(113 days)
Transcutaneous Electrical Nerve Stimulator (TENS) can be used for the following applications (Available for WR-2603/2603A, and TENS function of WR-2605/ 2605A):
· For symptomatic relief of chronic intractable pain
Electrical Muscle Stimulation (EMS) on can be used for the following applications (Available for WR-2604/2604A, and EMS function of WR-2605/ 2605A):
- · Relax muscle spasms
- Prevent or retard disuse atrophy
- Increase local blood circulation
- · Re-educate muscles
- · Maintain or increase the range of motion
Not Found
The provided text is a Food and Drug Administration (FDA) 510(k) clearance letter for the WELL LIFE Rx Wireless TENS/EMS Stimulator. This document indicates that the device has been deemed substantially equivalent to a legally marketed predicate device.
Crucially, this document does not contain information about acceptance criteria or a study proving the device meets specific acceptance criteria in the manner you've outlined for diagnostic or AI-driven medical devices.
Instead, the 510(k) process focuses on demonstrating equivalence to another legally marketed device, often through a comparison of technological characteristics, safety, and performance. While performance data may be submitted, it's typically to show that the new device performs as intended and is as safe and effective as the predicate, rather than meeting predefined numerical acceptance criteria against a clinical ground truth as would be seen in studies for novel diagnostic algorithms.
Therefore, I cannot populate the table or answer most of your specific questions based on the provided text. The requested information (sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, training set details) is typically found in detailed clinical validation reports that are not part of this summary FDA clearance letter.
Here's what I can and cannot infer from the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in document | Not specified in document |
Explanation: The document states the device is "substantially equivalent" to predicate devices. This implies it meets the performance and safety standards of those predicates, but it doesn't provide specific numerical acceptance criteria or performance metrics (like sensitivity, specificity, accuracy) for a new device's performance against a gold standard.
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified.
- Data Provenance: Not specified. The 510(k) process primarily reviews comparisons to predicate devices and engineering/bench testing, not necessarily large-scale clinical trials with defined test sets.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. The document does not describe a study involving human experts establishing ground truth for a test set.
4. Adjudication method for the test set:
- Not applicable. The document does not describe a study with a test set requiring adjudication.
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 Transcutaneous Electrical Nerve Stimulator (TENS) and Electrical Muscle Stimulator (EMS), not an AI-driven diagnostic tool that would typically involve an MRMC study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a stimulator, not an algorithm. Its performance is inherent in its electrical output and design.
7. The type of ground truth used:
- Not applicable. No "ground truth" (in the context of a diagnostic or AI study) is mentioned. Compliance with safety and performance standards for TENS/EMS devices would be verified through engineering tests and comparison to predicates.
8. The sample size for the training set:
- Not applicable. No "training set" is relevant for this type of device and submission.
9. How the ground truth for the training set was established:
- Not applicable.
In summary: The provided document is an FDA clearance letter for a medical device (TENS/EMS stimulator) based on substantial equivalence. It does not contain the detailed methodology and results of a clinical study designed to establish acceptance criteria or evaluate performance against a ground truth, as would be expected for a diagnostic or AI-enabled device.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an emblem featuring a stylized caduceus, which is a symbol often associated with healthcare and medicine.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 17, 2017
Well-life Healthcare Limited Chin-Chih Hsieh Official Correspondent 1f, No. 16, Lane 454, Jungjeng Road Yunghe District, New Taipei City, 234 TW
Re: K162663
Trade/Device Name: WELL LIFE Rx Wireless TENS/EMS Stimulator, model WR-2603/2603A, WR-2604/2604A and WR-2605/2605A Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator for Pain Relief Regulatory Class: Class II Product Code: GZJ, IPF Dated: December 8, 2016 Received: December 12, 2016
Dear Chin-Chih Hsieh:
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 (reporting of medical device
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related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
MichaelJ. Hoffmann -S
for Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K162663
Device Name
WELL LIFE Rx Wireless TENS/EMS Stimulator, model WR-2603/2603A, WR-2604/2604A and WR-2605/2605A
Indications for Use (Describe)
Transcutaneous Electrical Nerve Stimulator (TENS) can be used for the following applications (Available for WR-2603/2603A, and TENS function of WR-2605/ 2605A):
· For symptomatic relief of chronic intractable pain
Electrical Muscle Stimulation (EMS) on can be used for the following applications (Available for WR-2604/2604A, and EMS function of WR-2605/ 2605A):
- · Relax muscle spasms
- Prevent or retard disuse atrophy
- Increase local blood circulation
- · Re-educate muscles
- · Maintain or increase the range of motion
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X | Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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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).