(240 days)
Not Found
No
The device description focuses on mechanical components for patient positioning and does not mention any software, algorithms, or data processing that would indicate AI/ML.
No.
The device is used for patient positioning during radiotherapy and radio diagnostics, which are diagnostic and treatment procedures, but the device itself does not directly treat or diagnose a disease. It facilitates the process but is not therapeutic in nature.
No
Explanation: The device is described as aiding in the 'Positioning of the patient during radiotherapy and radiodiagnostics', specifically to create 'reproducible positioning'. Its components (cushions, supports, baseplates, strips) are all designed to hold the patient in a specific position, not to diagnose a medical condition.
No
The device description details multiple physical components (cushions, supports, baseplates, strips) used for patient positioning, indicating it is a hardware-based medical device. There is no mention of software as a component or the primary function.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "Positioning of the patient during radiotherapy and radio diagnostics, including MR where indicated." This describes a physical positioning device used in medical imaging and treatment procedures.
- Device Description: The description details physical components like cushions, supports, and baseplates used to physically position a patient.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information about a physiological state, health, disease, or congenital abnormality.
IVD devices are specifically designed to perform tests on biological samples to aid in diagnosis or monitoring. This device's function is purely mechanical positioning of the patient's body.
N/A
Intended Use / Indications for Use
Positioning of the patient during radiotherapy and radio diagnostics, including MR where indicated.
Product codes (comma separated list FDA assigned to the subject device)
IYE, LNH
Device Description
The submission covers four types of patient positioning devices:
- VacuumCushions: These are cushions formed around the patient by drawing air out to create a rigid impression of the patient's anatomy, facilitating reproducible positioning. They are made out of Polystyrene Beads in Polyurethane-coated Nylon bag, and feature a valve for creating the vacuum.
- FeetSupports: These devices facilitate the positioning of the patient's feet. They are available in fixed and rotatable variants and can be fixed to various baseplates and couchtops.
- LEPS (Lower Extremities Positioning System): This system enables a patient's lower extremities to be positioned, using a Kneesupport, FeetSupport and, as desired, a LiftBlock. Shoulder Retractors can also be used. The base of the LEPS is the LEPS baseplate, which can be positioned on the couch treatment table using couch strips.
- CouchStrips: These are bars that connect the patient positioning device onto the treatment table at indexed positions. VacuumCushion Positioning Strips (VCPS) are a type of CouchStrips placed on other CouchStrips to secure a VacuumCushion.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Not Found
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.
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.
Not Found
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
§ 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.
0
Image /page/0/Picture/0 description: The image shows the logo for 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 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.
MacroMedics BV % Elizabeth Hajos QARA Manager Oostbaan 670 2841ML Moordrecht, South Holland NETHERLANDS
Re: K212909
Trade/Device Name: Vacuum Cushions, FeetSupports, LEPS (Lower Extremities Positioning System) CouchStrips Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: Class II Product Code: IYE, LNH Dated: April 7, 2022 Received: April 18, 2022
Dear Elizabeth Hajos:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Julie Sullivan, Ph.D. Assistant Director DHT 8C: Division of Radiological Imaging and Radiation Therapy Devices OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K212909
Device Name
VacuumCushions, Feetsupports, LEPS (Lower Extremities Positioning System) CouchStrips
Indications for Use (Describe)
Both the Intended Use and the Indications for Use of the devices included in this submission are as follows:
Positioning of the patient during radiotherapy and radio diagnostics, including MR where indicated.
| Type of Use (Select one or both, as applicable) |
|---|
| Residential Use (Part 21 CFR 201 Subpart D) |
| Over-The-Counter Use (21 CFR 201 Subpart C) |
Prescription Use (Part 21 CFR 801 Subpart D)
__ Over-The-Counter Use (21 CFR 801 Subpart C)
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3
Image /page/3/Picture/0 description: The image is a logo for Macromedics, a company that provides solutions in radiotherapy. The logo consists of a stylized "m" symbol on the left, followed by the company name "macromedics" in a sans-serif font. Below the company name is the tagline "SOLUTIONS IN RADIOTHERAPY" in a smaller font. The entire logo is in a light blue color.
