(238 days)
EV-807 Digital EMS is an electrically powered muscle stimulator intended for use for medical purposes to repeatedly contract muscles by passing electrical currents through electrodes contacting the affected body area. In particular, this device is indicated for use for:
- Relaxing muscle spasms. a
- Increasing local blood circulation. -
- Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis.
- Muscle re-education. ।
- Maintaining or increasing range of motion. -
- Preventing or retarding disuse atrophy
EV-807 Digital EMS is a battery operated pulse generator that sends electrical impulses through electrodes to the body and reaches the underlying or muscle group. The device is provided with two controllable output channels, each independent of each other. An electrode pair can be connected to each output channel.
The electronics of the EVERYWAY EV-807 DIGITAL EMS create electrical impulses whose intensity, pulse width, pulse rate, contraction, relaxation and ramp may be altered with the switches. Press buttons are very easy to use and the slide cover prevents accidental changes in the setting.
Acceptance Criteria and Study for EV-807 Digital EMS
The provided document describes the 510(k) submission for the EV-807 Digital EMS device, which is an electrically powered muscle stimulator. The core of its acceptance criteria and the study proving it meets these criteria is based on demonstrating substantial equivalence to a previously cleared predicate device.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate Device (510k #K010665) | The EV-807 Digital EMS is Identical to the predicate device across all technological characteristics. |
| Indications for Use | Identical to predicate device. |
| Target Population | Identical to predicate device. |
| Design | Identical to predicate device. |
| Materials | Identical to predicate device. |
| Performance | Identical to predicate device. |
| Sterility | Identical to predicate device. |
| Biocompatibility | Identical to predicate device. |
| Mechanical Safety | Identical to predicate device. |
| Chemical Safety | Identical to predicate device. |
| Anatomical Sites | Identical to predicate device. |
| Human Factors | Identical to predicate device. |
| Energy Used and/or Delivered | Identical to predicate device. |
| Compatibility with Environment and Other Devices | Identical to predicate device. |
| Where Used | Identical to predicate device. |
| Electrical Safety (EN 60601-1:1990+A1:1993+A2:1995) | Conforms to the standard (indicated by explicit statement of conformance). |
| Thermal Safety (EN 60601-1:1990+A1:1993+A2:1995) | Conforms to the standard (indicated by explicit statement of conformance). |
| Radiation Safety (EN60601-1-2:1993) | Conforms to the standard (indicated by explicit statement of conformance). |
| Immunity to Electromagnetic Disturbances (EN60601-1-2:1993) | Conforms to the standard (indicated by explicit statement of conformance). |
| Quality System Requirements (DIN EN ISO 9002/08.1994, DIN EN 46002/09.1996, ISO 13488/12.1996) | Conforms to these standards. |
| CE Mark (EE Directive 93/42) | Conforms to this directive. |
Study Proving Device Meets Acceptance Criteria:
The study that proves the EV-807 Digital EMS meets its acceptance criteria is a comparative study against a legally marketed predicate device (TransAmerica Medical Systems, 510k #K010665). This is an abbreviated 510(k) submission, which relies on demonstrating that the new device is "identical" to a predicate device.
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size for Test Set: Not explicitly stated as a separate "test set" in the traditional sense of a clinical trial. The "test" here is the direct comparison of the design and specifications of the EV-807 Digital EMS with the predicate device. The "sample" is implicitly the EV-807 device itself and its documented specifications.
- Data Provenance: The data provenance is from the Taiwan, R.O.C. (country of origin for Everyway Medical Instruments Co., Ltd.) manufacturing and design documentation, compared against the publicly available information for the predicate device. This is a retrospective comparison against an existing cleared device.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Number of Experts: Not applicable in the context of this type of submission. The "ground truth" for the comparison is established by the documented specifications and regulatory clearance status of the predicate device.
- Qualifications of Experts: The expertise involved would be that of the device manufacturer's design and regulatory teams, and subsequently, the FDA reviewers who evaluate the claim of substantial equivalence. Specific qualifications are not listed for this direct comparison.
4. Adjudication Method for the Test Set:
- Adjudication Method: Not applicable. There is no ambiguous outcome requiring adjudication by multiple readers or experts. The assessment is a direct comparison of specifications and claims of identicality.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
- No, an MRMC comparative effectiveness study was not done. This type of study is typically used for diagnostic or screening devices to assess the impact of an AI algorithm on human reader performance. The EV-807 Digital EMS is a therapeutic muscle stimulator, and its submission relies on direct equivalence to a predicate device, not on improving human reader performance.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop) Performance Was Done:
- No, a standalone performance study was not done. The EV-807 Digital EMS is a physical medical device, not an AI algorithm. Its performance is assessed through its physical characteristics and functionality, which are claimed to be identical to the predicate device.
7. The Type of Ground Truth Used:
- Ground Truth Type: The ground truth used is the regulatory clearance and documented specifications of the predicate device (510k #K010665). The submission asserts that the new device is "identical" to this established, legally marketed device.
8. The Sample Size for the Training Set:
- Not applicable. There is no "training set" in the context of this submission. The device is not based on a machine learning algorithm that requires training data.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable. As there is no training set, there is no ground truth established for it.
§ 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).