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U.S. Department of Health and Human Services

Product Classification

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Device conformal brachytherapy source
Regulation Description Radionuclide brachytherapy source.
Definition The intended use of the device is for the treatment of cancer by tempeorary intraoperative or surface irradiation. The device contains radioactive material with activity up to 200 mci and is indicated for treatment of temporary intraoperative, interstitial, intracavitary or surface application to treat selected localized tumors. This brachytherapy source may be used concurrently with or following treatment with other interventions, such as external beam therapy. Chordomas, chondrosarcomas, soft tissue sarcomas, skin cancers and other accessible tumors could be commonly treated by the device.
Physical State The device consissts of a thin polymeric film which is coated with a thin flexible biocompatible coating.
Technical Method Radioactive Phosphorus-32 is chemically bonded to a biocompatible epoxy backbone to form a flat flexible planar radioactive brachytherapy source.
Target Area This brachytherapy source may be used intraoperatively, interstitially, intrcavitarily, or as a surface applicator to treat selected localized tumors.
Regulation Medical Specialty Radiology
Review Panel Radiology
Product CodeONL
Premarket Review Office of Radiological Health (OHT8)
Division of Radiological Imaging and Radiation Therapy Devices (DHT8C)
Submission Type 510(k)
Regulation Number 892.5730
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible