(232 days)
The TENS programs of HIVOX Electric Stimulator TENS & EMS, HD2:
The device is an electrical nerve stimulator indicated for use for pain relief by applying an electrical current to electrodes on a patient's skin to treat pain. In particular, this device is indicated for use for (1) Symptomatic relief of chronic (long term) intractable pain, and (2) adjunctive treatment in the management of post-surgical and post-traumatic pain problems.
The EMS programs of HIVOX Electric Stimulator TENS & EMS, HD2:
The device is an electrical powered muscle stimulator indicated for medical purpose to repeatedly contract muscles by passing electrical currents through electrodes contacting the affected body area. In particular, this device is indicated for use for (1) Relaxing muscle spasms, (2) Increasing local blood circulation, (3) Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis, (4) Muscle re-education, (5) Maintaining or increasing range of motion, and (6) Preventing or retarding disuse atrophy.
The HIVOX Electric Stimulator TENS & EMS, HD2 generates small pulses of electrical current. Delivered along lead cables to electrodes placed on your skin, these pulses pass through the skin and activated underlying nerves. The relief from chronic and acute pain that the HD2 can provide results from this electrical stimulation.
Here's an analysis of the provided text regarding the acceptance criteria and study for the HIVOX Electric Stimulator TENS & EMS, HD2:
1. Table of Acceptance Criteria and Reported Device Performance
For this specific device, the "acceptance criteria" are implied by substantial equivalence to a predicate device. The performance is assessed against recognized medical device standards and compared to the predicate device's specifications.
| Acceptance Criteria (Implied by Substantial Equivalence and Standards) | Reported Device Performance (HIVOX HD2) |
|---|---|
| Safety Standards Adherence: | |
| - Medical electrical equipment Part 1. General requirements for safety (IEC/EN 60601-1) | - Tested in accordance with IEC/EN 60601-1:1996 |
| - Medical electrical equipment, Part 2. Electromagnetic compatibility (IEC/EN 60601-1-2) | - Tested in accordance with IEC/EN 60601-1-2:2004 |
| - Medical electrical equipment Part 2. Safety of Nerve and Muscle Stimulators (IEC/EN 60601-2-10) | - Tested in accordance with IEC/EN 60601-2-10:1987 |
| - Electrical safety for accessories (electrodes, patient cables) | - 510(k) electrodes specified; patient cable utilizes shrouded connectors to meet lead wire safety requirements. |
| - System level testing (waveform testing) | - System-level testing, including waveform testing, was performed. |
| Functional Equivalence to Predicate Device (MEDIHIGHTEC K082514): | |
| - Ability to provide TENS programs for pain relief (symptomatic relief of chronic intractable pain, adjunctive treatment for post-surgical/post-traumatic pain) | - Indicated for the same TENS uses: (1) Symptomatic relief of chronic (long term) intractable pain, and (2) adjunctive treatment in the management of post-surgical and post-traumatic pain problems. |
| - Ability to provide EMS programs for muscle stimulation (relaxing spasms, increasing circulation, preventing venous thrombosis, muscle re-education, maintaining/increasing range of motion, preventing disuse atrophy) | - Indicated for the same EMS uses: (1) Relaxing muscle spasms, (2) Increasing local blood circulation, (3) Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis, (4) Muscle re-education, (5) Maintaining or increasing range of motion, and (6) Preventing or retarding disuse atrophy. |
| - Similar technical specifications (e.g., output characteristics, channels, controls, safety features) | - Detailed comparison table provided (Page 2), highlighting similarities and differences, with the conclusion that the new device is "as safe and effective as, and the function in a manner equivalent to the predicate device." Key differences in electrical characteristics (e.g., max output voltage/current, pulse width, frequency, max phase charge, max current/power density) were presented, but deemed acceptable for substantial equivalence. Other features like channels, synchronous/reciprocal operation, computerized capabilities, patient override, burst mode, housing, product standards, timer, and low battery indicator are compared. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not applicable in the context of this 510(k) submission. This is a premarket notification primarily based on non-clinical performance testing and comparison to a predicate device, rather than a clinical trial with a specific test set of patients.
- Data Provenance: The performance data primarily comes from non-clinical tests conducted by HIVOX Biotek Inc. related to the specified IEC/EN standards. The data is retrospective in the sense that it's based on tests performed on the device itself, but it does not involve human subject data or a specific "test set" of patient cases. The country of origin of the device manufacturer and the testing company (implied) is Taiwan.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts/Qualifications: Not applicable. There was no "test set" requiring expert ground truth in the traditional sense of clinical opinion or diagnosis. The ground truth for electrical and performance characteristics is established by the relevant engineering and medical device standards (IEC/EN). Regulatory bodies (like the FDA) review compliance with these standards and the comparison data.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable, as there was no test set requiring human adjudication.
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
- MRMC Study: No. This device is an electrical stimulator (TENS & EMS), not an AI-powered diagnostic or assistive tool. Therefore, a multi-reader multi-case comparative effectiveness study with human readers assisting AI or vice-versa is entirely irrelevant to this submission.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Standalone Performance: Not applicable. This is not an algorithm or AI device. Its performance is inherent in its physical and electrical characteristics as measured against standards.
7. The Type of Ground Truth Used
- Ground Truth: The "ground truth" for this device's performance and safety is derived from:
- International/National Standards: Compliance with IEC/EN 60601-1, IEC/EN 60601-1-2, and IEC/EN 60601-2-10.
- Predicate Device Specifications: The established safety and effectiveness profile of the legally marketed predicate device (MEDIHIGHTEC TENS/EMS Combo, K082514). The comparison aims to demonstrate that the new device meets or exceeds the critical performance aspects and safety features of the predicate.
- Engineering and Electrical Measurements: Verifiable data from tests on the device's electrical output, waveforms, and physical construction.
8. The Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. This device does not employ machine learning or AI, so there is no concept of a "training set" for an algorithm.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set: Not applicable, as there is no training set for this 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).