(117 days)
The Evolve System with the T3 Applicator employs RF technology or EMS-TENS technology for the treatment of selected medical conditions.
The T3 Applicator in RF mode is intended for the temporary relief of minor muscle aches and pain, temporary relief of muscle spasm, and temporary improvement of local blood circulation.
The T3 Applicator in EMS mode is intended for:
- Relaxation of muscle spasms
- Prevention or retardation of disuse atrophy
- Increasing local blood circulation
- Muscle re-education
- Maintaining or increasing range of motion
- Immediate post surgical stimulation of calf muscles to prevent venous thrombosis
The T3 Applicator in TENS mode is intended for:
- Symptomatic relief and management of chronic, intractable pain
- Post-surgical acute pain
- Post-trauma acute pain
The RF treatment mode and EMS/TENS mode should not be used in combination or sequentially.
The Evolve System with the T3 Applicator is designed to deliver non-thermal RF energy and electro-muscle and transcutaneous nerve stimulation for the treatment of different body areas for various medical applications. The Evolve System software controls and regulate the different applied energies in accordance with the user system preprograming and treatment settings. The subject device platform system is identical to the FDA-Cleared Evolve System platform (a.k.a EmBody System and the subject of K183450). The same platform system was recently FDA-Cleared for the use with the Tone Applicator (subject of K201285).
The Evolve System supports the placement of the following components:
- LCD display touch screen,
- Audio loudspeaker,
- 48V AC/DC power supply,
- Real time controller, distributor card and 2 RF generators,
- Fans
The System operates while connected to the T3 Applicator.
The Evolve System with the T3 Applicator is intended for temporary relief of minor muscle aches and pain, muscle spasm, and improved local blood circulation (RF mode), as well as relaxation of muscle spasms, prevention of disuse atrophy, increased local blood circulation, muscle re-education, maintaining/increasing range of motion, and immediate post-surgical stimulation of calf muscles to prevent venous thrombosis (EMS mode), and symptomatic relief of chronic, intractable, post-surgical, and post-trauma acute pain (TENS mode).
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance:
| Characteristic | Acceptance Criteria (Subject Device, EVOLVE System with T3 Applicator) | Reported Device Performance (as per document) |
|---|---|---|
| RF Mode | ||
| Maximal Output Power | 75 W | 75 W |
| Frequency | 1 MHz | 1 MHz |
| Pulse Duration | 2 sec | 2 sec |
| EMS Mode | ||
| Waveform | Symmetrical Biphasic | Symmetrical Biphasic Waveform |
| Pulse Shape | Rectangular | Rectangular |
| Max Output Voltage | Up to 50 intensity level (=54 Vpeak) | Up to 50 intensity level (=54 Vpeak) |
| Pulse Width | 20 to 400 µs | 20 to 400 µs |
| Frequency | 3 to 200 Hz | 3 to 200 Hz |
| Net Charge @ 500Ω | 0 µC/pulse @ 500Ω | 0 µC/pulse @ 500Ω |
| Max Phase Charge | 24 µC @ 500Ω | 24 µC @ 500Ω |
| Max Current Density | 0.74 mA/cm² | 0.74 mA/cm² (Surface = 6.46cm²) |
| Max Power Density | 22.2 mW/cm² @500Ω | 22.2 mW/cm² @500Ω |
| Burst Mode | Yes: a. 3-200, b. 1, c. 1-60 sec, d. Time on / off | Yes: a. 3-200, b. 1, c. 1-60 sec, d. Time on / off |
| On Time | 1 - 60 sec | 1 - 60 sec |
| Off Time | 1 - 60 sec | 1 - 60 sec |
| Treatment Time | Up to 60 min. | Up to 60 min. |
| TENS Mode | ||
| Waveform | Symmetrical Biphasic | Symmetrical Biphasic Waveform |
| Pulse Shape | Rectangular | Rectangular |
| Max Output Voltage | Up to 15 intensity level (=19 Vpeak) | Up to 15 intensity level (=19 Vpeak) |
| Pulse Width | 20 to 400 µs | 20 to 400 µs |
| Frequency | 3 to 200 Hz | 3 to 200 Hz |
| Net Charge @ 500Ω | 0 µC/pulse @ 500Ω | 0 µC/pulse @ 500Ω |
| Max Phase Charge | 15.2 µC @ 500Ω | 15.2 µC @ 500Ω |
| Max Current Density | 0.47 mA/cm² | 0.47 mA/cm² (Surface = 6.46cm²) |
