(382 days)
TENS stands for Transcutaneous Electrical Nerve Stimulation. Unipro TENS is used to provide symptomatic pain relief for chronic, acute or post-operative pain.
EMS stands for Electrical Neuromuscular Stimulation. Unipro EMS is indicated for:
- · Relaxation of muscle spasm
- · Increasing local blood circulation and muscle re-education
- · Prevention or retardation of disuse atrophy
- · Prevention of venous thrombosis of the calf muscles immediately after surgery
- · Maintaining on increasing range of motion
MIC stands for Microcurrent Stimulation. Unipro MIC is used to provide sumptomatic pain relief for chronic intractable pain, post traumatic pain or post surgical pain.
IFT stands for Interferntial Stimulation. Unipro IFT is indicated for symptomatic relief of chronic intractable pain.
Unipro is a non-invasive, non-sterile, reusable medical device which is intended to be used in both the hospital and home healthcare environment. It is a microprocessor controlled, non-implantable, portable neuromuscular electrical stimulator which is powered by a built in Li-ion rechargeable battery.
Unipro is a multitherapy unit that combines the treatment capabilities of TENS (Transcutaneous Electrical Nerve Stimulation), EMS (Electrical Muscle Stimulation), MIC (Microcurrent Stimulation) and IFT (Interferential Therapy). The mode selection button on device will enable the user to switch between different modes (TENS, EMS II, EMS III, or massage). Each time the user changes the mode or program, the intensity level will revert to zero. This is a safety feature to alleviate any sudden feeling of a surge, as each program gives a different sensation.
Unipro Case L (large) features a white ABS case with a white silicone button pad and white power button. Power button is located on the right-hand side of the device. The hardware features a black perimeter border and black LCD display. Charging cable and lead inserts are located on the bottom of the device.
Unipro is supplied with self-adhesive electrodes which attach to the control unit via lead wires. A gentle electrical current is sent to underlying nerves and muscle groups via these electrodes applied on the skin to relieve pain. Placement of the electrode pads of the device depends on the selected device mode (TENS, EMS, IFT2, IFT4, MIC). For TENS, the easiest way is to apply the electrode pads around/near the source of the pain. For EMS, place two electrode pads over the bulk of the muscle, with one electrode over the muscle's motor point. For IFT2, electrodes should be placed either side of the area of pain and for IFT4, the pads need to apply in positions so that the signals from each channel cross over the point to be treated. Finally, for MIC, the electrode pads should be placed in such a way that a straight line between them passes through the problem area.
The TensCare Ltd Unipro (K232441) is a multi-therapy electrical stimulator combining TENS, EMS, MIC, and IFT functionalities. The submission claims substantial equivalence to the predicate device, Ultima NEO (K120054).
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
The provided documentation does not explicitly list "acceptance criteria" for performance metrics in a pass/fail format. Instead, it compares the technical characteristics and indications for use of the Unipro to its predicate device, Ultima NEO, to demonstrate substantial equivalence. The "Comparison" column in the tables serves as a qualitative assessment of whether the Unipro's performance characteristics are similar enough to the predicate.
