(142 days)
Not Found
No
The summary describes a standard TENS device with pre-programmed settings controlled via an app or remote. There is no mention of adaptive algorithms, learning from user input, or any other characteristics indicative of AI/ML. The software is described as "Moderate" level of concern, which is typical for devices with fixed functionality.
Yes
The device is described as an electrotherapy device intended for "temporary relief of pain associated with sore and aching muscles" and "symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis", which are therapeutic indications.
No
The device is described as an electrotherapy device (TENS) intended for the relief and management of pain, not for the diagnosis of a condition.
No
The device description explicitly states it is a "wireless, two channels wearable electrotherapy device" and includes physical components like a "main TENS unit," "electrodes," and a "remote control." While it utilizes software (APP) for control, it is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for the temporary relief and management of pain associated with muscles and joints. This is a therapeutic purpose, not a diagnostic one.
- Device Description: The device description details a TENS (Transcutaneous Electrical Nerve Stimulation) device that delivers electrical pulses to the body for pain relief. This is a physical therapy modality, not a method for analyzing biological samples.
- Lack of IVD Characteristics: The description does not mention any components or processes related to collecting, analyzing, or interpreting biological samples (like blood, urine, tissue, etc.) to diagnose a condition or disease.
- Performance Studies: The performance studies focus on biocompatibility, electrical safety, software validation, and output waveform testing, all of which are relevant to a therapeutic electrical stimulation device, not an IVD.
In summary, the device's function is to provide pain relief through electrical stimulation applied to the body, which falls under the category of a therapeutic medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The device is intended to be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, upper extremities(arm) and lower extremities (leg) due to strain from exercise or normal household work activities. And to be used for the symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis.
Product codes
NUH, NYN
Device Description
The ThermaCare® Quick Therapy TENS device is a wireless, two channels wearable electrotherapy device that is designed to alleviate chronic muscle and joint pain on multiple body locations. It delivers TENS (Transcutaneous Electrical Nerve Stimulation) technology through the simple, convenient use of the dedicated APP (iOS or Android) or remote control. Reusable, self-adhesive pads allow for discreet and convenient placement on multiple pain locations on the body. The ThermaCare® Quick Therapy TENS contains 23 TENS programs. It is designed to be used at home, by adults of all genders.
The ThermaCare® Quick Therapy TENS device contains one main TENS unit which is rechargeable and one remote control which is powered by 2 AAA batteries. The pads with attached TENS unit can then be applied to intact skin at the desired location for pain relief. Control of the ThermaCare® Quick Therapy TENS device is completed through the available TENS APP (iOS or Android)or remote control. The communication is done via Bluetooth Low Energy.
The device will be packaged with an Instruction Manual which provides details on setting up the device for use, installing of the App, setting and controlling therapy programs, and troubleshooting. The ThermaCare® Quick Therapy TENS consists of the following elements:
- Main device: generates the TENS pulses; connects to the electrode; controlled by APP on smart phone and remote control.
- Electrodes: Self-adhesive re-usable hydrogel electrodes connects to the device.
- APP on mobile device: The APP controls the functions of the main device via a Bluetooth (4.0) Low Energy connection between the mobile device and the main device.
- Remote control: The remote controls the functions of the main device via a Bluetooth (4.0) Low Energy connection between the remote control and the main device.
- Adapter (optional): for charging the battery unit via a micro-USB socket which connected with the adapter, and insert the adapter to the supply mains.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
shoulder, waist, back, upper extremities(arm) and lower extremities (leg)
Indicated Patient Age Range
adults
Intended User / Care Setting
Home use, by adults of all genders.
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)
Performance data provided in support of substantial equivalence determination include:
- Biocompatibility testing conducted in accordance with ISO 10993-1, including Cytotoxicity, Sensitization, and Irritation tests.
- Electrical safety and electromagnetic compatibility (EMC) testing in compliance with IEC 60601-1, IEC60601-1-11, IEC 60601-2-10, and FCC part 15 RADIO FREQUENCY DEVICES, Subpart C—Intentional Radiators.
- Software Verification and Validation Testing based on FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software was considered a "Moderate" level of concern.
