SOF-PACH REUSABLE NEUROSTIMULATION ELECTRODES

K020735 · Cathay International, Ltd. · GXY · Jul 12, 2002 · Neurology

Device Facts

• Record ID: K020735
• Device Name: SOF-PACH REUSABLE NEUROSTIMULATION ELECTRODES
• Applicant: Cathay International, Ltd.
• Product Code: GXY · Neurology
• Decision Date: Jul 12, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1320
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

SOF-PACH™ Reusable Cutaneous Neurostimulation Electrodes are intended for use as the disposable, conductive adhesive interface between the patient's skin and the Electrical Stimulator. SOF-PACH™ Reusable Electrodes are designed and intended to be used with marketed. Electrical Stimulators i.e. TENS (Transcutaneous Electrical Nerve Stimulation), EMS (Electrical Muscular Stimulation), IF (Interferential) of PGF (Pulsed Galvanic Stimulation). These electrodes will include the precaution statement: Federal Law restricts the device to sale by or on the order of a licensed practitioner or therapist.

Device Story

SOF-PACH™ Reusable Neurostimulation Electrodes serve as a conductive interface between patient skin and electrical stimulators (TENS, EMS, IF, PGF). Device consists of a multi-layer flexible structure: top layer of fabric/foam with adhesive; middle layer of carbon/conductive mesh; bottom layer of biocompatible conductive hydrogel. Electrodes attach directly to skin via hydrogel adhesive; no external securing materials required. Connects to stimulation devices via lead wire assembly or male snap assembly. Used in clinical or home settings under practitioner guidance. Output is electrical stimulation delivered to the patient. Benefits include low-profile design for comfort and reduced visibility under clothing. Effectiveness verified by comparing point-to-point impedance levels (125-250 ohms at 1 kHz) against predicate devices.

Clinical Evidence

Bench testing only. Biocompatibility testing (Cytotoxicity, Sensitization, Primary Skin Irritation) performed per ISO 10993-1 and Tripartite Biocompatibility Guidance. Electrical performance validated via point-to-point impedance testing (1 kHz) comparing subject device to predicate devices; results (125-250 ohms) were comparable.

Technological Characteristics

Multi-layer flexible electrode. Materials: Tricot/polyester fabric, polyethylene foam, polypropylene substrate, biocompatible adhesive, carbon/Ag/AgCl conductive layer, conductive hydrogel. Connectivity: Lead wire (21 CFR 898 compliant) or male snap assembly. Dimensions: Low profile. Sterilization: Non-sterile. Energy: Passive conductive interface for TENS/EMS/IF/PGF stimulators.

Indications for Use

Indicated for use as a conductive adhesive interface between patient skin and electrical stimulators (TENS, EMS, IF, or PGF) for patients requiring neurostimulation therapy. Prescription use only.

Regulatory Classification

Identification

A cutaneous electrode is an electrode that is applied directly to a patient's skin either to record physiological signals (e.g., the electroencephalogram) or to apply electrical stimulation.

Predicate Devices

• K963125 (M & R Manufacturing, Inc.)
• K932849 (Pepin Mfg., Inc.)
• K011411 (Pain Management Technologies)

Reference Devices

• Uni-Patch (K962910)
• Katecho Incorporated (K000870)
• MSB Iimited (K980229)
• Axelgaard (K983741)
• Selective Med Components, Inc. (K946230)
• Medtronic, Inc. (K875284)
• Medical Design & Manufacturing Corp. (K895604)
• Labeltape Meditect, Inc. (K900656)
• Labeltape Meditect, Inc. (K902719)
• Labeltape Meditect, Inc. (K894043)

Submission Summary (Full Text)

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K020735

# ເງິນເ 12 2002

## SOF-PACH™ Reusable Neurostimulation Electrodes 510(k) Summary

The following information is submitted in accordance with the requirements of 21CFR807.92

| Submitter's name: | Anne Jen<br>CATHAY INTERNATIONAL LTD.<br>8F-3, NO. 29, CHUNGSHAN N.RD. SEC. 3,<br>TAIPEI, TAIWAN, R. O. C.<br>TEL: [phone]<br>FAX: [phone]<br>E-Mail: [e-mail] |
|----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact person: | Anne Jen |
| Date Prepared: | 17 January 2002 |
| Device Name: | SOF-PACH™ Reusable Neurostimulation Electrodes |
| Comment/Usual Name: | Neurostimulation Electrodes |
| Classification Name: | Electrodes, cutaneous |
| Predicate devices: | K963125 (M & R Manufacturing, Inc.)<br>K932849 (Pepin Mfg., Inc.)<br>K011411 (Pain Management Technologies) |

Device description: SOF-PACH™ Reusable Neurostimulation Electrodes are non-sterile laminated, flexible structures composed of materials commonly used in this application:

> First layer - Various cloths, tapes, etc. including Tricot/polyester fabric, polyethylene foam or a polypropylene substrate, coated with biocompatible adhesive.

