ENDOSOLV (new device, K172839/S001) is a solvent used for eugenate-type or phenolic resin-based endodontic cements in the context of endodontic retreatment. This solvent is able to soften conventional zinc oxide eugenol cements and phenolic resin type sealers in the context of endodontic retreatment. It is indicated for use as a root canal sealer solvent when canal retreatment is required. ENDOSOLV (new device, K172839/S001) composition consists of ethyl acetate, amyl acetate and thymol. Ethyl acetate and amyl acetate are the two main components of the formulation that are effective in dissolving zinc oxide-eugenol-based and resin based filling material.

AI/ML Overview

The provided text describes the 510(k) premarket notification for ENDOSOLV (K172839) and compares it to a predicate device, ENDOSOLV E (K980633). The study focuses on demonstrating substantial equivalence, primarily through performance testing of the new device's ability to dissolve root canal sealers.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The text doesn't explicitly state "acceptance criteria" in a quantitative manner (e.g., "must dissolve within X seconds"). Instead, the performance studies aim to show that the new device, ENDOSOLV, is "as effective as" or "comparable to" the predicate device, ENDOSOLV E, and a positive control (ENDOSOLV R) in softening root canal sealers.

Therefore, the reported device performance is framed as a comparison to the predicate and positive control.

Performance Metric	Acceptance Criteria (Implied)	Reported Device Performance (ENDOSOLV K172839)
Dissolution of Eugenate-based Root Canal Sealers	As effective as ENDOSOLV E (predicate device) in softening eugenate-based sealers.	For Endomethasone SP: 47 seconds (compared to 70 seconds for ENDOSOLV E). For PCS Pulp Canal Sealer: 41 seconds (compared to 68 seconds for ENDOSOLV E). For Sealite regular: 141 seconds (compared to 68 seconds for ENDOSOLV E). Conclusion stated: "ENDOSOLV (new device, K172839/S001) is as effective as ENDOSOLV E (predicate device, K980633) to dissolve eugenate based root canal sealer."
Dissolution of Resin-based Root Canal Sealers	Comparable to ENDOSOLV R (positive control) in softening resin-based sealers.	For resin-based root canal filling material: 50 seconds (compared to 83 seconds for ENDOSOLV E and 68 seconds for ENDOSOLV R). Also, against Acroseal (resin-based root canal sealer): 7 minutes 10 seconds (compared to 19 minutes 57 seconds for ENDOSOLV E). Conclusion stated: "This study showed ENDOSOLV (new device, K172839/S001) results comparable to those obtained with ENDOSOLV R."
Biocompatibility	Not cytotoxic, not sensitizer, negligible irritation.	Cytotoxicity: Not cytotoxic (ISO 10993-5) Hypersensitivity: Not sensitizer (ISO 10993-10) Irritation: Negligible irritation (ISO 10993-10)

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

Sample Size for Performance Testing: Not explicitly stated. The tables provide softening times for different types of cements, suggesting multiple tests were performed for each, but the exact number of samples or replicates for each test is not provided.
Data Provenance: The performance testing was performed by Septodont, the manufacturer. No information on the country of origin of the data or whether it was retrospective or prospective is provided beyond the location of the study site (Septodont itself did the performance testing, biocompatibility was outsourced to Envigo and Phycher).

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

Not applicable. The performance testing involves direct measurements of softening time for root canal sealers, not interpretation by human experts. Biocompatibility testing follows ISO standards and lab protocols.

4. Adjudication Method for the Test Set

Not applicable, as the tests involve objective measurements (softening time) and standardized biocompatibility assays, not expert interpretation requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. This study is for a medical device (solvent) and involves laboratory performance testing (softening time) and biocompatibility, not an imaging or diagnostic device requiring human reader analysis.

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

Not applicable, as the device is a chemical solvent and does not involve an algorithm. Performance is assessed directly through its chemical and physical properties.

7. The Type of Ground Truth Used

The ground truth for the performance testing is the objectively measured "softening time" of various root canal sealers when exposed to the solvent. For biocompatibility, the ground truth is established by the results of standardized ISO 10993 tests (cytotoxicity, hypersensitivity, irritation).

8. The Sample Size for the Training Set

Not applicable. This device is a chemical solvent, not a machine learning model, so there is no "training set."

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

Not applicable, as there is no training set.

Summary

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Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

Septodont Jaimie Woodruff RA Supervisor 416 South Taylor Avenue Louisville, Colorado 80027

Re: K172839

Trade/Device Name: Endosolv Regulation Number: 21 CFR 872.3820 Regulation Name: Root Canal Filling Resin Regulatory Class: Class II Product Code: KIF Dated: September 28, 2017 Received: September 29, 2017

Dear Jaimie Woodruff:

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.

