MIDAS REX MOTOR

{0}------------------------------------------------ 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. {1}------------------------------------------------ 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<br>(OPTIONAL) | |---------------------|------|---------------------------------------|-------------------------|-------------------------------------------------------------------| | MOTOR | 1 | 400 SERIES<br>STAINLESS STEEL | TITANIUM ALLOY | 300 SERIES<br>STAINLESS STEEL | | | 2 | YELLOW BRASS | TITANIUM ALLOY | YELLOW BRASS | | | 3 | BEARING | BEARING | BEARING | | | 4 | ALUMINUM ALLOY | ALUMINUM ALLOY | ALUMINUM ALLOY<br>POLYPHENYL SULF<br>OR POLYAMIDE | | | 5 | PHENOLIC CELLULOSE<br>(IMPREGNATION) | PTFE<br>POLYAMIDE-IMIDE | NONE - | | | 6 | PRECIP. HARDENABLE<br>STAINLESS STEEL | TITANIUM ALLOY | 300 SERIES<br>STAINLESS STEEL | | | 7 | YELLOW BRASS | YELLOW BRASS | NONE | | | 8 | ALUMINUM ALLOY | ALUMINUM ALLOY | NONE | | | 9 | BEARING | BEARING | BEARING | | COLLET<br>(ASS'Y) | 10 | 400 SERIES<br>STAINLESS STEEL | TITANIUM ALLOY | POLYPHENYL SULF<br>(OR POLYAMIDE)<br>400 SERIES<br>STAINLESS STEE | | | 11 | NONE | CERAMIC | NONE | | | 12 | NONE | TITANIUM ALLOY | NONE | | | 13 | NONE | PHOSPHOROUS BRONZE | NONE | | ATTACHMENTS<br>BASE | 14 | ALUMINUM ALLOY | TITANIUM ALLOY | ALUMINUM ALLOY | | TUBE | 15 | 300 SERIES<br>STAINLESS STEEL | TITANIUM ALLOY | 300 SERIES<br>STAINLESS STEE | | SPACER | 16 | ALUMINUM ALLOY | ALUMINUM ALLOY | POLYPHENYL SULF<br>OR POLYAMIDE | | BEARING | 17 | BEARING | BEARING | BEARING | | TOOLS | 18 | TOOL STEEL | TITANIUM ALLOY | 300 SERIES<br>STAINLESS STEE<br>W/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 {2}------------------------------------------------ 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. {3}------------------------------------------------ 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 {4}------------------------------------------------ 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)