SMALL HIGH SPEED MOTOR DRILL SYSTEM

• K Number: K030172
• Device Name: SMALL HIGH SPEED MOTOR DRILL SYSTEM
• Manufacturer: BRASSELER USA I, L.P.
• Date Cleared: 2003-04-03 ( 76 days)
• Product Code: HBE
• Regulation Number: 882.4310
• Type: Traditional
• Panel: NE
• Reference & Predicate Devices: N/A

Intended Use

THE SMALL HIGH SPEED DRICE SYSTEM IS INTENDED FOR RAPID DISSEETTON OF BONE, BOPLASTICS AND BIOMATERIALS DURING NEUROSURGICAL, ENT AND MAXILLOFACIAL SURGICAL PROCEDURES

Device Description

SMALL MIGH SPEED MOTOR DRILL SYSTEMS

AI/ML Overview

This document is a 510(k) premarket notification decision letter from the FDA for a "Small High Speed Motor Drill System." It confirms that the device is substantially equivalent to a legally marketed predicate device.

However, this document does not contain the information requested in your prompt regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement.

The letter is a regulatory approval document and does not detail the technical performance studies that would have been submitted as part of the 510(k) application. To answer your questions, one would need to access the actual 510(k) submission documentation, which is not provided here.

Regulation Number and Section

§ 882.4310 Powered simple cranial drills, burrs, trephines, and their accessories.

(a)
Identification. Powered simple cranial drills, burrs, trephines, and their accessories are bone cutting and drilling instruments used on a patient's skull. The instruments are used with a power source but do not have a clutch mechanism to disengage the tip after penetrating the skull.(b)
Classification. Class II (performance standards).