(46 days)
PASCO MIC AND MIC/ID PANELS are used for quantitatively measuring (with the exception of the Breakpoint/ID panel which provides qualitative measurement or category results) the susceptibility of rapidly growing aerobic and facultative anaerobic bacterial pathogens to a battery of antimicrobial agents and determining the biochemical identification of those organisms.
This 510(k) notification is for the addition of the antimicrobial Gatifloxacin at concentrations of 0.03 - 8 mcg/ml to Pasco Panels. Gatifloxacin has been shown to be active in vitro against most strains of microorganisms listed below, as described in the FDA-approved package insert for this antimicrobic.
Active In Vitro and in Clinical Infectious Against:
Aerobic Gram-positive microorganisms Staphylococcus aureus (methicillin-susceptible strains only) Aerobic Gram-negative microorganisms Escherichia coli Klebsiella pneumoniae Proteus mirabilis
Active In Vitro but their clinical significance is unknown
Aerobic Gram-positive microorganisms Staphylococcus saprophyticus
Aerobic Gram-negative microorganisms Acinetobacter lwoffii Citrobacter koseri Citrobacter freundii Enterobacter aerogenes Enterobacter cloacae Klebsiella oxytoca Morganella morganii Proteus vulgaris
Pasco Panels are used for quantitatively measuring the susceptibility of rapidly growing aerobic and facultative anaerobic bacterial pathogens to a battery of antimicrobial agents and determining the biochemical identification of those organisms. Varying concentrations of antimicrobial agents (usually in two-fold dilutions) are dispensed into the Pasco microdilution panels and the panels are then frozen. Panels are thawed prior to use, inoculated with the test organisms, incubated the traditional 16-24 hours and panels are then observed for visible growth or color changes as described in the package insert.
The lowest concentration of each antimicrobial agent with no apparent visible growth of the test organism is recorded as the minimum inhibitory concentration (MIC). Changes in pH and production of specific metabolites from growth in biochemical substrates are interpreted as described in the package insert for conventional tubed media.
This document describes the regulatory submission for the Pasco MIC and MIC/ID Panels, specifically for the inclusion of the antimicrobial Gatifloxacin. The study's purpose is to demonstrate substantial equivalence to previously cleared devices.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Nonfastidious Gram-Positive Organisms (410 tested) | Essential Agreement (EA): 100% |
| - Major (M) errors | None observed |
| - Very Major (VM) errors | None observed |
| - Minor errors | 10 minor errors observed (all within EA) |
| Category Agreement (CA) | 98.3% |
| Gram-Negative Organisms (615 tested) | Essential Agreement (EA): 99.6% |
| - Major (M) errors | None observed |
| - Very Major (VM) errors | None observed |
| - Minor errors | 17 minor errors observed (all within EA except one) |
| Category Agreement (CA) | 98.1% |
| OC Endpoints for NCCSL Recommended OC Organisms (S. aureus ATCC 29213, E. faecalis ATCC 29212, E. coli ATCC 25922, P. aeruginosa ATCC 27853) | Acceptable for both reference and test methodology |
| Inter-site Reproducibility (10 organisms, 3 days, triplicate) | 99.6% |
| Intra-site Reproducibility | 100% for 2 sites, 98.9% for 1 site |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Test Set Sample Size:
- Nonfastidious gram-positive organisms: 410
- Gram-negative organisms: 615
- Reproducibility testing: 10 organisms (tested in triplicate over 3 days at each of 3 sites, total 90 tests per site for reproducibility and 270 total tests across all sites)
- Data Provenance: The document does not specify the country of origin. It indicates that "Challenge strains, fresh clinical isolates, stock clinical isolates and QC strains were tested concurrently." The testing was conducted at "three test sites." The type of study is prospective, as it involves concurrent testing of "fresh clinical isolates" and "challenge strains."
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)
The document does not provide information on the number or qualifications of experts used to establish the ground truth. The "reference methodology" is used as the comparator, which typically implies established laboratory practices and expert interpretation but specific details are not provided.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
The document does not describe an explicit adjudication method. The comparison is made against "reference methodology," and errors (major, very major, minor) are reported based on this comparison. It does not mention multiple readers or an adjudication process for discrepancies.
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
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This study focuses on a standalone device's performance (antimicrobial susceptibility test panel) against a reference method, not on human reader performance with or without AI assistance. This device is not an AI-powered diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, a standalone study was done. The "Pasco MIC and MIC/ID Panels" are a device for quantitatively measuring antimicrobial susceptibility. The performance metrics (Essential Agreement, Category Agreement, reproducibility) are reported for the device itself against a "reference methodology." While human observation is involved in reading the panels (visible growth or color changes), the evaluation is of the device's accuracy in determining MIC values compared to the reference, not human performance using the device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The ground truth was established by "reference methodology" for antimicrobial susceptibility testing. This typically refers to established and validated laboratory methods for determining Minimum Inhibitory Concentrations (MICs), often following guidelines from organizations like the Clinical and Laboratory Standards Institute (CLSI) or its predecessors (like NCCLS, mentioned in the document). The specific nature of this "reference methodology" is not detailed but is implied to be a standard, accepted laboratory procedure.
8. The sample size for the training set
This document does not describe a "training set" as it would for a machine learning or AI model. The study is a traditional device validation comparing the Pasco panels to a reference method, not a development of an algorithm that requires a separate training phase.
9. How the ground truth for the training set was established
Not applicable, as there is no "training set" in the context of this device validation study.
§ 866.1640 Antimicrobial susceptibility test powder.
(a)
Identification. An antimicrobial susceptibility test powder is a device that consists of an antimicrobial drug powder packaged in vials in specified amounts and intended for use in clinical laboratories for determining in vitro susceptibility of bacterial pathogens to these therapeutic agents. Test results are used to determine the antimicrobial agent of choice in the treatment of bacterial diseases.(b)
Classification. Class II (performance standards).