(315 days)
Transcutaneous Electrical Nerve Stimulator (Model:TENS WMPS2-1) can be used for the symptomatic relief of chronic intractable pain, post traumatic pain adjunctive treatment, and post-surgical pain adjunctive treatment.
Transcutaneous Electrical Nerve Stimulator sends gentle electrical current to underlying nerves and muscle groups via electrodes applied onto the skin to relieve pain. The device has 16 programs (12 standard programs and 4 editable programs). It is a lithium battery-powered device comprising the electronic stimulatory module, the accessories of lead wires, the electrodes and the adapter. Two outlet sockets are used to connect skin electrodes by lead wires. The accessories of electrodes are 510(k) cleared devices (K192568). Size 50*50mm.
Here's a breakdown of the acceptance criteria and the study information based on the provided document:
1. Table of Acceptance Criteria and the Reported Device Performance:
The document describes the acceptance criteria in terms of compliance with various international standards for medical electrical equipment and a comparison to a predicate device. The reported performance is implicitly stated by asserting compliance with these standards and the substantial equivalence to the predicate.
| Criteria Category | Acceptance Criteria (from referenced standards or predicate comparison) | Reported Device Performance (as stated in the document) |
|---|---|---|
| General Safety & Essential Performance | Compliance with Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance (ANSI AAMI ES60601-1: 2005/(R) 2012 And A1: 2012, C1: 2009/(R) 2012 And A2: 2010/(R) 2012 (Consolidated Text) Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance (IEC 60601-1: 2005, MOD)) | Bench tests demonstrated the device met all design specifications. Specifically, it passed ANSI AAMI ES60601-1. The differences in power source, output intensity control, average DC current at no load, number of output modes, channel output design and isolation methods, automatic no trip, user override control, net charge, maximum phase charge, maximum average current, maximum current density, and maximum average power density were evaluated and found to not raise any new safety or effectiveness issues, demonstrating compliance with the standard's safety limits. |
| Nerve & Muscle Stimulator Specifics | Compliance with Medical Electrical Equipment - Part 2-10: Particular Requirements for the Basic Safety and Essential Performance Of Nerve and Muscle Stimulators (IEC 60601-2-10 Edition 2.1 2016-04) | The device passed IEC 60601-2-10 tests. All programs passed these tests. The differences in power source, output intensity control, average DC current at no load, number of output modes, channel output design and isolation methods, automatic no trip, user override control, net charge, maximum phase charge, maximum average current, maximum current density, and maximum average power density were evaluated and found to not raise any new safety or effectiveness issues, demonstrating compliance. |
| Electromagnetic Compatibility (EMC) | Compliance with Medical electrical equipment - Part 1-2: General Requirements for Basic Safety and Essential Performance - Collateral Standard: Electromagnetic Disturbances - Requirements and Tests (IEC 60601-1-2 Edition 4.0 2014-02) | The device passed IEC 60601-1-2. |
| Home Healthcare Environment | Compliance with Medical Electrical Equipment -- Part 1-11: General Requirements For Basic Safety and Essential Performance -- Collateral Standard: Requirements for Medical Electrical Equipment and Medical Electrical Equipment and Medical Electrical Systems Used in Home Healthcare Environment (IEC 60601-1-11 Edition 2.0 2015-01) | The device passed IEC 60601-1-11. |
| Power Source(s) | Complies with IEC 60601-1 requirements. | DC3.7 V Li-battery powered. Considered "Similar" to predicate but complies with IEC 60601-1. Differences will not raise safety or effectiveness issues. |
| Output Intensity Control | Complies with IEC 60601-1 requirements. | Current control. Considered "Similar" to predicate but complies with IEC 60601-1. Differences will not raise safety or effectiveness issues. |
| Average DC current at no load | Similar to predicate device and passes AAMI / ANSI ES60601-1 and IEC 60601-2-10 tests. | <0.01μΑ. Considered "Similar" to predicate. Passed AAMI / ANSI ES60601-1 and IEC 60601-2-10. Will not raise new safety or effectiveness issues. |
| Number of Program(s) | Similar to predicate device and passes AAMI / ANSI ES60601-1 and IEC 60601-2-10 tests. | 16. Considered "Similar" to predicate. Passed AAMI / ANSI ES60601-1 and IEC 60601-2-10. Will not raise new safety or effectiveness issues. |
| Channel Output Design & Isolation | Similar to predicate device and passes AAMI / ANSI ES60601-1 and IEC 60601-2-10 tests. | 2 channels, Alternating, By Transformer. Considered "Similar" to predicate. Passed AAMI / ANSI ES60601-1 and IEC 60601-2-10. Will not raise new safety or effectiveness issues. |
| Automatic No-Load Trip | Similar to predicate device and passes AAMI / ANSI ES60601-1 and IEC 60601-2-10 tests. | No. Considered "Similar" to predicate. Passed AAMI / ANSI ES60601-1 and IEC 60601-2-10. Will not raise new safety or effectiveness issues. |
