(90 days)
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.
Not Found
The provided text describes a 510(k) premarket notification for the Amertek™ Sure-Point Tracker System. This device is described as a "Stepping and Stabilization Device, and template" for use with ultrasound probes, specifically for brachytherapy treatments (e.g., prostate cancer) and other surgical procedures requiring accurate instrument fixation.
However, the document does not contain specific acceptance criteria, a study that proves the device meets those criteria, or any of the detailed information requested in your prompt (e.g., sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details).
Instead, the submission states that the device is "substantially equivalent" to predicate devices already cleared for marketing. This means the FDA's decision was based on the device having the same intended uses, similar technological characteristics, and comparable materials as existing devices, rather than on new performance studies with specific acceptance criteria.
Therefore, I cannot provide a table of acceptance criteria or details about a study proving the device meets them, as this information is not present in the provided text. The submission explicitly states:
- "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." (Page 1)
- 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 uses, as the classified device and those cleared for marketing as equivalent to it by the 510(k) process...
- 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 made are substantially equivalent those of similar products, used for identical purposes, currently on the market." (Page 0)
The lack of such detailed performance study information is common in 510(k) submissions where substantial equivalence is claimed based on similarity to predicate devices, rather than novel performance claims requiring new clinical or analytical studies.
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Image /page/0/Picture/1 description: The image shows a handwritten string of characters. The characters appear to be "K030518". The writing is in black ink on a white background. The style of writing is somewhat stylized and cursive.
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:
-
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.
-
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 made are substantially equivalent those of similar products, used for identical purposes, currently on the market.
-
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.
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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 | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
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 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 (800) 638-2041 or (301) 443-6597 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
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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)
§ 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.