(50 days)
Not Found
No
The device description and performance studies focus on the chemical properties and efficacy of an aqueous solution for root canal irrigation, with no mention of AI or ML technology.
Yes
The device is intended to cleanse and disinfect root canal systems, which aligns with the definition of a therapeutic device as it is treating a condition (infection/debris in the root canal).
No
The device is described as an aqueous solution for cleansing and disinfecting root canal systems, not for diagnosing a condition or disease. Its intended use is to "cleanse and disinfect root canal systems after endodontic instrumentation," which is a treatment rather than a diagnostic function.
No
The device description explicitly states that Irritrol™ is an "aqueous solution," indicating it is a liquid chemical substance, not software. The performance studies also focus on the properties of this solution (biocompatibility, antimicrobial activity, smear layer removal).
Based on the provided information, this device is NOT an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "cleanse and disinfect root canal systems after endodontic instrumentation." This is a procedure performed on the patient's body (specifically, within the root canal), not on a sample taken from the body for diagnostic purposes.
- Device Description: The description confirms it's an "aqueous solution for use during the irrigation phase of endodontic root canal preparation procedures." This further reinforces its use within the patient's body during a treatment procedure.
- Lack of Diagnostic Purpose: There is no mention of the device being used to diagnose a condition, measure a substance in a sample, or provide information about a patient's health status based on analysis of a biological sample.
IVDs are devices used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnostic, monitoring, or compatibility purposes. Irritrol™ does not fit this definition. It is a therapeutic/procedural device used during a dental treatment.
N/A
Intended Use / Indications for Use
Irritrol™ is intended to cleanse and disinfect root canal systems after endodontic instrumentation.
Product codes (comma separated list FDA assigned to the subject device)
KJJ
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
root canal systems
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
N/A
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. 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 a stylized human figure in profile, with three faces overlapping to create a sense of depth and connection. The logo is presented in black and white.
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 Irrigating |
| Solution | ||
| Manufacturer | Essential Dental Systems | Dentsply International |
| Intended Use | Cleanses and disinfects root | |
| canal systems | Cleanses and disinfects the root | |
| canal system | ||
| Physical | ||
| Properties | Clear, green, odorless liquid | |
| solution | Clear, colorless, odorless liquid | |
| solution | ||
| 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.