(271 days)
The Electronic Pulse Stimulator MDTS100 is 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 and work activities.
The MDTS100 Electronic Pulse Stimulator is an electrically powered device intended for over the counter use and used to apply an electrical current to electrodes on a user's skin to relieve pain. The proposed device is intended for at home use in delivering electric pulses to tired and sore muscles. The proposed device consists of controlling host device, output connecting cable and skin electrodes. The proposed device has many safety measures such as output load detection, timing indication and so on. It is adopted battery as the power supply. The output waveform is adopted "square waveform" as the basic wave. It simulates the various output modes by various frequency combination. The waveform is mainly for single rectangular. The output waveform intensity is continuous adjustable. The working time is controlled automatic. The MDTS100 is adopted the method that inputting the specific low frequency pulse current into the human body through the human skin to treat the pain. The MDTS100 Electronic Pulse Stimulator has seven stimulation modes. These stimulation modes can be selected by pressing the MODE button on the front of the unit. The MDTS100 comes with 2 independent output channels by pressing the CHA button. Channel A&B are selected by default. Pressing the & buttons will decrease & increase the intensity of stimulation. LCD screen display the left remaining stimulation time in the lower left corner. The default time is 20 minutes. The proposed device is not for life-supporting or life-sustaining, not for implant. The device is not sterile and the transducers are reusable and do not need sterilization and re-sterilization. The device is for over the counter use. The device does not contain drug or biological products. The device is software-driven and software validation is provided in software.
This document is a 510(k) Premarket Notification for the Electronic Pulse Stimulator Model MDTS100, which is a Transcutaneous Electrical Nerve Stimulator (TENS) device. The purpose of this submission is to demonstrate that the device is substantially equivalent to a legally marketed predicate device (Prospera OTC TENSE Electronic Pulse Massager, Model PL029, K122744).
The document details the device's indications for use, its technical characteristics compared to the predicate, and functional and safety testing performed.
Here's an analysis of the provided information, focusing on acceptance criteria and supporting studies:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in a quantitative performance metric sense for clinical effectiveness. Instead, the "acceptance criteria" are implied by the demonstration of substantial equivalence to a predicate device, which inherently means meeting safety and performance characteristics similar to a device already deemed safe and effective by the FDA. The comparison tables (Table 3-1 and Table 3-2) illustrate the technical characteristics of the proposed device against the predicate.
While no quantitative clinical performance metrics (e.g., sensitivity, specificity, accuracy) are reported for this device, a table comparing key technical parameters and their reported values for both the proposed and predicate device is provided.
Table: Comparison of Technical Characteristics and Performance
| Parameter | Proposed Device (MDTS100) | Predicate Device (PL029) | Implied "Acceptance Criteria" (Substantial Equivalence) |
|---|---|---|---|
| Power Source | DC 3V, 2 AAA batteries | 3V Battery | Similar power source characteristics |
| Normal Condition Leakage Current | ≤10 µA | 2.0 µA | Acceptable leakage current (within safety standards) |
| Single Fault Condition Leakage Current | ≤50 µA | 3.0 µA | Acceptable leakage current (within safety standards) |
| Avg DC current (device on, no pulses) | ≤10 µA | 0 µA | Acceptable DC current (within safety standards) |
| Number of Output Modes | 7 | 8 | Similar range of therapy modes |
| Output Type | Alternating | Alternating | Similar output channel handling |
| Regulated Output | Regulated Voltage | Voltage control | Similar output regulation type |
| Software/Firmware Control | Yes | Yes | Software-driven operation |
| Automatic Overload Trip? | No | No | Not present in either |
| Automatic No-Load Trip? | Yes | No | Enhanced safety feature in proposed |
| Automatic Shut Off? | Yes | Yes | Presence of critical safety feature |
| User Override Control? | Yes | Yes | User control over therapy |
| Display: On/OFF Status? | Yes | Yes | Basic operational display |
| Display: Low Battery? | Yes | No | Enhanced user information in proposed |
