(18 days)
The AIO Solution 3.0 is a positioning and immobilization system to set-up and reproduce the supine and prone position of belly & pelvic patients and the prone position of breast patients during radiation therapy.
The AIO Solution 3.0 with accessories provides the immobilization and positioning system necessary to set-up and reproduce the position of a patient for supine and prone belly & pelvic treatments or prone breast treatments in radiation therapy.
For belly & pelvic treatments, the AIO solution 3.0 base plates (already cleared: K191158) can be used in combination with the green AIO 3.0 belly & pelvic positioning cushions and accessories. Depending on the anatomy of the patient, 2 different sizes of belly inserts are available to make sure the intestines can be pulled out of the treatment area when in prone position. The arms of the patient are positioned above the head to bring them out of the treatment field. A full belly insert should be used in supine position while the arms of the patient can be positioned on the chest to bring them out of the treatment field. The legs of the patient are supported by the grey AIO 3.0 knee & leg positioning cushions and/or the AIO 3.0 indexable feet support (already cleared; K191158). For increased precision, the set-up can be combined with an Orfit thermoplastic EFFICAST mask.
For prone breast treatments, the AIO solution 3.0 base plates (already cleared; K191158) can be used in combination with the yellow AIO 3.0 prone breast positioning cushions and accessories. The arms of the patient are positioned above the head to bring them out of the treatment field. The legs of the patient are supported by the grey AIO 3.0 knee & leg positioning cushions (already cleared; K191158). For increased precision, the set-up can be combined with an Orfit thermoplastic EFFICAST mask.
The provided text describes a medical device, "The AIO Solution 3.0," and its substantial equivalence determination by the FDA. However, the document does not contain any information regarding acceptance criteria or the study details typically associated with AI/ML-driven medical devices, such as performance metrics (e.g., sensitivity, specificity), ground truth establishment, expert adjudication, or training/test set sample sizes.
The "PERFORMANCE DATA" section of the document primarily focuses on:
- Sterilization and Shelf Life: Stating devices are non-sterile and made of durable polymers with low degradation.
- Biocompatibility: Emphasizing that materials are identical to the predicate device, thus no new testing is needed.
- Electrical Safety, EMC, Software, Cybersecurity: Stating the device contains no active components, software, or ports, rendering these categories irrelevant.
- MRI Safety: Confirming material compatibility with MR environments.
- "Performance Testing": This solely refers to dosimetry testing (measurement of radiation attenuation and water equivalent thickness), not clinical performance or diagnostic accuracy. It states, "The test data meets the A/R criteria predetermined for the device," but does not define what those A/R criteria are or what the actual reported performance values were.
Therefore, based only on the provided input, I cannot answer the questions related to AI/ML device performance, acceptance criteria, study design for diagnostic accuracy, or ground truth establishment. The device in question appears to be a physical positioning and immobilization system for radiation therapy, not an AI/ML diagnostic or predictive tool.
If this was a misunderstanding and the request was for a hypothetical AI/ML device, I would need more specific attributes to invent a plausible scenario. However, as per the input, the device's assessment focuses on material properties and physical radiation attenuation, not AI/ML performance.
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August 14, 2020
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Orfit Industries NV % Mr. Raymond Kelly Consultant Arazy Group Consultants, Inc. 3422 Leonardo Lane NEW SMYRNA BEACH FL 32168
Re: K202068
Trade/Device Name: The AIO Solution 3.0 Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: Class II Product Code: IYE Dated: July 15, 2020 Received: July 27, 2020
Dear Mr. Kelly:
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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for
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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.
For
Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name
The AIO Solution 3.0
Indications for Use (Describe)
The AIO Solution 3.0 is a positioning and immobilization system to set-up and reproduce the supine and prone position of belly & pelvic patients and the prone position of breast patients during radiation therapy.
| 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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Orfit Industries NV 9A Vosveld 2110 Wijnegem Belgium
510(k) Summary K202068
Date Prepared: August 12, 2020
SUBMITTER I.
