The P-Stim is a miniaturized, battery-powered, transcutaneous electrical nerve stimulator that has a pre-programmed frequency, pulse, and duration for the stimulation of auricular acupuncture points. The device connects via three stainless steel wires to acupuncture needles that have been applied to the appropriate auricular acupuncture points. The device is powered by three zinc air batteries, each with a voltage of 1.4 V. The device is on for 180 minutes, then off for 180 minutes, for a maximum period of up to 96 hours.

AI/ML Overview

This device submission does not contain a study that demonstrates the device meets specific acceptance criteria based on performance metrics such as sensitivity, specificity, or accuracy.

The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device, not on proving new performance claims through a clinical or technical study with defined acceptance criteria.

Here's a breakdown based on the information provided and the absence of certain details:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria Category	Acceptance Criteria (Specific Metric & Threshold)	Reported Device Performance
Performance (Clinical/Technical)	Not defined in the provided document.	Not reported in the provided document.
Intended Use	Device is an electro-acupuncture device to stimulate auricular acupuncture points.	P-Stim is an electro-acupuncture device for use in the practice of acupuncture by qualified practitioners to stimulate appropriate auricular acupuncture points. (Meets intention)
Operating Principles	Similar operating principles to the Acu-Stim.	Both P-Stim and Acu-Stim are transcutaneous electrical nerve stimulators with a single output channel and mode, and similar pulse widths and frequencies. (Meets intention)
Technological Characteristics	Technical differences from predicate do not affect safety or efficacy.	Statement made: "Technical differences do not affect the safety or efficacy of the product." (Meets intention)

Notes on the Absence of Performance Criteria:

The 510(k) summary for the P-Stim focuses on demonstrating substantial equivalence to a legally marketed predicate device (Acu-Stim, K014273).
For substantial equivalence, manufacturers typically show that the new device has the same intended use and similar technological characteristics, and that any differences do not raise new questions of safety or effectiveness. This often does not involve new clinical performance studies unless the technological differences are significant enough to warrant them.
The document states, "Substantial equivalence is claimed because the P-Stim has the same intended use and similar operating principles to the Acu-Stim." This is the primary "acceptance criterion" for a 510(k) submission of this nature.

2. Sample size used for the test set and the data provenance:

Not applicable. The provided document does not describe a performance study with a test set. It's a regulatory submission for substantial equivalence.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. No test set or ground truth establishment is described.

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

Not applicable. No test set or adjudication process is described.

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 an electro-acupuncture stimulator, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study related to AI assistance is irrelevant.

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

Not applicable. The device is a physical electro-acupuncture stimulator, not an algorithm.

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

Not applicable. No performance study with ground truth is described.

8. The sample size for the training set:

Not applicable. No training set is described.

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

Not applicable. No training set or ground truth establishment is described.

In summary, the provided 510(k) summary for the P-Stim device is a regulatory document focused on demonstrating substantial equivalence to a predicate device, not on presenting data from a clinical or technical performance study with specific acceptance criteria, test sets, or ground truth.

Summary

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MAR 3 0 2006

P-STIM 510(k) SUMMARY

(As required by 21 C.F.R. § § 807.87(h), 807.92)

Date of Submission

January 17, 2005

Identification of Applicant

Applicant

NeuroScience Therapy Corp. 135 Lake St. So., #100 Kirkland, WA 98033

Contact Person

Richard J. Forsell Corporate Secretary 425-889-4659 rforsell@ix.netcom.com

Trade or Proprietary Name
Common Name
Classification Name
Classification

P-Stim Electro-acupuncture device Electro-acupuncture stimulator Unclassified

Predicate Device

The legally marketed predicate device to which the P-Stim is substantially equivalent is the Acu-Stim (K014273).

Intended Use

The P-Stim is intended for use as an electro-acupuncture device to stimulate appropriate auricular acupuncture points.

Device Description

NeuroScience Therapy Corp. CONFIDENTIAL

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Summary of Technological Characteristics

Substantial equivalence is claimed because the P-Stim has the same intended use and similar operating principles to the Acu-Stim. Both devices are transcutaneous electrical nerve stimulators with a single output channel and mode and similar pulse widths and frequencies. Both use a conductive gel between the electrode and the patient's skin. Technical differences do not affect the safety or efficacy of the product.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three horizontal lines forming its body and head. The bird is positioned to the right of a circular text element that reads "DEPARTMENT OF HEALTH AND HUMAN SERVICES USA".

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 3 0 2006

Neuroscience Therapy Corp. c/o Jan McComb, Ph. D. ICRC, Inc. 22691 Lambert Street Suite 517 Lake Forest, California 92630

Rc: K050123

Trade/Device Name: P-Stim System Regulation Name: Electro-Acupuncture Stimulator Regulatory Class: Unclassified Product Code: BWK Dated: January 20, 2006 Received: January 23, 2006

Dear Dr. McComb:

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- Dr. Jan McComb

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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Hulbert Ziemer as

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

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Indications for Use

510(k) Number (if known):

K050123

Device Name:

P-Stim System

Indications For Use:

P-Stim is an electro-acupuncture device for use in the practice of acupuncture by qualified practitioners of acupuncture as determined by the states.

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)

Hulut Semer
(Division Sign-Off)

Division of General, Restorative, and Neurological Devices

Page 1 of

510(k) Number K050123

Regulation Number and Section

N/A