(87 days)
Endocyn Root Canal Irrigation Solution is intended to irrigate, cleanse, and debride root canal systems including the removal of foreign material and debris during root canal therapy. It is also intended to provide for lubrication and irrigation during root canal instrumentation.
The Endocyn Root Canal Irrigation Solution is a colorless, slightly chlorinated odor, clear aqueous solution intended to irrigate, cleanse, and debride root canal systems. The solution will be supplied in polyethylene terephthalate (PET) round-bottles with polypropylene (PP) screw-top closure.
The provided document is a 510(k) premarket notification for the "Endocyn Root Canal Irrigation Solution." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than proving clinical effectiveness through extensive studies against predefined acceptance criteria. Therefore, the information typically found in such a study (like sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance) is not presented in this document.
Here's an analysis of the available information:
1. Acceptance Criteria and Reported Device Performance
The document does not define explicit "acceptance criteria" in the sense of performance thresholds for efficacy in a clinical study. Instead, the device's performance is demonstrated through a series of tests to show it meets specifications and is comparable to predicate devices.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Package integrity specification | Endocyn Root Canal Irrigation Solution meets package integrity specifications. |
| Visual inspection specification | Endocyn Root Canal Irrigation Solution meets visual inspection specifications (colorless, slightly chlorinated odor, clear aqueous solution). |
| pH specification | Endocyn Root Canal Irrigation Solution meets pH specifications. |
| Osmolality specification | Endocyn Root Canal Irrigation Solution meets osmolality specifications. |
| Free available chlorine specification | Endocyn Root Canal Irrigation Solution meets free available chlorine specifications. |
| Bioburden specification | Endocyn Root Canal Irrigation Solution meets bioburden specifications. |
| Biocompatibility requirements per ISO 10993 (Blue Book Memo G95-1) | Biocompatibility Testing confirmed the device meets the applicable requirements of the Blue Book Memorandum G95-1 entitled Use of International Standards ISO-10993 Biological Evaluation of Medical Devices and is biocompatible. |
| Substantial Equivalence to Predicate Devices (Aquatine EC and Sodium Hypochlorite 3% & 6%) | The device is substantially equivalent in intended use, technological characteristics, safety, and effectiveness to Aquatine EC Endodontic Cleanser (K061689) and Sodium Hypochlorite 3% and 6% (K082470). This includes comparable indications for use (irrigate, cleanse, debride root canal systems), non-sterile status, and delivery as an aqueous solution. No new safety and efficacy concerns are raised. |
2. Sample size used for the test set and the data provenance:
This document describes a 510(k) submission, which relies on performance testing and comparison to predicate devices, not a clinical study involving a test set of patient data. Therefore, there is no "sample size used for the test set" or "data provenance" (country of origin, retrospective/prospective) in the context of a clinical performance study. The tests would have been performed on batches of the Endocyn Root Canal Irrigation Solution itself.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable as the submission is not a clinical study involving human interpretation of data for ground truth establishment.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
This information is not applicable for the same reason as point 3.
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:
This is not applicable. The device is an irrigation solution, not an AI-powered diagnostic tool, and therefore no MRMC study would be performed for this product.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
This is not applicable as the device is not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for the performance tests (pH, osmolality, etc.) would be established by analytical chemistry and microbiology standards and laboratory testing protocols, not expert consensus or pathology in a clinical sense. For biocompatibility, it relied on established ISO standards (ISO-10993).
8. The sample size for the training set:
This is not applicable as the device is not an AI/machine learning model that requires a training set. The "training" for this device would refer to the development and manufacturing processes to ensure it consistently meets specifications.
9. How the ground truth for the training set was established:
This is not applicable for the same reason as point 8.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 18, 2014
Oculus Innovative Sciences. Inc. Mr. Brian W. Martin Director of Regulatory Affairs and Ouality Control 1129 North McDowell Blvd. Petaluma, CA 94954
Re: K141352
Trade/Device Name: Endocyn Root Canal Irrigation Solution Regulation Number: N/A Regulation Name: N/A Regulatory Class: Unclassified Product Codes: KJJ Dated: June 11, 2014 Received: June 12, 2014
Dear Mr. Martin:
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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Page 2 - Mr. Martin
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 Small Manufacturers, International and Consumer Assistance at its tollfree 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" (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 Small Manufacturers, International and Consumer Assistance 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,
Mary S. Runner -S
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) K141352
Device Name Endocyn Root Canal Irrigation Solution
Indications for Use (Describe)
Endocyn Root Canal Irrigation Solution is intended to irrigate, cleanse, and debride root canal systems including the removal of foreign material and debris during root canal therapy. It is also intended to provide for lubrication and irrigation during root canal instrumentation.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
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FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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Image /page/3/Picture/0 description: The image contains the logo for Oculus Innovative Sciences. The logo features a series of overlapping golden rings above the word "OCULUS" in a bold, dark font. Below "OCULUS" are the words "Innovative Sciences" in a smaller font.
