(58 days)
TENS: ElectroPulse-Cosmetic is intended to stimulate the face. The device is indicated for cosmetic use.
Infrared Light and Heat: Emits energy in the necr-IR spectrum for temporarily promoting relaxation of muscle tissue; and to temporarily increase local blood circulation where heat is indicted.
Not Found
This document is a 510(k) clearance letter from the FDA for the "Electropulse - Cosmetic" device, a Transcutaneous Electrical Nerve Stimulator (TENS) for pain relief.
The acceptance criteria and study information typically found in a comprehensive clinical study report or a more detailed 510(k) submission summary are not present in this FDA clearance letter. This document primarily focuses on the FDA's decision regarding substantial equivalence to a predicate device and the regulatory classification.
Therefore, many of the requested details cannot be extracted from the provided text. The letter doesn't describe the studies that were performed to demonstrate the device meets any specific performance criteria, nor does it detail a training or test set, expert involvement, or ground truth establishment.
However, based on the information provided, we can infer some details related to the device classification and intended use, which might be linked to performance expectations for TENS devices in general.
Here's an attempt to answer based only on the provided text, with many fields explicitly marked as "Not provided in the document."
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not provided in the document. This document does not specify quantitative performance criteria for TENS or infrared light/heat functionality. | Not provided in the document. The document confirms substantial equivalence but does not present specific performance metrics from a study. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not provided in the document.
- Data Provenance (country of origin, retrospective/prospective): Not provided in the document. The document mainly discusses regulatory classification and substantial equivalence, not clinical study details.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Number of Experts: Not provided in the document.
- Qualifications of Experts: Not provided in the document.
4. Adjudication Method for the Test Set
- Adjudication Method: Not provided in the document.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Done?
- MRMC Study Done?: Not provided in the document. The document is an FDA clearance letter based on substantial equivalence, not a detailed clinical study report that would typically include MRMC study findings.
- Effect Size of Human Readers Improve with AI vs. without AI assistance: Not applicable, as this device is a TENS/infrared light device and not an AI-powered diagnostic tool.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study Done?
- Standalone Study Done?: Not applicable, as this device is a physical TENS/infrared light device, not an algorithm.
7. Type of Ground Truth Used
- Type of Ground Truth: Not provided in the document. For a TENS device, ground truth related to efficacy would typically come from patient-reported pain scales or physiological markers in clinical trials, but these details are not in this document.
8. Sample Size for the Training Set
- Sample Size for Training Set: Not provided in the document.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth Establishment for Training Set: Not provided in the document.
Summary from the provided document:
The provided document is an FDA 510(k) clearance letter confirming that the "Electropulse - Cosmetic" device is substantially equivalent to legally marketed predicate devices for its stated indications for use.
- Indications for Use:
- TENS: Intended to stimulate the face; indicated for cosmetic use.
- Infrared Light and Heat: Emits energy in the near-IR spectrum for temporarily promoting relaxation of muscle tissue; and to temporarily increase local blood circulation where heat is indicated.
- Regulatory Classification: Class II, Product Codes NFO (Transcutaneous electrical nerve stimulator for pain relief) and ILY (unspecified, but typically related to cosmetic or similar devices).
- Use: Over-The-Counter Use.
The letter focuses on the regulatory decision of substantial equivalence and does not contain details regarding specific clinical trial protocols, acceptance criteria, study methodologies, or performance metrics from any studies that might have been submitted to support the 510(k). These details are typically found in the full 510(k) summary or traditional 510(k) submission, which is not provided here.
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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 features a stylized caduceus symbol, which is a staff with two snakes coiled around it, representing medicine and healing. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Pain Relief Technologies, Inc. c/o Mr. Kendall Gorham President 15048 SW Capstone Court Beaverton, OR 97007
FEB 1 5 2012
Re: K113724
Trade/Device Name: Electropulse - Cosmetic Regulation Number: 21 CFR 882.5890. Regulation Name: Transcutaneous electrical nerve stimulator for pain relief. Regulatory Class: II Product Codes: NFO, ILY Dated: December 15, 2011 Received: December 19, 2011
Dear Mr. Gorham:
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
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CFR Part 807); labeling (21 CFR Part 801); medical device reporting (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); 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Keria Alexander
Malvina B. Eydelman, M.D.
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Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
k 113724 510(k) Number:
Device Name: ElectroPulse -- Cosmetic
Indications For Use:
TENS: ElectroPulse-Cosmetic is intended to stimulate the face. The device is indicated for cosmetic use.
Infrared Light and Heat: Emits energy in the necr-IR spectrum for temporarily promoting relaxation of muscle tissue; and to temporarily increase local blood circulation where heat is indicted.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use X (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)
Signature
(Division Sign-Off) (Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices
510(k) Number K113724
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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).