SURVIVALINK MULTIFUNCTIONAL ELECTRODE (SVL-9630)

K993072 · Survivalink Corp. · MKJ · Dec 10, 1999 · Cardiovascular

Device Facts

• Record ID: K993072
• Device Name: SURVIVALINK MULTIFUNCTIONAL ELECTRODE (SVL-9630)
• Applicant: Survivalink Corp.
• Product Code: MKJ · Cardiovascular
• Decision Date: Dec 10, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.5310
• Device Class: Class 3
• Attributes: Therapeutic

Intended Use

The SVL-9630 electrodes are single use, non sterile, and intended to be used in conjunction with low energy semi-automatic external defibrillators (AED) and/or external transcutaneous pacemakers to monitor, defibrillate or pace the adult patient. The electrodes meet AAMI DF-39 performance standards. The electrodes can be used with external defibrillators/pacing devices that had been tested for compatibility with the proper electrode connector or adapter. The electrodes are intended for short-term use (< 8 hours) and must be used before the expiration date listed on the packaging. These electrodes provide the conductive interface between the defibrillator and/or the external transcutaneous cardiac pacemaker and the patient skin.

Device Story

SVL-9630 is a pair of non-sterile, hydrogel polymeric self-adhesive electrode pads; provides conductive interface between patient skin and external defibrillator/transcutaneous pacemaker; used for monitoring, defibrillation, or pacing; intended for adult patients; short-term use (<8 hours); device functions as passive accessory to AEDs/pacemakers; no active processing or software components.

Clinical Evidence

Bench testing only. Device performance verified against AAMI DF-39 standards and internal specifications.

Technological Characteristics

Hydrogel polymeric self-adhesive electrode pads; single-use; non-sterile; dimensions equal for both pads; conductive interface; meets AAMI DF-39 performance standards.

Indications for Use

Indicated for adult patients requiring cardiac monitoring, defibrillation, or transcutaneous pacing via compatible low-energy semi-automatic external defibrillators or external pacemakers. Intended for short-term use (<8 hours).

Regulatory Classification

Identification

An automated external defibrillator (AED) system consists of an AED and those accessories necessary for the AED to detect and interpret an electrocardiogram and deliver an electrical shock (e.g., battery, pad electrode, adapter, and hardware key for pediatric use). An AED system analyzes the patient's electrocardiogram, interprets the cardiac rhythm, and automatically delivers an electrical shock (fully automated AED), or advises the user to deliver the shock (semi-automated or shock advisory AED) to treat ventricular fibrillation or pulseless ventricular tachycardia.

Predicate Devices

• Survivalink Model 9130 electrodes (K971149)
• Katecho KDP-60 electrodes (K981737)

Submission Summary (Full Text)

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SurVivaLink

Amendment 1

P.05/06

DEC I 0 1999

# 510(k) Summary

#### ADMINSTRATIVE INFORMATION H-1.

## H-1.1 Name and address

Survivalink Corporation Submitted by: 5430 Feltl Road Minneapolis, MN 55343

| Contact Person: | Sew-Wah Tay, Ph.D. |
|-----------------|----------------------|
| Telephone No .: | 612-939-2942 |
| Facsimile No .: | 612-939-4191 |
| Email address: | [e-mail] |

Date Prepared: September 8, 1999

# H-1.2 Device Name

| Common or Usual Name: | Disposable Polymer (Hydrogel) Multifunctional Electrode |
|-----------------------|---------------------------------------------------------|
| Device Name: | SVL-9630 |
| Trade Name: | SVL-9630 |

#### Classification Name H-1.3

Disposable Single Use Accessory (Electrode) to: a) Semi-automatic low energy DC defibrillator 21CFR 870.5300; Class II b) Cardiac Monitor (Cardiotachometer and Rate Alarm) 21CFR \$870.2300; Class II

# H-1.4 Applicant

| Applicant's Name: | Survivalink, Corporation<br>5430 Feltl Road<br>Minneapolis, MN 55343 |
|-------------------|----------------------------------------------------------------------|
|-------------------|----------------------------------------------------------------------|

#### H-2. PREDICATE DEVICE

- 1. Survivalink Model 9130 electrodes (K971149)
- 2. Katecho KDP-60 electrodes (K981737)

#### H-3. INDICATION FOR USE

The SVL-9630 electrodes are single use, non sterile, and intended to be used in conjunction with low energy semi-automatic external defibrillators (AED) and/or external transcutaneous pacemakers to monitor, defibrillate or pace the adult patient. The electrodes meet AAMI DF-39 performance standards. The electrodes can be used with external defibrillators/pacing devices that had been tested for compatibility with the proper electrode connector or adapter.

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510(k) K993072

The electrodes are intended for short-term use (<8 hours) and must be used before the expiration date listed on the packaging. These electrodes provide the conductive interface between the defibrillator and/or the external transcutaneous cardiac pacemaker and the patient skin.

## DEVICE DESCRIPTION H-4

The SVL-9630 electrodes consists of a pair of non sterile, hydrogel polymeric selfadhesive electrode pads of equal dimension. The electrode are packaged in such a way that the two conductive areas are in electrical contact.

### H-5 SUBSTANTIAL EQUIVALENCE

The Company's SVL-9630 electrodes covered by this submission are substantially equivalent to other legally marketed electrodes for semi-automatic low power DC defibrillators. Specifically, the SVL-9130 electrode is substantially equivalent to SVL-9130 electrodes (K971146) and Katecho's D-Defib/Pace electrodes (K 981737).

### PERFORMANCE DATA H-6.

The SVL-9630 electrodes meet all the specifications for single use hydrogel electrodes of the AAMI DF-39 specifications and Survivalink's internal specifications. In all instances, the SVL-9630 electrodes functioned as intended.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol resembling three human profiles facing right, arranged in a stacked formation.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 0 1999

Sew-Wah Tay, Ph.D. Survivalink Corporation 5420 Feltl Road Minneapolis, MN 55343

Re: K993072 Survivalink 9630 Defibrillation Electrode Regulatory Class: III (three) Product Code: 74 MLN September 13, 1999 Dated: Received: September 14, 1999

Dear Dr. Tay:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 A substantially equivalent determination assumes compliance to 895. with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Sew-Wah Tay, Ph.D.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone], or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

,
Carl C. Casey

Celia M. Witten, Ph. D , M.D. Acting Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) K993072

Amendment 1

# Indication for Use

510(k) Number: K993072

Device Name: Survivalink Multifunctional Electrode (SVL-9630).

### INDICATION FOR USE 1.

The SVL-9630 electrodes are single use, non sterile, and intended to be used in conjunction with low energy semi-automatic external defibrillators (AED) and/or external transcutaneous pacemakers to monitor, defibrillate or pace the adult patient. The electrodes meet AAMI DF-39 performance standards. The electrodes can be used with external defibrillators/pacing devices that had been tested for compatibility with the proper electrode connector or adapter.

The electrodes are intended for short-term use (< 8 hours) and must be used before the expiration date listed on the packaging. These electrodes provide the conductive interface between the defibrillator and/or the external transcutaneous cardiac pacemaker and the patient skin.

Daerle C. Cruz
(Division Sign-Off)

Division of Cardiovascular, Respiratory, and Neurological Device 510(k) Number

PRESCRIPTION USE
(PER 21 CFR 801.109)
A. Carey
12/8/95