MODIFICATION TO:BREVIO NERVE CONDUCTION TEST INSTRUMENT

K012069 · Neurotron Medical, Inc. · JXE · Aug 1, 2001 · Neurology

Device Facts

• Record ID: K012069
• Device Name: MODIFICATION TO:BREVIO NERVE CONDUCTION TEST INSTRUMENT
• Applicant: Neurotron Medical, Inc.
• Product Code: JXE · Neurology
• Decision Date: Aug 1, 2001
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 882.1550
• Device Class: Class 2

Intended Use

The BREVIO is intended for use for the measurement of nerve response latency and amplitude in the diagnosis and monitoring of peripheral neuropathies. The BREVIO is intended to be used as a waveform display nerve conduction monitor. It displays the latency value derived from an action potential. The display shows the latency value in milliseconds from the potontial. The onset. The internal circuitry has the complete waveform from which the latency value is derived and this is delivered to the digital storage oscilloscope for compete waveform display. The latency value is important in the diagnosis of median nerve dysfunction. The physician can use the BREVIO to examine the features of the waveform generated by the stimuli. The physician can determine the action potential latency, amplitude configuration and duration.

Device Story

BREVIO is a battery-powered, handheld nerve conduction monitor used in clinical settings by physicians. It delivers electrical stimuli to peripheral nerves and records resulting motor and sensory nerve responses. The device features a handheld processor with an LCD screen and a stimulator; it can be coupled with HP inkjet printers for reporting. The system automatically detects and calculates waveform latency and amplitude, though users may manually adjust these values based on clinical judgment. It stores up to 28 waveforms for review. By displaying latency and amplitude, the device assists physicians in diagnosing and monitoring peripheral neuropathies, specifically median nerve dysfunction. It provides objective data to support clinical decision-making regarding nerve health.

Clinical Evidence

Comparative human testing was conducted to evaluate the performance of the BREVIO against a predicate device. Results demonstrated a high correlation between the BREVIO and the predicate device for both latency and amplitude measurements. Bench testing was also performed to verify that the device meets design controls and specifications.

Technological Characteristics

Handheld device powered by 4 AA alkaline batteries (9V output). Features a 128 x 112 pixel graphical LCD. Stimulator output: max 300V, 250 microsecond pulse width. Detects motor responses down to 100 microvolts and sensory responses down to 5 microvolts. Latency range: 0-45 ms. Amplitude detection range: 5-10,000 microvolts. Includes internal memory for 28 waveforms. Connectivity: supports external HP inkjet printers.

Indications for Use

Indicated for use as a nerve conduction monitor for patients requiring diagnosis and monitoring of peripheral neuropathies, including median nerve dysfunction. Used by physicians to measure and display action potential latency, amplitude, and duration.

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

• NervePace Nerve Conduction Viewscope (VS 200) (K963208)
• Digital Electroneurometer (S-100) (K843924)

Submission Summary (Full Text)

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K012069

# 510(k) Summary

# Trade Name: BREVIO

Common/Classification Name: Nerve Conduction Velocity Measurement Device 21 CFR 882.1550

> Neurotron Medical, Inc. 1590 Reed Rd., Suite 102B Pennington, NJ 08534 800-367-1238

Contact: Jack Guldalian, President

Prepared: June 29, 2001

## LEGALLY MARKETED PREDICATE DEVICES A.

K963208 NervePace Nerve Conduction Viewscope (VS 200) Neurotron Medical, Inc.

K843924 Digital Electroneurometer (S-100) Neurotron Medical, Inc.

### DEVICE DESCRIPTION B.

The BREVIO is a battery powered (4 AA batteries) hand held device that is utilized to perform motor and sensory nerve conduction testing on peripheral nerves in a clinical setting. It consists primarily of two units, a handheld processor with LCD screen and a stimulator. It may also be coupled with a number of HP inkjet printers to print patient information and results.

The BREVIO automatically picks out the latency and amplitude of waveforms presented to determine the values associated with them. The automatically chosen values may be manually adjusted by the user should the user feel the necessity to manually make such a change.

The BREVIO has memory storage of 28 waveforms for later viewing and printing of the test results.

