TAYMAN MEDICAL, INC. STEPPING & STABILIZING SYSTEM

K963302 · Tayman Medical, Inc. · ITX · Feb 6, 1997 · Radiology

Device Facts

• Record ID: K963302
• Device Name: TAYMAN MEDICAL, INC. STEPPING & STABILIZING SYSTEM
• Applicant: Tayman Medical, Inc.
• Product Code: ITX · Radiology
• Decision Date: Feb 6, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1570
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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.

Device Story

System provides precision ultrasound probe alignment and needle guidance for radioactive seed implantation; used in prostate cancer treatment. Comprised of adjustable height base, adjustable multi-axis head, and ultrasound probe holder/needle guide. Operated by clinicians to stabilize imaging and delivery tools during brachytherapy procedures. Facilitates accurate seed placement; improves procedural consistency.

Clinical Evidence

No clinical data; substantial equivalence based on design, material, and intended use similarities to predicate.

Technological Characteristics

Mechanical assembly consisting of adjustable height base, multi-axis head, and ultrasound probe/needle guide. Materials identical to predicate device.

Indications for Use

Indicated for patients requiring radioactive seed implantation for the treatment of prostate cancer.

Regulatory Classification

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.

Predicate Devices

• Teknar, Inc. Seeding device

Submission Summary (Full Text)

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FEB - 6 1997
K9C3302

# 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 substantially equivalent in intended use, safety and effectiveness and construction to the Teknar, Inc. Seeding device. That device was produced and marketed by Teknar, Inc. formally located at 267 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 System is used to provide precision ultrasound probe alignment and radioactive seed implantation in the treatment of prostate cancer.

Clinical and Non-Clinical Similarities and Differences: The Tayman Medical, Inc. Stepping and Stabilization System is substantially equivalent to the Teknar, Inc. Seeding device since they both are used to provide precision ultrasound probe alignment and radioactive seed implantation in the treatment of prostate cancer. They are operated in the exact same way and are made from the same materials.

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