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 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);

U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.qov

February 13, 2018

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and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Mary S. Runner -S

for Tina Kiang, Ph.D. Acting 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

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

Indications for Use

510(k) Number (if known) K172839

Device Name ENDOSOLV

Indications for Use (Describe)

Root canal sealers solvent when canal retreatment is required.

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

Prescription Use (Part 21 CFR 801 Subpart D)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

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FORM FDA 3881 (7/17)

Page 1 of 1

PSC Publishing Services (301) 443-6740 EF

004 Indications for Use Statement

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Image /page/3/Picture/0 description: The image shows the Septodont logo. The logo features the word "septodont" in black, sans-serif font, positioned to the left of a white tooth shape. The tooth and the text are set against a solid red circle. The tooth shape is stylized, with a rounded top and a curved base.

5 510(k) Summary K172839

Traditional 510(k) Summary

I. MANUFACTURER:

SEPTODONT 58, Rue Du Pont De Creteil 94107 Saint Maur Des Fosses Cedex France Phone 33(0)1.49.76.70.00 Fax 33(0)1.48.85.54.01

Contact Person: Jaimie Woodruff, RAC Regulatory Affairs Supervisor Septodont 416 South Taylor Avenue Louisville, CO 80027 Phone (303) 665-7535 x6270 (303) 666-4320 FAX Email: jwoodruff@septodont.com
Date Prepared: September 8, 2017

II. DEVICE

Trade/Proprietary Name:	ENDOSOLV
Common Name:	Resin, Root Canal Filling
Classification Name:	Root Canal Filling Resin (21 CFR 872.3820)
Regulatory Class:	II
Product Code:	KIF

III. PREDICATE DEVICE(S)

K980633 ENDOSOLV E	Product code: KIF (predicate device)
K780003 ENDOSOLV E	Product code: KJJ (reference device)

IV. Device Description

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sealers in the context of endodontic retreatment. It is indicated for use as a root canal sealer solvent when canal retreatment is required.

Despite being highly successful, some endodontic treatments do not respond to initial therapy for different reasons and, hence, retreatment, also called canalar desobturation, becomes necessary. Many techniques are available for endodontic retreatment including the use of a solvent.

ENDOSOLV (new device, K172839/S001) composition consists of ethyl acetate, amyl acetate and thymol. Ethyl acetate and amyl acetate are the two main components of the formulation that are effective in dissolving zinc oxide-eugenol-based and resin based filling material.

V. Indication for Use

ENDOSOLV (new device. K172839/S001): Root canal sealers solvent when canal retreatment is required.

ENDOSOLV E (predicate device, K980633): Root canal filling remover for zinc-oxide eugenol-based materials.

The Indication for Use statement for ENDOSOLV (new device. K172839/S001) is not identical to the predicate devices; however, the differences do not alter the intended therapeutic use nor do they affect the safety and effectiveness of the device in comparison to the predicate device.

ENDOSOLV (new device. K172839/S001) in comparison to ENDOSOLV E (predicate device. K980633) does not limit the intended use of the root canal filling remover to zincoxide eugenol based material. ENDOSOLV (new device. K172839/S001) widens the intended use scope of the product to 'root canal sealers solvent when canal retreatment is required. This new indication for use includes both the conventional zinc oxide eugenol cement and resin type sealers in context of endodontic retreatment.

VI Comparison of Technological Characteristics with the Predicate Device

Ethyl acetate and amyl acetate are the two main components of the formulation in ENDOSOLV (new device, K172839/S001) that are effective in dissolving zinc oxideeugenol-based and resin based filling materials.

The predicative devices ENDOSOLV E (reference device, K780003) and ENDOSOLV E (predicate device, K980633) the only difference between the two devices was the removal of solvent, trichloroethane replaced by tetrachloroethylene in ENDOSOLV E (predicate device, K980633). The formula was changed because trichloroethane is banned in France.

Next, the ENDOSOLV (new device, K172839/S001) in relation to ENDOSOLV E (predicate device, K980633) the major difference is the ingredient tetrachloroethylene

005_510(k) Summary Page 2 of 4

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which has been replaced by Ethyl Acetate. The reason for the change is Tetrachloroethylene is due to concerns of toxicity. In addition, overall formulation quantities has been modified minimally between the predicate devices and new device. ENDOSOLV (new device, K172839/S001) has been adjusted to account for the substitutional change in solvent from tetrachloroethylene to Ethyl Acetate.

