TORQUE DEVICE

K964352 · B.Braun Medical, Inc. · DQX · Jan 28, 1997 · Cardiovascular

Device Facts

• Record ID: K964352
• Device Name: TORQUE DEVICE
• Applicant: B.Braun Medical, Inc.
• Product Code: DQX · Cardiovascular
• Decision Date: Jan 28, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1330
• Device Class: Class 2

Intended Use

The guidewire torque device is a cylindrical clamp which slides over the proximal end of a guidewire. The device is used to facilitate the manipulation of a guidewire into a vein or artery.

Device Story

Cylindrical clamp device; slides over proximal end of guidewire; facilitates manual manipulation/rotation of guidewire into veins or arteries; used by clinicians in clinical settings; provides mechanical grip to improve guidewire control; enhances precision during vascular access; simple mechanical accessory.

Clinical Evidence

Bench testing only; physical testing and visual examination performed per Quality Control Test Procedures to ensure conformance to design specifications.

Technological Characteristics

Cylindrical clamp; materials tested per Tripartite Guidance for Plastics; mechanical operation; no energy source; standalone accessory.

Indications for Use

Indicated for use by clinicians to facilitate the manipulation of a guidewire into a vein or artery during catheterization procedures.

Regulatory Classification

Identification

A catheter guide wire is a coiled wire that is designed to fit inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel.

Special Controls

*Classification.* Class II (special controls). The device, when it is a torque device that is manually operated, non-patient contacting, and intended to manipulate non-cerebral vascular guide wires, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.

Predicate Devices

• Torque Device (K903606)
• Scout Torque Device (K936032)

Submission Summary (Full Text)

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K964352

# II 510(k) Summary of Safety and Effectiveness in Accordance with SMDA'90

B. Braun Medical, Inc
824 Twelfth Avenue
Bethlehem, PA 18018
[phone]

JAN 28 1997
October 28, 1996

Contact: Mark S. Alsberge, Regulatory Affairs Manager

Product Name: TORQUE DEVICE

Trade Name: LTD Torque Device

Classification name: Catheter Guide Wire

Cardiovascular
Class II, 74DQX
21 CFR 870.1330

## SUBSTANTIAL EQUIVALENCE¹ TO:

| 510(k) number | Name | Applicant |
| --- | --- | --- |
| K903606 | Torque Device | Namic |
| K936032 | Scout Torque Device | Merit Medical |

## Device Description:

In accordance with section 510(k) for the Federal Food, Drug, and Cosmetic Act, B. Braun Medical, Inc. intends to introduce into interstate commerce a Torque Device. The guidewire torque device is a cylindrical clamp which slides over the proximal end of a guidewire. The device is used to facilitate the manipulation of a guidewire into a vein or artery.

¹ The term "substantially equivalent" as use herein is intended to be a determination of substantial equivalence from an FDA -regulatory point of view under the Federal Food, Drug, and Cosmetic Act and relates to the fact that the product can be marketed without premarket approval or reclassification. These products may be considered distinct from a patent point of view. The term "substantially equivalent" is not applicable to and does not diminish any patent claims related to this product or the technology used to manufacture the product.

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## Material:

The Torque Device is composed of materials that have been tested in accordance with Tripartite Guidance for Plastics and determined to be suitable for the intended use of this product.

## Substantial equivalence:

The Torque Device is similar in materials, form, and intended use to the Torque Device cleared by Namic and the Scout Torque Device cleared by Merit Medical. There are no new issues of safety or effectiveness raised by the Torque Device.

## Safety And Effectiveness:

All finished products are tested and must meet all required release specifications before distribution. The array of testing required for release include, but are not limited to; physical testing, visual examination (in process and finished product).

The physical testing is defined by Quality Control Test Procedure documents. These tests are established testing procedures and parameters which conform to the product design specifications.

The testing instruction records for each of the individually required procedures are approved, released, distributed and revised in accordance with document control GMP’s.