BIONICARE STIMULATOR SYSTEM, MODEL BIO-1000

K052625 · Bionicare Medical Technologies, Inc. · NYN · Dec 5, 2005 · Neurology

Device Facts

• Record ID: K052625
• Device Name: BIONICARE STIMULATOR SYSTEM, MODEL BIO-1000
• Applicant: Bionicare Medical Technologies, Inc.
• Product Code: NYN · Neurology
• Decision Date: Dec 5, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5890
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

BioniCare® Stimulator Model BIO-1000™ is indicated for use as an adjunctive therapy in reducing the level of pain, and stiffness associated with pain, from rheumatoid arthritis of the hand.

Device Story

BIO-1000 is a portable, battery-operated, dual-channel transcutaneous electrical nerve stimulator (TENS). Device generates spike-shaped monophasic pulses via voltage-regulated output circuit; amplitude 0-12V peak; fixed frequency 100 ± 5 Hz. System comprises signal generator, lead wires, and glove electrodes. Used as adjunctive therapy for rheumatoid arthritis of the hand. Healthcare provider prescribes device for patient use. Added garment facilitates lead wire management, reducing tangling and remote strangulation risk. Modified electrical connection ensures conductive middle glove becomes nonconductive if insulating outer glove is removed. Output provides electrical stimulation to target area to manage pain and stiffness.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and identical signal generation to predicate.

Technological Characteristics

Portable, battery-operated, dual-channel TENS. Voltage-regulated output circuit; spike-shaped monophasic pulse; 0-12V peak amplitude; 100 ± 5 Hz fixed frequency. Components: signal generator, lead wires, glove electrodes. Safety modification: conductive middle glove becomes nonconductive if insulating outer glove is removed. Garment added for lead wire management.

Indications for Use

Indicated for patients with rheumatoid arthritis of the hand to reduce pain and associated stiffness as an adjunctive therapy.

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)
• BioniCare® Stimulator Model BIO-1000™ (k983228)

Submission Summary (Full Text)

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#### DEC & 2005

K052625

Section 5. 510(k) Summary

# 510(k) Summary

#### Submitter Information:

Kent Hoffman Executive Vice President Rescarch, Development And Regulatory Affairs and Chief Technical Officer BioniCare Medical Technologies Inc. 47 R. Loveton Circle Sparks, MD 21152 [phone]

#### Date Prepared:

July 11, 2005

#### Name and Classification of Device:

Transcutaneous electrical nerve stimulator for pain relief, Class II, 21 CFR 882.5890, Product Code GZJ

#### Device:

BioniCare® Stimulator Model BIO-1000™

#### Predicate device:

BioniCare® Stimulator Model BIO-1000™, k030332 and k983228

#### Device Description:

The BIO-1000 is a portable, rechargeable, battery-operated dual-channel device that utilizes a voltage regulated output circuit to generate a spike-shaped monophasic pulse with an adjustable amplitude of 0-12 volts peak and repeating at a single fixed frequency of 100 ± 5 Hertz.

The device consists of electrodes, lead wires and a signal generator.

#### Statement of Intended use:

BioniCare® Stimulator Model BIO-1000™ is indicated for use as an adjunctive therapy in reducing the level of pain, and stiffness associated with pain, from rheumatoid arthritis of the hand.

### Summary of technological characteristics of New Device Compared to Predicate Device:

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The new device's signal generator is identical to that in k030332. The electrical connection to the glove electrode was slightly modified so that if the insulating outer glove is removed, the conductive middle glove becomes nonconductive. A garment was added through which the lead wires travel to simplify use of the device and mitigate any tangling inconvenience or extremely remote strangling hazard.

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville, Maryland 20850

JUN - 8 2006

Kent Hoffman Executive Vice President Research, Development and Regulatory Affairs and Chief Technical Officer BioniCare Medical Technologies, Inc. 47 R. Loveton Circle Sparks, Maryland 21152

Re: K052625

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: September 22, 2005 Received: September 23, 2005

Dear Mr. Hoffman:

This letter corrects our substantially equivalent letter of December 5, 2005.

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 Eederal Register.

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#### 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 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 (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 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 A. Millican

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

Enclosure

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1 Promoting Public . Health

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## Indications for Use

510(k) Number (if known):_K052625

# Device Name: BioniCare Stimulator, Model BIO-1000™

Indications For Use: The BioniCare Stimulator, Model BIO-1000™, is indicated for use as an adjunctive therapy in reducing the level of pain, and stiffness associated with pain, from rheumatoid arthritis of the hand.

Prescription Use_J (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

2

(Division Sign-Off) Division of General, Restorative. and Neurological scries 3

510(k) Number KO'S 262 > 262 >