The EndoVac® System is intended for the delivery and evacuation of endodontic irrigation solutions during root canal procedures. EndoVac® Apical Negative Pressure Irrigation System is used in root canal therapy and is comprised of four main components. The Multi-Port Adapter is used to connect the Master Delivery Tip to the dental office Hi-Vac system. The Master Delivery Tip provides a constant flow of irrigant that lowers the risk of overflow due to continuous suction. Additional tips include the MacroCannula which is used to remove coarse debris after instrumentation, and the MicroCannula which features microscopic evacuation holes allowing the irrigant to flow to the apical termination.

AI/ML Overview

This document pertains to a 510(k) premarket notification for the EndoVac® Apical Negative Pressure Irrigation System. The purpose of the 510(k) is to demonstrate substantial equivalence to a legally marketed predicate device, not to prove that the device meets specific acceptance criteria through a standalone study with defined performance metrics.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment cannot be fully provided from this document as it does not contain the specific type of performance study typically conducted for AI/ML device evaluations.

Here's a breakdown of why and what information can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria: Not explicitly stated as performance metrics in this 510(k) summary. The "acceptance criteria" for a 510(k) are typically demonstrating substantial equivalence to a predicate device, which is a regulatory standard rather than a set of quantitative performance targets.
Reported Device Performance: This document focuses on technological characteristics and a comparison to a predicate device, rather than quantitative performance data like sensitivity, specificity, or accuracy. The performance is assessed through compliance with various ISO and AAMI standards for aspects like biocompatibility and sterilization.

Criterion	Reported Performance of EndoVac® System
Intended Use Equivalence:	The EndoVac® system is intended for the delivery and evacuation of endodontic irrigation solutions during root canal procedures. (This is equivalent to the predicate RinsEndo for root canal irrigation/disinfection).
Biocompatibility:	Complies with ISO 10993 standards (ISO 10993-1, -5, -10).
Sterilization:	Autoclavable Master Delivery Tip, Multi-Port Adapter, Handpiece and Finger-Piece. Verified using AAMI TIR 12, ANSI/AAMI ST:79, AAMI TIR 39, ISO 17665-1, and an internal method for autoclave life testing.
Method of Aspiration:	Suction through tubing attached to dental office Hi-Vac (This differs technologically from the predicate's air-driven piston but achieves the same intended purpose of irrigation/disinfection).
Safety - General:	The document asserts that "The similarities in design, function, safety and intended use of EndoVac® Apical Negative Pressure Irrigation System with the legally marketed device RinsEndo dental handpiece (K052271) provide evidence that these devices are substantially equivalent." Compliance with several biological and sterilization standards also supports safety.
Electrical Safety/EMC (Implied):	Not explicitly mentioned but often part of general controls for medical devices. The document focuses on the mechanical and material aspects of the device's safety.
Single-use disposable cannula (tips):	Yes

2. Sample size used for the test set and the data provenance:

Not applicable / Not provided: This document describes compliance with recognized standards (e.g., ISO, AAMI) and a literature review, not a specific performance study with a "test set" in the context of AI/ML or a new, novel performance claim. The biocompatibility and sterilization tests would have involved specific sample sizes as per the standards referenced, but these are not disclosed here.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable / Not provided: There was no "test set" and no "ground truth" to establish in the context of an AI/ML device. The "ground truth" for the predicate device's safety and effectiveness was established through its prior 510(k) clearance and market history.

4. Adjudication method for the test set:

Not applicable / Not provided: No test set or adjudication process described.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

No: This is not an AI-powered device. Therefore, no MRMC study or AI assistance effect size is relevant or provided.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

Not applicable / No: This is not an algorithm, it is a physical medical device.

7. The type of ground truth used:

Regulatory Substantial Equivalence and Compliance with Recognized Standards: The "ground truth" is effectively the established safety and effectiveness of the predicate device (RinsEndo, K052271) and the compliance with consensus standards for material safety (biocompatibility) and functional attributes (sterilization). For the non-clinical performance data, the "ground truth" is that the device complies with the specified ISO and AAMI standards.

