
|---|---|---|---|---|
| Component/Parameter | Proposed Device | Predicate Device | Reference Device | Reference Device |
| 510k | K180021 | K973842 | K080072 | K982624 |
| Intended Use/Indications forUse | The device is indicatedto aid in supporting,positioning, and/orimmobilization of adultand pediatric patientsundergoing radiationtherapy of the head,brain, neck, and spineincluding radiosurgeryand electron, photon,and proton treatments.The device is also usedduring image acquisitionto support treatmentplanning. | The intended use ofthe MED-TEC, INC.Carbon FiberConformal CouchTop is to supportand aid inpositioning a patientduring radiologicand other medicalprocedures. | Patient PositioningDevices are used toaid in the support andpositioning of patientsduring an MRI. | The intended useof this device is toprovide anadditional aid tothe fast andaccurate repeatpositioning of thepatient for radiationor other treatment. |
| DesignFeatures | The Extension attachesto the Couchtop junctionoutside of the treatmentzone and is shaped sothat it follows thecontours of the patient'shead, neck, andshoulder outline.Extensions do notrequire a supportmechanism that needs tobe moved or accountedfor during planning andtreatment. | The Couch Top isplaced onto thetreatment pedestaland includesindexing foraccessories to beattached onto toallow for patientpositioning andimmobilization. | The device isattached to thetreatment pedestal viaLok-Bar and allowsattachment of otherpositioning andimmobilizationdevices or to be usedstand-alone. Thedevice allows aheadrest to be addedand thermoplasticmasks to be attached. | AccuFormCushions areactivated by achemical reactionwhen water isintroduced to theinside materials.After the devicehas hardened it isa custom fit to thepatient and can beused over thecourse oftreatment. |
| Principle ofOperation | Mechanical devices without the use of software or electronics. |
{19}------------------------------------------------
Image /page/19/Picture/0 description: The image shows the CIVCO Radiotherapy logo. The logo is blue and features the word "CIVCO" in a stylized font, with a blue circle above the "V". Below the word "CIVCO" is the word "Radiotherapy" in a smaller, sans-serif font. The logo is clean and modern, and the blue color gives it a professional and trustworthy feel.
| Device BodyContactCategory | Limited contact duration (<24 hours) for surface devices (skin). |
|---|---|
| Sterility | N/A Devices are non-sterile |
| MTACL4060 | AccuForm™ Cushion | |||
|---|---|---|---|---|
| Component/Parameter | Proposed Device | Predicate Device | Reference Device | ReferenceDevice |
| 510k | K180021 | K973842 | K080072 | K982624 |
| Intended Use/Indications forUse | The device is indicatedto aid in supporting,positioning, and/orimmobilization of adultand pediatric patientsundergoing radiationtherapy of the head,brain, neck, and spineincluding radiosurgeryand electron, photon,and proton treatments.The device is also usedduring image acquisitionto support treatmentplanning. | The intended use ofthe MED-TEC, INC.Carbon FiberConformal CouchTop is to supportand aid inpositioning a patientduring radiologicand other medicalprocedures. | Patient PositioningDevices are used toaid in the support andpositioning of patientsduring an MRI. | The intended useof this device is toprovide anadditional aid tothe fast andaccurate repeatpositioning of thepatient for radiationor other treatment. |
| DesignFeatures | The Extension attachesto the Couchtop junctionoutside of the treatmentzone and is shaped sothat it follows thecontours of the patient'shead, neck, andshoulder outline.Extensions do notrequire a supportmechanism that needs tobe moved or accountedfor during planning andtreatment. | The Couch Top isplaced onto thetreatment pedestaland includesindexing foraccessories to beattached onto toallow for patientpositioning andimmobilization. | The device isattached to thetreatment pedestal viaLok-Bar and allowsattachment of otherpositioning andimmobilizationdevices or to be usedstand-alone. Thedevice allows aheadrest to be addedand thermoplasticmasks to be attached. | AccuFormCushions areactivated by achemical reactionwhen water isintroduced to theinside materials.After the devicehas hardened it isa custom fit to thepatient and can beused over thecourse oftreatment. |
| Principle ofOperation | Mechanical deviceswithout the use ofsoftware or electronics. | Mechanical deviceswithout the use ofsoftware orelectronics. | Mechanical deviceswithout the use ofsoftware orelectronics. | Mechanicaldevices without theuse of software orelectronics. |
{20}------------------------------------------------
Image /page/20/Picture/0 description: The image shows the CIVCO Radiotherapy logo. The logo is in blue and features the word "CIVCO" in a stylized font. A blue circle is above the V in CIVCO. Below the word "CIVCO" is the word "Radiotherapy" in a smaller font.
