NEUROMED ELECTROANALGESIC DELIVERY SYSTEMS

K083250 · Aa Neuromed Corp. · GZJ · Aug 18, 2009 · Neurology

Device Facts

• Record ID: K083250
• Device Name: NEUROMED ELECTROANALGESIC DELIVERY SYSTEMS
• Applicant: Aa Neuromed Corp.
• Product Code: GZJ · Neurology
• Decision Date: Aug 18, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5890
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Stimulate peripheral nerves for the purpose of providing pain relief Stimulate motor nerves for the purpose of muscle rehabilitation Management and symptomatic relief of chronic (long-term) intractable pain, Adjunctive treatment of post-traumatic pain syndromes Adjunctive treatment in the management of post-surgical pain problems Increasing local blood circulation Maintaining or increasing range of motion Muscle Re-education Relaxation of muscle spasms Prevention or retardation of disuse atrophy Immediate post-surgical stimulation of the calf muscles to prevent phlebothrombosis

Device Story

NeuroMed Electroanalgesic Delivery System is an electrical signal generator console; applies sinusoidal current via two pairs of contact electrodes (or one pair) using temporal interference patterns. Used in clinical settings for transcutaneous stimulation of muscles and peripheral nerves. Input: household current. Output: electrical stimulation signals. Healthcare providers operate the system to provide pain relief or adjunctive physical therapy. Output affects clinical decision-making by facilitating muscle rehabilitation, pain management, and circulation improvement. Benefits include reduced pain, muscle spasm relaxation, and prevention of disuse atrophy or post-surgical thrombosis.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on technological characteristics and intended use comparison to predicate devices.

Technological Characteristics

Console-type electrical signal generator; sinusoidal current output; temporal interference patterns. Uses household current power source. Includes suction cup electrode applicators, electrodes, and cables. Embedded software for control. Compliance with equivalent IEC standards.

Indications for Use

Indicated for patients requiring pain relief or muscle rehabilitation. Includes management of chronic intractable pain, post-traumatic pain, and post-surgical pain. Also indicated for increasing local blood circulation, maintaining/increasing range of motion, muscle re-education, relaxation of muscle spasms, prevention/retardation of disuse atrophy, and immediate post-surgical calf stimulation to prevent venous thrombosis.

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

• TRANSCUTANEOUS ELECTRICAL NERVE STIMULATOR (Nemectron EDiT) (K932897)
• Metron Vectorsurge 5 (K03048)

Submission Summary (Full Text)

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## 510 (k) Summary

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AUG 1 8 2009

## Submittor's Identification:

AA NeuroMed Company 1911 Rodger Avenue Port Coquitlam, BC V3C 1M9 Canada

Telephone: [phone] Facimile: 604-941-5659

Contact person: Hermann Dolker

Date prepared: 10/27/2008

### Device identification:

Trade name: NeuroMed Electroanalgesic Delivery Systems Common name: Interferential Current Therapy Classification name: Interferential Current Therapy Device. Product Code: LIH (Unclassified), IPF, GZJ

## Predicate Devices Information:

TRANSCUTANEOUS ELECTRICAL NERVE STIMULATOR (Nemectron EDiT) (K932897),

Metron Vectorsurge 5 (K03048)

### Device Description:

NeuroMed Electroanalgesic Delivery Systems consist of a system console with a control and display panel, control electronics and software and device accessories including a suction cup electrode applicator, electrodes and cables. The device uses regular household current as a power source. The physical measurements of the device are 17.5" long x 11.5" wide x 5.5" high at a weight of approximately 9 Ibs.

NeuroMed Electroanagesic Delivery Systems is an electrical signal generator which applies sinusoidal current through two pairs of contact electrodes using temporal interference patterns to stimulate muscles and peripheral nerves transcutaneously for the purpose of providing pain relief or as an adjunctive treatment in physical therapy. Alternatively, this device can perform the forementioned functions by applying sinusoidal current through only one pair of electrodes.

### Intended Use:

The intended use of the NeuroMed Electroanagesic Delivery Systems is the same as for the predicate devices namely to:

Stimulate peripheral nerves for the purpose of providing pain relief Stimulate motor nerves for the purpose of muscle rehabilitation Management and symptomatic relief of chronic (long-term) intractable pain, Adjunctive treatment of post-traumatic pain syndromes Adjunctive treatment in the management of post-surgical pain problems Increasing local blood circulation

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Maintaining or increasing range of motion Muscle Re-education Relaxation of muscle spasms Prevention or retardation of disuse atrophy Immediate post-surgical stimulation of the calf muscles to prevent phlebothrombosis

## Summary of technological characteristic in comparison to predicate devices:

The NeuroMed Electroanalgesic Delivery Systems and the predicate devices are console type electrical signal generators which apply sinusoidal current through two pairs of contact electrodes to the patient. Their output currents consist of similar intensity and frequency range. They have electronic control circuits with embedded software and use common household current as a power source. They are in compliance with equivalent IEC standards.

## Conclusions:

The NeuroMed Electroanalgesic Delivery Systems have the same intended use and similar characteristics as the predicate devices. Documentation supplied in this submission demonstrates that any differences in their technological characteristics do not raise any new concerns of safety or effectiveness. Thus, the NeuroMed Electroanalgesic Delivery Systems can be determined to be substantially equivalent to the the predicate devices.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002

AA NeuroMed Corp. c/o Hermann Dolker 1911 Rodger Avenue Port Coquitlam, British Columbia Canada V3C 1B8

## AUG 1 8 2009

Re: K083250

Trade/Device Name: NeuroMed Electroanalgesic Delivery System Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator for Pain Relief Regulatory Class: Class II Product Code: GZJ, LIH, IPF Dated: July 27, 2009 Received: August 13, 2009

Dear Mr. Dolker:

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 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

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Page 2 - Mr. Hermann Dolker

CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/Resourcesfor You/Industry/default.htm.

http://www.fda.gov/MedicalDevices/Resourcecenter/You/Industry/default.htm.

Sincerely yours.

Mark N. Melkerson

Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known):

K083250

Device Name:

NeuroMed Electroanalgesic Delivery System

Indications For Use:

## Pain Management for use with interferential and/or TENS mode programs/parameters

Stimulate peripheral nerves for the purpose of providing pain relief. Management and symptomatic relief of chronic (long-term) intractable pain. Adjunctive treatment of post-traumatic pain. Adjunctive treatment in the management of post-surgical pain.

## Muscle Stimulation for use with muscle stimulation programs

Increasing local blood circulation. Maintaining or increasing range of motion. Muscle Re-education. Relaxation of muscle spasms. Prevention or retardation of disuse atrophy. Immediate post-surgical stimulation of the calf muscles to prevent venous thrombosis.

Prescription Use

(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)

Lawrence P. Leyva

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K083250

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