| Display: Voltage/Current Level? | Yes | No | Enhanced user information in proposed |
| Timer Range (minutes) | 20 minutes | 5, 10 minutes | Similar timer functionality |
| Compliance with Voluntary Standards? | Yes | Yes | Compliance with relevant safety standards |
| Compliance with 21 CFR 898? | Yes | Yes | Compliance with FDA regulations |
| Waveform | pulsed monophasic | Monophasic | Similar waveform characteristics |
| Shape | Rectangular | Rectangular | Similar waveform shape |
| Max Output Voltage (volts) (+/- 20%) | 150V@500Ω, 160V@2kΩ, 165V@10kΩ | 49.6V@500Ω, 99.2V@2kΩ, 114V@10kΩ | While different, the conclusion states they "do not raise any new questions of safety or effectiveness." |
| Maximum Output Current (mA) (+/- 20%) | 18mA@500Ω, 3.2mA@2kΩ, 16.5mA@10kΩ | 300mA@500Ω, 80mA@2kΩ, 0.6mA@10kΩ | While different, the conclusion states they "do not raise any new questions of safety or effectiveness." |
| Pulse Duration (µsec) | 50~140 µsec | 120~6800 µsec | While different, the conclusion states they "do not raise any new questions of safety or effectiveness." |
| Frequency (Hz) | 0.9Hz~82Hz | 0.5~86Hz | Similar frequency range |
| Net Charge (µC per pulse) @500Ω | 42 µC | 18000 µC | While different, the conclusion states they "do not raise any new questions of safety or effectiveness." |
| Max Phase Charge (µC) @500Ω | 42 µC | 23 µC | While different, the conclusion states they "do not raise any new questions of safety or effectiveness." |
| Max Current Density (mA/cm2, r.m.s.) | 3.3mA/cm2@1.57"x1.57"Elec Pad | 1.4mA/cm2 | While different, the conclusion states they "do not raise any new questions of safety or effectiveness." |
| Burst Mode characteristics | E.g., Pulses/burst: 197, Burst/sec: 0.185 | Some values like 1, 0-7 | Different but concluded as not raising new safety/effectiveness questions. |
The document concludes that the differences in output parameters (voltage, current, pulse duration, charge) between the proposed device and the predicate device "do not raise any new questions of safety or effectiveness." This statement effectively serves as the "acceptance criteria" for these differing parameters – that they fall within a range considered safe and effective for TENS devices when evaluated against recognized safety standards.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document focuses on non-clinical (bench) testing for substantial equivalence, not clinical studies involving human subjects with a "test set" in the context of clinical performance. Therefore, there is no mention of a human "test set" sample size or data provenance in this submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is a non-clinical submission. Ground truth, in a clinical context, is not established for this type of submission.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. This is a non-clinical submission.
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 an Electronic Pulse Stimulator (TENS), not an AI-assisted diagnostic or therapeutic device. No MRMC study was performed or is relevant to this submission.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. While the device is "software-driven," the performance evaluation is not an "algorithm-only" standalone test in the context of AI or diagnostic algorithms. The device's performance is tested as a complete system (hardware and software) through bench testing against electrical safety and EMC standards.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the non-clinical testing:
- Electrical Safety & EMC: The "ground truth" is defined by the voluntary standards cited: IEC 60601-1:2005, IEC 60601-1-2:2007, IEC 60601-1-11:2010, and IEC 60601-2-10:2012. These standards specify thresholds and testing methodologies for electrical characteristics, electromagnetic compatibility, and specific requirements for nerve and muscle stimulators.
- Biocompatibility: The "ground truth" for the electrode pads is established by their prior FDA clearance (K090198) and compliance with ISO 10993 standards, which cover biological evaluation of medical devices.
- Software Validation: The "ground truth" for software functionality is established against the FDA Guidance for the Content of Premarket Submission for Software Contained in Medical Devices.
- Cleaning: The "ground truth" is simply that the cleaning instructions were tested and found sufficient, as presented in the system test report.
8. The sample size for the training set
Not applicable. This is not an AI/machine learning device that involves a "training set."
9. How the ground truth for the training set was established
Not applicable. This is not an AI/machine learning 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).