Orfit Industries NV 9A Vosveld 2110 Wijnegem Belgium
II. DEVICE
Name of Device: The AIO Solution 3.0, K202068 Common or Usual Name: Accelerator, linear, medical Classification Name: Medical charged-particle radiation therapy system (21 CFR 892.5050) Regulatory Class: II Product Code: IYE
III. PREDICATE DEVICE
Name of Device: The AIO Solution, K191158. This predicate has not been subject to a design-related recall. Common or Usual Name: Accelerator, linear, medical Classification Name: Medical charged-particle radiation therapy system (21 CFR 892.5050) Regulatory Class: II Product Code: IYE Reference Device: Macromedics Pelvic Prone Board MR, K142420; CDR Systems Prone Breast Patient Positioning System, K122888
IV. DEVICE DESCRIPTION
The AIO Solution 3.0 with accessories provides the immobilization and positioning system necessary to set-up and reproduce the position of a patient for supine and prone belly & pelvic treatments or prone breast treatments in radiation therapy.
For belly & pelvic treatments, the AIO solution 3.0 base plates (already cleared: K191158) can be used in combination with the green AIO 3.0 belly & pelvic positioning cushions and accessories. Depending on the anatomy of the patient, 2 different sizes of belly inserts are available to make sure the intestines can be pulled out of the treatment area when in prone
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position. The arms of the patient are positioned above the head to bring them out of the treatment field. A full belly insert should be used in supine position while the arms of the patient can be positioned on the chest to bring them out of the treatment field. The legs of the patient are supported by the grey AIO 3.0 knee & leg positioning cushions and/or the AIO 3.0 indexable feet support (already cleared; K191158). For increased precision, the set-up can be combined with an Orfit thermoplastic EFFICAST mask.
For prone breast treatments, the AIO solution 3.0 base plates (already cleared; K191158) can be used in combination with the yellow AIO 3.0 prone breast positioning cushions and accessories. The arms of the patient are positioned above the head to bring them out of the treatment field. The legs of the patient are supported by the grey AIO 3.0 knee & leg positioning cushions (already cleared; K191158). For increased precision, the set-up can be combined with an Orfit thermoplastic EFFICAST mask.
V. INDICATIONS FOR USE
The AIO Solution 3.0 is a positioning and immobilization system to set-up and reproduce the supine and prone position of belly & pelvic patients and the prone position of breast patients during radiation therapy.
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
| Subject Device | Predicate Device |
|---|---|
| K202068 (The AIO Solution 3.0) | K191158 (The AIO Solution 3.0) |
| The AIO Solution 3.0 is a positioning andimmobilization system to set-up and reproducethe supine and prone position of belly & pelvicpatients and the prone position of breast patientsduring radiation therapy. | The AIO Breast and Lung Board Solution is apositioning and immobilization system to set-up and reproduce the supineposition of a breast or lung patient duringradiation. |
| The AIO Head and Neck Solution is indicatedto aid in supporting the knees or ankles ofpatients undergoing radiationtherapy in the supine or prone position. Thedevice is also used during image acquisition tosupport treatment planning. |
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| Attributes | Subject Device | Predicate Device K191158 | Comparison |
|---|---|---|---|
| Manufacturer | Orfit Industries NV | Orfit Industries NV | |
| Name | AIO Solution 3.0 | AIO Solution | Same |
| Product Code | IYE | IYE | Same |
| Regulation | 892.5050 | 892.5050 | Same |
| Class | II | II | Same |
| Sterile | Non-Sterile | Non-Sterile | Same |
| Cleaned BeforeUse? | Yes | Yes | Same |
| Principle ofOperation | Device uses AIO solution baseplates cleared in K191158 forpositioning andimmobilization to set-up andreproduce the supine andprone position of patientsduring radiation therapy. | Device uses AIO solution baseplates cleared in K191158 forpositioning andimmobilization to set-up andreproduce the supine andprone position of patientsduring radiation therapy. | Same |
| Device - BodyContact | Limited contact duration (<24hours) surface contact (skin) | Limited contact duration (<24hours) surface contact (skin) | Same |
| Sterility | Not sterile | Not sterile | Same |
