(261 days)
The Diego Elite Drill is intended for cutting, drilling, and removal of bone, and soft and hard tissue in general ENT, and Otoneurologic procedures when used in conjunction with the Diego Elite console.
Specific procedures would include Mastoid Neurotology (Mastoidotomy) and Stapes procedures.
The Diego Elite Drill is similar to the drills associated with the predicate Diego® RF Powered Dissector and Drill System cleared under K034004. The Diego Elite Drill is the next generation drill and it is functionally equivalent to the predicate Gyrus ACMI product and other predicates.
The proposed Drill and accessories are to be used only in conjunction with the Diego Elite system (K123429) for Otologic procedures. The Diego Elite system original submission did not include an Otologic drill, and the predicate (K034004) is not compatible with the Diego Elite system.
Accessories include straight and angled attachments, an irrigation clip, various burrs, an irrigation tubeset, a cleaning kit, and a cleaning / sterilization tray. The drill base plugs into the existing Diego Elite console and is activated by the existing Diego Elite footswitch. The drill base and the straight and angled attachments, and irrigation clip are provided non-sterile and are reusable. The burrs and tubeset are provided sterile and are single-use. The cleaning kit is provided non-sterile and is single-use.
This document describes the premarket notification for the "Diego Elite Drill" (K152744), a surgical drill intended for ENT and Otoneurologic procedures. The submission claims substantial equivalence to existing predicate devices.
Here's an analysis of the acceptance criteria and study data:
Acceptance Criteria and Device Performance
The acceptance criteria for the "Diego Elite Drill" are primarily based on simulated use testing and preclinical evaluations to demonstrate substantial equivalence to predicate devices, focusing on functionality, usability, and safety. There are no explicit quantitative performance metrics like sensitivity, specificity, or AUC provided in the context of diagnostic accuracy, as this is a surgical device. Instead, performance is evaluated through surgeon feedback against predefined usability criteria.
| Acceptance Criteria Category | Specific Metric / Criterion | Acceptance Threshold | Reported Device Performance |
|---|---|---|---|
| Simulated Use Testing (Phacon Temporal Bone) | Average Rating for Set-up |
§ 874.4250 Ear, nose, and throat electric or pneumatic surgical drill.
(a)
Identification. An ear, nose, and throat electric or pneumatic surgical drill is a rotating drilling device, including the handpiece, that is intended to drive various accessories, such as an ear, nose, and throat bur (§ 874.4140), for the controlled incision or removal of bone in the ear, nose, and throat area.(b)
Classification. Class II.