The VATEA device is a self contained, digitally-controlled fluid delivery unit consisting of a pump unit console, irrigation reservoir and tubing intended to be connected to an endodontic file. The device consists of a positive pressure peristaltic pump console with control panel, LCD display, irrigation reservoir, disposable silicone tubing, and a footswitch control to provide irrigation during endodontic rocedures. One end of the silicone tubing connects to the VATEA and the other end connects to the dental handpiece using a silicone ring. The silicone ring is elastic, and may be stretched to the domar handpiece as my of dental handpieces used in endodontic procedures. The irrigation reservoir is filled as needed with sodium hypochlorite solution for irrigation during endodontic rocedures. The irrigation fluid is pumped from the reservoir and then out of the silicone tubing, proodation: the internet of the tooth. The silicone tubing for the delivery of the iring the lumand the silicone ring connecting the pump to the dental handpiece are disposable and replaced after each treatment.

The irrigation fluid flow may be switched on and off with a footswitch that is connected to the VATEA. The fingulon had now his his of the device are displayed on the LCD screen on the control r no how rate and operation is 0, and the user must increase the flow rate using the - / + buttons on panel. The using for face of the irrigation fluid. The irrigation fluid flow rate may be adjusted the control parter in increments of 1 ml/min using the - /+ push-button control on the control panel.

The VATEA is an electronically operated device, powered by a rechargeable battery.

AI/ML Overview

Here's a summary of the acceptance criteria and the study details for the VATEA Endodontic Irrigation System, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Verification of flow rate	Actual irrigant flow rate matched the displayed flow rate.
Battery indication and life time	With batteries fully charged, the system can operate without the charger for 4 continuous hours at maximum output.
Compliance with IEC 60601-1 Medical Electrical Equipment Part 1, General Requirements for Safety	The company performed testing to evaluate the safety and performance, implying compliance with this standard.
Compliance with IEC 60601-1-2 Medical Electrical Equipment, General Requirements for Safety. Collateral Standard: Electromagnetic Compatibility- requirements and tests.	The company performed testing to evaluate the safety and performance, implying compliance with this standard.
Comparable performance and safety to predicate device	Performance data establishes that the VATEA has comparable performance and safety as compared to its claimed predicate device (Quantec-E Irrigation System). The minor technological differences raise no new issues of safety or effectiveness. Preclinical performance data demonstrates it is as safe and effective.

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state a sample size for a test set in the traditional sense of a clinical trial involving human subjects or a large collection of case data. The "test set" here refers to the number of units or conditions tested during the performance validation.

Sample Size for performance validation: Not explicitly stated as a number of devices, but implies testing of the device's flow rate mechanism and battery under specified conditions.
Data Provenance: The studies were performed by the company (ReDent Nova Ltd.) as "performance validation." The location is Israel, as this is the sponsor's country of origin. The studies are prospective in the sense that they are specifically designed to test the VATEA device's performance.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. The performance validation involved objective measurements of flow rate and battery life, not interpretation by experts.

4. Adjudication Method for the Test Set

Not applicable. The data appears to be quantitative measurements, not subjective evaluations requiring adjudication.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, the performance validation represents a standalone study of the device's functionality. The device (VATEA) itself was tested for its performance characteristics (flow rate, battery life). There is no "algorithm" in the sense of AI being evaluated here; rather, it is electro-mechanical performance.

7. The Type of Ground Truth Used

The ground truth used was based on:

Objective measurement: For flow rate, the "actual irrigant flow rate" was measured against the "displayed flow rate." For battery life, it was based on continuous operation at maximum output.
Engineering and safety standards: Compliance with IEC 60601-1 and IEC 60601-1-2 implies that the device was tested against established international safety and performance benchmarks.

8. The Sample Size for the Training Set

Not applicable. There is no mention of a "training set" as this is not a machine learning or AI-driven device.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set.

Summary

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K100604

510(k) SUMMARY REDENT NOVA's VATÈÁ Endodontic Irrigation System

Submitter's Name, Address, Telephone Number, Contact Person: and Date Prepared

Hogan Lovells US LLP Phone: (202) 637-5794 Facsimile: (202) 637-5910 Contact Person: Jonathan S. Kahan

Date Prepared: May 25, 2010

MAY 2 8 2010

Name of Device and Name/Address of Sponsor:

VATEA Endodontic Irrigation System

ReDent Nova Ltd. 15 Hataasia street P.O.B 4159 Raanana 43000, Israel

Common or Usual Name

VATEA Endodontic Irrigation System

Classification Name

Name:	Dental Handpiece & Accessories
-------	--------------------------------

Product code: NYL

872.4200 Classification panel:

-Class:

Dental Panel:

Predicate Devices

Quantec-E Irrigation System (K991035), Sybron Dental Specialties Inc., CA, US.

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K100606

Intended Use / Indications for Use

The VATEA system is intended to be attached to dental handpieces to deliver irrigation during endodontic procedures.

Technological Characteristics

The VATEA is an electronically operated device, powered by a rechargeable battery.

Performance Characteristics

The company performed the following testing to evaluate the safety and performance of the device:

IEC 60601-1 Medical Electrical Equipment Part 1, General Requirements for Safety .
IEC 60601-1-2 Medical Electrical Equipment, General Requirements for Safety. Collateral . Standard: Electromagnetic Compatibility- requirements and tests.
Performance validation: .
- o Verification of flow rate Actual irrigant flow rate matched the displayed flow rate
- Battery indication and life time With batteries fully charged, the system can operate o without the charger for 4 continuous hours at maximum output.

Performance data establishes that the VATEA has comparable performance and safety as compared to its claimed predicate device.

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3873

K100604

Substantial Equivalence

The VATEA has the same intended uses and similar indications, technological characteristics, and principles of operation as its predicate device. The minor technological differences between the VATEA and its predicate device raise no new issues of safety or effectiveness. Preclinical performance data demonstrates that the VATEA is as safe and effective as the Quantec-E. Thus, it can be concluded that the VATEA is substantially equivalent.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features an abstract design of an eagle with three tail feathers. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

ReDent Nova Limited C/O Jonathan S. Kahan Hogan & Hartson LLP Columbia Square, 555 13" Street, NW Washington, District of Columbia 20004

Re: K100606

Trade/Device Name: VATEA Endontic Irrigation System Regulation Number: 21 CFR 872.4200 Regulation Name: Dental Handpiece and Accessories Regulatory Class: I Product Code: NYL Dated: May 25, 2010 Received: May 25, 2010

Dear Mr. Kahan:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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.

MAY 2 8 2010

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Page 2-Mr. Jonathan S. Kahan

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.htm for 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.

Sincerely vours.

h for

Anthony D. Watson, B.S., M.S., M.B.A. Director

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

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K100606

Indications for Use Statement

510(k) Number (if known): _

Device Name:

VATEA Endodontic Irrigation System

Indications for Use:

The VATEA system is intended to be attached to dental handpieces to deliver irrigation during endodontic procedures.

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

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Rai Mulay for MSR
(Division Sign-Off)

Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K100606

Page __ of

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.