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510(k) Data Aggregation
(57 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 Gemifloxacin at concentrations of 0.015 - 4 mcg/ml to Pasco Panels. Gemifloxacin 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-negative microorganisms Klebsiella pneumoniae Active In Vitro but their clinical significance is unknown Aerobic Gram-positive microorganisms Staphylococcus aureus (methicillin-susceptible strains only) Aerobic Gram-negative microorganisms Acinetobacter lwoffi Klebsiella oxytoca 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.
The information provided describes the acceptance criteria and the study conducted for the Pasco MIC and MIC/ID Panels with the addition of Gemifloxacin.
Here's the breakdown as requested:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Essential Agreement (EA) | Acceptable (e.g., >90-95%) | 99.7% |
| Major Errors (M) | Zero | No major errors observed |
| Very Major Errors (VM) | Zero | No very major errors observed |
| Category Agreement (CA) | Acceptable (e.g., >90-95%) | 99.3% |
| Minor Discrepancies | Acceptable; within EA | 5 random minor discrepancies (all within EA) |
| QC Endpoints (S. aureus ATCC 29213, E. faecalis ATCC 29212, E. coli ATCC 25922, P. aeruginosa ATCC 27853) | Acceptable | Acceptable |
| Inter-site Reproducibility (MIC results) | Acceptable | 99.6% |
| Intra-site Reproducibility (MIC results) | Acceptable | 100% (two sites), 99% (one site) |
Note: The specific numerical acceptance criteria (e.g., a precise percentage for EA or CA) are not explicitly stated in the provided text. However, "acceptable" and the absence of major/very major errors imply that the reported performance met the pre-defined thresholds for regulatory approval.
2. Sample Sizes Used for the Test Set and Data Provenance
- Sample Size (Test Set): 615 isolates (challenge and clinical Enterobacteriaceae and Acinetobacter sp.)
- Data Provenance: The isolates included "challenge strains, fresh clinical isolates, stock clinical isolates and QC strains." The study was conducted at "three test sites." The text does not specify the country of origin but implies a multi-site clinical evaluation. It is a prospective or concurrent evaluation as it compares the Pasco methodology to a reference methodology.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- This information is not provided in the given text. The ground truth (reference methodology) is mentioned, but details about the experts involved in establishing it are absent.
4. Adjudication Method for the Test Set
- This information is not provided in the given text.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted as the device is an automated antimicrobial susceptibility test panel, not an interpretive imaging device requiring human readers.
6. Standalone Performance
- Yes, a standalone (algorithm only) performance was done. The device's performance (Essential Agreement, Category Agreement, etc.) was directly compared against a reference methodology without human intervention in the interpretation of the core MIC values.
7. Type of Ground Truth Used
- The ground truth used was established by a "reference methodology". The text doesn't specify the exact nature of this reference methodology (e.g., specific manual dilution methods, another FDA-approved AST system, etc.), but it is implied to be a gold standard for antimicrobial susceptibility testing.
8. Sample Size for the Training Set
- This information is not provided in the given text. The document focuses on the validation of the device, not its development or training phase.
9. How the Ground Truth for the Training Set Was Established
- This information is not provided in the given text, as details on the training set are absent.
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