(435 days)
Not Found
No
The device description explicitly states it has a "pre-programmed frequency, pulse, and duration," indicating fixed parameters rather than adaptive or learning algorithms. There are no mentions of AI, ML, or related concepts in the provided text.
Yes
The device is described as an "electro-acupuncture device" and a "transcutaneous electrical nerve stimulator" for the "stimulation of auricular acupuncture points." These characteristics indicate it is intended for a therapeutic purpose, specifically pain relief or other therapeutic benefits associated with acupuncture.
No
The device description states its purpose is for stimulation of auricular acupuncture points, and it details electrical stimulation parameters. It does not mention any function related to diagnosing a condition or disease.
No
The device description clearly states it is a "miniaturized, battery-powered, transcutaneous electrical nerve stimulator" that connects via "three stainless steel wires to acupuncture needles." This indicates a physical hardware device that delivers electrical stimulation, not a software-only solution.
Based on the provided information, the P-Stim device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "electro-acupuncture... for the stimulation of auricular acupuncture points." This describes a therapeutic or stimulatory function applied directly to the patient's body.
- Device Description: The description details a "transcutaneous electrical nerve stimulator" that connects to acupuncture needles. This is a physical device delivering electrical stimulation.
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The P-Stim does not interact with or analyze such specimens.
Therefore, the P-Stim is a therapeutic or stimulatory medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The P-Stim is intended for use as an electro-acupuncture device to stimulate appropriate auricular acupuncture points.
P-Stim is an electro-acupuncture device for use in the practice of acupuncture by qualified practitioners of acupuncture as determined by the states.
Product codes (comma separated list FDA assigned to the subject device)
BWK
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
auricular acupuncture points
Indicated Patient Age Range
Not Found
Intended User / Care Setting
qualified practitioners of acupuncture as determined by the states.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
N/A
0
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
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.
NeuroScience Therapy Corp. CONFIDENTIAL
1
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.
2
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.
3
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
4
Indications for Use
510(k) Number (if known):
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