| Device BodyContactCategory | Limited contact duration(<24 hours) for surfacedevices (skin). | Limited contactduration (<24 hours)for surface devices(skin). | Limited contactduration (<24 hours)for surface devices(skin). | Limited contactduration (<24hours) for surfacedevices (skin). |
|---|---|---|---|---|
| Sterility | N/A Devices are non-sterile | N/A Devices arenon-sterile | N/A Devices are non-sterile | N/A Devices arenon-sterile |
| MTACL6060 | AccuForm™ Cushion | |||
| Component/Parameter | Proposed Device | Predicate Device | Reference Device | ReferenceDevice |
| 510k | K180021 | K973842 | K080072 | K982624 |
| Intended Use/Indications forUse | The device is indicatedto aid in supporting,positioning, and/orimmobilization of adultand pediatric patientsundergoing radiationtherapy of the head,brain, neck, and spineincluding radiosurgeryand electron, photon,and proton treatments.The device is also usedduring image acquisitionto support treatmentplanning. | The intended use ofthe MED-TEC, INC.Carbon FiberConformal CouchTop is to supportand aid inpositioning a patientduring radiologicand other medicalprocedures. | Patient PositioningDevices are used toaid in the support andpositioning of patientsduring an MRI. | The intended useof this device is toprovide anadditional aid tothe fast andaccurate repeatpositioning of thepatient for radiationor other treatment. |
| DesignFeatures | The Extension attachesto the Couchtop junctionoutside of the treatmentzone and is shaped sothat it follows thecontours of the patient'shead, neck, andshoulder outline.Extensions do notrequire a supportmechanism that needs tobe moved or accountedfor during planning andtreatment. | The Couch Top isplaced onto thetreatment pedestaland includesindexing foraccessories to beattached onto toallow for patientpositioning andimmobilization. | The device isattached to thetreatment pedestal viaLok-Bar and allowsattachment of otherpositioning andimmobilizationdevices or to be usedstand-alone. Thedevice allows aheadrest to be addedand thermoplasticmasks to be attached. | AccuFormCushions areactivated by achemical reactionwhen water isintroduced to theinside materials.After the devicehas hardened it isa custom fit to thepatient and can beused over thecourse oftreatment. |
| Principle ofOperation | Mechanical devices without the use of software or electronics. | |||
| Device BodyContactCategory | Limited contact duration (<24 hours) for surface devices (skin). | |||
| MTACL14242 | AccuForm™ Cushion | |||
| Component/Parameter | Proposed Device | Predicate Device | Reference Device | ReferenceDevice |
| 510k | K180021 | K973842 | K080072 | K982624 |
| Intended Use/Indications forUse | The device is indicatedto aid in supporting,positioning, and/orimmobilization of adultand pediatric patientsundergoing radiationtherapy of the head,brain, neck, and spineincluding radiosurgeryand electron, photon,and proton treatments.The device is also usedduring image acquisitionto support treatmentplanning. | The intended use ofthe MED-TEC, INC.Carbon FiberConformal CouchTop is to supportand aid inpositioning a patientduring radiologicand other medicalprocedures. | Patient PositioningDevices are used toaid in the support andpositioning of patientsduring an MRI. | The intended useof this device is toprovide anadditional aid tothe fast andaccurate repeatpositioning of thepatient forradiation or othertreatment. |
| DesignFeatures | The Extension attachesto the Couchtop junctionoutside of the treatmentzone and is shaped sothat it follows thecontours of the patient'shead, neck, andshoulder outline.Extensions do notrequire a supportmechanism that needsto be moved oraccounted for duringplanning and treatment. | The Couch Top isplaced onto thetreatment pedestaland includesindexing foraccessories to beattached onto toallow for patientpositioning andimmobilization. | The device isattached to thetreatment pedestalvia Lok-Bar andallows attachment ofother positioning andimmobilizationdevices or to be usedstand-alone. Thedevice allows aheadrest to be addedand thermoplasticmasks to beattached. | AccuFormCushions areactivated by achemical reactionwhen water isintroduced to theinside materials.After the devicehas hardened it isa custom fit to thepatient and can beused over thecourse oftreatment. |
| Principle ofOperation | Mechanical deviceswithout the use ofsoftware or electronics. | Mechanical deviceswithout the use ofsoftware orelectronics. | Mechanical deviceswithout the use ofsoftware orelectronics. | Mechanicaldevices withoutthe use ofsoftware orelectronics. |
| Device BodyContactCategory | Limited contact duration(<24 hours) for surfacedevices (skin). | Limited contactduration (<24hours) for surfacedevices (skin). | Limited contactduration (<24 hours)for surface devices(skin). | Limited contactduration (<24hours) for surfacedevices (skin). |
| Sterility | N/A Devices are non-sterile | N/A Devices arenon-sterile | N/A Devices are non-sterile | N/A Devices arenon-sterile |
{21}------------------------------------------------
Image /page/21/Picture/0 description: The image shows the logo for CIVCO Radiotherapy. The logo is in blue and features the word "CIVCO" in a stylized font. Below the word "CIVCO" is the word "Radiotherapy" in a smaller font, also in blue. The logo is simple and modern.
N/A Devices are non-sterile Sterility
www.civcort.com
Corporate Office | 2301 Jones Boulevard | Coralville, IA 52241 | USA | office +1 (319) 248.6757 | info@civcort.com Global Sales Office | 1401 8º Street SE | Orange City, IA 51041 | USA | office +1 (712) 737.8688 | fax +1 (877) 613.6300
510(k) Summary – Page 19
{22}------------------------------------------------
Image /page/22/Picture/0 description: The image shows the CIVCO Radiotherapy logo. The word "CIVCO" is in large, bold, blue letters, with a light blue circle above the "V". Below the word "CIVCO" is the word "Radiotherapy" in a smaller, blue font.
| MTACLTYPES1 | AccuForm™ Cushion | |||
|---|---|---|---|---|
| Component/Parameter | Proposed Device | PredicateDevice | Reference Device | ReferenceDevice |
| 510k | K180021 | K973842 | K080072 | K982624 |
| Intended Use/Indications forUse | The device is indicatedto aid in supporting,positioning, and/orimmobilization of adultand pediatric patientsundergoing radiationtherapy of the head,brain, neck, and spineincluding radiosurgeryand electron, photon,and proton treatments.The device is also usedduring imageacquisition to supporttreatment planning. | The intended useof the MED-TEC,INC. Carbon FiberConformal CouchTop is to supportand aid inpositioning apatient duringradiologic andother medicalprocedures. | Patient PositioningDevices are used toaid in the supportand positioning ofpatients during anMRI. | The intended useof this device is toprovide anadditional aid tothe fast andaccurate repeatpositioning of thepatient forradiation or othertreatment. |
| Design Features | The Extension attachesto the Couchtopjunction outside of thetreatment zone and isshaped so that itfollows the contours ofthe patient's head,neck, and shoulderoutline. Extensions donot require a supportmechanism that needsto be moved oraccounted for duringplanning and treatment. | The Couch Top isplaced onto thetreatment pedestaland includesindexing foraccessories to beattached onto toallow for patientpositioning andimmobilization. | The device isattached to thetreatment pedestalvia Lok-Bar andallows attachment ofother positioning andimmobilizationdevices or to beused stand-alone.The device allows aheadrest to be addedand thermoplasticmasks to beattached. | AccuFormCushions areactivated by achemical reactionwhen water isintroduced to theinside materials.After the devicehas hardened it isa custom fit to thepatient and canbe used over thecourse oftreatment. |
| Principle ofOperation | Mechanical devices without the use of software or electronics. | |||
| Device BodyContact Category | Limited contact duration (<24 hours) for surface devices (skin). | |||
| Sterility | N/A Devices are non-sterile |
{23}------------------------------------------------
Image /page/23/Picture/0 description: The image shows the CIVCO Radiotherapy logo. The logo is in blue and features the word "CIVCO" in a stylized font. The "V" in CIVCO has a blue circle above it. Below the word "CIVCO" is the word "Radiotherapy" in a smaller font.
