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Conformal Brachytherapy Source

Page Type
Product Code
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
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
892.5730
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 892.5730 Radionuclide brachytherapy source

§ 892.5730 Radionuclide brachytherapy source.

(a) Identification. A radionuclide brachytherapy source is a device that consists of a radionuclide which may be enclosed in a sealed container made of gold, titanium, stainless steel, or platinum and intended for medical purposes to be placed onto a body surface or into a body cavity or tissue as a source of nuclear radiation for therapy.

(b) Classification. Class II (special controls). A prostate seeding kit intended for use with a radionuclide brachytherapy source only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.

[48 FR 53047, Nov. 23, 1983, as amended at 84 FR 71819, Dec. 30, 2019]

Conformal Brachytherapy Source

Page Type
Product Code
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
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
892.5730
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 892.5730 Radionuclide brachytherapy source

§ 892.5730 Radionuclide brachytherapy source.

(a) Identification. A radionuclide brachytherapy source is a device that consists of a radionuclide which may be enclosed in a sealed container made of gold, titanium, stainless steel, or platinum and intended for medical purposes to be placed onto a body surface or into a body cavity or tissue as a source of nuclear radiation for therapy.

(b) Classification. Class II (special controls). A prostate seeding kit intended for use with a radionuclide brachytherapy source only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.

[48 FR 53047, Nov. 23, 1983, as amended at 84 FR 71819, Dec. 30, 2019]