MIDAS REX III MOTOR AND ATTACHMENTS (MIDAS III)
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)
Related Devices
- K962483 — MIDAS REX III MOTOR · Midas Rex Pneumatic Tools, Inc. · Nov 19, 1996
- K030172 — SMALL HIGH SPEED MOTOR DRILL SYSTEM · Brasseler USA I, L.P. · Apr 3, 2003
- K013091 — ZMM 2000 ZEPPELIN MILLENNIUM MOTORDRILL SYSTEM · Von Zeppelin GmbH · Jan 25, 2002
- K980686 — AESCULAP HILAN MOTOR SYSTEM · Aesculap, Inc. · Sep 2, 1998
- K020069 — MEDTRONIC MIDA REX LEGEND SYSTEM, MIDAS REX LEGEND PNEUMATIC HIGH SPEED SYSTEM OR LEGEND SYSTEM · Medtronic Midas Rex · Mar 18, 2002
