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 a modification of the algorithm for Vancomycin (0.5-32 ug/mL) with Enterococcus species and Staphylococcus species and updates for software from the last software cleared by FDA under K040099 through version 6.01.

Vancomycin 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:

Enterococci (e.g., Enterococcus faecalis)

Staphylococci, including Staphylococcus aureus and Staphylococcus epidermidis (including heterogeneous methicillin-resistant strains).

Device Description

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 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 PhoenixTM 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 agents 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° ± 19C. 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).

AI/ML Overview

BD Phoenix™ Automated Microbiology System Vancomycin (VA_18, 0.5-32 µg/mL) - GP and Phoenix Instrument SW Update through Version 6.01

1. Acceptance Criteria and Reported Device Performance:

Performance Metric	Acceptance Criteria (Implied by previous clearances/guidance)	Reported Device Performance (Vancomycin, 0.5-32 µg/mL)
Overall Reproducibility	> 95% (+/- 1 dilution) agreement	> 95% (+/- 1 dilution) agreement
Essential Agreement (EA)	Not explicitly stated, but high agreement expected	99.0% (n=1538)
Category Agreement (CA)	Not explicitly stated, but high agreement expected	99.6% (n=1538)

2. Sample Size for Test Set and Data Provenance:

Sample Size: The clinical studies report an "n" of 1538 for both Essential Agreement (EA) and Category Agreement (CA) for Vancomycin (0.5-32 µg/mL). This represents the total number of isolates tested in the clinical and challenge sets.
Data Provenance: The isolates were tested "across multiple geographically diverse sites across the United States." The study included "Clinical, stock and challenge isolates," indicating a mix of retrospective (stock/challenge could represent archived isolates) and prospective (clinical isolates collected during the study) data.

3. Number of Experts Used to Establish Ground Truth for Test Set and Qualifications:

The document does not explicitly state the number of experts or their specific qualifications. However, it mentions that the Phoenix System results for clinical isolates were compared to the results obtained from the CLSI reference broth microdilution method. This implies that the CLSI method, which is a standardized and widely accepted laboratory procedure, served as the ground truth. The execution and interpretation of this reference method would inherently involve trained microbiologists or laboratory technicians, who can be considered experts in their field.

4. Adjudication Method for the Test Set:

The document does not describe an explicit adjudication method involving multiple human readers for discrepancies. The comparison is primarily between the BD Phoenix System results and the CLSI reference broth microdilution method. Deviations would likely be analyzed based on the established accuracy and precision of the reference method and the Phoenix system's performance metrics (EA, CA).

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study focusing on human reader improvement with AI assistance was not performed. This study is an evaluation of an automated antimicrobial susceptibility testing system, not an AI-assisted diagnostic tool for human interpretation.

6. Standalone (Algorithm Only) Performance:

Yes, a standalone performance study was done. The entire study describes the performance of the BD Phoenix™ Automated Microbiology System, which is an algorithm-driven device, in determining antimicrobial susceptibility. The Essential Agreement (EA) and Category Agreement (CA) values reported (99.0% and 99.6% respectively) represent the standalone performance of the algorithm without human intervention in the interpretation of the results from the Phoenix system.

7. Type of Ground Truth Used:

The primary ground truth used was the CLSI reference broth microdilution method. For the "Challenge set isolates," the Phoenix System results were compared to "expected results," which would also be derived from established reference methods or known antimicrobial profiles of the challenge organisms. The CLSI method is a well-established and accepted laboratory gold standard for antimicrobial susceptibility testing.

8. Sample Size for the Training Set:

The document does not provide a specific sample size for a "training set." This submission is for a modification of an existing algorithm and a software update. The existing algorithm was likely developed and "trained" on a large dataset over time. The current study focuses on demonstrating the performance of the modified algorithm and software against a clinical and challenge test set.

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

As no specific "training set" and its ground truth establishment are detailed in this document, it's inferred that the initial development and "training" of the BD Phoenix system's algorithms would have relied on extensive data generated through established reference methods, such as the CLSI broth microdilution method, from a wide variety of bacterial isolates and antimicrobial agents. This iterative process of development, testing against reference standards, and refinement would have established the ground truth for the underlying algorithms.

Summary

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BD Phoenix™ Automated Microbiology System Vancomycin (VA_18, 0.5-32 µg/mL) - GP and Phoenix Instrument SW Update through Version 6.01

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510(k) SUMMARY

SUBMITTED BY:	Becton, Dickinson and Company 7 Loveton Circle Sparks, MD 21152 Phone: 410-316-4287 Fax: 410-316-4499	JUL 1 0 2013
CONTACT NAME:	Monica E. Giguere, RAC Regulatory Affairs Project Manager
DATE PREPARED:	May 3, 2013
DEVICE TRADE NAME:	BD Phoenix™ Automated Microbiology System - Vancomycin (0.5-32 µg/mL) and Software Update through Version 6.01
DEVICE COMMON NAME:	Antimicrobial susceptibility test system – short incubation
DEVICE CLASSIFICATION:	21 CFR 866.1645 Fully Automated Short-Term Incubation Cycle Antimicrobial Susceptibility System. (Product Code LON)
PREDICATE DEVICES:	VITEK® System (PMA No. N50510)
INTENDED USE:	The BD Phoenix Automated Microbiology System is intended for the in vitro rapid identification (ID) of gram positive bacteria from pure culture belonging to the genera Staphylococcus, Enterococcus, other gram positive cocci and gram positive bacilli. The BD Phoenix Automated Microbiology System is also intended for the quantitative determination of antimicrobial susceptibility by minimal inhibitory concentration (MIC) of most gram positive bacteria isolates from pure culture belonging to the genera Staphylococcus and Enterococcus.