8. The sample size for the training set:

Not applicable / Not provided: This is not an AI/ML device that requires a training set.

9. How the ground truth for the training set was established:

Not applicable / Not provided: No training set.

In summary: This document is a 510(k) premarket notification for a traditional medical device, not an AI/ML device. The "study" described is a demonstration of substantial equivalence to a predicate device and compliance with relevant non-clinical (biocompatibility, sterilization) performance standards. It does not involve performance metrics, expert adjudication, or AI-specific evaluation methodologies.

Summary

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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three heads in profile, facing right. The eagle is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

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

July 2, 2014

SybronEndo C/O Ms. Courtney Clark, CBA, RAC Regulatory Affairs Manager, Submissions Sybron Dental Specialties, Incorporated 1717 W. Collins Avenue Orange. California 92867

Re: K140685

Trade/Device Name: Endo Vac® Apical Negative Pressure Irrigation System Regulation Number: 21 CFR 872.4200 Regulation Name: Handpiece, Air-Powered, Root Canal Irrigation Regulatory Class: I Product Code: NYL Dated: May 30, 2014 Received: June 2, 2014

Dear Ms. Clark:

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.

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Page 2 - Ms. Clark

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 contact the Division of Small Manufacturers. International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 yours,

Mary S. Runner -S

Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory. Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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SECTION 4. INDICATIONS FOR USE STATEMENT

510(k) Number (if known): K140685

Device Name: EndoVac® Apical Negative Pressure Irrigation System

Indications for Use:

The EndoVac® system is intended for the delivery and evacuation of endodontic irrigation solutions during root canal 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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Sheena A. Green -S 2014.07.02 08:42:50 -04'00'

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SECTION 5. 510(k) SUMMARY

Image /page/3/Picture/1 description: The image shows a logo for Sybron Dental Specialties. The logo features the letters 'sds' in a stylized, sans-serif font, with a curved line above the letters. Below the letters, the words 'SYBRON DENTAL SPECIALTIES' are written in a smaller, sans-serif font. The color of the text and the curved line is a dark blue.

EndoVac® Apical Negative Pressure Irrigation System

Submitter Information: 1.
Sybron Dental Specialties 1717 W. Collins Ave. Orange CA, 92687

Contact Person:	Courtney Clark
Telephone Number:	714-516-7426
Fax Number:	714-516-7472
Date Prepared:	17 March 2014

2. Device Name:

EndoVac® Negative Pressure Irrigation System Proprietary Name: ●
- Classification Name: Handpiece, air-powered, root canal irrigation
Regulation Description: Dental handpiece and accessories ●
CFR Number: 872.4200
Device Class: Class I reserved ●
. Product Code: NYL
1. Predicate Device:

EndoVac® Apical Negative Pressure Irrigation System is substantially equivalent to the legally marketed device RinsEndo, manufactured by Air Techniques, K052271 cleared on May 26, 2006, product code NYL.

1. Description of Device:
  The EndoVac® System is intended for the delivery and evacuation of endodontic irrigation solutions during root canal procedures. EndoVac® Apical Negative Pressure Irrigation System is used in root canal therapy and is comprised of four main components. The Multi-Port Adapter is used to connect the Master Delivery Tip to the dental office Hi-Vac system. The Master Delivery Tip provides a constant flow of irrigant that lowers the risk of overflow due to continuous suction. Additional tips include the MacroCannula which is used to remove coarse debris after instrumentation, and the MicroCannula which features microscopic evacuation holes allowing the irrigant to flow to the apical termination.

