(30 days)
The Codman Disposable Perforator is for use in perforating the cranium. When properly used, it is designed to automatically disengage once perforation is accomplished and when pressure is removed from the drill point.
The Codman Disposable Perforators are pre-assembled, single-use, sterile devices that are designed to perforate the cranium. When properly used, the Disposable Perforators are designed to automatically disengage once perforation is accomplished and when pressure is removed from the drill point. They are designed with a Hudson end and are available in three color-coded sizes:
- 14mm (blue ABS sleeve) – product number: 26-1221
- 11mm (green ABS sleeve) product number: 26-1222 ●
- 9mm (yellow ABS sleeve) product number: 26-1223 ●
This document describes a 510(k) premarket notification for "Codman Disposable Perforators," which are medical devices used to perforate the cranium. The submission aims to demonstrate substantial equivalence to previously cleared devices.
Here's an analysis of the acceptance criteria and study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance
| Test | Test Method / Purpose | Acceptance Criteria | Result |
|---|---|---|---|
| Full Dose Mapping Validation | Establish a new gamma radiation sterilization cycle in compliance with ISO 11137-1 | Dose Uniformity Ratio: |
§ 882.4305 Powered compound cranial drills, burrs, trephines, and their accessories.
(a)
Identification. Powered compound cranial drills, burrs, trephines, and their accessories are bone cutting and drilling instruments used on a patient's skull. The instruments employ a clutch mechanism to disengage the tip of the instrument after penetrating the skull to prevent plunging of the tip into the brain.(b)
Classification. Class II (performance standards).