(97 days)
DePuy Mitek FMS VUE Fluid Management and Tissue Debridement System is intended to provide controlled fluid distention and suction, controlled cutting, burring, shaving and abrading of bone and tissue for use in arthroscopic surgery of the shoulder, knee, ankle, elbow, wrist and hip joints.
The FMS CONNECT Interface Cables are accessories to the DePuy Mitek FMS Fluid Management and Tissue Debridement Systems; they connect competitive shavers to FMS arthroscopy pumps.
The FMS VUE is DePuy Mitek's next generation of Fluid Management and Tissue Debridement System. The system consists of a pump, tube sets, and the following optional accessories Foot Pedal, Remote Control, Handpiece and FMS Connect Interface Cable. As with its predicate devices, FMS DUO+ and FMS SOLO, this system utilizes pump technology designed to provide a range of arthroscopic surgical treatments including soft tissue ablation, contouring, cutting and coagulation and temperature control.
The FMS VUE provides irrigation (inflow) and aspiration (outflow) of fluid to and from joint cavities during arthroscopic procedures by way of 2 peristaltic roller pumps. Both roller pumps are software controlled to automatically manage fluid and intra-articular joint pressure based on default settings or adjusted setting chosen by the surgeon. Additionally, the pumps automatically manage shaver and cannula suction. By controlling both flow and pressure setting, the FMS VUE Fluid Management & Tissue Debridement System accurately requlates pressure and flow in the joint.
The FMS VUE can be used in either the DUO mode (default mode) which provides irrigation, shaver control and suction or the SOLO mode which provides irrigation and shaver control but not suction.
Like its predicates, the FMS VUE also incorporates an integrated debridement function for controlled shaving and burring of tissue and bone.
The FMS Connect Interface Cable allows the use of competitive shaver systems to interface with the FMS VUE. When the FMS Connect device is attached to the cable of a competitors hand piece and the hand piece is running, the FMS Connect sends a signal to the FMS VUE.
The provided document is a 510(k) summary for the DePuy Mitek FMS VUE Fluid Management & Tissue Debridement System and FMS Connect Interface Cable. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than detailed reports of clinical studies proving specific performance metrics against pre-defined acceptance criteria.
Therefore, the document does not contain the requested information regarding specific acceptance criteria, a study proving the device meets those criteria, sample sizes, data provenance, ground truth establishment, or multi-reader multi-case studies.
Instead, the document states:
- Clinical Studies: "No clinical studies are required to demonstrate safety and efficacy of Testing the device in support of an application for premarket clearance. The FMS VUE Fluid Management & Tissue Debridement System and FMS Connect Interface Cables do not differ from the predicate device in fundamental scientific technology or intended use." (Page 3)
- Safety and Performance: "Verification of the FMS VUE Fluid Management & Tissue Debridement System and accessories includes electrical, software and performance tests to show that the device meets its product specifications over a range of operating conditions. Validation testing for the FMS VUE includes testing to show the device meets user needs." (Page 2)
- Conclusion: "Safety and performance testing have been executed to validate the performance and safety of the devices. It has been demonstrated that these device modifications will not affect safety and effectiveness of the subject devices. Results of performance and safety testing have demonstrated that the modified device is suitable for its intended use." (Page 3)
The submission refers to compliance with various electrical, software, and general medical device standards (EN 60601-1, EN 60601-1-2, IEC 62304, and FDA guidance documents for software and validation) as part of proving safety and performance. However, these are general compliance standards, not specific acceptance criteria for a particular performance study on the device's diagnostic or clinical effectiveness.
In summary, the detailed information requested about acceptance criteria, study design, sample sizes, ground truth, and expert involvement for proving device performance is not present in this 510(k) summary. The submission relies on demonstrating substantial equivalence to predicate devices and adherence to relevant safety and performance standards for medical electrical equipment.
§ 888.1100 Arthroscope.
(a)
Identification. An arthroscope is an electrically powered endoscope intended to make visible the interior of a joint. The arthroscope and accessories also is intended to perform surgery within a joint.(b)
Classification. (1) Class II (performance standards).(2) Class I for the following manual arthroscopic instruments: cannulas, currettes, drill guides, forceps, gouges, graspers, knives, obturators, osteotomes, probes, punches, rasps, retractors, rongeurs, suture passers, suture knotpushers, suture punches, switching rods, and trocars. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 888.9.