(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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