(77 days)
EPIEN ROOT CANAL CLEANSER is indicated for use as an adjunctive rinse of tooth root canal systems and adjacent tooth surfaces during standard professional dental procedures to enhance the removal of post-instrumentation dentinal debris and smear-layer within the root canal systems.
EPIEN ROOT CANAL CLEANSER is an aqueous, moderately viscous and dense solution that is used to irrigate root canals to provide a rinse to tooth surfaces as an adjunctive to professional mechanical dental procedures. The EPIEN ROOT CANAL CLEANSER is applied onto tooth root canal surfaces for a brief duration using standard dental irrigation syringes. It is then rinsed away with saline or water. EPIEN ROOT CANAL CLEANSER cleanses the root canal system by enhancing the removal of the post-instrumentation smear layer.
The EPIEN ROOT CANAL CLEANSER consists of hydroxybenzenesulfonic acid, hydroxymethoxybenzenesulfonic acid, sulfuric acid, and water, in addition to a colorant.
The provided text does not contain acceptance criteria related to a device's performance in a clinical or diagnostic setting, nor does it describe a study that directly proves the device meets such criteria.
This document is a 510(k) Summary for a medical device called "EPIEN ROOT CANAL CLEANSER." A 510(k) premarket notification is submitted to the FDA to demonstrate that the device is at least as safe and effective as a legally marketed device (predicate device). The evaluation focuses primarily on comparisons to predicate devices and results of non-clinical studies.
Here's an analysis of the provided text based on your request, highlighting what is and isn't present:
1. A table of acceptance criteria and the reported device performance
- Not Applicable. The document does not define specific "acceptance criteria" in terms of clinical performance metrics (e.g., sensitivity, specificity, accuracy, or a specific level of smear layer removal effectiveness in patients) that the device must meet. Instead, the performance data provided supports the safety and effectiveness for its intended use through various non-clinical studies.
2. Sample size used for the test set and the data provenance
- Animal Performance Testing (Test Set):
- Specific sample sizes for the animal studies (Canine Oral Mucosa Metabolism and IV ADME of c14-ERCC, Canine Vital Pulp ERCC Exposure Study, and Canine Periodontal tissue ERCC Exposure Study) are not provided in this summary.
- Data Provenance: The studies are described as "Animal Performance Testing." The country of origin is not specified, and they are inherently prospective in nature, as they are conducted specifically to test the device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. The studies described are primarily laboratory-based (in vitro, chemical/physical characterization, biocompatibility) and animal studies. There is no mention of human subject testing, clinical trials, or expert-based adjudication to establish a "ground truth" as would be relevant for a diagnostic device's clinical performance. The "ground truth" in these studies would be derived from the experimental results themselves (e.g., cytotoxicity levels, erosion measurements, biofilm disruption percentages in a lab setting, or histological findings in animal tissues).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. As no expert-based ground truth establishment or human reader study is described, there is no adjudication method mentioned.
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 cleanser for root canals, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not relevant and was not performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This device is a manual chemical cleanser, not an algorithm. Therefore, "standalone algorithm performance" is not relevant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For the biocompatibility studies, the "ground truth" would be established by standardized laboratory tests (e.g., ISO 10993-1 methods) that objectively measure cytotoxicity, sensitization, mutagenicity, irritation, and intracutaneous reactivity.
- For chemical and physical characterization studies, the "ground truth" is determined by established analytical methods (e.g., chromatographic analyses, acid titration, viscosity measurements, enamel and dentin erosion assays).
- For in vitro microbial biofilm disruption assays, the "ground truth" would be quantitative measurements of biofilm reduction or removal using laboratory techniques.
- For animal performance testing, the "ground truth" would be derived from physiological measurements, histological examinations of tissues, and pharmacokinetic/pharmacodynamic analyses in the animal models, interpreted by veterinary pathologists or relevant specialists.
8. The sample size for the training set
- Not Applicable. The device is not an AI/machine learning model, so there is no concept of a "training set" in the context of its development or validation.