| User Override Control | Similar to predicate device and passes AAMI / ANSI ES60601-1 and IEC 60601-2-10 tests. | Yes. Considered "Similar" to predicate. Passed AAMI / ANSI ES60601-1 and IEC 60601-2-10. Will not raise new safety or effectiveness issues. |
| Net Charge & Max Phase Charge | Complies with IEC 60601-1 and IEC 60601-2-10 requirements. | Net Charge: 0μC @500Ω (Balanced waveform). Maximum Phase Charge: 9μC @500Ω. Stated to comply with IEC 60601-1 and IEC 60601-2-10 requirements and will not raise safety or effectiveness issues. |
| Max Average Current | <10mA, and passes AAMI/ANSI ES 60601-1 and IEC 60601-2-10 tests. | 2.16mA @500Ω. Meets the limit and passed the relevant tests. |
| Max Current Density | <2mA/cm², and passes AAMI/ANSI ES 60601-1 and IEC 60601-2-10 tests. | 0.043mA/cm² @500Ω. Meets the limit and passed the relevant tests. |
| Max Average Power Density | <0.25W/cm², and passes AAMI/ANSI ES 60601-1 and IEC 60601-2-10 tests. | 1.30mW/cm² @500Ω. Meets the limit and passed the relevant tests. |
| All Programs Compliance | All programs comply with AAMI/ANSI ES 60601-1 and IEC 60601-2-10 tests. | All programs have passed AAMI/ANSI ES 60601-1 and IEC 60601-2-10 tests. |
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not applicable. The tests performed were non-clinical bench tests on the device itself, not tests involving human subjects or data sets.
- Data Provenance: Not applicable, as no external data was used for performance validation in terms of a clinical test set. The provenance relates to the device's design specifications and its manufacturing processes.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. As this was a non-clinical bench test study, there were no human experts establishing a "ground truth" for a test set in the way one would for diagnostic imaging studies. The "ground truth" was established based on compliance with internationally recognized electrical safety and performance standards (e.g., IEC 60601 series). The experts involved would be engineers and testing personnel qualified to perform and interpret these specific standards, but their number and specific qualifications are not detailed in this summary.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. There was no clinical test set requiring adjudication. The assessment was based on objective measurements and adherence to engineering standards.
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:
- No. This filing is for a Transcutaneous Electrical Nerve Stimulator (TENS device), which directly manages pain through electrical stimulation. It is not an AI-assisted diagnostic imaging device, so an MRMC comparative effectiveness study involving human readers and AI assistance is not relevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an algorithm or AI-based device. The device operates as a standalone pain relief stimulator.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this device's acceptance is its compliance with established international safety and performance standards for medical electrical equipment, specifically those applicable to nerve and muscle stimulators (e.g., IEC 60601-1, IEC 60601-2-10, IEC 60601-1-2, IEC 60601-1-11). The predicate device's performance also serves as a benchmark for demonstrating substantial equivalence.
8. The sample size for the training set:
- Not applicable. There is no training set for this type of medical device. Product development and testing are based on engineering specifications and compliance with standards.
9. How the ground truth for the training set was established:
- Not applicable, as there is no training set.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image shows 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 text logo on the right. The text logo has the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
March 27, 2024
Wuxi Jiajian Medical Instrument Co., Ltd % Doris Dong General manager Shanghai CV Technology Co., Ltd. Room 602, No.19 Dongbao Road, Songjiang Area, Shanghai. Shanghai 201613 China
Re: K231425
Trade/Device Name: Transcutaneous Electrical Nerve Stimulator (TENS WMPS2-1) Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous electrical nerve stimulator for pain relief Regulatory Class: Class II Product Code: NUH Dated: December 28, 2023 Received: December 28, 2023
Dear Doris Dong:
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 (the 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 available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
{1}------------------------------------------------
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-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
Pamela Scott Assistant Director DHT5B: Division of Neuromodulation and Rehabilitation Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
{2}------------------------------------------------
Indications for Use
510(k) Number (if known) K231425
Device Name
Transcutaneous Electrical Nerve Stimulator(TENS WMPS2-1)
Indications for Use (Describe)
Transcutaneous Electrical Nerve Stimulator (Model:TENS WMPS2-1) can be used for the symptomatic relief of chronic intractable pain, post traumatic pain adjunctive treatment, and post-surgical pain adjunctive treatment.
