PacEndo™ EDTA is an EDTA solution in water with surfactant to lower surface tension. The solution is a root canal cleanser for use in endodontic procedures to remove the smear layer produced from root canal instrumentation.

AI/ML Overview

Here's a breakdown of the requested information based on the provided text, focusing on the acceptance criteria and the study that proves the device meets them:

Disclaimer: This document is a 510(k) premarket notification summary. It focuses on demonstrating substantial equivalence to a predicate device rather than providing extensive details of a novel device's performance validation. Therefore, many of the requested categories (especially those related to AI/MRMC studies, ground truth establishment for large datasets, and clinical trials) are not applicable or detailed in this type of submission.

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria / Characteristic	Reported Device Performance (PacEndo™ EDTA)	Comparison with Predicate (EDTA Plus)
Indications for Use	Facilitate removal of dentinal debris from the walls of root canals prior to obturation.	Same as predicate
Composition	EDTA, Buffer, Surfactant	Different composition, but functions of ingredients are the same.
Appearance	Clear liquid	Not the same (predicate is light peach color liquid).
pH	7.56	7.55
Surface Tension	Similar to predicate device (via contact angle measurement)	Found to have similar surface tension compared to the predicate device.
Biocompatibility	Demonstrated no biocompatibility testing was needed.	Not explicitly compared to predicate, but both are likely assumed to be biocompatible for their intended use.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample size for test set: The document does not specify the sample size for the surface tension test.
Data provenance: Not specified. The tests were "Non-Clinical Tests," implying laboratory-based.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. The "ground truth" for non-clinical performance tests like pH and surface tension would be based on standard scientific measurements, not expert human interpretation.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable for non-clinical laboratory tests.

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 device is a chemical solution (root canal cleanser), not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study is not relevant.

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

Not applicable. This device is a chemical solution, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the performance characteristics (pH, appearance, composition, surface tension), the "ground truth" is derived from standard analytical chemistry and physical property measurements.

8. The sample size for the training set

Not applicable. This is not a machine learning device; there is no training set.

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

Not applicable. There is no training set.

Study Proving Device Meets Acceptance Criteria:

The document describes a Non-Clinical Performance Test to demonstrate that PacEndo™ EDTA is substantially equivalent to its predicate device, EDTA Plus (K072555).

Name of Study: "Surface tension test using contact angle measurement" was performed in comparison to the predicate device.
Outcome: "The subject device was found to have similar surface tension compared to the predicate device and can be used as intended."
Biocompatibility: A biocompatibility assessment and risk analysis were conducted. The results "demonstrated that no biocompatibility testing was needed to demonstrate biocompatibility of the device for the intended use."
Conclusion: The summary states, "non-clinical performance testing demonstrates that PacEndo™ EDTA is substantially equivalent to the identified predicate product for its intended use."

The entire submission focuses on showing substantial equivalence through direct comparison of technological characteristics (Indications for Use, Composition, Performance properties like pH and appearance) and a targeted non-clinical test (surface tension) rather than a comprehensive, independent validation against specific performance targets. No clinical testing was provided or deemed necessary for this 510(k) submission.

Summary

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

February 1, 2016

Pac-dent International, Inc. Mr. Wenying Zhu Materials Engineer 670 Endeavor Circle Brea, California 92821

Re: K153528

Trade/Device Name: PacEndo™ EDTA Regulation Number: 21 CFR Regulatory Class: Unclassified Product Code: KJJ Dated: December 2, 2015 Received: December 9, 2015

Dear Mr. Zhu:

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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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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

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

Sincerely yours,

Tina Kiang -S

for 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

Enclosure

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Image /page/2/Picture/0 description: The image shows the logo for PacDent. The logo features the text "PacDent" in a bold, blue font. Above the text is an orange swoosh. To the right of the main logo is the text "Pac-De" in a smaller, gray font.

Pac-Dent International, Inc.

Section III

Indications for Use Statement

510(k) Number (if known): _ K153528

Device Name: _ PacEndo™EDTA

Indications for Use:

PacEndo™ EDTA is intended to facilitate removal of dentinal debris from the walls of root canals prior to obturation.