#### C. INTENDED USE

The BREVIO is intended for use for the measurement of nerve response

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Neurotron Medical Inc. 510(k) Notification

latency and amplitude in the diagnosis and monitoring of peripheral neuropathies.

# Indication for use:

The BREVIO is intended to be used as a waveform display nerve conduction monitor. It displays the latency value derived from an action potential. The display shows the latency value in milliseconds from the potontial. The onset. The internal circuitry has the complete waveform from which the latency value is derived and this is delivered to the digital storage oscilloscope for compete waveform display.

The latency value is important in the diagnosis of median nerve dysfunction. The physician can use the BREVIO to examine the features of the waveform generated by the stimuli. The physician can determine the action potential latency, amplitude configuration and duration.

### SUBSTANTIAL EQUIVALENCE SUMMARY D.

The BREVIO is a medical device that has the same indication, intended use and target population as the legally marketed predicate devices.

The BREVIO has the same technological characteristics as the predicate devices.

The BREVIO has incorporated a change in the software that allows the device to automatically pick out the latency and amplitude of waveforms presented to determine the values associated with them. These automatically chosen values may be manually adjusted by the user should the user feel the necessity to manually make such a change or adjustment based upon the user's experience or analysis. In addition the BREVIO has incorporated the mechanical features of both the NERVEPACE® ViewScope™ (200 VS) and Digital Electroneurometer S-100 into a single device.

### TECHNOLOGICAL CHARACTERISTICS E.

The BREVIO operates utilizing four AA Alkaline batteries with an output of 9V. It has a graphical LCD display format of 128 x 112 pixels displaying motor and sensory nerve responses.

The BREVIO is capable of detecting motor response signals down to 100 microvolts covering motor and F wave responses. Sensory signal

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Neurotron Medical Inc. 510(k) Notification

responses can be detected to 5 microvolts. Latency detection capability covers the time range from 0 to 45 milliseconds. Amplitudes of signal responses can be detected in the range of 5 to 10,000 microvolts. Once the waveform is recorded the system will determine in the case of motor responses the onset latency value and baseline peak amplitude. For sensory responses, the peak latency value and baseline to peak amplitude value will be reported. These values will appear on the screen display and in the printed report.

The memory of the device is capable of storing up to 28 waveform responses.

The maximum stimulator output is 300 volts, pulse width 250 microseconds.

#### F. TESTING

Bench testing has been done with this device demonstrating that it meets design controls.

Comparative human testing was done demonstrating a high correlation between the BREVIO device and a predicate device for latency and amplitude comparison.

#### G. CONCLUSIONS

Design specifications, comparison to predicate device specifications and testing has demonstrated that this BREVIO device meets design requirements and is equivalent to the predicate devices.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines representing its wings. The eagle is enclosed in a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is written around the circle's perimeter. The text is in all capital letters and is arranged to follow the curve of the circle.

1 2001 AUG

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Neurotron Medical, Inc. c/o Mr. T. Whit Athey C. L. McIntosh & Associates 12300 Twinbrook Parkway Suite 230 Rockville, Maryland 20852

Re: K012069

Trade/Device Name: BREVIO Regulation Number: 882.1550 Regulatory Class: II Product Code: JXE Dated: July 2, 2001 Received: July 2, 2001

Dear Mr. Athey:

We have reviewed your Section 510(k) notification of intent to market the device referenced we have have determined the device is substantially equivalent (for the indications for use above and we nave acterificated predicate devices marketed in interstate commerce stated in the energials, to regary and date of the Medical Device Amendments, or to devices that provisions of the 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 Cosments for (110). - Tot Ine)y and controls provisions of the Act include requirements for annual provisions of the Frea - Process, 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 (1 remancer ipps of ally to the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to mopelvestity 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 - Mr. T. Whit Athey

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 regulation (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" (21CFR 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,

Mark N. Mikkelsen

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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# STATEMENT OF INDICATIONS FOR USE

1 012069 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: BREVIO

Indications For Use:

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The latency value is important in the diagnosis of median nerve dysfunction. The The facelley varies is interestine the features of the waveform generated by the stimuli. The physician can determine the action potential latency, amplitude configuration and duration.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109) ✓

R. Masha OR. Melson Over-The-Counter Use
Division Sign-Off

. Restorative

510(k) Number

**00256**