LogoFDA 510(k) Search
K Number
K023210
Device Name
SEEDLINKS, MODELS 70301, 70302, 70303
Manufacturer
SOURCETECH MEDICAL, L.L.C.
Date Cleared
2003-03-28

(183 days)

Product Code
KXK
Regulation Number
892.5730
Type
Traditional
Panel
RA
Reference & Predicate Devices
N/A
Predicate For
K113210
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The SeedLinks™ are indicated for use in brachytherapy source spacing and linking in brachytherapy procedures.

Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text does not contain the detailed information necessary to describe the acceptance criteria and the study proving the device meets them in the format requested. The document is a 510(k) clearance letter from the FDA, which confirms that the SeedLinks™ device is substantially equivalent to a legally marketed predicate device.

Specifically, the text does not include:

  • A table of acceptance criteria and reported device performance.
  • Details about the sample size used for the test set or its data provenance.
  • Information about the number or qualifications of experts used for ground truth.
  • The adjudication method.
  • Whether a multi-reader multi-case (MRMC) comparative effectiveness study was done, or its effect size.
  • Whether a standalone performance study was done.
  • The type of ground truth used.
  • The sample size for the training set.
  • How the ground truth for the training set was established.

The document primarily focuses on the regulatory clearance and the intended use of the device, which is "for use in brachytherapy source spacing and linking in brachytherapy procedures." It confirms that the device is classified as a radionuclide brachytherapy source (21 CFR 892.5730, Class II, Product Code 90 KXK) and can be marketed based on its substantial equivalence to a predicate device, subject to general and special controls.

§ 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.