(218 days)
Not Found
No
The description focuses on electro-therapy and programmable micro-current modes, with no mention of AI or ML terms or functionalities.
Yes
The device is described as an OTC medical device intended to temporarily relieve pain through electro-therapy, indicating a therapeutic purpose.
No
The device is indicated for "Temporary relief of pain," which is a therapeutic function, not a diagnostic one. It uses electrotherapy to alleviate symptoms rather than to identify or characterize a disease or condition.
No
The device description explicitly states it consists of "two Stimulator pads connected by a USB cable" and operates via "electro-therapy," indicating it includes hardware components for delivering electrical stimulation.
Based on the provided information, the PainKARE device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the temporary relief of pain in muscles, joints, and tissues due to strain. This is a therapeutic use, not a diagnostic one.
- Device Description: The device uses electrotherapy to provide electrical stimulation to the body for pain relief. This is a physical intervention, not a test performed on samples taken from the body.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions
In summary, the PainKARE is a therapeutic medical device that applies electrical stimulation to the body for pain relief, which is distinct from the function of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
NUH
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
muscles, joints, and tissues
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Painmaster MCT Patch (K090042; K130114)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
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
1
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
2
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., #166 |
| Fremont, CA 94538 | |
| Contact Person: | Parul Chansoria, |
| Elexes; Elexes Medical Consulting Pvt Ltd. | |
| Phone: | 650-528-2445 |
| Fax: | -------- |
| Email: | parul@elexes.com |
| Date of Summary | |
| Preparation: | October 20, 2015 |
5.2 Device Information
| Table 2-Device Information | |
|---|---|
| Trade Name: | PainKARE |
| Common Name: | Transcutaneous electrical nerve |
| Stimulator | |
| 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)
4
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 MCT | |||
| Patch | ||||
| (Predicate Device) | ||||
| K090042 | Painmaster MCT Patch | |||
| (Predicate Device) | ||||
| K130114 | Proposed Device | |||
| (Subject Device) | ||||
| PainKARE | ||||
| Stimulator | ||||
| Manufacturer | Newmark Inc. | Newmark Inc. | TrioWave | |
| Technologies | ||||
| Indications 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 extremities | ||||
| (arm and/or leg) due | ||||
| to strain from exercise | ||||
| or normal household | ||||
| and work activities. | Temporary relief of | |||
| pain of sore and | ||||
| aching muscles, | ||||
| joints, and tissues | ||||
| due to 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 | Waveform: pulsed | |||
| square wave. | ||||
| Amplitude: 50μA | ||||
| Frequency: 0.5Hz | ||||
| Polarity: Mono-phasic | Waveform: pulsed | |||
| square wave. | ||||
| Amplitude: 50μA | ||||
| Frequency: 0.3Hz | ||||
| Polarity: Biphasic | ||||
| (Alternating Mono- | ||||
| phasic) | ||||
| Power Source(s)† | Primary battery only. | |||
| One time use | Primary battery only. | |||
| One time use | Primary Battery only. | |||
| Rechargeable | ||||
| Micro-processor | ||||
| Control | Yes | Yes | Yes | |
| Table 3-PainKARE (Stimulator pads) vs. Painmaster MCT Patch (K090042; K130114) | ||||
| Parameter | Painmaster MCT | |||
| Patch | ||||
| (Predicate Device) | ||||
| K090042 | Painmaster MCT Patch | |||
| (Predicate Device) | ||||
| K130114 | Proposed Device | |||
| (Subject Device) | ||||
| PainKARE | ||||
| Stimulator | ||||
| Automatic | ||||
| Overload | ||||
| Protection | Yes | Yes | Yes | |
| Automatic No Load | ||||
| Alarm | Yes | Yes | Yes | |
| User Override | ||||
| Control | No | No | Yes | |
| Operational | ||||
| Indicator | Yes | Yes | Yes | |
| Time Range | Not adjustable. Up to | |||
| 250 hours | Not adjustable. Up to | |||
| 250 hours | 30 minutes to 4 | |||
| hours, depending on | ||||
| pain | ||||
| Housing Materials | ||||
| and Construction | Plastic (ABS) | |||
| enclosure | Plastic (ABS) enclosure | Plastic (ABS) | ||
| enclosure | ||||
| Body contact | ||||
| material | Electrode, CE certified | Electrode, CE certified | Electrodes, FDA | |
| approved | ||||
| Maximum Average | ||||
| current | 50 μA | 50 μA | 50 μA | |
| OTC use | Yes | Yes | Yes | |
| Dimensions (in.) [W | ||||
| x 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. | |
| Operating | ||||
| temperature and | ||||
| humidity | 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 | |
| - Normal
Condition (μΑ) | Unspecified | Unspecified | 0 | |
| - Single Fault
Condition (μΑ) | Unspecified | Unspecified | 50μA | |
| Average DC current
through electrodes
when device is on | 0 | 0 | N/A (Pulse always
applied when on) | |
| Table 3-PainKARE (Stimulator pads) vs. Painmaster MCT Patch (K090042; K130114) | | | | |
| Parameter | | Painmaster MCT
Patch
(Predicate Device)
K090042 | Painmaster MCT Patch
(Predicate Device)
K130114 | Proposed Device
(Subject Device)
PainKARE
Stimulator |
| but no pulses are
being applied (µA) | | | | |
| Number of output
modes | | 1 | 1 | 2 |
| Number
of Output
Channels
††††: | Synchro
nous or
Alternati
ng? | 1 channel,
monophasic | 1 channel, monophasic | 1 channel, biphasic
(alternating
monophasic) |
| | Method
of
Channel
Isolation | NA | NA | NA |
| Regulated Current
or Regulated
Voltage? | | Regulated Current | Regulated Current | Regulated Current |
| Software/Firmware
/Microprocessor
Control? | | Yes | Yes | Yes |
| Automatic
Overload
Trip? | | No | No | Yes |
| Automatic No-Load
Trip? | | Yes | Yes | Yes |
| Automatic Shut
Off? | | Yes | Yes | Yes |
| Indicator
Display: | On/Off
Status? | Yes | Yes | Yes |
| | Low
Battery? | No | No | Yes |
| | Voltage/
Current
Level? | No | No | No |
| Table 3-PainKARE (Stimulator pads) vs. Painmaster MCT Patch (K090042; K130114) | | | | |
| Parameter | Painmaster MCT
Patch
(Predicate Device)
K090042 | Painmaster MCT Patch
(Predicate Device)
K130114 | Proposed Device
(Subject Device)
PainKARE
Stimulator | |
| Compliance with
Voluntary
Standards? | Yes, UL260,
EN60601-2 Part1, A1
& A2
EN 60601-2-10, Part
2-10
EN 60601-1-2 EMI | Yes, UL260,
EN60601-2 Part1, A1 & A2
EN 60601-2-10, Part 2-
10
EN 60601-1-2 EMI | Yes, AAMI ES 60601-
1,
AAMI HA60601-1-
11,
IEC 60601-1-2
IEC 60601-1-6, IEC
60601-2-10, | |
| Compliance with 21
CFR 8987? | N/A | N/A | N/A | |
5.6.1 PainKARE (Stimulator pads) vs. Painmaster MCT Patch (K090042; K130114)
5
6
7
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.