510(k) SUMMARY
The following is a summary of 510(k) safety and effectiveness information in accordance with 21 CFR 807.92.
| 510(k) OwnerOculus Innovative Sciences, Inc.1129 North McDowell Blvd.Petaluma, CA 94954Phone: (707) 283-0550Fax: (707) 283-0551 | Official ContactBrian W. MartinDirector of Regulatory Affairs and QualityControl |
|---|---|
| Device InformationTrade or ProprietaryName: | Endocyn Root Canal Irrigation Solution |
| Common Name: | Endodontic Cleanser |
| Classification Name: | Cleanser, Root Canal |
| Regulation: | 21 CFR Unclassified, Pre-amendment status |
| Product Code(s) | KJJ |
| Device Panel | Dental |
| Legally marketeddevice(s) to whichequivalence is claimed: | Aquatine EC Endodontic Cleanser manufactured by PuriCore(K061689) and Sodium Hypochlorite 3% and 6% and 6%Sodium Hypochlorite with wetting agents marketed as Chlor-XTRA manufactured by Inter-Med, Inc./Vista-Dental, Inc.(K082470) |
| Reason for 510(k)submission | New Device |
| Device Description | The Endocyn Root Canal Irrigation Solution is a colorless,slightly chlorinated odor, clear aqueous solution intended toirrigate, cleanse, and debride root canal systems. The solutionwill be supplied in polyethylene terephthalate (PET) round-bottles with polypropylene (PP) screw-top closure. |
| Intended Use | Endocyn Root Canal Irrigation Solution is intended to irrigate,cleanse, and debride root canal systems including the removalof foreign material and debris during root canal therapy. It is |
| also intended to provide for lubrication and irrigation duringroot canal instrumentation. | |
| Performance Testing | The following tests were reviewed to support the performanceof the Endocyn Root Canal Irrigation Solution: packageintegrity, visual inspection, pH, osmolality, free availablechlorine, and bioburden. The Endocyn Root Canal IrrigationSolution meets specification and performance characteristicsand is substantially equivalent to the predicate devices. |
| Biocompatibility Testing | Biocompatibility Testing of the Oculus Endocyn Root CanalIrrigation Solution confirmed that the device meets theapplicable requirements of the Blue Book Memorandum G95-1 entitled Use of International Standards ISO-10993Biological Evaluation of Medical Devices and isbiocompatible. |
| Safety and Effectiveness | The Endocyn Root Canal Irrigation Solution does not raiseany new safety and efficacy concerns when compared to asimilar device already legally marketed. |
Oculus Innovative Sciences, Inc. Endocyn Root Canal Irrigation Solution 510(k) K141352
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Image /page/4/Picture/0 description: The image shows the logo for Oculus Innovative Sciences. The logo features a stylized golden swirl above the word "OCULUS" in a bold, sans-serif font. Below "OCULUS" is the text "Innovative Sciences" in a smaller font.
| Substantial Equivalence (SE) Rationale | ||||
|---|---|---|---|---|
| ---------------------------------------- | -- | -- | -- | -- |
| Endocyn Root CanalIrrigation Solution | Aquatine ECEndodonticCleanser | Sodium Hypochlorite 3% and6% | |
|---|---|---|---|
| RegulatoryStatus | Present application | Predicate | Predicate |
| 510(k)Number | K141352 | K061689 | K082470 |
| ProductCode | KJJ | KJJ | KJJ |
| Indicationsfor Use | Endocyn Root Canal IrrigationSolution is intended to irrigate,cleanse, and debride root canalsystems including the removalof foreign material and debrisduring root canal therapy. It isalso intended to provide forlubrication and irrigation duringroot canal instrumentation. | Intended toirrigate,cleanse, anddebride rootcanal systems. | Sodium Hypochlorite 3% and6% and Sodium Hypochlorite6% with wetting agents to lowersurface tension marketed asChlor-XTRA are solutions usedfor debridement and theinstrumentation of root canal.Sodium Hypochlorite-3% and6% and Chlor-XTRA 6% areSodium Hypochlorite in water. |
| Sterility | Non-sterile | Non-sterile | Non-sterile |
| DeliverySystem | Aqueous solution | Aqueoussolution | Aqueous solution |
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The Endocyn Root Canal Irrigation Solution is substantially equivalent in intended use, technological characteristics, safety and effectiveness to the Aquatine EC Endodontic Cleanser manufactured by PuriCore (K061689) and Sodium Hypochlorite 3% and 6% manufactured by Inter-Med, Inc./Vista-Dental, Inc. (K082470). Therefore, the Oculus Endocyn Root Canal Irrigation Solution is substantially equivalent to the predicate devices.
Submitted by:
Brian W. Martin Director of Regulatory Affairs and Quality Control
Bin Wint 06/11/2014
Date Submitted:
June 11, 2014
N/A