SODEM PERFORATOR DRIVE

{0}------------------------------------------------ | (<br>S<br>K | 0<br>2<br>-<br>(<br>) | | |-------------|-----------------------|--| |-------------|-----------------------|--| DEC 27 1999 ### 510(k) SUMMAR Y FOR SODEM PERFORATOR DRIVE /oss #### 1 APPLICANT sodemsystems Sodem Diffusion SA 110, ch. Du Pont du Centenaire CH-1228 Geneva, Switzerland | Contact Person : | Daniel BACCINO | |----------------------|----------------------------------------------------------------------| | Tel : | +41 22 794 96 96 | | Fax : | +41 22 794 45 46 | | Manufacturing site : | sodemsystems<br>Sodem Diffusion SA<br>110, ch. Du Pont du Centenaire | #### 2 DEVICE NAME | Trade Name : | Sodem Perforator Drive | |-----------------------|-------------------------------| | Classification Name : | Pneumatic Cranial Drill Motor | | Common / Usual Name : | Surgical drill | ### 3 PREDICATE DEVICES The Sodem Perforator Drive claims equivalence to the following systems: - . Sodem Power System ( K935567) - Sodem High Speed System ( K954717) . CH-1228 Geneva, Switzerland {1}------------------------------------------------ ### 510(k) SUMMARY FOR SODEM PERFORATOR DRIVE #### 4 DEVICE DESCRIPTION The Sodem Perforator Drive PN 3510 is made out of the combination of 2 components from the Sodem Power System. the Pneumatic motor currently used as part of the Sodem Power System and a Hudson Adapter. Sodem is not manufacturing "Cranial Perforator attachment". The technological characteristics of the Sodem Perforator Drive are similar to the pneumatic handpiece from the Sodem Power System. The safety device (disengagement of rotational movement of the "cranial perforator attachment"after relevant perforation of skull) is exclusively dependent of this attachment (not the motor). This safety device is functional so far the speed range is being respected. The speed range is indicated on the instructions for use of the manufacturer(s) of the "cranial perforator attachments" and our perforator drive motor is falling within recommended range of operation. #### 5 INTENDED USE The Sodem Perforator Drive is a pneumatically operated power source used with removable rotating surgical cutting tools or drill bits on a patien's skull. The system is intended for use in neurosurgery. #### 6 BASIS FOR CLAIM OF SUBSTANTIAL EQUIVALENCE Sodemsystems claims substantial equivalence to other Perforator Motors. This claim is based on equivalence in: # Intended use The intended use of the Sodem Perforator Drive is identical to that of the Sodem High Speed System as cited above. # Materials The materials of the Sodem Perforator Drive are not in direct patient contact and similar with the Sodem Power System. {2}------------------------------------------------ # 305 3 ### 510(k) SUMMARY FOR SODEM PERFORATOR DRIVE ### Sterility Status The Sodem Perforator Drive is, like the cited predicate systems, provided non-sterile, require decontamination after use, and resterilzation by the user facility. ## Pneumatic power Systems operate using compressed air or nitrogen. Power to the Sodem Perforator Drive is adjustable from 0-950. Range is comparable for the cited predicate device, Sodem Power System. # Operational Principles The Sodem Perforator Drive and cited predicate system use the same operational principles. {3}------------------------------------------------ Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling a stylized caduceus or a bird-like figure with three curved lines. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 DEC 2 7 1999 Mr. Daniel Baccino Ouality and Regulatory Affairs Director Sodemsystems Sodem diffusion s.a. 110, ch. du Pont-du-Centenaire CH 1228 Geneva Switzerland K993851 Re: > Trade Name: Sodem Perforator Drive Regulatory Class: II Product Code: HBB Dated: November 9, 1999 Received: November 12, 1999 Dear Mr. Baccino: 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 current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation 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. {4}------------------------------------------------ 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) 594-4595. 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, Nunc et /ε,, I. E. Dill. XIII. James E. Dillard III 86-Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {5}------------------------------------------------ ### 510(k) PREMARKET NOTIFICATION For the Sodem Perforator Drive # Indications for Use Statcment 510(k) Number: K993851 Device Name: Perforator Drive Indication for Use : The Sodem Perforator Drive is intended for use in neurosurgery. (PI.FASF. DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Usc (Por 21 CFR 801. 109) Over-The-Counter Use Tirnell' c'ajoux. s.-1771 vision Sign-Off) ·sion of General Restorative Devices O(k) Number .