- Output waveform Testing: For each program, oscilloscope tracing diagrams describing the electrical output waveform were provided to verify the output specifications of the device according to IEC 60601-2-10.
Key results: The new devices are evaluated and passed the testing according to IEC 60601-1 and IEC 60601-2-10. Technological differences (number of output modes, number of output channels, timer range, weight and dimension, Max Output Voltage/Current, Pulse Duration, Maximum Phase Charge, Maximum Current Density and Maximum Average Power Density) do not pose any new questions of safety and effectiveness.
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.
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).
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
September 15, 2018
Pfizer Inc. % Siping Yuan R.A. Specialist Shenzhen Dongdixin Technology Co., Ltd No. 3 Building, Xilibaimang Xusheng Industrial Estate Nanshan, Shenzhen, Cn 518108
Re: K181102
Trade/Device Name: ThermaCare Quick Therapy TENS, TC001 Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator For Pain Relief Regulatory Class: Class II Product Code: NUH, NYN Dated: April 20, 2018 Received: April 26, 2018
Dear Siping Yuan:
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 mav, 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); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820);
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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 mediation-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).
Sincerely,
Pamela D. Scott -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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Indications for Use
510(k) Number (if known) K181102
Device Name ThermaCare® Quick Therapy TENS Model: TC001
Indications for Use (Describe)
The device is intended to be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, upper extremities(arm) and lower extremities (leg) due to strain from exercise or normal household work activities. And to be used for the symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis.
| 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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005_510 (k) Summary Version: 1.1
510(k) SUMMARY
as required by section 21 CFR 807.92
ThermaCare® Quick Therapy TENS
| Date of Submission: | 04/23/2018 |
|---|---|
| Submitter/510(k) | |
| Owner's Name: | Pfizer Inc. |
| Address: | 235 East 42nd Street, New York, New York 10017, |
| USA | |
| Contact Person: | Nicola Romano |
| E-mail: | nicola.romano@pfizer.com |
| Tel: | 973-660-5858 |
| Correspondent's Name: | Shenzhen Dongdixin Technology Co., Ltd. |
| Address: | No.3 Building Xilibaimang Xusheng Industrial Estate, |
| Nanshan, Shenzhen, CHINA 518108 | |
| Correspondent | |
| Contact: | Siping Yuan |
| E-mail: | ra@dundex.com |
| Tel: | +86(755) 27652471 |
| FAX: | +86(755) 27652674 |
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1. Proposed Device:
| Device Name: | ThermaCare® Quick Therapy TENS |
|---|---|
| Model: | TC001 |
| Device classification Name: | Stimulator, Nerve, Transcutaneous, Over-The-Counter |
| Regulation Description: | Transcutaneous electrical nerve stimulator for pain relief |
| Regulation Medical Specialty: | Neurology |
| Review Panel: | Neurology |
| Regulation Number: | 882.5890 |
| Product Code: | NUH |
| Device Class: | II |
| Device classification Name: | Stimulator, Electrical, Transcutaneous, For Arthritis |
| Regulation Description: | Transcutaneous electrical nerve stimulator for pain relief |
| Regulation Medical Specialty: | Neurology |
| Medical Specialty: | Neurology |
|---|---|
| Review Panel: | Neurology |
| Regulation Number: | 882.5890 |
| Product Code: | NYN |
| Device Class: | II |
2. Predicate Device:
| Legally Marketed Device: | Wireless Pain Relieve Device |
|---|---|
| LT5018C | |
| 510(k) Number: | K173462 |
| Manufacturer: | Shenzhen Dondixin Technology Co., Ltd. |
3. Description of Proposed Device:
The ThermaCare® Quick Therapy TENS device is a wireless, two channels wearable electrotherapy device that is designed to alleviate chronic muscle and joint pain on multiple body locations. It delivers TENS (Transcutaneous Electrical Nerve Stimulation) technology through the simple, convenient use of the dedicated APP (iOS or Android) or remote control. Reusable, self-adhesive pads allow for discreet and convenient placement on multiple pain locations on the body. The ThermaCare® Quick Therapy TENS contains 23 TENS programs. It is designed to be used at home, by adults of all genders.
