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510(k) Data Aggregation
(300 days)
MPS2 Myocardial Protection System Console
The Quest Medical MPS®2 Myocardial Protection System, consisting of the MPS2 console and the MPS Delivery Set together, is intended for use by perfusionists and physicians to deliver whole blood (from any arterial source) and/or cardioplegia solutions to the heart during open heart surgery on either an arrested or beart for use up to six hours in duration.
The MPS 2 console is a single device for myocardial perfusion that incorporates several different functions: heat exchanger, temperature control, pressure control, flow rate control, automatic priming and air detection / removal, and 3 flow modes - normal, cyclic, low volume.
The provided text describes a 510(k) premarket notification for the Quest Medical MPS2 Myocardial Protection System Console, focusing on a labeling modification related to disinfection protocols. The submission asserts substantial equivalence to a predicate device (K041979).
Based on the information provided, here's a breakdown of the acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Disinfection Efficacy) | Reported Device Performance |
|---|---|
| Intermediate level of disinfection against Pseudomonas aeruginosa (P. aeruginosa) | 6-Log reduction against P. aeruginosa |
| Intermediate level of disinfection against Mycobacterium chimaera (M. chimaera) | 3-Log reduction against M. chimaera |
| Compatibility of disinfectant and microbial growth inhibitor with water circulation system materials | Disinfectant and microbial growth inhibitor were shown to be compatible with the materials of the water circulation system. |
| Surface cleaning and disinfection effectiveness | Supported with results from surface cleaning and disinfection testing (specific performance metrics not detailed). |
| Heat exchanger performance | Supported with results from heat exchanger performance testing (specific performance metrics not detailed, but implies continued function after disinfection). |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not explicitly state the sample size used for the disinfection efficacy testing (e.g., number of test articles, number of microbial inoculations). It mentions "bench testing," which implies laboratory-based studies. The provenance information (country of origin, retrospective/prospective) is also not provided.
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)
This section is not applicable as the study is a benchtop disinfection validation, not a clinical study requiring expert interpretation of patient data. The ground truth for microbial reduction (e.g., 6-Log and 3-Log reduction) is established through standardized microbiological testing methods rather than expert consensus on medical images or clinical outcomes.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This section is not applicable for a benchtop disinfection validation study. Adjudication methods are relevant for clinical studies where multiple experts interpret data.
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 section is not applicable. The study described is a benchtop validation of a disinfection protocol for a medical device, not an AI-assisted diagnostic tool. Therefore, no MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This section is not applicable. The device is a "Myocardial Protection System Console" and the study focuses on validating a disinfection protocol for its water circulation system. There is no mention of an algorithm or AI functionality for standalone performance testing.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The ground truth used for the disinfection efficacy testing is microbiological quantification. This involves:
- Inoculation: Introducing a known concentration of target microorganisms (P. aeruginosa and M. chimaera) onto surfaces or into test systems.
- Disinfection: Applying the validated disinfection protocol.
- Recovery and Enumeration: Quantifying the number of surviving microorganisms after disinfection using standard microbiological techniques (e.g., plating and colony counting).
- Log Reduction Calculation: Comparing the initial microbial load to the post-disinfection load to determine the log reduction.
8. The sample size for the training set
This section is not applicable. There is no mention of a "training set" as this is not a machine learning or AI device that requires training data. The study is a validation of a disinfection protocol.
9. How the ground truth for the training set was established
This section is not applicable for the same reason as point 8.
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