The raw materials of the ENDOSEAL are Natural Pure Cement, Zirconium dioxide, and Citric acid anhydrous, and the device has been showing good sealing ability and biocompatibility. It is prepared as a mixture of powder and water, and it is used in a putty form which gradually hardens in the oral environment.

AI/ML Overview

The provided text describes the submission of a 510(k) premarket notification for a medical device called ENDOSEAL, a root canal filling resin. The document focuses on demonstrating substantial equivalence to a predicate device (ENDOCEM MTA) rather than proving the device meets specific performance criteria through a clinical study.

Here's an analysis of the provided information concerning acceptance criteria and studies:

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

Acceptance Criteria (Set by Standard)	Reported Device Performance (as stated)
ISO 6876:	All test results met the preset test criteria.
- Visual properties	(Implicitly met based on general statement)
- Packaging properties	(Implicitly met based on general statement)
- Setting time	(Implicitly met based on general statement)
- Solubility	(Implicitly met based on general statement)
- Radiopacity	(Implicitly met based on general statement)
ISO 7405:	All test results met the preset test criteria.
- Cytotoxicity	(Implicitly met based on general statement)
ISO 10993-10:	All test results met the preset test criteria.
- Skin sensitization (Local Lymph Node Assay, LLNA)	(Implicitly met based on general statement)
ISO 10993-11:	All test results met the preset test criteria.
- Acute systemic toxicity	(Implicitly met based on general statement)
Other Bench Testing:	All test results met the preset test criteria.
- Capacity	(Implicitly met based on general statement)
- pH (Saline Extracts)	(Implicitly met based on general statement)

Note: The document explicitly states: "All the test results met the preset test criteria." It does not provide the specific numerical acceptance criteria for each test or the specific numerical results obtained for the ENDOSEAL device. It relies on a general statement of compliance.

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

The document does not describe any human-subject study or "test set" in the context of clinical performance. The "tests" mentioned are non-clinical bench and biocompatibility tests. Therefore, sample sizes for a test set, data provenance, and related information are not applicable to the studies described.

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

Not applicable, as no human-subject clinical test set is described.

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

Not applicable, as no human-subject clinical test set is 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

Not applicable. This is a submission for a root canal filling material, and the studies described are non-clinical bench and biocompatibility tests. There is no mention of AI or human readers.

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

Not applicable. This is a medical device (root canal filling material), not an algorithm or AI system.

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

For the non-clinical tests described, the "ground truth" would be the established methods and criteria within the referenced ISO standards (ISO 6876, ISO 7405, ISO 10993-10, ISO 10993-11) and standard bench testing protocols for capacity and pH. These standards define the acceptable range or outcome for the specific properties being tested.

8. The sample size for the training set

Not applicable. No training set for an algorithm is described.

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

Not applicable. No training set for an algorithm is described.

Summary of the Study:

The study described is a non-clinical evaluation of the ENDOSEAL device, focusing on bench testing and biocompatibility assessments to demonstrate substantial equivalence to a predicate device (ENDOCEM MTA).

Objective: To show that ENDOSEAL has similar physical and biocompatible properties and comparable performance specifications to ENDOCEM MTA. The primary goal is to address whether adding Zirconium dioxide and Citric acid anhydrous and removing Bismuth Trioxide from the formulation raises new questions of safety and effectiveness.
Methodology: The device underwent a series of tests based on international standards:
- ISO 6876: Visual inspection, packaging integrity, setting time, solubility, and radiopacity.
- ISO 7405: Cytotoxicity.
- ISO 10993-10: Skin sensitization (Local Lymph Node Assay, LLNA).
- ISO 10993-11: Acute systemic toxicity.
- Other bench testing: Capacity and pH (Saline Extracts).
Results: The submission states, "All the test results met the preset test criteria."
Conclusion: Based on these non-clinical tests, the manufacturer concluded that ENDOSEAL is substantially equivalent in safety and effectiveness to the predicate device.

Key takeaway: This 510(k) summary primarily demonstrates that the new device's material composition changes do not negatively impact its performance or biocompatibility compared to a legally marketed predicate device, as evidenced by non-clinical testing. It does not involve human-subject clinical trials or AI performance evaluations.

