Endo-CHX™ is a root canal cleanser for use in endodontic procedures. After endodontic instrumentation, the product should be used to cleanse the canal space before placement of the endodontic filling. The material should be delivered into the canal using an irrigating neede. A side-vented, closed tip irrigation needle is most preferred.

AI/ML Overview

The provided document is a 510(k) summary for a root canal cleanser called Endo-CHX™. As such, it primarily focuses on establishing substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a study demonstrating performance against those criteria in the way that might be expected for an AI-powered diagnostic device.

Here's an analysis based on the information provided, while noting the limitations due to the nature of the device:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not applicable in the traditional sense for this type of device and submission. For a root canal cleanser, "acceptance criteria" would typically relate to its chemical properties, biocompatibility, and efficacy in cleaning the root canal system, often demonstrated through in vitro or ex vivo studies. The 510(k) summary focuses on substantial equivalence to predicate devices rather than setting and meeting specific quantitative performance metrics like sensitivity or specificity.

The "device performance" is implicitly established by demonstrating that it functions similarly to legally marketed predicate devices and is considered safe and effective.

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

There is no test set in the context of an AI/diagnostic device performance study. The 510(k) relates to a chemical solution.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not applicable. Ground truth, expert consensus, or clinical adjudication as would be relevant for an AI/diagnostic device is not part of this submission type.

4. Adjudication Method

This information is not applicable.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

This information is not applicable. This is not an AI-powered diagnostic device.

6. Standalone Performance Study

The submission mentions "Non-Clinical Testing: The performance and biocompatibility documentation provided the submission support the safety and effectiveness of the Endo-CHX root canal cleanser for the indicated uses." This suggests standalone testing was performed, but the details (e.g., specific tests, outcomes, quantitative measures) are not provided in this summary exhibit. It just states that such documentation exists and supports safety and effectiveness.

7. Type of Ground Truth Used

For non-clinical testing of a root canal cleanser, the "ground truth" would likely involve standardized in vitro models or ex vivo tooth specimens. The effectiveness would be measured by properties such as debris removal, antibacterial activity, or smear layer removal, often compared to controls or predicate devices. However, direct "ground truth" establishment in a clinical sense (like pathology for cancer) is not specified or generally applicable here.

8. Sample Size for the Training Set

There is no training set for this device as it is not an AI/machine learning product.

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

There is no training set for this device.

Summary of Relevant Information from the Provided Text:

Acceptance Criteria & Performance: Not explicitly stated as quantitative metrics. Performance is inferred through "substantial equivalence" to predicate devices and general statements about non-clinical testing supporting safety and effectiveness.
Study Type: Non-clinical (e.g., in vitro or ex vivo) testing was performed for performance and biocompatibility. No clinical trials were deemed necessary ("Clinical Testing: Not applicable").
Predicate Devices: The device was compared to K061689 (Aquatine™ EC Endodontic Cleanser) and K053167 (BioPure™ MTAD™ Root Canal Cleanser). The comparison focuses on mechanism of action and composition.
Conclusion: The device is considered "substantially equivalent to the predicates and raises no issues of safety and effectiveness."

Summary

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Exhibit #2

JUL 1 1 2007

Image /page/0/Picture/3 description: The image is a logo for Essential Dental Systems (EDS). The logo is black and white and features the letters "EDS" in a bold, blocky font on the left side. To the right of the letters, the words "ESSENTIAL DENTAL SYSTEMS" are stacked vertically in a smaller, sans-serif font. The entire logo is enclosed in a rounded rectangle with a thin black border. There is a registered trademark symbol on the top right corner of the rounded rectangle.

( € APPROVED PRODUCTS

89 Leuning Street S. Hackensack New Jersey 07606

1(800) 22-FLEXI Tel.: (201) 487-9090 Fax: (201) 487-5120

510(k) Summary
Name and address of sponsor of the510(k) submission:	Essential Dental Systems, Inc.89 Leuning StreetSouth Hackensack, NJ 07606
Official contact person for allcorrespondence:	Brian RasimickPhone: 201-487-9090Fax: 201-487-5120E-mail: brasimick@edsdental.com
Date Prepared:	June 26, 2007
Device Name:	Endo-CHXTM
Generic name of the device:	Root Canal Cleanser
Classification, Product Code andCFR Regulation Number:	Unclassified, Product Code KJJ
Classification Panel:	Dental
Predicate Device Names and 510(k)numbers:	K061689, AquatineTM EC Endodontic Cleanser, PuriCore, Inc.K053167, BioPureTM MTADTM Root Canal Cleanser, Dentsply International

Device Description:

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Comparison with Predicate Device:

Both Endo-CHX "M and Aquatine" EC irrigate and cleanse via the mechanical action of the solution moving through the root canal system.

Both Endo-CHX™ and BioPure™ MTAD™ are combination products containing a drug component.

Endo-CHX™ is an aqueous solution of 2% chlorhexidine digluconate with surfactant and coloring. Aquatine™ EC is an aqueous hypochlorite solution (hypochlorous acid). BioPure™ MTAD™ is an aqueous doxycycline solution with citric acid and surfactant.

Intended Use:

Endo-CHXTM is intended to irrigate and cleanse root canal systems.

Non-Clinical Testing:

The performance and biocompatibility documentation provided the submission support the safety and effectiveness of the Endo-CHX root canal cleanser for the indicated uses.

Clinical Testing:

Not applicable

Conclusion:

In our opinion, Endo-CHXTM is substantially equivalent to the predicates and raises no issues of safety and effectiveness.

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Image /page/2/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular with text around the perimeter. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". In the center of the seal is an emblem that resembles an eagle.

JUL 1 1 2007

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Essential Dental Systems, Incorporated C/O Ms. Susan D. Goldstein-Falk Official Correspondent mdi Consultants, Incorporated 55 Northern Boulevard, Suite 200 Great Neck, New York 11021

Re: K070401

Trade/Device Name: ENDO-CHX TM Regulation Number: None Regulation Name: None Regulatory Class: Unclassified Product Code: KJJ Dated: June 27, 2007 Received: July 3, 2007

Dear Ms. Goldstein-Falk:

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 such 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. Goldstein-Falk

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 your 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 (240) 276-3150 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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K070401

Exhibit #1

INDICATIONS FOR USE

Page 1 of 1

510(k) Number (if known):

Device Name: ENDO-CHX™

Indications for Use:

ENDO-CHX™ is intended to irrigate and cleanse root canal systems.

Prescription Use (Per 21 CFR 801 Subpart D)

Over-The Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

MSR

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

510(k) Number: K070461

Regulation Number and Section

N/A