QMix™ 2in1 Endodontic Irrigating Solution is a premixed dual-action device that cleanses and disinfects the root canal system after endodontic instrumentation.

Device Description

QMix™ 2in1 Endodontic Irrigating Solution is a premixed dual-action device that cleanses and disinfects the root canal system by removing the smear layer and killing bacteria after endodontic instrumentation.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the QMix™ 2in1 Endodontic Irrigating Solution:

1. Table of Acceptance Criteria and Reported Device Performance

Based on the provided text, the device is a "Cleanser, Root Canal" and its indication for use is to "cleanse and disinfect the root canal system after endodontic instrumentation." The core of the submission relies on demonstrating substantial equivalence to a predicate device.

Acceptance Criterion	Reported Device Performance
Safety	- All components have been used in legally marketed devices and found safe for dental use.
	- Biocompatibility data provided.
Effectiveness/Performance	- Efficacy demonstrated via non-clinical in vitro and ex vivo studies.
	- Device "cleanses and disinfects the root canal system by removing the smear layer and killing bacteria after endodontic instrumentation," similar to the predicate device.
Substantial Equivalence	- Believed to be substantially equivalent to the cleared and marketed BioPure MTAD root canal cleanser based on prior use of components, performance, and biocompatibility data.

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

Sample Size: Not applicable. No clinical studies were conducted, meaning no test set of patient data was used.
Data Provenance: Not applicable. The studies mentioned are non-clinical (in vitro and ex vivo).

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

Number of Experts: Not applicable. No clinical studies were performed requiring expert ground truth establishment for a test set.
Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable. No clinical studies with a test set were conducted.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

MRMC Study: No. The document explicitly states: "No clinical studies were conducted on this device." Therefore, no MRMC study comparing human readers with and without AI assistance was performed.
Effect Size: Not applicable.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Standalone Study: Yes, in a sense, but not for an "algorithm" in the context of an AI device. The efficacy of the chemical solution itself was demonstrated through non-clinical in vitro and ex vivo studies. These studies evaluate the direct performance of the device (the irrigating solution) without human interpretation of images or data in a diagnostic context.

7. Type of Ground Truth Used

Type of Ground Truth: For the non-clinical in vitro and ex vivo studies, the "ground truth" would be established by scientific methods appropriate for laboratory assays, such as:
- Microbiological assays: To quantify bacteria killing.
- Electron microscopy or other imaging techniques: To assess smear layer removal.
- Chemical analysis: To confirm component presence, stability, and reaction kinetics.

8. Sample Size for the Training Set

Sample Size: Not applicable. This device is a chemical solution, not an AI/ML algorithm. Therefore, there is no "training set" in the context of machine learning. The term "training set" is typically used for data used to train an AI model.

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

How Ground Truth Was Established: Not applicable, as there is no training set for an AI/ML model.

Summary

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FEB 1 4 2011

K103244

Image /page/0/Picture/2 description: The image shows the word "DENTSPLY" in a bold, sans-serif font. The letters are all capitalized and black. The letters are tightly spaced, and the overall appearance is clean and modern. The image is likely a logo or branding element for a company named DENTSPLY.

SECTION 5. 510(k) SUMMARY

for

DENTSPLY International

World Headquarters Susquehanna Commerce Center 221 West Philadelphia Street ork. PA 17405-0872 717) 845-7511 (voice) 717) 849-4343 (fax) ww.dentsply.com

QMix™ 2in1 Endodontic Irrigating Solution

1. Submitter Information: DENTSPLY International Susquehanna Commerce Center 221 West Philadelphia Street York, PA 17405

Contact Person:	Helen Lewis
Telephone Number:	717-849-4229
Fax Number:	717-849-4343

01 February 2011 Date Prepared:

1. Device Name:
- Proprietary Name: .

Cleanser, Root Canal
CFR Number: .

Classification Name:

N/A Unclassified

Device Class: . Product Code: KJJ .
1. Predicate Device: BioPure MTAD Root Canal Cleanser, DENTSPLY International, K053167
Description of Device: 4.

റ് Indications for Use: QMix™ 2in1 Endodontic Irrigating Solution is a premixed dual-action device that cleanses and disinfects the root canal system after endodontic instrumentation.
Description of Safety and Substantial Equivalence: Q. Technological Characteristics.

All of the components found in QMix™ 2in1 Endodontic Irrigating Solution 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 QMix™ 2in1 Endodontic Irrigating Solution for the indicated uses.

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Non-Clinical Performance Data.

The efficacy and biocompatibility of QMix™ 2in1 Endodontic Irrigating Solution was demonstrated via non-clinical in vitro and ex vivo studies.

Clinical Performance Data.

No clinical studies were conducted on this device.

Conclusion as to Substantial Equivalence

QMix™ 2in1 Endodontic Irrigating Solution, to be manufactured by DENTSPL Y International, is substantially equivalent to the currently cleared and marketed BioPure MTAD root canal cleanser.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows a logo for the Department of Health & Human Services USA. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the circumference. To the right of the circle is a stylized symbol that resembles three abstract human figures or waves, stacked vertically.

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

Ms. Helen Lewis Director of Corporate Compliance and Regulatory Affairs DENTSPLY International Susquehanna Commerce Center 221 West Philadelphia Street York, Pennsylvania 17405

FFB 1 4 201

Re: K103244

Trade/Device Name: QMix" 2in1 Endodontic Irrigating Solution Regulatory Class: Unclassified Product Code: KJJ Dated: February 1, 2011 Received: February 2, 2011

Dear Ms. Lewis:

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- Ms. Lewis

Enclosure

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 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.

N for

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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SECTION 4. INDICATIONS FOR USE STATEMENT

510(k) Number (if known): K103244

Device Name: QMix™ 2in1 Endodontic Irrigating Solution

Indications for Use:

QMix™ 2in1 Endodontic Irrigating Solution is a premixed dual-action device that cleanses and disinfects the root canal system after endodontic instrumentation.

Prescription Use ____X (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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Buenger

(Division Sign-Off) (Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K102241

Regulation Number and Section

N/A