(120 days)
The Painmaster MCT Patch is indicated for 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.
The Painmaster MCT Patch operates in a single non-programmable microcurrent mode, delivering a pulsed monophasic waveform that provides electrical stimulation to the body to relieve pain. The Painmaster MCT Patch consists of two electrodes mounted on adhesive material connected by a small-diameter wire. One electrode contains the control unit that includes a small circuit board, a battery, and an LED light.
This device (Painmaster MCT Patch) is a Transcutaneous Electrical Nerve Stimulator (TENS) intended for over-the-counter (OTC) use for temporary pain relief. The submission for this device, K090042, relies on substantial equivalence to previously cleared devices rather than new performance studies demonstrating its effectiveness.
Here's an analysis based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| No performance acceptance criteria were explicitly stated or required for this 510(k) submission. The submission is based on substantial equivalence to a predicate device that was previously cleared for prescription use (K013167, Model 7500 Microcurrent TENS Device, Version F5), and other OTC TENS devices (K033122, K060222). | Substantial Equivalence: The Painmaster MCT Patch is deemed substantially equivalent to the predicate devices because its technological characteristics are identical to the F-5 version cleared under K013167, and its intended use for OTC pain relief is a subset of the previous prescription clearance and identical to other OTC TENS devices. |
| Usability (for OTC use) | A usability study was conducted and demonstrated that "users could correctly identify themselves as candidates for treatment, and could properly assemble and apply the device according to the instructions for use." However, specific quantitative acceptance criteria for this study (e.g., success rates, error rates) are not provided in this summary document. |
2. Sample Size Used for the Test Set and Data Provenance:
- Performance Testing: "Additional performance testing was not required to determine the substantial equivalence of this device for OTC use because the device is the same as the device previously cleared for prescription use via 510(k) #K013167." Therefore, there was no new test set for performance evaluation. The data provenance for the previous clearance (K013167) is not detailed in this document.
- Usability Study: The document states "A usability study was conducted," but does not specify the sample size for this study. The data provenance (country of origin, retrospective/prospective) for the usability study is also not provided.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
- Not applicable for performance testing. As stated above, no new performance testing was conducted that would require a test set with expert-established ground truth.
- Not applicable for the usability study in the way typically thought of for clinical image-based or diagnostic device studies. The "ground truth" for a usability study would be the ability of users to correctly perform tasks, which is typically observed and recorded by trained researchers, not established by clinical experts.
4. Adjudication Method for the Test Set:
- Not applicable. No new performance test set requiring adjudication was used.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
- No, an MRMC comparative effectiveness study was not done. The submission relies on substantial equivalence and a usability study for OTC use.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
- This is not applicable. The device is a physical TENS patch, not an algorithm or AI system.
7. The Type of Ground Truth Used:
- For the original prescription clearance (K013167), this document does not specify the ground truth used (e.g., pain scales, patient outcomes, etc.).
- For the current OTC clearance, the "ground truth" for the usability study was the observation of users successfully understanding instructions and applying the device. This is a form of empirical observation of user behavior.
8. The Sample Size for the Training Set:
- Not applicable. This device is hardware for electrical stimulation; it does not involve machine learning or AI that would require a "training set" of data in the conventional sense.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable. As above, there is no AI/ML training set.
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MAY - 6 2009
5.0 510(k) Summary
The following information is provided as required by 21 CFR §§ 807.87 and 807.92 for Newmark, Inc.'s 510(k) premarket notification. The following is a summary of the information upon which the substantial equivalence determination is based.
| Sponsor | Newmark Inc.182 Sandbank RoadCheshire, CT 06410 |
|---|---|
| Manufacturer | Newmark Inc.182 Sandbank RoadCheshire, CT 06410Registration Number: 1226514 |
| Contact: | Deborah LivorneseBuc & Beardsley919 Eighteenth Street, N.W., Suite 600Washington, D.C. 20006Phone: 202.736.3622Fax: 202.736.3608dlivornese@bucbeardsley.com |
| Date Prepared: | 12/30/08 |
| Proposed Class: | II |
| Proprietary Name: | Painmaster MCT Patch |
| Common Name: | Transcutaneous electrical nerve stimulator for pain relief |
| Classification Name: | Stimulator, nerve, transcutaneous, over-the-counter |
| Regulation Number: | 21 CFR 882.5890 |
| Product Code: | NUH |
| Predicate Devices: | K013167 - Model 7500 Microcurrent TENS Device (VersionF5) (same device as subject for prescription use)K033122 - Prizm Medical 5000Z System (OTC), andK060222 - Gemore Technology Low Back Pain Relief System(OTC). |
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Intended Use
The Painmaster MCT Patch is indicated for 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. This intended use is a subset of the intended use for the device when it was cleared for prescription use, and is also identical to that of other OTC cleared TENS devices.
Device Description
The Painmaster MCT Patch operates in a single non-programmable microcurrent mode, delivering a pulsed monophasic waveform that provides electrical stimulation to the body to relieve pain.
The Painmaster MCT Patch consists of two electrodes mounted on adhesive material connected by a small-diameter wire. One electrode contains the control unit that includes a small circuit board, a battery, and an LED light.
Technological Characteristics
The technological characteristics of the Painmaster MCT Patch are identical to one of the devices (the F-5 version) cleared under K013167.
Performance Testing
Additional performance testing was not required to determine the substantial equivalence of this device for OTC use because the device is the same as the device previously cleared for prescription use via 510(k) #K013167.
Usability Study
A usability study was conducted and demonstrated that users could correctly identify themselves as candidates for treatment, and could properly assemble and apply the device according to the instructions for use. The Final Study Report for the Usability Study is attached as Exhibit 6.
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Conclusion
The Painmaster MCT Patch is substantially equivalent to legally marketed devices because it has the same technological characteristics and the same intended use as predicate devices.
.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/12 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
MAY - 6 2009
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Newmark, Inc. % Ms. Deborah Livornese Buc & Beardsley 919 Eighteenth St. NW, Suite 600 Washington, DC 20006
Re: K090042
Trade/Device Name: Painmaster MCT Patch Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous electrical nerve stimulator for pain relief Regulatory Class: II Product Code: NUH Dated: March 24, 2009 Received: March 30, 2009
Dear Ms. Livornese:
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 for ass battle in the May 28, 1976, the enactment date of the Medical Device Amendments, or to conniner of the rial) 2011-03-12) 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 r ou may, therefore, mailes 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 If your devioo is classified (over soon). Existing major regulations affecting your device can be may of subject to additions, Title 21, Parts 800 to 898. In addition, FDA may round in ther announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean I lease of advised that I Dris issuants over device complies with other requirements of the Act that I Dri has made a avoid regulations administered by other Federal agencies. You must or any I carates and regaranents, including, but not limited to: registration and listing (21 Compry with an the Fee Frequent 801); medical device reporting (reporting of medical Crici rat 607), laborning (21 CFR 803); good manufacturing practice requirements as set de vice-iclated adverse ovenes (2) CFR Part 820); and if applicable, the electronic form in the quality by beenss (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2- Ms. Deborah Livornese
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. 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 contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.
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,
Daniel Krone
Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement 4.0
To be assigned 510(k) Number: -
Device Name: Painmaster MCT Patch
Indications for Use:
The Painmaster MCT Patch is indicated for 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.
Prescription Use _
AND/OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (21 CFR 807 Subpart C)
(Part 21 CFR 801 Subpart D)
(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 Surgical, Orthopedic, and Restorative Devices
510(k) Number K090042
Page 1 of 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).