General Positioning Devices
| MTIL6720 | IPPS™ Couchtop | |
|---|---|---|
| Component/Parameter | Proposed Device | Predicate Device |
| 510k | K180021 | K973842 |
| Intended Use/Indications forUse | The device is indicated to aid in supporting andpositioning adult and pediatric patients undergoingradiation therapy including electron, photon, andproton treatments. The device is also used duringimage acquisition to support treatment planning. | The intended use of the MED-TEC,INC. Carbon Fiber Conformal CouchTop is to support and aid in positioninga patient during radiologic and othermedical procedures. |
| DesignFeatures | The Couchtop is attached to a treatment deliverysystem pedestal. The Couchtop uses Prodigy 2indexing at seven centimeter increments to allowindexing for accessories to be attached whichallows patient positioning and immobilization. | The Couch Top is placed onto thetreatment pedestal and includesindexing for accessories to be attachedonto to allow for patient positioning andimmobilization. |
| Principle ofOperation | Mechanical devices without the use of software or electronics. | |
| Device BodyContactCategory | Limited contact duration (<24 hours) for surface devices (skin). | |
| Sterility | N/A Devices are non-sterile |
| MTIL6740 | Universal Couchtop | |
|---|---|---|
| Component/Parameter | Proposed Device | Predicate Device |
| 510k | K180021 | K973842 |
| Intended Use/Indications forUse | The device is indicated to aid in supporting andpositioning adult and pediatric patients undergoingradiation therapy including electron, photon, andproton treatments. The device is also used duringimage acquisition to support treatment planning. | The intended use of the MED-TEC, INC.Carbon Fiber Conformal Couch Top isto support and aid in positioning apatient during radiologic and othermedical procedures. |
| DesignFeatures | The Couchtop is attached to a treatment deliverysystem pedestal. The Couchtop uses Prodigy 2indexing at seven centimeter increments | The Couch Top is placed onto thetreatment pedestal and includesindexing for accessories to be attachedonto to allow for patient positioning andimmobilization. |
| Principle ofOperation | Mechanical devices without the use of software or electronics. | |
| Device BodyContactCategory | Limited contact duration (<24 hours) for surface devices (skin). | |
| Sterility | N/A Devices are non-sterile |
www.civcort.com
{24}------------------------------------------------
Image /page/24/Picture/0 description: The image shows the logo for CIVCO Radiotherapy. The logo is in blue and features the word "CIVCO" in a bold, sans-serif font. Above the "V" is a light blue circle. Below the word "CIVCO" is the word "Radiotherapy" in a smaller, sans-serif font.
| MTIL6660 | Rectangular Extension | |
|---|---|---|
| Component/Parameter | Proposed Device | Predicate Device |
| 510k | K180021 | K973842 |
| Intended Use/Indications forUse | The device is indicated to aid in supporting andpositioning adult and pediatric patients undergoingradiation therapy including electron, photon, and protontreatments. The device is also used during imageacquisition to support treatment planning. | The intended use of the MED-TEC,INC. Carbon Fiber ConformalCouch Top is to support and aid inpositioning a patient duringradiologic and other medicalprocedures. |
| DesignFeatures | The Rectangular Extension attaches to a Couchtopjunction, outside of the treatment zone, and is shapedto allow a variety of treatment areas. The patient layson top of the device while receiving treatment. TheRectangular Extension has seven-centimeter indexingto allow for reproducible patient positioning withaccessory devices. | The Couch Top is placed onto thetreatment pedestal and includesindexing for accessories to beattached onto to allow for patientpositioning and immobilization. |
| Principle ofOperation | Mechanical devices without the use of software or electronics. | |
| Device BodyContactCategory | Limited contact duration (<24 hours) for surface devices (skin). | |
| Sterility | N/A Devices are non-sterile |
| MTIL662501 | Patient Hand Grip | |
|---|---|---|
| Component/Parameter | Proposed Device | Predicate Device |
| 510k | K180021 | K973842 |
| Intended Use/Indications forUse | The device is indicated to aid in supporting andpositioning adult and pediatric patients undergoingradiation therapy including electron, photon, and protontreatments. The device is also used during imageacquisition to support treatment planning. | The intended use of the MED-TEC, INC. Carbon FiberConformal Couch Top is tosupport and aid in positioning apatient during radiologic and othermedical procedures. |
| DesignFeatures | The hand grips are optional accessories and areattached to the indexing on the side of the extensionsand Couchtops. The Hand Grips provide a location forpatients to place their hands, or to grasp, duringtreatments. The Hand Grips are ergonomically shaped,there is a defined left-Hand Grip and right-Hand Grip forpatient positioning and comfort. | The Couch Top is placed onto thetreatment pedestal and includesindexing for accessories to beattached onto to allow for patientpositioning and immobilization. |
| Principle ofOperation | Mechanical devices without the use of software or electronics. |
{25}------------------------------------------------
Image /page/25/Picture/0 description: The image shows the CIVCO Radiotherapy logo. The logo is in blue and features the word "CIVCO" in a bold, sans-serif font. A light blue circle is placed above the V. Below the word "CIVCO" is the word "Radiotherapy" in a smaller, sans-serif font.
