(212 days)
The MPP is to be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities (arm), and lower extremities (leg) due to strain from exercise and normal household and work activities.
The MPP is intended for muscle conditioning by stimulating muscle in order to improve or facilitate muscle performance.
The MPP consists of a portable battery operated electrical stimulation device with two channels, two sets of lead wires, six packages of self-adhesive electrodes, and a battery charger. Each channel has a pair of buttons to select the desired frequency and a dial to control the intensity of the signal. The stimulator also is supplied with an output jack for each channel, a charging jack, timer buttons, and an LCD display. The device creates stimulation at frequencies of 1-70 Hz depending on the desired effects.
The provided text describes a 510(k) summary for the MPP device, a transcutaneous electrical nerve stimulator. However, it does not contain any information about acceptance criteria or a study that proves the device meets those criteria, nor does it provide performance data in the format requested.
The document states that the MPP device conforms to several recognized consensus standards (IEC 60601-2-10, IEC 60601-1, and IEC 60601-1-2) and that its software was validated for a moderate level of concern. It also establishes substantial equivalence to predicate devices (K081998, K121757, K112485) based on identical or substantially similar intended uses and output parameters. This is the basis for regulatory clearance.
Therefore, I cannot fulfill your request for specific acceptance criteria and performance study details from this document.
Summary of missing information:
- Acceptance Criteria Table: Not present. The submission relies on conformance to standards and substantial equivalence to predicate devices.
- Reported Device Performance: No specific performance metrics (ee.g., accuracy, sensitivity, specificity) are reported.
- Sample Size for Test Set: No clinical study data is provided.
- Data Provenance: Not applicable, as no clinical study data is presented.
- Number of Experts & Qualifications: Not applicable, as no clinical study data is presented.
- Adjudication Method: Not applicable, as no clinical study data is presented.
- MRMC Comparative Effectiveness Study: Not mentioned or conducted.
- Standalone Performance Study: Not mentioned or conducted.
- Type of Ground Truth: Not applicable, as no clinical study data is presented.
- Sample Size for Training Set: Not applicable, as no machine learning training data is discussed.
- Ground Truth for Training Set: Not applicable.
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K131910
5. 510(k) Summary
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
Marc Pro, Inc. 5702 Bolsa Ave. Huntington Beach, CA 92649
Phone: (855) 627-2776 Facsimile: (714) 500-4092
Contact Person: Ryan P. Heaney
Date Prepared: December 11, 2013
Name of Device
MPP
Common or Usual Name/Classification Name
Transcutaneous Electrical Nerve Stimulator for Pain Relief - OTC 21 C.F.R. § 882.5890 (Product Code NUH) Powered Muscle Stimulator for Muscle Conditioning - OTC 21 C.F.R. § 890.5850 (Product Code NGX)
Predicate Devices
Intended Use / Indications for Use
The MPP is to be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities (arm), and lower extremities (leg) due to strain from exercise and normal household and work activities.
The MPP is intended for muscle conditioning by stimulating muscle in order to improve or facilitate muscle performance.
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Technological Characteristics
The MPP consists of a portable battery operated electrical stimulation device with two channels, two sets of lead wires, six packages of self-adhesive electrodes, and a battery charger. Each channel has a pair of buttons to select the desired frequency and a dial to control the intensity of the signal. The stimulator also is supplied with an output jack for each channel, a charging jack, timer buttons, and an LCD display. The device creates stimulation at frequencies of 1-70 Hz depending on the desired effects.
Performance Data
The MPP conforms to the following recognized consensus standards:
- IEC 60601-2-10 1987/Amendment 1 2001, Medical electrical equipment -. Part 2-10: Particular requirements for the safety of nerve and muscle stimulators.
- IEC 60601-1 Medical Electrical Equipment Part 1: General Requirements for Safety, 1988; Amendment 1, 1991-11, Amendment 2, 1995 subclause 56.3(c).
- IEC 60601-1-2: Medical Electrical Equipment Part 1-2: General . Requirements for Safety - Collateral Standard: Electromagnetic Compatibility - Requirements and Tests (2001).
. Software
The software was validated for a moderate level of concern device.
Substantial Equivalence
The MPP has the same intended uses and/or substantially similar output parameters as the predicate devices.
The MPP has the same intended uses and substantially similar output parameters as the legally marketed electrical nerve stimulator K121757. This demonstrates the safety of these for over the counter indications.
The muscle conditioning indication of the proposed MPP device is identical to the indication of the legally marketed OTC stimulator K081998. The two devices have identical output parameters other than the fact that the MPP can deliver a larger frequency range to allow for the additional 'temporary pain' indication for use. This demonstrates that the technology is effective for over the counter muscle conditioning and safe for over the counter use.
The MPP is technologically identical to the predicate K112485, which is cleared for pain relief including temporary pain. The only difference is that the MPP
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indication is for over the counter temporary relief of pain. This demonstrates that the technology is effective for temporary pain relief.
The identical technology has already been cleared for OTC muscle conditioning and for temporary pain relief with a prescription; in addition the K121757 has the same two OTC indications for use and substantially similar technology. Therefore the proposed device does not raise new questions of safety or effectiveness.
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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles an eagle or bird-like figure with three curved lines representing its wings or body.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administratio 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 24, 2014
Marc Pro, Inc. c/o Gregory Holland Regulatory Specialists, Inc. 3722 Sausalito Ave. Irvine, CA 92606 US
Re: K131910
Trade/Device Name: MPP Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator for Pain Relief Regulatory Class: Class II Product Code: NUH, NGX Dated: December 20, 2013 Received: December 26, 2013
Dear Mr. Holland:
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 or any I outhal the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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Page 2 - Mr. Gregory Holland
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 Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/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 Small Manufacturers, International and Consumer Assistance 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 yours,
Joyce M. Whang -S
for
Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES . Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.
510(k) Number (if known) K131910
Device Name MPP
Indications for Use (Describe)
The MPP is to be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, upper extremities (arm), and lower extremities (leg) due to strain from exercise and normal household and work activities.
The MPP is intended for muscle conditioning by stimulating muscle in order to improve or facilitate muscle performance.
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)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signalure)
FORM FDA 3881 (1/14)
PSC Publishing Services (10)) 443-6740
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§ 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).