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510(k) Data Aggregation
K Number
K030594Device Name
I-125 RAPID STRAND, MODEL 7000
Manufacturer
AMERSHAM HEALTH
Date Cleared
2003-04-10
(44 days)
Product Code
KXK, GAM
Regulation Number
892.5730Why did this record match?
Applicant Name (Manufacturer) :
AMERSHAM HEALTH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
RAPID Strand ™ is indicated for permanent interstitial implantation of selected localized tumors which are low to moderate radiosensitivity. They may be used either as primary treatment (such as prostate cancer or unresectable tumors) or for treatment of residual disease after excision of the primary tumor.
RAPID Strand™ may be indicated for use concurrent with or at the completion of other treatment modalities, such as external beam radiation therapy or chemotherapy.
Device Description
RAPID Strand™ consists of 11 absorbable seeding spacers and 10 Model 6711 OncoSeed™ seeds (welded titanium capsule containing I-125 adsorbed onto a silver rod) spaced at a fixed distance within absorbable braided carrier. The absorbable braided carrier containing OncoSeeds and absorbable seeding spacer is stiffened and then sterilized by Ethylene Oxide. The seeds are housed in a plastic spacing jig within a stainless steel shielding tube which attenuates >99% of the I-125 photons. RAPID Strand™ is STERILE when shipped.
The Customized RAPID Strand allows the variable seed spacing to reflect individual patient prescriptions as specified by the treating physician. This Customized RAPID Strand will have less than ten (10) OncoSeed™ seeds and a variable number of Absorbable Seeding Spacers. The treating physician will determine the required dose and total number of active seeds for each Customized RAPID Strand.
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