| MR Safety | MR Safe | MR Safe(Carbon fiber base plates =MR Unsafe) | Both thepredicate andsubject devicesare MR Safe, thecarbon fiberplates in thepredicate deviceare MR Unsafe.This does notraise differentquestions ofsafety andeffectivenessbecause thesubject devicedoes not containbase plates |
| Attributes | Subject Device | Predicate Device K191158 | Comparison |
| Cleaning-Disinfection | Same | Same | The samecleaningprocedures areintended to beused in thelabeling, thepredicate andsubject materialsare the same andthe patientcontact type withunbroken skin isthe same for thesame duration<24 hours. |
| SupportComponents | Contains leg separatorcomponents | Contains knee and anklesupport components | Components aremade from samematerials |
| CushionMaterials | Polyethylene, Polyurethane,Polypropylene | Polyethylene, Polyurethane,Polypropylene | Same |
| FormedMaterials | Polyethylene,Polyoxymethylene | Polyethylene,Polyoxymethylene | Same |
| LaminateMaterials | Fiberglass | Fiberglass | Same |
| Packaging | PE bags, bubble wrap, PEfoam, cardboard box | PE bags, bubble wrap, PEfoam, cardboard box | Same |
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VII. PERFORMANCE DATA
The following performance data were provided in support of the substantial equivalence determination.
STERILIZATION:
Devices are non-sterile when used (and no processing required).
SHELF LIFE:
Device is made from durable inert polymers such as Polypropylene, Polyethylene, Polyurethane, and Polyoxymethylene which are provided nonsterile and have a low likelihood of time dependent product degradation, performance data is not needed to establish maintenance of device performance characteristics over the shelf-life period.
BIOCOMPATIBILITY:
Device has direct contact with intact skin, for a limited contact duration of ≤ 24 hours. The patient contacting components of the AIO Solution 3.0 are constructed of the same Expanded Polypropylene, Polyethylene, Polyurethane, Glass Fiber Laminate, and Polyoxymethylene components which are cleared in the predicate AIO Solution (K191158) and the Expanded Polypropylene, Polyethylene, Polyurethane, Glass Fiber Laminate, and Polyoxymethylene materials that are used to construct the AIO Solution 3.0 are processed and manufactured in the same manner
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as the Expanded Polypropylene, Polyethylene, Polyurethane, Glass Fiber Laminate, and Polyoxymethylene materials that are used to construct the predicate AIO Solution originally cleared in K191158. Biocompatibility testing is not needed because the materials, manufacturing, and processing in the AIO Solution 3.0 are identical to the predicate device. No new materials are being introduced in AIO Solution 3.0.
ELECTRICAL SAFETY AND ELECTROMAGNETIC COMPATIBILITY (EMC): AIO Solution 3.0 does not contain active components.
SOFTWARE VERIFICATION AND VALIDATION:
AIO Solution 3.0 does not contain software or firmware.
CYBERSECURITY:
AIO Solution 3.0 does not contain ports or connections at risk for cybersecurity.
MRI SAFETY:
Expanded Polypropylene, Polyethylene, Polyurethane, Glass Fiber Laminate, and Polyoxymethylene were found to be non-magnetic and non-conductive. None of these materials pose a threat in the MR environment. The AIO Solution 3.0 are safe within an MR environment and pose no threat to patient safety. This analysis considers recommendations made by the FDA in its guidance published in December 2014 "Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment - Guidance for Industry and Food and Drug Administration Staff".
PERFORMANCE TESTING:
Dosimetry testing was performed on the AIO Solution 3.0 to demonstrate substantial equivalence to the predicate device. Testing included measurement of attenuation and water equivalent thickness on different positions of the AIO Solution 3.0. Readings were taken at 6MV and 15MV. All measurements were scaled for output variations between calibration and measurement dates. The attenuation and the equivalent water thickness at predefined points of the material were defined. The measurements of the base plates show higher values for attenuation and water equivalent thickness on the places that were expected to have higher values: places where the plate has more carbon material or is reinforced.
The test data meets the A/R criteria predetermined for the device.
VIII. CONCLUSIONS
Through performance testing the subject device has demonstrated substantial equivalence to the predicate.
§ 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.