(126 days)
PacEndo™ Sodium Hypochlorite is intended to irrigate, cleanse, and debride root canal systems. It is also intended to provide irrigation during root canal instrumentation.
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.
The provided text describes the 510(k) premarket notification for PacEndo™ Sodium Hypochlorite. Here's an analysis of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly defined by the comparison to the predicate device in terms of performance characteristics. The document indicates that the subject device (PacEndo™ Sodium Hypochlorite) meets these criteria by demonstrating similar properties and, in one aspect, improved performance.
| Acceptance Criteria | Reported Device Performance (PacEndo™ Sodium Hypochlorite) | Predicate Device Performance (3% and 6% Sodium Hypochlorite with wetting agents marketed as Chlor-XTRA™ (K082470)) |
|---|---|---|
| Appearance | clear to light yellow liquid | clear to light yellow liquid |
| pH | 12.11 | 12.02 |
| % Active Chlorine (w/w) | 4.6% | 5.3% |
| Surface Tension | Lower surface tension compared to the predicate device | Higher surface tension compared to the subject device (implied by the subject device's reported lower tension) |
2. Sample size used for the test set and the data provenance
The document does not specify a distinct "test set" and its sample size in the context of clinical or large-scale comparative studies. The performance characteristics (Appearance, pH, % Active Chlorine (w/w), Surface Tension) are likely based on laboratory testing of batches of the product. No information is provided regarding the country of origin of the data or whether it was retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the document. The type of device (sodium hypochlorite solution) does not typically involve expert interpretation for its core performance characteristics (pH, active chlorine, etc.).
4. Adjudication method for the test set
This information is not applicable and therefore not provided, as there is no indication of a test set requiring adjudication by multiple experts.
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
There is no mention of an MRMC comparative effectiveness study, nor is AI assistance relevant to this type of device (a chemical solution).
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable as the device is a chemical solution and does not involve algorithms or human-in-the-loop performance. The performance characteristics listed (appearance, pH, % active chlorine) are standalone measurements of the chemical product.
7. The type of ground truth used
The ground truth for the non-clinical tests (Appearance, pH, % Active Chlorine (w/w), Surface Tension) would be defined by standard chemical and physical measurement methods. For instance, pH meters, titration for active chlorine, and contact angle measurement for surface tension. There's no reliance on expert consensus, pathology, or outcomes data for these specific parameters.
8. The sample size for the training set
This information is not provided and is not applicable in the context of "training set" for an AI/algorithm-based device. If "training set" refers to the development and formulation of the chemical product, such details are not disclosed.
9. How the ground truth for the training set was established
As there is no "training set" in the context of AI/algorithm, this question is not applicable. For the development and quality control of the chemical product, the ground truth would be established through documented chemical and physical testing protocols and specifications.
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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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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
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III-1
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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
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| DescriptiveInformation | Subject DevicePacEndo™ Sodium Hypochlorite | Predicate Device3% and 6% Sodium Hypochloritewith wetting agents marketed asChlor-XTRA™ (K082470) |
|---|---|---|
| Indications forUse | PacEndo™ Sodium Hypochlorite isintended to irrigate, cleanse, anddebride root canal systems. It isalso intended to provide irrigationduring root canal instrumentation. | Sodium Hypochlorite 3% and 6%and Sodium Hypochlorite 6% withwetting agents to lower surfacetension marketed as Chlor-XTRAare solutions used for debridementand the instrumentation of rootcanal. Sodium Hypochlorite 3% and6% and Chlor-XTRA 6% areSodium Hypochlorite in water. |
| Composition ofMaterials | Sodium HypochloriteSurfactant | Sodium HypochloriteSurfactantWetting agent |
| Performance | Appearance: clear to light yellowliquidpH: 12.11% Active Chlorine (w/w): 4.6% | Appearance: clear to light yellowliquidpH: 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.
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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.
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