| Device BodyContactCategory | Limited contact duration (<24 hours) for surface devices (skin). |
|---|---|
| Sterility | N/A Devices are non-sterile |
| MTIL662502 | Patient Hand GripProposed Device | Predicate Device |
|---|---|---|
| Component/Parameter | ||
| 510k | K180021 | K973842 |
| Intended Use/Indications forUse | The device is indicated to aid in supporting andpositioning adult and pediatric patients undergoingradiation therapy including electron, photon, and protontreatments. The device is also used during imageacquisition to support treatment planning. | The intended use of the MED-TEC, INC. Carbon FiberConformal Couch Top is tosupport and aid in positioning apatient during radiologic and othermedical procedures. |
| DesignFeatures | The hand grips are optional accessories and areattached to the indexing on the side of the extensionsand Couchtops. The Hand Grips provide a location forpatients to place their hands, or to grasp, duringtreatments. The Hand Grips are ergonomically shaped,there is a defined left-Hand Grip and right-Hand Grip forpatient positioning and comfort. | The Couch Top is placed onto thetreatment pedestal and includesindexing for accessories to beattached onto to allow for patientpositioning and immobilization. |
| Principle ofOperation | Mechanical devices without the use of software or electronics. | |
| Device BodyContactCategory | Limited contact duration (<24 hours) for surface devices (skin). | |
| Sterility | N/A Devices are non-sterile |
| MTVLG35FC | Vac-Lok Cushion | |||
|---|---|---|---|---|
| Component/Parameter | Proposed Device | PredicateDevice | Reference Device | Reference Device |
| 510k | K180021 | K973842 | K080072 | K935300 |
| Intended Use/Indications forUse | The device isindicated to aid insupporting andpositioning adult andpediatric patientsundergoing radiationtherapy includingelectron, photon, andproton treatments.The device is also | The intended useof the MED-TEC,INC. Carbon FiberConformal CouchTop is to supportand aid inpositioning apatient duringradiologic and | Patient PositioningDevices are used toaid in the support andpositioning of patientsduring an MRI. | The intended use ofthis device is toimmobilize the patientduring radiationtherapy. |
{26}------------------------------------------------
Image /page/26/Picture/0 description: The image shows the CIVCO Radiotherapy logo. The logo is blue and features the word "CIVCO" in a stylized font, with a blue circle above the "V". Below the word "CIVCO" is the word "Radiotherapy" in a smaller font. The logo is simple and modern, and the blue color gives it a professional and trustworthy look.
| used during imageacquisition to supporttreatment planning. | other medicalprocedures. | |||
|---|---|---|---|---|
| DesignFeatures | The Vac-Lok™Cushions indexes tothe Couchtop forreproduciblepositioning of thepatient fromsimulation to imagingto treatment. TheCushion is placed ona treatment table andformed around patientanatomy to allow forreproduciblepositioning. TheCushions are filledwith polystyrenebeads with a nyloncasing whichbecomes rigid andforms to the patient'sanatomy when thevacuum removes airfrom the cushionthrough a valve | The Couch Top isplaced onto thetreatment pedestaland includesindexing foraccessories to beattached onto toallow for patientpositioning andimmobilization. | The Vac-Lok™Cushions indexes tothe Couchtop forreproduciblepositioning of thepatient fromsimulation to imagingto treatment. TheCushion is placed ona treatment table andformed around patientanatomy to allow forreproduciblepositioning. TheCushions are filledwith polystyrenebeads with a nyloncasing whichbecomes rigid andforms to the patient'sanatomy when thevacuum removes airfrom the cushionthrough a valve | The Vac-Lok™Cushions indexes tothe Couchtop forreproduciblepositioning of thepatient fromsimulation to imagingto treatment. TheCushion is placed ona treatment table andformed around patientanatomy to allow forreproduciblepositioning. TheCushions are filledwith polystyrenebeads with a nyloncasing whichbecomes rigid andforms to the patient'sanatomy when thevacuum removes airfrom the cushionthrough a valve |
| Principle ofOperation | Mechanical devices without the use of software or electronics. | |||
| Device BodyContactCategory | Limited contact duration (<24 hours) for surface devices (skin). | |||
| Sterility | N/A Devices are non-sterile |
| 151004 | Combifix Cushion | ||
|---|---|---|---|
| Component/Parameter | Proposed Device | Predicate Device | Reference Device |
| 510k | K180021 | K973842 | K060737 |
| Intended Use/Indications forUse | The device is indicated to aid insupporting and positioning adultand pediatric patientsundergoing radiation therapyincluding electron, photon, andproton treatments. The deviceis also used during image | The intended use of theMED-TEC, INC. CarbonFiber Conformal Couch Topis to support and aid inpositioning a patient duringradiologic and othermedical procedures. | Positioning of hip and lowerextremities of a patient duringradiotherapy and diagnostics. |
{27}------------------------------------------------
Image /page/27/Picture/0 description: The image shows the logo for CIVCO Radiotherapy. The logo is blue and features the word "CIVCO" in a stylized font. The "V" in CIVCO has a blue circle above it. Below the word "CIVCO" is the word "Radiotherapy".
| acquisition to support treatment planning. | |||
|---|---|---|---|
| Design Features | The Combifix Cushion indexes to the Couchtop and combines the Kneefix and Feetfix for reproducible positioning of a patient. The Combifix Cushion provides patient support to the leg region and ease to the back region. | The Couch Top is placed onto the treatment pedestal and includes indexing for accessories to be attached onto to allow for patient positioning and immobilization. | The Combifix Cushion indexes to the Couchtop and combines the Kneefix and Feetfix for reproducible positioning of a patient. The Combifix Cushion provides patient support to the leg region and ease to the back region. |
| Principle of Operation | Mechanical devices without the use of software or electronics. | ||
| Device Body Contact Category | Limited contact duration (<24 hours) for surface devices (skin). | ||
| Sterility | N/A Devices are non-sterile |
Support Garments
| CRTBRA01 | Chabner XRT® Radiation Bra | |||
|---|---|---|---|---|
| Component/Parameter | Proposed Device | Predicate Device | Reference Device | |
| 510k | K180021 | K973842 | K121284 | |
| Intended Use/Indications forUse | The device is indicated to aid insupporting adolescent andadult patients undergoingradiation therapy includingelectron, photon, and protontreatments. The device is alsoused during image acquisitionto support treatment planning.The device is not intended foruse with patients under 12years of age. | The intended use of theMED-TEC, INC. CarbonFiber Conformal CouchTop is to support and aidin positioning a patientduring radiologic andother medicalprocedures. | Chabner XRT™ Garments areintended to be used as an aid inthe support of the patient duringX-ray, computed tomography,magnetic resonance imaging,radiotherapy, and otherdiagnostic radiologicalprocedures. The Chabner XRTGarments are not intended forpediatric use. | |
| DesignFeatures | The device is composed ofseveral pliable materialsstitched together. A patient ismeasured and fit by theprovider. The adjustablelocations of the bra are able tobe marked to return to thesame position for eachtreatment. The bra is to be | The Couch Top is placedonto the treatmentpedestal and includesindexing for accessoriesto be attached onto toallow for patientpositioning andimmobilization. | The device is composed ofseveral pliable materials stitchedtogether. A patient is measuredand fit by the provider. Theadjustable locations of the braare able to be marked to returnto the same position for eachtreatment. The bra is to be single |
www.civcort.com
{28}------------------------------------------------
Image /page/28/Picture/0 description: The image shows the CIVCO Radiotherapy logo. The logo is in blue and features the word "CIVCO" in a stylized font. Above the V is a blue circle. Below the logo is the word "Radiotherapy" in a smaller, sans-serif font.
