ULTRASONIC SCALER, MODELS UDS-N1, UDS-N2. UDS-J, UDS-K, UDS-L by GUILIN WOODPECKER MEDICAL INSTRUMENT CO., LTD

I am sorry, but the provided text only contains a letter from the FDA regarding a 510(k) premarket notification for an ultrasonic scaler. It confirms that the device is substantially equivalent to legally marketed predicate devices and outlines regulatory requirements.

The document does not contain any information regarding:

Acceptance criteria for device performance.
A study that demonstrates the device meets acceptance criteria.
Performance metrics of the device.
Sample sizes for test or training sets.
Data provenance.
Number or qualifications of experts for ground truth.
Adjudication methods.
MRMC comparativeeffectiveness studies.
Standalone performance.
Type of ground truth used.
How ground truth for training was established.

Therefore, I cannot fulfill your request for this specific information based on the provided text.

Summary

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AUG 2 1 2006

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Guilin Woodpecker Medical Instrument Company, Limited C/O Mr. Charlie Mack Principal Engineer International Regulatory Consultants 340 Shady Grove Road Flintville, Tennessee 37335

Re: K053555

ﮨﺴ ﺮ

Trade/Device Name: Ultrasonic Scaler, Models UDS-J, UDS-K, UDS-N1, UDS-N2 Regulation Number: 872.4850 Regulation Name: Ultrasonic Scaler Regulatory Class: II Product Code: ELC Dated: August 9, 2006 Received: August 18, 2006

Dear Mr. Mack:

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 me road application (PMA). You may, therefore, market the device, subject to the general approvisions 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 (1 Mr.), it may 80 ode of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 -- Mr. Mark

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 of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic 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 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 vour device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Chiu Lin, Ph.D.

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

Enclosure

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K053555

Indications for Use

510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________

Device Name: __ Ultrasonic Scaler, Models UDS-J, UDS-K, UDS-L, UDS-N1, UDS-N2

Indications For Use:

Model :UDS-J/K/N1/N2 :

Removing supra and sub gingival calculus deposits and stains from the teeth
Periodontal pocket lavage with simultaneous ultrasonic tip movement

Model: UDS-L :

1. Removing supra and sub gingival calculus deposits and stains from the teeth
  AND/OR

Periodontal pocket lavage with simultaneous ultrasonic tip movement
Preparing, cleaning, and irrigating root canals
Retrograde preparation of root canals

Prescription Use X X (Part 21 CFR 801 Subpart D)

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

(21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Sincerly

n of Anesthesiology, General Hospital, on Control, Dental Device

) Number: 105 335K

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Regulation Number and Section

§ 872.4850 Ultrasonic scaler.

(a)
Identification. An ultrasonic scaler is a device intended for use during dental cleaning and periodontal (gum) therapy to remove calculus deposits from teeth by application of an ultrasonic vibrating scaler tip to the teeth.(b)
Classification. Class II.