(113 days)
EDS Combo-Rinse is intended to cleanse root canal systems by irrigating root canals.
EDS Combo-Rinse is an aqueous solution for use during the irrigation phase of endodontic root canal preparation procedures. The device has a dual purpose of flushing out any loosened debris and removing the smear layer produced from root canal instrumentation.
The provided text describes a 510(k) summary for the EDS Combo-Rinse device, which is an aqueous solution for use during root canal preparation. The submission focuses on demonstrating substantial equivalence to a predicate device (QMix™ 2in1 Endodontic Irrigating Solution). Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" are framed in terms of equivalence to the predicate device, rather than independent performance metrics defined specifically for EDS Combo-Rinse.
Here's the breakdown of the information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (based on predicate device equivalence) | Reported Device Performance (for EDS Combo-Rinse) |
|---|---|
| Biocompatibility equivalent to predicate device (QMix™ 2in1 Endodontic Irrigating Solution) | Demonstrated equivalence to the predicate device in five biocompatibility tests according to ISO 10993. |
| Smear layer removal performance equivalent to predicate device (QMix™ 2in1 Endodontic Irrigating Solution) | Demonstrated equivalence to the predicate device in smear layer removal performance. |
| Safety equivalent to legally marketed devices containing the same components | Prior use of components in legally marketed devices (including predicate devices with common components) supports safety. |
| Effectiveness equivalent to legally marketed devices containing the same components | Prior use of components in legally marketed devices (including predicate devices with common components) supports effectiveness. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state sample sizes for the biocompatibility or smear layer removal testing.
Regarding data provenance:
- The tests were conducted to determine equivalence to the predicate device.
- The document implies these were non-clinical tests.
- Country of origin is not specified but is assumed to be part of the manufacturer's testing process.
- The studies were retrospective in the sense that they compared the new device to existing predicate devices, but the testing itself would have been prospective for the EDS Combo-Rinse samples.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. The "ground truth" here is the established safety and performance profile of the predicate device and the accepted standards (ISO 10993). There is no mention of human experts establishing ground truth for a test set in the context of device performance. The assessment is based on laboratory test results against established benchmarks.
4. Adjudication Method for the Test Set
Not applicable. There was no explicit adjudication method for a test set described, as the evaluation was based on objective, standardized tests (biocompatibility according to ISO 10993, and smear layer removal testing).
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. This type of study is not relevant for a root canal irrigating solution and was not performed. The device is a physical/chemical irrigant, not an imaging or diagnostic AI tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, in a sense. The biocompatibility and smear layer removal tests are standalone evaluations of the device's physical and chemical properties and performance, without human intervention in the device's function during testing. This is a "device only" performance assessment.
7. The Type of Ground Truth Used
The ground truth used for comparison was:
- Established performance of the predicate device: QMix™ 2in1 Endodontic Irrigating Solution, particularly its biocompatibility and smear layer removal capabilities.
- International standards: ISO 10993 for biocompatibility testing.
- Regulatory precedence: The fact that components have been "used in legally marketed devices and were found safe for dental use."
8. The Sample Size for the Training Set
Not applicable. This device is not an AI/ML algorithm that requires a training set. The term "training set" is not relevant to this type of device submission.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this device.
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Image /page/0/Picture/0 description: The image shows the logo for Essential Dental Systems. The logo is inside of a rounded rectangle. The letters "EDS" are in bold, black font on the left side of the logo, and the words "ESSENTIAL DENTAL SYSTEMS" are in a smaller, black font on the right side of the logo. There is a registered trademark symbol in the upper right corner of the logo.
K1408446 1111 2 5 2014
( € APPROVED PRODUCTS
89 Leuning Street S. Hackensack New Jersey 07606
1(800) 22-FLEXI Tel .: (201) 487-9090 Fax: (201) 487-5120
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.
-
- Submitter's Identification:
Essential Dental Systems 89 Leuning Street South Hackensack, NJ 07606
- Submitter's Identification:
Date Summary Prepared: July 1, 2014
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: EDS Combo-Rinse Common name: Cleanser, Root Canal CFR Number: N/A Device class: Unclassified Product Code: KJJ
3. Predicate Device Information:
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- QMix™ 2in1 Endodontic Irrigating Solution, Dentsply International, K103244
-
- Etch-37TM, Bisco Inc., K101485
-
- MicroPrime B, Danville Engineering Inc., K953504
4. Device Description:
EDS Combo-Rinse is an aqueous solution for use during the irrigation phase of endodontic root canal preparation procedures. The device has a dual purpose of flushing out any loosened debris and removing the smear layer produced from root canal instrumentation.
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5. Intended Use:
EDS Combo-Rinse is a device that cleanses root canal systems by irrigating root canals.
6. Comparison to Predicate Devices:
A comparison of EDS Combo-Rinse and the 510(k) cleared QMix™ 2in1 Endodontic Irrigating Solution indicates the following similarities and differences to the device which received 510(k) clearance:
EDS Combo-Rinse is similar to the predicate device QMix™ 2in1 Endodontic Irrigating Solution in that they are both aqueous solutions intended as endodontic irrigants to clean the root canal system and remove the smear layer. Two active ingredients contained in the proposed device are also found in the predicate device.
EDS Combo-Rinse is different from the predicate device QMix™ 2in1 Endodontic Irrigating Solution in that the proposed device does not disinfect the root canal. The proposed device also differs from the predicate device 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 EDS Combo-Rinse for the indicated uses.
7. Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence are as Follows:
Biocompatibility testing and smear laver removal testing was conducted to determine equivalence of EDS Combo-Rinse to the predicate device QMix™ 2in1 Endodontic Irrigating Solution.
The results of five biocompatibility tests according to ISO 10993 demonstrate equivalence in safety to the predicate device.
The smear layer removal testing performance data demonstrates equivalence in performance to the predicate device.
8. Discussion of Clinical Tests Performed:
Not Applicable
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9. Conclusions:
EDS Combo-Rinse is substantially equivalent to the currently cleared and marketed QMix™ 2in1 Endodontic Irrigating Solution.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/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 caduceus or a 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 20993-0002
July 25, 2014
Essential Dental Systems, Inc. Mr. Jeffrey Wan Research and Development Manager 89 Leuning Street South Hackensack, NJ 07606
Re: K140846
Trade/Device Name: EDS Combo-Rinse Product Code: KJJ Regulatory class: unclassified Dated: July 1, 2014 Received: July 1, 2014
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. 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/ResourcesforYou/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.
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Mary S. Runner -S
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
Page _1_of _1
510(k) Number (if known): K140846
Device Name: EDS Combo-Rinse
Indications for Use:
EDS Combo-Rinse is intended to cleanse root canal systems by irrigating root canals.
Prescription Use X (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)
Sheena A. Green -S 2014.07.28 08:44:34 -04'00'
N/A