(307 days)
Everyway OTC EMS is intended to stimulate healthy muscles in order to improve or facilitate muscle performance. The various types of muscle work that Everyway OTC EMS can impose on the stimulated muscles are able to improve or facilitate muscle performance. Everyway OTC EMS may therefore be considered a technique of muscle training.
The Everyway OTC EMS, model EV-805 is a dual channel powered muscle stimulator intended to stimulate healthy muscles in order to improve or facilitate muscle performance. The various types of muscle work that Everyway OTC EMS can impose on the stimulated muscles are able to improve or facilitate muscle performance by applying an electrical current to electrodes, which are attached on the user's skin.
The device measures 101mm(H)x 68mm(W)x21.5mm(D). Its outer housing is made of injection molded thermoplastic resin with the output contact probes consist of chrome-plated spheres. The device is powered by a 9-Volt battery to generate output pulses that is discharged through the two adhesive electrode placed on the patient's skin for treatment and muscle training.
The device is operated in such a way that turn on the intensity control knob and adjust the intended intensity or turn off the device during operation through the same control knob. While device is turned on for operation. User then follow the instruction for use to get appropriate stimulation treatment and/or training on the healthy muscles.
This document describes the 510(k) premarket notification for the Everyway OTC EMS, Model EV-805, a powered muscle stimulator. The purpose of this submission is to demonstrate substantial equivalence to a predicate device (K102926: Gemore Muscle Conditioner/Model GM320PE).
Here's an analysis of the provided information concerning acceptance criteria and supporting studies:
1. Table of Acceptance Criteria and Reported Device Performance
The core of the acceptance criteria for this device, as presented in the document, is demonstrating substantial equivalence to a predicate device. This is achieved through a comparison of key parameters, with "Substantial Equivalence (SE)" being the reported performance. The table below summarizes the comparison:
| Parameter | Acceptance Criteria (Predicate Device) | Reported Device Performance (Everyway OTC EMS, Model EV-805) | Substantial Equivalency |
|---|---|---|---|
| Product Code | NGX | NGX | Identical |
| Prescription (Rx) or OTC | OTC | OTC | Identical |
| Indication for Use (IFU) | Intended to stimulate healthy muscles in order to improve or facilitate muscle performance. May be considered a technique of muscle training. (Includes additional contraindications related to injured/ailing muscles). | Intended to stimulate healthy muscles in order to improve or facilitate muscle performance. The various types of muscle work that Everyway OTC EMS can impose on the stimulated muscles are able to improve or facilitate muscle performance. Everyway OTC EMS may therefore be considered a technique of muscle training. | SE* |
| Waveform | Biphasic | Biphasic | Identical |
| Shape | Rectangular | Rectangular | Identical |
| Maximum Output Voltage (volts) (+/-20%) | 7.5V @500Ω | ||
| 18.0V @2KΩ | |||
| 23V @10KΩ | 7.66V @500Ω | ||
| 8.2V @2KΩ | |||
| 8.2V @10KΩ | SE* | ||
| Maximum Output Current (mA) (+/-20%) | 15.0mA @500Ω | ||
| 9.0mA @2KΩ | |||
| 2.3mA @10KΩ | 15.3mA @500Ω | ||
| 4.1mA @2KΩ | |||
| 0.82mA @10KΩ | SE* | ||
| Duration of primary phase (usec) | 200-300us (single phase) | 210us (single phase) | SE* |
| Pulse Duration (usec) | 600us | 420us | SE* |
| Frequency (Hz) [or Rate (pps)] | 2~99Hz | 2~99Hz | Identical |
| For multiphasic waveforms only: Symmetrical phases? | Yes | Yes | Identical |
| Maximum Charge (Microcoulombs per pulse) | 22.5uC | 15.75uC | SE* |
| Maximum Phase Charge (uC) | 22.5uC | 15.75uC | SE* |
| Maximum Current Density | 0.0716mA/cm2 | 0.0624mA/cm2 | SE* |
| Maximum Average Current | 4.455 mA | 3.119mA | SE* |
| Maximum Average Power Density | 2.685mW/cm2 | 2.34mW/cm2 | SE* |
| Pulse per burst | No burst mode | No burst mode | Identical |
| Burst Mode (i.e. pulse trains) | No burst mode | No burst mode | Identical |
| Burst duration | No burst mode | No burst mode | Identical |
| Duty Cycle | No burst mode | No burst mode | Identical |
| On Time (Second) | 0s, 5s, 6s, All time | 0s, 5s, 6s, All time | Identical |
| Off Time (second) | 0s, 1s, 5s, 10s | 0s, 1s, 5s, 10s | Identical |
*SE = Substantially equivalent
The document states that "through the detailed calculation comparison of stimulation output energy for each operation mode (in particular the output current density and power density), we found the output level in each operation mode for our OTC EMS, Model EV-805 and predicate device are very close and within the acceptable range. So we believe the difference in detailed output parameters does not affect the determination of substantial equivalence."
2. Sample Size Used for the Test Set and Data Provenance
The presented document does not describe a test set with a sample size in the context of clinical performance evaluation for this device. The submission relies entirely on non-clinical tests (compliance to standards) and a comparison to a predicate device to establish substantial equivalence.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
As there was no clinical performance test set, there were no experts used to establish ground truth in this context. The determination of substantial equivalence is based on engineering and performance criteria compared to the predicate through non-clinical testing.
4. Adjudication Method for the Test Set
Not applicable, as no clinical test set requiring adjudication was used.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. The submission is focused on demonstrating substantial equivalence to a predicate device through non-clinical testing and comparison of technical specifications, not on evaluating the improvement of human readers with or without AI assistance.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
N/A. This device is a powered muscle stimulator, not an algorithm or AI system. Therefore, the concept of "standalone performance" for an algorithm doesn't apply. Its performance is evaluated based on its electrical output characteristics and compliance with safety standards.
7. Type of Ground Truth Used
The "ground truth" implicitly used for this submission is the established safety and effectiveness of the legally marketed predicate device (K102926), and compliance with recognized national and international safety standards. The assessment is that the new device's technical specifications and non-clinical test results are comparable or fall within acceptable limits of the predicate.
8. Sample Size for the Training Set
The document does not mention a training set. This type of device (powered muscle stimulator) typically does not involve machine learning algorithms or AI that would require a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there was no training set.
§ 890.5850 Powered muscle stimulator.
(a)
Identification. A powered muscle stimulator is an electrically powered device intended for medical purposes that repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area.(b)
Classification. Class II (performance standards).