9. How the ground truth for the training set was established
- Not Applicable. As there is no training set, this question is not relevant.
Summary of Device Performance Data Provided (not an acceptance criteria table):
| Study Type | Reported Performance / Findings |
|---|---|
| Overall Performance Claim | The performance data support the safety and effectiveness of the EPIEN ROOT CANAL CLEANSER. Studies demonstrate the product is safe and effective for its intended use, citing its mechanical rinsing action and desiccation effects. |
| Biocompatibility Studies | Product is non-toxic, non-sensitizing, a non-irritant, and non-mutagenic (in accordance with ISO 10993-1). |
| 36-month real-time stability/shelf-life studies | (Implied successful demonstration of stability over 36 months, but specific results not detailed). |
| Chemical & Physical Characterization | (Specific results not detailed, but studies included Chromatographic Analyses, Acid Titration Curve/Total Acidity, Viscosity, Hygroscopicity, Exothermia on Solvation, Enamel and Dentin Erosion Assays, contributing to overall safety and effectiveness profile). |
| In vitro microbial biofilm disruption assays | (Specific results not detailed, but studies included Disclosing Solution Demonstration, MBEC Assays, Dental root canal and root surface rinse test, demonstrating biofilm disruption capabilities). |
| Animal Performance Testing | (Specific results not detailed, but studies included Canine Oral Mucosa Metabolism and IV ADME of c14-ERCC*, Canine Vital Pulp ERCC Exposure Study, and Canine Periodontal tissue ERCC Exposure Study, demonstrating performance and safety in a biological model). |
| Adverse Event Reporting | No specific adverse events reported in the summary, but the FDA approval letter reminds the applicant of requirements for medical device reporting. |
Note: c14-ERCC likely refers to a ¹⁴C-labeled version of the "EPIEN ROOT CANAL CLEANSER" for metabolic and distribution studies.
In conclusion, the provided document focuses on premarket notification requirements, establishing substantial equivalence to predicate devices through non-clinical laboratory and animal studies, not on clinical performance criteria or studies in human subjects often associated with AI/ML devices.
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510(k) Summary for EPIEN ROOT CANAL CLEANSER
FEB 0 1 2013
| Submitter/Holder | EPIEN Medical, Inc.4225 White Bear ParkwaySuite 600St. Paul, MN 55110-3389 |
|---|---|
| Contact Person | Reginald DupreCEOEPIEN Medical, Inc.4225 White Bear ParkwaySuite 600St. Paul, MN 55110Ph: 651.653.3380 ext.102Fax: 651.653.8569Email:rdupre@epien.com |
| Date Prepared | November 13, 2012 |
| Trade Name | EPIEN ROOT CANAL CLEANSER |
| Common Name | Tooth Root Canal Cleanser |
| ClassificationName | Root Canal Cleanser, Unclassified |
| Predicate Devices | K063703, Ultradent Products Ultradent Citric Acid 20% Solution K053167, DENTSPLY International Biopure™ MTAD™ Root Canal Cleanser K061689, PuriCore, Inc Aquatine™ EC Endodontic Cleanser |
| DeviceDescription | EPIEN ROOT CANAL CLEANSER is an aqueous, moderately viscous and dense solution that is usedto irrigate root canals to provide a rinse to tooth surfaces as an adjunctive to professional mechanicaldental procedures. The EPIEN ROOT CANAL CLEANSER is applied onto tooth root canal surfacesfor a brief duration using standard dental irrigation syringes. It is then rinsed away with saline or water.EPIEN ROOT CANAL CLEANSER cleanses the root canal system by enhancing the removal of thepost-instrumentation smear layer.The EPIEN ROOT CANAL CLEANSER consists of hydroxybenzenesulfonic acid,hydroxymethoxybenzenesulfonic acid, sulfuric acid, and water, in addition to a colorant. |
| Intended Use | EPIEN ROOT CANAL CLEANSER is indicated for use as an adjunctive rinse of tooth root canalsystems and adjacent tooth surfaces during standard professional dental procedures to enhance theremoval of post-instrumentation dentinal debris and smear-layer within the root canal systems. |