| 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{3}------------------------------------------------
510(k) Summary
[As required by 21 CFR 807.92]
1. Submission Information
| 510(k) Number: | K231425 |
|---|---|
| Date: | May 10, 2023 |
| Type of 510(k) Submission: | Traditional 510(k) |
| Submitter/Manufacturer: | Wuxi Jiajian Medical Instrument Co., Ltd.No. 35 Baiqiao Rd., Ehu Town, Xishan District, Wuxi, Jiangsu, China214116E-mail: sch@jjmed.com.cnTel: 86 510-88745788 |
| Contactor: | Doris Dong[Consultant, from Shanghai CV Technology Co., Ltd.]Add: Room 602, No. 19 Dongbao Road, Songjiang Area, Shanghai,201613 ChinaE-mail: doris.d@ceve.org.cnTel: 86 21-31261348 / Fax: 86 21-57712250 |
2. Device Description
| Proprietary Name: | Transcutaneous Electrical Nerve Stimulator |
|---|---|
| Model: | TENS WMPS2-1 |
| Common Name: | Stimulator, Nerve, Transcutaneous, Over-The-Counter |
| Classification Name: | Transcutaneous electrical nerve stimulator for pain relief |
| Product Code: | NUH |
| Device Class: | 2 |
| Regulation Number: | 21 CFR 882.5890 |
| Review Panel: | Neurology |
| Indications for use: | Transcutaneous Electrical Nerve Stimulator (Model:TENS WMPS2-1) canbe used for the symptomatic relief of chronic intractable pain, posttraumatic pain adjunctive treatment, and post-surgical pain adjunctivetreatment. |
| Device Description: | Transcutaneous Electrical Nerve Stimulator sends gentle electrical currentto underlying nerves and muscle groups via electrodes applied onto the skinto relieve pain.The device has 16 programs (12 standard programs and 4 editableprograms). It is a lithium battery-powered device comprising the electronicstimulatory module, the accessories of lead wires, the electrodes and theadapter.Two outlet sockets are used to connect skin electrodes by lead wires. Theaccessories of electrodes are 510(k) cleared devices (K192568). Size50*50mm. |
{4}------------------------------------------------
3. Predicate Device Identification
| Predicate 510(k) Number: | K210223 |
|---|---|
| Marketing Clearance Date: | December 15,2021 |
| Product Name: | Transcutaneous Electrical Nerve Stimulator |
| Manufacturer: | Top-Rank Health Care Co.,Ltd. |
| Reference Predicate 510(k) Number: | K123958 |
| Marketing clearance date: | October 28,2013 |
| Product name: | Jiajian® Pointoselect Digital |
| Manufacturer: | Wuxi Jiajian Medical Instrument Co., Ltd |
| Parameters | New Device | Predicate Device | ReferencePredicate Device | Comparison | |
|---|---|---|---|---|---|
| 510(k) Number | K231425 | K210223 | K123958 | -- | |
| Device Name | TranscutaneousElectrical NerveStimulator | TranscutaneousElectrical NerveStimulator | Jiajian® PointoselectDigital | -- | |
| Model | TENS WMPS2-1 | TOPTENS-01 | -- | ||
| Manufacturer | Wuxi JiajianMedical InstrumentCo., Ltd | Top-Rank HealthCare Co.,Ltd. | Wuxi JiajianMedical InstrumentCo., Ltd | -- | |
| Indications for use | TranscutaneousElectricalNerveStimulator(Model:TENSWMPS2-1) can beusedforthesymptomatic reliefof chronicintractable pain,post traumatic painadjunctivetreatment,andpost-surgical painadjunctivetreatment. | The TOPTENS-01can be used for thesymptomatic reliefof chronicintractable pain,post traumatic painadjunctivetreatment, andpost-surgical painadjunctivetreatment. | Jiajian® PointoselectDigital is intendedfor use in thesymptomatic reliefof chronicintractable pain,postoperative pain,and acute pain. | Same | |
| Type of use | OTC | OTC | Prescription use | Same | |
| Power Source(s) | DC3.7 V Li-batterypowered | DC 4.5V, 3 AAAbatteries | DC 9V battery,Type 6F22 | SimilarNote 1 | |
| - Method of LineCurrent Isolation | N/A | N/A | N/A | Same | |
| - Patient LeakageCurrent | -- | -- | -- | Same | |
| - Normal Condition | 2μA | 2μA | 20μA | ||
| (μΑ) | |||||
