# K030518: Ameritek Sure-Point Tracker System

- Pathway: 510(k) (Traditional)
- Applicant: Amertek Medical, Inc.
- Decided: May 20, 2003 after 90 days
- Product code: ITX (Transducer, Ultrasonic, Diagnostic)
- Device class: 2
- Regulation: 21 CFR 892.1570
- 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). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K972152: Devmed Stepping and Stabilizing System, Devmed Corp. (1997) Summary page 1.
- K011581: Ameritek Brachytherapy Template, Amertek Medical, Inc. (2001) Summary page 1.
- K000960: Barzell-Whitmore Maroon Bells, Inc. Colo-Rectal Mover, Model 3900, Barzell-Whitmore Maroon Bells, Inc. (2000) Summary page 1.
- K864807: Teknar Proscan (TM), Teknar, Inc. (1987) Summary page 1.
- K871413: Civco Stepper, CIVCO Medical Instruments Co., Inc. (1987) Summary page 1.
- K913293: Quick Seeder, Mick Radio-Nuclear Instruments, Inc. (1992) Summary page 1.
- K991517: Cryo-Hit II, Models EP3T3, EP5T2, EP5T5, EP7T5, EP8T5, Galil Medical, Ltd. (1999) Summary page 1.
- K881605: Biopsy Guide, Teknar, Inc. (1988) Summary page 1.
- K003270: Prostate Stepper Template Set, Model Part Number 189,065,189,066,189,067, Nucletron Corp. (2000) Summary page 1.
- K963302: Tayman Medical, Inc. Stepping & Stabilizing System, Tayman Medical, Inc. (1997) Summary page 1.
- K802032: Mini Mick Applicator, Mick Radio-Nuclear Instruments, Inc. (1980) Summary page 1.

## Cited in the summary but kept off the family tree
- K961303: Life Imaging Systems. Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 1.

## Indications for use
The major intended use of the Amertek Sure-Point Trackerm is the same as that of its unmodified predecessors cleared in KO11581 and K972152: to allow precision ultrasound probe alignment and radioactive seed implantation in brachytherapy treatments. A specific application is the treatment of prostate (or other) cancer. The Amertek Sure-Point TrackerTMalso allows data from the use of probe location indicators to be fed directly into the brachytherapy planning program, such as that of Varian. Like other basic stabilizers and steppers (e.9. Barzell-Whitmore Omnistand; Tayman Accuguide; Teknar, Proscan), this device is applicable in other surgical procedures or specialties which require accurate instrument fixation, such as cryosurgery, biopsy, and remote afterloading equipment (HDR) such as that used with the Nucletron device.

Source page: https://510kreport.com/device/K030518
Methodology: https://510kreport.com/methodology