(258 days)
The D7108 handpiece, as connected to the D7106 drive tube and detachable microscissors, is intended to be used with the Storz PREMIERE® or Storz DAISY™ Microsurgical Systems to cut intraocular tissue in the posterior segment of the eye during ophthalmic surgical procedures.
The Storz D7108 Microscissors Handpiece is a reusable, electrically powered, pneumatic handpiece that is used to operate a variety of detachable microscissors. A selected microscissors attachment screws on to the tip of the D7108 Microscissors Handpiece The D7108 handpiece attaches to the Storz D7106 Microscissors Drive Tube, which in turn connects to the Storz PREMIERE® or the Storz DAISY™ Ophthalmic Microsurgical System. As the "Scissors" function of the microsurgical system is activated, the piston inside the D7108 handpiece is driven forward and backward by air pressure, causing the blades of the attached microscissors to open and close rapidly. The handpiece also has a manual over-ride lever near the tip of the handpiece that allows the physician to manually operate the scissors without requiring external power.
This document is a 510(k) summary for medical devices, specifically for surgical scissors and related components. It does not contain information about acceptance criteria or a study proving device performance in the way you've requested (e.g., in terms of diagnostic accuracy, sensitivity, specificity, etc., which are typical for AI/diagnostic device evaluations).
Instead, this document focuses on demonstrating substantial equivalence to a predicate device, which is a regulatory pathway for lower-risk devices. The evaluation here is about comparing physical characteristics, intended use, and operational functionality, not about measuring clinical performance against a ground truth.
Therefore, I cannot extract the information you've requested as it's not present in the provided text. The document is about:
- Device Description/Intended Use: Explaining what the Storz D7108 Microscissors Handpiece and D7106 Microscissors Drive Tube do (cut intraocular tissue).
- Predicate Device: Identifying a similar device already on the market (Escalon™ Trek Medical Vertical Automated Scissors).
- Predicate Comparison: Showing that the new device is "substantially equivalent" to the predicate device based on characteristics like intended use, components, compatible systems, and reusability.
If you are looking for evaluation criteria and studies related to diagnostic or AI-powered devices, you would need a different type of document, such as a clinical study report or a 510(k) summary for a device that makes a diagnostic claim or involves image analysis.
§ 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.