(218 days)
The PainKARE is indicatied for Temporary relief of pain of sore and aching muscles, joints, and tissues due to strain from exercise or normal household and work activities.
PainKARE is an OTC medical device intended to temporarily relieve pain due to strain from exercise or normal household work or activities via electro-therapy. The Device consists two Stimulator pads connected by a USB cable for Electrotherapy. PainKARE's Stimulator pads operate in a programmable micro-current mode and deliver Biphasic waveforms which in turn provide electrical stimulation to the body that aids in relieving pain.
The provided document is a 510(k) premarket notification for a medical device called PainKARE, a Transcutaneous Electrical Nerve Stimulator (TENS) for pain relief. The document aims to demonstrate that PainKARE is substantially equivalent to legally marketed predicate devices.
Here's an analysis of the acceptance criteria and study information, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of acceptance criteria with corresponding performance results in a clear, quantitative manner typically seen for complex AI/diagnostic devices. Instead, it lists the standards the device was tested against and states that the test data showed safety and effectiveness for its intended use, implying compliance with those standards.
Below is a table summarizing the technological characteristics of the subject device (PainKARE) and its predicate devices, which can be interpreted as demonstrating how the device's technical specifications are comparable or superior to the predicates. While not "acceptance criteria" in a strict performance metric sense, these are the points of comparison used to establish substantial equivalence.
| Parameter | Acceptance Criteria (Implied by Predicate Devices) | Reported Device Performance (PainKARE) |
|---|---|---|
| Intended Use | Temporary relief of pain of sore and aching muscles, joints, and tissues | Temporary relief of pain of sore and aching muscles, joints, and tissues due to strain from exercise or normal household and work activities. |
| Operation Mode (Waveform) | Pulsed square wave, Amplitude: 50μA, Frequency: 0.5Hz, Polarity: Mono-phasic | Pulsed square wave, Amplitude: 50μA, Frequency: 0.3Hz, Polarity: Biphasic (Alternating Mono-phasic) |
| Power Source | Primary battery only, one-time use | Primary Battery only, Rechargeable |
| Micro-processor Control | Yes | Yes |
| Automatic Overload Protection | Yes (Predicate K090042, K130114), No (Predicate K090042, K130114 in second occurrence) | Yes |
| Automatic No Load Alarm | Yes | Yes |
| User Override Control | No | Yes |
| Operational Indicator | Yes | Yes |
| Time Range | Not adjustable, Up to 250 hours | 30 minutes to 4 hours, depending on pain |
| Housing Materials | Plastic (ABS) enclosure | Plastic (ABS) enclosure |
| Body Contact Material | Electrode, CE certified | Electrodes, FDA approved |
| Maximum Average Current | 50 μA | 50 μA |
| OTC Use | Yes | Yes |
| Dimensions (W x H x D) | 1.55 x 0.29 x 1 in. | 1.2 x 0.6 x 1.6 in. |
| Weight | 0.03 lb. | 0.1 lb. |
| Operating Temperature/Humidity | 10-45°C, 20%-90% | 10-45°C, 20%-90% |
| Method of Line-Current Isolation | N/A | N/A |
| Patient Leakage - Current | Type CF | Type BF (Normal: 0 μA, Single Fault: 50 μA) |
| Average DC current through electrodes when device is on but no pulses are being applied | 0 | N/A (Pulse always applied when on) |
| Number of output modes | 1 | 2 |
| Number of Output Channels | 1 channel, monophasic | 1 channel, biphasic (alternating monophasic) |
| Regulated Current/Voltage | Regulated Current | Regulated Current |
| Software/Firmware/Microprocessor Control? | Yes | Yes |
| Automatic Overload Trip? | No | Yes |
| Automatic No-Load Trip? | Yes | Yes |
| Automatic Shut Off? | Yes | Yes |
| Indicator Display: On/Off Status? | Yes | Yes |
| Indicator Display: Low Battery? | No | Yes |
| Indicator Display: Voltage/Current Level? | No | No |
| Compliance with Voluntary Standards | UL260, EN60601-2 Part1, A1 & A2, EN 60601-2-10, Part 2-10, EN 60601-1-2 EMI | AAMI ES 60601-1, AAMI HA60601-1-11, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-2-10 |
2. Sample size used for the test set and the data provenance
The document states: "The following Performance testing has been performed on the Subject Device in accordance with appropriate FDA guidance documents and relevant standards, to support the determination of substantial equivalence."
