(146 days)
Not Found
No
The 510(k) summary describes a chemical solution for root canal irrigation and cleansing, with no mention of AI or ML technology.
No
The device is a root canal cleanser, which is used for irrigation and cleansing after endodontic instrumentation, not for treating or curing a disease or condition. Its function is to facilitate the dental procedure.
No
Explanation: The device is described as a root canal cleanser intended to irrigate and cleanse root canal systems after endodontic instrumentation. It does not perform any diagnostic function such as detecting, monitoring, or predicting disease.
No
The device description clearly states it is a "2% Chlorhexidine Gluconate solution in water with surfactant," which is a chemical substance, not software.
Based on the provided information, PacEndo™ Chlorhexidine is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "irrigate and cleanse 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 patient's body for diagnostic purposes.
- Device Description: The description confirms it's a solution for use in endodontic procedures, which are clinical treatments.
- Lack of Diagnostic Elements: There is no mention of analyzing samples, detecting substances, or providing diagnostic information about a patient's condition.
IVDs are devices used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnostic, monitoring, or screening purposes. PacEndo™ Chlorhexidine is a therapeutic/procedural device used directly in a clinical setting.
N/A
Intended Use / Indications for Use
PacEndo™ Chlorhexidine is intended to irrigate and cleanse root canal systems after endodontic instrumentation.
Product codes (comma separated list FDA assigned to the subject device)
KJJ
Device Description
PacEndo™ Chlorhexidine is a 2% Chlorhexidine Gluconate solution in water with surfactant to lower surface tension. The solution is root canal cleanser for use in endodontic procedures.
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)
Comparative testing was done to the noted predicate device for both pH and surface contact angle. The results of the comparative testing demonstrate that the subject device performs as well as the noted predicate in the surface contact angle testing and that both devices share similar pH values.
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.
CHX and CHX-Plus™ (K112250)
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 seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, overlapping each other to create a sense of depth and connection. The profiles are rendered in a simple, line-art style.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 25, 2016
Pac-Dent International, Inc. Ms. Wenying Zhu Materials Engineer 670 Endeavor Circle Brea, California 92821
Re: K160577
Trade/Device Name: PacEndo™ Chlorhexidine Regulation Number: n/a Regulation Name: n/a Regulatory Class: Unclassified Product Code: KJJ Dated: June 8, 2016 Received: June 15, 2016
Dear Ms. 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 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 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/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 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,
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
2
Indications for Use
510(k) Number (if known) K160577
Device Name PacEndo Chlorhexidine
Indications for Use (Describe)
PacEndo Chlorhexidine is intended to irrigate and cleanse root canal systems after endodontic instrumentation.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Image /page/3/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 that curves over the word. The logo is simple and clean, with a focus on the company name.
Pac-Dent International, Inc.
Section IV
510(k) Summary
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:
Feb 19 2016
Device Name
Trade Name: PacEndo™ Chlorhexidine Common Name: Endodontic Cleanser Device Classification: Unclassified Classification Product Code: KJJ Classification Name: Cleanser, Root Canal Predicate Device CHX and CHX-Plus™ (K112250)
Description of Device
PacEndo™ Chlorhexidine is a 2% Chlorhexidine Gluconate solution in water with surfactant to lower surface tension. The solution is root canal cleanser for use in endodontic procedures.
Indications for Use
PacEndo™ Chlorhexidine is intended to irrigate and cleanse root canal systems after endodontic instrumentation.
Comparison of Technological Characteristics
4
Image /page/4/Picture/0 description: The image shows the logo for Pac-Dent International, Inc. The logo features the word "PacDent" in a bold, blue font, with an orange swoosh above it. To the right of "PacDent" is the text "Pac-Dent International, Inc." in a smaller, gray font. The logo is simple and professional, and it is likely used on the company's website, marketing materials, and products.
| Descriptive
Information | Subject Device
PacEndo™ Chlorhexidine | Predicate Device
CHX and CHX-Plus™ (K112250) | Summary |
|-----------------------------|--------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for
Use | PacEndo™ Chlorhexidine is
intended to irrigate and cleanse
root canal systems after
endodontic instrumentation. | CHX and CHX-Plus™ are used as
a final endodontic rinse after
instrumentation to irrigate and
cleanse the root canal system for
long lasting cleansing | Although the wording is not
identical, both devices are used
for endodontic procedures to
irrigate and cleanse the root
canal. |
| Composition of
Materials | Chlorhexidine Gluconate
Surfactant | Chlorhexidine Gluconate
Surfactant
Colorant | The functions of the ingredients in
subject and predicate devices are
the same. |
| Performance | Appearance: clear to light
yellow liquid
pH Testing
Surface Contact Angle Testing | Appearance: clear to light blue
liquid
pH Testing
Surface Contact Angle Testing | The difference between the
appearances of the subject and
predicate devices doesn't affect
the substantial equivalent of the
subject and predicate devices. |
Based on the above comparisons, Pac-Dent concludes that the subject device is substantially equivalent in intended use, composition and performance to the predicate device.
Non-Clinical Tests
Comparative testing was done to the noted predicate device for both pH and surface contact angle. The results of the comparative testing demonstrate that the subject device performs as well as the noted predicate in the surface contact angle testing and that both devices share similar pH values.
Conclusion
In summary, non-clinical performance testing demonstrates that PacEndo™ Chlorhexidine is substantially equivalent to the identified predicate product for its intended use.