| Max Power Density | 8.9 mW/cm² @500Ω | 8.9 mW/cm² @500Ω |
| Burst Mode | Yes: a. 3-200, b. 1, c. 1-60 sec, d. Time on / off | Yes: a. 3-200, b. 1, c. 1-60 sec, d. Time on / off |
| On Time | 1 - 60 sec | 1 - 60 sec |
| Off Time | 1 - 60 sec | 1 - 60 sec |
| Treatment Time | Up to 60 min. | Up to 60 min. |
| General Safety/Design | ||
| Biocompatibility | Materials are biocompatible | Materials are biocompatible |
| Complies with standards | ANSI AAMI ES 60601-1, IEC 60601-1-2, IEC 60601-2-10, IEC 60601-1-6, IEC 60601-2-2 | Yes, tested and complies with listed standards |
| Software Validation | Yes | Yes |
| Electrical/Mechanical Safety | Yes (IEC 60601-1) | Yes (IEC 60601-1) |
| Electromagnetic Compatibility | Yes (IEC 60601-1-2) | Yes (IEC 60601-1-2) |
| Nerve/Muscle Stimulator Safety | Yes (IEC 60601-2-10) | Yes (IEC 60601-2-10) |
| High-Frequency Surgical Equip. Safety | Yes (IES 60601-2-2) | Yes (IES 60601-2-2) |
2. Sample Size Used for the Test Set and Data Provenance:
The document states that Non-Clinical (Bench) Performance Data was conducted to demonstrate the device performs as expected and meets design requirements. This included various bench tests (e.g., accuracy of RF output, electrode temperature sensors, thermal build-up, ex-vivo tissue thermal profile, safety and thermal profile testing, EMS/TENS output specifications).
However, the document explicitly states "Clinical Performance Data: Non-Applicable." This implies that there was no clinical test set using human subjects or patient data. The evaluation for substantial equivalence relies on non-clinical bench testing and comparison to predicate devices, rather than a clinical study with a test set of patient data. Therefore, questions regarding sample size, data provenance (e.g., country of origin, retrospective/prospective) for a clinical test set are not applicable here.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
Since no clinical test set was conducted, the concept of "ground truth" derived from expert consensus on patient data (e.g., from radiologists, pathologists) is not applicable to this submission. The "ground truth" for the non-clinical bench tests would be the established engineering and safety standards and design specifications against which the device's performance was measured.
4. Adjudication Method for the Test Set:
Not applicable, as no clinical test set was conducted.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, an MRMC comparative effectiveness study was not done. The submission explicitly states "Clinical Performance Data: Non-Applicable," making any evaluation of human reader improvement with or without AI assistance irrelevant in this context. The device is a physical therapeutic system, not an AI-assisted diagnostic tool.
6. Standalone (Algorithm Only) Performance Study:
Not applicable. This device is a physical therapeutic system, not an algorithm or AI. Its performance is tied directly to its hardware functionality and energy delivery.
7. Type of Ground Truth Used:
For the non-clinical performance data, the "ground truth" was based on:
- Engineering and Design Requirements: The device was tested to verify that its performance meets its own design requirements.
- Consensus Standards: The device's performance was evaluated against recognized consensus standards for medical electrical equipment, such as ANSI AAMI ES 60601-1, IEC 60601-1-2, IEC 60601-2-10, IEC 60601-1-6, and IEC 60601-2-2.
- Predicate Device Specifications: The device's technical specifications and performance characteristics were compared directly to those of legally marketed predicate devices to establish substantial equivalence.
8. Sample Size for the Training Set:
Not applicable. This device is not an AI/ML algorithm that requires a training set. Its functionality is based on established physical principles of RF and EMS/TENS technology.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set for this device.
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.