(83 days)
Not Found
Not Found
No
The description focuses on the mechanical and control functions of a surgical drilling unit and does not mention any AI/ML capabilities or related concepts like image processing, training data, or performance metrics associated with AI/ML.
Yes
The device is described as driving attachments for "drilling, reaming, decorticating, and smoothing of bone and other bone related tissue," which are all interventional procedures intended to treat or modify anatomical structures.
No
The device description clearly states its purpose is for "drilling, reaming, decorticating, and smoothing of bone and other bone related tissue," indicating a surgical or therapeutic function, not a diagnostic one.
No
The device description explicitly details hardware components such as a control unit, roller pump, electric micromotor, cord, and irrigation tube set, indicating it is not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used for surgical procedures involving bone and bone-related tissue. This is an in vivo application (within a living organism).
- Device Description: The description reinforces the surgical nature of the device, mentioning driving contra angles, burs, drills, and irrigation for surgical procedures.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or screening.
IVD devices are specifically designed to be used in vitro (outside the living body) to analyze samples for diagnostic purposes. This device is used in vivo for surgical intervention.
N/A
Intended Use / 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.
Product codes
EBW
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bone and other bone related tissue
Indicated Patient Age Range
Not Found
Intended User / Care Setting
dental, oral surgical and other small surgical procedures
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
Image /page/0/Picture/10 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of three birds in flight, arranged in a stacked formation. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the bird symbol.
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
1
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
ូ
Enclosure
2
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)