(50 days)
Irritrol™ is intended to cleanse and disinfect root canal systems after endodontic instrumentation.
Irritrol™ is an aqueous solution for use during the irrigation phase of endodontic root canal preparation procedures. This multi-purpose device disinfects the root canal, flushes out any loosened debris, and removes the smear layer produced from root canal instrumentation.
The provided text describes the submission for a medical device (Irritrol™) to the FDA for a 510(k) premarket notification. This type of submission aims to demonstrate substantial equivalence to a legally marketed predicate device, rather than proving novel effectiveness through clinical trials. As such, the information you're requesting regarding acceptance criteria and a study proving a device meets those criteria, particularly in the context of an AI device with specific performance metrics, is not directly applicable to this document.
However, I can extract the information that is present and frame it in a way that aligns with your request where possible, while clearly indicating when specific aspects (like AI performance metrics or human reader studies) are not pertinent to this traditional medical device submission.
Here's an analysis based on the provided text:
Device: Irritrol™ (Root Canal Cleanser)
Purpose of Submission: Demonstrate substantial equivalence to a predicate device (QMix™ 2in1 Endodontic Irrigating Solution) for regulatory clearance, not to prove meeting specific performance criteria for an AI algorithm.
1. Table of Acceptance Criteria and Reported Device Performance
For this type of device (a chemical solution), "acceptance criteria" and "device performance" are typically related to its physical properties, biocompatibility, and intended functions (antimicrobial activity, smear layer removal) compared to its predicate. There isn't a direct "acceptance criteria" in the sense of accuracy, sensitivity, or specificity as one would find for an AI diagnostic tool.
| Acceptance Criteria (Implied from Predicate Comparison & Testing) | Reported Device Performance (Irritrol™) |
|---|---|
| Safety: Biocompatibility | Demonstrates equivalence in safety to the predicate device per ISO 10993 (results of five biocompatibility tests). |
| Efficacy (Antimicrobial): Ability to suppress Enterococcus faecalis growth | Demonstrates equivalence in ability to suppress Enterococcus faecalis growth compared to predicate (comparative in vitro antimicrobial testing). |
| Efficacy (Smear Layer Removal): Ability to remove smear layer from instrumented root canals | Demonstrates equivalence in ability to remove smear layer from instrumented root canals compared to predicate (comparative smear layer removal testing). |
| Physical Properties: | Clear, green, odorless liquid solution |
| - pH | Slightly basic solution |
| - Shelf Life | 2 years |
| Intended Use: Cleanses and disinfects root canal systems | Intended to cleanse and disinfect root canal systems after endodontic instrumentation (identical to predicate). |
2. Sample Size Used for the Test Set and Data Provenance
This information is not directly provided in the submission summary. The non-clinical tests were "in vitro," meaning conducted in a lab setting, not on human patients. Therefore, terms like "test set" in the context of patient data or data provenance (country of origin, retrospective/prospective) are not applicable.
- Sample Size: Not specified for the in vitro tests (e.g., number of bacterial cultures, number of teeth/root canals tested).
- Data Provenance: Not applicable as these were laboratory tests (in vitro), not human data.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This is not applicable to the submitted document. Ground truth for an AI device involves expert consensus on medical images or clinical outcomes. For this chemical solution, "ground truth" relates to the objective outcomes of the in vitro tests (e.g., bacterial growth measurements, microscopic evaluation of smear layer removal), which are typically determined by laboratory methods and instrumentation, not expert human interpretation in the sense of diagnostic imaging.
4. Adjudication Method
Not applicable. Adjudication methods (e.g., 2+1, 3+1) are used for resolving discrepancies among human experts in establishing ground truth for diagnostic decisions, which is not relevant for this device.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No. An MRMC study is designed for AI-assisted diagnostic devices to assess how the AI impacts human reader performance. This device is a chemical solution used in a procedure, not a diagnostic tool read by humans.
6. If a Standalone (Algorithm Only) Performance Study Was Done
Again, this is not applicable. This device is not an algorithm. The performance studies mentioned (biocompatibility, antimicrobial, smear layer removal) assess the chemical properties and effects of the solution itself, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the non-clinical tests would have been established through:
- Biocompatibility: Standardized toxicological endpoints as per ISO 10993 (e.g., cell viability, irritation indices).
- Antimicrobial testing: Direct measurement of bacterial growth/inhibition (e.g., colony counts, zones of inhibition).
- Smear layer removal testing: Likely microscopic evaluation (e.g., SEM) of instrumented root canal walls to assess the presence or absence of smear layer.