Summary

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KI33054

MAY 1 2 2014

510(k) Summary

This summary of 510(k)-safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92.

Date: 02/26/2014

Submission Applicant / Submitter: 1.

MARUCHI 2-208, 42-10, Taejanggongdan-gil, Wonju-si. Gangwon-do, 220-962, Republic of Korea

Tel: +82-33-734-0330 Fax: +82-33-746-2804

2. Submission Correspondent:

Priscilla Chung LK Consulting Group USA, Inc. 2651 E Chapman Ave Ste 110, Fullerton CA 92833 Phone: 714-202-5789 Fax: 714-409-3357 Email: juhee.c@lkconsultinggroup.com

3. Device:

Proprietary Name:	ENDOSEAL
Common Name:	Root Filling Material
Classification Name:	Root Canal Filling Resin
Classification:	Class II, 21 CFR 872.3820
Classification Product Code:	KIF

4. Predicate Device:

ENDOCEM MTA (Mineral Trioxide Aggregate) (K112078) by MARUCHI

5. Device Description:

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દ. Intended Use:

. Repair of perforation
. Root canal filling

Performance Data(Non-Clinical): 7.

The following properties were tested based on the referenced standard. All the test results met the preset test criteria.

ISO 6876 Visual, Packaging, Setting time, Solubility and Radiopacity
ISO 7405 Cytotoxicity
ISO 10993-10 Skin sensitization, Local Lymph Node Assay, LLNA
ISO 10993-11 Acute systemic toxicity
· Other bench testing Capacity and pH (Saline Extracts)

8. Substantial Equivalence

ENDOSEAL has similar physical and biocompatible properties, and demonstrates comparable performance specifications to ENDOCEM MTA (Mineral Trioxide Aggregate). In addition. ENDOSEAL has a comparable delivery system to ENDOCEM MTA. In comparison, ENDOSEAL contains Zirconium dioxide and Citric acid anhydrous, but Bismuth Trioxide, which is in ENDOCEM MTA, is not present in ENDOSEAL. The results of bench and biocompatibility testing performed demonstrate that this difference does not raise any new questions as to safety and effectiveness. Therefore, it is concluded that ENDOSEAL is substantially equivalent in safety and

effectiveness to the predicate device.

9. Conclusion:

Based on the testing results, MARUCHI concludes that the ENDOSEAL is substantially equivalent in safety and effectiveness to the predicate device.

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May 12, 2014

MARUCHI C/O Priscilla Chung Regulatory Affairs Consultant LK Consulting Group USA, Incorporated 2651 East Chapman Avenue, Suite 110 Fullerton, CA 92833

Re: K133054

Trade/Device Name: ENDOSEAL Regulation Number: 21 CFR 872.3820 Regulation Name: Root Canal Filling Resin Regulatory Class: II Product Code: KIF Dated: February 26, 2014 Received: March 4, 2014

Dear Ms. Chung:

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 10 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.

Public Health Service

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

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Page 2 - Ms. Chung

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. Acting Division 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K133054

Device Name ENDOSEAL

Indications for Use (Describe)

· Repair of perforation
· Root canal filling

Type of Use (Select one or both, as applicable)

[x] Prescription Use (Part 21 CFR 801 Subpart D)

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

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Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.

Regulation Number and Section

§ 872.3820 Root canal filling resin.

(a)
Identification. A root canal filling resin is a device composed of material, such as methylmethacrylate, intended for use during endodontic therapy to fill the root canal of a tooth.(b)
Classification. (1) Class II if chloroform is not used as an ingredient in the device.(2) Class III if chloroform is used as an ingredient in the device.
(c)
Date PMA or notice of completion of a PDP is required. A PMA or a notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before December 26, 1996 for any root canal filling resin described in paragraph (b)(2) of this section that was in commercial distribution before May 28, 1976, or that has, on or before December 26, 1996 been found to be substantially equivalent to a root canal filling resin described in paragraph (b)(2) of this section that was in commercial distribution before May 28, 1976. Any other root canal filling resin shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.