Search Results
Found 1 results
510(k) Data Aggregation
(23 days)
The BD Phoenix™ Automated Microbiology System is intended for the rapid identification and in vitro antimicrobial susceptibility testing of isolates from pure culture of most aerobic and facultative anaerobic Gram-negative and Gram-positive bacteria of human origin.
The BD Phoenix™ Automated Microbiology System is intended for in vitro quantitative determination of antimicrobial susceptibility by minimal inhibitory concentration (MIC) of most Gram-negative aerobic and facultative anaerobic bacteria isolates from pure culture for Enterobacteriaceae and Non-Enterobacteriaceae and most Gram-positive bacteria isolates from pure culture belonging to the genera Staphylococcus, Enterococcus, and Streptococcus.
This premarket notification is for additional Gram-negative organism groups and Ampicillin -0.5-32 µg/mL on the BD Phoenix Automated Microbiology System.
Ampicillin 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 antimicrobial agent.
Active In Vitro and in Clinical Infections Against:
Escherichia coli Proteus mirabilis Salmonella species Shigella species
The BD Phoenix Automated Microbiology System (Phoenix System) is an automated system for the rapid identification (ID) and antimicrobial susceptibility testing (AST) of clinically relevant bacterial isolates. The system includes the following components:
- BD Phoenix instrument and software. .
- BD Phoenix panels containing biochemicals for organism ID testing and antimicrobial agents . for AST determinations.
- BD Phoenix ID Broth used for performing ID tests and preparing AST Broth inoculum. ●
- BD Phoenix AST Broth used for performing AST tests only. .
- BD Phoenix AST Indicator solution added to the AST Broth to aid in bacterial growth . determination.
The Phoenix AST method is a broth based microdilution test. The Phoenix System utilizes a redox indicator for the detection of organism growth in the presence of an antimicrobial agent.
The Phoenix AST method is a broth based microdilution test. The Phoenix System utilizes a redox indicator for the detection of organism growth in the presence of an antimicrobial agent. Measurements of changes to the indicator as well as bacterial turbidity are used in the determination of bacterial growth. Each AST panel configuration contains several antimicrobial agents with a wide range of two-fold doubling dilution concentrations.
The Phoenix panel is a sealed and self-inoculating molded polystyrene tray with 136 micro-wells containing dried reagents. Organisms for susceptibility testing must be a pure culture and preliminarily identified as a Gram-negative or Gram-positive isolate. Phoenix panels are inoculated with a specified organism density and placed into the instrument.
The instrument houses the panels where they are continuously incubated at a nominal temperature of 35°C. The instrument takes readings of the panels every 20 minutes. The readings are interpreted to give an identification of the isolate, minimum inhibitory concentration (MIC) values and category interpretations, S, I, or R (sensitive, intermediate, or resistant).
This document describes the acceptance criteria and study proving the BD Phoenix™ Automated Microbiology System with Ampicillin meets these criteria.
1. Acceptance Criteria and Reported Device Performance
The acceptance criteria for the BD Phoenix™ Automated Microbiology System are based on achieving pre-defined Essential Agreement (EA) and Category Agreement (CA) with a CLSI reference broth microdilution method.
| Metric | Acceptance Criteria (Not explicitly stated as a numerical threshold, but implied by substantial equivalence to CLSI reference method) | Reported Device Performance |
|---|---|---|
| Essential Agreement (EA) | Expected to be high, demonstrating agreement within ± one two-fold dilution to the reference. | Not explicitly quantified in a table but stated "excellent" |
| Category Agreement (CA) | Expected to be high, demonstrating agreement with FDA categorical interpretive criteria (S, I, R). | Not explicitly quantified in a table but stated "excellent" |
| Site Reproducibility | > 90% intra-site, > 95% inter-site | > 90% intra-site reproducibility, > 95% inter-site reproducibility |
2. Sample Size and Data Provenance
- Test Set Sample Size: Not explicitly stated as a single number. The study tested "clinical, stock and challenge isolates."
- Clinical isolates: Number not specified.
- Challenge isolates: Number not specified.
- Data Provenance: Multiple geographically diverse sites across the United States. The study included both retrospective (stock and challenge isolates) and prospective (clinical isolates) data.
3. Number of Experts and Qualifications for Ground Truth
Not applicable. The ground truth was established by a reference laboratory method (CLSI reference broth microdilution method), not by expert consensus.
4. Adjudication Method for Test Set
Not applicable. The primary comparison was against a reference laboratory method (CLSI reference broth microdilution method), not through human adjudication of results.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, an MRMC comparative effectiveness study was not performed. This device is an automated system for antimicrobial susceptibility testing, not a diagnostic imaging or interpretive aid that would typically involve human readers.
6. Standalone Performance (Algorithm Only)
Yes, standalone performance was assessed. The BD Phoenix™ Automated Microbiology System is an automated system that provides results without human intervention in the interpretation of the raw data. Its performance was compared directly to the CLSI reference broth microdilution method.
7. Type of Ground Truth Used
The ground truth used was the CLSI reference broth microdilution method (AST panels prepared according to NCCLS M7). For challenge isolates, the Phoenix System results were compared to "expected results," which would also be derived from a validated reference method.
8. Sample Size for Training Set
The document does not explicitly mention a "training set" in the context of machine learning. The system's underlying algorithm for growth detection and MIC determination is based on a redox indicator and bacterial turbidity measurements. The development of this algorithm would have involved a large number of diverse isolates, but a specific "training set" size in the modern machine learning sense is not provided. The phrase "Clinical, stock and challenge isolates were tested" refers to the evaluation/validation set discussed.
9. How Ground Truth for Training Set was Established
Given that this is an automated microbiology system, the "training" (development) of the system's algorithm and decision rules would have been based on extensive studies correlating the redox indicator changes and turbidity measurements with MIC values historically determined by established reference methods like CLSI broth microdilution. The document implies that the system's ability to determine MIC values and category interpretations (S, I, or R) was developed based on comparing its output to these reference methods.
Ask a specific question about this device
Page 1 of 1