| Characteristics | EPIEN ROOT CANAL CLEANSER improves the thoroughness of mechanical cleaning procedures byproviding a mechanical rinsing action to the surfaces of the tooth root. EPIEN ROOT CANALCLEANSER also provides superficial dehydration of material in instrumented tooth root canal systemson contact. This causes reduction of the attachment of dentinal debris and the smear layer to toothsurfaces. This disruption assists with the removal of the smear layer. |
| Performance Data | The performance data provided support the safety and effectiveness of the EPIEN ROOT CANAL |
| mechanical rinsing action of the product and desiccation effects. The studies demonstrate that theproduct is safe and effective for its intended use. Biocompatibility studies indicate that the product isnon-toxic, non-sensitizing, a non-irritant, and non-mutagenic.The following studies were conducted:• 36-month real-time stability/shelf-life studies• Biocompatibility studies in accordance with ISO 10993-1 (cytotoxicity, sensitization, mutagenicity,irritation, and intracutaneous reactivity)• Chemical and physical characterization studies (Chromatographic Analyses, Acid TitrationCurve/Total Acidity, Viscosity, Hygroscopicity, Exothermia on Solvation, Enamel and DentinErosion Assays)• In vitro microbial biofilm disruption assays (Disclosing Solution Demonstration, MBEC Assays,Dental root canal and root surface rinse test)• Animal Performance Testing (Canine Oral Mucosa Metabolism and IV ADME of c14-ERCC,Canine Vital Pulp ERCC Exposure Study, and Canine Periodontal tissue ERCC Exposure Study) | |
| PredicatesComparison | The proposed device is substantially equivalent to the currently cleared and marketed devices. TheEPIEN ROOT CANAL CLEANSER is equivalent in intended use, design characteristics, and method of application to predicate devices.The composition of the EPIEN ROOT CANAL CLEANSER represents a different technology from the predicates in that it is composed of an aqueous solution of sulfonated aromatics and free sulfuric acid.The questions of safety and effectiveness that have applied to the predicates also apply to the EPIEN ROOT CANAL CLEANSER in an identical manner. The results from biocompatibility, bench, and animal studies demonstrate that any differences between the EPIEN ROOT CANAL CLEANSER and the predicate devices do not constitute a new intended use, affect safety or effectiveness, or raise different questions of safety and effectiveness.The information submitted in this 510(k) support a determination of Substantial Equivalence for the EPIEN ROOT CANAL CLEANSER product. |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
February 1, 2013
Epien Medical, Incorporated C/O Mr. Jeffery K. Shapiro Director Hyman Phelps & McNamara. P.C. 700 Thirteenth Street, North West, Suite 200 WASHINGTON DC 20005
Re: K123538
Trade/Device Name: Epien Root Canal Cleanser Regulation Number: Unclassified Regulation Name: Root Canal Cleanser Regulatory Class: Unclassified Product Code: KJJ Dated: November 16, 2012 Received: November 16, 2012
Dear Mr. Shapiro:
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 (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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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,
Anthong ls m
Anthony D. Watson, B.S., M.S., M.B.A. 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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EPIEN MEDICAL. INC. EPIEN ROOT CANAL CLEANSER Original Premarket 510(k) Notification
Volume 001 File 006
Indications for Use
510(k) Number (if known): K123538
Device Name: EPIEN ROOT CANAL CLEANSER
Indications for Use: EPIEN ROOT CANAL CLEANSER is indicated for use as an adjunctive rinse of tooth root canal systems and adjacent tooth surfaces during standard professional dental procedures to enhance the removal of post-instrumentation dentinal debris and smear-layer within the root canal systems.
Prescription Use XXX (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 OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Andrew I. Steen 2013.02.01 10:09:42 -05'00'
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number:
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