ANSPACH ACCESS CRANIAL PERFORATOR

• K Number: K982991
• Device Name: ANSPACH ACCESS CRANIAL PERFORATOR
• Manufacturer: THE ANSPACH EFFORT, INC.
• Date Cleared: 1998-10-21 ( 55 days)
• Product Code: HBF
• Regulation Number: 882.4305
• Type: Traditional
• Panel: NE
• Reference & Predicate Devices: N/A

Intended Use

For performing cranial trephination.

Device Description

Not Found

AI/ML Overview

This document is a 510(k) clearance letter from the FDA for a medical device called the "Anspach Access Cranial Perforator". It confirms that the device is substantially equivalent to legally marketed predicate devices.

The information provided in this clearance letter does not contain any details about acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, or ground truth establishment.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets those criteria using only the provided text. The document is a regulatory approval notice, not a technical report detailing the device's validation.

Regulation Number and Section

§ 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).