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న్. Statement of Intended Use:
The EndoVac® System is intended for the delivery and evacuation of endodontic irrigation solutions during root canal procedures.
1. Description of Safety and Substantial Equivalence:

Technological Characteristics

The EndoVac® System is intended for the delivery and evacuation of endodontic irrigation solutions during root canal procedures. EndoVac® Apical Negative Pressure Irrigation System presents a method to effectively irrigate during root canal treatments. Unlike positive pressure systems which use a cannula or side-port needles to deliver irrigants to the canal, the EndoVac® is a negative pressure system that draws fluid apically by way of vacuum suction. Because the system utilizes negative pressure irrigation, irrigants are suctioned from the pulp chamber, apically, to the apical termination and then away into the office Hi-Vac system. The EndoVac® Apical Negative Pressure Irrigation System is comprised of a Multi-Port Adapter which attaches to the dental Hi-Vac system, the Master Delivery Tip which allows for simultaneous irrigation and evacuation, the MacroCannula which removes coarse debris left in the canal from instrumentation, and the MicroCannula which removes microscopic debris at the apical 1 mm via 12 microscopic, laser-drilled holes, each 100 um in diameter. Other accessories include handpiece and finger-piece attachments, evacuation tubing and syringes.

EndoVac® Apical Negative Pressure Irrigation System is substantially equivalent to the legally marketed RinsEndo dental handpiece manufactured by Airtechniques, Inc. (K052271). The RinsEndo uses a turbine driven dental handpiece to provide hydrodynamic rinsing and flushing of root canals, but has the same intended use as the proposed EndoVac® Apical Negative Pressure Irrigation System. A comparison of the proposed and predicate devices is provided in Table 1.

Device Name	Proposed EndoVac® System	Predicate RinsEndo (K052271)
FDA ProductCode	NYL; Handpiece, air-powered,root canal irrigation	NYL; Handpiece, air-powered,root canal irrigation
Classification	Class I reserved	Class I reserved
Manufacturer	SybronEndo1332 South Lone Hill AvenueGlendora CA, 91740	Air Techniques, Incorporated70 Cantiague Rock RoadHicksville, New York 11801
Method ofaspiration	Suction through tubing attachedto dental office Hi-Vac	Air-driven piston that createsflushing action for rinsing rootcanals; attached to dental officeHi-Vac
Attached to dentalhandpiece	No	Yes

Table 1: Comparison of Proposed and Predicate Devices

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Indications for use	The EndoVac® system is	The RinsEndo is used for root
	intended for the delivery and	canal irrigation/disinfection.
	evacuation of endodontic
	irrigation solutions during root
	canal procedures.
Single use	Yes	Yes
disposable cannula
(tips)
Biocompatibility	Complies with ISO 10993	Complies with ISO 10993
	standards	standards
Sterilization	Autoclavable Master Delivery	Autoclavable handpiece
	Tip, Multi-Port Adapter,
	Handpiece and Finger-Piece

Non-Clinical Performance Data.

The performance of EndoVac® Apical Negative Pressure Irrigation System has been verified utilizing the following standards:

ISO 10993-1 Biological Evaluation of Medical Devices Evaluation and Testing ●
ISO 10993-5:2009 Biological evaluation of medical devices -- Tests for in vitro ● cytotoxicity
ISO 10993-10 Biological evaluation of medical devices -- Tests for irritation and ● skin sensitization
AAMI TIR 12: 2010 Designing, Testing and Labeling Reusable Medical Devices ● for Reprocessing in Health Care Facilities: A Guide for Manufacturers
. ANSI/AAMI ST:79:2010 Comprehensive guide to steam sterilization and sterility assurance in health care facilities
AAMI TIR 39:2009 Guidance on selecting microbial challenge and inoculation . sites for sterilization validation of medical devices
ISO 17665-1:2006 Sterilization of health care products Moist Heat Part 1: . Requirements for the development, validation and routine control of a sterilization process for medical devices
Internal method for autoclave life testing of reusable products

Clinical Performance Data.

SybronEndo has not performed human clinical evaluations for EndoVac® Apical Negative Pressure Irrigation System. A summary of published literature has been included in order to support the safety and efficacy of the device.

Conclusion as to Substantial Equivalence

The similarities in design, function, safety and intended use of EndoVac® Apical Negative Pressure Irrigation System with the legally marketed device RinsEndo dental handpiece (K052271) provide evidence that these devices are substantially equivalent. The data provided in this submission support the substantial equivalence of the Endo Vac® Apical Negative Pressure Irrigation System to the predicate, RinsEndo dental handpiece (K052271).

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.