- Sample Size for Test Set: The document does not specify a sample size for any clinical or performance test set involving human subjects or data. The testing mentioned appears to be related to engineering bench testing against standards.
- Data Provenance: The document does not specify country of origin or whether data was retrospective or prospective. Given the nature of a 510(k) submission focused on substantial equivalence through technical comparison and compliance with electrical safety standards, it is unlikely a clinical trial with human data was conducted. The performance data primarily refers to adherence to electrical and safety standards (e.g., AAMI ES 60601-1, IEC 60601-1-2, IEC 60601-1-6, AAMI HA60601-1-11, IEC 60601-2-10).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This type of information would be relevant for devices involving image interpretation or diagnostic performance studies where expert consensus defines ground truth. The PainKARE device is a TENS unit for pain relief, and its "performance" is assessed by adherence to design specifications and safety/electrical standards, not through expert-adjudicated clinical outcomes in a test set.
4. Adjudication method for the test set
Not applicable. As noted above, the evaluation framework is not based on expert adjudication of a test set.
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 not an AI-based diagnostic tool, and therefore, MRMC studies are not relevant to its submission.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. The PainKARE is a physical medical device, not a standalone algorithm. Its performance is assessed against technical specifications and safety standards, not algorithmic output accuracy.
7. The type of ground truth used
The "ground truth" for this submission is adherence to established electrical and safety performance standards (e.g., AAMI ES 60601-1, IEC 60601-1-2, IEC 60601-1-6, AAMI HA60601-1-11, IEC 60601-2-10) and functional specifications. There is no biological "ground truth" (like pathology or clinical outcomes data) in the context of this 510(k) submission.
8. The sample size for the training set
Not applicable. This device does not use machine learning or AI, and therefore, there is no "training set."
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this device.
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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized human face in profile, with three overlapping heads. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the image.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 21, 2015
TrioWave Technologies Attn: Ms. Parul Chansoria Regulatory Consultant for TrioWave Technologies 3984 Washington Blvd. #166 Fremont, CA 94538
Re: K151034 Trade Name: PainKARE Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous electrical nerve stimulator for pain relief Regulatory Class: Class II Product Code: NUH Dated: October 20, 2015 Received: October 23, 2015
Dear Ms. Chansoria:
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 27f 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); medical device reporting (reporting of medical
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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 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/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 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,
Carlos L. Pena -S
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
510(k) Number (if known) K151034
Device Name PainKARE
Indications for Use (Describe)
The PainKARE is indicatied for Temporary relief of pain of sore and aching muscles, joints, and tissues 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)
|X | Over-The-Counter Use (21 CFR 801 Subpart C)
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5. 510 (K) Summary
This 510(k) Summary has been created per the requirements of the Safe Medical Device Act (SMDA) of 1990, and the content is provided in conformance with 21 CFR Part 807.92.
5.1 Submitter's Information
| Table 1-Submitter's Information | |
|---|---|
| Submitter's Name: | Huiyou Zhu, Founder |
| Company: | TrioWave Technologies. |
| Address: | 3984 Washington Blvd., #166Fremont, CA 94538 |
| Contact Person: | Parul Chansoria,Elexes; Elexes Medical Consulting Pvt Ltd. |
| Phone: | 650-528-2445 |
| Fax: | -------- |
| Email: | parul@elexes.com |
| Date of SummaryPreparation: | October 20, 2015 |
5.2 Device Information
| Table 2-Device Information | |
|---|---|
| Trade Name: | PainKARE |
| Common Name: | Transcutaneous electrical nerveStimulator |
| Classification Name: | Stimulator, nerve, Transcutaneous, Over-the-counter |
| Classification Number: | Class II per 21 CFR 882.5890(b) |
| Product Code: | NUH |
| Classification Panel: | Neurology |
5.3 Predicate Device Information
Painmaster MCT Patch (K090042; K130114)
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5.4 Device Description
PainKARE is an OTC medical device intended to temporarily relieve pain due to strain from exercise or normal household work or activities via electro-therapy. The Device consists two Stimulator pads connected by a USB cable for Electrotherapy.
