COMPREHENSIVE NEUROMUSCULAR PROFILER

K031995 · Medical Technologies Unlimited, Inc. · IKN · Jan 7, 2004 · Physical Medicine

Device Facts

• Record ID: K031995
• Device Name: COMPREHENSIVE NEUROMUSCULAR PROFILER
• Applicant: Medical Technologies Unlimited, Inc.
• Product Code: IKN · Physical Medicine
• Decision Date: Jan 7, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.1375
• Device Class: Class 2

Intended Use

The CNMPs primary intended use is for muscular injury testing. It strives to achieve this goal through non-invasive testing, using range-of-motion and functional capacity integration, as well as using standard EMG sensors. The CNMP is specifically designed to testing the cervical, thoracic and the upper and lower extremities. It observes muscle functioning and characteristics. These functions and characteristics include muscle tone, fatigue, and a number of activities which take place in the muscle. The CNMP can be used in a number of arenas, such as sports medicine, rehabilitation clinics, employee evaluation, and litigation.

Device Story

Comprehensive Neuromuscular Profiler (CNMP) is a portable, stand-alone muscle and range-of-motion monitoring system. Inputs include EMG signals from muscle groups, motion data, and strength measurements via off-the-shelf grip and load cell-based pinch sensors. Sensors connect to a customized enclosure for signal conditioning and analog-to-digital conversion; data is transferred to a notebook PC. Used in medical environments (rehabilitation, sports medicine, employee evaluation) by clinicians. System provides real-time monitoring of muscle tone, fatigue, and functional capacity. Output allows clinicians to assess muscle injury and performance, aiding in clinical decision-making for rehabilitation and evaluation.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Portable, stand-alone system. Components: EMG sensors, off-the-shelf grip/pinch strength sensors, ROM tracking device. Signal processing: conditioning, analog-to-digital conversion, data transfer to PC. Connectivity: wired sensor-to-enclosure, enclosure-to-PC. Software: data acquisition and signal filtering/conditioning.

Indications for Use

Indicated for surface electromyography with range of motion tracking, functional capacity, and grip strength measuring in patients requiring muscular injury testing of the cervical, thoracic, and upper/lower extremities.

Regulatory Classification

Identification

A diagnostic electromyograph is a device intended for medical purposes, such as to monitor and display the bioelectric signals produced by muscles, to stimulate peripheral nerves, and to monitor and display the electrical activity produced by nerves, for the diagnosis and prognosis of neuromuscular disease.

Predicate Devices

• Physical Monitoring Registration Unit (K022719)
• Combined Physiological Monitoring System (K002104)

Submission Summary (Full Text)

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510(k) Number: K031995 Section E: 510(k) Summary

Submitted by: Medical Technologies Unlimited, Inc. 9495 Sunset Drive Suite B282 Miami, FL 33173 Telephone: [phone] Fax: [phone]

June 20, 2003 Date Prepared: Contact Name: Marco Vitiello, M.D. Product Trade Name: Comprehensive Neuromuscular Profiler Classification Name: Diagnostic Eletromyograph (890.1375)

List of Predicate Devices to which we claim substantial equivalence

- 1. Physical Monitoring Registration Unit (K022719)
- 2. Combined Physiological Monitoring System (K002104)

## Description of Device

The Comprehensive Neuromuscular Profiler is a muscle and range of motion monitoring system that is portable, stand-alone and in a convenient package suitable for use in a medical environment. The system consists of a number of sensors to be connected to various parts of the human body which will be fed into a customized enclosure containing all connectors and mediums for conditioning, acquiring and transferring the sensor data. The conditioned data will then be sent to the notebook computer (PC) that is connected to the enclosure.

The system will be capable of monitoring and recording data from electromyography (EMG) sensors connected to various muscle groups in the human body. During the acquisition of EMG signals, the system will simultaneously acquire motion of the body and/or muscle strength.

Image /page/0/Figure/11 description: The image shows a block diagram of a system. The system starts with a block labeled "Patient", which is connected to a block labeled "Sensors". The "Sensors" block is connected to a block labeled "Signal Conditioning", which is connected to a block labeled "Analog to Digital Conversion". Finally, the "Analog to Digital Conversion" block is connected to a block labeled "Data Transfer".

## Intended Use of Device

The CNMPs primary intended use is for muscular injury testing. It strives to achieve this goal through non-invasive testing, using range-of-motion and functional capacity integration, as well as using standard EMG sensors. The CNMP is specifically designed to testing the cervical, thoracic and the upper and lower extremities. It observes muscle functioning and characteristics. These functions and characteristics include muscle tone, fatigue, and a number of activities which take place in the muscle. The CNMP can be used in a number of arenas, such as sports medicine, rehabilitation clinics, employee evaluation, and litigation.

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The CNMP and the predicate systems both use a range of motion device in combination with functional capacity devices and EMG sensors to obtain similar data. Like the predicate systems, the CNMP uses an off-the-shelf grip strength sensor and an off-the-shelf, standard load cell-based pinch strength sensor. The off-the-shelf ROM device used by the CNMP allows a more accurate method of data acquisition, and it provides more freedom for the patient. The EMG system used by the CNMP covers a greater frequency range and allows for a more substantial amount of signal filtering and conditioning through noise reduction and increased resolution.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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

JAN - 7 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Medical Technologies Unlimited, Inc. c/o Ms. Angela Morris ALM Consulting 7538 Bear Canyon Road, NE Albuquerque, New Mexico 87109

Re: K031995

Trade/Device Name: Comprehensive Neuromuscular Profiler Regulation Number: 21 CFR 890.1375 Regulation Name: Diagnostic electromyograph Regulatory Class: II Product Code: IKN Dated: October 8, 2003 Reccived: October 9, 2003

Dear Ms. Morris:

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 interstatc 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 agencics. 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 sct 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 - Ms. Angela Morris

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 Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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 yours.

Sincerely yours,

Mark N. Milken

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

K031995 510(k) Number (if known):

Comprehensive Neuromuscular Profiler Device Name:

Indications For Use:

Surface electromyography with range of motion tracking, functional capacity and grip strength measuring.

Prescription Use _ × (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, Officelet fficelot Device Evaluation (ODE)

ivision Sign-Off)
Division of Ger eral, Restative
and Neurological Devices

Numbe K031995

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