| - Single FaultCondition (μΑ) | N/A | N/A | N/A | ||
| Average DC currentthrough electrodeswhen device is onbut no pulses arebeing applied (µA) | <0.01μΑ | Not Published | Not Published | SimilarNote 2 | |
| Number of program | 16 | 9 | 1 | SimilarNote 2 | |
| Number of Outputchannels: | 2 | 2 | 1 | Same | |
| - Synchronous orAlternating? | Alternating | Synchronous | N/A | SimilarNote 2 | |
| - Method ofChannel Isolation | By Transformer | By enclosure | N/A | SimilarNote 2 | |
| Regulated Currentor RegulatedVoltage? | Current control | Voltage control | Current control | SimilarNote 1 | |
| Software/Firmware/MicroprocessorControl? | Yes | Yes | Yes | Same | |
| Automatic OverloadTrip? | No | No | No | Same | |
| Automatic No-LoadTrip? | No | Yes | No | SimilarNote 2 | |
| Automatic ShutOff? | Yes | Yes | Yes | Same | |
| User OverrideControl? | Yes | No | No | SimilarNote 2 | |
| On/OffStatus? | Yes | Yes | Yes | Same | |
| IndicatorDisplay | LowBattery? | Yes | Yes | Yes | Same |
| Voltage/CurrentLevel? | Yes | Yes | Yes | Same | |
| Timer Range(minutes) | 10~99 min | 50~60 min(5,10,15,20,25,30,35,40, 45,50,55and 60min selectable) | Manually controlled | SimilarNote 3 | |
| Compliance withVoluntaryStandards? | AAMI/ANSI ES60601-1, IEC60601-1-2, IEC60601-2-10, IEC60601-1-11 | AAMI/ANSI ES60601-1, IEC60601-1-2, IEC60601-2-10, IEC60601-1-11 | AAMI/ANSI ES60601-1, IEC60601-1-2, IEC60601-2-10 | Same |
4. Substantially Equivalent Comparison Conclusion
{5}------------------------------------------------
{6}------------------------------------------------
| Compliance with 21CFR 898? | Yes | Yes | Yes | Same |
|---|---|---|---|---|
| Weight (grams) | Approx.106g | 0.18 (BatteryExcluded).lbs | 123g | SimilarNote 3 |
| Dimensions (mm)[W x H x D] | 1406020mm | 2.324.961.18 mm | 1156030mm | SimilarNote 3 |
| Housing Materials& Construction | ABS | Plastic (ABS)enclosure | ABS; Injectionmolded | Same |
| Waveform | Biphasic | Biphasic | Biphasic | Same |
| Shape | Square | Square | Asymmetricbiphasic squarewave | Same |
| Maximum OutputVoltage (volts) | Program 1 | Mode 4 | -- | SimilarNote 4 |
| 15V±20% @500Ω | 23V @500Ω | 6.6V±15%@500Ω | ||
| 60V±20% @2kΩ | 60V@2kΩ | 26.0 ±15%@2kΩ | ||
| 85V±20% @10kΩ | 100V @10kΩ | 125V ±15% @10kΩ | ||
| Maximum OutputCurrent (specifyunits) | Program 1 | Mode 4 | -- | |
| 30mA±20% @500Ω | 46mA @500Ω | 13.2mA±15%@500Ω | ||
| 30mA±20% @2kΩ | 30mA @2kΩ | 13.0mA±15%@2kΩ | ||
| 8.5mA±20% @10kΩ | 10mA @10kΩ | 12.5mA±15%@10kΩ | ||
| Pulse width (μsec) | 75-300μs±20% | 100-260μs | 60-120μs | |
| Pulse Period (msec) | 8.33-1000ms | 6.67-16.67ms | 55.6-500ms | |
| Max. pulsefrequency (Hz) [orRate (pps)] | 1-120Hz±20% | 60-150Hz | 2-18Hz | |
| Net Charge (μC perpulse) | 0μC@500Ω(Method:Balancedwaveform) | 0μC@500Ω(Method:Balancedwaveform) | 0μC @500Ω, + and– pulses cancel | Same |
| Maximum PhaseCharge, (μC) | 9μC @500Ω | 17.16μC @500Ω | 2.4μ C@500Ω | |
| Maximum AverageCurrent, (mA) | 2.16mA @500Ω | 2.22mA @500Ω | Not Published | |
| Maximum CurrentDensity, (mA/cm², r.m.s.) | 0.043mA/cm²@500Ω | 0.14mA/cm²@500Ω | 12.08mA/cm²@500Ω | SimilarNote 5 |
| Maximum AveragePower Density,(mW/cm²) | 1.30mW/cm²@500Ω | 1.50mW/cm²@500Ω | 0.0036W/cm²@500Ω | |
| Accessories | Electrodes, cables,adapter | Electrodes, cables | 1 pcs. of hand probefor stimulation withlead wire;1 pcs. of handelectrode with leadwire | SimilarNote 3 |
| Comparison in details: |
{7}------------------------------------------------
{8}------------------------------------------------
Note 1:
Although the proposed device's power source(s) and output intensity control are a little different from those of the predicate device, they all comply with IEC 60601-1 requirements. So the differences will not raise any safety or effectiveness issues.
