UNIVERSAL ELECTRODES

K083818 · Neurometrix, Inc. · GXY · Jan 21, 2009 · Neurology

Device Facts

• Record ID: K083818
• Device Name: UNIVERSAL ELECTRODES
• Applicant: Neurometrix, Inc.
• Product Code: GXY · Neurology
• Decision Date: Jan 21, 2009
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 882.1320
• Device Class: Class 2

Intended Use

The NeuroMetrix UNIVERSAL Electrodes are intended for use with electrodiagnostic equipment for the recording of electrophysiological activity from peripheral nerves and muscles, and for peripheral nerve electrical stimulation UNIVERSAL Electrodes are nonsterile and are for single patient use only

Device Story

UNIVERSAL Electrodes serve as interface between neurodiagnostic equipment and patient; transduce bioelectric signals into electronic signals for measurement of peripheral nerve/muscle responses; provide interface for peripheral nerve stimulation. Used in nerve conduction studies (NCS). Multi-Electrode Sets (UE-004, UE-005) include bar configuration electrodes for stimulation, recording electrodes, and reference electrode. Features include embedded digital thermometer for skin-surface temperature measurement and integrated ruler for inter-electrode distance measurement to calculate conduction velocities. Electrodes are individually placed, non-sterile, single-patient use, and repositionable up to four times. Healthcare providers use output to assess nerve/muscle function.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Surface electrodes with leads and connector. Includes embedded digital thermometer and integrated ruler for distance measurement. Non-sterile, single-patient use. No active energy source; passive interface for electrodiagnostic equipment.

Indications for Use

Indicated for patients requiring electrophysiological recording of peripheral nerves and muscles or peripheral nerve electrical stimulation during nerve conduction studies (NCS).

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

• NeuroMetrix UNIVERSAL Electrodes (K081871)
• NeuroMetrix Biosensors (K060584)

Submission Summary (Full Text)

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# 683818

### JAN 2 1 2009

### 510(k) Summary for NeuroMetrıx UNIVERSAL Electrodes

#### 1 SPONSOR

NeuroMetrix, Inc 62 Fourth Avenue Waltham, MA 02451

Contact Person Ramer Maas Telephone [phone]

Date Prepared

December 19, 2008

#### 2. DEVICE NAME

| Proprietary Name | UNIVERSAL Electrodes |
|---------------------|--------------------------------------------------------|
| Common/Usual Name | Pre-gelled surface electrodes with leads and connector |
| Classification Name | 882 1320 GXY Electrode, Cutaneous |

#### 3 PREDICATE DEVICES

- NeuroMetrix UNIVERSAL Electrodes (K081871)
- . NeuroMetrix Biosensors (K060584)

#### 4 INTENDED USE

The NeuroMetrix UNIVERSAL Electrodes are intended for use with electrodiagnostic equipment for the recording of electrophysiological activity from peripheral nerves and muscles, and for peripheral nerve electrical stimulation UNIVERSAL Electrodes are nonsterile and are for single patient use only

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#### 5 DEVICE DESCRIPTION

Surface electrodes are the interface medium between neurodiagnostic equipment and the patient When used for detection, they transduce broelectric signals into electronic signals for measurement of bioelectrical phenomena in the body, such as peripheral nerve or muscle responses When used in conjunction with stimulation circuitry in neurodiagnostic devices. they provide the interface necessary to stimulate perspheral nerves Surface electrodes are used in the performance of nerve conduction studies (NCS) They are provided non-stertle and are designed and intended to be for single patient use only and are disposable

- 트 UNIVERSAL Multi-Electrode Set A (UE-004)
- 0 UNIVERSAL Multi-Electrode Set B (UE-005)

These individually placed electrodes are not configured for specific nerves. limbs, or clinical applications They may be repositioned on the same patient up to four times Both of the Multi-Electrode Sets include two surface electrodes in a bar configuration for perspheral nerve stumulation, two pars of recording electrodes for measurement of broelectrical potentials, and a reference electrode The par of recording surface electrodes in Multi-Electrode set A (UE-004) are distinct with one arranged as ring electrodes In Multi-Electrode Set B (UE-005), three surface electrodes are used to create two recording pars by sharing of one of the electrodes All of the surface electrodes in the Multi-Electrode Sets are individually placed by The UNIVERSAL Electrodes include an embedded digital thermometer for the user measurement of skin-surface temperature, and a ruler (as part of the graphics layers) for the measurement of inter-electrode distances that are used for calculating conduction velocities

#### 6. BASIS FOR SUBSTANTIAL EQUIVALENCE

The two UNIVERSAL Electrodes that are the subject of this 510(k) Premarket Notrfication are substantially equivalent to the predicate UNIVERSAL Electrodes (K081871) The proposed and predicate UNIVERSAL Electrodes share intended use, clinical applications, and technological characteristics

The materials, manufacturing process, and packaging for the two new UNIVERSAL Electrodes are the same as for NeuroMetrix Biosensors (K060584) and are therefore also substantially equivalent to these devices

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract image of an eagle.

JAN 2 1 2009_ _

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NeuroMetrix, Inc % Mr Rainer Maas 62 Fourth Avenue Waltham, MA 02451

Re K083818

Trade Name UNIVERSAL Electrodes Regulation Number 21 CFR 882 1320 Regulation Names Cutaneous Electrode Regulatory Class II Product Code GXY Dated December 19, 2008 Received December 22, 2008

Dear Mr Maas

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 musbranding and adulteration

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), tt 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 product radiation control provisions (Sections 531-542 of the Act), 21 CFR 1000-1050

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Page 2 - Mr Rainer Maas

This letter will allow you to begin marketing your device as described in your Section 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 regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone] Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807 97) For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Brometric's (OSB's) Division of Postmarket Surveillance at [phone] For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone] You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number [phone] or [phone] or Internet address http //www fda gov/cdrh/industry/support/index html

Sincerely yours.

Mark N Mulhearn

Mark N Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## INDICATIONS FOR USE

510(k) Number (if known)

Device Name UNIVERSAL Electrodes

Intended Use

The NeuroMetrix UNIVERSAL Electrodes are intended for use with electrodiagnostic equipment for the recording of electrophysiological activity from peripheral nerves and muscles, and for peripheral nerve electrical stimulation UNIVERSAL Electrodes are non-sterile and are for single patient use only

Prescription Use X (Part 21 CFR 801 Subparts D) AND/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)

Page 1 of 1

FOR M.MELKERSON
Division Sign-Off

Division of General, Restorative, and Neurological Devices

-(k) **Number** K083818

NeuroMetrix, Inc UNIVERSAL Electrodes Special 510(k)

December 19, 2008

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