(85 days)
The Midas Rex MRIV pneumatic motor provides power to operate an assortment of rotating surgical cutting tools. The motor is intended for skull based bone dissection and other microsurgical applications, including specialties in which a lightweight, high-speed bone dissecting system can be used in or near a magnetic field.
The Midas Rex MRIV motor is an Ergonomically, designed lightweight variable speed motor, with a small overall diameter. The motor provides pneumatic power to operate removable attachments and rotating surgical dissecting tools. The motor operates at variable speeds on operating pressures range from 20-150 psi.
This document (K972289) is a 510(k) premarket notification for a medical device submitted to the US FDA. The 510(k) pathway is used to demonstrate that a device is "substantially equivalent" to a legally marketed predicate device, meaning it has the same intended use and technological characteristics, or if there are differences, those differences do not raise new questions of safety and effectiveness.
The document does not describe a study that proves the device meets specific acceptance criteria in the manner one would typically expect for a software or AI/ML device. Instead, it focuses on demonstrating substantial equivalence to a predicate device.
Here's an analysis based on the provided text, addressing your questions where applicable given the nature of a 510(k) for a pneumatic motor:
1. Table of Acceptance Criteria and Reported Device Performance
This document does not contain a table of acceptance criteria and reported device performance in the context of a clinical or performance study. The "performance" described is largely comparison of technological characteristics to a predicate device. The acceptance criteria for substantial equivalence are met by showing that the new device is as safe and effective as the predicate.
| Acceptance Criteria (Implied for Substantial Equivalence) | Reported Device Performance |
|---|---|
| Intended Use: Same as predicate device | The Midas Rex MRIV pneumatic motor is designed for skull based and other microsurgical applications. (Same as predicate) |
| Technological Characteristics: Same or equivalent to predicate, raising no new safety/effectiveness questions | Material changes (e.g., Titanium alloy for some components) are described, but the document asserts "same technological characteristics in design properties and features, quality and energy source as the predicate devices." No new safety/effectiveness issues are raised by these changes. |
| Safety: Device is as safe as predicate | Implicitly accepted by the FDA's clearance letter based on the submission. Specific safety testing results are not detailed in this summary. |
| Effectiveness: Device is as effective as predicate | Implicitly accepted by the FDA's clearance letter based on the submission. Specific effectiveness testing results are not detailed in this summary. |
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. This is a mechanical device (pneumatic motor), not a diagnostic device relying on a "test set" of data for performance evaluation in the way a software or AI/ML device would. The "test" here involves comparing the device's technical specifications and intended use to a predicate device. There is no mention of a "test set" of patient data or clinical images.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This is a mechanical device. "Ground truth" in the context of expert consensus on medical conditions is not relevant for this type of submission. The "ground truth" for a 510(k) for a pneumatic motor would relate to its manufacturing specifications, mechanical properties, and performance parameters, verified through engineering tests rather than expert interpretation of clinical data.
4. Adjudication Method for the Test Set
Not applicable. See point 3.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is a pneumatic surgical motor, not an AI or imaging diagnostic device. MRMC studies are used for evaluating the performance of diagnostic tools (often imaging-based) where human reader interpretation is involved.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a mechanical device, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for this 510(k) submission primarily relies on engineering specifications and comparative analysis to the predicate device. For example, the material specifications (e.g., Titanium Alloy, Stainless Steel) are a form of ground truth for the device's composition. Performance characteristics (like operating pressure range 20-150 psi) would be verified through engineering testing, which serves as the "ground truth" for its functional parameters. There is no pathology, outcomes data, or expert consensus on clinical cases mentioned.
8. The Sample Size for the Training Set
Not applicable. This is a mechanical device. There is no concept of a "training set" in the context of an AI/ML algorithm for this type of submission.
9. How the Ground Truth for the Training Set was Established
Not applicable. See point 8.
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SEP 1 2 1997
510 (K) SUMMARY OF SAFETY AND EFFECTIVENESS
Date prepared:
June 18, 1997
Submitter:
Midas Rex, L. P. 3001 Race Street Fort Worth, Texas 76111 (817) 831-4181
Director Regulatory Affairs
Contact Person:
Trade (proprietary) Name: Model
Common / Classification Name: Regulation no. Product code Device Classification:
Predicate Device:
Description of the Device:
Midas Rex Motor (MRIV)
Michael Fowler
(v)
Pneumatic Cranial Drill Motor 882.4370 84 HBB Class II
Midas Rex Motors, Midas I, Midas II & Convertible K 953434
The Midas Rex MRIV motor is an Ergonomically, designed lightweight variable speed motor, with a small overall diameter. The motor provides pneumatic power to operate removable attachments and rotating surgical dissecting tools. The motor operates at variable speeds on operating pressures range from 20-150 psi.
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Statement of Intended Use:
Technological Characteristics:
The Midas Rex MRIV pneumatic motor is designed for skull based and other microsurgical applications.
