(124 days)
The Transcutaneous Electrical Nerve Stimulator (model: TENS WMPS6-1) is an electrical nerve stimulator indicated for use for pain relief by applying an electrical current to electrodes on a patient's skin to treat pain. In particular, the TENS WMPS6-1 is indicated for use for symptomatic relief of chronic intractable pain and adjunctive treatment in the management of post-surgical and post traumatic pain.
Transcutaneous Electrical Nerve Stimulator (model: TENS WMPS6-1) is an electrical nerve stimulator indicated for use for pain relief by applying an electrical current to electrodes on a patient's skin to treat pain. The device has 18 programs (13 standard programs and 5 editable programs), powered by 6 pieces of 1.5V batteries or AC 100-240V, comprising electronic stimulatory module and accessories of lead wires, electrodes. Six outlet sockets are used to connect skin electrodes by lead wires. The accessories of electrodes is 510(k) cleared device (K192568), Size: 50*50mm.
The provided text is a 510(k) summary for a Transcutaneous Electrical Nerve Stimulator (TENS) device. It details the device's technical specifications and a comparison to a predicate device to establish substantial equivalence for regulatory clearance. This document does not describe an AI-powered medical device or an associated study for complex acceptance criteria like those involving AI performance metrics (e.g., sensitivity, specificity, MRMC studies, ground truth establishment by experts).
Therefore, I cannot extract the requested information regarding AI device acceptance criteria and study details from the provided text. The device is a physical medical device (TENS) and the "study" referred to in the document is a series of non-clinical bench tests to compare it to a predicate device, and to verify safety and performance standards.
Here's a breakdown of why I cannot fulfill your request based on the provided text:
- No AI Component: The device is a Transcutaneous Electrical Nerve Stimulator, a physical product that applies electrical current. There is no mention of any AI or machine learning component.
- No Diagnostic/Interpretive Task: The device is for pain relief, not for image analysis, diagnosis, risk prediction, or any other task that would typically involve acceptance criteria like sensitivity, specificity, or the need for ground truth established by experts.
- No Human-in-the-Loop Study: Since there's no AI component, there's no MRMC (Multi-Reader Multi-Case) study described for human readers improving with AI assistance.
- No Standalone Algorithm Performance: There is no algorithm to assess in a standalone capacity.
- No Training Set/Test Set (in the AI context): The concepts of training and test sets as they apply to machine learning models are not relevant to the clearance of this physical device. The "test set" here refers to the device itself undergoing bench tests.
- No Ground Truth Establishment by Experts: Ground truth for AI models is often established by expert consensus (e.g., radiologists reviewing images). For this TENS device, "ground truth" would refer to its physical and electrical properties meeting specified standards, validated through engineering tests, not human interpretation.
Summary of what the document DOES describe in terms of performance and comparison:
The document describes acceptance criteria in the context of substantial equivalence to an existing predicate device and compliance with voluntary standards for electrical medical equipment.
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Acceptance Criteria (Implicit via Comparison to Predicate and Standards Compliance): The acceptance criteria are primarily demonstrated by showing that the new device's specifications (e.g., power source, output channels, waveform, voltage, current, safety features) are either identical, similar with acceptable differences (justified by safety and effectiveness analyses), or meet the requirements of relevant electrical safety and performance standards (ANSI AAMI ES60601-1, IEC 60601-1-2, IEC 60601-2-10). The reported device performance is presented as compliance with these standards and the specific electrical output values listed in the comparison table.
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Study That "Proves" Compliance: The "study" here is a series of non-clinical bench tests.
- Sample Size: This is not a study with a "sample size" in the statistical sense of patient data. It refers to testing the physical device itself.
- Data Provenance: Not applicable as it's not a data-driven AI study. The tests are bench tests performed on the device.
- Experts and Ground Truth: Not applicable in the way you've defined them for an AI study. Electrical engineers and regulatory compliance experts would be involved in setting and verifying the test standards.
