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510(k) Data Aggregation
(35 days)
CIDEX® Activated Dialdehyde Solution is a liquid chemical sterilant and a high level disinfectant for reprocessing heat sensitive medical/dental devices such as endoscopes, respiratory therapy equipment and ultrasonic transducers.
Sterilant:
CIDEX Solution is a sterilant when used or reused, according to the Directions for Use, at or above its Minimum Effective Concentration (MEC) as determined by the CIDEX® Solution Test Strip, at 25°C (77°) with an immersion time of at least 10 hours with a reuse period not to exceed 14 days.
High Level Disinfectant:
CIDEX Solution is a high level disinfectant when used or reused, according to the Directions for Use, at or above its Minimum Effective Concentration (MEC) as determined by the CIDEX® Solution Test Strip, at 25°C (77°) with an immersion time of at least 45 minutes with a reuse period not to exceed 14 days.
CIDEX Solution is intended for use in manual systems as well as in automated endoscope reprocessors.
CIDEX Solution is a liquid chemical sterilant/high level disinfectant used for sterilization/high-level disinfection of heat sensitive semi-critical medical devices that cannot be processed by another process. The active ingredient is not specified in the provided text. The modification to the device incorporates an anti-oxidant and solubilizing agent to increase the shelf life of the product beyond the current 2 years.
The provided text describes a Special 510(k) submission for an advanced sterilization product. However, it does not contain the detailed information typically associated with acceptance criteria and study designs for algorithmic or AI-powered medical devices. Instead, it focuses on the performance of a chemical sterilant/disinfectant. As such, many of the requested elements (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set details) are not applicable or cannot be extracted from the given text.
Here's the information that can be extracted and how it relates to your request:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria (Predicate) | Reported Device Performance (Modified) |
|---|---|---|
| Sterilization Claim | Achieve sterilization (implied by "legally marketed equivalent device" K924434, which is also CIDEX Activated Dialdehyde Solution, and the statement "The sterilization claim...for the Modified Device was confirmed to be the same as the Predicate Device"). Specific log reduction for predicate not explicitly stated but must meet regulatory standards for sterilization. | Achieved sterilization: Sampling of surface and lumens indicated a >10^6 log reduction in viable Bacillus subtilis spores after 10 hours soaking at 25°C. |
| High-Level Disinfection Claim | Achieve high-level disinfection (implied by "legally marketed equivalent device" K924434 and the statement "The high level disinfection claim for the Modified Device was confirmed to be the same as the Predicate Device"). Specific log reduction for predicate not explicitly stated but must meet regulatory standards for high-level disinfection. | Achieved high-level disinfection: Exposure to the Modified Device for 45 minutes at 25°C reduced viable M. terrae by >6 log10 (assumed, as "610g10" likely a typo for ">6 log10" or similar). |
| Shelf Life (Accelerated Stability) | At least 6 months (based on predicate performance, though not explicitly stated for predicate; the modified device "increase over the stability of the Predicate Device" implies the predicate had at least 6 months). | Improved: Accelerated stability studies (40°C/75%RH) indicate the product is stable for 6 months, which is an increase over the stability of the Predicate Device. |
| Shelf Life (Real-Time Stability) | At least 18 months (based on predicate performance; implied by real-time data for modified device already reaching 18 months). | Ongoing, currently stable: Real-time stability (30°C/60%RH) is ongoing. Data at 18 months indicates the product is stable. Data will be collected out to 3 years. (Goal is expected to be 3 years, exceeding the predicate's 2 years as previously mentioned for increased shelf-life). |
| Active Ingredients | Based on CIDEX Activated Dialdehyde Solution (K924434) | Active ingredient is a liquid chemical sterilant described as "the active ingredient" in the Description of Device. The modification adds "an anti-oxidant and solubilizing agent." The core chemistry remains similar to the predicate, as implied by substantial equivalence. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set:
- For sterilization and high-level disinfection simulated use studies, three types of endoscopes were used. For each endoscope type, external surfaces and internal lumens were inoculated. The actual number of individual endoscopes tested is not specified (e.g., if one of each type, or multiple of each type).
- Data Provenance: The studies were conducted internally as part of the 510(k) submission, likely in the United States by Advanced Sterilization Products. The data is prospective for the modified device, as it was specifically generated to support this submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Not applicable / Not explicitly stated. This device is a chemical sterilant/disinfectant. Its effectiveness is measured through microbiological assays rather than expert interpretation of medical images or other subjective data. Therefore, "experts" in the context of establishing ground truth for human-interpretable data (like radiologists) are not relevant here. The "ground truth" is determined by direct microbiological testing (colony forming units, log reduction).
4. Adjudication Method for the Test Set
- Not applicable. As the ground truth is established by direct microbiological measurement, there is no human interpretation or adjudication process required in the sense of consensus among experts.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study
- Not applicable. This is a chemical sterilant/disinfectant, not an AI or imaging device that would involve human readers.
6. Standalone (Algorithm Only) Performance
- Not applicable. This is a chemical product, not an algorithm. The performance described is inherently "standalone" in that it is the performance of the chemical itself.
7. Type of Ground Truth Used
- Microbiological laboratory data. The ground truth for effectiveness claims (sterilization and high-level disinfection) was established through quantitative measurement of microbial reduction (log reduction in Bacillus subtilis spores and Mycobacterium terrae) on inoculated endoscopes. This is a direct, objective measurement.
8. Sample Size for the Training Set
- Not applicable. Chemical sterilants do not have "training sets" in the context of machine learning. The product formulation is developed through chemical research and development, and its performance is validated through specific studies, not "trained" on data.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. See #8.
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