(90 days)
POCKET TENS (EP-300) which is home used device is designed to be used for temporary relief of pain associated with sore and aching muscles in the shoulder, back, upper extremities (arm) and lower extremities (leg) due to strain from exercise or normal household work activities.
This device powered by CR2032 Lithium 3V battery is a self-adhesive TENS with 15 adjustable intensity levels falling into the electro-stimulation device category. It includes pocket storage rack for electrodes and TENS device. It designed for shoulder, back, upper extremities (arm) and lower extremities (leg) pain relief. Users only need to place the electrode gel pads on the sides of pain point and then power on the device, and adjust the pulse intensity to a proper level to start a 20 minute treatment session. For optimum result, rest 30 minutes between sessions.
TENS refers to the electrical stimulation of nerves through the skin which is a non-pharmacological method of pain relief. Any symptoms that could be relieved using TENS must be checked by patient's general practitioner who will also give patient instruction on how to carry out a TENS self-treatment regime.
This device is only compatible with the 75 mm x 48 mm gel pads which are the OTC medical device cleared by FDA under K083302 or K180865, and come with the device.
The provided text describes the acceptance criteria and the study conducted for the POCKET TENS (EP-300) device.
Here's the information extracted from the document:
1. A table of acceptance criteria and the reported device performance
The document states that the POCKET TENS (EP-300) device underwent a series of safety and performance tests. It doesn't explicitly list specific quantitative acceptance criteria values next to the device performance for most parameters, but generally states that "All the test results demonstrate the subject device, POCKET TENS (EP-300), meets the requirements of its pre-defined acceptance criteria and intended use, and is substantially equivalent to the predicate devices."
However, a comparison table (Section 12) between the subject device and two predicate devices provides various specifications. This comparison indirectly implies the acceptance criteria are met if the subject device's specifications are comparable or within acceptable ranges of the predicate devices and comply with relevant standards.
Here's a summary of the stated performance and comparison points, implying acceptance criteria are met by equivalence or compliance:
| Acceptance Criteria (Implied) | Reported Device Performance (POCKET TENS (EP-300)) |
|---|---|
| Intended Use | Temporary relief of pain associated with sore and aching muscles in the shoulder, back, upper extremities (arm) and lower extremities (leg) due to strain from exercise or normal household work activities. |
| FDA product code | NUH |
| Prescription or OTC | OTC (Identical to predicate devices) |
| Power source(s) | CR2032 Lithium 3V (Identical to Predicate device #2) |
| Function and design | Electrical stimulation (Identical to predicate devices) |
| Number of output modes (TENS) | 1 (Identical to Predicate device #2) |
| Number of output channels | Single Channel (Identical to Predicate device #2) |
| Method of channel isolation | N/A (Identical to Predicate device #2) |
| Regulated current or regulated voltage | Regulated voltage (Identical to predicate devices) |
| Software/Firmware/Microprocessor Control? | Yes (Identical to predicate devices) |
| Automatic overload trip? | Yes (Identical to predicate devices) |
| Automatic no-load trip? | Yes (Identical to predicate devices) |
| Automatic shut off? | Yes (Identical to predicate devices) |
| Patient override control? | Yes (Identical to predicate devices) |
| Indicator display (On/off status, Low battery, Voltage/current level) | No (Identical to Predicate device #2 for all three) |
| Timer range (minutes) | 20 (Identical to Predicate device #2) |
| Compliance with voluntary standards | ISO 10993-1, 10993-5, 10993-10, 10993-23, IEC 62304, ISO 14971, ISO TR 24971, IEC 60601-1-2, IEC TR 60601-4-2, ANSI/AAMI ES60601-1, IEC 60601-1-11, IEC 60601-2-10, IEC 60086-4, IEC 60601-1-6, ANSI/AAMI/IEC 62366-1 (Complies with the latest standards) |
| Compliance with 21 CFR 898? | Yes (Identical to predicate devices) |
| Weight | Main device (including a set of pad): 35.6 g; Gel pads (2 pieces): 9.4 g; Battery: 3.0 g |
| Dimensions | Main device: 66.8 × 35.0 × 10.6 mm; Pad: 99.5 × 62.0 × 1.0 mm; Wire: 391.0 mm |
| Housing materials and construction | ABS plastic enclosure (Identical to predicate devices) |
| Waveform | Biphasic, Symmetrical (Identical to Predicate device #1) |
| Shape | Rectangular (Identical to predicate devices) |
| Maximum output voltage (@ 500 Ω, 2 kΩ, 10 kΩ) | 50V for both phases, peak of 25V for each phase; 92V; 101V (Refer to Section 13 for substantial equivalence) |
| Maximum output current (@ 500 Ω, 2 kΩ, 10 kΩ) | 100mA peak-to-peak, 50mA peak; 37.5mA; 10.1mA (Refer to Section 13 for substantial equivalence) |
| Pulse Width (μs) | 50mA x 0.4mSec = 20 μC (Refer to Section 13 for substantial equivalence) |
| Frequency (Hz) | 4, 6 and 50 (Refer to Section 13 for substantial equivalence) |
| Net charge (μC per pulse @ 500Ω) | 0 (Refer to Section 13 for substantial equivalence) |
| Maximum phase charge (μC @ 500Ω) | 20 (Refer to Section 13 for substantial equivalence) |
| Maximum average current (mA @ 500Ω) | 3.46 (Refer to Section 13 for substantial equivalence) |
| Electrode conductive surface area (cm²) | 31.04 cm² × 2 (=62.08 cm²) (Refer to Section 13 for substantial equivalence) |
| Maximum current density (mA/cm² @ 500Ω) | 1.61080 (Refer to Section 13 for substantial equivalence) |
| Maximum power density (W/cm² @ 500Ω) | 0.0801 (Refer to Section 13 for substantial equivalence) |
| Burst Mode (Pulse per burst, Burst per second, Burst duration, Duty cycle, Average DC current) | N/A (Identical to Predicate device #1 where applicable, otherwise N/A for those parameters) |
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 does not explicitly mention a "test set" in the context of clinical data. It states, "No clinical test data was used to support the decision of substantial equivalence."
Instead, the evaluation appears to be based on non-clinical testing, compliance with recognized standards, and comparison with predicate devices. For these non-clinical tests (e.g., biocompatibility, software validation, EMC, electrical safety, performance verification, usability), the sample sizes are not specified, nor is the country of origin or whether they were retrospective or prospective.
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, as no clinical test data was used and therefore no need for experts to establish ground truth for a clinical test set. The substantial equivalence relies on technical comparison and compliance with standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as no clinical test data was used and therefore no adjudication was necessary.
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. The device is a Transcutaneous Electrical Nerve Stimulator (TENS) for pain relief, not an AI-assisted diagnostic or interpretative tool that would involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The device is a physical TENS unit, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable, as no clinical test data was used. The "ground truth" for the non-clinical tests would be the established scientific and engineering principles outlined in the referenced national and international standards (e.g., ISO, IEC, ANSI/AAMI standards, FDA guidance documents).
8. The sample size for the training set
Not applicable, as the device is not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable, as the device is not an AI/ML algorithm.
§ 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).