NET-2000 MICROCURRENT STIMULATOR

K060158 · Auri-Stem Medical, Inc. · QJQ · Oct 13, 2006 · Neurology

Device Facts

• Record ID: K060158
• Device Name: NET-2000 MICROCURRENT STIMULATOR
• Applicant: Auri-Stem Medical, Inc.
• Product Code: QJQ · Neurology
• Decision Date: Oct 13, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5800
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

Application of electrical current to the head to treat insomnia, depression, or anxiety.

Device Story

NET-2000 Microcurrent Stimulator is a precision electronic instrument for treating anxiety, depression, or insomnia. Device comprises a microprocessor-controlled box and silver, self-adhesive ear-clip electrodes. Operates by delivering low-intensity bipolar asymmetric rectangular electrical pulses (0-600 microamperes) to the head. Typically set at 0.5 Hz, with 1.5 Hz and 100 Hz options for physician use. Features a 50% duty cycle with 0 net current and a fixed 16.5-minute treatment timer. Designed for simple, self-administered use. Output provides therapeutic electrical stimulation intended to alleviate symptoms of the specified conditions.

Clinical Evidence

Bench testing only. Comparative performance testing against the predicate device (Alpha-Stim 100) demonstrated equivalence in electrical output and waveform characteristics. Electrical safety verified via EN60601-1 and EN60601-1-2 standards. Biocompatibility of patient-contacting electrodes confirmed through testing.

Technological Characteristics

Microprocessor-controlled electronic stimulator. Output: 0-600 microamperes, bipolar asymmetric rectangular waveform, 50% duty cycle, 0 net current. Frequencies: 0.5, 1.5, 100 Hz. Power: 9V battery. Electrodes: Silver, self-adhesive pads with conduction solution. Dimensions: 3.25" x 2" x 0.14". Weight: 3 oz. Safety standards: EN60601-1, EN60601-1-2.

Indications for Use

Indicated for the treatment of insomnia, depression, or anxiety in patients via application of electrical current to the head. No specific age or gender contraindications noted.

Regulatory Classification

Identification

A cranial electrotherapy stimulator is a prescription device that applies electrical current that is not intended to induce a seizure to a patient's head to treat psychiatric conditions.

Special Controls

In combination with the general controls of the FD&C Act, the virtual reality behavioral therapy device for pain relief is subject to the following special controls:

*Classification.* (1) Class II (special controls) when intended to treat insomnia and/or anxiety. The special controls for this device are:(i) A detailed summary of the clinical testing pertinent to use of the device to demonstrate the effectiveness of the device to treat insomnia and/or anxiety. (ii) Components of the device that come into human contact must be demonstrated to be biocompatible. (iii) The device must be designed and tested for electrical safety and electromagnetic compatibility (EMC) in its intended use environment. (iv) Appropriate software verification, validation, and hazard analysis must be performed. (v) The technical parameters of the device, including waveform, output mode, pulse duration, frequency, train delivery, maximum charge, and energy, must be fully characterized and verified. (vi) The labeling for the device must include the following: (A) The intended use population and the intended use environment; (B) A warning that patients should be monitored by their physician for signs of worsening; (C) A warning that instructs patients on how to mitigate the risk of headaches, and what to do should a headache occur; (D) A warning that instructs patients on how to mitigate the risk of dizziness, and what to do should dizziness occur; (E) A detailed summary of the clinical testing, which includes the clinical outcomes associated with the use of the device, and a summary of adverse events and complications that occurred with the device; (F) Instructions for use that address where to place the electrodes, what stimulation parameters to use, and duration and frequency of treatment sessions. This information must be based on the results of clinical studies for the device; (G) A detailed summary of the device technical parameters, including waveform, output mode, pulse duration, frequency, train delivery, and maximum charge and energy; and (H) Information on validated methods for reprocessing any reusable components between uses. (vii) Cranial electrotherapy stimulator devices marketed prior to the effective date of this reclassification must have an amendment submitted to the previously cleared premarket notification (510(k)) demonstrating compliance with these special controls. (2) Class III (premarket approval) when intended to treat depression. (c) Date premarket approval application (PMA) or notice of completion of product development protocol (PDP) is required. A PMA or notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before March 19, 2020, for any cranial electrotherapy stimulator device with an intended use described in paragraph (b)(2) of this section, that was in commercial distribution before May 28, 1976, or that has, on or before March 19, 2020, been found to be substantially equivalent to any cranial electrotherapy stimulator device with an intended use described in paragraph (b)(2) of this section, that was in commercial distribution before May 28, 1976. Any other cranial electrotherapy stimulator device with an intended use described in paragraph (b)(2) of this section shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution.

