(190 days)
Temporary relief of pain associated with sore and aching muscles and joints due to strain from exercise or normal household and work activities.
PAT is an OTC medical device. This device is used for temporary relief of pain of sore and aching muscles and joints, due to strain from exercise or normal household and work activities. The device consists of a small battery operated enclosure with an LCD screen and user buttons to control the device. A monophasic micro-current waveform is transmitted to the affected body part through a cable connected via snaps to skin surface electrodes. There are 8 non-programmable modes representing 8 different body areas to treat.
The provided document is a 510(k) Premarket Notification from the FDA for the device "PAT (Pain Alleviation Technologies)", which is a Transcutaneous Electrical Nerve Stimulator (TENS) for pain relief. The document focuses on establishing substantial equivalence to a predicate device, the Painmaster MCT Patch (K130114).
1. Table of Acceptance Criteria and Reported Device Performance
This document primarily describes the equivalence to a predicate device rather than setting specific acceptance criteria for performance metrics in a clinical study. The "acceptance criteria" here are understood as the comparison between the proposed device (PAT) and the predicate device (Painmaster MCT Patch) across various technical specifications to demonstrate substantial equivalence.
| Parameter | Predicate Device (Painmaster MCT Patch) Performance | Proposed Device (PAT) Performance | Acceptance Criteria/Remarks (Based on Substantial Equivalence Logic) |
|---|---|---|---|
| Waveform | Monophasic square wave with 50% duty cycle | Monophasic square wave with 50% duty cycle | Waveform should be similar. |
| Amplitude | 42 μA | 40 μA | Amplitude should be similar or within safe limits. |
| Frequency | 0.5 Hz | 3 Hz | Frequency is different but within historical TENS ranges for safety and effectiveness. This difference is not deemed to raise new questions of safety or effectiveness. |
| Maximum Output Voltage (500 Ω) | 22 mV | 20.8 mV | Output voltage should be similar. |
| Maximum Output Current (500 Ω) | 42 μA | 41.6 μA | Output current should be similar. |
| Max. Phase Charge @500 Ω | 44 microcoulombs | 6.9 microcoulombs | Phase charge should be similar or within safe and effective limits. The proposed device has a significantly lower phase charge, indicating potential safety benefits (lower risk of tissue damage). |
| Max. Average Current @500 Ω | 42 μA | 41.6 μA | Average current should be similar. |
| Max. Current Density @500 Ω | 0.002 mA/cm² | 0.0016 mA/cm² | Current density should be similar or lower for safety. |
| Maximum Power Density (500 Ω) | 0.00005 mW/cm² | 0.000035 mW/cm² | Power density should be similar or lower for safety. |
| Indications for Use | Temporary relief of pain associated with sore and aching muscles in upper and lower extremities due to strain from exercise or normal household and work activities. | Temporary relief of pain associated with sore and aching muscles and joints due to strain from exercise or normal household and work activities. | Indications for Use should be similar or the expanded use should be supported by similar technology characteristics that do not raise new questions of safety or effectiveness. "Joints" added. |
| OTC Use | Yes | Yes | Same use environment. |
| Safety Standards Compliance | EN 60601-1, HA60601-1-11, IEC 60601-1-2, IEC 60601-2-10 | AAMI ES 60601-1, IEC 60601-1-2, IEC 60601-2-10 | Compliance with recognized electrical safety standards. |
The study described primarily relies on nonclinical tests and a comparison of technical specifications to demonstrate substantial equivalence, rather than a clinical study with specific performance acceptance criteria for diagnosing or treating a condition. The conclusion is that "The waveform used in both devices is similar with a square waveform with a 50% duty cycle as discovered with oscilloscope readings. The indications for use are very similar, both devices met the same test standards, and both use very low frequency pulses." This establishes that the differences in output parameters and indications for use "do not raise new questions of safety or effectiveness."
2. Sample Size Used for the Test Set and Data Provenance
The document does not describe a clinical test set with human subjects for performance evaluation. The "test set" in this context refers to the device specifications and nonclinical test results (e.g., electrical safety and performance testing) of the PAT device, which are then compared to the predicate device.
- Sample size: Not applicable, as no human subject test set is described.
