(54 days)
Not Found
No
The device description and performance studies focus on the chemical properties and physical performance of an EDTA solution, with no mention of AI or ML.
No
The device is a solution used to clean root canals, not directly treat a disease or condition in a therapeutic manner. It facilitates the removal of debris, serving an adjunctive role rather than a primary therapeutic one.
No
The device is described as a "root canal cleanser" intended to "facilitate removal of dentinal debris" and "remove the smear layer produced from root canal instrumentation." Its function is therapeutic/procedural, not diagnostic.
No
The device description clearly states that the device is an "EDTA solution in water with surfactant," which is a chemical substance, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "facilitate removal of dentinal debris from the walls of root canals prior to obturation." This is a therapeutic or procedural use, not a diagnostic one. IVDs are used to examine specimens derived from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The description states it's a "root canal cleanser for use in endodontic procedures." This further reinforces its role in a dental procedure, not in analyzing biological samples for diagnostic purposes.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples, detecting biomarkers, or providing diagnostic information.
Therefore, based on the provided text, PacEndo™ EDTA is a medical device used in endodontic procedures, but it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
PacEndo™ EDTA is intended to facilitate removal of dentinal debris from the walls of root canals prior to obturation.
Product codes (comma separated list FDA assigned to the subject device)
KJJ
Device Description
PacEndo™ EDTA is an EDTA solution in water with surfactant to lower surface tension. The solution is a root canal cleanser for use in endodontic procedures to remove 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 canals
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)
Non-Clinical Tests:
Surface tension test using contact angle measurement was performed in comparison to the predicate device.
A biocompatibility assessment and risk analysis were conducted and the results demonstrated that no biocompatibility testing was needed to demonstrate biocompatibility of the device for the intended use.
Clinical Performance Test:
No clinical testing was provided.
Summary of Non-Clinical and Clinical Performance Testing:
The subject device was found to have similar surface tension compared to the predicate device and can be used as intended.
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.
EDTA Plus (K072555)
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 & Human Services. The logo consists of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". Inside the circle is a symbol that resembles three stylized human profiles facing to the right, with flowing lines beneath them.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 1, 2016
Pac-dent International, Inc. Mr. Wenying Zhu Materials Engineer 670 Endeavor Circle Brea, California 92821
Re: K153528
Trade/Device Name: PacEndo™ EDTA Regulation Number: 21 CFR Regulatory Class: Unclassified Product Code: KJJ Dated: December 2, 2015 Received: December 9, 2015
Dear Mr. Zhu:
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.
1
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 (OS) 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 Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education 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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Image /page/2/Picture/0 description: The image shows the logo for PacDent. The logo features the text "PacDent" in a bold, blue font. Above the text is an orange swoosh. To the right of the main logo is the text "Pac-De" in a smaller, gray font.
Pac-Dent International, Inc.
Section III
Indications for Use Statement
510(k) Number (if known): _ K153528
Device Name: _ PacEndo™EDTA
Indications for Use:
PacEndo™ EDTA is intended to facilitate removal of dentinal debris from the walls of root canals prior to obturation.
OR
Prescription Use _______________
C
Over-The-Counter Use
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Pac-Dent International, Inc.
510(k) Summary
510(k) Number: K153528
Submitter:
Pac-Dent International, Inc. 670 Endeavor Circle Brea, CA 92821
Contact Person:
Wenying Zhu Materials Engineer 909-839-0888 ext.111
Date Summary Prepared:
December 2015
Device Name Trade Name: PacEndo™ EDTA Common Name: Endodontic Cleanser Device Classification: Unclassified Classification Product Code: KJJ Classification Name: Cleanser, Root Canal Predicate Device EDTA Plus (K072555)
Description of Device
PacEndo™ EDTA is an EDTA solution in water with surfactant to lower surface tension. The solution is a root canal cleanser for use in endodontic procedures to remove the smear layer produced from root canal instrumentation.
Indications for Use
PacEndo™ EDTA is intended to facilitate removal of dentinal debris from the walls of root canals prior to obturation.
Image /page/3/Picture/16 description: The image shows four different logos. The first logo is the FDA logo, which is gray and has the letters FDA in a stylized font. The second logo is the CE logo, which is blue and has the letters CE in a simple font. The third logo is the DTA logo, which is blue and has the letters DTA in a stylized font inside of a circle. The fourth logo is the OSAP logo, which is green and has the letters OSAP in a stylized font with the words "Because Safety Matters" below it and ".org" to the right.
IV-1
4
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| Comparison of Technological Characteristics | |||
|---|---|---|---|
| Descriptive | |||
| Information | Subject Device | Predicate Device | Summary |
| Indications for | |||
| Use | PacEndo™ EDTA | EDTA Plus (K072555) | |
| PacEndo™ EDTA is intended to | |||
| facilitate removal of dentinal | |||
| debris from the walls of root | |||
| canals prior to obturation. | EDTA Plus is a root canal cleanser | ||
| designed to facilitate removal of | |||
| dentinal debris from the walls of | |||
| root canals prior to obturation. | The indications for | ||
| use of the subjective | |||
| and predicate | |||
| devices are the | |||
| same. | |||
| Composition of | |||
| Materials | EDTA | ||
| Buffer | |||
| Surfactant | EDTA | ||
| Buffer | |||
| Surfactant | The composition of | ||
| subject and predicate | |||
| devices is different. | |||
| However, the | |||
| functions of the | |||
| ingredients are the | |||
| same. | |||
| The difference | |||
| between the | |||
| composition of the | |||
| subject and predicate | |||
| devices doesn't affect | |||
| the substantial | |||
| equivalent of the | |||
| subject and predicate | |||
| devices. | |||
| Performance | Appearance: clear liquid | ||
| pH: 7.56 | Appearance: light peach color | ||
| liquid | |||
| pH: 7.55 | The appearances of | ||
| the subject and | |||
| predicate devices are | |||
| not the same. | |||
| However, it doesn't | |||
| affect the substantial | |||
| equivalent of the | |||
| subject and predicate | |||
| devices. |
Comparison of Technological Characteristics
Based on the above comparisons, Pac-Dent concludes that the subject device is substantially
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1
IV-2
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equivalent in intended use, composition and performance to the predicate device.
Non-Clinical Tests
Surface tension test using contact angle measurement was performed in comparison to the predicate device.
A biocompatibility assessment and risk analysis were conducted and the results demonstrated that no biocompatibility testing was needed to demonstrate biocompatibility of the device for the intended use.
Clinical Performance Test
No clinical testing was provided.
Summary of Non-Clinical and Clinical Performance Testing_
The subject device was found to have similar surface tension compared to the predicate device and can be used as intended.
Conclusion
In summary, non-clinical performance testing demonstrates that PacEndo™ EDTA is substantially equivalent to the identified predicate product for its intended use.
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