Predicate Devices

• Alpha-Stim 100 (K903014)

Submission Summary (Full Text)

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

Ko60158

## 510(k) Summary

Prepared 10-10-06 Auri-Stim Medical, Inc. 11272 Huron Street, #22 Northglenn, CO 80234 Phone [phone] Fax [phone] Contact: Lewis Ward

OCT 1 3 2006

Trade Name: NET-2000 Microcurrent Stimulator Common Name: Stimulator, Cranial Electrotherapy Classification: 21 CFR 882.5800 Product Code: JXK

The NET-2000 Microcurrent Stimulator is a precision electronic instrument used for the treatment of anxiety, depression, or insomnia. The treatment is simple and can easily be selfadministered.

The device consists of a microprocessor controller box and skin contact electrodes. The small controller box is a software controlled low-intensity output. Current ranges from 0-600 microamperes typically set at 0.5 Hz. Additional frequencies at 1.5 and 100 Hz are available for the physician's use. The waveform is a bipolar asymmetric rectangular shape. Duty cycle is 50% with a 0 net current. Timed treatment is set at 16.5 minutes.

The following comparison table demonstrates the NET-2000 equivalent to the predicate.

| Feature | NET-2000 | Alpha-Stim 100 |
|-------------------|---------------------------------------------|---------------------------------------------|
| Indication | Treats anxiety,<br>depression, and insomnia | Treats anxiety,<br>depression, and insomnia |
| Classification | CES, Class III<br>Prescription, 882.5800 | CES, Class III<br>Prescription, 882.5800 |
| Contraindications | None | None |
| Power Source | 9 volt battery | 9 volt battery |
| 510(k) | This submission | K903014 |
| Size | 3.25" x 2" x .14" | 13.5cm x 6.4cm x 3.3cm |
| Weight | 3 oz. | 5.5 oz. |
| Current | 0-600 microamperes | 10-600 microamperes |

### COMPARISON TABLE, Microcurrent Stimulator

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

| Frequency | 0.5, 1.5, 100 Hz | 0.5, 1.5, 100 Hz |
|--------------------------|-------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------|
| Waveform | Bipolar asymmetric rectangular waves<br>50% duty cycle, 0 net<br>current | Bipolar asymmetric rectangular waves<br>50% duty cycle, 0 net<br>current |
| Electrodes | Silver, self adhesive pads<br>with conduction solution,<br>clip style. Applied to ear<br>lobes. | Silver, self adhesive pads<br>with conducting solution,<br>clip style. Applied to ear<br>lobes. |
| Timer Treatment Settings | 16.5 minutes | 10, 20, 60 minutes and<br>continuous |

Performance testing is confirmed by a comparative testing to the Alpha-Stim 100 and demonstrates equivalence. Electrical safety is confirmed by testing and passing requirements under EN60601-1-2 and EN60601-1. Biocompatibility for the electrode patient contact is confirmed by testing.

The NET-2000 is safe and effective and does not introduce new questions of safety or effectiveness.

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

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" are arranged in a circular pattern around the eagle. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# OCT 1 3 2006

L.W. Ward and Associates, Inc. 4655 Kirkwood Court Boulder, Colorado 80301

Auri-Stim Medical Inc.

% Mr. Lewis Ward

Re: K060158

Trade/Device Name: Net-2000 Microcurrent Stimulator Regulation Number: 21 CFR 882.5800 Regulation Name: Cranial Electrotherapy Stimulator Regulatory Class: Class III Product Code: JXK Dated: January 16, 2006 Received: January 20, 2006

Dear Mr. Ward:

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 (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.

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

Page 2 - Mr. Lewis Ward

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 vours.

Barbara Buchner
for

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

Enclosure

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

### INDICATIONS FOR USE

#### KOGOISB 510(k)

Device Name: NET-2000 Microcurrent Stimulator

Indications for Use:

Application of electrical current to the head to treat insomnia, depression, or anxiety.

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

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)

K060158
(Division Sign-Off)

Division of General, Restorative, and Neurological Devices

**510(k) Number** L060158