BERENSTEIN COIL

K961923 · Target Therapeutics · HCG · Aug 15, 1996 · Neurology

Device Facts

• Record ID: K961923
• Device Name: BERENSTEIN COIL
• Applicant: Target Therapeutics
• Product Code: HCG · Neurology
• Decision Date: Aug 15, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5950
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

Berenstein Coil is an occlusion coil for neurovascular malformation embolization. Delivered via injection through Target Therapeutics Infusion Catheters or Balt Magic 1.5F/1.8F catheters. Available in helical shapes with 0.008 or 0.016 inch primary wind diameters. Radiopaque; supplied in sheath-like introducer. Requires specific adapter for use with Balt Magic catheters. Used by physicians in clinical settings to occlude vascular malformations, potentially reducing blood flow to target lesions.

Clinical Evidence

Bench testing only. Functional testing included force required for delivery through catheters and coil/catheter compatibility. Biocompatibility testing performed. Results demonstrate performance equivalent to predicate devices.

Technological Characteristics

Platinum wire occlusion coil; helical shape; 0.008 or 0.016 inch primary wind diameters; radiopaque; sheath-like introducer; requires adapter for specific catheter compatibility.

Indications for Use

Indicated for patients requiring embolization of neurovascular malformations.

Regulatory Classification

Identification

A neurovascular embolization device is an intravascular implant intended to permanently occlude blood flow to cerebral aneurysms and cerebral ateriovenous malformations. This does not include cyanoacrylates and other embolic agents, which act by polymerization or precipitation. Embolization devices used in other vascular applications are also not included in this classification, see § 870.3300.

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 § 882.1(e).

Predicate Devices

• Target Therapeutics Platinum Occlusion Coils
• Cook Embolization Coils

Submission Summary (Full Text)

{0}

08/14/96 WED 12:47 FAX [phone]
TARGET FREMONT
002
A 15
K961923

# TARGET
# THERAPEUTICS

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 neuro vasculature.

510(k) Notification K961923
Target Therapeutics Berenstein Coil Occlusion Device
August 14, 1996

{1}

08/14/96 WED 12:48 FAX [phone]
TARGET FREIGHT
003

# PREDICATE DEVICES:

The Berenstein Coil is substantially equivalent in materials, intended use, performance, and design parameters to Target Therapeutics Platinum Occlusion Coils. It is equivalent in the method of delivery to Cook Embolization Coils. All predicate devices are currently cleared for commercial distribution. The only difference between the Berenstein Coils and the predicates is the outer diameter of the platinum wire. In instances where the technological characteristics are different, it has been demonstrated with in-vivo and in-vitro testing that there are no new questions raised regarding safety or efficacy of the Berenstein Coil.

# TESTING in SUPPORT of SUBSTANTIAL EQUIVALENCE DETERMINATION:

In-vitro, in-vivo, and biocompatibility testing was performed to demonstrate that the Berenstein Coil is as safe, as effective, and performs as well as or better than the predicate device.

Functional bench testing was comprised of: 1) force required to deliver coils through catheters, and 2) coil/catheter compatibility. The results of these tests showed the Berenstein Coil is substantially equivalent to the predicate device.

510(k) Notification K961923
Target Therapeutics Berenstein Coil Occlusion Device
August 14, 1996