(30 days)
ELECTRICAL MUSCLE STIMULATOR SERIES 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 ARGA. IN PORTICULAR, THIS DEVICE IS INDICATED FOR USE for 2: RELAXING MUSCLE SPASHS; INCREASING LOCAL BLOGO CIRCULATIon; INCESSION BEST SURGICAL STIMULATION of CALF MUSELES TO PECIENT THROMBOSIS; MUSCLE RE-EDUCATION; MAINTAINING OR INCREASING RANGE of MOTIO; PREVENTING OR RETARDING DISUSE
The Special 510(k) premarket notification describes a modification to Everyway's currently legally marketed EV-807 Digital Electrical Stimulator. The proposed modifications include technical specifications (Output amplitude, range of pulse width, pulse rate, ramp time), buttons to adjust parameters and shape unit. Basically the change is from digital version to analogue version of EMS. The specifications of units are modified according to the requirements of customers while are still very similar to the predicated unit.
The provided text is a 510(k) summary for the Everyway Medical Instruments Co., Ltd Electrical Muscle Stimulator (Models N605 and N607). It describes the device, its intended use, and claims substantial equivalence to a predicate device (Digital EMS, model EV-807 from Everyway Medical Instruments Co., Ltd., 510k# K020750).
Here's an analysis of the acceptance criteria and study data based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not provide specific quantitative acceptance criteria or results from a performance study demonstrating that the device meets those criteria. Instead, it relies on a comparison table to the predicate device to claim substantial equivalence.
| Acceptance Criteria Category | Predicate Device Performance / Claim | New Device Performance / Claim |
|---|---|---|
| Indications for Use | Identical | Identical |
| Target Population | Identical | Identical |
| Design | Similar (Digital to Analog) | Similar |
| Materials | Similar | Similar |
| Performance | Similar | Similar |
| Sterility | Not Applicable | Not Applicable |
| Biocompatibility | Identical | Identical |
| Mechanical Safety | Identical | Identical |
| Chemical Safety | Not Applicable | Not Applicable |
| Anatomical Sites | Identical | Identical |
| Human Factors | Similar | Similar |
| Energy Used/Delivered | Similar | Similar |
| Compatibility with Environment and Other Devices | Identical | Identical |
| Where Used | Identical | Identical |
| Standards Met | Identical | Identical |
| Electrical Safety | Identical | Identical |
| Thermal Safety | Identical | Identical |
| Radiation Safety | Not Applicable | Not Applicable |
2. Sample Size for the Test Set and Data Provenance
The document does not mention a specific test set, sample size, or any data provenance (country of origin, retrospective/prospective) for a performance study. The submission primarily relies on a comparative analysis to a predicate device rather than independent testing for this submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not applicable as the submission does not describe a performance study with a test set requiring expert ground truth establishment.
4. Adjudication Method for the Test Set
This information is not applicable as the submission does not describe a performance study with a test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC study was conducted or reported in this submission. The effectiveness is claimed through substantial equivalence to a predicate device. Therefore, no effect size of human readers improving with AI vs. without AI assistance is reported.
6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance
This is not applicable. The device is an Electrical Muscle Stimulator, not an AI algorithm. Performance is claimed through substantial equivalence to a predicate device, which is also an Electrical Muscle Stimulator.
7. Type of Ground Truth Used
This is not applicable in the context of a diagnostic test or AI algorithm. The "ground truth" in this submission is the established safety and effectiveness of the predicate device, which the new device claims to be substantially equivalent to.
8. Sample Size for the Training Set
This is not applicable. The device is a medical instrument (Electrical Muscle Stimulator), not an AI system that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This is not applicable for an Electrical Muscle Stimulator.
Summary of Device Acceptance:
The acceptance of the Electrical Muscle Stimulator (Models N605 and N607) by the FDA was based on substantial equivalence to a legally marketed predicate device (Digital EMS, model EV-807, K020750) rather than a new clinical study with specific acceptance criteria and performance data. The manufacturer demonstrated that the modified device, despite changes from digital to analog and adjustments in technical specifications (output amplitude, pulse width, pulse rate, ramp time), buttons, and unit shape, had identical or similar characteristics to the predicate device across various aspects including indications for use, target population, design, materials, performance, safety, and standards met. The FDA's decision letter confirms that the device was found substantially equivalent to predicate devices, thus permitting it to enter the market subject to general controls. No new clinical trials or performance studies with specific acceptance criteria were needed for this 510(k) submission.
§ 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).