(126 days)
Not Found
No
The device description and performance studies focus on the chemical properties and physical performance (surface tension) of a sodium hypochlorite solution, with no mention of AI or ML.
No.
The device is a solution used for irrigation, cleansing, and debridement during root canal procedures, which are therapeutic acts, but the solution itself is primarily a cleanser and irrigant rather than a device that directly causes a therapeutic effect on a disease or condition itself.
No
The device is a root canal cleanser intended for irrigation, cleansing, and debridement during endodontic procedures, not for diagnosing medical conditions.
No
The device description clearly states it is a "Sodium Hypochlorite 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 "irrigate, cleanse, and debride root canal systems" and "provide irrigation during root canal instrumentation." This describes a procedure performed on a patient's body (in vivo), not a test performed on a sample taken from a patient (in vitro).
- Device Description: The device is a "Sodium Hypochlorite solution in water with surfactant." This is a chemical solution used for cleaning and disinfection within the body, not a reagent or kit used to analyze a biological sample.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in a sample
- Providing diagnostic information about a patient's health status
The device is clearly intended for use within the root canal system of a patient during an endodontic procedure. This falls under the category of a medical device used for treatment or procedural support, not for in vitro diagnosis.
N/A
Intended Use / Indications for Use
PacEndo™ Sodium Hypochlorite is intended to irrigate, cleanse, and debride root canal systems. It is also intended to provide irrigation during root canal instrumentation.
Product codes
KJJ
Device Description
PacEndo™ Sodium Hypochlorite is a Sodium Hypochlorite 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
Surface tension test using contact angle measurement was performed in comparison to the predicate device.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an image of three stylized human profiles facing to the right. The profiles are stacked on top of each other, with the top profile being the most prominent.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 10, 2015
Pac-dent International, Inc. Wenving Zhu Materials Engineer 670 Endeavor Circle Brea, California 92821
Re: K151852
Trade/Device Name: PacEndo™ Sodium Hypochlorite Regulatory Class: Unclassified Product Code: KJJ Dated: September 28, 2015 Received: October 6, 2015
Dear Wenying 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.
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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 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
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 contains the PacDent logo. 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-D" in a gray font.
Section III
Indications for Use Statement
510(k) Number (if known): _ K151852
Device Name: PacEndo™ Sodium Hypochlorite
Indications for Use:
PacEndo™ Sodium Hypochlorite is intended to irrigate, cleanse, and debride root canal systems. It is also intended to provide irrigation during root canal instrumentation.
Prescription Use
OR
Over-The-Counter Use
Image /page/2/Picture/12 description: The image shows a series of logos for different organizations. The first logo is for the FDA, which is the Food and Drug Administration. The second logo is for CE, which is a European safety standard. The third logo is for DTA, which is the Digital Transformation Agency. The fourth logo is for OSAP, which is the Organization for Safety, Asepsis and Prevention.
III-1
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Image /page/3/Picture/0 description: The image shows the logo for PacDent. The logo is blue and orange. The word "PacDent" is written in blue, and there is an orange swoosh above the word.
Section IV
510(k) Summary K151852
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:
November 9th 2015
Device Name Trade Name: PacEndo™ Sodium Hypochlorite Common Name: Endodontic Cleanser Device Classification: Unclassified Classification Product Code: KJJ Classification Name: Cleanser, Root Canal
Predicate Device 3% and 6% Sodium Hypochlorite with wetting agents marketed as Chlor-XTRA™ (K082470)
Description of Device
PacEndo™ Sodium Hypochlorite is a Sodium Hypochlorite solution in water with surfactant to lower surface tension. The solution is root canal cleanser for use in endodontic procedures.
Indications for Use
PacEndo™ Sodium Hypochlorite is intended to irrigate, cleanse, and debride root canal systems. It is also intended to provide irrigation during root canal instrumentation.
Comparison of Technological Characteristics
Image /page/3/Picture/19 description: The image shows the logos for FDA, CE, DTA, and OSAP. The FDA logo is in gray and features the letters FDA in a stylized font. The CE logo is in blue and features the letters CE in a simple font. The DTA logo is in blue and features the letters DTA inside of a blue circle. The OSAP logo is in green and features the letters OSAP with the tagline "Because Safety Matters".
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| Descriptive
Information | Subject Device
PacEndo™ Sodium Hypochlorite | Predicate Device
3% and 6% Sodium Hypochlorite
with wetting agents marketed as
Chlor-XTRA™ (K082470) |
|-----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for
Use | PacEndo™ Sodium Hypochlorite is
intended to irrigate, cleanse, and
debride root canal systems. It is
also intended to provide irrigation
during root canal instrumentation. | Sodium Hypochlorite 3% and 6%
and Sodium Hypochlorite 6% with
wetting agents to lower surface
tension marketed as Chlor-XTRA
are solutions used for debridement
and the instrumentation of root
canal. Sodium Hypochlorite 3% and
6% and Chlor-XTRA 6% are
Sodium Hypochlorite in water. |
| Composition of
Materials | Sodium Hypochlorite
Surfactant | Sodium Hypochlorite
Surfactant
Wetting agent |
| Performance | Appearance: clear to light yellow
liquid
pH: 12.11
% Active Chlorine (w/w): 4.6% | Appearance: clear to light yellow
liquid
pH: 12.02
% Active Chlorine (w/w): 5.3% |
The indications for use statement for the subject device is similar to the predicate device, but introduces the use of the device more in details, which is to irrigate, cleanse, and debride root canal systems. The indications for use doesn't change the intended use of the product.
Non-Clinical Tests
Surface tension test using contact angle measurement was performed in comparison to the predicate device.
Justification based on risk analysis, for not doing biocompatibility testing was provided.
Clinical Performance Test
No clinical testing was provided.
Summary of Non-Clinical and Clinical Performance Testing
The subject device was found to have lower surface tension compared to the predicate device and can be used as intended.
Conclusion
In summary, this submission demonstrates that PacEndo™ Sodium Hypochlorite is substantially equivalent to the identified predicate product for its intended use.
Image /page/4/Picture/14 description: The image shows the text "IV-2" in a simple, sans-serif font. The text is black against a white background. The "IV" is written in uppercase Roman numerals, and the "-2" is written in standard Arabic numerals.
Image /page/4/Picture/15 description: The image shows five different logos lined up next to each other. The first logo is the FDA logo in gray. The second logo is the CE logo in blue. The third logo is the DTA logo in blue. The fourth logo is the OSAP logo in green with the text "Because Safety Matters" underneath. The fifth logo is ".org" in blue.