- Second layer Electrically conductive carbon coated with or without Ag/AgCl, and Activated Carbon Mesh material.
- Third layer Biocompatible conductive hydrogel coupling media (CATHAY's Gel) which has passed the required skin sensitivity testing criteria as specified in the Tripartite Biocompatibility Guidance for Medical Devices and ISO 10993-1 requirements for skin contact. These tests include Cytotoxicity, Sensitization and Primary Skin Irritation Tests.

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K020735

The electrodes are designed for single-patient/multiple application use. They have a low profile construction designed for comfort under clothing and utilize tan-tone fabric for reduced visibility. Because of the adhesive nature of the biocompatible hydrogel, no securing materials are required to secure the device to the patient's skin. The electrodes have two different types of contact points that can be used to link the stimulation device to the electrodes. These contact points are compatible with standard marketed Neurostimulation devices.

- 1. Lead wire assembly 6" wire with .080 inch diameter recessed female socket connected to one side of the wire. The lead wire assembly is in compliance with the requirements of FDA performance standard 21 CFR Part 898
- 2. Male snap assembly Two-part sensor and stud mated together.

Technological Characteristics: SOF-PACH™ Reusable Neurostimulation electrodes are technologically equivalent to the predicate devices. They are physically and technically similar to those currently being marketed for "Neurostimulation" i.e., TENS (Transcutaneous Electrical Nerve Stimulation), MENS (Microcurrent Electrical Nerve Stimulation), EMS (Electrical Muscular Stimulation), IF (Interferential) and PGS (Pulsed Galvanic Stimulation).

Safety and Effectiveness: CATHAY considers their SOF-PACH™ Neurostimulation electrodes to be as safe and effective as the M&R Disposable Neurostimulation electrodes, the PMI Neurostimulation electrodes and the PMT Neurostimulation electrodes, which were previously found to be substantially equivalent via 510(k) Premarket Notifications. The safety issues analyzed were skin irritation. The effectiveness of the electrodes was determined by comparing impedance levels in point-to-point testing using a voltmeter.

The first safety issue considered was whether the gel, which is used to adhere the electrode to the skin and which is the only portion of the electrode to maintain skin contact, would cause any skin irritation. CATHAY's Gel has passed the required skin sensitivity testing criteria specified in the Tripartite Biocompatibility Guidance for Medical Devices and ISO 10993-1 requirements for skin contact. These tests include Cytotoxicity, Sensitization and Primary Skin Irritation tests.

Because there are no published performance standards for Neurostimulation electrodes, CATHAY uses impedance levels as the criteria for effectiveness testing. When measuring the electrodes' impedance, driven at 1 K-Hz, using a standard voltmeter, the point-to-point impedance testing for all manufacturers' electrodes (including SOF-PACH™) ranged from 125-250 ohms from the top center portion of the electrode to the underside of the outside edge. Once this testing was complete, it was determined that SOF-PACH™s electrode impedance values were comparable to other marketed electrodes tested.

For the above reason, CATHAY considers its Reusable TENS/NMES electrodes to be as safe and effective as the predicate devices, as well as to multiple other TENS/NMES electrodes currently being marketed, including those manufactured by:

Uni-Patch (K962910), Katecho Incorporated (K000870), MSB Iimited (K980229), Axelgaard (K983741), Selective Med Components, Inc. (K946230), Medtronic, Inc. (K875284), Medical Design & Manufacturing Corp. (K895604), and Labeltape Meditect, Inc. (K900656, K902719 and K894043).

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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 image of an eagle or bird-like figure, represented by three curved lines that suggest wings or feathers.

JUL 12 2002

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mrs. Anne Jen Cathay International Ltd. 8F-3, No. 29, Chungshan N.Rd. Sec.3, Taipei, Taiwan, R.O.C.

Re: K020735

Trade/Device Name: SOF-PACH Reusable Neurostimulation Electrodes Models: CM4040, CM505, CM50100, and CM 75 Regulation Number: 21 CFR 882.1320 Regulation Name: Cutaneous electrode Regulatory Class: Class II Product Code: GXY Dated: June 11, 2002 Received: June 14, 2002

Dear Mrs. Jen:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA), 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 (PMA), 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 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic

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Page 2 - Mrs. Anne Jen

product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in vour Section 510(k) Page 2 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 regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-. 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely vours.

Sincerely yours,

Arto Salin, M. Witte, PhD, M.D.

lia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K020735

# DEVICE NAME: SOF-PACH™ REUSABLE NEUROSTIMULATION ELECTRODES

## INDICATIONS FOR USE:

SOF-PACH™ Reusable Cutaneous Neurostimulation Electrodes are intended for use as the disposable, conductive adhesive interface between the patient's skin and the Electrical Stimulator. SOF-PACH™ Reusable Electrodes are designed and intended to be used with marketed. Electrical Stimulators i.e. TENS (Transcutaneous Electrical Nerve Stimulation), EMS (Electrical Muscular Stimulation), IF (Interferential) of PGF (Pulsed Galvanic Stimulation).

These electrodes will include the precaution statement: Federal Law restricts the device to sale by or on the order of a licensed practitioner or therapist.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription use X (Per 21 CFR 801, 109) OR:

Over-the Counter Use (Optional Format 1-2-96)

Stupt. Qurchu

(Division Sign-Off) Division of General, Restorative and Neurological Devices

510(k) Number K020735