Who is the manufacturer of The AIO Solution 3.0?

Orfit Industries NV filed the 510(k) submission for The AIO Solution 3.0 (K202068).

What is the FDA product code for The AIO Solution 3.0?

IYE. It is classified under 21 CFR 892.5050 as a Class 2 device in the Radiology panel.

What is the regulatory pathway for The AIO Solution 3.0?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like The AIO Solution 3.0?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

The AIO Solution 3.0

K202068 · Orfit Industries NV · IYE · Aug 14, 2020 · Radiology

Device Facts

Record ID	K202068
Device Name	The AIO Solution 3.0
Applicant	Orfit Industries NV
Product Code	IYE · Radiology
Decision Date	Aug 14, 2020
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 892.5050
Device Class	Class 2

Intended 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.

Device Story

AIO Solution 3.0 is a passive positioning and immobilization system for radiation therapy. It consists of base plates, belly/pelvic positioning cushions, belly inserts, knee/leg cushions, and indexable feet supports. Used in clinical radiation therapy settings by oncology staff to stabilize patients in supine or prone positions. The device facilitates precise patient setup; belly inserts allow intestinal displacement in prone positions; arms are positioned to clear the treatment field. The system is compatible with Orfit thermoplastic EFFICAST masks for increased precision. By ensuring reproducible patient positioning, the device enables accurate radiation delivery, potentially improving treatment outcomes. It contains no active components, software, or electronics.

Clinical Evidence

Bench testing only. Dosimetry testing measured attenuation and water equivalent thickness at 6MV and 15MV at predefined points. Results met predetermined acceptance criteria, demonstrating equivalence to the predicate device.

Technological Characteristics

Passive positioning system; materials include expanded polypropylene, polyethylene, polyurethane, glass fiber laminate, and polyoxymethylene. Non-sterile, MR-safe, non-conductive, non-magnetic. No active components, software, or firmware. Dimensions/form factor include base plates, cushions, and inserts.

Indications for Use

Indicated for belly and pelvic patients (supine and prone) and breast patients (prone) requiring positioning and immobilization during radiation therapy.

Regulatory Classification

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.

Predicate Devices

The AIO Solution (K191158)

Reference Devices

Macromedics Pelvic Prone Board MR (K142420)
CDR Systems Prone Breast Patient Positioning System (K122888)

Related Devices

K191158 — The AIO Solution · Orfit Industries NV · Aug 6, 2019
K040773 — PELVIS BELLYBOARD PLUS PATIENT POSITIONING SYSTEM · Bionix Development Corp. · Apr 9, 2004
K212909 — VacuumCushions, FeetSupports, LEPS (Lower Extermities Positioning System), CouchStrips · Macromedics BV · May 11, 2022
K060737 — SINMED POSITIONING DEVICES · Sinmed BV · Mar 31, 2006
K142420 — Patient Positioning Devices · Macromedics BV · Mar 27, 2015

Submission Summary (Full Text)

{0}------------------------------------------------ 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 {2}------------------------------------------------ DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration # Indications for Use 510(k) Number (if known) K202068 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) | #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below. {3}------------------------------------------------ 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. | {5}------------------------------------------------ | 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 (<24 hours) surface contact (skin) | Limited contact duration (<24 hours) surface contact (skin) | Same | | Sterility | Not sterile | Not sterile | Same | | MR Safety | MR Safe | MR Safe (Carbon fiber base plates = MR Unsafe) | Both the predicate and subject devices are MR Safe, the carbon fiber plates in the predicate device are MR Unsafe. This does not raise different questions of safety and effectiveness because the subject device does not contain base plates | | Attributes | Subject Device | Predicate Device K191158 | Comparison | | Cleaning- Disinfection | Same | Same | The same cleaning procedures are intended to be used in the labeling, the predicate and subject materials are the same and the patient contact type with unbroken skin is the same for the same duration <24 hours. | | Support Components | Contains leg separator components | Contains knee and ankle support components | Components are made from same materials | | Cushion Materials | Polyethylene, Polyurethane, Polypropylene | Polyethylene, Polyurethane, Polypropylene | Same | | Formed Materials | Polyethylene, Polyoxymethylene | Polyethylene, Polyoxymethylene | Same | | Laminate Materials | Fiberglass | Fiberglass | Same | | Packaging | PE bags, bubble wrap, PE foam, cardboard box | PE bags, bubble wrap, PE foam, cardboard box | Same | {6}------------------------------------------------ ## 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 {7}------------------------------------------------ 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.