The ThermaCare® Quick Therapy TENS device contains one main TENS unit which is rechargeable and one remote control which is powered by 2 AAA batteries. The pads with attached TENS unit can then be applied to intact skin at the desired location for pain relief. Control of the ThermaCare® Quick Therapy TENS device is completed through the available TENS APP (iOS or Android)or remote control. The
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communication is done via Bluetooth Low Energy.
The device will be packaged with an Instruction Manual which provides details on setting up the device for use, installing of the App, setting and controlling therapy programs, and troubleshooting. The ThermaCare® Quick Therapy TENS consists of the following elements:
• Main device: generates the TENS pulses; connects to the electrode; controlled by APP on smart phone and remote control.
• Electrodes: Self-adhesive re-usable hydrogel electrodes connects to the device.
• APP on mobile device: The APP controls the functions of the main device via a Bluetooth (4.0) Low Energy connection between the mobile device and the main device.
• Remote control: The remote controls the functions of the main device via a Bluetooth (4.0) Low Energy connection between the remote control and the main device.
· Adapter (optional): for charging the battery unit via a micro-USB socket which connected with the adapter, and insert the adapter to the supply mains.
4. Proposed Device Intended for Use Statement:
Device Name: ThermaCare® Quick Therapy TENS, Model: TC001
Indications for Use:
The device is intended to be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, upper extremities(arm) and lower extremities (leg) due to strain from exercise or normal household work activities. And to be used for the symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis.
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5. Technological Characteristics and Substantial Equivalence
Both the TC001 and Predicate Device utilize the application of electrical current through electrodes placed on the impulses are generated by the device and delivered through electrodes on the skin in direct proximity to the (painful) muscles to be stimulated. Basic technological characteristics, new device vs. Predicate device.
| New device | Predicate device | S.E. Discussion | ||
|---|---|---|---|---|
| 1 | 510K# | To be assigned | K173462 | N/A |
| 2 | Device Name and | |||
| Model | ThermaCare® Quick Therapy TENS | |||
| Mode: TC001 | Wireless Pain Relieve Device | |||
| Mode: LT5018C | N/A | |||
| 3 | Applicant | Pfizer Inc. | Shenzhen Dongdixin Technology Co., Ltd | N/A |
| 4 | Manufacturer | Shenzhen Dongdixin Technology Co., Ltd | Shenzhen Dongdixin Technology Co., Ltd | Same |
| 5 | Intended for use | TENS: The device is designed to be used | ||
| for temporary relief of pain associated | ||||
| with sore and aching muscles in the | ||||
| shoulder, waist, back, upper extremities | ||||
| (arm) and lower extremities (leg) due to | ||||
| strain from exercise or normal household | ||||
| work activities. And to be used for the | ||||
| symptomatic relief and management of | ||||
| chronic, intractable pain and relief of pain | ||||
| associated with arthritis. | TENS: The device is designed 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 or | ||||
| normal household work activities. And | ||||
| to be used for the symptomatic relief | ||||
| and management of chronic, intractable | ||||
| pain and relief of pain associated with | ||||
| arthritis. | ||||
| EMS: The device is designed to be used | ||||
| for stimulate healthy muscles in order to | ||||
| improve and facilitate muscle | ||||
| performance. | Applicant is not pursuing | |||
| EMS use statement for the | ||||
| new device. | ||||
| 6 | Power Source | DC 3.7V Li-ion Battery(main device) | ||
| DC 3.0V, 2 x AAA Batteries (Remote | ||||