PainKARE's Stimulator pads operate in a programmable micro-current mode and deliver Biphasic waveforms which in turn provide electrical stimulation to the body that aids in relieving pain.
5.5 Indications for Use
The PainKARE system is indicated for "temporary relief of pain of sore and aching muscles, joints, and tissues due to strain from exercise or normal household and work activities".
5.6 Technological Characteristics
The PainKARE (Subject Device) makes use of two Predicate Devices; Painmaster MCT Patch (K090042; K130114) for the Stimulator pads (for electrotherapy).
| Table 3-PainKARE (Stimulator pads) vs. Painmaster MCT Patch (K090042; K130114) | ||||
|---|---|---|---|---|
| Parameter | Painmaster MCTPatch(Predicate Device)K090042 | Painmaster MCT Patch(Predicate Device)K130114 | Proposed Device(Subject Device)PainKAREStimulator | |
| Manufacturer | Newmark Inc. | Newmark Inc. | TrioWaveTechnologies | |
| Indications for use | Temporary relief ofpain associated withsore and achingmuscles in the lowerback due to strainfrom exercise ornormal householdand work activities. | Temporary relief ofpain associated withsore and achingmuscles in the upperand lower extremities(arm and/or leg) dueto strain from exerciseor normal householdand work activities. | Temporary relief ofpain of sore andaching muscles,joints, and tissuesdue to due to strainfrom exercise ornormal householdand work activities. | |
| Operation Mode | Waveform: pulsedsquare wave.Amplitude: 50μAFrequency: 0.5HzPolarity: Mono-phasic | Waveform: pulsedsquare wave.Amplitude: 50μAFrequency: 0.5HzPolarity: Mono-phasic | Waveform: pulsedsquare wave.Amplitude: 50μAFrequency: 0.3HzPolarity: Biphasic(Alternating Mono-phasic) | |
| Power Source(s)† | Primary battery only.One time use | Primary battery only.One time use | Primary Battery only.Rechargeable | |
| Micro-processorControl | Yes | Yes | Yes | |
| Table 3-PainKARE (Stimulator pads) vs. Painmaster MCT Patch (K090042; K130114) | ||||
| Parameter | Painmaster MCTPatch(Predicate Device)K090042 | Painmaster MCT Patch(Predicate Device)K130114 | Proposed Device(Subject Device)PainKAREStimulator | |
| AutomaticOverloadProtection | Yes | Yes | Yes | |
| Automatic No LoadAlarm | Yes | Yes | Yes | |
| User OverrideControl | No | No | Yes | |
| OperationalIndicator | Yes | Yes | Yes | |
| Time Range | Not adjustable. Up to250 hours | Not adjustable. Up to250 hours | 30 minutes to 4hours, depending onpain | |
| Housing Materialsand Construction | Plastic (ABS)enclosure | Plastic (ABS) enclosure | Plastic (ABS)enclosure | |
| Body contactmaterial | Electrode, CE certified | Electrode, CE certified | Electrodes, FDAapproved | |
| Maximum Averagecurrent | 50 μA | 50 μA | 50 μA | |
| OTC use | Yes | Yes | Yes | |
| Dimensions (in.) [Wx H x D] | 1.55 x 0.29x1 | 1.55 x 0.29x1 | 1.2" x0.6" x1.6" | |
| Weight | 0.03 lb. | 0.03 lb. | 0.1 lb. | |
| Operatingtemperature andhumidity | 10-45°C, 20%-90% | 10-45°C, 20%-90% | 10-45°C, 20%-90% | |
| Method of Line-Current Isolation | N/A | N/A | N/A | |
| Patient Leakage-Current++ | Type CF | Type CF | Type BF | |
| - NormalCondition (μΑ) | Unspecified | Unspecified | 0 | |
| - Single FaultCondition (μΑ) | Unspecified | Unspecified | 50μA | |
| Average DC currentthrough electrodeswhen device is on | 0 | 0 | N/A (Pulse alwaysapplied when on) | |
| Table 3-PainKARE (Stimulator pads) vs. Painmaster MCT Patch (K090042; K130114) | ||||
