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.

AI/ML Overview

The provided text describes the NET-2000 Microcurrent Stimulator, a device used for the treatment of anxiety, depression, or insomnia. The submission is a 510(k) premarket notification, which seeks to demonstrate substantial equivalence to a legally marketed predicate device.

Here's an analysis of the acceptance criteria and the study (or lack thereof) based on the provided information:

1. A table of acceptance criteria and the reported device performance

The provided information does not explicitly state "acceptance criteria" in terms of performance metrics like sensitivity, specificity, or accuracy. Instead, the submission relies on a comparison table to demonstrate the NET-2000's features are equivalent to its predicate device, the Alpha-Stim 100. This is the primary method of showing "performance" in this context.

Feature	NET-2000	Alpha-Stim 100 (Predicate)	Equivalence Justification/Reported Performance
Indication	Treats anxiety, depression, and insomnia	Treats anxiety, depression, and insomnia	Identical
Classification	CES, Class III Prescription, 882.5800	CES, Class III Prescription, 882.5800	Identical
Contraindications	None	None	Identical
Power Source	9 volt battery	9 volt battery	Identical
Current	0-600 microamperes	10-600 microamperes	Within comparable range
Frequency	0.5, 1.5, 100 Hz	0.5, 1.5, 100 Hz	Identical
Waveform	Bipolar asymmetric rectangular waves, 50% duty cycle, 0 net current	Bipolar asymmetric rectangular waves, 50% duty cycle, 0 net current	Identical
Electrodes	Silver, self-adhesive pads with conduction solution, clip style. Applied to earlobes.	Silver, self-adhesive pads with conducting solution, clip style. Applied to earlobes.	Identical
Timer Treatment Settings	16.5 minutes	10, 20, 60 minutes and continuous	Similar (device offers a specific timed setting, predicate offers options)
Electrical Safety	Confirmed by testing and passing requirements under EN60601-1-2 and EN60601-1	(Implied predicate meets similar standards for marketing)	Demonstrated through compliance with standards
Biocompatibility	For the electrode patient contact is confirmed by testing.	(Implied predicate materials are biocompatible)	Demonstrated through testing

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not describe any clinical study with a test set involving human subjects or data. The "performance testing" mentioned is comparative testing to the Alpha-Stim 100 and electrical safety and biocompatibility testing. This implies bench testing rather than clinical data from a sample size.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. No clinical data or human evaluation with a "ground truth" established by experts is mentioned for this device. The assessment is based on technical specifications and safety/performance standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. As no clinical study with a test set is described, there is no adjudication method.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a microcurrent stimulator, not an AI-powered diagnostic tool. Therefore, an MRMC study related to AI assistance for human readers is irrelevant and not mentioned.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This section is typically relevant for AI/ML-based algorithms. The NET-2000 is a physical medical device; its "performance" is assessed through its electrical characteristics, safety, and functional equivalence to a predicate, not through an algorithm's standalone performance.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable. For this type of 510(k) submission and device, the "ground truth" for demonstrating substantial equivalence is primarily the technical specifications and established safety and effectiveness of the predicate device, alongside adherence to recognized electrical safety and biocompatibility standards. There is no mention of clinical outcomes data in terms of "ground truth" for the device's efficacy. The claim of "safe and effective" is based on the equivalence to a device already deemed safe and effective.

8. The sample size for the training set

Not applicable. There is no mention of a "training set" as this is not an AI/ML device.

9. How the ground truth for the training set was established

Not applicable. As there is no training set, this question is not relevant.

In summary:

This 510(k) submission for the NET-2000 Microcurrent Stimulator focuses on "substantial equivalence" to a predicate device (Alpha-Stim 100) based on technical specifications, indications for use, and a demonstration of electrical safety and biocompatibility. It does not present evidence from clinical trials or studies involving human subjects with a "test set" and "ground truth" as typically seen in submissions for diagnostic algorithms or devices requiring new clinical evidence of efficacy. The "study that proves the device meets the acceptance criteria" in this context refers to the comparative analysis of features, electrical safety testing, and biocompatibility testing, all demonstrating the NET-2000's similarity to the predicate and compliance with relevant standards.

Summary

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Ko60158

510(k) Summary

Prepared 10-10-06 Auri-Stim Medical, Inc. 11272 Huron Street, #22 Northglenn, CO 80234 Phone 303-254-4206 Fax 303-457-4861 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,depression, and insomnia	Treats anxiety,depression, and insomnia
Classification	CES, Class IIIPrescription, 882.5800	CES, Class IIIPrescription, 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

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Frequency	0.5, 1.5, 100 Hz	0.5, 1.5, 100 Hz
Waveform	Bipolar asymmetric rectangular waves50% duty cycle, 0 netcurrent	Bipolar asymmetric rectangular waves50% duty cycle, 0 netcurrent
Electrodes	Silver, self adhesive padswith conduction solution,clip style. Applied to earlobes.	Silver, self adhesive padswith conducting solution,clip style. Applied to earlobes.
Timer Treatment Settings	16.5 minutes	10, 20, 60 minutes andcontinuous

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.

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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.

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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 (240) 276-0120. 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 (800) 638-2041 or (240) 276-3150 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

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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

Regulation Number and Section

§ 882.5800 Cranial electrotherapy stimulator.

(a)
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.(b)
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.