| control) | DC 3.7V Li-ion Battery(main device) | |||
| DC 3.0V, 2 x AAA Batteries (Remote | ||||
| control) | Same | |||
| -Method of | ||||
| Line | N/A | N/A | Same | |
| current isolation | ||||
| - Patient Leakage | ||||
| Current (μΑ) | ||||
| -Normal condition | ||||
| -Single fault | ||||
| condition | d.c:0 uA. a.c.:29 uA max | |||
| d.c:0 uA. a.c.:69 uA max | 0uA | |||
| 2.0uA | Different, TC 001 have been | |||
| evaluated and passed the test | ||||
| according to the requirement | ||||
| of IEC 60601-1. | ||||
| 7 | Average DC current | |||
| through electrodes | ||||
| when device is on but | ||||
| no pulses are being | ||||
| applied (μΑ) | 0 | 0 | Same | |
| 8 | Number of Output | |||
| Modes | 1 (TENS) | 2 (TENS/EMS(including MASSAGE)) | Different, TC001 only has | |
| TENS mode and TC001 | ||||
| remove indications for use of | ||||
| EMS mode accordingly. | ||||
| 9 | Number of Output Channels | |||
| Synchronous or | ||||
| Alternating? | Alternating | N/A | Different, TC001 has two | |
| channels and each channel | ||||
| outputs have been evaluated | ||||
| and passed the test according | ||||
| to the requirement of IEC | ||||
| 60601-2-10. | ||||
| Method of Channel | ||||
| Isolation | By Electrical Circuit and Software | N/A | Different, TC001 has two | |
| channels and have been | ||||
| evaluated and passed the test | ||||
| according to the requirement | ||||
| of IEC 60601-1. | ||||
| 10 | Regulated Current or | |||
| Regulated Voltage? | Current control | Current control | Same | |
| 11 | Software/Firmware/ | |||
| Micro processor | ||||
| Control? | Yes | Yes | Same | |
| 12 | Automatic Overload | |||
| Trip | Yes | Yes | Same | |
| 13 | Automatic No Load | |||
| contact Trip | Yes | Yes | Same | |
| 14 | Automatic Shut off | Yes | Yes | Same |
| 15 | User Override | |||
| Control? | Yes | |||
| Power [on/off] button on the device | ||||
| Power [on/off] button on the remote | ||||
| control | ||||
| [Stop session] button in the APP software | Yes | |||
| Power on/off button on the device | ||||
| Power on/off on the remote control | ||||
| Power on/off in the APP software | Same function | |||
| 16 | Indicator Display: | |||
| On/Off Status? | Yes | Yes | Same | |
| Low Battery? | Yes | Yes | Same | |
| Voltage/ | ||||
| Current | ||||
| Level? | Yes | Yes | Same | |
| 17 | Timer | |||
| Range | ||||
| (minutes) | 5-30 minutes | 30 minutes | Different, new device have | |
| been evaluated and passed | ||||
| the test according to the | ||||
| requirement of IEC | ||||
| 60601-2-10. | ||||
| User can set the treatment | ||||
| time according their needs. | ||||
| 18 | Weight (grams.) | 32grams (Main device) | ||
| 55 grams (Remote control without | ||||
| batteries) | 36grams (Main device) | |||
| 65 grams (Remote control) | Different, the new device | |||
| have been evaluated and | ||||
| 19 | Dimensions | |||
| (cm.) | ||||
| H*W * L | 80.5(L)x45(W)x13.5(H)mm (Main | |||
| device) | ||||
| 127(L)x48.6(W)x24.4(H)mm (Remote | ||||
| control) | 360(L)x59(W)x11.5(H)mm | |||
| (Main | ||||
| device) | ||||
| 115(L)x53(W)x25(H)mm | ||||
| (Remote | ||||
| control) | passed the testing according | |||
| to the requirement of IEC | ||||
| 60601-1. | ||||
| 20 | Housing Materials & | ABS | ABS | Same |
| Construction | ||||
| 21 | Compliance with 21 | |||
| CFR 898 | Yes | Yes | Same | |
| 22 | Compliance | |||
| with | IEC 60601-1:2005+A1:2012 | IEC 60601-1:2005+A1:2012 | Same | |
| Voluntary Standards? | IEC 60601-1-2:2014 | IEC 60601-1-2:2014 | ||
| IEC 60601-2-10: 2012 | IEC 60601-2-10: 2012 | |||
| IEC60601-1-11: 2015 | IEC60601-1-11: 2015 | |||
| ISO 10993-1:2009 | ISO 10993-1:2009 | |||
| ISO 10993-5:2009 | ISO 10993-5:2009 | |||
| ISO 10993-10:2010 | ISO 10993-10:2010 | |||
| Table 2: Output Specification TENS mode | ||||
| New device | Predicate device | S.E. Discussion | ||
