The Quantec-E Irrigation System is a self-contained, fluid delivery unit consisting of a pump unit console, irrigation reservoirs and tubing intended to be used in dentistry to provide irrigation while using the dental handpieces attached to the Quantec-E Endo System.

Device Description

The device is a self-contained, fluid delivery unit consisting of a pump console, two irrigation reservoirs and tubing intended to be used in dentistry to provide irrigation while using the dental handpieces attached to the Quantec-E Endo System. The unit attaches to the Quantec-E Endo System via the accessory port located on the rear panel of the unit. The Quantec-E Irrigation System cannot operate as a stand alone device. The unit has a positive displacement peristaltic design to prevent fluid retraction which could result in patient cross-contamination. To operate the Quantec-E Endo System without irrigation, the Power Switch on the Quantec-E Irrigation System console is turned to the "O" position. When irrigation is desired, the switch is turned to "I". The irrigation tip assemblies supplied with the Quantec-E Irrigation System is autoclavable.

AI/ML Overview

The provided 510(k) summary for the Quantec-E Irrigation System (K991035) does not contain information regarding detailed acceptance criteria or a study proving the device meets specific performance criteria.

Instead, this submission is a premarket notification (510(k)) which aims to demonstrate substantial equivalence to a predicate device already legally marketed in the United States. The focus of the 510(k) process is not to establish new performance metrics through clinical trials or detailed validation studies, but rather to show that the new device is as safe and effective as a legally marketed predicate device.

Therefore, the requested information about acceptance criteria, detailed performance results, sample sizes, expert qualifications, ground truth establishment, and MRMC studies is not available in the provided document because the nature of a 510(k) submission for this type of device does not typically require such extensive performance testing to be detailed in the summary.

The document primarily focuses on:

Device Description: What the device is and how it functions.
Intended Use: The purpose for which the device is designed.
Substantial Equivalence Claim: Identifying a predicate device (Micro Motors, Inc., Micro SWP Sterile Water Pump) and arguing that the new device is sufficiently similar in function and intended use.

In summary, the provided text does not contain the information requested in your prompt regarding acceptance criteria and performance study details.

Summary

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Kg91035

SYBRON DENTAL SPECIALTIES Section III - 510(k) Summary of Safety and Effectiveness

Submitter:

Sybron Dental Specialties, Inc. 1717 W. Collins Avenue Orange, California 92867 (714) 516-7484 - Phone (714) 516-7488 - Facsimile Colleen Boswell - Contact Person

March 1999 Date Summary Prepared:

Device Name:

Trade Name Quantec-E Irrigation System .
Common Name Fluid Delivery Unit ●
Classification Name Dental Handpiece and Accessories, per 21 CFR § 872.4200 ●

Devices for Which Substantial Equivalence is Claimed:

Micro Motors, Inc., Micro SWP Sterile Water Pump .

Device Description:

Intended Use of the Device:

The intended use of the Quantec-E Irrigation System is to provide irrigation while using the dental handpieces attached to Quantec-E Endo System.

Substantial Equivalence:

The Quantec-E Irrigation System is substantially equivalent to several other legally marketed devices in the United States. The Quantec-E Irrigation System functions in a manner similar to and is intended for the same use as the Micro SWP Sterile Water Pump designed by Micro Motors, Inc.

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Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines connecting them.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 2 4 1999

Ms. Colleen Boswell Manager, Regulatory Affairs Syborn Dental Specialties, Incorporated 1717 West Collins Avenue Orange, California 92867

K991035 Re: Quantec-E Irrigation System Trade Name: Regulatory Class: I Product Code: EIA March 24, 1999 Dated: Received: March 29, 1999

Dear Ms. Boswell:

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, qood 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. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Ms. Boswell

this response to your premarket notification Please note: submission does 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 regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA findinq 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 diaqnostic devices), please contact the Office of Compliance at (301) 594-4692. 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 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

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

Enclosure

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Section I - Indications for Use

510(k) Number:

Device Name: Quantec-E Irrigation System

Indications for Use:

Prescription Use
(Per 21 CFR 801.109)

Susan Runner

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital I 5 1 O(k) Number

Regulation Number and Section

§ 872.6640 Dental operative unit and accessories.

(a)
Identification. A dental operative unit and accessories is an AC-powered device that is intended to supply power to and serve as a base for other dental devices, such as a dental handpiece, a dental operating light, an air or water syringe unit, and oral cavity evacuator, a suction operative unit, and other dental devices and accessories. The device may be attached to a dental chair.(b)
Classification. Class I (general controls). Except for dental operative unit, accessories are exempt from premarket notification procedures in subpart E of part 807 of this chapter subject to § 872.9.