DEVICE DESCRIPTION:

. 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. .

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BD Phoenix™ Automated Microbiology System Vancomycin (VA 18, 0.5-32 µg/mL) ~ GP and Phoenix Instrument SW Update through Version 6.01

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DEVICE COMPARISON:

The BD Phoenix™ Automated Microbiology System demonstrated substantially equivalent performance for inoculum prepared manually and inoculum prepared with the BD Phoenix™ AP instrument when compared with the CLSI reference broth microdilution method. This premarket notification is for a modification of a portion of the algorithm for Vancomycin (0.5-32 µg/mL) with Enterococcus species and Staphylococcus species and updates for software from the last software cleared by FDA under K040099 through software version 6.01.

SUMMARY OF SUBSTANTIAL EQUIVALENCE TESTING:

The BD Phoenix™ Automated Microbiology System has demonstrated substantially equivalent performance when compared to the CLSI reference broth microdilution method (AST panels prepared according to CLSI M7). The system has been evaluated as defined in the FDA guidance document. "Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems; Guidance for Industry and FDA)", August 28, 2009. Shelf life (stability data) for the drug is being collected and will be maintained on file at BD as indicated in the guidance document.

Site Reproducibility

Intra- and inter-site reproducibility of this antimicrobial agent in the BD Phoenix System was evaluated at three sites using a panel of Gram-positive isolates. Each site tested the isolates in triplicate on three different days using one lot of Gram Positive Phoenix panels containing this antimicrobial agent and associated reagents.

The results of the study demonstrate that for this antimicrobial agent and the Gram-positive organisms tested there was an overall reproducibility across test sites of greater than 95% (+/- 1 dilution) agreement when compared to the test mode.

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Clinical Studies

Clinical, stock and challenge isolates were tested across multiple geographically diverse sites across the United States to demonstrate the performance of the Phoenix antimicrobial susceptibility test with a Gram Positive Phoenix Panel containing this antimicrobial agent. Phoenix System results for Challenge set isolates were compared to the expected results. Phoenix System results for clinical isolates were compared to the results obtained from the CLSI reference broth microdilution method.

The performance of the Phoenix System was assessed by calculating Essential Agreement (EA) and Category Agreement (CA) to expected/reference results for all isolates tested. Essential Agreement (EA) occurs when the BD Phoenix™ Automated Microbiology System agrees exactly or within + one two-fold dilution to the reference result. Category Agreement (CA) occurs when the BD Phoenix™ Automated Microbiology System agrees with the reference method with respect to the FDA categorical interpretive criteria (susceptible, intermediate, resistant or not susceptible).

The following table summarizes the performance for Clinical and Challenge isolates tested in this study.

Antimicrobial	Concentration	EA (n)	EA (%)	CA (n)	CA (%)
Vancomycin	0.5-32 $µg/mL$	1538	99.0	1538	99.6

Performance of BD Phoenix System for Gram-Positive Organisms by Vancomvein

Conclusions Drawn from Substantial Equivalence Studies

The data collected from the substantial equivalence studies demonstrate that testing on the BD Phoenix™ Automated Microbiology System with this antimicrobial agent is substantially equivalent 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. Technological characteristics of this system are substantially equivalent to those used in the VITEK® system, which received approval by the FDA under PMA number N50510.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

Becton, Dickinson and Company c/o Monica Giguere Regulatory Affairs Project Manager BD Diagnostic System 7 Loveton Circle- MC614 Sparks, MD. 21152

July 10, 2013

Re: K131331

Trade/Device Name: BD Phoenix™ Automated Microbiology System- Vancomycin (0.5-32ug/mL) - Gram Positive ID/AST or AST only Phoenix Panels and update to the BD Phoenix Software through Version 6.01 Regulation Number: 21 CFR §866.1645 Regulation Name: Fully Automated Short-Term Incubation Cycle Antimicrobial Susceptibility System Regulatory Class: II Product Code: LON Dated: May 3, 2013 Received: May 13, 2013

Dear Ms. Giguere:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations. Title 21. Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements

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Page 2-Ms. Giguere

as set forth in the quality systems (QS) regulation (21 CFR Part 820): and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYowIndustry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincercly yours.

Uwe Scherf -S for

Sally A. Hojvat, M.Sc., Ph.D Director Division of Microbiology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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INDICATIONS FOR USE

510(k) Number: K131331

Device Name: Vancomycin (VA - Gram-Positive ID/AST or AST only Phoenix Panels) and update to the BD Phoenix Software through Version 6.01.

Indications for Use:

Vancomycin 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:

Enterococci (e.g., Enterococcus faecalis)

Staphylococci, including Staphylococcus aureus and Staphylococcus epidermidis (including heterogeneous methicillin-resistant strains).

Prescription Use (Per 21 CFR 801.109) Over-the-Counter Use

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

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BD Diagnostic Systems Becton, Dickinson and Company

Regulation Number and Section

§ 866.1645 Fully automated short-term incubation cycle antimicrobial susceptibility system.

(a)
Identification. A fully automated short-term incubation cycle antimicrobial susceptibility system is a device that incorporates concentrations of antimicrobial agents into a system for the purpose of determining in vitro susceptibility of bacterial pathogens isolated from clinical specimens. Test results obtained from short-term (less than 16 hours) incubation are used to determine the antimicrobial agent of choice to treat bacterial diseases.(b)
Classification. Class II (special controls). The special control for this device is FDA's guidance document entitled “Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems; Guidance for Industry and FDA.”