-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.

-temporary relief of pain associated with sore and aching muscles in the upper and lower extremities (arm and/or leg) due to strain from exercise or normal household and work activities.

-symptomatic relief of chronic, intractable pain.

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.

AI/ML Overview

The provided text is a 510(k) summary for the Painmaster MCT Patch, which is a transcutaneous electrical nerve stimulator. It states that "Additional performance testing was not required to determine the substantial equivalence of this device because the device is the same as the device previously cleared via 510(k) K090442, K130114 and MCT F5 model K013167."

Therefore, this document does not contain information about acceptance criteria or specific studies proving the device meets those criteria for the current submission (K151995). Instead, it relies on prior clearances.

However, a usability study was conducted for one of the predicate devices (K090042). While not explicitly acceptance criteria in terms of performance metrics, the "usability study" section can be interpreted as demonstrating the device meets criteria related to user comprehension and proper application.

Here's the information extracted, specifically focusing on the usability study as it's the only performance-related study mentioned for a predicate device:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Inferred from Usability Study)	Reported Device Performance
Users could correctly identify themselves as candidates for treatment.	Achieved
Users could properly assemble the device.	Achieved
Users could properly apply the device according to the instructions for use.	Achieved

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: Not specified.
Data Provenance: Not specified (presumably prospective, as it was a study conducted for a prior submission).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable for a usability study. The "ground truth" would be the successful completion of tasks by the users themselves.

4. Adjudication Method for the Test Set

Not applicable as this was a usability study, not a diagnostic or comparative effectiveness study requiring adjudication. The assessment would likely be based on observers' evaluation of user behavior.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, an MRMC comparative effectiveness study was not done.

6. Standalone (Algorithm Only) Performance Study

No, a standalone performance study was not done. This device is a transcutaneous electrical nerve stimulator, not an algorithm-based diagnostic tool.

7. Type of Ground Truth Used

For the usability study, the ground truth was based on observed user behavior and comprehension of the instructions for use and device application.

8. Sample Size for the Training Set

Not applicable, as this was a usability study (for a predicate device) and clinical performance was not re-evaluated for the current submission.

9. How the Ground Truth for the Training Set Was Established

Not applicable.

Summary

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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 representation of three human profiles facing to the right, stacked on top of each other. The profiles are rendered in a simple, black line drawing style. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the graphic.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

October 5, 2016

Newmark, Inc c/o Cherita James Regulatory Consultant M Squared Associates, Inc. 575 8th Ave, Suite 1212 New York, NY 10018

Re: K151995

Trade/Device Name: Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous electrical nerve stimulator Regulatory Class: Class II Product Code: NUH Dated: August 31, 2016 Received: September 1, 2016

Dear Ms. James:

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 and 8091); medical device reporting

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(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 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/Resourcesfor You/Industry/default.htm. 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 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,

Image /page/1/Picture/8 description: The image shows the name "William J. Heetderks -A" in a large font on the left side of the image. On the right side of the image, there is a digital signature from "William J. Heetderks -A". The digital signature includes the date "2016.10.05 16:32:48-04'00'".

for

Carlos L. Peña, Ph.D., M.S. 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) K151995

Device Name Painmaster MCT Patch

Indications for Use (Describe) 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.

-temporary relief of pain associated with sore and aching muscles in the upper and lower extremities (arm and/or leg) due to strain from exercise or normal household and work activities.

-symptomatic relief of chronic, intractable pain.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

|X Over-The-Counter Use (21 CFR 801 Subpart C)

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510(K) SUMMARY

The following information is provided as required by 21 CFR § 807.87 for the Painmaster MCT Patch 510(k) premarket notification. In response to the Safe Medical Devices Act of 1990, the following is a summary of the information upon which the substantial equivalence determination is based.

