(11 days)
The Sodem High Speed System (with associated accessories/attachments) is intended for use for neuro surgery (spine and craniatomy) and median sternotomy.
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This document is a 510(k) clearance letter from the FDA for the Sodem High Speed System. It does not contain information about acceptance criteria, detailed study designs, or performance metrics. Therefore, I cannot extract the requested information from the provided text.
The letter primarily confirms that the device is substantially equivalent to legally marketed predicate devices and is thus cleared for marketing. It mentions "indications for use" and refers to general controls, but does not include specific efficacy or performance study details, acceptance criteria, or expert review processes.
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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of an eagle with its wings spread. The eagle is facing to the right and has three stripes across its body.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 2 1 1999
Mr. Daniel Baccino Ouality and Regulatory Affairs Director Sodem Systems 110.ch. du Pont-du-Centenaire CH 1228 Geneva Switzerland
K994175 Re:
Trade Name: Sodem High Speed System Regulatory Class: II Product Code: HBB Dated: December 8, 1999 Received: December 10, 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.
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Page 2 - Mr. Daniel Baccino
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,
Hypt. Rhodes
James E. Dillard II Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Special 510(k) Device Modification For The Sodem High Speed System
Attachment 2
Indications for Use Statement
15994175 510(k) Number: K954717-
Device Name: Sodem High Speed System
Indication for Use :
The Sodem High Speed System (with associated accessories/attachments) is intended for use for neuro surgery (spine and craniatomy) and median sternotomy.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801. 109)
Over-The-Counter Use
Stipt Rlucle
(Division Sign-Off) Division of General Restorative Devices K994175 510(k) Number .
§ 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).