| 1 | 510K# | To be assigned | K173462 | N/A |
| 2 | Device Name | |||
| or | ThermaCare® Quick Therapy TENS | Wireless Pain Relieve Device | N / A | |
| Program Name | Mode:TC001 | Mode:LT5018C | ||
| 4 | Waveform | Biphasic | Biphasic | Same |
| 5 | Shape | Rectangular | Rectangular | Same |
| 6 | Max Output Voltage (V) ±20% | |||
| 7 | 500Ω | 30.4 | 31 | Similar, the new device have |
| 8 | 2kΩ | 70 | 66 | been evaluated and passed |
| 9 | 10kΩ | 70 | 66 | the test according |
| to the | ||||
| requirement | ||||
| IEC | ||||
| of | ||||
| 60601-2-10. | ||||
| 10 | Max Output Current (mA) ±20% | |||
| 11 | 500Ω | |||
| 2kΩ | 60.8 | 62 | Similar, the new device have | |
| been evaluated and passed | ||||
| 12 | ||||
| 13 | 35 | |||
| 7 | 33 | |||
| 6.6 | the test according to the | |||
| 10kΩ | requirement of | |||
| IEC60601-2-10 | ||||
| 14 | Pulse | |||
| Duration | 100~200us | 150~250us | Similar, the new device have | |
| (µsec) | been evaluated and passed | |||
| the test according to the | ||||
| of | ||||
| requirement | ||||
| IEC60601-2-10 | ||||
| 15 | Frequency (Hz) | 2~100Hz | 2~100Hz | Same |
| 16 | Maximum Phase | 24.32 | 31 | Similar, the new device have |
| Charge (uC) 500Ω | been evaluated and passed | |||
| 17 | Maximum Current | 0.295mA/cm2 | 0.48mA/cm2 | the test according to the |
| Density 500Ω | requirement of IEC | |||
| 18 | Maximum Average | 1.22 | 1.2 | 60601-2-10. |
| Current | ||||
| (average | ||||
| absolute | ||||
| value), | ||||
| mA, 500Ω | ||||
| 19 | Maximum Average | |||
| Power Density, | ||||
| (mW/cm²),500Ω | 1.8 | 2.88 |
Table 1: Substantial Equivalence Comparison Table
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Discussion:
The number of output modes, number of output channels, timer range, weight and dimension of the new device are different from the predicate devices, but the new devices are evaluated and passed the testing according to IEC 60601-1 and IEC 60601-2-10, this difference does not pose any new questions of safety.
The Max Output Voltage/Current, Pulse Duration, Maximum Phase Charge, Maximum Current Density and Maximum Average Power Density are similar with the predicate devices, but the new devices are evaluated and passed the testing according to IEC 60601-2-10, this difference doesn't pose any new questions of safety and effectiveness.
Performance Data: 6.
The following performance data are provided in support of the substantial equivalence determination:
6.1 Biocompatibility testing
The biocompatibility evaluation for the TC001 was conducted in accordance with the International Standard ISO 10993-1 "Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing Within a Risk Management Process". As dictated by the application and duration of contact with the intact skin, the testing included the following tests:
- Cytotoxicity
- Sensitization
- Irritation
6.2 Electrical safety and electromagnetic compatibility (EMC)
Electrical safety and EMC testing were conducted on the TC001. The system complies with the IEC 60601-1, IEC60601-1-11 and IEC 60601-2-10 standards for safety and the IEC 60601-1-2 standard for EMC.
For FCC part 15 RADIO FREQUENCY DEVICES, Subpart C—Intentional Radiators.
6.3 Software Verification and Validation Testing
Main device, Remote control and APP software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "Moderate" level of concern.
6.4 Output waveform Testing
For each program, oscilloscope tracing diagrams describing the electrical output waveform was provided to verify the output specifications of the device according to IEC 60601-2-10.
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7. Conclusions
The intended use and basic technological characteristics of the ThermaCare® Quick Therapy TENS are equivalent with those of the Predicate device K173462. Any technological differences do not raise new questions regarding safety and effectiveness.