BERENSTEIN COIL

K964112 · Target Therapeutics · KRD · Feb 26, 1997 · Cardiovascular

Device Facts

• Record ID: K964112
• Device Name: BERENSTEIN COIL
• Applicant: Target Therapeutics
• Product Code: KRD · Cardiovascular
• Decision Date: Feb 26, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.3300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Berenstein Coils are intended for the embolization of vascular malformations of the peripheral and neuro vasculature.

Device Story

Berenstein Coil; radiopaque occlusion coil; helical shape; 0.008 or 0.016 inch primary wind diameters. Delivered via injection through Target Therapeutics Infusion Catheters or Balt Magic 1.5F/1.8F catheters; requires adapter for Balt Magic catheters. Loaded in sheath-like introducer for catheter transfer. Used by physicians in clinical settings for embolization of vascular malformations; provides mechanical occlusion to reduce or stop blood flow to malformation; aids in treatment of vascular abnormalities.

Clinical Evidence

No clinical data; substantial equivalence based on identical materials, design, and performance parameters to predicate device.

Technological Characteristics

Radiopaque occlusion coil; helical geometry; 0.008 or 0.016 inch primary wind diameters; supplied with sheath-like introducer; requires adapter for specific catheter compatibility.

Indications for Use

Indicated for embolization of vascular malformations in peripheral and neuro vasculature. Patient population includes individuals requiring vascular occlusion for malformations.

Regulatory Classification

Identification

A vascular embolization device is an intravascular implant intended to control hemorrhaging due to aneurysms, certain types of tumors (e.g., nephroma, hepatoma, uterine fibroids), and arteriovenous malformations. This does not include cyanoacrylates and other embolic agents, which act by polymerization or precipitation. Embolization devices used in neurovascular applications are also not included in this classification, see § 882.5950 of this chapter.

Special Controls

*Classification.* Class II (special controls.) The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Vascular and Neurovascular Embolization Devices.” For availability of this guidance document, see § 870.1(e).

Predicate Devices

• Target Therapeutics Berenstein Coils (K961923)

Submission Summary (Full Text)

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K964112
FEB 26 1997

a. 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

## CONTACT PERSON:

Laraine Pangelina
Manager, Regulatory Affairs
Target Therapeutics, Inc.
47201 Lakeview Blvd.
Fremont, CA 94538

## DEVICE NAME:

Berenstein Coil, Class III

## DEVICE DESCRIPTION:

The Berenstein Coil is an occlusion coil designed to be delivered by injection through either Target Therapeutics Infusion Catheters or Balt Magic 1.5F and 1.8F catheters. These coils are radiopaque.

The Berenstein Coil is available in a helical shape, in 0.008 or 0.016 inch primary wind diameter (Berenstein Coil - 10 and Berenstein Coil - 18, respectively), and in a variety of lengths. The Berenstein Coil comes loaded in a sheath-like introducer for easy transfer into a catheter.

An adapter, manufactured by Target Therapeutics, is required when Berenstein Coil - 10 Occlusion Devices are used with Balt Magic catheters. The Adapter may be supplied with the Berenstein Coil or may be available separately.

## INTENDED USE:

Berenstein Coils are intended for the embolization of vascular malformations of the peripheral and neuro vasculature.

## PREDICATE DEVICES:

The Berenstein Coil is identical in materials, performance, and design parameters to Target Therapeutics Berenstein Coils, cleared for commercial distribution for neuro vascular indications in K961923 and is similar to other Target Therapeutics occlusion coils cleared for use in the peripheral vasculature including

510(k) Notification,
Target Therapeutics Berenstein Coil Occlusion Device,
Peripheral Indications
October 14, 1996