(146 days)
No
The description focuses on the mechanical and operational aspects of a surgical motor, with no mention of AI or ML capabilities.
No
The device is described as a high-speed bone dissection system used for surgical applications, which is an interventional tool, not a therapeutic device.
No
The device is a surgical motor designed for bone dissection, not for diagnosing conditions or diseases. Its purpose is to perform a medical procedure (dissection), not to identify or monitor medical conditions.
No
The device description explicitly details a physical motor with specific dimensions, operating pressures, and attachments, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical tool for bone dissection in various anatomical areas (skull base, ear, nose, throat, craniofacial, maxillofacial). This is an in vivo application, meaning it's used directly on a living patient.
- Device Description: The description details a motor and attachments for surgical procedures. There is no mention of analyzing samples (like blood, urine, tissue) outside of the body, which is the core function of an IVD.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples.
- Providing information about a patient's health status based on sample analysis.
- Reagents, calibrators, or controls.
Therefore, the Midas Rex Motor is a surgical device used for in-vivo procedures, not an in-vitro diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes
Not Found
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
skull base and other microsurgical applications, including otolaryngology, ear, nose and throat, craniofacial and maxillofacial specifications
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)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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 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 |
| Device Classification: | Class II |
| Predicate Device: | Midas Rex Motors, |
| Midas ( I, II, & Convertible) K953434 Class II | |
| Midas ( I, II, & Convertible) K952300 Class I | |
| Whirl Wind TM ( Pre-1976 ) | |
| Predicate Attachments: | Midas GS and GS20 Surgical Tool System |
| K952463 Class I | |
| Midas Drill Guide Attachment | |
| K954076 Class I | |
| Midas Telescoping System K953433 Class I |
1
| Description Of the Device: | 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. |
|--------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Statement of Intended Use: | 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. |
| Technological Characteristics: | The modified device has the same technological
characteristics (i.e., design, material, energy
source) as the predicate device. The
specifications are as follows: |