(300 days)
Not Found
Midas Rex Whirlwind™ Motor
No
The device description focuses on mechanical and pneumatic components, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes.
This device is a surgical motor designed to operate cutting tools or drill bits on a patient's skull, directly performing a medical procedure for therapeutic purposes.
No
The device is described as an air-powered rotating motor used to operate surgical cutting tools or drill bits on a patient's skull, indicating its function is for surgical procedures, not for diagnosing a condition.
No
The device description clearly outlines a physical, air-powered motor constructed of stainless steel, aluminum, and brass, designed to operate surgical cutting tools. This is a hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "provide power to operate removable rotating surgical cutting tools or drill bits on a patient's skull." This describes a surgical tool used directly on a patient's body for a surgical procedure.
- Device Description: The description details a surgical motor and its components, designed for mechanical operation during surgery.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, tissue, urine, etc.) to provide information for diagnosis, monitoring, or treatment. IVDs are typically used in a laboratory or clinical setting to analyze biological samples.
Therefore, this device falls under the category of a surgical instrument or tool, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
o provide power to operate removable rotating surgical cutting tools or drill bits on a patient's skull.
Product codes (comma separated list FDA assigned to the subject device)
84HBB
Device Description
The Midas Rex Motors (Midas I, Midas II and Convertible models) are air-powered, rotating motors designed to operate at 20-120 psi or at up to 200 psi. The motor is connected to an air-supply source by means of a stainless steel joint and a plastic air hose with inner rubber pressure hose.
The motors are constructed of stainless steel, aluminum and brass and are designed to operate at 20-120 psi or at up to 200 psi with the same performance characteristics. Depending on user preference, the 200 psi motor is available in either a round or hexagonal casing, approximately 0.75 inch in diameter. Similarly, the 120 psi motor can be supplied in either a round or hexagonal casing in diameters of approximately 0.375, 0.5 or 0.75 inch.
Again depending on user preference, the joint connecting the motor to the air hose can be equipped with a rotating cuff at one or both ends, allowing the motor and/or air hose to swivel independently with respect to the joint, thus providing greater freedom of movement during surgical procedures and avoiding possible "kinking" of the air hose. Thus, a variety of device configurations are possible based on the surgeon's personal preference, as shown below:
Midas Rex Motors are supplied non-sterilization by hospital staff immediately prior to each use. The materials of construction of the motor and air hose are compatible with both ethylene oxide and steam sterilization (flash or standard autoclave procedures). A 4-minute cycle is recommended for high vacuum steam sterilization at 270º F. Gravity displacement steam sterilization may be performed at 250º F for 35 minutes or at 270º F for 15 minutes. A minimum of 18 hours mechanical aeration is recommended following ethylene oxide sterilization.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
patient's skull
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Midas Rex Whirlwind™ Motor
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
510 (k) SUMMARY
I. ADMINISTRATIVE
Submitter: Midas Rex Pneumatic Tools, Inc. 3001 Race Street Fort Worth, Texas 76111 (817) 831-2604
Forest Barber, Jr. Contact Person:
Date of Preparation: July 20, 1995
II. DEVICE NAME
Proprietary Name: Midas Rex Motors (Midas I Midas II and Convertible Models)
Common Name: Surgical Instrument Motor
Classification Name: Pneumatic Cranial Drill Motor (84HBB)
III. PREDICATE DEVICE
Midas Rex Whirlwind™ Motor, legally marketed prior to May 28, 1976.
IV. DEVICE DESCRIPTION
The Midas Rex Motors (Midas I, Midas II and Convertible models) are air-powered, rotating motors designed to operate at 20-120 psi or at up to 200 psi. The motor is connected to an air-supply source by means of a stainless steel joint and a plastic air hose with inner rubber pressure hose.
The motors are constructed of stainless steel, aluminum and brass and are designed to operate at 20-120 psi or at up to 200 psi with the same performance characteristics. Depending on user preference, the 200 psi motor is available in either a round or hexagonal casing, approximately 0.75 inch in diameter. Similarly, the 120 psi motor can be supplied in either a round or hexagonal casing in diameters of approximately 0.375, 0.5 or 0.75 inch.