Newmark Inc. Sponsor: 131 Quarry Village Rd. Cheshire, CT 06410
Manufacturer Newmark Inc. PO Box 896 Cheshire, CT 06410 Registration Number: 1226514
M Squared Associates, Inc. Contact: Cherita James 575 8th Ave, Suite 1212 New York, New York 10018 Ph. 703-562-9800 Ext 257 Fax. 703-562-9797

Date of Submission: August 31, 2016

Proprietary Name:	Painmaster MCT Patch
Common Name:	Transcutaneous electrical nerve stimulator for pain relief, over-the-counter
Regulation Number:	21 CFR 882.5890
Regulatory Class:	II
Product Code:	NUH
Predicate Device(s):	Painmaster MCT Patch (K090042 & K130114)Newcare MCT F5 (K013167)

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.

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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.
temporary relief of pain associated with sore and aching muscles in the upper and lower . extremities (arm and/or leg) due to strain from exercise or normal household and work activities.
. symptomatic relief of chronic, intractable pain.

Technological Characteristics

The technological characteristics of the Painmaster MCT Patch are identical to the device cleared under K090042, K130114, and MCT F5 model K013167.

Performance Testing

Additional performance testing was not required to determine the substantial equivalence of this device because the device is the same as the device previously cleared via 510(k) K090442, K130114 and MCT F5 model K013167.

The MCT Patch is compliant with the following standards.

. IEC/EN60601-1, 3rd Ed, (2012) Medical Electrical Equipment Part1: General Requirements for Safety and essential performance.
UL2601-1 Medical Electrical Equipment Part1: General Requirements for Safety and . essential performance
. IEC 60601-2-10, Medical Equipment Part2: Particular Requirements for the Safety of Nerve and Muscle Stimulators.
IEC/EN60601-1-2: Electromagnetic Emissions and Immunity Requirements for Medical . Electrical Equipment.

Usability Study

A usability study was conducted in support of the K090042 submission 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 revised labeling is comparable to the previous labeling in presentation of device selection and application.

No additional usability evaluation or clinical data was required in support of this submission.

Device Comparisons-Prior MCT Patch Clearance

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	Painmaster MCTPatch(Newmark Inc)Subject device	Painmaster MCTPatch (Newmark Inc)	MCT F5 model (Newcarecurrently DBA Newmark Inc.)
K number	Not yet assigned	K090042 &K130114	K013167
Product Code	NUH	NUH	GZJ
Indication for Use	Temporary relief of painassociated with sore andaching muscles in thelower back due to strainfrom exercise or normalhousehold and workactivities.Temporary relief of painassociated with sore andaching muscles in theupper and lowerextremity (arm and/orleg) due to strain fromexercise or normalhousehold and workactivities.Symptomatic relief ofchronic, intractable pain.	Temporary relief ofpain associated withsore and achingmuscles in the lowerback due to strainfrom exercise ornormal household andwork activities.Temporary relief ofpain associated withsore and achingmuscles in the upperand lower extremity(arm and/or leg) dueto strain from exerciseor normal householdand work activities.	To be used for the symptomaticrelief of chronic, intractable pain.
Prescription orOTC	OTC	OTC	Prescribed
Power Source	3 V Li Battery	3 V Li Battery	3 V Li Battery
Number ofChannels	1	1	1
Regulated Currentor RegulatedVoltage?	Current	Current	Current
Waveform	Continuous, monophasiconly	Continuous, monophasiconly	Continuous, monophasic only
Shape	Rectangular	Rectangular	Rectangular
Max output voltage(+/- %)	21mV@500 ohms	21mV@500 ohms	21mV@500 ohms
Max outputcurrent-specifyunits (+/- %)	42μA @500 ohms	42μA @500 ohms	42μA @500 ohms
Frequencyt (Hz)[or Ratet (pps)]	0.5pps	0.5pps	0.5pps

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Conclusion

The Painmaster MCT Patch as the same intended use and technological characteristics as the cleared devices (K090042, K130114, and K013167). Minor revisions to include the indications for over-the-counter use do not impact the safety or effectiveness. Differences in the Painmaster MCT Patch and the predicate devices do not present new issues of safety and effectiveness.

Regulation Number and Section

§ 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).