- Data provenance: The data regarding the device specifications and nonclinical tests would originate from the manufacturer's internal testing and reports (Shenzhen Bless Electronic Technology Co., Ltd. and Marchan Medical, LLC). It is retrospective in the sense that these are design specifications and test results conducted prior to the submission, not a prospective clinical trial. The country of origin for manufacturing and base specifications development is likely China (Shenzhen Bless Electronic Technology Co., Ltd.) and the USA (Marchan Medical, LLC for specifications developer).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This is a technical and regulatory comparison for substantial equivalence, not a study requiring expert readers to establish ground truth for diagnostic or therapeutic efficacy in a human population. The "ground truth" here is the established safety and effectiveness profile of the predicate device and the technical/performance specifications of both devices.
4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set
Not applicable, as there is no human subject test set or review of images/data by multiple experts for adjudication. The "adjudication" is performed by the FDA reviewers based on the engineering, electrical safety, and performance testing data provided by the manufacturer.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is a Transcutaneous Electrical Nerve Stimulator (TENS), not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study comparing human reader performance with and without AI assistance is irrelevant to this device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is not an algorithm, it is a physical medical device (TENS unit). The "performance" is its ability to generate electrical impulses as specified, which was assessed through nonclinical engineering and electrical safety tests.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the purpose of substantial equivalence, the "ground truth" relies on:
- Established safety and effectiveness of the predicate device: The predicate device (Painmaster MCT Patch) is a legally marketed device with a known safety and efficacy profile under its 510(k) clearance (K130114).
- Engineering and electrical testing data: The PAT device underwent nonclinical tests to ensure it meets electrical safety standards (e.g., AAMI ES 60601-1, IEC 60601-1-2, IEC 60601-2-10) and performs according to its specifications (waveform, amplitude, frequency, current, voltage, etc.). This data serves as the "ground truth" for its technical performance and safety.
8. The sample size for the training set
Not applicable. This is not an AI/machine learning device, so there is no "training set."
9. How the ground truth for the training set was established
Not applicable. There is no training set for this device.
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February 27, 2019
Marchan Medical, LLC Mark Chandler Managing Partner 165 S Ashe St. Southern Pines, North Carolina 28387
Re: K182267
Trade/Device Name: PAT (Pain Alleviation Technologies) Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator For Pain Relief Regulatory Class: Class II Product Code: NUH Dated: January 18, 2019 Received: January 28, 2019
Dear Mark Chandler:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Actinclude 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
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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Scott -S
Sincerely,
Pamela D. Digitally
D. Scott
Digitally signed by Pamela D. Scott -S Date: 2019.02.27 21:10:33 -05'00'
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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Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known) K182267
Device Name PAT
Indications for Use (Describe)
Temporary relief of pain associated with sore and aching muscles and joints due to strain from exercise or normal household and work activities.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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510(K) Summary
PAT is an OTC medical device. This device is used for temporary relief of pain of sore and aching muscles and joints, due to strain from exercise or normal household and work activities. The device consists of a small battery operated enclosure with an LCD screen and user buttons to control the device. A monophasic micro-current waveform is transmitted to the affected body part through a cable connected via snaps to skin surface electrodes. There are 8 non-programmable modes representing 8 different body areas to treat.
| Sponsor: | Marchan Medical, LLC165 S Ashe StSouthern Pines, NC 28387 |
|---|---|
| Contact Person: | Mark Chandler, MD |
| Phone: | 910-783-5285 |
| Email: | Markmd@marchanmedical.com |
| Date of Original Submission: August 15, 2018 | |
| Proprietary Name: | PAT |
| Common Name: | Transcutaneous electrical nerve stimulator (TENS) |
| Classification Name: | Stimulator, nerve, Transcutaneous, Over-the-Counter |
| Regulation Number: | 21 CFR 882.5890 |
| Regulatory Class: | II |
| Product Code: | NUH |
| Classification Panel: | Neurology |
| Predicate Device: | Painmaster MCT Patch (K130114) |
Indications for Use:
Temporary relief of pain associated with sore and aching muscles and joints due to strain from exercise or normal household and work activities.
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Basic Unit Characteristics
PAT uses Painmaster MCT Patch as the predicate device.