| Characteristic | Acceptance Criteria (Implied: Similar to Predicate) | Reported Device Performance (Unipro) | Comparison |
|---|---|---|---|
| Indications for Use | Identical to Ultima NEO | TENS, EMS, MIC, IFT for pain relief and muscle stimulation (detailed in text) | Identical |
| Intended Population | Similar to Ultima NEO (Male and female patients over 18) | Male and female patients over 21 | Substantially Equivalent (difference in age: 21 vs 18) |
| Power Source | Similar to Ultima NEO (Li-ion rechargeable battery) | 3.7V 1500mAh Lithium-ion battery (rechargeable) | No substantial difference |
| Average DC current through Electrodes (no pulses) | 0 µA | 0 µA | Identical |
| Number of Output Modes | 4 (TENS, EMS, MIC, IFT) | 4 | Identical |
| Number of programs/modes | Similar to Ultima NEO (41 programs) | 76 | No substantial difference (Both comply with IEC 60601-1) |
| Number of Output Channels | 2 | 2 | Identical |
| Timer Range | Similar to Ultima NEO (10-90 minutes, constant) | 5-90 minutes, constant | No substantial difference (Unipro can be set lower) |
| Regulated Current or Voltage? | Current and Voltage | Current and Voltage | Identical |
| Software/Firmware/Microprocessor Control? | Yes | Yes | Identical |
| Automatic No-Load Trip? | Not publicly available for predicate (implied: similar/present) | Yes (TENS/EMS) | - |
| Automatic Overload Trip? | Not publicly available for predicate (implied: similar/present) | No | - |
| Automatic Shut Off? | Not publicly available for predicate (implied: similar/present) | Yes | - |
| User Override Control? | Not publicly available for predicate (implied: similar/present) | Yes | - |
| Indicator Display | On/Off, Low battery, Voltage/Current level, Time to cut-off | Yes for all | Identical |
| Compliance Voluntary Standards | IEC 60601-1, IEC 60601-1-2, IEC 60601-2-10, etc. | IEC 60601-1, IEC 60601-1-2, IEC 60601-2-10, etc. | Substantial equivalent |
| Compliance with 21 CFR regulations | Yes | Yes | Identical |
| Dimensions | Similar to Ultima NEO (123 x 61 x 22mm) | 125mm x 62mm x 29.6mm | Different, but does not affect safety/effectiveness |
| Weight | Similar to Ultima NEO (160g) | 128.5g | Different, but does not affect safety/effectiveness |
| Housing Materials | ABS 757 material | ABS 757 material | Identical |
| Sterilization | N/A | N/A | Identical |
| Waveform (TENS/EMS) | Bi-phase Symmetrical Rectangular, Asymmetrical Rectangular, Mono-Phase Symmetrical Rectangular (predicate) | TENS/EMS: Symmetrical Rectangular | No substantial difference |
| Waveform (Microcurrent) | Symmetrical Rectangular (predicate) | Continuous square unipolar, sawtooth unipolar, symmetrical balanced wave | No substantial difference (Both comply with IEC 60601-1) |
| Waveform (IFT) | Symmetrical balanced sine wave | Symmetrical balanced wave | Identical |
| Maximum Output Voltage (TENS/EMS) | 73.6V@500Ω, 120V@2 kΩ, 124V@10 kΩ (predicate) | 54V@500Ω, 114 V@2 kΩ, 116 V@10 kΩ | No substantial difference (lower, but proportional to current, complies with IEC 60601-1) |
| Maximum Output Voltage (Microcurrent) | 0.54V@500Ω, 2.12V@2 kΩ, 10.2V@10 kΩ (predicate) | 0.4V@500Ω, 1.56 V@2 kΩ, 7.8 V@10 kΩ | No substantial difference (lower, but proportional to current, complies with IEC 60601-1) |
| Maximum Output Voltage (IFT) | 17V@500Ω, 30V@2 kΩ, 32 V@10 kΩ (predicate) | 24V@500Ω, 34.4 V@2 kΩ, 40 V@10 kΩ | No substantial difference (complies with IEC 60601-1) |
| Maximum Output Current (TENS/EMS) | 147mA@500Ω, 60mA@2 kΩ, 12.4mA@10kΩ (predicate) | 108mA@500Ω (200μs), 80mA @500Ω (400μs), 57mA@2 kΩ, 11.6 mA@10 kΩ | No substantial difference (Unipro features amplitude modulation mode) |
| Maximum Output Current (Microcurrent) | 1.08mA, 1.06mA, 1.02mA (predicate) | 0.8mA, 0.78 mA @2 kΩ, 0.78 mA @10 kΩ | No substantial difference (Unipro MIC amplitude smaller, complies with IEC 60601-1) |
| Maximum Output Current (IFT) | 34mA@500Ω, 15mA@2 kΩ, 3.2mA@10kΩ (predicate) | 48mA@500Ω, 17.2mA@2 kΩ, 4mA@10 kΩ | No substantial difference (complies with IEC 60601-1) |
