The Insight Ultrasonic Insert is designed to be used in the handpiece of any conventional magnetostrictive ultrasonic scaler, an instrument used for dental cleaning and removal of tenacious calculus and plaque using ultrasonic vibration. The last 4.3 mm of the insert tip vibrates ultrasonically to remove the tenacious calculus from the teeth.

Device Description

The Insight Ultrasonic Insert is designed to be used in the handpiece of any conventional magnetostrictive ultrasonic scaler, an instrument used to remove tenacious calculus and plaque by ultrasonic vibrations. When place inside the handpiece, the ultrasonic insert is exposed to a varying magnetic field created by a unique pattern of copper wiring wrapping the plug of the handpiece. The varying magnetic field causes the insert "stack" of the metal tips to contract and expand, thus resulting in insert tip vibration in an elliptical motion. The water supply in the insert washes away the debris and cools the insert tip. The distal 4.3 mm portion of the insert tip is affected by the frequency of 25,000 to 30,000 Hz and performs the instrumentation. The tips are offered in two frequencies, six different colors and twenty different tip styles.

AI/ML Overview

The provided text is a 510(k) summary and FDA clearance letter for the Insight Ultrasonic Inserts. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, it does not contain information about acceptance criteria, detailed study results, sample sizes for test or training sets, expert qualifications, adjudication methods, or MRMC comparative effectiveness studies.

The document is a regulatory submission focused on demonstrating substantial equivalence to already cleared devices, rather than presenting a performance study with detailed acceptance criteria and study data as one might find for a novel device requiring more rigorous clinical validation.

Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance using the provided input, nor can I answer the specific questions about sample sizes, expert qualifications, or study methodologies because this information is not present in the text.

The document indicates that the device is "substantially equivalent" to predicate devices, implying that its performance is expected to be similar to those devices without necessarily undergoing a new performance study against explicit acceptance criteria in this specific submission.

Summary

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KO92412

DEC 1 1 2009

B. Summary of Safetv and Effectiveness

Insight Ultrasonic Inserts

1. Date of Summary Preparation:
  July 23, 2009
1. Submitting Firm:
  Discus Dental, LLC.

Contact Person

Winkie Wong Associate, Regulatory Affairs Discus Dental, LLC. 8550 Higuera Street Culver City, CA 90232 310.845.8339 310.845.8647 - fax

Name of Medical Device Proprietary Name:

Insight Ultrasonic Inserts

Common/Usual Name: Ultrasonic Inserts

Classification Name:

Scaler, Ultrasonic

న. Description of Medical Device

The Insight Ultrasonic Insert is designed to be used in the handpiece of any conventional magnetostrictive ultrasonic scaler, an instrument used to remove tenacious calculus and plaque by ultrasonic vibrations. When place inside the handpiece, the ultrasonic insert is exposed to a varying magnetic field created by a unique pattern of copper wiring wrapping the plug of the handpiece. The varying magnetic field causes the insert "stack" of the metal tips to contract and expand, thus resulting in insert tip vibration in an elliptical motion. The water supply in the insert washes away the debris and cools the insert tip. The distal 4.3 mm portion of the insert tip is affected by the frequency of 25,000 to 30,000 Hz and The tips are offered in two frequencies, six performs the instrumentation. different colors and twenty different tip styles.

Intended Use 6.

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Substantial Equivalence Determination 7.

. . . . .

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Discus Dental, LLC. believes that the Insight Ultrasonic Inserts are substantially equivalent to the following commercially marketed ultrasonic inserts:

Predicate Device	Company	510(k) No.
Protégé Ultrasonic Inserts	Discus Dental	K051776
Ultrasonic Scaler Inserts	Hu-Friedy MFG. CO., Inc.	K953919
Satin Swivel Ultrasonic Inserts	Hu-Friedy MFG. CO., Inc.	K012060

END OF SUMMARY OF SAFETY AND EFFECTIVENESS

: :

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100 - 100 - 100

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Discus Dental, LLC.

B-2

CONFIDENTIAL

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles a caduceus, a symbol often associated with healthcare, but in this case, it is a modern interpretation of the symbol.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

Mr. Winkie Wong Regulatory Affairs Associate Regulatory Affairs Discus Dental, LLC 8550 Higuera Street Culver City, California 90232

DEC 1 1 2009

Re: K092417

Trade/Device Name: Insight Ultrasonic Inserts Regulation Number: 872.4850 Regulation Name: Ultrasonic Scaler Regulatory Class: II Product Code: ELC Dated: . December 8, 2009 Received: December 10, 2009

Dear Mr. Wong:

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 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.

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Page 2- Mr. Wong

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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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.html fart the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR, Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Susan Runnes

2 Anthony D. Watson, BS, MS, MBA 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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E. Indications for Use Statement

510(k) Number: K092417

Device Name: Insight Ultrasonic Inserts

Intended Use

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use - X Per 21 CFR Sections 801.109)

OR Over-The-Counter Use
Susan Runyon

(Division Sign-Of) Division of Anesthesiology. General Hospital Infection Control, Dental Devices

510(k) Number: _

Discus Dental, LLC.

E - 1

CONFIDENTIAL

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.