- Adjudication Method: Not applicable.
- MRMC Comparative Effectiveness Study: No.
- Standalone Performance: The "standalone" performance here refers to the device successfully passing all required electrical and safety tests independently (i.e., not reliant on human interpretation for its function).
- Type of Ground Truth: The "ground truth" is compliance with established engineering and medical device safety standards for TENS devices (e.g., maximum current density limits, electrical isolation, waveform characteristics).
- Training Set/Ground Truth for Training: Not applicable.
If you have a document describing an AI medical device, please provide that, and I will be able to answer your questions with the level of detail you are seeking.
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January 24, 2023
Wuxi Jiajian Medical Instrument Co., Ltd Wu Zhifang General manager No.35 Baiqiao Rd., Ehu Town, Xishan District, WuXi, JiangSu 214116 China
Re: K222879
Trade/Device Name: Transcutaneous Electrical Nerve Stimulator (model: TENS WMPS6-1) Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator For Pain Relief Regulatory Class: Class II Product Code: GZJ Dated: December 7, 2022 Received: December 8, 2022
Dear Wu Zhifang:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the 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.
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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) for devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/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.
Lauren E. Woodard -S
for Amber Ballard, PhD Assistant Director DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K222879
Device Name
Transcutaneous Electrical Nerve Stimulator (model: TENS WMPS6-1)
Indications for Use (Describe)
The Transcutaneous Electrical Nerve Stimulator (model: TENS WMPS6-1) is an electrical nerve stimulator indicated for use for pain relief by applying an electrical current to electrodes on a patient's skin to treat pain. In particular, the TENS WMPS6-1 is indicated for use for symptomatic relief of chronic intractable pain and adjunctive treatment in the management of post-surgical and post traumatic pain.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | |
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary [As required by 21 CFR 807.92]
| 1. Submission Information | |
|---|---|
| 510(k) Number: | K222879 |
| Date: | January 23, 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, China214116 | |
| Contact:Wu Zhifang | |
| E-mail: doris.d@ceve.org.cn | |
| Tel: 86 510-88745788 | |
| 2. Device Description | |
| Proprietary Name: | Transcutaneous Electrical Nerve Stimulator (model: TENS WMPS6- 1) |
| Common Name: | TENS (Transcutaneous Electrical Nerve Stimulator) |
| Classification Name: | Transcutaneous electrical nerve stimulator for pain relief |
| Product Code: | GZJ |
| Device Class: | 2 |
| Regulation Number: | 21 CFR 882.5890 |
| Review Panel: | Neurology |
| Indications for use: | The Transcutaneous Electrical Nerve Stimulator (model: TENSWMPS6-1) is an electrical nerve stimulator indicated for use for pain reliefby applying an electrical current to electrodes on a patient's skin to treatpain. In particular, the TENS WMPS6-1 is indicated for use forsymptomatic relief of chronic intractable pain and adjunctive treatment inthe management of post-surgical and post traumatic pain. |
| Device Description: | Transcutaneous Electrical Nerve Stimulator (model: TENS WMPS6-1) isan electrical nerve stimulator indicated for use for pain relief by applyingan electrical current to electrodes on a patient's skin to treat pain.The device has 18 programs (13 standard programs and 5 editableprograms), powered by 6 pieces of 1.5V batteries or AC 100-240V,comprising electronic stimulatory module and accessories of lead wires,electrodes.Six outlet sockets are used to connect skin electrodes by lead wires. Theaccessories of electrodes is 510(k) cleared device (K192568), Size:50*50mm. |