| Pulse Width (TENS/EMS) | 50-400µs (predicate) | TENS: 50-300 µs, EMS: 100-400 µs | No substantial difference (within recommended output, complies with IEC 60601-2-10) |
| Pulse Width (Microcurrent) | 2-200ms (predicate) | 10-200ms | No substantial difference (within recommended output, complies with IEC 60601-2-10) |
| Pulse Width (IFT) | 120-125µs (predicate) | 125 µs | No substantial difference (within recommended output, complies with IEC 60601-2-10) |
| Frequency (TENS/EMS) | 1-150Hz (predicate) | TENS: 2-150Hz, EMS: 10-120Hz | No substantial difference (Unipro's range is within recommended range, complies with IEC 60601-2-10) |
| Frequency (Microcurrent) | 1-150Hz (predicate) | 0.5Hz, 1Hz, 1.5Hz, 2Hz, 3Hz, 4Hz, 5Hz to 50Hz | No substantial difference (within recommended range, complies with IEC 60601-2-10) |
| Frequency (IFT) | 4000-4160Hz (predicate) | 2-160Hz (Carrier Frequency: 4000Hz fixed (CH1)) | No substantial difference (Predicate's higher frequency may not offer additional benefit, complies with IEC 60601-2-10) |
| Net Charge (µC per pulse) | 0.4µC@ 500 Ω (predicate) | 0.3µC@ 500 Ω | No substantial difference (Charge output dependent on current, complies with IEC 60601-1) |
| Maximum Phase Charge (µC) | TENS/EMS: 21.62μC@500Ω, Microcurrent: 220.8μC@500Ω, IFT: 5.16μC@500Ω (predicate) | TENS/ EMS: 22.76μC@500Ω, Microcurrent: 160μC@500Ω, IFT: 2.8μC@500Ω | No substantial difference (Charge used to set pulse width, complies with IEC 60601-1) |
| Maximum Current Density (mA/cm²) | TENS/EMS: 5.88mA/cm²@500Ω, Microcurrent: 0.022mA/cm²@500Ω, IFT: 1.65mA/cm²@500Ω (predicate) | TENS/EMS: 0.8mA/cm²@500Ω, Microcurrent: 0.008mA/cm²@500Ω, IFT: 0.82mA/cm²@500Ω | No substantial difference (both comply with IEC 60601-1) |
| Maximum Power Density (W/cm²) | TENS/EMS: 0.0086W/cm², Microcurrent: 0.012W/cm², IFT (predicate) | TENS/ EMS: 0.0076 W/cm2, Microcurrent: 0.0001049 W/cm2, IFT | No substantial difference (both comply with IEC 60601-1) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The submission indicates that "No clinical testing was considered necessary." Therefore, there is no sample size for a new test set or details on data provenance from a prospective or retrospective study involving the Unipro device. The equivalence claim is based on comparison to the predicate and literature review.
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 testing was performed on the device to establish a new ground truth. The basis of the submission relies on the established safety and effectiveness of the predicate device and the modes of therapy.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as no clinical testing was performed that would require adjudication of a test set.
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 not an AI-assisted diagnostic or interpretative tool, and no MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This device is a direct-use electrical stimulator, not an algorithm. Its performance is evaluated through bench testing against established standards and comparison to a predicate device.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
The "ground truth" for the Unipro's substantial equivalence claim is based on the established safety and effectiveness of the legally marketed predicate device (Ultima NEO), and recognized international consensus standards (e.g., IEC 60601-1, IEC 60601-2-10). Additionally, it mentions a formal review of published research and clinical evaluation on the use of TENS, EMS, IFT, and MC for pain relief and muscle training, which serves as a form of expert consensus and outcomes data from the broader scientific community.
8. The sample size for the training set
Not applicable, as this is not an AI/machine learning device that requires a training set.
9. How the ground truth for the training set was established
Not applicable, as this is not an AI/machine learning device that requires a training set.
§ 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).