K Number

Device Name

Manufacturer

NAKANISHI, INC.

Date Cleared

2002-04-08

(67 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

N/A

Predicate For

N/A

Intended Use

Device Description

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 autoclavable. 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.

AI/ML Overview

I am sorry, but based on the provided text, there is no information about the acceptance criteria or a study that proves the device meets specific acceptance criteria. The document is an FDA 510(k) clearance letter for the "Surgic IV Dental Implant Unit," stating that the device is substantially equivalent to legally marketed predicate devices.

The letter discusses:

The device name and regulation details.
The FDA's substantial equivalence determination.
General controls provisions of the act.
Requirements for registration, labeling, good manufacturing practice, and quality systems.
Contact information for various FDA offices.
Indications for Use for the device.
Remarks about the device's features (roller pump, micromotor, irrigation tube set, risk of explosion with flammable anesthetics).

However, it does not include:

A table of acceptance criteria and reported device performance.
Sample sizes or data provenance for any tests.
Details about experts used for ground truth or adjudication methods.
Information about MRMC comparative effectiveness studies.
Results of standalone algorithm performance studies.
The type of ground truth used in any study.
The sample size for any training set or how ground truth for a training set was established.

Therefore, I cannot provide the requested information based on the given input.

Summary

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle with three human profiles incorporated into its design. The eagle's head and wings are stylized, and the profiles are facing to the right.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Hiroji Sekiguchi Marketing Director Nakanishi, Incorporated 700 Shimohinata Kanuma-Shi. Touchigi-Ken, JAPAN

Re: K020327

Trade/Device Name: Surgic IV Dental Implant Unit Regulation Number: 872.4200 Regulation Name: Dental Handpiece and Accessories Regulatory Class: I Product Code: EBW Dated: January 29, 2002 Received: January 31, 2002

Dear Mr. Sekiguchi:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements

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Page 2 - Mr. Sekiguchi

of the Act or any Federal statutes and regulations administered by other Federal agencies. or the Act of all - such all the Act's requirements, including, but not limited to: registration r ou intist compry with a 807); labeling (21 CFR Part 801); good manufacturing practice and ifsing (21 et read on the quality systems (QS) regulation (21 CFR Part 820); and if requirents as between product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 110(k) premarket notification. The FDA finding of substantial equivalence of your device to s rotts) premiered 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 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and alle Act may of overained its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours

Timothy Ulatowski

Timo Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

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020327

Indications For Use Statement

510(k) Number (if known):

Device Name:

Surgic IV Dental Implant Unit

Indications For Use:

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 autoclavable. 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.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Runne

(Division Sign-Off)
Division of Dental, Infection Control, and General Hospital Devices
510(k) Number	K020327

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter Use _

(Optional Format 1-2-96

Regulation Number and Section

§ 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.