Predicate Devices

Reference Devices

K933227, K080072, K060737, K982624, K935300, K121284, K974703

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on the physical properties and positioning capabilities of static, non-powered devices, with no mention of AI/ML algorithms, image processing for analysis, or data training/testing.

Therapeutic

Yes.
The device's intended use clearly states it supports and positions patients undergoing radiation therapy (including proton, photon, and electron treatments), which is a therapeutic intervention.

Diagnostic

No

The device is primarily a positioning and immobilization device used during radiation therapy treatment and image acquisition for treatment planning, not for diagnosing medical conditions. It aids in "supporting and positioning" patients and is used for "therapeutic treatment" and "diagnostics (including CT and MR as indicated)" in the context of treatment planning.

SaMD (Software as a Medical Device)

No

The device description explicitly mentions physical components like Couchtops, Cushions, Thermoplastic Masks, Overlays, Extensions, and Support Garments, and describes them as non-powered and static. The performance studies also focus on the physical properties of these materials in relation to proton beam attenuation. There is no mention of software as a component of the device itself.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
Device Function: The described devices are used to support, position, and immobilize patients during radiation therapy and image acquisition. They are external devices that interact with the patient's body but do not analyze biological specimens.
Intended Use: The intended use clearly states the purpose is to aid in supporting and positioning patients for radiation therapy and image acquisition for treatment planning. This is a therapeutic and diagnostic imaging support function, not an in vitro diagnostic function.

The device description and performance studies further reinforce that these are physical positioning and immobilization tools, not devices for analyzing biological samples.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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.

Product codes (comma separated list FDA assigned to the subject device)

IYE, LNH

Device Description

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

CT, MR (as indicated), X-ray

Anatomical Site

Head, brain, neck, spine, breast, chest region, thorax, abdomen, pelvis, prostate.

Indicated Patient Age Range

Adult and pediatric patients (Head, Neck, and Shoulders Devices, General Positioning Devices). Adolescent and adult patients (Support Garments, Breast Positioning Devices), not intended for use with patients under 12 years of age for Support Garments and Breast Positioning Devices.

Intended User / Care Setting

Radiation oncology therapists, medical physicists, and oncologists. Used in a healthcare facility/hospital.

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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.

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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K973842

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

K933227, K080072, K060737, K982624, K935300, K121284, K974703

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 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.

Summary

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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

2

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. SE
Orange City, IA 51041 |
|------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Alena Newgren, Regulatory Specialist
Telephone: 712-737-8688, Fax: 877-613-6300
regulatory@civcort.com |
| Date Summary Prepared: | June 13, 2018 |
| Trade Name: | Proton Positioning and Immobilization Solutions |
| Common Name: | Head, Neck and Shoulders Devices
General Positioning Devices
Support Garments
Breast 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.