| Parameter | Painmaster MCT PatchPredicate Device(K130114) | PATProposed Device(K182267) |
|---|---|---|
| Manufacturer | Newmark, Inc. | Shenzhen Bless ElectronicTechnology Co., Ltd. |
| Specifications Developer | Marchan Medical, LLC | |
| Product Code | NUH | NUH |
| Environment of use | Clinics, hospital and homeenvironment | Clinics, hospital and homeenvironment |
| Indications for Use | Temporary relief of painassociated with sore andaching muscles in theupper and lowerextremities due to strainfrom exercise or normalhousehold and workactivities. | Temporary relief of painassociated with sore andaching muscles andjoints due to strain fromexercise or normalhousehold and workactivities. |
| Patient Population | Adult | Adult |
| Operation Mode | Waveform: monophasicsquare wave with 50%duty cycle.Amplitude: 42 μAFrequency: 0.5 Hz | Waveform: monophasicsquare wave. with 50%duty cycle.Amplitude:40 μAFrequency: 3 Hz |
| Power Source | Primary battery only.One time use. | Primary battery only.3 replaceable AAAbatteries, notrechargeable. |
| Operational Indicator | Yes, LED light | Yes, LCD screen |
| Time Range | Not adjustable, up to300 hours | 40-55 minutes dependingon area treated |
| Housing Materials andConstruction | Plastic (ABS) enclosure | Plastic (ABS) enclosure |
| Body contact material | Electrode, CE certified | Electrode, FDA cleared |
| Maximum Average Current | 42 μΑ | 40 μΑ |
| OTC Use | Yes | Yes |
| Dimensions (in.)W x H x D | 1.6 x 0.3 x 1 | 6 x 2.75 x 1 |
| Weight | 0.03 lb. | 0.25 lb. |
| Operating Temperature andHumidity | 10-45°C, 20%-90% | 10-45°C, 20%-90% |
| Method of Line CurrentIsolation | N/A | N/A |
| Patient Leakage Current | Type BF | Type BF |
| Normal Condition | 0 | 0 |
| Single Fault Condition | 50 μΑ | 50 μΑ |
| Average DC current throughelectrodes when device is onbut no pulses being applied | N/A (Pulse is alwaysapplied when on) | 0 |
| Number of Output Modes | 1 | 1 (8 different timingsbased on body part beingtreated but only onepreset waveform) |
| Number of Output Channels | 1 | 1 |
| Regulated Current of Voltage | Regulated Current | Regulated Current |
| Software/Firmware/Microprocessor Control? | Yes | Yes |
| Automatic Overload Trip | Yes | Yes |
| Automatic No-Load Trip | Yes | Yes |
| Automatic Shut-Off | Yes | Yes |
| IndicatorDisplay | On/Off Status? YesLow Battery? NoVoltage/Current Level No | Yes |
| Compliance with VoluntaryStandards? | EN 60601-1HA60601-1-11IEC 60601-1-2IEC 60601-2-10 | AAMI ES 60601-1IEC 60601-1-2IEC 60601-2-10 |
| Compliance with 21 CFR 898 | N/A | N/A |
| Electrode cable | 4 Inch snap | 40 inch double snap,3.5mm |
| Parameter | Predicate Device | Proposed Device |
| Product Name | Painmaster MCT Patch | PAT |
| 510(K) number | K130114 | K182267 |
| Number of output modes | 1 | 1 (8 different timings basedon body part being treated butonly one preset waveform ) |
| Number of output channels | 1 | 1 |
| Waveform | Square monophasic,50% duty cycle | Square monophasic,50% duty cycle |
| Maximum outputVoltage (max) 500 Ω2K Ω 10K Ω | 500 Ω : 22mV2K Ω: 84mV10K Ω: 370mV | 500 Ω :20.8 mV2K Ω: 82.0 mV10K Ω: 416 mV |
| Maximum outputCurrent (max) 500 Ω2K Ω 10K Ω | 500 Ω : 42 μA2K Ω: 42 μA10K Ω: 37 μA | 500 Ω : 41.6 μA2K Ω: 41.0 μA10K Ω: 41.6 μA |
| Max. Phase charge @500 Ω(Phase charge=pulse duration Xcurrent amplitude) | 44 microcoulombs | 6.9 microcoulombs |
| Max. Average Current @500Ω | 42 μA | 41.6 μA |
| Max. Current density @500 Ω) | 0.002 mA/ cm² | 0.0016 mA/cm²(using included 5X5cm electrodes) |
| Maximum Power Density (500 Ω) | 0.00005mW/cm² | 0.000035 mW / cm²(using included 5X5cm electrodes) |
| Frequency (Hz) | 0.5Hz | 3 Hz |
| Pulse Duration | 1.0 sec | 0.166 sec |
| Burst Mode | N/A | N/A |
| Timer range (min) | 0-300 hours, depending onbattery life | 40-55 min selectable byMODE. |
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Output Specifications
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The conclusions drawn from the nonclinical tests described above demonstrate that the device is as safe and effective as the predicate device. The waveform used in both devices is similar with a square waveform with a 50% duty cycle as discovered with oscilloscope readings. The indications for use are very similar, both devices met the same test standards, and both use very low frequency pulses.
§ 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).