| single patient use anddiscarded at the end of thetreatment cycle. | patient use and discarded at theend of the treatment cycle. | |
|---|---|---|
| Principle ofOperation | Mechanical devices without the use of software or electronics. | |
| Device BodyContactCategory | Limited contact duration (<24 hours) for surface devices (skin). | |
| Sterility | N/A Devices are non-sterile |
| CRTBRA02 | Chabner XRT® Radiation Bra | ||
|---|---|---|---|
| Component/Parameter | Proposed Device | Predicate Device | Reference Device |
| 510k | K180021 | K973842 | K121284 |
| Intended Use/Indications forUse | The device is indicated to aid insupporting adolescent andadult patients undergoingradiation therapy includingelectron, photon, and protontreatments. The device is alsoused during image acquisitionto support treatment planning.The device is not intended foruse with patients under 12years of age. | The intended use of theMED-TEC, INC. CarbonFiber Conformal CouchTop is to support and aidin positioning a patientduring radiologic andother medicalprocedures. | Chabner XRTTM Garments areintended to be used as an aid inthe support of the patient duringX-ray, computed tomography,magnetic resonance imaging,radiotherapy, and otherdiagnostic radiologicalprocedures. The Chabner XRTGarments are not intended forpediatric use. |
| DesignFeatures | The device is composed ofseveral pliable materialsstitched together. A patient ismeasured and fit by theprovider. The adjustablelocations of the bra are able tobe marked to return to thesame position for eachtreatment. The bra is to besingle patient use anddiscarded at the end of thetreatment cycle. | The Couch Top is placedonto the treatmentpedestal and includesindexing for accessoriesto be attached onto toallow for patientpositioning andimmobilization. | The device is composed ofseveral pliable materials stitchedtogether. A patient is measuredand fit by the provider. Theadjustable locations of the braare able to be marked to returnto the same position for eachtreatment. The bra is to be singlepatient use and discarded at theend of the treatment cycle. |
| Principle ofOperation | Mechanical devices without the use of software or electronics. | ||
| Device BodyContactCategory | Limited contact duration (<24 hours) for surface devices (skin). | ||
| Sterility | N/A Devices are non-sterile |
{29}------------------------------------------------
Image /page/29/Picture/0 description: The image shows the logo for CIVCO Radiotherapy. The logo is in blue and features the word "CIVCO" in a stylized font. Above the V is a light blue circle. Below the logo is the word "Radiotherapy" in a smaller, sans-serif font.
| CRTBRA03 | Chabner XRT® Radiation Bra | ||
|---|---|---|---|
| Component/Parameter | Proposed Device | Predicate Device | Reference Device |
| 510k | K180021 | K973842 | K121284 |
| Intended Use/Indications forUse | The device is indicated to aid insupporting adolescent andadult patients undergoingradiation therapy includingelectron, photon, and protontreatments. The device is alsoused during image acquisitionto support treatment planning.The device is not intended foruse with patients under 12years of age. | The intended use of theMED-TEC, INC. CarbonFiber Conformal CouchTop is to support and aidin positioning a patientduring radiologic andother medicalprocedures. | Chabner XRT™ Garments areintended to be used as an aid inthe support of the patient duringX-ray, computed tomography,magnetic resonance imaging,radiotherapy, and otherdiagnostic radiologicalprocedures. The Chabner XRTGarments are not intended forpediatric use. |
| DesignFeatures | The device is composed ofseveral pliable materialsstitched together. A patient ismeasured and fit by theprovider. The adjustablelocations of the bra are able tobe marked to return to thesame position for eachtreatment. The bra is to besingle patient use anddiscarded at the end of thetreatment cycle. | The Couch Top is placedonto the treatmentpedestal and includesindexing for accessoriesto be attached onto toallow for patientpositioning andimmobilization. | The device is composed ofseveral pliable materials stitchedtogether. A patient is measuredand fit by the provider. Theadjustable locations of the braare able to be marked to returnto the same position for eachtreatment. The bra is to be singlepatient use and discarded at theend of the treatment cycle. |
| Principle ofOperation | Mechanical devices without the use of software or electronics. | ||
| Device BodyContactCategory | Limited contact duration (<24 hours) for surface devices (skin). | ||
| Sterility | N/A Devices are non-sterile |
| CRTBRA04 | Chabner XRT® Radiation Bra | ||
|---|---|---|---|
| Component/Parameter | Proposed Device | Predicate Device | Reference Device |
| 510k | K180021 | K973842 | K121284 |
| Intended Use/Indications forUse | The device is indicated to aid insupporting adolescent andadult patients undergoingradiation therapy includingelectron, photon, and protontreatments. The device is also | The intended use of theMED-TEC, INC. CarbonFiber Conformal CouchTop is to support and aidin positioning a patientduring radiologic and | Chabner XRT TM Garments areintended to be used as an aid inthe support of the patient duringX-ray, computed tomography,magnetic resonance imaging,radiotherapy, and other |
{30}------------------------------------------------
Image /page/30/Picture/0 description: The image shows the CIVCO Radiotherapy logo. The logo is in blue and features the word "CIVCO" in a stylized font. The "V" in CIVCO has a blue circle above it. Below the word "CIVCO" is the word "Radiotherapy".
