(102 days)
To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, arm, and leg, due to strain from exercise or normal household and work activities.
Digital TENS Unit is a Transcutaneous Electrical Nerve Stimulator (TENS), intended for the over-the-counter use to relieve pain in different body areas (neck, shoulders, back, waists, arms, and legs). At the same time, the proposed TENS device, which is compact, portable, and microprocessor-controlled, delivers a gentle electrical pulse through the Pad Lead Cords and Electrode Gel Pads to the uses' skin for pain relief. to the user's skin through the pad lead cords and electrode gel pads to the user's skin for pain relief. According to the need of users, the pulse intensity can be adjustable on the Controller's interface of the device.
This document is a 510(k) Summary for a Digital TENS Unit (Model: 1653195). It is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to legally marketed predicate devices. As such, the document does not contain acceptance criteria or study results for device performance.
Instead, it focuses on demonstrating equivalence through comparisons of technical characteristics and compliance with recognized standards.
Here's what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
This document does not define acceptance criteria for device performance nor does it report on specific device performance metrics in the way a clinical study or performance evaluation would. Instead, it presents a comparison of the subject device's specifications against those of predicate devices, along with compliance to relevant standards.
The table in the document provides specifications for the "Subject Device" (Digital TENS Unit) and several "Predicate Device" TENS units. This is a comparison of technical specifications, not acceptance criteria and performance results.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This document refers to the safety and performance evaluation tests conducted according to various standards (Biocompatibility, EMC, Electrical Safety, Software V&V, Waveform test). It does not describe a clinical study with a test set of data, sample sizes, or data provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. Ground truth and expert consensus are typically part of clinical or diagnostic performance studies, which are not detailed in this 510(k) summary.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. As no clinical test set or ground truth establishment is described, no adjudication method is mentioned.
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
Not applicable. This device is a Transcutaneous Electrical Nerve Stimulator (TENS) for pain relief, not an AI-assisted diagnostic or imaging device. Therefore, MRMC studies and AI assistance metrics are not relevant here.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
Not applicable. See point 3. The "ground truth" for this type of device primarily relates to meeting established electrical and safety standards for TENS devices.
8. The sample size for the training set
Not applicable. This document does not describe a machine learning algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable. See point 8.
Summary of available information from the document related to "acceptance criteria" and "study":
The document details the evaluations conducted to demonstrate the safety and electrical performance of the Digital TENS Unit. These studies are not "clinical studies" in the sense of patient outcomes or diagnostic accuracy, but rather engineering and safety compliance tests.
"Acceptance Criteria" (Implied by Standards Compliance):
The implied "acceptance criteria" are the requirements set forth by the following international and FDA recognized standards:
- Biocompatibility: ISO 10993-5 (Tests for in vitro cytotoxicity) and ISO 10993-10 (Tests for irritation and skin sensitization).
- Electromagnetic Compatibility (EMC): IEC 60601-1-2 (Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral Standard: Electromagnetic compatibility – Requirements and tests).
- Electrical Safety: IEC 60601-1 (Medical electrical equipment – Part 1: General requirements for basic safety and essential performance), IEC 60601-2-10 (Medical electrical equipment – Part 2-10: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators), and IEC 60601-1-11 (Medical electrical equipment – Part 1-11: General requirements for basic safety and essential performance – Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment).
- Software Verification and Validation (V&V): According to FDA "Guidance for Pre Market Submissions and for Software Contained in Medical Devices."
- Waveform Test: According to FDA "Guidance for Transcutaneous Electrical Nerve Stimulator for Pain Relief Intended for Over the Counter Use."
The "acceptance criteria" would be that the device successfully passes all tests prescribed by these standards and guidance documents.
"Study that proves the device meets the acceptance criteria":
The document states:
"Digital TENS Unit has been evaluated the safety and performance as following:
- Biocompatibility test according to ISO 10993-5 and ISO 10993-10 standards
- Electromagnetic compatibility test according to IEC 60601-1-2 standard
- Electrical safety test according to IEC 60601-1, IEC 60601-2-10 and IEC 60601-1-11 standards
- Software verification and validation test according to the requirements of the FDA "Guidance for Pre Market Submissions and for Software Contained in Medical Devices"
- The waveform test report has also been conducted to verify the output specifications of the device according to Guidance for Transcutaneous Electrical Nerve Stimulator for Pain Relief Intended for Over the Counter Use"
The statement "The technological characteristics, features, specifications, materials, mode of operation, and intended use of the subject device is substantially equivalent to the predicate devices quoted above. The differences between the subject device and predicate devices do not raise new issues of safety or effectiveness" serves as the concluding statement that the device has met the regulatory "acceptance criteria" for substantial equivalence.
