KOMET XK-95 PERFORATOR MOTOR (MI-102)

• K Number: K991625
• Device Name: KOMET XK-95 PERFORATOR MOTOR (MI-102)
• Manufacturer: KOMET MEDICAL
• Date Cleared: 1999-07-30 ( 80 days)
• Product Code: HBB
• Regulation Number: 882.4370
• Type: Traditional
• Panel: NE
• Reference & Predicate Devices: N/A

Intended Use

The XK-95 Perforator Motor is intended to be used in conjunction with various cranial The XX-95 I criorator Motor adapter for cranial perforations.

Device Description

Not Found

AI/ML Overview

The provided text describes a 510(k) clearance letter for the Komet Medical Xk-95 Perforator Motor. This document primarily focuses on regulatory approval and does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth methodologies that are typically found in a clinical study report.

Therefore, I cannot provide the requested information based on the provided text. The document confirms that the device is substantially equivalent to legally marketed predicate devices, which is a regulatory and not a performance-based assessment.

Regulation Number and Section

§ 882.4370 Pneumatic cranial drill motor.

(a)
Identification. A pneumatic cranial drill motor is a pneumatically operated power source used with removable rotating surgical cutting tools or drill bits on a patient's skull.(b)
Classification. Class II (performance standards).