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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 ampicillin-sulbactam at concentrations of 1/0.5-32/16 µg/mL to Gramnegative ID/AST or AST only Phoenix panels with the removal of the limitations for Acinetobacter species and Proteus mirabilis. Ampicillin-sulbactam 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:
Beta-lactamase producing strains of: Acinetobacter calcoaceticus Enterobacter spp. Escherichia coli

Active In Vitro Against:
Escherichia coli (Beta-lactamase and non-beta-lactamase producing) Klebsiella species (all know strains are beta-lactamase producing) Morganella morganii Proteus mirabilis (Beta-lactamase and non-beta-lactamase producing) Beta-lactamase producing strains of: Klebsiella spp. (including K. pneumoniae) Proteus mirabilis

Providencia rettgeri Providencia stuartii

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. 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 in 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).

Acceptance Criteria and Device Performance Study for BD Phoenix™ Automated Microbiology System – Ampicillin-sulbactam

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the "Essential Agreement (EA)" and "Category Agreement (CA)" metrics, compared against the CLSI reference broth microdilution method. While explicit pass/fail thresholds are not stated here, regulatory guidance documents for AST systems typically require high percentages for both EA and CA (e.g., >90%).

Note: The table in the original document has non-English text in the EA (%) column, making the exact reported percentage for EA unclear. However, the overall conclusion of "substantial equivalence" suggests that the EA met the required performance.

2. Sample Size Used for the Test Set and Data Provenance

• Test Set Sample Size: 1106 isolates for clinical studies.
• Data Provenance:
  • Country of Origin: United States. Isolates were tested "across multiple geographically diverse sites across the United States."
  • Retrospective/Prospective: Not explicitly stated as either purely retrospective or prospective. The use of "clinical, stock and challenge isolates" suggests a mix. "Clinical isolates" would likely have been prospectively collected for the study or clinical practice, while "stock and challenge isolates" are laboratory-maintained collections.

3. Number of Experts Used to Establish Ground Truth and Qualifications

• Number of Experts: Not applicable, as expert consensus was not the method used for establishing ground truth for AST results.
• Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. The ground truth for antimicrobial susceptibility testing is typically established by a standardized reference method, not through consensus of human readers.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• Was an MRMC study done? No. This study evaluates the performance of an automated device against a reference method, not the improvement of human readers with AI assistance.

6. Standalone Performance Study

• Was a standalone study done? Yes. The study directly compares the BD Phoenix™ System's results (algorithm only, without human-in-the-loop performance influencing the MIC determination) against the CLSI reference broth microdilution method.

7. Type of Ground Truth Used

• Type of Ground Truth: The CLSI reference broth microdilution method was used as the ground truth for clinical isolates. For "challenge set isolates," the Phoenix System results were compared to "expected results," which are typically pre-determined by the reference method.

8. Sample Size for the Training Set

• The document does not explicitly state the sample size for a training set. This product is an AST system for a specific antimicrobial agent (Ampicillin-sulbactam), and its development likely involved internal data for algorithm training and optimization, but this information is not provided in this 510(k) summary. The clinical studies described are for validation, not training.

9. How the Ground Truth for the Training Set Was Established

• The document does not provide information on how the ground truth for any potential training set was established. This information is typically proprietary to the device manufacturer and not always included in a 510(k) summary focused on validation data. However, it would logically follow similar principles as the validation ground truth, i.e., using a recognized reference method like the CLSI broth microdilution method.

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