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K Number
K972271
Device Name
NORTH AMERICAN SCIENTIFIC (NASI) I-125 RADIONUCLIDE BRACHYTHERAPY SOURCE- MODEL MED 3631-A
Manufacturer
ML STRATEGIES, INC.
Date Cleared
1997-10-28

(132 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 Corporation's I-125 Radionuclide Brachytherapy Source Model MED3631-A is a device intended to deliver radiation by interstitial intracavity or surface application for therapy of malignant lesions.

Device Description

I-125 Radionuclide Brachytherapy Source Model MED3631-A

AI/ML Overview

This document is a 510(k) premarket notification letter from the FDA regarding an I-125 radionuclide brachytherapy source. As such, it does not contain the detailed information required to answer your request about acceptance criteria and a study proving device performance.

The letter approves the device based on substantial equivalence to a predicate device, meaning it was determined to be as safe and effective as a device already legally marketed. It does not provide data from a specific study designed to prove new acceptance criteria for this particular device.

Therefore, I cannot provide the requested information, which typically would be found in a clinical study report or a detailed performance validation report:

  1. Table of acceptance criteria and reported device performance: Not present in this document.
  2. Sample size used for the test set and the data provenance: Not present.
  3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not present.
  4. Adjudication method for the test set: Not present.
  5. Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable or present for this type of device (a brachytherapy source, not an AI diagnostic tool).
  6. Standalone (algorithm only) performance: Not applicable or present.
  7. Type of ground truth used: Not applicable.
  8. Sample size for the training set: Not applicable (no AI/machine learning involved).
  9. How the ground truth for the training set was established: Not applicable.

§ 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.