PAINMASTER MCT PATCH

K090042 · Newmark, Inc. · NUH · May 6, 2009 · Neurology

Device Facts

• Record ID: K090042
• Device Name: PAINMASTER MCT PATCH
• Applicant: Newmark, Inc.
• Product Code: NUH · Neurology
• Decision Date: May 6, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5890
• Device Class: Class 2
• Attributes: Therapeutic

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.

Device Story

Painmaster MCT Patch is a transcutaneous electrical nerve stimulator (TENS) for OTC pain relief. Device consists of two electrodes on adhesive material connected by wire; one electrode houses a control unit with a circuit board, battery, and LED indicator. It operates in a single, non-programmable microcurrent mode, delivering a pulsed monophasic waveform to the body. Used by patients for self-application to the lower back. The device provides electrical stimulation to alleviate muscle soreness and aching. Usability study confirmed that users can correctly identify candidacy, assemble, and apply the device.

Clinical Evidence

No clinical data. A usability study was conducted to demonstrate that users could correctly identify themselves as candidates for treatment and properly assemble and apply the device.

Technological Characteristics

Transcutaneous electrical nerve stimulator (TENS). Single non-programmable microcurrent mode. Pulsed monophasic waveform. Consists of two electrodes on adhesive material connected by wire. Control unit includes circuit board, battery, and LED. Identical to K013167 (F-5 version).

Indications for Use

Indicated for temporary relief of lower back muscle pain due to exercise, household, or work-related strain in adults.

Regulatory Classification

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.

Predicate Devices

• Model 7500 Microcurrent TENS Device (Version F5) (K013167)
• Prizm Medical 5000Z System (K033122)
• Gemore Technology Low Back Pain Relief System (K060222)

Submission Summary (Full Text)

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K090042

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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.<br>182 Sandbank Road<br>Cheshire, CT 06410 |
|----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Newmark Inc.<br>182 Sandbank Road<br>Cheshire, CT 06410<br>Registration Number: 1226514 |
| Contact: | Deborah Livornese<br>Buc & Beardsley<br>919 Eighteenth Street, N.W., Suite 600<br>Washington, D.C. 20006<br>Phone: [phone]<br>Fax: [phone]<br>[e-mail] |
| 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 (Version<br>F5) (same device as subject for prescription use)<br>K033122 - Prizm Medical 5000Z System (OTC), and<br>K060222 - Gemore Technology Low Back Pain Relief System<br>(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 [phone]. 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 [phone] or [phone] 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

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