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510(k) Data Aggregation
K Number
K020683Device Name
ISOROD PD-103 IMPLANT, MODEL ATI-PD-103
Manufacturer
Date Cleared
2002-12-17
(288 days)
Product Code
Regulation Number
892.5730Why did this record match?
Applicant Name (Manufacturer) :
ATI MEDICAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The ATI Medical, Inc. IsoRod Pd-103 Radionuclide Brachytherapy Source is intended for permanent interstitial implantation for the treatment of selected localized tumors with low to moderate radiosensitivity. They are used either as primary treatment for tumors such as those of the head, neck, lung, intra-abdominal, pancreas, prostate, and unresectable tumors, or for residual disease after excision of primary or secondary tumors. IsoRod Pd-103 implants may be used concurrently with or following treatment with other interventions, such as external beam therapy or chemotherapy.
Device Description
The IsoRod implant is a permanently implanted, radioactive device, designed for the treatment of deep- seated tumors. IsoRod implants are comprised of base metallic rods that are coated with radioactive palladium. The radioactive palladium is then encapsulated with a metallic coating.
The base rod is composed of a palladium/cobalt alloy. The rod is 1 millimeter and 10 millimeters in length. The thin layer (0.2 micron) that comprises the radioactive layer is a combination of radioactive and non-radioactive palladium (Pd-103 and Pd-102 respectively). The encapsulation layer of 6-8 microns is pure palladium, a metal that is utilized in permanent implants based on its favorable biocompatibility characteristics.
The activity of each IsoRod implant is between 0.5 mCi and 3.0 mCi. The source is exceptionally isotropic based on the fact that the radioactive material is evenly deposited on the source and is shielded in every direction only by the thin layer of non-radioactive palladium.
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