Who is the manufacturer of TAYMAN MEDICAL, INC. STEPPING & STABILIZING SYSTEM?

Tayman Medical, Inc. filed the 510(k) submission for TAYMAN MEDICAL, INC. STEPPING & STABILIZING SYSTEM (K963302).

What is the FDA product code for TAYMAN MEDICAL, INC. STEPPING & STABILIZING SYSTEM?

ITX. It is classified under 21 CFR 892.1570 as a Class 2 device in the Radiology panel.

What is the regulatory pathway for TAYMAN MEDICAL, INC. STEPPING & STABILIZING SYSTEM?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like TAYMAN MEDICAL, INC. STEPPING & STABILIZING SYSTEM?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

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

Related Devices

K050724 — SURE-POINT MIDLINE STEPPING AND STABILIZATION SYSTEM · C.R. Bard, Inc. · Apr 18, 2005
K023430 — UF BRACHYTHERAPY STAND · University of Florida · Jun 24, 2003
K972152 — DEVMED STEPPING AND STABILIZING SYSTEM · Devmed Corp. · Aug 15, 1997
K011581 — AMERITEK BRACHYTHERAPY TEMPLATE · Amertek Medical, Inc. · Jul 17, 2001
K973786 — NORTHWEST RADIATION THERAPY PRODUCTS, PRECISION STEPPER AND GUIDE · Nw Radiation Therapy Products · Jan 2, 1998

Submission Summary (Full Text)

{0} 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. 34