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510(k) Data Aggregation
(150 days)
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM TIGECYCLINE (0.25-16 UG/ML)
The BD Phoenix™ Automated Microbiology System is intended for the in vitro rapid identification (ID) and quantitative determination of antimicrobial susceptibility by minimal inhibitory concentration (MIC) of Gram Negative aerobic and facultative anaerobic bacteria belonging to the family Enterobacteriaceae and non-Enterobacteriaceae.
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 the addition of the antimicrobial agent Tigecycline at concentrations of 0.25 - 16pg/mL to Gram-negative ID/AST or AST only Phoenix panels. Tigecycline 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.
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 or 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 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. Inoculum for use with the Phoenix system may be prepared either manually or may be automated using the BD Phoenix™ AP System.
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 aqents with a wide range of two-fold doubling dilution concentrations.
The instrument houses the panels where they are continuously incubated at a nominal temperature of 35° ± 1°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, R or N (susceptible, intermediate, resistant or not susceptible).
Acceptance Criteria and Study for BD Phoenix™ Automated Microbiology System - Tigecycline
1. Table of Acceptance Criteria and Reported Device Performance
| Parameter | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Site Reproducibility | > 95% agreement (+/- 1 dilution) across test sites compared to the "test mode" for the antimicrobial agent and Gram-negative organisms. | > 95% overall reproducibility across test sites (+/- 1 dilution) agreement compared to the test mode. |
| Essential Agreement (EA) | Not explicitly stated as a numerical criterion in the provided text, but the study aims to demonstrate "substantially equivalent performance" to the CLSI reference method. For AST systems, typical FDA guidance expects high EA. | 97.5% EA for Tigecycline (n=884 isolates). |
| Category Agreement (CA) | Not explicitly stated as a numerical criterion in the provided text, but the study aims to demonstrate "substantially equivalent performance" to the CLSI reference method. For AST systems, typical FDA guidance expects high CA. | 97.4% CA for Tigecycline (n=884 isolates). |
| Substantial Equivalence | The device demonstrates substantially equivalent performance when compared to the CLSI reference broth microdilution method and the VITEK® System, as outlined in the FDA guidance document "Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems; Guidance for Industry and FDA," August 28, 2009. | The study concludes that the data demonstrate substantial equivalence to the CLSI reference method and the VITEK® system. |
2. Sample Sizes Used for the Test Set and Data Provenance
- Test Set Sample Size:
- Clinical Studies (Primary Performance Evaluation): 884 isolates for Tigecycline (as indicated by the 'n' in the EA and CA percentages). This number includes clinical, stock, and challenge isolates.
- Site Reproducibility: A "panel of Gram-negative isolates" was tested, with each isolate tested in triplicate on three different days. The exact number of unique isolates in this panel is not specified.
- Data Provenance: Multiple geographically diverse sites across the United States. The study included both clinical isolates and stock/challenge isolates.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document does not explicitly state the number of experts used or their detailed qualifications (e.g., radiologist with 10 years of experience). However, the ground truth for the clinical isolates was established by the CLSI reference broth microdilution method, which is a standardized laboratory procedure, not typically an expert consensus per se. For challenge isolates, ground truth was "expected results," implying pre-defined or historically validated results often derived from expert validation of strains or widely accepted reference methods.
4. Adjudication Method for the Test Set
The document does not describe an adjudication method in the context of expert review for establishing ground truth, as the ground truth was primarily based on the CLSI reference method or "expected results" for challenge isolates. The comparison was statistical (Essential Agreement, Category Agreement) against these established reference values.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, an MRMC comparative effectiveness study involving human readers improving with or without AI assistance was not conducted or described. This study is an evaluation of an automated microbiology system's performance against a reference method, not an assessment of human reader performance.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Yes, a standalone study was performed. The BD Phoenix™ Automated Microbiology System operates without human intervention once the inoculated panel is placed in the instrument. The results (ID, MIC values, and category interpretations S, I, R, or N) are generated solely by the system's internal algorithms and sensors. The performance assessed (EA and CA) directly reflects the algorithm's standalone accuracy against the reference method.
7. Type of Ground Truth Used
- Clinical Isolates: The CLSI reference broth microdilution method was used to establish the ground truth for clinical isolates. This is a widely accepted laboratory standard for antimicrobial susceptibility testing.
- Challenge Isolates: "Expected results" were used. This typically refers to results for well-characterized strains where the true susceptibility is known or has been extensively validated.
8. Sample Size for the Training Set
The document does not provide any information regarding the sample size used for the training set of the BD Phoenix™ system's algorithms. The summary focuses solely on the validation/test studies for the new antimicrobial agent Tigecycline.
9. How the Ground Truth for the Training Set Was Established
The document does not provide any information on how the ground truth for the training set was established. This information would typically be part of the initial development and validation of the BD Phoenix™ system itself, rather than a submission for adding a new antimicrobial agent.
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