3. Predicate Device Identification
| Predicate 510(k) Number: | K220578 |
|---|---|
| Marketing clearance date: | May 25, 2021 |
| Product name: | Transcutaneous Electrical Nerve Stimulator |
| Manufacturer: | Bozhou Rongjian Medical Appliance Co.,Ltd. |
4. Substantially Equivalent Comparison Conclusion
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| Parameters | New Device | Predicate Device | Comparison | |
|---|---|---|---|---|
| 510(k) Number | K222879 | K220578 | -- | |
| Device Name | Transcutaneous ElectricalNerve Stimulator (model: TENSWMPS6-1) | Transcutaneous ElectricalNerve Stimulator (RJTENS-1) | -- | |
| Manufacturer | Wuxi Jiajian MedicalInstrument Co., Ltd | Bozhou Rongjian MedicalAppliance Co.,Ltd. | -- | |
| Intended use | Transcutaneous ElectricalNerve Stimulator(model: TENSWMPS6-1) is an electricalnerve stimulator indicated foruse for pain relief by applyingan electrical current toelectrodes on a patient's skin totreat pain. In particular, thisdevice is indicated for use forsymptomatic relief of chronicintractable pain and adjunctivetreatment in the management ofpost surgical and post traumaticpain. | Transcutaneous ElectricalNerve Stimulator is an electricalnerve stimulator indicated foruse for pain relief by applyingan electrical current toelectrodes on a patient's skin totreat pain. In particular, thisdevice is indicated for use forsymptomatic relief of chronicintractable pain and adjunctivetreatment in the management ofpost surgical and post traumaticpain. | Same | |
| Type of use | Prescription use | Prescription use | Same | |
| Power Source(s) | DC9V(6×1.5V disposablealkaline battery R14/UM2 type)Power adapter:Model:GTM96060-0612-3.0Input:100-240V~,50/60Hz;Output:DC9V,0.5A | 1.5Vx4 AAA alkaline battery | SimilarNote 1 | |
| - Method of LineCurrent Isolation | N/A | N/A | Same | |
| - Patient LeakageCurrent | -- | -- | -- | |
| - NormalCondition (μΑ)- Single FaultCondition (μA) | 2μANA | 2μANA | Same | |
| Average DC currentthrough electrodeswhen device is on butno pulses are beingapplied (μΑ) | <0.01μA | <0.01μA | Same | |
| Number of program | 18 | 16 | SimilarNote 2 | |
| Number of Outputchannels: | 6 (No more than two channelscan be used on the same | 2 | SimilarNote 2 | |
| - Synchronousor Alternating? | person.) | Synchronous | Same | |
| - Method ofChannel Isolation | By Transformer | By Transformer | Same | |
| Regulated Current orRegulated Voltage? | Current control | Current control | Same | |
| Software/Firmware/MicroprocessorControl? | Yes | Yes | Same | |
| Automatic OverloadTrip? | No | No | Same | |
| Automatic No-LoadTrip? | No | No | Same | |
| Automatic Shut Off? | Yes | Yes | Same | |
| User OverrideControl? | Yes | Yes | Same | |
| On/OffStatus? | Yes | Yes | Same | |
| Indicator LowBattery? | Yes | Yes | Same | |
| Display Voltage/CurrentLevel? | Yes | Yes | Same | |
| Timer Range(minutes) | 1~99 min | 10~90 min | SimilarNote 2 | |
| Compliance withVoluntary Standards? | ANSI AAMI ES60601-1, IEC60601-1-2, IEC 60601-2-10 | ANSI AAMI ES60601-1, IEC60601-1-2, IEC 60601-2-10 | Same | |
| Compliance with 21CFR 898? | Yes | Yes | Same | |
| Weight (grams) | Approx.650g without battery | Approx.96g without battery | SimilarNote 3 | |
| Dimensions (mm) [Wx H x D] | 23817572mm | 1406428 mm | SimilarNote 3 | |
| Housing Materials &Construction | ABS | ABS | Same | |
| Waveform | Biphase | Monophasic | SimilarNote 4 | |
| Shape | Rectangular pulse | Rectangular pulse | Same | |
| Maximum OutputVoltage (volts) | 50V±20% @500Ω | 30V±10% @500Ω | ||
| Maximum OutputCurrent (specifyunits) | 100mA±20% @500Ω | 60mA±10% @500Ω | SimilarNote 5 | |
| Pulse width (usec) | 50-250μs±20% | 75-300μs±10% | ||
| Pulse Period (msec) | 10-1000ms | 8.33-1000ms | ||
| Max. pulse frequency(Hz) [or Rate (pps)] | 1-100Hz±10% | 1-120Hz±10% | ||
| Net Charge ( $\mu$ C perpulse) | 0 $\mu$ C @500Ω(Method: Balancedwaveform) | 0.65 $\mu$ C @500Ω | ||
