(168 days)
The Tayman Medical, Inc. Stepping and Stabilization System is used to provide precision ultrasound probe alignment and radioactive seed implantation in the treatment of prostate cancer.
The seeding device is comprised of three basic components. The adjustable height base. The adjustable, multi-axis head. The ultrasound probe holder and needle guide.
The provided text is a summary of safety and effectiveness for a medical device (Tayman Medical, Inc. Stepping and Stabilization System). It describes the device, its intended use, and its similarities to a predicate device.
However, the document does not contain any information regarding acceptance criteria, study results, sample sizes, ground truth establishment, expert qualifications, or any of the other specific details requested in the prompt.
Therefore, I cannot fulfill the request using the provided input. The document focuses on regulatory equivalence rather than performance evaluation against specific criteria.
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FEB - 6 1997
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মিনিটের মাধ্যমে সামনে প্রতিষ্ঠান করে আমার প্রতিষ্ঠান করে তার করে পারেন।
প্রকল্পিত
কার্যালয়ের সামন্ত্রী
মানুষ
মানুষ
Section XI - Summary of Safety and Effectiveness
| Date of Preparation: | August 16, 1996 |
|---|---|
| Device Name: | Tayman Medical, Inc. Stepping and Stabilization System |
| Classification Name: | Guide Surgical Instrument 79FZX |
| Manufacturer: | Tayman Medical, Inc. located at 15 Foxhunt Drive,Chesterfield, Missouri 63017 |
| Predicate Device: | The Tayman Medical, Inc. Seeding Device is substantiallyequivalent in intended use, safety and effectiveness andconstruction to the Teknar, Inc. Seeding device. That devicewas produced and marketed by Teknar, Inc. formally located at267 Wolfner Drive, Fenton, Missouri 63026. |
| Device Description: | The seeding device is comprised of three basic components.The adjustable height base. The adjustable, multi-axis head.The ultrasound probe holder and needle guide. |
| Intended Use: | The Tayman Medical, Inc. Stepping and Stabilization Systemis used to provide precision ultrasound probe alignment andradioactive seed implantation in the treatment of prostatecancer. |
| Clinical and Non-ClinicalSimilarities and Differences: | The Tayman Medical, Inc. Stepping and Stabilization Systemis substantially equivalent to the Teknar, Inc. Seeding devicesince they both are used to provide precision ultrasound probealignment and radioactive seed implantation in the treatmentof prostate cancer. They are operated in the exact same wayand are made from the same materials. |
§ 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.