MODIFICATION TO BIONICARE STIMULATOR SYSTEM, MODEL BIO-1000

K030332 · Bionicare Medical Technologies, Inc. · NYN · Jun 6, 2003 · Neurology

Device Facts

• Record ID: K030332
• Device Name: MODIFICATION TO BIONICARE STIMULATOR SYSTEM, MODEL BIO-1000
• Applicant: Bionicare Medical Technologies, Inc.
• Product Code: NYN · Neurology
• Decision Date: Jun 6, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 882.5890
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The BioniCare® Stimulator, Model BIO-1000™ is indicated for use as an adjunctive therapy in reducing the level of pain and symptoms associated with osteoarthritis of the knee and for overall improvement of the knee as assessed by the physician's global evaluation (clinical studies.)

Device Story

BioniCare Stimulator Model BIO-1000 is a portable, battery-operated, rechargeable transcutaneous electrical nerve stimulator (TENS). It delivers pulsed electrical signals to a treatment site via lead wires and electrodes. The device generates a monophasic spike-shaped pulse at a fixed frequency of 100 ± 5Hz with a voltage range of 0-12 volts. Version A features a single output channel with LED indicators, while Version B features two output channels and an LCD display for numeric voltage values. The device is used as an adjunctive therapy for osteoarthritis of the knee. Healthcare providers assess patient improvement via global evaluation. The device aims to reduce pain and symptoms, potentially improving patient quality of life.

Clinical Evidence

No clinical data provided in the document; substantial equivalence is based on technological characteristics and compliance with electrical safety standards.

Technological Characteristics

Portable, battery-operated TENS device. Output: monophasic spike-shaped pulse, 100 ± 5Hz fixed frequency, 0-12V peak range. Version A: analog circuit, single channel, LED display. Version B: digital circuit, dual channel, LCD display. Complies with ANSI/AAMI NS-4: 1988. Electrodes and lead wires complete the circuit.

Indications for Use

Indicated for patients with osteoarthritis of the knee as an adjunctive therapy to reduce pain and symptoms and improve knee condition.

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

• Bionicare® Stimulator, Model BIO-1000™ (K030332)

Submission Summary (Full Text)

{0}------------------------------------------------

# Attachment E

## 510(k) Summary

#### Submitter Information:

Kent Hoffman Chief Operating Officer BioniCare Medical Technologies Inc. 47 R. Loveton Circle Sparks, MD 21152 [phone]

#### Date Prepared:

January 30, 2003

#### Name and Classification of Device:

Transcutaneous electrical nerve stimulator for pain relief Class II Regulation - 21 CFR 882.5890 Product Code -- 84GZJ

### Device:

BioniCare® Stimulator, Model BIO-1000™

### Predicate Device:

Bionicare® Stimulator, Model BIO-1000™

#### Device Description:

The BioniCare® Stimulator, Model BIO-1000™ consists of the electrodes, the lead wires, and the BioniCare Stimulator. The stimulator is portable, battery operated and rechargeable. The lead wires connect the electrodes to the stimulator. These electrodes complete an electrical circuit allowing current flow. The stimulator produces a pulsed electrical signal through the lead wires and electrodes at the treatment site.

{1}------------------------------------------------

#### Statement of Intended Use:

The BioniCare® Stimulator, Model BIO-1000™ is indicated for use as an adjunctive therapy in reducing the level of pain and symptoms associated with osteoarthritis of the knee and for overall improvement of the knee as assessed by the physician's global evaluation (clinical studies.)

## Summary of Technological Characteristics of New device compared to Predicate Device:

The Bionicare Model BIO-1000™ Version A, and the BioniCare® Model BIO-1000 Version B, systems generate the same electrical output. The analog circuit of Version A and the digital circuit of Version B produce the same frequency at 100 ± 5Hz, fixed.

The analog circuit of Version A and the analog circuit of Version B produce the same waveform as a monophasic spike shaped pulse.

The analog circuit of Version A and the digital circuit of Version B produce the same voltage output range which is 0-12 volts peak. Version A has a single channel of output and version B has two channels of output. The voltage pulse width, current output range, current pulse width, and maximum output change/channel are the same for Version A and Version B.

The output of Version A is displayed on red and green LEDs. The output on Version B is displayed on a LCD as numeric values in the range of the 0.0 to 12.0 volt output.

The twelve volt battery of Version A and the nine volt battery of Version B both produce the same output voltage over the range of 0.0 to 12.0 volts. Version A and Version B both comply with the standard ANSI/AAMI NS-4: 1988.)

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the symbol. The logo is presented in black and white.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville, Maryland 20850

JUN - 8 2006

Mr. Kent Hoffman Chief Executive Officer BioniCare Medical Technologies, Inc. 47 R Loveton Circle Sparks, MD 21152

Re: K030332

Trade/Device Name: BioniCare® Stimulator Model BIO-1000™ Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous electrical nerve stimulator for pain relief Regulatory Class: II Product Code: NYN Dated: May 9, 2003 Received: May 9, 2003

Dear Mr. Hoffman:

This letter corrects our substantially equivalent letter of June 6, 2003.

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 (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 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.

{3}------------------------------------------------

# Page 2 – Mr. Kent Hoffman

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 I oderal agencies: " Fou may comply 1 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.

This letter will allow you to continue marketing your device as described in your Section This lotter will and w you to comment The FDA finding of substantial equivalence of your device 510(t) promanteeted 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 10 galation onlines, "Thisolation on your responsibilities under the Act 0017777 - Fouring 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 M. Wilkerson

Mark N. Melkerson, M.S Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

Image /page/3/Picture/7 description: The image shows a circular logo with the letters "FDA" in the center. The text "Centennial" is written below the letters "FDA". The logo is surrounded by a dotted border.

1 Promoting Public . Health

{4}------------------------------------------------

### Attachment C

# Indications for Use Statement

#### Device Name

BioniCare® Stimulator, Model BIO-1000™

#### Indications for Use

The BioniCare® Stimulator, Model BIO-1000™ is indicated for use as an adjunctive The Diolicate "Stimulator, Model Dro" 1000 - 1000 - 1000 - 1000 - 1000 - 100 - 100 therapy in roducing the lover of the knee as assessed by the physician's global evaluation (clinical studies.)

Miriam C. Provost

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

510(k) Number_________________________________________________________________________________________________________________________________________________________________

PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use: (Per 21 CFR 801.109) OR Over-the-Counter Use

(Optional Format 1-2-96)

30