(23 days)
No Reference Device(s) were found
No
The 510(k) summary describes a pneumatic surgical motor and its attachments, focusing on mechanical specifications and intended use. There is no mention of AI, ML, image processing, or data-driven performance metrics typically associated with AI/ML devices.
Yes
The device is a pneumatic motor designed for surgical procedures in the Ear, Nose, Throat, Otolaryngology, and Maxillofacial specifications, indicating its use in treating diseases or injuries.
No
Explanation: The device description states its use is for surgical procedures, indicating it is an operative tool, not a diagnostic one.
No
The device description clearly details a physical pneumatic motor with specific dimensions, weight, operating parameters (speed, pressure), and attachments, indicating it is a hardware device.
Based on the provided information, the Midas Rex III pneumatic motor is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states it's for surgical procedures in Ear, Nose and Throat, Otolaryngology, and Maxillofacial specifications. This involves direct interaction with the patient's body during surgery.
- Device Description: The description details a surgical motor used for cutting and dissecting tissue. This is a surgical tool, not a device used to examine specimens in vitro (outside the body).
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis.
IVD devices are used to examine specimens obtained from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. The Midas Rex III is a surgical instrument used during treatment.
N/A
Intended Use / Indications for Use
The Midas Rex III pneumatic motor is designed for used in Ear, Nose and Throat, Otolaryngology and Maxillofacial specifications.
Product codes
77 ERL
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Ear, Nose and Throat, Otolaryngology and Maxillofacial
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 874.4250 Ear, nose, and throat electric or pneumatic surgical drill.
(a)
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.(b)
Classification. Class II.
0
APR - 9 1997
510 (K) SUMMARY OF SAFETY AND EFFECTIVEN
Date prepared:
Submitter:
Contact Person:
March 10. 1996
Midas Rex. L. P. 3001 Race Street Fort Worth, Texas 76111 (817) 831-4181
Michael Fowler Director Regulatory Affairs
Midas Rex Motor (Midas III)
Pneumatic Cranial Drill Motor 874.4250 77 ERL Class II
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
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.
Trade (proprietary) Name:
Common / Classification Name: Regulation no. Product code Device Classification:
Predicate Device:
Description of the Device:
1
Statement of Intended Use:
Technological Characteristics:
The Midas Rex III pneumatic motor is designed for used in Ear, Nose and Throat, Otolaryngology and Maxillofacial specifications.
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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