Product Name – Patient Positioning Devices
510(k) Summary
Statement: Information supporting claims of substantial equivalence, as defined under the Federal Food, Drug, and Cosmetic Act, respecting safety and effectiveness is summarized below. For the convenience of the Reviewer, this summary is formatted in accordance with the Agency's final rule "510(k) Summarises and 510(k) Statements" (21 CFR 807) and can be used to provide a substantial equivalence summary to anyone requesting it from the Agency.
Submitter Details 1.
| Name: | MacroMedics BV |
|---|---|
| Address: | Oostbaan 670, 2841ML Moordrecht, The Netherlands |
| Contact Person: | Jaap Drenth |
| Phone Number: | +31 (0)182 389777 |
| Date Prepared: | 09-SEP-2021 |
2. Device Details
| Name: | Vacuum Cushions, FeetSupports, LEPS (Lower Extremities Positioning
System), CouchStrips |
|------------------|--------------------------------------------------------------------------------------------------|
| Trade Name: | MacroMedics |
| Common Name: | Patient Positioning Devices |
| Classification: | Class II |
| Regulation: | 21 CFR 892.5050, 21 CFR 892.1000 |
| Regulation Name: | Medical Charged-Particle Radiation Therapy System,
System, Nuclear Magnetic Resonance Imaging |
| Product Code: | IYE, LNH |
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Image /page/4/Picture/0 description: The image shows the logo for Macromedics. The logo consists of a stylized lowercase "m" inside a circle on the left, followed by the word "macromedics" in a sans-serif font. Below the word "macromedics" is the phrase "SOLUTIONS IN RADIOTHERAPY" in a smaller font. The logo is primarily in a light blue color.
Review Panel: Radiology
3. Predicate Device Details
| 510k Number | Device Name | Manufacturer |
|---|---|---|
| K180021 | Cushions (Vac-Lok) | MEDTEC, Inc. d/b/a “CIVCO Medical |
| Solutions” and “CIVCO Radiotherapy” | ||
| K142420 | LEPS (Lower Extremities | |
| Positioning System), | ||
| FeetSupports | MacroMedics BV | |
| K142420 | CouchStrips | MacroMedics BV |
4. Subject Device Description, Intended Use, Technological Characteristics, Substantial Equivalence & Conclusion
Device (1) - VacuumCushions 4.1
Model/Variants
| Selling code | Brand name | Device Identifier |
|---|---|---|
| 155110 | VacuumCushion 30x40 | 08719425702940 |
| 155140 | VacuumCushion 25x50 | 08719425702957 |
| 155150 | VacuumCushion 50x70 T | 08719425702964 |
| 155210 | VacuumCushion 50x70 | 08719425702971 |
| 155300 | VacuumCushion 65x65 | 08719425702988 |
| 155400 | VacuumCushion 100x70 | 08719425702995 |
| 155410 | VacuumCushion 100x80 | 08719425703008 |
| 155430 | VacuumCushion 120x80 | 08719425703015 |
| 155450 | VacuumCushion 100x150 | 08719425703022 |
| 155510 | VacuumCushion 200x100 | 08719425703039 |
| 155520 | VacuumCushion 120x120 T | 08719425705194 |
| 123450 | VacuumCushion, abdom.S | 08719425702650 |
| 123470 | VacuumCushion, abdom.XL | 08719425702667 |
Intended Use and/or Indications for Use
Positioning of the patient during radiotherapy and radio diagnostics, including MR where indicated.
Description
The VacuumCushions (Vacuum Cushions) are cushions which are formed around the patient to create a rigid impression of the patient's anatomy in order to facilitate reproducible positioning.
5
Image /page/5/Picture/0 description: The image shows the logo for Macromedics. The logo consists of a circular icon with a stylized "m" inside, followed by the word "macromedics" in a sans-serif font. Below the word "macromedics" is the phrase "SOLUTIONS IN RADIOTHERAPY" in a smaller font.
