(18 days)
No
The device description focuses on physical positioning and immobilization components and does not mention any software or analytical capabilities that would suggest the use of AI or ML.
No
The device is described as a 'positioning and immobilization system' used during radiation therapy, indicating it is an accessory to a therapeutic procedure rather than a therapeutic device itself.
No
Explanation: The device is described as a "positioning and immobilization system" for radiation therapy, designed to set-up and reproduce patient positions. Its purpose is to physically position and stabilize patients during treatment, not to diagnose conditions or interpret medical data.
No
The device description explicitly details physical components such as base plates, positioning cushions, belly inserts, knee & leg positioning cushions, feet support, and thermoplastic masks, indicating it is a hardware-based system.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Function: The AIO Solution 3.0 is a positioning and immobilization system used during radiation therapy. Its purpose is to hold the patient in a specific, reproducible position for treatment.
- Lack of Diagnostic Testing: The description focuses entirely on the physical positioning and support of the patient. There is no mention of analyzing biological samples or providing diagnostic information about a patient's condition.
- Performance Studies: The performance studies described are related to the physical properties of the device (attenuation and water equivalent thickness) in the context of radiation therapy, not diagnostic accuracy.
Therefore, the AIO Solution 3.0 falls under the category of a medical device used for treatment support, not an In Vitro Diagnostic device.
N/A
Intended Use / 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.
Product codes
IYE
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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
belly & pelvic, breast
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
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.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
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August 14, 2020
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. Food & Drug Administration".
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
1
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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Image /page/3/Picture/0 description: The image shows the word "orfit" in black font. There is an orange circle that starts under the "o" and goes over the "i" in the word. There is an orange dot above the "i" in the word.
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
4
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 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 Breast and Lung Board Solution is a |
| positioning and immobilization system to set- | |
| up and reproduce the supine | |
| position of a breast or lung patient during | |
| radiation. | |
| The AIO Head and Neck Solution is indicated | |
| to aid in supporting the knees or ankles of | |
| patients undergoing radiation | |
| therapy in the supine or prone position. The | |
| device is also used during image acquisition to | |
| support 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 Before | |||
| Use? | Yes | Yes | Same |
| Principle of | |||
| Operation | Device uses AIO solution base | ||
| plates cleared in K191158 for | |||
| positioning and | |||
| immobilization to set-up and | |||
| reproduce the supine and | |||
| prone position of patients | |||
| during radiation therapy. | Device uses AIO solution base | ||
| plates cleared in K191158 for | |||
| positioning and | |||
| immobilization to set-up and | |||
| reproduce the supine and | |||
| prone position of patients | |||
| during radiation therapy. | Same | ||
| Device - Body | |||
| Contact | Limited contact duration ( |