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K Number
K060679
Device Name
SURTRAK IMPLANTATION KIT
Manufacturer
NORTH AMERICAN SCIENTIFIC, INC.
Date Cleared
2006-04-21

(37 days)

Product Code
KXK
Regulation Number
892.5730
Type
Traditional
Panel
RA
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The North American Scientific, Inc Brachytherapy Preloaded Needle Kit is indicated for interstitial implantation of select localized tumors with low to medium radiosensitivity. They are used either as primary treatment for tumors such as those in the head, neck, lung, pancreas, breast, cervix and prostate and unresectable turnors or for residual disease after excision of the primary turnor. North American Scientific Brachytherapy Preloaded Needle Kit implants are indicated for use with or at the completion of other treatment modalities, such as external beam radiation therapy or chemotherapy.

Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text does not contain the information requested in your prompt. The document is a 510(k) clearance letter from the FDA for a medical device called the "Surtrak® Implantation Kit". It primarily addresses regulatory aspects, substantial equivalence to predicate devices, and indications for use.

It does not include:

  • A table of acceptance criteria and reported device performance.
  • Details about sample sizes, data provenance, or the type of study conducted.
  • Information on ground truth establishment, expert qualifications, or adjudication methods.
  • Data on Multi-Reader Multi-Case (MRMC) studies or standalone algorithm performance.
  • Training set details or how their ground truth was established.

Therefore, I cannot fulfill your request using the provided input.

§ 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.