MIDAS REX III MOTOR

K962483 · Midas Rex Pneumatic Tools, Inc. · HBB · Nov 19, 1996 · Neurology

Device Facts

• Record ID: K962483
• Device Name: MIDAS REX III MOTOR
• Applicant: Midas Rex Pneumatic Tools, Inc.
• Product Code: HBB · Neurology
• Decision Date: Nov 19, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.4370
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Midas Rex Motor is designed for skull base and other microsurgical applications, including otolaryngology, ear, nose and throat, craniofacial and maxillofacial specifications in which a small, lightweight, high speed bone dissection system is desired.

Device Story

Pneumatic cranial drill motor; lightweight, ergonomic design; variable speed operation. Input: compressed air (20-150 psi). Output: high-speed mechanical bone dissection. Used in OR by surgeons for microsurgical applications. Integrates with existing Midas Rex GS dissecting tools, tube attachments, fixed/rotating footed attachments, telescoping microsystems, and micro mini drill guides. Facilitates precise bone removal in skull base and ENT procedures.

Clinical Evidence

Bench testing only; no clinical data provided. Substantial equivalence based on design and performance similarity to predicate devices.

Technological Characteristics

Pneumatic motor; operating pressure 20-150 psi (2-10 bar), recommended 100 psi (6.9 bar). Lightweight, small diameter housing. Quick disconnect interface for GS dissecting tools and attachments. Mechanical energy source.

Indications for Use

Indicated for patients requiring skull base and microsurgical bone dissection procedures, including otolaryngology, ENT, craniofacial, and maxillofacial surgeries.

Regulatory Classification

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.

Predicate Devices

• Midas Rex Motors, Midas (I, II, & Convertible) (K953434)
• Midas Rex Motors, Midas (I, II, & Convertible) (K952300)
• Whirl Wind TM (Pre-1976)
• Midas GS and GS20 Surgical Tool System (K952463)
• Midas Drill Guide Attachment (K954076)
• Midas Telescoping System (K953433)

Submission Summary (Full Text)

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NOV 19 1996
K962483

# 510 (K) SUMMARY OF SAFETY AND EFFECTIVENESS

Date prepared: June 17, 1996

Submitter: Midas Rex Pneumatic Tools Inc.
3001 Race Street
Fort Worth, Texas 76111
[phone]

Contact Person: Michael Fowler
Director Regulatory Affairs

Trade (proprietary) Name: Midas Rex Motor (Midas III)

Common / Classification Name: Pneumatic Cranial Drill Motor

Device Classification: Class II

Predicate Device: Midas Rex Motors,
Midas (I, II, & Convertible) K953434 Class II
Midas (I, II, & Convertible) K952300 Class I
Whirl Wind TM (Pre-1976)

Predicate Attachments: Midas GS and GS20 Surgical Tool System
K952463 Class I
Midas Drill Guide Attachment
K954076 Class I
Midas Telescoping System K953433 Class I

Premarket Notification: Midas Rex Pneumatic Tools Inc. Billmansafety

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Premarket Notification: Midas Rex Pneumatic Tools. Cstansafety

# Description Of the Device:

Ergonomically, designed lightweight motor featuring small, overall diameter for comfort and ease of handling. The Midas Rex III motor operates at variable speeds. Operating pressures range from 20-150 psi (2-10 bar), with a suggested operating pressure of 100 psi (6.9 bar).

The Midas Rex III has a standard quick disconnect GS dissecting tool and tube attachment system, which includes a fixed or rotating footed attachment, the telescoping microsystems, and the micro mini drill guide.

# Statement of Intended Use:

The Midas Rex Motor is designed for skull base and other microsurgical applications, including otolaryngology, ear, nose and throat, craniofacial and maxillofacial specifications in which a small, lightweight, high speed bone dissection system is desired.

# Technological Characteristics:

The modified device has the same technological characteristics (i.e., design, material, energy source) as the predicate device. The specifications are as follows: