(83 days)
The device is a control unit intended to drive contra angles and other attachments that are used with appropriate burs and drills for drilling, reaming, decorticating, and smoothing of bone and other bone related tissue in a variety of dental, oral surgical and other small surgical procedures.
The device is a control unit intended to drive contra angles and other attachments that are used with appropriate burs and drills for drilling, reaming, decorticating, and smoothing of bone and other bone related tissue in a variety of dental, oral surgical and other small surgical procedures. The control unit is equipped with a roller pump to deliver saline solution or sterile water as irrigant to the handpiece. The electric micromotor and its cord are not autoclavable; therefore, adequate covering by plastic sleeving as commonly used in dental for infection control method is necessary. The irrigation tube set used between the irrigation nozzle at the handpiece and the saline solution bottle via roller pump is supplied as an accessory item in the control unit package. It is ETO sterilized for 10 ° sterility, pyrogen-free. The control unit has risk of explosion if used in the presence of flammable anesthetics.
The provided document is a 510(k) premarket notification letter from the FDA for a dental surgical control unit (Surgic II Implant Control Unit). This type of document primarily confirms substantial equivalence to a predicate device and allows marketing. It does not contain acceptance criteria or study results as typically found in clinical trial reports or performance testing summaries.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the criteria. The document focuses on regulatory approval based on "substantial equivalence" rather than detailed performance reporting against pre-defined acceptance criteria from a specific study.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 3 0 1997
Mr. Hiroji Sekiguchi International Division II Manager Official Correspondent NAKANISHI Incorporated 340 Kamihinata, Kanuma-Shi Tochiqi-Ken Japan
Re : K972924 Surqic II Implant Control Unit Trade Name: Regulatory Class: I Product Code: EBW Dated: August 7, 1997 Received: August 8, 1997
Dear Mr. Seliquchi:
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 The general controls provisions of the Act 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 requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਜੋ 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 requlation may result in requlatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does
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Page 2 - Mr. Sekiguchi
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 requlations.
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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. 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
Timothy A. Ulatowski
Director Divison of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
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Enclosure
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510(k) Number (if known):
Device Name:
Surgic II Implant Unit
Indications For Use:
The device is a control unit intended to drive contra angles and other attachments that are used with appropriate burs and drills for drilling, reaming, decorticating, and smoothing of bone and other bone related tissue in a variety of dental, oral surgical and other small surgical procedures.
Remarks:
The control unit is equipped with a roller pump to deliver saline solution or sterile water as irrigant to the handpiece. The electric micromotor and its cord are not autoclavable; therefore, adequate covering by plastic sleeving as commonly used in dental for infection control method is necessary. The irrigation tube set used between the irrigation nozzle at the handpiece and the saline solution bottle via roller pump is supplied as an accessory item in the control unit package. It is ETO sterilized for 10 ° sterility, pyrogen-free.
The control unit has risk of explosion if used in the presence of flammable anesthetics.
LEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Suon Runge
Division Sign-Off)
Division of Dental, Infection Control,
and General Hospital Devices
(k) Number KA72924
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
§ 872.4200 Dental handpiece and accessories.
(a)
Identification. A dental handpiece and accessories is an AC-powered, water-powered, air-powered, or belt-driven, hand-held device that may include a foot controller for regulation of speed and direction of rotation or a contra-angle attachment for difficult to reach areas intended to prepare dental cavities for restorations, such as fillings, and for cleaning teeth.(b)
Classification. Class I.