NEUROTECH BAXOLVE TYPE 294

K023913 · Bio-Medical Research, Ltd. · GZJ · Aug 25, 2003 · Neurology

Device Facts

• Record ID: K023913
• Device Name: NEUROTECH BAXOLVE TYPE 294
• Applicant: Bio-Medical Research, Ltd.
• Product Code: GZJ · Neurology
• Decision Date: Aug 25, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5890
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Transcutaneous Electrical Nerve Stimulation (TENS), which provides the symptomatic relief and manaqement of chronic lower back pain. Lumbar support.

Device Story

BAXOLVE is a battery-operated transcutaneous electrical muscle stimulator integrated into a lumbar support belt. Device delivers electrical stimulation via adhesive electrodes to manage chronic lower back pain. Operated by patient under medical supervision. Features LCD screen for user compliance logging. Device provides non-invasive prescriptive therapy. Clinical benefit is symptomatic pain relief.

Clinical Evidence

Bench testing only. No clinical data provided. Device performance validated through comparative electrical output analysis against predicate and adherence to safety/EMC standards including IEC 60601-1, IEC 60601-2-10, IEC 61000-4-2/3, and EN 55011.

Technological Characteristics

Battery-operated transcutaneous electrical nerve stimulator; integrated lumbar support belt with adhesive electrodes. Features LCD screen for compliance logging. Tested to IEC 60601-1, IEC 60601-2-10, IEC 601-1-1, IEC 601-1-2, IEC 61000-4-2, IEC 61000-4-3, DD ENV 50204, and EN 55011 standards.

Indications for Use

Indicated for symptomatic relief and management of chronic and intractable lower back pain; provides lumbar support. Requires medical supervision. Not curative.

Regulatory Classification

Identification

A transcutaneous electrical nerve stimulator for pain relief is a device used to apply an electrical current to electrodes on a patient's skin to treat pain.

Predicate Devices

• NeuroTech Smart-TENS, Type 456

Submission Summary (Full Text)

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K023913

AUG 2 5 2003

510(k) Summary Page 1 of 2

| Image: BMR logo and Bio-Medical Research Ltd address | | | |
|------------------------------------------------------|------------------------------------------------------------|----------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------|
| | | | |
| 510 (k) Summary of Safety and Effectiveness. | | | |
| | This summary is submitted in accordance with 21 CFR 807.92 | | |
| a) | 1 | Submitted by | Bio-Medical Research Ltd<br>BMR House<br>Parkmore Business Park, West<br>Galway<br>Republic of Ireland |
| | | Establishment Registration<br>Number<br>Contact Person<br>Phone<br>Fax<br>e-mail | 8020867<br>Michelle Sawyer<br>[phone]<br>[phone]<br>[e-mail] |
| | | Title<br>Date of Preparation | Regulatory Affairs Manager<br>November 2002. |
| | 2 | Trade Name of Device | NeuroTech© BAXOLVETM. Type 294. |
| | | Common Name | NeuroTech© BAXOLVETM |
| | | Classification name | Transcutaneous Electrical Nerve<br>Stimulator.(882.5810) |
| | 3 | Identification of predicate<br>device | NeuroTech© Smart-TENS , Type 456, |

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K023913

Page 2 of 2 510(k) Summary

## Description of Device 4

The BAXOLVE™ TENS device is a self-contained battery operated transcutaneous electrical muscle stimulator. The adhesive electrodes are mounted on a belt offering lumbar support to the user during therapy delivery.

The device is intended to provide a non-invasive prescriptive therapy.

#### ട Intended Use

The device is indicated for:

- · Transcutaneous Electrical Nerve Stimulation (TENS), which provides the symptomatic relief and manaqement of chronic lower back pain.
- · Lumbar support.

#### Technological Comparison ട

The BAXQLVE™ is similar to the Smart-TENS in it's delivery of the stimulation signal and has similar parameter settings. Both products utilise a LCD screen with user compliance logging.

### Non- clinical Tests 7

Comparisons of electrical outputs for the two devices show similar results. They have both been designed and independently tested to the following requirements;

- . IEC 60601-1:1990 Medical electrical equipment - Part 1: General requirements for safety.
- . IEC 60601-2-10
- IEC 601-1-1 and appendices A1:1991,A2:1995 . IEC 601-1-2: EMC requirements
- . IEC 61000-4-2:1995: Electromagnetic compatibility
- IEC 61000-4-3:1997: Electromagnetic compatibility
- DD ENV 50204:1996: Electromagnetic compatibility .
- EN 55011:1998: radiated emissions. .

Bio-Medical Research Ltd, (BMR), adheres to recognised and established industry practice, and all devices are subject to final performance testing.

A hazard analysis, a risk analysis and a failure mode effects analysis have been carried out for the device.

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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 is 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 with its wings spread.

Public Health Service

AUG 2 5 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Michelle Sawyer Regulatory Affairs Manager Bio-Medical Research Limited BMR House Parkmore Business Park, West Galway Republic of Ireland

Re: K023913

Trade/Device Name: NeuroTech® BAXOLVE™, Type 294 Regulation Number: 21 CFR 882.5890; 890.3490 Regulation Name: Transcutaneous electrical nerve stimulator for pain relief Truncal orthosis Regulatory Class: II Product Code: GZJ, IQE Dated: May 22, 2003 Received: May 27, 2003

Dear Ms. Sawyer:

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 (OS) 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. Michelle Sawyer

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.

Mark n Mellem

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 Statement

510(k) Number (if known):

Not yet available

Device Name:

NeuroTech© BAXOLVE™ , type 294

Sponsor Name:

Bio-Medical Research Ltd.

KDZ3913

The device is intended for prescriptive use.

Indications for Use:

- Transcutaneous electrical nerve stimulation for the symptomatic relief and . management of chronic and intractable pain in the lower back region. The device has no curative values and should only be used in conjunction with medical supervision.
- . Lumbar support.

Do Not Write Below This Line - Continue on Another Page if Needed

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use Over-The-Counter Use

Mark N. Milliken

eral, Restorative

510(k) Number.

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