The Midas Rex MRIV motor, attachments and accessories have the same technological characteristics in design properties and features, quality and energy source as the predicate devices. The material of several of the components has been changed to non- magnetic material.
...
.:"
The material specifications are as follows:
| ITEM | WHIRLWIND. | MRIV | MRIV(OPTIONAL) | |
|---|---|---|---|---|
| MOTOR | 1 | 400 SERIESSTAINLESS STEEL | TITANIUM ALLOY | 300 SERIESSTAINLESS STEEL |
| 2 | YELLOW BRASS | TITANIUM ALLOY | YELLOW BRASS | |
| 3 | BEARING | BEARING | BEARING | |
| 4 | ALUMINUM ALLOY | ALUMINUM ALLOY | ALUMINUM ALLOYPOLYPHENYL SULFOR POLYAMIDE | |
| 5 | PHENOLIC CELLULOSE(IMPREGNATION) | PTFEPOLYAMIDE-IMIDE | NONE - | |
| 6 | PRECIP. HARDENABLESTAINLESS STEEL | TITANIUM ALLOY | 300 SERIESSTAINLESS STEEL | |
| 7 | YELLOW BRASS | YELLOW BRASS | NONE | |
| 8 | ALUMINUM ALLOY | ALUMINUM ALLOY | NONE | |
| 9 | BEARING | BEARING | BEARING | |
| COLLET(ASS'Y) | 10 | 400 SERIESSTAINLESS STEEL | TITANIUM ALLOY | POLYPHENYL SULF(OR POLYAMIDE)400 SERIESSTAINLESS STEE |
| 11 | NONE | CERAMIC | NONE | |
| 12 | NONE | TITANIUM ALLOY | NONE | |
| 13 | NONE | PHOSPHOROUS BRONZE | NONE | |
| ATTACHMENTSBASE | 14 | ALUMINUM ALLOY | TITANIUM ALLOY | ALUMINUM ALLOY |
| TUBE | 15 | 300 SERIESSTAINLESS STEEL | TITANIUM ALLOY | 300 SERIESSTAINLESS STEE |
| SPACER | 16 | ALUMINUM ALLOY | ALUMINUM ALLOY | POLYPHENYL SULFOR POLYAMIDE |
| BEARING | 17 | BEARING | BEARING | BEARING |
| TOOLS | 18 | TOOL STEEL | TITANIUM ALLOY | 300 SERIESSTAINLESS STEEW/TIN, ZON OR |
, t
Image /page/1/Figure/6 description: The image contains the text "WHIRL WIND MOTOR/ ATTACHMENT/ TOOL". The text is written in a simple, sans-serif font. The words are separated by forward slashes, suggesting a list or a set of related items. The overall impression is that of a label or heading, possibly for a product or a section in a manual.
Image /page/1/Figure/7 description: This image shows a technical drawing of a device with various labeled components. The components are labeled with numbers ranging from 1 to 18. The drawing appears to be a cross-sectional view, revealing internal parts and their arrangement within the device. The device seems to be a connector or a coupling mechanism, possibly for electrical or mechanical connections.
MRIV MOTOR/ ATTACHMENT/ TOOL
Image /page/1/Figure/9 description: The image shows a diagram of a mechanical device with various numbered components. The components are labeled with numbers ranging from 1 to 18, indicating different parts of the device. The diagram appears to be a technical illustration, possibly from a manual or engineering document, detailing the assembly or function of the device. The device seems to be composed of several interconnected parts, including a spring, a nozzle, and a connector.
C:\510kfile\mriv\summaryletter Confidential
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Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features the department's name encircling a symbol. The symbol is a stylized representation of three human profiles facing right, stacked on top of each other. The profiles are rendered in a simple, flowing line, creating a sense of unity and connection.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 1 2 1997
Mr. Michael Fowler Director of Regulatory Affairs Midas Rex Pneumatic Tools, Inc. 3001 Race Street Fort Worth, Texas 76111-4117
Re: K972289 Trade Name: Midas Rex Motor Requlatory Class: II Product Code: 84HBB Dated: June 18, 1997 Received: June 19, 1997
Dear Mr. Fowler:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Mr. Michael Fowler
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Thomas J. Callahon
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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June 18, 1997
510(K) Number:
Device Name: Midas Rex Motor
Indications for Use:
The Midas Rex MRIV pneumatic motor provides power to operate an assortment of rotating surgical cutting tools. The motor is intended for skull based bone dissection and other microsurgical applications, including specialties in which a lightweight, high-speed bone dissecting system can be used in or near a magnetic field.
Name: Regulation no: Product code: Class II
Midas Rex MRIV Motor 882.4370 84 HBB
Michael Fowler
Michael Fowler Director of Regulatory Affairs
Prescription Use (Per 21 CFR 801.109)
OR
Over The Counter Use _
Thomas L. Callahon
(Division Sign-Off)
§ 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).