(146 days)
PacEndo™ Chlorhexidine is intended to irrigate and cleanse root canal systems after endodontic instrumentation.
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.
This document is a 510(k) premarket notification for a medical device, specifically PacEndo™ Chlorhexidine, an endodontic cleanser. The document focuses on establishing substantial equivalence to a predicate device, not on proving device performance against specific acceptance criteria through a clinical study. Therefore, much of the requested information regarding acceptance criteria, study design, sample sizes, expert involvement, and ground truth cannot be directly extracted from this document as it pertains to a different type of evaluation.
Here's a breakdown of what can be inferred or is missing based on the document:
1. A table of acceptance criteria and the reported device performance
The document does not define explicit "acceptance criteria" in the sense of predefined thresholds for clinical efficacy or safety that might be found in a clinical trial protocol. Instead, it relies on comparison to a predicate device.
| Acceptance Criterion (Inferred from comparison) | Reported Device Performance (PacEndo™ Chlorhexidine) | Predicate Device Performance (CHX and CHX-Plus™) | Summary/Conclusion |
|---|---|---|---|
| Intended Use Equivalence | Intended to irrigate and cleanse root canal systems after endodontic instrumentation. | Used as a final endodontic rinse after instrumentation to irrigate and cleanse the root canal system for long lasting cleansing. | Both devices are used for endodontic procedures to irrigate and cleanse the root canal. |
| Compositional Comparability | Chlorhexidine Gluconate, Surfactant | Chlorhexidine Gluconate, Surfactant, Colorant | The functions of the ingredients in subject and predicate devices are the same. (The presence of colorant in the predicate is noted as a difference but not affecting substantial equivalence of function). |
| Performance - Appearance | Clear to light yellow liquid | Clear to light blue liquid | The difference in appearance doesn't affect substantial equivalence. |
| Performance - pH Testing | Similar pH values (specific values not provided but implied to be comparable to predicate) | Similar pH values (specific values not provided but implied to be comparable to subject device) | Both devices share similar pH values. |
| Performance - Surface Contact Angle Testing | Performs as well as the noted predicate device (specific values not provided) | Performs as well as the noted subject device (specific values not provided) | The subject device performs as well as the noted predicate. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not applicable in the context of this 510(k) submission. No human or clinical "test set" for performance evaluation is described. The "test set" essentially refers to laboratory samples used for non-clinical comparative testing. The document does not specify the number of samples (e.g., number of pH measurements, number of contact angle measurements) used for these non-clinical tests.
- Data Provenance: Not applicable for a non-clinical comparison study. No information on country of origin for non-clinical lab data.
- Retrospective or Prospective: Not applicable as this is not a clinical study involving patients. The non-clinical tests would have been performed prospectively as part of the device development and submission process.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. "Ground truth" in the context of clinical expert consensus is not relevant to this type of non-clinical, comparative device evaluation. The "ground truth" for the non-clinical tests (pH, contact angle) would be the physical measurements themselves.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is not a clinical study involving human readers or interpretation of medical images/data that would require an adjudication method.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No. This is not mentioned as this device is a chemical solution (root canal cleanser), not an AI diagnostic or assistive tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No. This question applies to AI-driven devices, which this is not. The "performance" here is intrinsic to the chemical properties of the solution.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the non-clinical tests (pH and surface contact angle) would be the results of the physical and chemical measurements obtained in a laboratory setting. There is no expert consensus, pathology, or outcomes data used for this type of submission.
8. The sample size for the training set
Not applicable. This device does not involve a "training set" as it is not an AI/machine learning device.
9. How the ground truth for the training set was established
Not applicable. There is no training set mentioned or implied.
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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.
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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 (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
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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)
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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
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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.
| DescriptiveInformation | Subject DevicePacEndo™ Chlorhexidine | Predicate DeviceCHX and CHX-Plus™ (K112250) | Summary |
|---|---|---|---|
| Indications forUse | PacEndo™ Chlorhexidine isintended to irrigate and cleanseroot canal systems afterendodontic instrumentation. | CHX and CHX-Plus™ are used asa final endodontic rinse afterinstrumentation to irrigate andcleanse the root canal system forlong lasting cleansing | Although the wording is notidentical, both devices are usedfor endodontic procedures toirrigate and cleanse the rootcanal. |
| Composition ofMaterials | Chlorhexidine GluconateSurfactant | Chlorhexidine GluconateSurfactantColorant | The functions of the ingredients insubject and predicate devices arethe same. |
| Performance | Appearance: clear to lightyellow liquidpH TestingSurface Contact Angle Testing | Appearance: clear to light blueliquidpH TestingSurface Contact Angle Testing | The difference between theappearances of the subject andpredicate devices doesn't affectthe substantial equivalent of thesubject 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.
N/A