| DesignFeatures | used during image acquisitionto support treatment planning.The device is not intended foruse with patients under 12years of age. | other medicalprocedures. | diagnostic radiologicalprocedures. The Chabner XRTGarments are not intended forpediatric use. |
|---|---|---|---|
| The device is composed ofseveral pliable materialsstitched together. A patient ismeasured and fit by theprovider. The adjustablelocations of the bra are able tobe marked to return to thesame position for eachtreatment. The bra is to besingle patient use anddiscarded at the end of thetreatment cycle. | The Couch Top is placedonto the treatmentpedestal and includesindexing for accessoriesto be attached onto toallow for patientpositioning andimmobilization. | The device is composed ofseveral pliable materials stitchedtogether. A patient is measuredand fit by the provider. Theadjustable locations of the braare able to be marked to returnto the same position for eachtreatment. The bra is to be singlepatient use and discarded at theend of the treatment cycle. | |
| Principle ofOperation | Mechanical devices without the use of software or electronics. | ||
| Device BodyContactCategory | Limited contact duration (<24 hours) for surface devices (skin). | ||
| Sterility | N/A Devices are non-sterile | ||
| CRTBRA05 | Chabner XRT® Radiation Bra | ||
| Component/Parameter | Proposed Device | Predicate Device | Reference Device |
| 510k | K180021 | K973842 | K121284 |
| Intended Use/Indications forUse | The device is indicated to aid insupporting adolescent andadult patients undergoingradiation therapy includingelectron, photon, and protontreatments. The device is alsoused during image acquisitionto support treatment planning.The device is not intended foruse with patients under 12years of age. | The intended use of theMED-TEC, INC. CarbonFiber Conformal CouchTop is to support and aidin positioning a patientduring radiologic andother medicalprocedures. | Chabner XRT™ Garments areintended to be used as an aid inthe support of the patient duringX-ray, computed tomography,magnetic resonance imaging,radiotherapy, and otherdiagnostic radiologicalprocedures. The Chabner XRTGarments are not intended forpediatric use. |
| DesignFeatures | The device is composed ofseveral pliable materialsstitched together. A patient ismeasured and fit by theprovider. The adjustablelocations of the bra are able to | The Couch Top is placedonto the treatmentpedestal and includesindexing for accessoriesto be attached onto toallow for patient | The device is composed ofseveral pliable materials stitchedtogether. A patient is measuredand fit by the provider. Theadjustable locations of the braare able to be marked to return |
{31}------------------------------------------------
Image /page/31/Picture/0 description: The image shows the CIVCO Radiotherapy logo. The logo is blue and features the word "CIVCO" in a stylized font. A blue circle is above the V. Below the word "CIVCO" is the word "Radiotherapy" in a smaller font.
| be marked to return to thesame position for eachtreatment. The bra is to besingle patient use anddiscarded at the end of thetreatment cycle. | positioning andimmobilization. | to the same position for eachtreatment. The bra is to be singlepatient use and discarded at theend of the treatment cycle. | |
|---|---|---|---|
| Principle ofOperation | Mechanical devices without the use of software or electronics. | ||
| Device BodyContactCategory | Limited contact duration (<24 hours) for surface devices (skin). | ||
| Sterility | N/A Devices are non-sterile |
| CRTBRA06 | Chabner XRT® Radiation Bra | ||
|---|---|---|---|
| Component/Parameter | Proposed Device | Predicate Device | Reference Device |
| 510k | K180021 | K973842 | K121284 |
| Intended Use/Indications forUse | The device is indicated to aid insupporting adolescent andadult patients undergoingradiation therapy includingelectron, photon, and protontreatments. The device is alsoused during image acquisitionto support treatment planning.The device is not intended foruse with patients under 12years of age. | The intended use of theMED-TEC, INC. CarbonFiber Conformal CouchTop is to support and aidin positioning a patientduring radiologic andother medicalprocedures. | Chabner XRT™ Garments areintended to be used as an aid inthe support of the patient duringX-ray, computed tomography,magnetic resonance imaging,radiotherapy, and otherdiagnostic radiologicalprocedures. The Chabner XRTGarments are not intended forpediatric use. |
| DesignFeatures | The device is composed ofseveral pliable materialsstitched together. A patient ismeasured and fit by theprovider. The adjustablelocations of the bra are able tobe marked to return to thesame position for eachtreatment. The bra is to besingle patient use anddiscarded at the end of thetreatment cycle. | The Couch Top is placedonto the treatmentpedestal and includesindexing for accessoriesto be attached onto toallow for patientpositioning andimmobilization. | The device is composed ofseveral pliable materials stitchedtogether. A patient is measuredand fit by the provider. Theadjustable locations of the braare able to be marked to returnto the same position for eachtreatment. The bra is to be singlepatient use and discarded at theend of the treatment cycle. |
| Principle ofOperation | Mechanical devices without the use of software or electronics. |
{32}------------------------------------------------
Image /page/32/Picture/0 description: The image shows the logo for CIVCO Radiotherapy. The logo is in blue and features the word "CIVCO" in a stylized font, with a blue circle above the "V". Below the word "CIVCO" is the word "Radiotherapy" in a smaller, sans-serif font.