Table of Acceptance Criteria and Reported Device "Performance" (Specifications):
While not an "acceptance criteria" in the traditional sense, the comparison table in the document provides the specifications of the subject device against the predicates. The implied "acceptance" is that these specifications are within the range or comparable to those of already approved predicate devices.
| Feature / Standard Compliance | Acceptance Criterion (Implicit: Compliance with Standard/Guidance) | Subject Device's Reported "Performance" (Specification or Test Result) |
|---|---|---|
| Biocompatibility | ISO 10993-5, ISO 10993-10 | Tested according to standards |
| EMC | IEC 60601-1-2 | Tested according to standard |
| Electrical Safety | IEC 60601-1, IEC 60601-2-10, IEC 60601-1-11 | Tested according to standards |
| Software V&V | FDA Guidance for Software Contained in Medical Devices | Tested according to guidance requirements |
| Waveform Test | FDA Guidance for OTC TENS for Pain Relief | Waveform test report conducted to verify output specifications |
| Device Name and Model | -- | Digital TENS Unit (Model: 1653195) |
| Intended Use | -- | Temporary relief of pain associated with sore and aching muscles... |
| Power Source | Comparable to predicates, safe | DC 3.7V Lithium Battery (rechargeable) |
| Patient Leakage Current | ≤10μA (Normal), ≤50μA (Single Fault) | 0.7μA (Normal), 0.7μA (Single Fault) (Meets/Exceeds predicate) |
| Number of Output Modes | -- (Comparable to predicates) | 6 |
| Number of Output Channels | -- (Comparable to predicates) | 2 (Synchronous channel isolation: No) |
| Regulated Current/Voltage | -- (Comparable to predicates) | Regulated Voltage |
| Software/Firmware/Microprocessor Control | -- (Comparable to predicates) | Yes |
| Automatic Overload Trip? | -- (Comparable to predicates) | No |
| Automatic No-Load Trip? | -- (Comparable to predicates) | Yes |
| Automatic Shut Off? | -- (Comparable to predicates) | Yes |
| User Override Control | -- (Comparable to predicates) | Yes |
| Indicator On/Off: Status? | -- (Comparable to predicates) | Yes |
| Indicator Low Battery? | -- (Comparable to predicates) | Yes |
| Timer (Min) | Range 10-60 (Comparable to predicates) | Range 10, 20, 30, 40, 50 and 60 |
| Weight | -- (Comparable to predicates; differences noted as insignificant) | 35g (1.2 oz, Battery Included) |
| Dimensions (W x H x D) | -- (Comparable to predicates; differences noted as insignificant) | 84.93mm x 43mm x 10.3 mm |
| Housing Materials | Non-toxic, durable (e.g., ABS) | ABS |
| Output Waveform | Pulsed symmetric, biphasic / Pulsed monophasic | Pulsed symmetric, biphasic / Pulsed monophasic |
| Waveform Shape | Rectangular | Rectangular |
| Maximum Output Voltage | Within safe limits, comparable to predicates | 58 V @ 500 Ω, 86 V @ 2k Ω, 142V @ 10k Ω |
| Maximum Output Current | Within safe limits, comparable to predicates | 116 mA @ 500 Ω, 43 mA @ 2k Ω, 14.2 mA @ 10k Ω |
| Pulse Width | Within therapeutic range, comparable to predicates | 94 µs |
| Pulse frequency | Within therapeutic range, comparable to predicates | 1.2~100Hz |
| Net Charge (per pulse) | 0 µC @ 500Ω (for biphasic) or comparable for monophasic | 0 µC @ 500Ω / 13.28 μC @ 500Ω |
| Maximum Phase Charge | Within safe limits, comparable to predicates | 13.28 μC @ 500Ω |
| Maximum Average Current | Within safe limits, comparable to predicates | 8.79 mA @ 500Ω |
| Maximum Current Density | Within safe limits, comparable to predicates | 0.235 mA/cm² @ 500 Ω |
| Maximum Power Density | Within safe limits, comparable to predicates | 0.029 W/cm2 @ 500 Ω |
| ON Time | 1s | 1s |
| OFF Time | 1s | 1s |
§ 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).