Note 2:
The proposed device's average DC current at no load, number of output modes, channel output design and isolation methods,automatic no trip and user override control are different from those of the primary predicate device. As the proposed device and predicate device adopt the same fundamental output technology and have similar treatment effect, therefore, the proposed device is considered to be substantially equivalent. Also, the proposed device had passed AAMI / ANSI ES60601-1 and IEC 60601-2-10 tests, so these differences will not raise any new safety and effectiveness issues.
Note 3:
The time range, weight, dimensions and accessories of the proposed device are a little different from those of the predicate device, depending on the design and sales requirements of the product. But these differences are insignificant in terms of safety or effectiveness.
Note 4:
There are some differences in the maximum output voltage and maximum output current between the proposed device and the predicate device. Based on the calculation of maximum current density, maximum average power density, these parameters don't exceed the safety limit. Also, these parameters have passed IEC 60601-2-10 test codes and all deviation and the worst cases have been considered in risk analysis report..So these differences will not raise any new safety and effectiveness issues. Although the pulse width, pulse period and frequency of the proposed device are a little different from those of the predicate device, but they are all in compliance with IEC 60601-2-10 requirements. The minor differences of function specification will not raise any safety or effectiveness issue, either.
Note 5:
The net charge and maximum phase charge of the proposed device are different from those of the predicate device, but both of them comply with IEC 60601-1 and IEC 60601-2-10 requirements, so the differences will not raise any safety or effectiveness issues. The maximum average current, maximum current density, maximum average power density have some differences between the proposed device and the predicate device. But both of them meet the maximum average current of <10mA, the maximum current density of <2mA/cm² and the maximum average power density of <0.25W/cm². Also, all programs have passed AAMI/ANSI ES 60601-1 and IEC 60601-2-10 tests. Therefore, these differences will not raise any new safety and effectiveness issues.
5. Non-Clinical Test Conclusion
Bench tests were conducted on Transcutaneous Electrical Nerve Stimulator (TENS WMPS2-1) to verify that the proposed device met all design specifications and was Substantially Equivalent (SE) to the predicate devices. The following tests were performed on the proposed device:
• ANSI AAMI ES60601-1: 2005/(R) 2012 And A1: 2012, C1: 2009/(R) 2012 And A2: 2010/(R) 2012 (Consolidated Text) Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance (IEC 60601-1: 2005, MOD);
• IEC 60601-2-10 Edition 2.1 2016-04, Medical Electrical Equipment - Part 2-10: Particular Requirements for the Basic Safety and Essential Performance Of Nerve and Muscle Stimulators;
· IEC 60601-1-2 Edition 4.0 2014-02 Medical electrical equipment - Part 1-2: General Requirements for Basic Safety and Essential Performance - Collateral Standard: Electromagnetic Disturbances - Requirements and Tests;
{9}------------------------------------------------
• IEC 60601-1-11 Edition 2.0 2015-01 Medical Electrical Equipment -- Part 1-11: General Requirements For Basic Safety and Essential Performance -- Collateral Standard: Requirements for Medical Electrical Equipment and Medical Electrical Equipment and Medical Electrical Systems Used in Home Healthcare Environment
6. Clinical Test
Clinical data were not included in this submission.
7. Conclusion
The conclusion drawn from the non-clinical tests demonstrates that the device performs well and is as safe, and effective as the legally marketed device identified in the submission. Thus, the 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).