| Device BodyContactCategory | Limited contact duration (<24 hours) for surface devices (skin). |
|---|---|
| Sterility | N/A Devices are non-sterile |
| CRTBRA07 | Chabner XRT® Radiation Bra | ||
|---|---|---|---|
| Component/Parameter | Proposed Device | Predicate Device | Reference Device |
| 510k | K180021 | K973842 | K121284 |
| Intended Use/Indications forUse | The device is indicated to aid insupporting adolescent andadult patients undergoingradiation therapy includingelectron, photon, and protontreatments. The device is alsoused during image acquisitionto support treatment planning.The device is not intended foruse with patients under 12years of age. | The intended use of theMED-TEC, INC. CarbonFiber Conformal CouchTop is to support and aidin positioning a patientduring radiologic andother medicalprocedures. | Chabner XRTTM Garments areintended to be used as an aid inthe support of the patient duringX-ray, computed tomography,magnetic resonance imaging,radiotherapy, and otherdiagnostic radiologicalprocedures. The Chabner XRTGarments are not intended forpediatric use. |
| DesignFeatures | The device is composed ofseveral pliable materialsstitched together. A patient ismeasured and fit by theprovider. The adjustablelocations of the bra are able tobe marked to return to thesame position for eachtreatment. The bra is to besingle patient use anddiscarded at the end of thetreatment cycle. | The Couch Top is placedonto the treatmentpedestal and includesindexing for accessoriesto be attached onto toallow for patientpositioning andimmobilization. | The device is composed ofseveral pliable materials stitchedtogether. A patient is measuredand fit by the provider. Theadjustable locations of the braare able to be marked to returnto the same position for eachtreatment. The bra is to be singlepatient use and discarded at theend of the treatment cycle. |
| Principle ofOperation | Mechanical devices without the use of software or electronics. | ||
| Device BodyContactCategory | Limited contact duration (<24 hours) for surface devices (skin). | ||
| Sterility | N/A Devices are non-sterile | ||
| CRTBRA08 | Chabner XRT® Radiation Bra | ||
| Component/Parameter | Proposed Device | Predicate Device | Reference Device |
| 510k | K180021 | K973842 | K121284 |
{33}------------------------------------------------
Image /page/33/Picture/0 description: The image is the logo for CIVCO Radiotherapy. The logo is blue and features the word "CIVCO" in a stylized font. The "V" in CIVCO has a light blue circle above it. Below the word "CIVCO" is the word "Radiotherapy" in a smaller, sans-serif font.
| Intended Use/ Indications for Use | |||
|---|---|---|---|
| The device is indicated to aid in supporting adolescent and adult patients undergoing radiation therapy including electron, photon, and proton treatments. The device is also used during image acquisition to support treatment planning. The device is not intended for use with patients under 12 years of age. | The intended use of the MED-TEC, INC. Carbon Fiber Conformal Couch Top is to support and aid in positioning a patient during radiologic and other medical procedures. | Chabner XRT™ Garments are intended to be used as an aid in the support of the patient during X-ray, computed tomography, magnetic resonance imaging, radiotherapy, and other diagnostic radiological procedures. The Chabner XRT Garments are not intended for pediatric use. | |
| Design Features | The device is composed of several pliable materials stitched together. A patient is measured and fit by the provider. The adjustable locations of the bra are able to be marked to return to the same position for each treatment. The bra is to be single patient use and discarded at the end of the treatment cycle. | The Couch Top is placed onto the treatment pedestal and includes indexing for accessories to be attached onto to allow for patient positioning and immobilization. | The device is composed of several pliable materials stitched together. A patient is measured and fit by the provider. The adjustable locations of the bra are able to be marked to return to the same position for each treatment. The bra is to be single patient use and discarded at the end of the treatment cycle. |
| Principle of Operation | Mechanical devices without the use of software or electronics. | ||
| Device Body Contact Category | Limited contact duration (<24 hours) for surface devices (skin). | ||
| Sterility | N/A Devices are non-sterile |
| CRTBRA09 | Chabner XRT® Radiation Bra | |||
|---|---|---|---|---|
| Proposed Device | Predicate Device | Reference Device | ||
| Component/Parameter | 510k | K180021 | K973842 | K121284 |
| Intended Use/Indications forUse | The device is indicated to aid insupporting adolescent andadult patients undergoingradiation therapy includingelectron, photon, and protontreatments. The device is alsoused during image acquisitionto support treatment planning.The device is not intended foruse with patients under 12years of age. | The intended use of theMED-TEC, INC. CarbonFiber Conformal CouchTop is to support and aidin positioning a patientduring radiologic andother medicalprocedures. | Chabner XRT™ Garments areintended to be used as an aid inthe support of the patient duringX-ray, computed tomography,magnetic resonance imaging,radiotherapy, and otherdiagnostic radiologicalprocedures. The Chabner XRTGarments are not intended forpediatric use. |
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Image /page/34/Picture/0 description: The image shows the CIVCO Radiotherapy logo. The logo is blue and features the word "CIVCO" in a stylized font. A blue circle is above the V. Below the word "CIVCO" is the word "Radiotherapy".
| Design Features | The device is composed of several pliable materials stitched together. A patient is measured and fit by the provider. The adjustable locations of the bra are able to be marked to return to the same position for each treatment. The bra is to be single patient use and discarded at the end of the treatment cycle. | The Couch Top is placed onto the treatment pedestal and includes indexing for accessories to be attached onto to allow for patient positioning and immobilization. | The device is composed of several pliable materials stitched together. A patient is measured and fit by the provider. The adjustable locations of the bra are able to be marked to return to the same position for each treatment. The bra is to be single patient use and discarded at the end of the treatment cycle. |
|---|---|---|---|
| Principle of Operation | Mechanical devices without the use of software or electronics. | ||
| Device Body Contact Category | Limited contact duration (<24 hours) for surface devices (skin). | ||
| Sterility | N/A Devices are non-sterile |
| CRTEXT01 | Bra Extender | ||
|---|---|---|---|
| Component/Parameter | Proposed Device | Predicate Device | Reference Device |
| 510k | K180021 | K973842 | K121284 |
| Intended Use/Indications forUse | The device is indicated to aid insupporting adolescent andadult patients undergoingradiation therapy includingelectron, photon, and protontreatments. The device is alsoused during image acquisitionto support treatment planning.The device is not intended foruse with patients under 12years of age. | The intended use of theMED-TEC, INC. CarbonFiber Conformal CouchTop is to support and aidin positioning a patientduring radiologic andother medicalprocedures. | Chabner XRT™ Garments areintended to be used as an aid inthe support of the patient duringX-ray, computed tomography,magnetic resonance imaging,radiotherapy, and otherdiagnostic radiologicalprocedures. The Chabner XRTGarments are not intended forpediatric use. |
| DesignFeatures | The device is composed ofseveral pliable materialsstitched together. A patient ismeasured and fit by theprovider. The adjustablelocations of the bra are able tobe marked to return to thesame position for eachtreatment. The bra is to besingle patient use and | The Couch Top is placedonto the treatmentpedestal and includesindexing for accessoriesto be attached onto toallow for patientpositioning andimmobilization. | The device is composed ofseveral pliable materials stitchedtogether. A patient is measuredand fit by the provider. Theadjustable locations of the braare able to be marked to returnto the same position for eachtreatment. The bra is to be singlepatient use and discarded at theend of the treatment cycle. |
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Image /page/35/Picture/0 description: The image shows the logo for CIVCO Radiotherapy. The logo is blue and features the word "CIVCO" in a stylized font. Above the V is a light blue circle. Below the word "CIVCO" is the word "Radiotherapy" in a smaller font.
