The Amertek Template is designed to allow precision ultrasound probe alignment and radioactive seed implantation in brachytherapy treatments. A specific application is the treatment of prostate (or other) cancer.

Device Description

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AI/ML Overview

The provided text is a 510(k) summary for the Amertek™ Brachytherapy Template, a device designed to assist in brachytherapy treatments. It focuses on establishing substantial equivalence to existing predicate devices rather than presenting a performance study with acceptance criteria and results.

Therefore, the document does not contain the information requested regarding acceptance criteria and a study to prove the device meets them. The summary primarily addresses:

Device identification and classification
Substantial equivalence claims based on intended use, technological characteristics, and materials compared to predicate devices.
Indications for Use.

There is no mention of:

A table of acceptance criteria and reported device performance.
Sample sizes for test sets, data provenance.
Number of experts, their qualifications, or adjudication methods for ground truth.
MRMC studies or effect sizes.
Standalone algorithm performance.
Type of ground truth used.
Sample size for training sets or how their ground truth was established.

Summary

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Koll581/

XI. 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS. May 30, 1997. [Separate Pages]

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

III. Common/Usual Name: Stepping and Stabilization Device

IV. Proprietary Names: Amertek™ Brachytherapy Template

V. Establishment Registration Number: in process

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

VII. Substantial Equivalence: Amertek™ is substantially equivalent (and nearly itemical to VII. Substantial Lydivalence. Annenox - 16 Substantially 6 mm like the Civco Brachytherapy the device cleared under R-972162. It is also equivalent to devices cleared for marketing by Template Geared ander K-864807 (Teknar), K-871413 (Civco), K-913293 (Mick Radio-Nuc.) 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:

These products have the same intended use, as the equivalent devices the classified 1. These products have the same include and the 510(k) process under (802032 and device "and" those" of our ou" mantaing "Teknar Corp.) and others listed above.
The technological characteristics for this product are the same as those for the predicate devices and those currently on the market.
Descriptive information provided shows that the materials from which Amertek™ is 5. Descriptive information pronuou se of similar products, used for identical purposes, currently on the market.
The FDA "Decision-Making Process" chart was used and appears in Attachment IV.

(End of Summary)

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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with three heads facing right, representing health, human services, and well-being. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 1 7 2001

Mr. Greg Wiita President Amertek Medical, Inc. 2655 North Ocean Drive SINGER ISLAND FL 33404 Re: K011581

Ameritek Brachytherapy Template (Seeding Device; Probe Stabilization Device) Dated: April 24, 2001 Received: May 23, 2001 Regulatory Class: II 21 CFR 892.1570/Procode: 90 ITX

Dear Mr. Wiita:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the I vice 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). You may, that have boon revelastics in abbect 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing The 21, For and 000 0099 : 1 battle in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 1 Not that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure o comply with the GMP regulation way result in regulatory action. In addition, FDA may publish further announcements conceming your device in the Federal Register. Please note: this response to your prematies notification submission does not ection any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4639. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Nancy C. Bogdon

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

Enclosure (s)

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VIII.1 Indications for Use: [Separate Page]

Note: This is the same "Indications for Use" as for the original except (or other) is Note: "This to the can's since the applications of brachytherapy have expanded.

510(k) Number: NA

Device Name: Amertek™ Brachytherapy Template

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

Concurrence of CDRH, Office of Device Evaluation(ODE)

Prescription Use

Over-The-Counter Use

(Optional Format 1-2-96)

Elmer C. Diggins

(Division Sign-Off) Division of Reproductive, A and Radiological D 510(k) Number

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.