GDC PATIENT RETURN ELECTTRODE MODEL 45021

K963307 · Target Therapeutics · HCG · Dec 17, 1996 · Neurology

Device Facts

• Record ID: K963307
• Device Name: GDC PATIENT RETURN ELECTTRODE MODEL 45021
• Applicant: Target Therapeutics
• Product Code: HCG · Neurology
• Decision Date: Dec 17, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5950
• Device Class: Class 2

Indications for Use

The Patient Return Electrode is indicated for use only with Target Therapeutics GDC System as the patient return electrode.

Device Story

Single-use, non-sterile patient return electrode (PRE); applied to patient deltoid skin; includes prep pad for skin exfoliation. Replaces hypodermic needle as return electrode for Target Therapeutics GDC system. Used in clinical settings by physicians. Enhances patient comfort; no impact on GDC system safety or efficacy. Bench testing (tensile, impedance), animal studies, and biocompatibility testing confirm performance.

Clinical Evidence

Bench testing (tensile and impedance), animal studies, and biocompatibility testing performed. No human clinical trial data reported.

Technological Characteristics

Single-use, non-sterile disposable electrode. Applied to skin via adhesive. Includes skin exfoliation prep pad. Passive electrical return component.

Indications for Use

Indicated for use as a patient return electrode exclusively with the Target Therapeutics GDC System.

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

• Silver Sircuit, Sentry Medical Products (K851522)
• Polyhesive II, Valleylab, Inc (K861036)
• Hypodermic Needle, Target Therapeutics (K951256)

Submission Summary (Full Text)

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K963307

TARGET THERAPEUTICS

DEC 17 1996

# 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
Sr. Manager, Regulatory Affairs
Target Therapeutics, Inc.
47201 Lakeview Blvd.
Fremont, CA 94538-6530

## DEVICE NAME:

Patient Return Electrode (PRE); Class II

## DEVICE DESCRIPTION:

Target Therapeutics' Patient Return Electrode (PRE) is a single use, disposable, non-sterile electrode. The PRE is intended to be used as an alternative patient return electrode for Target Therapeutics GDC system (K951256 & K960705). A hypodermic needle is currently used as the patient return electrode. The PRE is applied to the skin on the patient's upper arm (deltoid). The PRE is being made available for patient comfort and has no effect on the safety or efficacy of the GDC system as functional testing indicates.

A small Prep pad is included with the PRE to exfoliate the skin prior to applying the PRE.

## INDICATIONS FOR USE:

The Patient Return Electrode is indicated for use only with Target Therapeutics GDC System as the patient return electrode.

## PREDICATE DEVICE:

| Product Design: | Silver Sircuit™, Sentry Medical Products | K851522 |
| --- | --- | --- |
| Indications for Use: | Polyhesive® II, Valleylab, Inc | K861036 |
| Functional Performance: | Hypodermic Needle, Target Therapeutics | K951256 |

Patient Return Electrode
510(K)
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# TESTING in SUPPORT of SUBSTANTIAL EQUIVALENCE DETERMINATION:

The results of bench testing (Tensile Test, Impedance Test), animal studies, and biocompatibility testing support the substantial equivalence claims of the PRE for its intended use. Results of the bench testing, animal studies, and biocompatibility testing in conjunction with the substantial equivalence claims as outlined in the premarket notification, effectively demonstrate the PRE is substantially equivalent to the predicate devices.

Patient Return Electrode 510(K)
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