NANOR AND EFFICAST/NANOR HYBRID THERMOPLASTIC MATERIALS

K131795 · Orfit Industries NV · IYE · Sep 26, 2013 · Radiology

Device Facts

• Record ID: K131795
• Device Name: NANOR AND EFFICAST/NANOR HYBRID THERMOPLASTIC MATERIALS
• Applicant: Orfit Industries NV
• Product Code: IYE · Radiology
• Decision Date: Sep 26, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5050
• Device Class: Class 2

Intended Use

The NANOR and NANOR/EFFICAST Hybrid Thermoplastic materials are used to retain and reproduce a patient's position during radiation therapy.

Device Story

NANOR and NANOR/EFFICAST Hybrid Thermoplastic materials are patient immobilization devices used in radiation therapy. These materials are heated to become pliable, molded to the patient's anatomy to create a custom immobilization mask or support, and then cooled to harden, maintaining the patient's position during treatment. Used in clinical radiation oncology settings by radiation therapists or technicians. The device ensures precise, reproducible patient positioning, which is critical for accurate radiation dose delivery and minimizing exposure to healthy tissue.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Thermoplastic materials; moldable when heated, rigid when cooled. Used for patient immobilization in radiation therapy. Class II device (21 CFR 892.5050).

Indications for Use

Indicated for patients undergoing radiation therapy requiring immobilization to retain and reproduce body positioning.

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

• Orfit Thermoplastic Materials (K093606)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows a logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles three overlapping human figures or abstract shapes.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

September 26, 2013

ORFIT Industries NV % Mr. Eddy Marivoet Quality Assurance & Regulatory Affairs Manager Vosveld 9a B-2110 Wijnegem BELGIUM

Re: K131795

Trade/Device Name: NANOR and EFFICAST/NANOR Hybrid Thermoplastic Materials Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: IYE Dated: May 8, 2013 Received: June 28, 2013

Dear Mr. Marivoet:

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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Page 2-Mr. Marivoet

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/ReportalProblem/dcfault.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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industrv/default.htm.

Sincerely yours,

Michael D. O'Hara

for

Janine M. Morris 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): K131795

Device Name: NANOR and NANOR/EFFICAST Hybrid Thermoplastic Materials

Indications for Use: The NANOR and NANOR/EFFICAST Hybrid Thermoplastic materials are used to retain and reproduce a patient's position during radiation therapy.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

Michael D. O'Hagan

(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health

K131795 510(k)

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