INTERX5000

K042912 · Neuro Resource Group, Inc. · GZJ · May 17, 2005 · Neurology

Device Facts

• Record ID: K042912
• Device Name: INTERX5000
• Applicant: Neuro Resource Group, Inc.
• Product Code: GZJ · Neurology
• Decision Date: May 17, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5890
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The InterX5000 is indicated for: - symptomatic relief and management of chronic, intractable pain - adjunctive treatment in the management of post-surgical and post-traumatic pain - relaxing muscle spasms - increasing local blood circulation - immediate post surgical stimulation of calf muscles to prevent venous thrombosis - muscle reeducation - maintaining or increasing range of motion - preventing or retarding disuse atrophy

Device Story

InterX5000 is a handheld, battery-powered transcutaneous electrical nerve stimulator. Device uses concentric electrodes placed on unbroken skin to deliver high-amplitude, short-duration bi-polar pulses. System operates by introducing electrical pulses into tissue and monitoring real-time impedance changes; digital display provides biofeedback to the operator. Operator adjusts output characteristics based on tissue response during treatment. Device intended for clinical or home use to manage pain, relax muscle spasms, and improve circulation. Benefits include conditioned training process to enhance body's pain management capabilities. Optional external electrode accessories allow treatment in areas inaccessible to main unit electrodes.

Clinical Evidence

Bench testing only. Performance bench testing was conducted to characterize the electrical performance of the InterX5000 and compare it against published data for the predicate devices.

Technological Characteristics

Handheld device in plastic case; powered by 9V alkaline battery. Features concentric electrode system for stimulation and sensing; no conductive gel required. Includes LCD display, 5 control buttons, and 3.5mm stereo jack for external electrode accessories. Waveform is high-amplitude, short-duration bi-polar pulse. Integrated circuitry monitors time and dosage.

Indications for Use

Indicated for patients requiring symptomatic relief and management of chronic, intractable pain, or adjunctive treatment for post-surgical and post-traumatic pain. Also indicated for muscle spasm relaxation, increased local blood circulation, prevention of venous thrombosis via calf muscle stimulation, muscle reeducation, range of motion maintenance, and prevention of disuse atrophy.

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

• Fenzian Treatment System (K041575)
• EMPI Focus 795 (K951951)
• Dynatron 500 Electrical Muscle Stimulator (K870947)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows a document with the title "Image 2000" at the top. The document contains information about a user named GARCIA, DIANE M (dmp), and a folder named K042912 - 8 pages. The company is NEURO RESOURCE GROUP, INC. (NEURRESOGROU), and the product is STIMULATOR, NERVE, TRANSCUTANEOUS, FOR PAIN RELIEF (GZJ). The summary indicates the product is INTERX5000, the date requested is Mon Jan 07 11:47:39 2008, the date printed is Mon Jan 07 11:48:16 2008, and the printer is file.

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| CORRESPONDENCE - 3 pages | 1 |
|--------------------------|---|
| ORIGINAL - 3 pages | 4 |

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal is circular and contains the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of an eagle.

Public Health Service

MAY 1 7 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Krista Oakes Vice President, Regulatory Affairs Neuro Resource Group, Inc. 1100 Jupiter Road, Suite 190 Plano, Texas 75074

Re: K042912

Trade/Device Name: InterX5000 Regulation Numbers: 21 CFR 882.5890 Regulation Names: Transcutaneous electrical nerve stimulator for pain relief Regulatory Class: II Product Code: GZJ Dated: April 14, 2005 Received: April 18, 2005

Dear Ms. Oakes:

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 docs 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.

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Page 2 - Ms. Krista Oakes

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/industry/support/index.html.

Sincerely yours,

Hytl Rhodes
Miriam Provost, Ph.D.

Mirian Provost, Ph.D. Acting 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

510(k) # (if known): K042912

Device Name: InterX5000

Indications for Use:

The InterX5000 is indicated for symptomatic relief and management of chronic, intractable pain, and adjunctive treatment in the management of post-surgical and post-traumatic pain.

Prescription Use X (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)

Htp. Curda

ign-Off (Division' Division of General, Restorative. and Neurological Devices

KOYZ912 510(k) Number ___

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# APPENDIX A

# SUMMARY OF SAFETY AND EFFECTIVENESS

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### 510(k) Summary

#### Submitter Information:

#### Contact:

Krista Oakes Tel: [phone] Fax: [phone]

#### Date Prepared:

September 30, 2004

#### Product Name & Classification:

Classification Regulation: 882.5950, 890.5850, Panel: Neurology, Physical Medicine Product Code: GZJ, IPF Trade Name(s): InterX5000

#### Predicate Device:

K041575 - Fenzian Treatment System K951951 - EMPI Focus 795 K870947 - Dynatron 500 Electrical Muscle Stimulator

#### Description:

InterX means "Interactive". InterX technology is designed to work by introducing very brief pulses of electricity into the tissue and immediately monitoring impedance changes as the tissue responds. Stimulation and sensing take place via a concentric electrode system that is moved over the skin surface, and a digital display enables the operator to follow the course of the treatments and adjust the output.

The InterX 5000 consists of a small handheld device in a plastic case. It is powered by one nine-volt alkaline battery. On the upper face of the machine there are two LED's, an LCD display and 5 control buttons. The underside of the machine two metal surfaces that form the poles of a treatment electrodes are placed directly on the unbroken skin and do not use any conductive material or gel.

On the side of the machine is one socket for a standard 3.5mm stereo jack socket that connects to the main electrodes of the machine to an optional external electrode accessory. The device's electrodes are disabled when the optional external electrode accessory is

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attached. The optional external electrode accessories only serve as an extension and allow the user to apply treatment in a areas which may not be accessible by the main unit electrodes. user to apply ucannell in a accessories intended for use with the InterX 5000 have any active electrical components.

The waveform is a high amplitude, short-duration bi-polar pulse (circuitry in the device integrates time and dosage delivered). A digital display monitors the biofeedback process in mtegrates thire and dosage convolling the operator to track changes in the tissues being treated and make appropriate adjustments to the output characteristics if necessary. This interaction and human adjustment continues throughout the length of the InterX treatment. The result is that the body experiences a conditioned training process that enhances the body's ability to effectively reduce and manage the level of pain.

#### Intended Use:

The InterX5000 is indicated for:

- symptomatic relief and management of chronic, intractable pain ■
- adjunctive treatment in the management of post-surgical and post-traumatic 트 pain
- 트 relaxing muscle spasms
- increasing local blood circulation
- immediate post surgical stimulation of calf muscles to prevent venous 트 thrombosis
- . muscle reeducation
- 트 maintaining or increasing range of motion
- preventing or retarding disuse atrophy ■

#### Comparison to Predicate Devices:

- . Does the new Device have the same indications for use? Yes
- Does the new Device have the same Technological Characteristics? Yes l
- Are Descriptive Characteristics precise enough to ensure Equivalence? Yes.
- Are Performance Data available to assess Equivalence? Yes
- Performance Data Demonstrate Equivalence? Yes

A comparison matrix has been provided as part of this premarket notification.

### Performance Data & Conclusions:

Performance bench testing was conducted to characterize the electrical performance of the InterX5000 as compared to published data of predicate devices.