(219 days)
Sodium Hypochlorite 3% & 6% Solution and Sodium Hypochlorite 6% with wetting agents to lower surface tension marketed as Chlor-XTRATM are solutions used for debridement and the instrumentation of root canal. Sodium Hypochlorite-3% & 6% and Chlor-XTRATM 6% are Sodium Hypochlorite in water.
Sodium Hypochlorite 3% & 6%: Solutions are 3% & 6% Sodium Hypochlorite in water.
Sodium Hypochlorite 6% with wetting agents to lower surface tension marketed as Chlor-XTRATM is a Sodium Hypochlorite solution in water with alkalizing salt agents to increase the electrical capacity of the solution.
The provided document is a 510(k) summary for a medical device (Sodium Hypochlorite solutions for root canal cleaning) and a letter from the FDA determining substantial equivalence to predicate devices. This type of regulatory submission does not typically include detailed performance studies with acceptance criteria, sample sizes, expert ground truth, or MRMC comparative effectiveness studies in the way an AI/ML device submission would.
For devices classified as Endodontic Cleansers (Product Code KJJ), the FDA primarily relies on demonstrating substantial equivalence to legally marketed predicate devices, meaning the new device is as safe and effective as existing ones. The "performance" section mentions "Laboratory analyses are provided in this premarket notification" and "Several published articles supporting this statement have been included in this premarket notification," indicating that the "study" proving the device meets acceptance criteria is likely a combination of these laboratory analyses and existing scientific literature on sodium hypochlorite as a root canal irrigant, rather than a novel clinical trial designed to establish specific performance metrics for this particular device.
Therefore, I cannot extract the specific information requested in the prompt's numbered list because it is not present in the provided 510(k) summary. The summary focuses on demonstrating equivalence to predicate devices based on formula and intended use, and the established standard of care for the active ingredient.
To address the prompt as best as possible with the available information:
1. Table of Acceptance Criteria and Reported Device Performance:
Based on the provided document, specific quantitative acceptance criteria or device performance metrics for the new device (beyond its chemical composition and intended use) are not explicitly stated. The acceptance criteria for this type of device, as per the 510(k) process, revolve around substantial equivalence to predicate devices in terms of:
- Indications for Use: Identical or similar
- Technological Characteristics: Similar (e.g., Sodium Hypochlorite in water)
- Safety and Effectiveness: Demonstrated by similarity to established predicate devices and the known properties of sodium hypochlorite as a root canal irrigant.
| Acceptance Criteria (Inferred from 510(k) process) | Reported Device Performance (Inferred from 510(k) Summary) |
|---|---|
| Purity and Concentration: Device is 3% or 6% Sodium Hypochlorite solution, with or without wetting agents. | Confirmation of Composition: "Sodium Hypochlorite 3% & 6%: Solutions are 3% & 6% Sodium Hypochlorite in water. Sodium Hypochlorite 6% with wetting agents... is a Sodium Hypochlorite solution in water with alkalizing salt agents." The primary "performance" is the composition as stated, which aligns with established and effective formulations. |
| Intended Use: Device functions as a root canal cleanser for debridement and instrumentation. | Confirmation of Indication: "Sodium Hypochlorite 3% & 6% Solution and Sodium Hypochlorite 6% with wetting agents... are solutions used for debridement and the instrumentation of root canal." This aligns with the intended use of predicate devices and the widely accepted role of sodium hypochlorite in endodontics. |
| Safety and Effectiveness: Equivalent to legally marketed predicate devices. | Substantial Equivalence: The device is stated to be "similar in function and intended use to" three predicate devices (Pulpdent Sodium Hypochlorite Solution, Aquatine EC Endodontic Cleanser, ChlorCid Sodium Hypochlorite Solution). The summary notes: "Sodium Hypochlorite is the standard of care for root canal irrigation. Several published articles supporting this statement have been included in this premarket notification." This indicates that the safety and effectiveness are established by the well-known properties of the active ingredient and alignment with predicate devices, rather than new, device-specific performance metrics from a dedicated clinical trial for this 510(k). "Laboratory analyses are provided" likely refers to chemical composition verification, stability, etc., rather than efficacy in a clinical setting. |
Regarding the other points (2-9):
These points are directly related to the design and execution of clinical performance studies, which are typically required for novel devices or those with higher risk classifications where substantial equivalence cannot be adequately demonstrated through existing literature and technological characteristics alone.
For this 510(k) submission (K082470) for an Endodontic Cleanser, the FDA determined substantial equivalence based on the product's formulation (sodium hypochlorite) and its intended use being consistent with predicate devices and the established "standard of care." Therefore, the details requested in points 2-9 about specific clinical study parameters (sample sizes, ground truth, expert adjudication, MRMC studies, standalone performance, training sets) are not provided in this 510(k) summary. These types of studies were not deemed necessary explicitly for this specific device's clearance. The "performance" section mentions "Laboratory analyses" and "published articles," indicating a reliance on existing scientific knowledge and basic quality control, not a dedicated clinical effectiveness trial for this particular submission.
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