| Parameter | Painmaster MCTPatch(Predicate Device)K090042 | Painmaster MCT Patch(Predicate Device)K130114 | Proposed Device(Subject Device)PainKAREStimulator | |
| but no pulses arebeing applied (µA) | ||||
| Number of outputmodes | 1 | 1 | 2 | |
| Numberof OutputChannels††††: | Synchronous orAlternating? | 1 channel,monophasic | 1 channel, monophasic | 1 channel, biphasic(alternatingmonophasic) |
| MethodofChannelIsolation | NA | NA | NA | |
| Regulated Currentor RegulatedVoltage? | Regulated Current | Regulated Current | Regulated Current | |
| Software/Firmware/MicroprocessorControl? | Yes | Yes | Yes | |
| AutomaticOverloadTrip? | No | No | Yes | |
| Automatic No-LoadTrip? | Yes | Yes | Yes | |
| Automatic ShutOff? | Yes | Yes | Yes | |
| IndicatorDisplay: | On/OffStatus? | Yes | Yes | Yes |
| LowBattery? | No | No | Yes | |
| Voltage/CurrentLevel? | No | No | No | |
| Table 3-PainKARE (Stimulator pads) vs. Painmaster MCT Patch (K090042; K130114) | ||||
| Parameter | Painmaster MCTPatch(Predicate Device)K090042 | Painmaster MCT Patch(Predicate Device)K130114 | Proposed Device(Subject Device)PainKAREStimulator | |
| Compliance withVoluntaryStandards? | Yes, UL260,EN60601-2 Part1, A1& A2EN 60601-2-10, Part2-10EN 60601-1-2 EMI | Yes, UL260,EN60601-2 Part1, A1 & A2EN 60601-2-10, Part 2-10EN 60601-1-2 EMI | Yes, AAMI ES 60601-1,AAMI HA60601-1-11,IEC 60601-1-2IEC 60601-1-6, IEC60601-2-10, | |
| Compliance with 21CFR 8987? | N/A | N/A | N/A |
5.6.1 PainKARE (Stimulator pads) vs. Painmaster MCT Patch (K090042; K130114)
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Similarities:
- . The Subject and the Predicate devices have the same intended use and indications for use.
- Both the Subject and Predicate devices have similar technological characteristics, namely, number of output channel and output current (50μA), and have the same operating temperature and humidity ranges.
- Both devices are microprocessor controlled, and utilize certified/cleared electrode pads.
- The Subject and the Predicate Devices also have same features like the automatic overload trip protection, automatic no load trip, automatic shut off, operational Indicator and no current display.
- . The subject device has rechargeable battery whereas the Predicates do not have a rechargeable battery.
Differences:
- . The Subject device operates in biphasic waveforms/modes, whereas the Predicates only operates in monophasic mode/waveform.
- There are some minor technological differences namely user override control etc.
5.7 Performance Data
The following Performance testing has been performed on the Subject Device in accordance with appropriate FDA guidance documents and relevant standards, to support the determination of substantial equivalence. The test data showed that the Subject device is safe and effective for its intended use as compared to the Predicate.
- . The Subject Device was tested to conform to the electrical and safety requirements established in AAMI ES 60601-1 and the electromagnetic compatibility requirements in IEC 60601-1-2.
- The Subject Device was also tested to conform to IEC 60601-1-6, and AAMI HA60601-1-11 and IEC 60601-2-10.
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5.8 Conclusion
Based on the comparison of intended use and key technological characteristics, the PainKARE (Subject Device) is substantially equivalent to the Predicate Device.
§ 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).