This is objective, laboratory-based measurement, not expert consensus on diagnostic images or clinical outcomes.
8. The Sample Size for the Training Set
Not applicable. This device does not involve an AI algorithm, and therefore there is no "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no AI algorithm or training set for this device.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 25, 2015
Essential Dental Systems, Inc Mr. Jeffrey Wan Research and Development Manager 89 Leuning Street. Suite 8 South Hackensack, NJ 07606
Re: K150020
Trade/Device Name: IrritroI™ Regulation Name: Cleanser, Root Canal Regulatory Class: Unclassified Product Code: KJJ Dated: December 22, 2014 Received: January 06, 2015
Dear Mr. Wan:
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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Page 2 - Mr. Jeffery Wan
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/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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Section 4 - Indications for Use
510(k) Number K150020
Device Name: IrritroI™
Indications for Use:
Irritrol™ is intended to cleanse and disinfect root canal systems after endodontic instrumentation.
Prescription Use × (Per 21 CFR 801 Subpart D)
OR
Over the Counter Use (Per 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)
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K150020
Section 5 - 510(k) Summary
This summary of the 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
1. Submitter's Identification:
Essential Dental Systems 89 Leuning Street South Hackensack, NJ 07606
Date Summary Prepared: December 22, 2014 Date Summary Revised: February 11, 2015
Contact: Mr. Jeffrey Wan Contact Email: jwan@edsdental.com Contact Phone #: 201-487-9090 ext. 118 Contact Fax #: 201-487-5120
2. Name of the Device:
Trade name: IrritroI™ Common name: Cleanser, Root Canal CFR Number: N/A Device class: Unclassified Product Code: KJJ
3. Predicate Device Information:
- QMix 10 2in1 Endodontic Irrigating Solution, Dentsply International, K103244
4. Device Description:
Irritrol™ is an aqueous solution for use during the irrigation phase of endodontic root canal preparation procedures. This multi-purpose device disinfects the root canal, flushes out any loosened debris, and removes the smear layer produced from root canal instrumentation.
5. Intended Use:
Irritrol 110 is intended to cleanse and disinfect root canal systems after endodontic instrumentation.
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6. Comparison to Predicate Devices:
A comparison of Irritrol™ and the 510(k) cleared QMix™ 2in1 Endodontic Irrigating Solution indicates the following similarities and differences to the device which received 510(k) clearance:
Irritrol™ is similar to the predicate device QMix™ 2in1 Endodontic Irrigating Solution in that they are both aqueous solutions intended as endodontic irrigants to cleanse and disinfect root canal systems. Two active ingredients contained in the proposed device are also found in the predicate device.
Irritrol 100 is different from the predicate device QMix 100 2in1 Endodontic Irrigating Solution in the secondary components in their respective formulations.
All of the components found in the predicate devices have been used in legally marketed devices and were found safe for dental use. We believe that prior use of components in legally marketed devices, the performance and biocompatibility data provided support the safety and effectiveness of Irritrol™ for the indicated uses.
| Proposed Device | Predicate Device | |
|---|---|---|
| 510(k) | K150020 | K103244 |
| Device Name | IrritrolTM | QMixTM 2in1 Endodontic IrrigatingSolution |
| Manufacturer | Essential Dental Systems | Dentsply International |
| Intended Use | Cleanses and disinfects rootcanal systems | Cleanses and disinfects the rootcanal system |
| PhysicalProperties | Clear, green, odorless liquidsolution | Clear, colorless, odorless liquidsolution |
| pH | Slightly basic solution | Slightly basic solution |
| Shelf Life | 2 years | 2 years |
7. Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence are as Follows:
Biocompatibility testing, in vitro antimicrobial testing, and smear layer removal testing were conducted to determine equivalence of Irritrol "" to the predicate device QMix 100 2in1 Endodontic Irrigating Solution.
The results of five biocompatibility tests according to ISO 10993 demonstrate equivalence in safety to the predicate device.
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The results of comparative in vitro antimicrobial testing between Irritrol™ and QMix™ demonstrate equivalence in their ability to suppress the growth of Enterococcus faecalis.
The results of comparative smear layer removal testing between Irritrol™ and QMix™ demonstrate equivalence in their ability to remove smear layer from instrumented root canals.
8. Discussion of Clinical Tests Performed:
Not Applicable
9. Conclusions:
Irritrol™ is substantially equivalent to the currently cleared and marketed QMix™ 2in1 Endodontic Irrigating Solution.
N/A