The impression is created through drawing the air out of the cushion whilst the patient is in the desired position.
Comparison of technological characteristics
The designs of the MacroMedics and predicate device are equivalent in shape, construction, materials and functionality. Both the MEDTEC, Inc. d/b/a "CIVCO Medical Solutions" and "CIVCO Radiotherapy" devices and the MacroMedics devices are made out of Polystyrene Beads in Polyurethane-coated Nylon bag, and feature a valve for creating the vacuum.
Substantial equivalence summary
MacroMedics claims the proposed VacuumCushions to be substantially equivalent to the devices previously cleared by the FDA in the 510(k) specified above. These devices are also cleared for use in a radiotherapy and/or MR environment.
MacroMedics claims this equivalence because the proposed devices have equivalent designs, intended uses, tarqet populations and used materials. These products have very similar positioning and immobilization characteristics for use in radiotherapy and radio-diagnostics.
Conclusion
The substantial equivalence comparison in this premarket submission toqether with the additional provided information has demonstrated substantial equivalence to the predicate devices with respect to use, safety and effectiveness for their intended and indicated use.
4.2 Device (2) - FeetSupports
Model/Variants
| Selling code | Brand name | Device Identifier |
|---|---|---|
| 130260 | FeetSupport™™, rotatable, 3P | 08719425702308 |
| 130250 | FeetSupport™™, fixed, indexable on LEPS and DSCP platforms, 3P | 08719425702315 |
| 130460 | FeetSupport 2.0™, rotatable | 08720168160263 |
| 130450 | FeetSupport 2.0™, fixed | 08720168160362 |
Intended Use and/or Indications for Use
Positioning of the patient during radiotherapy and radio diagnostics, including MR where indicated.
Description
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Image /page/6/Picture/0 description: The image shows the logo for "macromedics". The logo consists of a circular icon with a stylized "m" inside, followed by the word "macromedics" in a sans-serif font. Below the word "macromedics" is the tagline "SOLUTIONS IN RADIOTHERAPY" in a smaller font size. The logo is a light blue color.
The FeetSupports facilitate the positioning of the patient's feet. They are available in fixed and rotatable variants and can be fixed to various baseplates and couchtops.
Comparison of technological characteristics
The designs of the MacroMedics subjective device (the Feetsupports which are part of the LEPS), and predicate device are equivalent in shape, construction materials and functionality.
Substantial equivalence summary
MacroMedics claims the proposed FeetSupports to be substantially equivalent to the devices previously cleared by the FDA in the 510(k)'s specified above. These devices are also cleared for use in a radiotherapy and/or MR environment.
MacroMedics claims this equivalence because the proposed devices have equivalent designs, intended uses, target population and used materials. These products have similar position and immobilization characteristics for use radiotherapy and radio-diagnostics.
Conclusion
The substantial equivalence comparison in this premarket submission together with the additional provided information has demonstrated substantial equivalence to the predicate devices with respect to use, safety and effectiveness for their intended and indicated use.
4.3 Device (3) - LEPS (Lower Extremities Positioning System)
Model/Variants
LEPS with the rotatable FeetSupport LEPS with the fixed FeetSupport
| Selling code | Brand name | Device Identifier |
|---|---|---|
| 130300 | LEPS ™, FeetSupport™, rot. | 08719425702261 |
| 130310 | LEPS™ FeetSupport™, fixed | 08719425702278 |
| 130260 | FeetSupport™, rotatable | 08719425702308 |
| 130250 | FeetSupport™, fixed | 08719425702315 |
| 130200 | LEPS™ baseplate | 08719425702322 |
| 130420 | LEPS™ baseplate short | 08719425709772 |
| 130100 | KneeSupport™ | 08719425702285 |
| 130120 | KneeSupport™ LiftBlock™ | 08719425702292 |
| 130130 | KneeSupport™ low,plastic | 08719425707129 |
| 130140 | KneeSupport™, plastic | 08719425707136 |
| 130350 | Shoulder retr. for LEPS™ | 08719425702339 |
Intended Use and/or Indications for Use
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Image /page/7/Picture/0 description: The image shows the logo for "macromedics". The logo consists of a stylized letter "m" inside a circle on the left, followed by the word "macromedics" in a sans-serif font. Below the word "macromedics" is the phrase "SOLUTIONS IN RADIOTHERAPY" in a smaller font. The logo is in a light blue color.
