(443 days)
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and describes a simple, non-programmable electrical stimulation device.
Yes
The device is indicated for temporary relief of pain and symptomatic relief of chronic, intractable pain, which are therapeutic uses.
No
The device is used for temporary relief of pain by providing electrical stimulation, not for diagnosing medical conditions.
No
The device description explicitly states it consists of electrodes, a control unit with a circuit board, battery, and LED light, which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Painmaster MCT Patch Function: The description clearly states that the Painmaster MCT Patch is an electrical stimulation device applied to the body to relieve pain. It delivers a pulsed monophasic waveform directly to the skin.
- Lack of Sample Analysis: There is no mention of the device collecting or analyzing any biological samples from the patient. Its function is purely external and therapeutic.
Therefore, the Painmaster MCT Patch falls under the category of a therapeutic device, not an in vitro diagnostic device.
N/A
Intended Use / 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.
-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.
Product codes
NUH
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lower back, upper and lower extremities (arm and/or leg)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Over-The-Counter Use
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Painmaster MCT Patch (K090042 & K130114), Newcare MCT F5 (K013167)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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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
1
(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.
4
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
5
| | Painmaster MCT
Patch(Newmark Inc)
Subject device | Painmaster MCT
Patch (Newmark Inc) | MCT F5 model (Newcare
currently DBA Newmark Inc.) |
|------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------|
| K number | Not yet assigned | K090042 &
K130114 | K013167 |
| Product Code | NUH | NUH | GZJ |
| Indication for Use | 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
extremity (arm and/or
leg) due to strain from
exercise or normal
household and work
activities.
Symptomatic relief of
chronic, intractable pain. | 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 extremity
(arm and/or leg) due
to strain from exercise
or normal household
and work activities. | To be used for the symptomatic
relief of chronic, intractable pain. |
| Prescription or
OTC | OTC | OTC | Prescribed |
| Power Source | 3 V Li Battery | 3 V Li Battery | 3 V Li Battery |
| Number of
Channels | 1 | 1 | 1 |
| Regulated Current
or Regulated
Voltage? | Current | Current | Current |
| Waveform | Continuous, monophasic
only | Continuous, monophasic
only | Continuous, monophasic only |
| Shape | Rectangular | Rectangular | Rectangular |
| Max output voltage
(+/- %) | 21mV@500 ohms | 21mV@500 ohms | 21mV@500 ohms |
| Max output
current-specify
units (+/- %) | 42μA @500 ohms | 42μA @500 ohms | 42μA @500 ohms |
| Frequencyt (Hz)
[or Ratet (pps)] | 0.5pps | 0.5pps | 0.5pps |
6
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.