(206 days)
The OTC Pain Relief TENS, model EV-804, is intended for temporary relief of pain associated with sore and aching muscles in the low back as well as upper and lower extremities (arm and/or leg) due to strain from exercise or normal household and work activities
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The provided text is an FDA 510(k) clearance letter for the Everyway Medical Instruments Co., Ltd. EV-804 OTC Pain Relief TENS device. It details the device's classification, regulatory status, and intended use as a transcutaneous electrical nerve stimulator for pain relief.
However, the document does NOT contain any information regarding acceptance criteria, study methodologies, sample sizes, expert qualifications, ground truth establishment, or any other details typically associated with the performance evaluation of a device, especially an AI/ML-driven one.
This is a standard 510(k) clearance letter, which means the device was found to be "substantially equivalent" to a legally marketed predicate device. This equivalence is often based on existing technological characteristics and indications for use, rather than extensive, new performance studies that would require the type of detailed information requested in your prompt. For TENS devices, substantial equivalence is usually demonstrated through electrical performance testing, labeling review, and comparison to existing devices on the market, not through clinical studies akin to those for AI-powered diagnostics.
Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and the reported device performance: This information is not present.
- Sample sizes used for the test set and data provenance: No such test set or data is described.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no such test set or ground truth establishment is mentioned.
- Adjudication method for the test set: Not applicable.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No, this is not mentioned. The device is a simple TENS unit, not an imaging or diagnostic AI.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used: Not applicable.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
The document is purely administrative regarding regulatory clearance and does not delve into the technical performance study details you're looking for, especially those related to AI/ML device validation.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the seal of the Department of Health & Human Services. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font size below that.
April 19, 2018
Everyway Medical Instruments Co., Ltd. Paul Hung Official Correspondent 3F1., No. 5, Lane 155, Sec. 3, Beishen Rd. Shenkeng Dist New Taipei City, 22203 Tw
Re: K172919
Trade/Device Name: EV-804 OTC Pain Relief TENS Regulation Number: 21 CFR 8825890 Regulation Name: transcutaneous electrical nerve stimulator for pain relief Regulatory Class: Class II Product Code: NUH Dated: March 20, 2018 Received: March 22, 2018
Dear Paul Hung:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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 CFR Part 807); labeling (21 CFR Part 801); medical device 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);
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and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
William J. Heetderks -S 2018.04.19 13:04:34 -04'00'
Carlos L. Peña. PhD. MS for Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known) K172919
Device Name
Everyway OTC Pain Relief TENS/Model EV-804
Indications for Use (Describe)
The OTC Pain Relief TENS, model EV-804, is intended for temporary relief of pain associated with sore and aching muscles in the low back as well as upper and lower extremities (arm and/or leg) due to strain from exercise or normal household and work activities
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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FORM FDA 3881 (7/17)
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§ 882.5890 Transcutaneous electrical nerve stimulator for pain relief.
(a)
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.(b)
Classification. Class II (performance standards).