VII Performance Data

Biocompatibility Testing

The biocompatibility evaluation for ENDOSOLV (new device, K172839/S001; based on ISO 10993 standards) are:

Type of study	Study number	Guideline	Study site	Main findings	Reference
Cytotoxicity	1752100	ISO10993-5(2009)	Envigo	Not cytotoxic	(Envigo and Markus Roth, 2016)
Hypersensitivity	SMKiso-PH-16/0032	ISO10993-10(2010)	PhycherBiodevelopment	Not sensitizer	(Colas, 2016)
Irritation	MJ-PH-16/0032	ISO10993-10(2010)	PhycherBiodevelopment	Negligible irritation	(Colas and Phycher, 2016)
Pulp and dentintest	NA	NA	NA	Not in contact.	NA

Performance Testing

Two studies were performed in accordance to ISO 6876:2012 by Septodont in order to compare the effectiveness of ENDOSOLV (new device, K172839/S001) in comparison with ENDOSOLV E (predicate device, K980633) and ENDOSOLV R, considered positive control. The literature review revealed the effectiveness of those solvents in their intended indication: soften respectively eugenate-based and phenolic resin based root canal sealer when an endodontic retreatment is necessary (Gambrel et al., 2005;Canakci et al., 2015;Ramzi et al., 2010;Saglam et al., 2013). Purified water is then used as negative control in both assays. Moreover, a sealer was also used as negative control: Acroseal, it is an epoxy-resin based root canal sealer and neither of the solvents is indicated to soften this material. The first assay permits to conclude that ENDOSOL V (new device, K172839/S001) is as effective as ENDOSOLV E (predicate device, K980633) to dissolve eugenate based root canal sealer. Because of the successful results obtained with the new formulation that were comparable to ENDOSOLV E (predicate device, K980633), the intended performance of dissolving eugenate based root canal filling material is confirmed. Please see Table 1 for Summary of Results.

Moreover, the second study permits to demonstrate the performance of ENDOSOLV (new device. K172839/S001) to dissolve resin based root canal filling material. This study showed ENDOSOLV (new device, K172839/S001) results comparable to those

005_510(k) Summary Page 3 of 4

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obtained with ENDOSOLV R (only approved for sale in EU; indication: soften phenolic resin based root canal sealer; voluntary withdrawal of device from EU and Canada for precautionary reasons in order to avoid any risk of exposure of formamide to pregnant patients), confirming the intended performance of ENDOSOLV (new device, K172839/S001) to dissolve resin based root canal filling material. Please see Table 2 for Summary of results.

Product	Cement	Softening Time
ENDOSOLV E (predicate device)	Endomethasone SP (eugenate-based root canal sealer)	70sec
ENDOSOLV (new device)	Endomethasone SP (eugenate-based root canal sealer)	47sec
ENDOSOLV E (predicate device)	PCS Pulp Canal Sealer(eugenate-based root canalsealer)	68sec
ENDOSOLV (new device)	PCS Pulp Canal Sealer(eugenate-based root canalsealer)	41sec
ENDOSOLV E (predicate device)	Sealite regular (eugenate-basedroot canal sealer)	68sec
ENDOSOLV (new device)	Sealite regular (eugenate-basedroot canal sealer)	141sec
ENDOSOLV E (predicate device)	Acroseal (resin-based root canalsealer)	19min 57sec
ENDOSOLV (new device)	Acroseal (resin-based root canalsealer)	7min 10sec

Table 1: Softening Time Required to Dissolve Root Canal Sealers

Table 2: Softening Time Required to Dissolve Resin- Based Root Canal Sealer

Product	Cement	Softening Time (sec)
ENDOSOLV (new device)	resin-based root canal fillingmaterial	50
ENDOSOLV E (predicateddevice)	resin-based root canal fillingmaterial	83
ENDOSOLV R (indicated forthe dissolution of phenolic basedroot canal sealers)	resin-based root canal fillingmaterial	68
Water (negative control)	resin-based root canal fillingmaterial	100

Substantial Equivalence

ENDOSOLV (new device, K172839/S001) in relation to ENDOSOLV E (predicate device, K980633) the major difference is the ingredient tetrachloroethylene which has been replaced by Ethyl Acetate. The reason for the change is Tetrachloroethylene has concerns of toxicity. In addition, overall formulation quantities has been modified minimally between the predicate device and new device. This is due to ENDOSOL V (new device, K172839/S001) has been adjusted to account for the substitutional change in solvent from tetrachloroethylene to Ethyl Acetate.

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.