(87 days)
For the Peeling and Vertical Cutting of Preretinal Membranes.
The PVRS - Peregrine Vitreoretinal Scissor is vertical cutting, provided sterile and consists of the following: A 6' length of (pneumatical) tubing with a luer connector at the proximal end to fit into a surgical console. A Delrin handpiece with a 20 GA stainless steel shaft and scissor tip at the distal end.
The provided text describes a 510(k) submission for the PVRS - Peregrine Vitreoretinal Scissor, a medical device. However, it does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications.
The document primarily focuses on:
- Device Description: What the device is and what it does (vertical cutting, preretinal membranes).
- Substantial Equivalence Comparison: Comparing the PVRS to predicate devices (Grieshaber MPC and Sutherland Instruments) based on features like cutting type, drive mechanism, shaft size, and insertion method.
- Sterility Validation: Mentioning ETO sterilization and the AAMI Overkill Method for validation.
- FDA Communication: The FDA's letter of substantial equivalence.
- Indications for Use: Explicitly stating "For the Peeling and Vertical Cutting of Preretinal Membranes."
Therefore, I cannot provide the requested information in the format you specified, as the source material does not contain it.
§ 886.4150 Vitreous aspiration and cutting instrument.
(a)
Identification. A vitreous aspiration and cutting instrument is an electrically powered device, which may use ultrasound, intended to remove vitreous matter from the vitreous cavity or remove a crystalline lens.(b)
Classification. Class II (special controls). The device, when it is phacofragmentation unit replacement tubing, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.