(165 days)
Used for the temporary relief of pain associated with sore and aching muscles in the lower back due to strain from exercise, or normal household and work activities.
Relaxing muscles and relieving minor aches and pains.
Emits energy at near infrared frequencies to provide topical heating and to provide temporary relief of minor muscle and joint pain, arthritis and muscle spasm; relieving stiffness, promoting relaxing of muscle tissue, and to temporarily increase local blood circulation where heat is indicated.
Not Found
Here's an analysis of the provided information, focusing on acceptance criteria and study details.
Analysis of the Provided Text:
The provided text is an FDA 510(k) clearance letter for the "ElectroPulse - Pain Relief" device. Unfortunately, this document primarily concerns the regulatory clearance process and does not contain the detailed study information or acceptance criteria that would typically be found in a clinical study report or a premarket submission summary.
The letter states that the device is "substantially equivalent" to legally marketed predicate devices. This means that the FDA determined the new device is as safe and effective as a device already on the market. This often relies on demonstrating that the new device has similar technological characteristics and performs comparably to the predicate, rather than providing new, extensive clinical trial data that defines and meets specific acceptance criteria.
Therefore, for many of your requested points, the information is not available in the provided document.
Based on the provided text, here's what can be extracted and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Not Explicitly Stated, Implied by 510(k) Process) | Reported Device Performance (Implied by 510(k) Clearance) |
|---|---|
| Safety: Device is as safe as legally marketed predicate devices. | Presumed to be as safe as predicate TENS/massager/heat lamp devices for the stated indications. |
| Effectiveness: Device is as effective as legally marketed predicate devices for the stated indications. | Presumed to be as effective as predicate TENS/massager/heat lamp devices for the stated indications. |
| Technological Characteristics: Device has similar technological characteristics to legally marketed predicate devices. | Presumed to have similar principles of operation (TENS, vibration, near-infrared heat) and intended use as predicate devices. |
Explanation: The FDA 510(k) process for "substantial equivalence" does not typically involve defining explicit, quantifiable acceptance criteria (e.g., "device must reduce pain by X% within Y days"). Instead, the primary "acceptance criterion" is demonstrating that the new device is as safe and effective as a predicate device already on the market. The specific performance metrics are often compared to the predicate's known performance or established benchmarks for that device type. The letter states the device is "substantially equivalent," implying these criteria were met.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not specified in the provided document. The 510(k) likely relied on a comparison to predicate device data or possibly non-clinical (e.g., bench) testing, rather than a separate clinical test set for this specific device.
- Data Provenance (e.g., country of origin of the data, retrospective or prospective): Not specified in the provided document.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified.
Explanation: As this is a 510(k) clearance based on substantial equivalence, a formal "ground truth" establishment by a panel of experts for a new clinical test set is unlikely to have been a requirement or part of the public record in this document. Substantial equivalence relies more on engineering documentation, performance testing against standards, and comparison to predicate devices.
4. Adjudication Method for the Test Set
- Adjudication Method: Not specified. Given the nature of a 510(k) and the lack of a detailed clinical study report, an adjudication method for a test set is not described.
5. If a Multi Reader Multi Case (MRMC) comparative effectiveness study was done
- MRMC Study Done?: Not indicated in the provided document.
- Effect Size of Human Readers Improve with AI vs without AI assistance: Not applicable. The device (ElectroPulse - Pain Relief) is a physical therapy device (TENS, massager, heat lamp), not an AI diagnostic or interpretive tool. Therefore, an MRMC study related to AI assistance for human readers would not be relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Study Done?: Not applicable. This is not an algorithmic device.
7. The type of ground truth used
- Type of Ground Truth: Not explicitly stated as "ground truth" in the context of clinical outcomes. For substantial equivalence, the "truth" is typically aligned with the understanding of the predicate device's safety and effectiveness and the device's adherence to relevant performance standards (e.g., electrical safety, TENS waveform characteristics, heat output). If any clinical claims were made, they would need to be supported by evidence, often in comparison to the predicate's known performance or through literature review.
8. The sample size for the training set
- Sample Size for Training Set: Not applicable. This is not an AI/machine learning device that requires a training set.
9. How the ground truth for the training set was established
- How Ground Truth for Training Set was Established: Not applicable. This is not an AI/machine learning device.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Pain Relief Technologies % Mr. Kendall Gorham President 15048 SW Capstone Court Beaverton, Oregon 97007
9 2007 FEB
Re: K062532
Trade/Device Name: ElectroPulse - Pain Relief Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous electrical nerve stimulator for pain relief Regulatory Class: II Product Code: NUH, ILY, IRO Dated: August 17, 2006 Received: August 18, 2006
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.
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 -- Mr. Kendall Gorham
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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark N. Melkerson
Mark N. Melk Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number: K062532
Device Name: ElectroPulse-Pain Relief
Indications For Use:
Used for the temporary relief of pain associated with sore and TENS: aching muscles in the lower back due to strain from exercise, or normal household and work activities.
Relaxing muscles and relieving minor aches and pains. Vibration:
Emits energy at near infrared frequencies to provide topical Heat Lamp: heating and to provide temporary relief of minor muscle and joint pain, arthritis and muscle spasm; relieving stiffness, promoting relaxing of muscle tissue, and to temporarily increase local blood circulation where heat is indicated.
Prescription Use (Part 21 CFR 801 Subpart D) 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) | |
|---|---|
| (Division Sign-Off) | |
| Division of General, Restorative, | Page 1 of 1 |
AND/OR
and Neurological Devices
510(k) Number L061376
ge 1 of 1
D - 1
§ 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).