PROSTIM REUSABLE NEUROSTIMULATION ELECTRODES

K052875 · Summit Manufacturing, LLC · GXY · Dec 27, 2005 · Neurology

Device Facts

• Record ID: K052875
• Device Name: PROSTIM REUSABLE NEUROSTIMULATION ELECTRODES
• Applicant: Summit Manufacturing, LLC
• Product Code: GXY · Neurology
• Decision Date: Dec 27, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1320
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The ProStim Reusable Neurostimulation Electrodes are intended for use as a disposable, conductive adhesive interface between the patient's skin and the Electrical Stimulator. ProStim Reusable Neurostimulation Electrodes are designed and intended to be used with marketed Electrical Stimulators, i.e. TENS (Transcutaneous Electrical Nerve Stimulation), MENS (Microcurrent Electrical Nerve Stimulation), EMS (Electrical Muscular Stimulation), IF (Interferential) or PGF (Pulsed Galvanic Stimulation).

Device Story

ProStim Reusable Neurostimulation Electrodes are non-sterile, disposable, laminated flexible structures. They function as a conductive interface between patient skin and external electrical stimulators (TENS, MENS, EMS, IF, or PGF). The device consists of a nonwoven tape or polyethylene foam/polypropylene substrate, a conductive plastic film, and a biocompatible conductive hydrogel. The hydrogel provides both adhesion and electrical coupling, eliminating the need for external securing materials. The electrode includes a 6-inch lead wire with a 0.080-inch female socket compatible with standard neurostimulation devices. Designed for single-patient, multiple-application use. Healthcare providers or patients use the device to deliver electrical stimulation for therapeutic purposes. Effectiveness is verified through impedance testing, ensuring comparability to predicate devices.

Clinical Evidence

Bench testing only. No clinical data provided. Evidence consists of biocompatibility testing (Cytotoxicity, Sensitization, and Primary Skin Irritation) per ISO 10993-1 and comparative impedance testing against predicate devices to demonstrate functional equivalence.

Technological Characteristics

Laminated flexible structure: nonwoven tape/polyethylene foam/polypropylene substrate, conductive plastic film, and biocompatible conductive hydrogel. 6-inch lead wire with 0.080-inch female socket. Passive electrical interface. Biocompatibility per ISO 10993-1. Non-sterile.

Indications for Use

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

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

• Naimco E-Z stik electrodes (K050469)
• Lead-Lok, Inc. (K010431)

Reference Devices

• Uni-Patch (K962910)
• MSB Limited (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)
• Katecho KM 10 Series gels (K00870)
• Amgel 700 Series gels (K983741)

Submission Summary (Full Text)

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K052875

# DEC 2 7 2005

### Exhibit #1

### 510(k) Summary

| Submitter's name: | Dan Woody<br>Summit Manufacturing, L.L.C.<br>1307 N. Glenville Dr.<br>Richardson, TX 75081<br>Phone: [phone]<br>FAX: [phone]<br>E-mail Address: [e-mail] |
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| Contact person: | Dan Woody |
| Date prepared: | October 4, 2005 |
| Device Name: | ProStim Reusable Neurostimulation Electrodes |
| Classification Name: | Neurostimulation Electrodes |
| Predicate devices: | K050469 (Naimco, Inc.)<br>K010431 (Lead-Lok, Inc.) |

ProStim Reusable Neurostimulation electrodes arc non-Device Description: sterile, disposable laminated. flexible structures composed of materials commonly used in this application:

> First Layer-White spun laced nonwoven tape or White 1/32" thick Polyethylene foam or a polypropylene substrate, coated with biocompatible adhesive.

Second Layer- Conductive plastic film.

Third Layer-Biocompatible conductive hydrogel coupling media (

The electrodes are designed for single-patient/multiple application use. Because of the adhesive nature of the biocompatible hydrogel, no securing materials are required to secure the device to the patient's skin. The electrode has one type of connection point that can be used to connect the stimulation device to the electrodes. This connection point is compatible with all standard, marketed Neurostimulation devices.

