(240 days)
The Revitive IX is indicated for:
- Relaxation of muscle spasms; .
- Prevention or retardation of disuse atrophy; ●
- Increasing local blood circulation; .
- Muscle re-education; .
- Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis; and .
- Maintaining or increasing range of motion. .
The Revitive IX consists of foot pads and/or electrode pads that deliver electrical stimulation to the muscles; an optional feature that allows for ankle movement during stimulation (IsoRocker); a remote control; and a user interface.
Here's an analysis of the provided 510(k) summary regarding acceptance criteria and the supporting study:
The provided 510(k) summary for the Actegy's Revitive IX does not contain specific acceptance criteria or a dedicated study explicitly designed to prove the device meets pre-defined performance acceptance criteria in the way typically found for novel diagnostic algorithms or complex medical devices requiring clinical efficacy studies.
Instead, the submission relies on demonstrating substantial equivalence to predicate devices through a comparison of technological characteristics, intended uses, and safety standards. The performance data mentioned refer to general safety and functional testing, not to specific clinical performance metrics with pre-defined acceptance thresholds.
Therefore, many of the requested fields cannot be directly answered from the provided text. I will address what information is available and indicate where information is absent.
Acceptance Criteria and Reported Device Performance
The concept of "acceptance criteria" in this 510(k) is primarily centered around safety, electromagnetic compatibility, biocompatibility, and functional equivalence to the predicate device. There are no specific quantitative clinical performance metrics (like sensitivity, specificity, accuracy, etc.) provided in relation to the stated indications for use.
| Acceptance Criterion (Implied) | Reported Device Performance |
|---|---|
| Safety and Functionality | "In all instances, the Revitive IX functioned as intended and the results observed were as expected." (General statement) |
| Biocompatibility | "Biocompatibility and electromagnetic compatibility and safety testing, and other performance testing were conducted." (General statement that testing was done, implying compliance) |
| Electromagnetic Compatibility (EMC) & Electrical Safety | "EMDD (93/42EEC), EN60601-1-2:2007" (Compliance with relevant standards is stated). |
| Patient Leakage Current (Normal condition): 6.21 µA max (vs. |
§ 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).