| discarded at the end of thetreatment cycle. | |||
|---|---|---|---|
| Principle ofOperation | Mechanical devices without the use of software or electronics. | ||
| Device BodyContactCategory | Limited contact duration (<24 hours) for surface devices (skin). | ||
| Sterility | N/A Devices are non-sterile |
Breast Positioning Devices
| MTM400 | C-Qual M with Monarch | ||
|---|---|---|---|
| Component/Parameter | Proposed Device | Predicate Device | Reference Device |
| 510k | K180021 | K973842 | K974703 |
| Intended Use/Indications forUse | The device is indicated to aid insupporting and positioning adultand adolescent patientsundergoing radiation therapy ofthe breast and chest regionincluding electron, photon, andproton treatments. The device isalso used during imageacquisition to support treatmentplanning. The device is notintended for use with patientsunder 12 years of age. | The intended use ofthe MED-TEC, INC.Carbon FiberConformal Couch Topis to support and aidin positioning apatient duringradiologic and othermedical procedures. | The intended use of the MED-Tec, INC. Carbon Fiber BreastBoard is to support and aid inpositioning a patient duringradiologic and other medicalprocedures. |
| DesignFeatures | The Breastboard indexes to theCouchtop for reproduciblepositioning of a patient. TheBreastboard provides patientsupport arms up positioning andallows for proper superior/inferioradjustments of the board to thepatient's anatomy. TheBreastboard elevates from 5 to 25degrees with nine different tiltpositions. The adjustablesuperior/inferior arms up and thevariable elevation allows forreproducible immobilization andadditional comfort while meetingclinically necessary positioning. | The Couch Top isplaced onto thetreatment pedestaland includes indexingfor accessories to beattached onto to allowfor patient positioningand immobilization. | The Breastboard indexes to theCouchtop for reproduciblepositioning of a patient. TheBreastboard provides patientsupport arms up positioning andallows for proper superior/inferioradjustments and elevations of theboard to the patient's anatomy.The adjustable superior/inferiorarms up and the variableelevation allows for reproducibleimmobilization and additionalcomfort while meeting clinicallynecessary positioning. |
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Image /page/36/Picture/0 description: The image shows the CIVCO Radiotherapy logo. The logo is in blue and features the word "CIVCO" in a stylized font, with a blue circle above the "V". Below the word "CIVCO" is the word "Radiotherapy" in a smaller, sans-serif font, also in blue. The logo is simple and modern, and the use of blue gives it a professional and trustworthy feel.
| Principle ofOperation | Mechanical devices without the use of software or electronics. |
|---|---|
| Device BodyContactCategory | Limited contact duration (<24 hours) for surface devices (skin). |
| Sterility | N/A Devices are non-sterile |
G. Non-Clinical Testing and Literature Review
Non-Clinical testing was done to confirm the safety and effectiveness of the use of devices in the Proton environment and/or in path of Proton Beam. Devices were selected for performance testing based on whether they will be used in the path of the proton beam. Performance tests were completed to ensure these devices would not perturb or impact the proton beam in a way that cannot be accounted for in the proton treatment planning process. This data is provided as reference only, as it is standard practice that all hospitals and clinics perform their own respective treatment planning and attenuation testing due to variation in setup and machines.
Devices were evaluated, including edge effects, and were considered as safe and effective as the predicate. Because there is no recognized threshold for Proton attenuation, the criteria used for determining acceptable performance was to verify the part will not perturb or impact the proton beam in a way that cannot be accounted for in the facility's proton treatment planning process.
Devices that were not tested by CIVCO would not be used in the treatment zone or have the Proton Beam directed through the material. These devices are still safe to use in the Proton environment.
The risk analysis confirms the safety and effectiveness of similar devices used for pediatrics/adolescents, Proton Therapy and to ensure no new issues are raised.
Proton therapy is a widely accepted form of radiation therapy due to the characteristics of being minimally invasive, accuracy, and least harmful to surrounding healthy tissue. Couchtop, overlay, extension, thermoplastic mask, cushion, support garment, breastboard, and accessories are an integral part of patient simulation and external beam treatment delivery for proton and photon.
CIVCO devices are safe and effective for use in Proton Beam therapy as they immobilize/support/position the patient and can be transferred between modalities. Devices were evaluated, including edge effects, and were considered safe and effective for use in Proton. Because there is no recognized threshold for Proton attenuation, the criteria used for determining acceptable performance was to verify the part will not
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Image /page/37/Picture/0 description: The image shows the logo for CIVCO Radiotherapy. The logo is in blue and consists of the word "CIVCO" in a stylized font, with a small blue circle above the "V". Below the word "CIVCO" is the word "Radiotherapy" in a smaller, simpler font, also in blue. The logo is clean and modern, and the use of blue gives it a professional and trustworthy feel.
perturb or impact the proton beam in a way that cannot be accounted for in the facility's proton treatment planning process.
Devices labeled for use in and MRI environment were previously cleared by predicate 510(k)'s included in this submission. Therefore, no additional MR testing is required.
The devices are intended for limited contact duration (<24 hours) for surface devices (skin). All devices are previously cleared and manufactured with the same or substantially equivalent material that was previously cleared and therefore no additional biocompatibility testing is required.
H. Conclusion
This premarket submission has demonstrated substantial equivalence as defined and understood in the Federal Food, Drug and Cosmetic Act and various guidance documents issued by the Center for Devices and Radiological Health. The CIVCO devices were found to be safe and effective for use with adults, pediatrics, and/or adolescents in the Proton Therapy environment.
www.civcort.com
§ 892.5050 Medical charged-particle radiation therapy system.
(a)
Identification. A medical charged-particle radiation therapy system is a device that produces by acceleration high energy charged particles (e.g., electrons and protons) intended for use in radiation therapy. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts, and accessories.(b)
Classification. Class II. When intended for use as a quality control system, the film dosimetry system (film scanning system) included as an accessory to the device described in paragraph (a) of this section, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.