Prescription Use _______________

Over-The-Counter Use

Image /page/2/Picture/12 description: The image shows four different logos. The first logo is the FDA logo, which is a stylized version of the letters FDA. The second logo is the CE logo, which is a stylized version of the letters CE. The third logo is the DTA logo, which is a stylized version of the letters DTA inside of a blue circle. The fourth logo is the OSAP logo, which is a stylized version of the letters OSAP with the tagline "Because Safety Matters" and ".org".

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Image /page/3/Picture/0 description: The image shows the logo for PacDent. The logo features the company name in a bold, blue font. Above the company name is an orange swoosh that curves from the upper left to the right side of the logo.

Pac-Dent International, Inc.

510(k) Summary

510(k) Number: K153528

Submitter:

Pac-Dent International, Inc. 670 Endeavor Circle Brea, CA 92821

Contact Person:

Wenying Zhu Materials Engineer 909-839-0888 ext.111

Date Summary Prepared:

December 2015

Device Name Trade Name: PacEndo™ EDTA Common Name: Endodontic Cleanser Device Classification: Unclassified Classification Product Code: KJJ Classification Name: Cleanser, Root Canal Predicate Device EDTA Plus (K072555)

Description of Device

Indications for Use

PacEndo™ EDTA is intended to facilitate removal of dentinal debris from the walls of root canals prior to obturation.

Image /page/3/Picture/16 description: The image shows four different logos. The first logo is the FDA logo, which is gray and has the letters FDA in a stylized font. The second logo is the CE logo, which is blue and has the letters CE in a simple font. The third logo is the DTA logo, which is blue and has the letters DTA in a stylized font inside of a circle. The fourth logo is the OSAP logo, which is green and has the letters OSAP in a stylized font with the words "Because Safety Matters" below it and ".org" to the right.

IV-1

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Image /page/4/Picture/0 description: The image displays the logo for Pac-Dent International, Inc. The logo features the company name in a combination of blue and gray text. To the left of the name, there is an orange graphic element that appears to be a stylized swoosh or arc, adding a visual accent to the overall design.

Comparison of Technological Characteristics
DescriptiveInformation	Subject Device	Predicate Device	Summary
Indications forUse	PacEndo™ EDTA	EDTA Plus (K072555)
	PacEndo™ EDTA is intended tofacilitate removal of dentinaldebris from the walls of rootcanals prior to obturation.	EDTA Plus is a root canal cleanserdesigned to facilitate removal ofdentinal debris from the walls ofroot canals prior to obturation.	The indications foruse of the subjectiveand predicatedevices are thesame.
Composition ofMaterials	EDTABufferSurfactant	EDTABufferSurfactant	The composition ofsubject and predicatedevices is different.However, thefunctions of theingredients are thesame.The differencebetween thecomposition of thesubject and predicatedevices doesn't affectthe substantialequivalent of thesubject and predicatedevices.
Performance	Appearance: clear liquidpH: 7.56	Appearance: light peach colorliquidpH: 7.55	The appearances ofthe subject andpredicate devices arenot the same.However, it doesn'taffect the substantialequivalent of thesubject and predicatedevices.

Comparison of Technological Characteristics

Based on the above comparisons, Pac-Dent concludes that the subject device is substantially

Image /page/4/Picture/5 description: The image shows four different logos. The first logo is the FDA logo in gray. The second logo is the CE logo in blue. The third logo is the DTA logo in blue. The fourth logo is the OSAP logo in green and blue.

IV-2

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equivalent in intended use, composition and performance to the predicate device.

Non-Clinical Tests

Surface tension test using contact angle measurement was performed in comparison to the predicate device.

A biocompatibility assessment and risk analysis were conducted and the results demonstrated that no biocompatibility testing was needed to demonstrate biocompatibility of the device for the intended use.

Clinical Performance Test

No clinical testing was provided.

Summary of Non-Clinical and Clinical Performance Testing_

The subject device was found to have similar surface tension compared to the predicate device and can be used as intended.

Conclusion

In summary, non-clinical performance testing demonstrates that PacEndo™ EDTA is substantially equivalent to the identified predicate product for its intended use.

Image /page/5/Picture/12 description: The image shows a series of logos for different organizations. From left to right, the logos are for FDA, CE, DIA, and OSAP. The OSAP logo includes the tagline "Because Safety Matters" and the website address ".org".

Regulation Number and Section

N/A