MODIFICATION TO NC-STAT

K041320 · Neurometrix, Inc. · JXE · Aug 12, 2004 · Neurology

Device Facts

• Record ID: K041320
• Device Name: MODIFICATION TO NC-STAT
• Applicant: Neurometrix, Inc.
• Product Code: JXE · Neurology
• Decision Date: Aug 12, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1550
• Device Class: Class 2

Intended Use

The NeuroMetrix NC-stat is intended to measure neuromuscular signals that are useful in diagnosing and evaluating systemic and entrapment neuropathies.

Device Story

NC-stat is a nerve conduction testing system; measures neuromuscular signals to diagnose systemic and entrapment neuropathies. System components: battery-powered monitor, docking station, single-use disposable biosensors, and onCall Information System. Monitor acquires/saves patient data and response waveforms; displays DML, DSL, SNAP amplitude, and F-wave latency. Docking station transmits data via analog phone line to onCall system. OnCall system generates hardcopy reports including CMAP amplitude and conduction velocity; compares results to normal ranges; delivers reports via fax or email. Used by clinicians to assist in clinical decision-making regarding neuropathy status. Benefits include objective nerve conduction measurements comparable to conventional equipment.

Clinical Evidence

Clinical data submitted demonstrates that nerve conduction measurements obtained using the NC-stat are comparable to those obtained using conventional nerve conduction measurement equipment.

Technological Characteristics

Battery-powered monitor with LCD display; single-use disposable biosensors for various nerves (median, ulnar, posterior tibial, deep peroneal, sural); analog phone line connectivity for data transmission to remote information system.

Indications for Use

Indicated for patients requiring diagnosis and evaluation of systemic and entrapment neuropathies.

Regulatory Classification

Identification

A nerve conduction velocity measurement device is a device which measures nerve conduction time by applying a stimulus, usually to a patient's peripheral nerve. This device includes the stimulator and the electronic processing equipment for measuring and displaying the nerve conduction time.

Predicate Devices

• NC-stat (K982359, K000565, K003508 and K013459)
• TECA TD-10/TD-20 (K802637)

Submission Summary (Full Text)

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K041320

### AUG 1 2 2004

510(k) Summary for NeuroMetrix NC-stat

#### 1. SPONSOR

NeuroMetrix, Inc. 62 Fourth Avenue Waltham. MA 02451

Contact Person: Joseph F. Burke [phone] Telephone:

May 14, 2004 Date Prepared:

#### 2. DEVICE NAME

| Proprietary Name: | NC-stat |
|----------------------|--------------------------------------------|
| Common/Usual Name: | Nerve Conduction Testing System |
| Classification Name: | Nerve Conduction Velocity Measuring Device |

#### 3. PREDICATE DEVICES

- NC-stat (K982359, K000565, K003508 and K013459) .
- TECA TD-10/TD-20 (K802637) .

#### 4. INTENDED USE

The NeuroMetrix NC-stat is intended to measure neuromuscular signals that are useful in diagnosing and evaluating systemic and entrapment neuropathies.

#### 5. DEVICE DESCRIPTION

The NC-stat consists of the following four components:

- 5.1 A battery-powered monitor. The monitor contains the electronic circuitry and software required to provide initiate and control the nerve conduction study, acquire and save patient and test information including the response

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waveforms, display information on the LCD readout, and transmit data to the docking station. LCD displays include the distal motor latency (DML) value, the distal sensory latency (DSL) value, the Sensory Nerve Action Potential (SNAP) amplitude value, the F-wave latency value. limb indicator (left or right), low battery indicator, the memory slot being used to store the test data. and user messages (menu selections, sensor serial numbers, device status. operator instructions, and error conditions).

- A docking station used to download the test data to the onCall Information 5.2 System via an analog phone line.
- Single-use, disposable biosensors are available for the median motor, ulnar 5.3 motor, median motor & sensory, ulnar motor & sensory, posterior tibial, deep peroneal and sural nerves. The sural biosensor is the only new biosensor for the NC-stat.
- The onCall Information System for automatic generation of the hardcopy 5.4 patient test report, which includes test results (DML, Compound Muscle Action Potential - CMAP - amplitude, DSL, SNAP amplitude, conduction velocity, F-wave latency, and associated response waveforms) and a comparison of patient results to normal ranges. Reports are sent to the user by facsimile or e-mail.

### BASIS FOR SUBSTANTIAL EQUIVALENCE 6.

The NC-stat that is the subject of this 510(k) Premarket Notification is substantially equivalent to the NC-stat as previously cleared for marketing and to the TECA TD-10/TD-20 EMG and nerve conduction velocity measurement device. The purpose of this 510(k) is to describe changes made to the NC-stat, including:

- 6.1 Addition of the sural biosensor for use in diagnosing neuropathies affecting the sural nerve.
- Modifications to the labeling. 6.2

None of the changes to the NC-stat have altered the intended use of the device, the basic device design or the device operation. Clinical data submitted in the 510(k) demonstrates that nerve conduction measurements obtained using the NC-stat are comparable to those obtained using conventional nerve conduction measurement equipment.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with three wavy lines representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# AUG 1 2 2004

Mr. Joseph F. Burke Vice President of Quality, Regulatory, & Clinical Affairs NeuroMetrix, Inc. 62 Fourth Avenue Waltham, Massachusetts 02451

Re: K041320

Trade/Device Name: NC-stat Regulation Number: 21 CFR 882.1550 Regulation Name: Nerve conduction velocity measurement device Regulatory Class: II Product Code: JXE Dated: May 17, 2004 Received: May 18, 2004

Dear Mr. Burke:

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 product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050.

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Page 2 - Mr. Joseph F. Burke

This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you'ls ough mading of substantial equivalence of your device to a legally premarket notification: "The Pro 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 If you desire specific at noliance at [phone]. Also, please note the regulation entitled, Contact the Office of Comparket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general 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 yours,

Miriam C. Provost

Celia 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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## Indications for Use

510(k) Number (if known) K 0 4 / 320

Device Name: NC - stat

Indications For Use:

The NeuroMetrix NC-stat is intended to measure neuromuscular signals that are useful in diagnosing and evaluating systemic and entrapment neuropathies.

Prescription Use V (Part 21 CFR 801 Subpart 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)

Muriam C. Provost

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

**510(k) Number** K041326
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