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510(k) Data Aggregation
(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.
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