| Maximum PhaseCharge, ( $\mu$ C) | 25 $\mu$ C @500Ω | 18 $\mu$ C @500Ω | ||
| Maximum AverageCurrent, (mA) | 2.5mA @500Ω | 2.16mA @500Ω | SimilarNote 6 | |
| Maximum CurrentDensity, (mA/cm², r.m.s.) | 0.1mA/cm² @500Ω | 0.09mA/cm² @500Ω | ||
| Maximum AveragePower Density, (mW/cm²) | 5mW/cm² @500Ω | 2.59mW/cm² @500Ω | ||
| Accessories | Electrodes, cables,battery(usersneed to purchase theirown),adapter(users need topurchase their own) | Electrodes, cables, battery | SimilarNote 3 |
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Comparison in details:
Note 1:
The power source(s) and battery charge of the proposed device are a little different from the predicate device, but these differences are insignificant in terms of safety or effectiveness. In addition, the proposed device has passed the electrical safety test and ,so these differences don't raise any new safety and effectiveness issues.
Note 2:
The number of modes and treatment times are only different by design; the core principles of these two devices are similar, although the number of channels is increased to 6 channels, the same person can use up to two channels, which is the same as the number of predicate device channels, and does not cause security and effectiveness problems.
Note 3:
The weight, dimensions and accessories of the proposed device are a little different from the predicate device, this is a slightly different product design, but these differences are insignificant in terms of safety or effectiveness.
Note 4:
The output waveform of the new device is different from that of the predicate device. In addition, the proposed device has passed AAMI / ANSI ES60601-1, IEC 60601-1-2 and IEC 60601-2-10 tests, so these differences don't raise any new safety and effectiveness issues.
Note 5:
There are some differences on the maximum output voltage and maximum output current between the proposed device and predicate device. Based on the calculation of maximum current density, maximum average power density, these parameters don't exceed the safety limit. All deviation and the worst case have been considered in risk analysis report, and these parameters have passed IEC 60601-2-10 test codes. So these differences will not raise any new safety and effectiveness issues. Although the pulse period and frequency of the proposed device are a little different from the predicate device, but they are all
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compliance with IEC 60601-2-10 requirements. So, the minor differences of function specification will not raise any safety or effectiveness issue.
Note 6:
The net charge and maximum phase charge of the proposed device are different from the predicate device, and both of them comply with IEC 60601-1 and IEC 60601-2-10 requirements. So, the differences will not raise any safety or effectiveness issue.The maximum average current, maximum current density, maximum average power density have some differences between proposed device and predicate device. Both of them meet maximum average current <10mA, maximum current density <2mA/cm² and maximum average power density <0.25W/cm². Therefore, these differences won't raise any new safety and effectiveness issues.Also, all programs have passed AAMI/ANSI ES 60601-2-10 tests. Therefore, these differences don't raise any new safety and effectiveness issues.
5. Non-Clinical Test Conclusion
Bench tests were conducted on Transcutaneous Electrical Nerve Stimulator (model: TENS WMPS6-1) to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. 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:
6. Clinical Test
Clinical data was not including in this submission.
7. Conclusions
The conclusions drawn from the non-clinical tests demonstrate that the device is as safe, as effective, and performs as well as the legally marketed device identified in 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).