Thermofit by ORFIT INDUSTRIES | FDA 510(k) Summary

I apologize, but the provided text from the FDA 510(k) clearance letter for "Thermofit" does not contain information on acceptance criteria or a study proving the device meets those criteria.

The document is a standard FDA clearance letter, which states that the device is substantially equivalent to a predicate device and can be marketed. It outlines regulatory requirements and contact information.

Specifically, it lacks the following information necessary to answer your request:

A table of acceptance criteria and reported device performance: There is no performance data or specific acceptance criteria mentioned.
Sample size and data provenance for a test set: No test set or study details are provided.
Number and qualifications of experts for ground truth: No ground truth establishment is discussed as no study is detailed.
Adjudication method for the test set: Not applicable without a study.
MRMC comparative effectiveness study details: No such study is mentioned.
Standalone (algorithm only) performance: Thermofit is described as a physical device (used to create a stable, reproducible, and comfortable head or head, neck, and shoulder radiation therapy), not an AI algorithm.
Type of ground truth used: Not applicable as no study is detailed.
Sample size for the training set: Not applicable to this type of device or document.
How ground truth for the training set was established: Not applicable.

The "Indications for Use" section (page 2 of the document) simply states: "THERMOFIT is used to create a stable, reproducible and comfortable head or head or head, neck and shoulder radiation therapy." This describes the intended purpose of the device, not performance metrics or study results.

In summary, the provided document does not contain the information requested regarding acceptance criteria and study data for the Thermofit device.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol, with three curved lines representing the bird's head and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.

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

November 9, 2015

Orfit Industries NV % Mr. Lee Leichter President P/L Biomedical 10882 Stonington Avenue FORT MYERS FL 33913

Re: K151946 Trade/Device Name: Thermofit Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: IYE Dated: September 25, 2015 Received: September 29, 2015

Dear Mr. Leichter:

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 (800) 638 2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 or at its Internet address

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

Sincerely yours.

Michael D'Hara For

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)

Device Name Thermofit

Indications for Use (Describe)

THERMOFIT is used to create a stable, reproducible and comfortable head or head or head, neck and shoulder radiation therapy.

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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Regulation Number and Section

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