21 CFR 892.5730 — Source, Wire, Iridium, Radioactive
Radiology (RA) · Subpart F—Therapeutic Devices · § 892.5730
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.
Classification Rationale
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.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| IWA | Source, Wire, Iridium, Radioactive | 2 | 8 | 3rd Party |
| IWF | Needle, Isotope, Gold, Titanium, Platinum | 2 | 0 | 3rd Party |
| IWG | Seed, Isotope, Gold, Titanium, Platinum | 2 | 3 | Implant |
| IWI | Source, Isotope, Sealed, Gold, Titanium, Platinum | 2 | 6 | 3rd Party |
| KXK | Source, Brachytherapy, Radionuclide | 2 | 151 | Implant |
| NMP | Needle, Isotope, Reprocessed | 2 | 0 | |
| OIN | Prostate Seeding Kit | 2 | 0 | |
| ONL | Conformal Brachytherapy Source | 2 | 1 |
Special Controls
IWA — Source, Wire, Iridium, Radioactive
*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.
eCFR
IWF — Needle, Isotope, Gold, Titanium, Platinum
*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.
eCFR
IWG — Seed, Isotope, Gold, Titanium, Platinum
*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.
eCFR
IWI — Source, Isotope, Sealed, Gold, Titanium, Platinum
*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.
eCFR
KXK — Source, Brachytherapy, Radionuclide
*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.
eCFR
NMP — Needle, Isotope, Reprocessed
*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.
eCFR
OIN — Prostate Seeding Kit
*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.
eCFR
ONL — Conformal Brachytherapy Source
*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.
eCFR
