AMERITEK SURE-POINT TRACKER SYSTEM

• K Number: K030518
• Device Name: AMERITEK SURE-POINT TRACKER SYSTEM
• Manufacturer: AMERTEK MEDICAL, INC.
• Date Cleared: 2003-05-20 ( 90 days)
• Product Code: ITX
• Regulation Number: 892.1570

Intended Use

The major intended use of the Amertek Sure-Point Tracker™ is the same as that of its unmodified predecessors cleared in K011581 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 Tracker 100 also 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.g. Barzell-Whitmore Omnistand; Tayman Accuquide; Teknar, Proscan), this device is applicable in other surqical 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.

Device Description

Not Found

Predicate Devices

K-972152, K-011581

Reference Devices

K-000960, K-864807, K-871413, K-913293, K-961303, K991517, K-881605, K-003270, K-963302, K802032

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a mechanical device for probe alignment and seed implantation, with no mention of AI, ML, or related concepts.

Therapeutic

Yes
The device is used for precision ultrasound probe alignment and radioactive seed implantation in brachytherapy treatments, specifically for the treatment of prostate (or other) cancer, which are therapeutic medical procedures.

Diagnostic

No
The device is used for precision ultrasound probe alignment and radioactive seed implantation in brachytherapy treatments, as well as accurate instrument fixation in other surgical procedures, which are therapeutic rather than diagnostic functions.

SaMD (Software as a Medical Device)

No

The device description is not provided, but the intended use describes a "device" that allows for precision ultrasound probe alignment and radioactive seed implantation, and mentions "stabilizers and steppers" and "instrument fixation." This strongly suggests a physical hardware component is involved, not just software.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

• Intended Use: The intended use clearly describes a device used for surgical procedures (brachytherapy, cryosurgery, biopsy) and instrument fixation. This involves direct interaction with the patient's body or instruments used on the body.
• IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections. This device does not perform such tests.
• Device Description (or lack thereof): While the device description is not found, the intended use and the comparison to predicate devices (which are also surgical/instrumentation devices) strongly suggest it's not an IVD.
• Input Imaging Modality: Ultrasound is an imaging modality used on the body, not a sample taken from the body.

The device is a surgical instrument/accessory used to guide and stabilize other instruments during procedures. This falls outside the scope of in vitro diagnostics.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The major intended use of the Amertek Sure-Point Tracker™ is the same as that of its unmodified predecessors cleared in K011581 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 Tracker 100 also 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.g. Barzell-Whitmore Omnistand; Tayman Accuquide; Teknar, Proscan), this device is applicable in other surqical 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.

Product codes (comma separated list FDA assigned to the subject device)

ITX

Device Description

Not Found

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

ultrasound

Anatomical Site

prostate (or other)

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Not Found

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K-972152, K-011581

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

K-000960, K-864807, K-871413, K-913293, K-961303, K991517, K-881605, K-003270, K-963302, K802032

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 892.1570 Diagnostic ultrasonic transducer.

(a)
Identification. A diagnostic ultrasonic transducer is a device made of a piezoelectric material that converts electrical signals into acoustic signals and acoustic signals into electrical signals and intended for use in diagnostic ultrasonic medical devices. Accessories of this generic type of device may include transmission media for acoustically coupling the transducer to the body surface, such as acoustic gel, paste, or a flexible fluid container.(b)
Classification. Class II.

Summary

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XI. 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS. May 30. 2002. [Separate Pagel

I.* Submitter: Greg Wiita, Amertek Medical, Inc., 2655 North Ocean Drive, Singer Island, Florida 33404.

II. Classification Names and numbers: Acc. to Ultrasound Probe: Stepping Device, Code ITX: brachytherapy template, Code ITX.

III. Common/Usual Name: Stepping and Stabilization Device, and template

IV. Proprietary Names: Amertek™ Sure-Point Tracker System

V. Establishment Registration Number: 1066424

VI. Classification: Accessories to ultrasonic transducer, Class II, CFR 892.1570

VII. Substantial Equivalence: Amertek™ is substantially equivalent (and nearly identical to) its predecessor devices cleared under K-972152 and K-011581. It is also equivalent to devices cleared for marketing by the 510(k) process under K-000960 (Barzell-Whitmore), K-864807 (Teknar), K-871413 (Civco), K-913293 (Mick Radio-Nuc.), K-961303 (Life Imaging Systems), K991517 (Galil Medical), K-881605 (Teknar Corp.), K-003270 (Nucletron Corp.) and K-963302 (Tayman Medical).

The "510(k) "Substantial Equivalence" Decision-Making Process (Detailed) from ODE Guidance Memorandum #86-3 was followed as described below:

1. These products have the same intended uses, as the classified device and those cleared for marketing as equivalent to it by the 510(k) process under K972152 (Devmed. Inc.), K011581 (Amertek Inc.), K802032 and K913293 (Mick Radio-Nuclear), under K864807 (Teknar Corp.) and others listed above.

2. The technological characteristics for this product are the same as those for the predicate devices and those currently on the market.

3. Descriptive information provided shows that the materials from which Amertek™ is made are substantially equivalent those of similar products, used for identical purposes, currently on the market.

4. The FDA "Decision-Making Process" chart was used and appears in Attachment VI.

(End of Summary)

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We have not found a specific guidance document on this subject, but believe we have complied fully with general guidance documents and usual practices in preparing premarket notifications. We have followed the software guidance document, "General Principles of Software Validation; Final Guidance for Industry and FDA Staff' issued Jan. 11, 2002. If additional information or explanation is needed, please call me at 800-533-2823 or fax me at 561-842-6660. Alternately, you may contact Dr. H. N. Dunning at 301-229-2138, for a local response.

Sincerely yours

L.H.W.S

Greg Wiita President

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Image /page/2/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the edge. In the center of the seal is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 2 0 2003

Mr. Greg Wiita President Amertek Medical, Inc. 2655 North Ocean Drive SINGER ISLAND FL 33404 Re: K030518 Trade/Device Name: Amertek™ Sure-Point Tracker System Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic ultrasonic transducer Regulatory Class: II Product Code: 90 ITX Dated: February 10, 2003 Received: February 19, 2003

Dear Mr. Wiita:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807): labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.

3

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of the letter:

8xx. 1xxx	[phone]
876.2xxx, 3xxx, 4xxx, 5xxx	[phone]
884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx	[phone]
892.2xxx, 3xxx, 4xxx, 5xxx	[phone]
Other	[phone]

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Nancy C. Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

4

VIII.1 Indication for use. [Separate page].

030518 510(k) number: N/A

Device Name: Amertek Sure-Point Tracker™

The major intended use of the Amertek Sure-Point Tracker™ is the same as that of its unmodified predecessors cleared in K011581 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 Tracker 100 also 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.g. Barzell-Whitmore Omnistand; Tayman Accuquide; Teknar, Proscan), this device is applicable in other surqical 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.

Nancy C. Brogdon

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K030518

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation(ODE)

Prescription Use V or (Per 21 CFR 801.109)

Over-The-Counter Use

(Optional format 1-2-96)