Raycast MammoRx Carbon Fibre Breast Board

K162355 · Orfit Industries NV · IYE · Nov 22, 2016 · Radiology

Device Facts

• Record ID: K162355
• Device Name: Raycast MammoRx Carbon Fibre Breast Board
• Applicant: Orfit Industries NV
• Product Code: IYE · Radiology
• Decision Date: Nov 22, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5050
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Raycast MammoRx Carbon Fibre Breast Board is a positioning and immobilization system to set-up and reproduce the supine position of a breast patient during radiation therapy.

Device Story

Raycast MammoRx Carbon Fibre Breast Board is a patient positioning and immobilization system used in radiation therapy departments. It provides a stable platform to set up and reproduce the supine position for breast cancer patients. The device is a physical board constructed from carbon fiber, designed to be compatible with radiation therapy equipment. It is operated by radiation therapists or clinicians to ensure patient stability and precise anatomical alignment during treatment sessions. By maintaining consistent patient positioning, the device facilitates accurate radiation delivery, potentially improving treatment outcomes and minimizing exposure to healthy tissue.

Clinical Evidence

Bench testing only.

Technological Characteristics

Constructed from carbon fiber; designed for radiolucency to minimize interference with radiation beams; form factor is a rigid board for patient support; non-powered, mechanical device.

Indications for Use

Indicated for breast cancer patients undergoing radiation therapy requiring supine positioning and immobilization.

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.

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

November 22, 2016

Orfit Industries NV % Mr. Raymond Kelly Consultant Licensale, Inc. 68 Southwoods Terr. SOUTHBURY CT 06488

Re: K162355

Trade/Device Name: Raycast MammoRx Carbon Fibre Breast Board Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: IYE Dated: October 9, 2016 Received: October 14, 2016

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. 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 (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); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Robert Ochs

Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known)

K162355

Device Name

Raycast MammoRx Carbon Fibre Breast Board

## Indications for Use (Describe)

The Raycast MammoRx Carbon Fibre Breast Board is a positioning and immobilization system to set-up and reproduce the supine position of a breast patient during radiation therapy.

| Type of Use (Select one or both, as applicable) | |
|-----------------------------------------------------------------|----------------------------------------------------------------|
| <div> Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> Over-The-Counter Use (21 CFR 801 Subpart C) </div> |

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