(87 days)
The FMS Blades and Burrs are an accessory to the FMS Fluid Management Systems. FMS Blades and Burrs are intended to provide controlled cutting, burring, shaving and abrading of bone and tissue for use in arthroscopic surgery.
The purpose of this 510(k) Notification is to outline modifications made to the currently marketed FMS Blades and Burrs. The changes being made to the proposed devices are to enhance performance and include modifications including: material changes, modified inner and outer blade window profiles, and modified inner and outer burr tip geometry. FMS Shaver Blades and Burrs are used with the FMSTM Tornado or Micro Hand pieces which are accessories to the and Fluid Management Systems. They consist of stainless steel outer tube and a rotating inner tube connected to an inner and outer plastic hubs. Distal tips of the tubes contain sharp edges to facilitate the cutting.
The provided text is a 510(k) summary for a medical device called "FMS Shaver Blades and Burrs." It describes a submission to the FDA for modifications to an already marketed device and aims to prove substantial equivalence to predicate devices.
However, the provided text does not contain the information requested in your bullet points regarding acceptance criteria, a specific study with performance metrics, sample sizes, expert involvement, or detailed ground truth methodologies. The text primarily focuses on:
- Device Description: What the FMS Shaver Blades and Burrs are and their components.
- Intended Use/Indications for Use: The purpose of the blades and burrs in arthroscopic surgery.
- Modifications: Changes made to enhance performance (material changes, blade/burr profiles).
- Substantial Equivalence: Claiming equivalence to existing cleared systems (K954465, K041824).
- Nonclinical Testing: Listing general verification activities like "Blade Tissue Cutting, Burr Bone Cutting, Blade Shed Testing and Burr Shed Testing." It states these were performed on proposed and predicate devices.
- Safety and Performance: A general statement that testing demonstrated substantial equivalence.
Therefore, I cannot populate the requested table or answer the specific questions because the necessary details are not present in the provided document.
The document states that "Verification activities such as Blade Tissue Cutting, Burr Bone Cutting, Blade Shed Testing and Burr Shed Testing were performed on the proposed and predicate devices," and that "Results of performance and safety testing have demonstrated that the modified devices are substantially equivalent to the predicate devices." However, it does not provide the acceptance criteria values, the reported device performance metrics, sample sizes, or details of how ground truth was established for these tests.
This type of 510(k) summary often summarizes extensive testing that is contained in the full 510(k) submission, but not typically in the public-facing summary document.
§ 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.