ADVANTAGE 3000

K973355 · Advantage Medical Division of Cme Telemetrix · IKN · Dec 5, 1997 · Physical Medicine

Device Facts

• Record ID: K973355
• Device Name: ADVANTAGE 3000
• Applicant: Advantage Medical Division of Cme Telemetrix
• Product Code: IKN · Physical Medicine
• Decision Date: Dec 5, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.1375
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Advantage 3000 system diagnoses disorders of the nervous and muscular systems.

Device Story

Advantage 3000 is an EMG/EP system for diagnosing nervous and muscular system disorders. Inputs include electrical signals from skin surface (via surface electrodes) or directly from nerves/muscles (via needle electrodes). Device provides timed electrical stimulation to patient; records and analyzes resulting responses. Signals pass through headbox to control module and Intel Pentium-based computer for display and analysis. Used in clinical/laboratory settings by healthcare professionals. Output allows clinicians to assess nerve/muscle function and inform diagnostic decisions. System features include constant voltage stimulator, improved interface, reduced speaker wattage, and portable/laboratory configurations.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

System utilizes surface and needle electrodes for signal acquisition. Employs constant voltage electrical stimulation. Architecture based on Intel Pentium processor. Available in portable and laboratory-based form factors. Connectivity via headbox to control module. Software performs signal analysis and display.

Indications for Use

Indicated for monitoring and analysis of electromyography data to determine presence of peripheral nerve or muscle disease in adult and pediatric patients.

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

• Advantage EMG/EP System (K885246)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo for Advantage Medical, a division of CME Telemetrix. The word "Advantage" is in a bold, sans-serif font and is set against a black background. Below that, the word "Medical" is in a similar font but is not set against a black background. Below that, the text "A Division of CME Telemetrix" is in a smaller font.

DEC - 5 1997

## 510(k) SUMMARY

Date: September 4, 1997

## Submitter's Name and Address:

Advantage Medical A Division of CME Telemetrix 100 - 100 Collip Circle London, ON Canada N6G 4X8

## Contact Name:

Mr. Robert Snow Advantage Medical A Division of CME Telemetrix 100 - 100 Collip Circle London, ON Canada N6G 4X8

> Tel: [phone] Fax: [phone]

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K 973355

| Trade Name: | ADVANTAGE 3000 |
|--------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | EMG/EP System |
| Classification Name: | Diagnostic Electromyography / Evoked<br>Response Electrical Stimulation System |
| Substantially Equivalent to: | Advantage EMG/EP System<br>K885246 |
| Classification: | Class II, 21 C.F.R. §890.1375 &<br>§882.1870 |
| Intended use: | The Advantage 3000 system diagnoses<br>disorders of the nervous and muscular<br>systems. |
| Technological characteristics: | Using surface electrodes, signals are<br>recorded from the surface of the skin or<br>directly from the nerves or muscles by<br>means of needle electrodes. It is also<br>possible to provide a timed stimulus to the<br>patient, so that the response to the<br>stimulus can be recorded and analysed. |
| | The signals from the subject are taken<br>through the headbox to the control module<br>and the computer for display and analysis.<br>The computer is based on the Intel Pentium<br>architecture. |
| | Differences from the predicate device are<br>the inclusion of a constant voltage<br>stimulator, a more efficient operating<br>interface, a reduction in the wattage of the<br>speaker, the availability of a portable<br>system, and the size reduction of the<br>laboratory based system. Beyond these<br>differences both devices have the same<br>technological characteristics. |

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its wing. The eagle is positioned to the right of a circular text element that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC = 5 1997

Mr. Robert Snow Advantage Medical Division of CME Telemetrix 100 Collip Circle #100 London Ontario N6G 4X8 CANADA

Re: K973355 Trade Name: Advantage 3000 Regulatory Class: II Product Code: IKN Dated: September 4, 1997 Received: September 8, 1997

Dear Mr. Snow:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 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 comply with 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

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Page 2 - Mr. Snow

devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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" (21 CFR 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/dsmamain.html".

Sincerely yours,

cella

ia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## INDICATIONS FOR USE

510(k) Number: K973355

Device Name:

Advantage 3000

Indications for use:

The Advantage 3000 is a Diagnostic Electromyography/Evoked Response Electrical Stimulation (EMG/EP) System designed for the monitoring and analysis of electromyography data. A variety of electrophysiologic tests can be performed to determine whether disease of peripheral nerves or muscles is present in adult and pediatric patients.

Concurrence of CDRH, Office of Device Evaluation (ODE)

| (Division Sign-Off) | |
|---------------------------------------------------------------------|---------|
| Division of Dental, Infection Control, and General Hospital Devices | |
| 510(k) Number | K973355 |

| Prescription Use | <div>✓</div> |
|----------------------|--------------|
| | or |
| Over-The-Counter Use | |