(264 days)
Minncare HD is intended for the disinfection of water purification systems for hemodialysis. It should be diluted to a 1% concentration (1 part Minncare HD to 99 parts water) and used for a minimum contact time of 36 minutes at 20°C.
Minncare HD is a clear liquid disinfectant solution that consists of a stabilized mixture of hydrogen peroxide, peracetic acid and acetic acid. Minncare HD is intended to be used for hemodialysis water purification system disinfection when diluted to a 1% concentration (1 part Minncare HD to 99 parts water) and applied for a minimum contact time of 36 minutes at 20℃. The active microbicidal ingredient is peracetic acid (PAA), and the recommended use concentration of 1%. The concentration of the use solution should be confirmed with 1% Minncare HD indicator test strips to have reached the furthest point of the distribution loop during the system disinfection contact time. Upon completion of disinfection the system must be rinsed to remove residual levels of the disinfectant. Residual levels should be checked using Minncare HD residual test strips to ensure residual levels of 1 ppm PAA or less. Minncare HD is supplied in cases containing high density polyethylene plastic bottles. Individual bottles are labeled with all information necessary to use the device safely.
This document is a 510(k) premarket notification for a disinfectant, not an AI/ML medical device. Therefore, the questions about acceptance criteria, study design, ground truth, and human reader performance with AI assistance are not applicable. The document describes a chemical disinfectant, Minncare HD, and its intended use for disinfecting water purification systems for hemodialysis.
However, I can extract and present the information available about the disinfectant's performance and the comparison to an equivalent predicate device.
1. A table of acceptance criteria and the reported device performance
Since this is a disinfectant and not an AI/ML device, the "acceptance criteria" here refers to the performance requirements for a chemical disinfectant. The document references "FDA Guidance for Content and Format of Premarket Notification [510(k)] Submission for Liquid Chemical Sterilants/High Level Disinfectants (Jan 2000)" as the basis for performance testing. However, it explicitly states that Minncare HD is not intended for high-level disinfection and is not claiming to be a sterilant.
The performance data listed as being submitted in support of substantial equivalence are:
- Sporicidal, tuberculocidal, fungicidal, virucidal and bactericidal efficacy
- Simulated-use disinfection efficacy
- Material compatibility
- Test strip performance
- Stability
The document does not explicitly state the quantitative acceptance criteria (e.g., specific log reduction values for microorganisms) for each of these categories in this summary. It only indicates that "Performance testing has been conducted to show that Minncare HD is safe and effective for its intended use." and "The performance testing data indicates that the subject device, Minncare HD, is substantially equivalent to the predicate device Hemoclean Disinfectant (K023064)."
Table: Acceptance Criteria and Reported Device Performance (as inferred for a disinfectant)
| Performance Metric | Acceptance Criteria (Inferred from regulatory guidance for disinfectants) | Reported Device Performance (Summary statement) |
|---|---|---|
| Microbicidal Efficacy | Demonstrated efficacy (e.g., specific log reduction) against relevant test organisms for: | Performance testing conducted to show safety and effectiveness. Data submitted included: |
| - Sporicidal Efficacy | Not explicitly detailed in this summary | Data provided |
| - Tuberculocidal Efficacy | Not explicitly detailed in this summary | Data provided |
| - Fungicidal Efficacy | Not explicitly detailed in this summary | Data provided |
| - Virucidal Efficacy | Not explicitly detailed in this summary | Data provided |
| - Bactericidal Efficacy | Not explicitly detailed in this summary | Data provided |
| Simulated-Use Disinfection Efficacy | Demonstrated effectiveness under simulated use conditions. | Data provided |
| Material Compatibility | Demonstrated compatibility with materials of intended use (e.g., water purification systems). | Data provided |
| Test Strip Performance | Demonstrated accuracy and reliability of associated test strips for monitoring concentration. | Data provided |
| Stability | Demonstrated shelf-life and stability of the product. | Shelf-life: 12 months (mentioned in comparison table) and data provided. |
| Substantial Equivalence | Performance comparable to a legally marketed predicate device. | Concluded to be substantially equivalent to Hemoclean Disinfectant (K023064). |
The document states that a "detailed description of physical and chemical properties" and "proposed labeling" were also provided, which are standard requirements for such submissions.
The following questions are not applicable to this document as it pertains to a chemical disinfectant and not an AI/ML medical device.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
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
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
8. The sample size for the training set
9. How the ground truth for the training set was established
§ 876.5665 Water purification system for hemodialysis.
(a)
Identification. A water purification system for hemodialysis is a device that is intended for use with a hemodialysis system and that is intended to remove organic and inorganic substances and microbial contaminants from water used to dilute dialysate concentrate to form dialysate. This generic type of device may include a water softener, sediment filter, carbon filter, and water distillation system.(b)
Classification. Class II (special controls). The device, when it is a water purification subsystem disinfectant, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.