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K Number
K031273
Device Name
AMERITEK SURE-POINT HDR NEEDLE TEMPLATE
Manufacturer
AMERTEK MEDICAL, INC.
Date Cleared
2003-07-15

(84 days)

Product Code
JAQ
Regulation Number
892.5700
Type
Traditional
Panel
RA
Reference & Predicate Devices
K990990,K910862,K011581,K003270,K993400
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Sure-Point™ HDR Needle Template is designed to allow precision ultrasound probe alignment, placement and position retention of HDR needles in cancer treatments. It was designed to work with commercially available high dose rate remote afterloaders. A specific application is the treatment of prostate (or other) cancer.

Device Description

Template for Seeding Device: Probe Stabilization Device. Applicator for Remote Controlled Afterloading Brachytherapy.

AI/ML Overview

This FDA 510(k) summary for the "Sure-Point™ HDR Needle Template" (K031273) does not contain the information requested in your prompt regarding acceptance criteria and performance studies.

This document is a declaration of substantial equivalence to existing predicate devices. This means that the manufacturer is asserting their device is as safe and effective as devices already on the market, based on similar intended use, technological characteristics, and materials.

Therefore, I cannot provide a table of acceptance criteria, device performance, sample sizes, ground truth information, or details about comparative effectiveness studies, because this information is not present in the provided text.

Here's what I can infer from the document:

  • Device Type: This is a physical medical device (a template for brachytherapy needles), not an AI/software device that would typically have performance metrics like sensitivity, specificity, or AUC.
  • Approval Basis: Substantial equivalence, not based on a new performance study demonstrating effectiveness against specific acceptance criteria.
  • Study Data: No study data is mentioned, as is common for many 510(k) submissions of physical medical devices demonstrating substantial equivalence.

If you have a document describing a performance study for an AI/software device, I would be happy to analyze it according to your prompt.

§ 892.5700 Remote controlled radionuclide applicator system.

(a)
Identification. A remote controlled radionuclide applicator system is an electromechanical or pneumatic device intended to enable an operator to apply, by remote control, a radionuclide source into the body or to the surface of the body for radiation therapy. This generic type of device may include patient and equipment supports, component parts, treatment planning computer programs, and accessories.(b)
Classification. Class II.