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Lead wire assembly - 6" wire with .080 in. diameter female socket connected to one side of the wire.

Predicate Technological Characteristics Comparison: ProStim 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: ProStim Reusable Neurostimulation electrodes are as safe and effective as the Naimco E-Z stik electrodes (K050469) and Lead-Lok (K010431) which were previously found to be substantially equivalent via 510(k) Premarket Notifications.

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. The Katecho KM 10 Series of gels (file number K00870) and the Amgel 700 Series gels (file number K983741), which may be used in this family of electrodes, have 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.

Because there are no published performance standards for Neurostimulation electrodes, Summit Manufacturing, L.L.C. uses impedance levels as the criteria for effectiveness testing. Results of the impedance testing revealed that the subject device's impedance values were comparable to the other predicate device(s) impedance values.

Based on the aforementioned information, ProStim considers its Reusable TENS/NMES electrodes to be as safe and effective as the predicate devices, as well as multiple other TENS/NMES electrodes currently being marketed including those manufactured by: Uni-Patch(k962910), MSB Limited (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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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol.

Public Health Service

DEC 2 7 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Summit Manufacturing, L.L.C. c/o Ms. Susan D. Goldstein-Falk mdi Consultants, Inc. 55 Northern Blvd., Suite 200 Great Neck, New York 11021

Re: K052875

Trade/Device Name: ProStim Reusable Neurostimulation Electrodes Regulation Number: 21 CFR 882.1320 Regulation Name: Cutaneous electrode Regulatory Class: II Product Codes: GXY Dated: October 11, 2005 Received: October 12, 2005

Dear Ms. Goldstein-Falk:

We have reviewed your Section 510(k) premarket notification of intent to market the device in the device in We nave reviewed your Section 310(tr) prehistantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, enclosure) to regarly mankelou prodreate a Amendments, or to devices that have been reclassified in the ellacinent date of the Mediour Do researl Food, Drug, and Cosmetic Act (Act) that do not require accordance with the provisions of the Fouolar Food, I reg, therefore, market the device, subject to approval of a provisions of the Act. The general controls provisions of the Act include the general connels providents of any 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 If your device is classified (see above) into ense lations affecting your device can be found in the Subject to such additional controlly - Entralignation, 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 Please be advised mat 1 DA 3 issuance of a saceannal securements of the Act or any Foderal statutes and regulations administered by other Federal agencies. You must comply with all the Federal Statues and Tegulations administered of vegistration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set

CFK Fall 801), good manufacturing praction (21 CFR Part 820), and if applicable, the electronic 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 your Section 5 10(k) premarkete notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate hourication. The 112A inding of substantal equive and thus, permits your device to proceed to the market.

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Page 2 – Mrs. Susan Goldstein-Falk

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact and If you desire specific advice tor your develop on on also regulation entitled, "Mishranding by the Office of Compliance at [phone]. Also, presentation of the general information on
reference to premarket notification" (21CFR Part 807.97). Your may of any mate reference to premarket notification (21) I I Pair of Small Manufacturers, International and your responsibilities under the Act non the DIVIsion of Sharless of Collection of Coll ) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Mark N. Melkerson

ﻖ Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

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# Exhibit B

Page __ 1 __ of __ 1

510(k) Number (if known):

K052875

### Device Name: ProStim Reusable Neurostimulation Electrodes

## Indications For Use:

The ProStim Reusable Neurostimulation Electrodes are intended for use as a disposable, conductive adhesive interface between the patient's skin and the Electrical Stimulator. ProStim Reusable Neurostimulation Electrodes are designed and intended to be used with marketed Electrical Stimulators, i.e. TENS (Transcutaneous Electrical Nerve Stimulation), MENS (Microcurrent Electrical Nerve Stimulation), EMS (Electrical Muscular Stimulation), IF (Interferential) or PGF (Pulsed Galvanic Stimulation).

Prescription Use X (Per 21 CFR 801 Subpart D)

OR

Over-The Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

202

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

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