Positioning of the patient during radiotherapy and radio diagnostics, including MR where indicated.
Description
The LEPS enables a patient's lower extremities to be positioned, using a Kneesupport, FeetSupport and, as desired, a LiftBlock. Shoulder Retractors can also be used to support the retraction of the patient's shoulders. The base of the LEPS is the LEPS baseplate.
The LEPS Short baseplate enables the patient's feet to be positioned using a FeetSupport. The LEPS baseplates can be positioned on the couch treatment table using couch strips.
Comparison of technological characteristics
The designs of the MacroMedics subjective device and predicate device are equivalent in shape, construction materials and functionality. The MacroMedics predicate device and the subject device are made out of the same materials.
Substantial equivalence summary
MacroMedics claims the proposed LEPS to be substantially equivalent to the devices previously cleared by the FDA in the 510(k)'s specified above. These devices are also cleared for use in a radiotherapy and/or MR environment.
MacroMedics claims this equivalence because the proposed devices have equivalent designs, intended uses, target population and used materials. These products have similar position and immobilization characteristics for use radiotherapy and radio-diagnostics.
Conclusion
The substantial equivalence comparison in this premarket submission together with the additional provided information has demonstrated substantial equivalence to the predicate devices with respect to use, safety and effectiveness for their intended and indicated use.
Device (4) - CouchStrips 4.4
Model/Variants
| Selling code | Brand name | Device Identifier |
|---|---|---|
| 147930 | CouchStrip CS53FGF-EX | 08719425709802 |
| 147110 | CouchStrip CS53FCF-IB | 08720168160317 |
| 147130 | CouchStrip CS53FCF-S | 08720168160188 |
| 147140 | CouchStrip CS50FCF-S | 08720168160324 |
| 147950 | CouchStrip CS50FCF-EX | 08719425705606 |
| 147960 | CouchStrip CS53FCF-EX | 08719425709796 |
| 155950 | VacuumCushion Pos.Strip MR | 08720168160355 |
| 147150 | CouchStrip CS53FGF-S | 08720168160331 |
8
Image /page/8/Picture/0 description: The image is a logo for "macromedics solutions in radiotherapy". The logo consists of a stylized letter "m" in a circle on the left, followed by the word "macromedics" in a sans-serif font. Below the word "macromedics" is the phrase "solutions in radiotherapy" in a smaller font. The logo is in a light blue color.
| 155870 VacuumCushion positioning strip |
|---|
| ------------------------------------------ |
08719425705231
Description
CouchStrips are bars which connect the patient positioning device onto the treatment table at indexed positions. Depending on the indexing system of the treatment table, its width, the preference in transverse adjustability and required MR safety, different types and indexing styles are available. VacuumCushion Positioning Strips (VCPS) are CouchStrips which are placed onto other CouchStrips in order to secure a VacuumCushion in place.
Indications for Use
Positioning of the patient during radiotherapy and radio diagnostics, including MR where indicated.
Comparison of technological characteristics
The designs of the MacroMedics subjective device and predicate device are equivalent in shape. construction materials and functionality.
Substantial equivalence summary
MacroMedics claims the proposed CouchStrips to be substantially equivalent to the devices previously cleared by the FDA in the 510(k)'s specified above. These devices are also cleared for use in a radiotherapy and/or MR environment.
MacroMedics claims this equivalence because the proposed devices have equivalent designs, intended uses, target population and used materials. These products have very similar position characteristics for use radiotherapy and radio-diagnostics.
Conclusion
The substantial equivalence comparison in this premarket submission toqether with the additional provided information has demonstrated substantial equivalence to the predicate devices with respect to use, safety and effectiveness for their intended and indicated use.