← Product Code [ERL](/submissions/EN/subpart-e%E2%80%94surgical-devices/ERL) · K970965 # MIDAS REX III MOTOR AND ATTACHMENTS (MIDAS III) (K970965) _Midas Rex Pneumatic Tools, Inc. · ERL · Apr 9, 1997 · Ear, Nose, Throat · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/EN/subpart-e%E2%80%94surgical-devices/ERL/K970965 ## Device Facts - **Applicant:** Midas Rex Pneumatic Tools, Inc. - **Product Code:** [ERL](/submissions/EN/subpart-e%E2%80%94surgical-devices/ERL.md) - **Decision Date:** Apr 9, 1997 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 874.4250 - **Device Class:** Class 2 - **Review Panel:** Ear, Nose, Throat - **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. ## Regulatory 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](/device/K962483.md)) - Midas GS and GS20 Surgical Tool System ([K962483](/device/K962483.md)) - Midas Drill Guide Attachment ([K962483](/device/K962483.md)) - Midas Telescoping System ([K962483](/device/K962483.md)) - Dissecting tools ([K962483](/device/K962483.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0} Apr-04-97 02:31 P.04 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 (817) 831-4181 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. C:\510\file\midas3\ex\summary\letter {1} Apr-04-97 02:32 P.05 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. C:\510kfile\midas3ce\summaryletter --- **Source:** [https://fda.innolitics.com/submissions/EN/subpart-e%E2%80%94surgical-devices/ERL/K970965](https://fda.innolitics.com/submissions/EN/subpart-e%E2%80%94surgical-devices/ERL/K970965) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com