(146 days)
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.
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.
This document is a 510(K) summary for a medical device (Midas Rex Motor (Midas III) - a pneumatic cranial drill motor). The provided text does not contain any information about acceptance criteria, device performance metrics, or study designs that would typically be found in a clinical study report or a more detailed regulatory submission.
The content focuses on:
- Administrative details: Date prepared, submitter information, contact person, trade name, common/classification name, device classification, and predicate devices.
- Description of the device: Ergonomic design, lightweight, small diameter, variable speeds (20-150 psi, suggested 100 psi), quick disconnect system.
- Statement of Intended Use: Skull base and other microsurgical applications (otolaryngology, ENT, craniofacial, maxillofacial) where a small, lightweight, high-speed bone dissection system is desired.
- Technological Characteristics: States the modified device has the "same technological characteristics (i.e., design, material, energy source) as the predicate device" and that "The specifications are as follows:", but then the specifications themselves are not provided in the excerpt.
Therefore, I cannot provide the requested information because it is not present in the given text. A 510(K) summary typically focuses on demonstrating substantial equivalence to a predicate device, and while it may reference performance data, the detailed study information is usually in a separate, more comprehensive submission.
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962483
510 (K) SUMMARY OF SAFETY AND EFFECTIVENESS
NOV 1 9 1996
| Date prepared: | June 17, 1996 |
|---|---|
| Submitter: | Midas Rex Pneumatic Tools Inc.3001 Race StreetFort Worth, Texas 76111(817) 831-4181 |
| Contact Person: | Michael FowlerDirector 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 IIMidas ( I, II, & Convertible) K952300 Class IWhirl Wind TM ( Pre-1976 ) |
| Predicate Attachments: | Midas GS and GS20 Surgical Tool SystemK952463 Class IMidas Drill Guide AttachmentK954076 Class IMidas Telescoping System K953433 Class I |
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| Description Of the Device: | Ergonomically, designed lightweight motorfeaturing small, overall diameter for comfortand ease of handling. The Midas Rex III motoroperates at variable speeds. Operatingpressures 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 quickdisconnect GS dissecting tool and tubeattachment system, which includes a fixed orrotating footed attachment, the telescopingmicrosystems, and the micro mini drill guide. |
|---|---|
| Statement of Intended Use: | The Midas Rex Motor is designed for skull baseand other microsurgical applications, includingotolaryngology, ear, nose and throat,craniofacial and maxillofacial specifications inwhich a small, lightweight, high speed bonedissection system is desired. |
| Technological Characteristics: | The modified device has the same technologicalcharacteristics (i.e., design, material, energysource) as the predicate device. Thespecifications are as follows: |
§ 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).