Again depending on user preference, the joint connecting the motor to the air hose can be equipped with a rotating cuff at one or both ends, allowing the motor and/or air hose to swivel independently with respect to the joint, thus providing greater freedom of movement during surgical procedures and avoiding possible "kinking" of the air hose. Thus, a variety of device configurations are possible based on the surgeon's personal preference, as shown below:
1
| | Motor | Joint | Hose | | Midas I | Midas II | Convertible | Midas I, II and
Convertible
(K952300) | Whirlwind™
(pre-1976) |
|-------------|------------------|------------------------------------|------------------|----------------------------------------|-------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------|
| Midas I | Fixed
Swivels | Straight (180°)
Straight (180°) | Fixed
Swivels | Construction | Stainless steel, brass
and aluminum | Stainless steel, brass
and aluminum | Stainless steel, brass
and aluminum | Stainless steel, brass
and aluminum | Stainless steel, brass
and aluminum |
| Midas II | Fixed | Angled (45°) | Fixed | Case Shape/Diameter | Round or hexagonal
0.375, 0.5 or 0.75 inch | Round or hexagonal
0.375, 0.5 or 0.75 inch | Round or hexagonal
0.375, 0.5 or 0.75 inch | Round or hexagonal
0.375, 0.5 or 0.75 inch | Round/0.75 inch |
| | Fixed | Angled (45°) | Swivels | Motor/Air hose Joint | Straight | Angled (45°) | Straight or Angled
(swivel joint) | Straight, Angled
and Swivel Joint | Straight |
| | Swivels | Angled (45°) | Fixed | Motor Alignment
(relative to joint) | Fixed or Swivel | Fixed or Swivel | Fixed or Swivel | Fixed or Swivel | Fixed |
| | Swivels | Angled (45°) | Swivels | Hose Alignment
(relative to joint) | Fixed or Swivel | Fixed or Swivel | Fixed or Swivel | Fixed or Swivel | Fixed |
| Convertible | Fixed | 180° or 45° | Fixed | Air Operating Pressure | 20-120 psi or 200 psi | 20-120 psi or 200 psi | 20-120 psi or 200 psi | 20-120 psi or 200 psi | 200 psi |
| | Fixed | 180° or 45° | Swivels | RPM (000's) | 40-75 (20-120 psi)
30-75 (200 psi) | 40-75 (20-120 psi)
30-75 (200 psi) | 40-75 (20-120 psi)
30-75 (200 psi) | 40-75 (20-120 psi)
30-75 (200 psi) | 30-75 |
| | Swivels | 180° or 45° | Fixed | Stall Torque | 1-5.3 (20-120 psi)
1.3-5.3 (200 psi) | 1-5.3 (20-120 psi)
1.3-5.3 (200 psi) | 1-5.3 (20-120 psi)
1.3-5.3 (200 psi) | 1-5.3 (20-120 psi)
1.3-5.3 (200 psi) | 1.3-5.3 |
| | Swivels | 180° or 45° | Swivels | Intended Use | To provide power to
operate removable
rotating surgical cut-
ting tools or drill bits
on a patient's skull. | To provide power to
operate removable
rotating surgical cut-
ting tools or drill bits
on a patient's skull. | To provide power to
operate removable
rotating surgical cut-
ting tools or drill bits
on a patient's skull. | To provide power to
operate various ac-
cessories or attach-
ments to cut hard tis-
sue or bone and soft
tissue. | To provide power to
operate various ac-
cessories or attach-
ments to cut hard tis-
sue or bone and soft
tissue. |
Midas Rex Motors are supplied non-sterilization by hospital staff immediately prior to each use. The materials of construction of the motor and air hose are compatible with both ethylene oxide and steam sterilization (flash or standard autoclave procedures). A 4-minute cycle is recommended for high vacuum steam sterilization at 270º F. Gravity displacement steam sterilization may be performed at 250º F for 35 minutes or at 270º F for 15 minutes. A minimum of 18 hours mechanical aeration is recommended following ethylene oxide sterilization.
V. INTENDED USE
o provide power to operate removable rotating surgical cutting tools or drill bits on a patient's skull.
VI. COMPARISON TO PREDICATE DEVICES
See Table.
Premarket Notification: Midas Rex Motors
2
Table of Comparison to Legally Marketed Device
(
:
.
100 - 100 -
.
L