MIDAS REX III MOTOR AND ATTACHMENTS (MIDAS III)

K970965 · Midas Rex Pneumatic Tools, Inc. · ERL · Apr 9, 1997 · Ear, Nose, Throat

Device Facts

• Record ID: K970965
• Device Name: MIDAS REX III MOTOR AND ATTACHMENTS (MIDAS III)
• Applicant: Midas Rex Pneumatic Tools, Inc.
• Product Code: ERL · Ear, Nose, Throat
• Decision Date: Apr 9, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.4250
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Midas Rex III pneumatic motor is designed for used in Ear, Nose and Throat, Otolaryngology and Maxillofacial specifications.

Device Story

Pneumatic cranial drill motor; 62g weight, 15mm diameter, 10.25cm length. Operates at 25,000-70,000 rpm using 20-150 psi air pressure. Features quick disconnect system for GS dissecting tools, tube attachments, fixed/rotating footed attachments, telescoping micro systems, and micro mini drill guide attachments. Used by surgeons in ENT and maxillofacial procedures to drive surgical tools for bone/tissue dissection. Provides mechanical power for cutting/drilling; facilitates surgical access and tissue removal.

Clinical Evidence

Bench testing only.

Technological Characteristics

Pneumatic motor; 25-70k rpm; 20-150 psi operating pressure; 62g weight; 15mm diameter; 10.25cm length. Quick disconnect interface for GS dissecting tools and attachments.

Indications for Use

Indicated for use in Ear, Nose and Throat, Otolaryngology, and Maxillofacial surgical procedures.

Regulatory Classification

Identification

An ear, nose, and throat electric or pneumatic surgical drill is a rotating drilling device, including the handpiece, that is intended to drive various accessories, such as an ear, nose, and throat bur (§ 874.4140), for the controlled incision or removal of bone in the ear, nose, and throat area.

Predicate Devices

• Midas Rex III motor, attachments and accessories (K962483)
• Midas GS and GS20 Surgical Tool System (K962483)
• Midas Drill Guide Attachment (K962483)
• Midas Telescoping System (K962483)
• Dissecting tools (K962483)

Submission Summary (Full Text)

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K970965

# 510 (K) SUMMARY OF SAFETY AND EFFECTIVENESS

Date prepared: March 10, 1996

Submitter: Midas Rex, L. P.
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
Regulation no. 874.4250
Product code 77 ERL
Device Classification: Class II

Predicate Device: Midas Rex III motor, attachments and accessories
Midas GS and GS20 Surgical Tool System
Midas Drill Guide Attachment
Midas Telescoping System
Dissecting tools
K962483 class II

Description of the Device: Ergonomically designed motor, 62 gram in weight, 15 mm in diameter with an overall length of approximately 10.25 centimeters. The Midas Rex III motor operates at variable speeds from 25 to 70 thousand rpm's. Operating pressures range from 20-150 psi (2-10 bar), with a suggested operating pressure of 100-psi (6.9 bar) and approximately 60 thousand rpm. 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 micro systems, and the micro mini drill guide attachment.

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Statement of Intended Use:
The Midas Rex III pneumatic motor is designed for used in Ear, Nose and Throat, Otolaryngology and Maxillofacial specifications.

Technological Characteristics:
The Midas Rex III motor, attachments and accessories have the same technological characteristics (i.e., design, material, energy source) as the predicate devices.

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