# K031273: Ameritek Sure-Point HDR Needle Template

- Pathway: 510(k) (Traditional)
- Applicant: Amertek Medical, Inc.
- Decided: Jul 15, 2003 after 84 days
- Product code: JAQ (System, Applicator, Radionuclide, Remote-Controlled)
- Device class: 2
- Regulation: 21 CFR 892.5700
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K802032 (1980). 17 ancestors in all.
No later device cites it as a predicate yet.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011581: Ameritek Brachytherapy Template, Amertek Medical, Inc. (2001)
- K003270: Prostate Stepper Template Set, Model Part Number 189,065,189,066,189,067, Nucletron Corp. (2000) Summary page 1.
- K993400: HDR Contour TP Template and Implant Accessories, Mick Radio-Nuclear Instruments, Inc. (2000) Summary page 1.
- K990990: Cet Prostate Applicator Set, Part Number 089.066, Nucletron Corp. (1999) Summary page 1.
- K910862: Various Template Applicators, Best Industries (1991) Summary page 1.

## Indications for use
The use of sealed radioisotopes to treat tumors within the body ha:: been documented and published since the turn of the century. Modem era radiation therapy has developed delivery systems using isotopes-of cesium, indium, iodine and gold, for a few examples. Many tumors now are treated by internal exposure to radiation emitted from sealed radioactive sources. The two common modalities are the Low dose rate and High dose rate afterloaders. The Sure-Pointm 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.

Source page: https://510kreport.com/device/K031273
Methodology: https://510kreport.com/methodology