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 and Enterococcus.

This premarket notification is for the antimicrobial agent quinupristin/dalfopristin at concentrations of 0.25-4 ug/mL to Gram Positive ID/AST or AST only Phoenix panels. Quinupristin/dalfopristin 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:

Aerobic Gram-positive microorganisms

Enterococcus faecium (vancomycin-resistant and multi-drug resistant strains only) Staphylococcus aureus (methicillin-susceptible strains only)

Active In Vitro Against:

Aerobic Gram-positive microorganisms

Staphylococcus aureus (methicillin-resistant strains) Staphylococcus epidermidis (including methicillin-resistant strains)

Synercid is not active against Enterococcus faecalis. Differentiation of enterococcal species is important to avoid misidentification of Enterococcus faecalis as Enterococcus faecium.

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. For each isolation equivalent to 0.5 McFarland standard is prepared in Phoenix ID broth.

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°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).

AI/ML Overview

This document describes the performance of the BD Phoenix™ Automated Microbiology System for Quinupristin/dalfopristin with Gram-positive organisms.

1. Table of Acceptance Criteria and Reported Device Performance:

The acceptance criteria are implicitly defined by the FDA's "Guidance on Review Criteria for Assessment of Antimicrobial Susceptibility Devices," March 8, 2000, which guides the evaluation of Essential Agreement (EA) and Category Agreement (CA). While specific numerical targets for EA and CA are not explicitly stated in the provided text as "acceptance criteria," the study aimed to demonstrate "substantially equivalent performance" to the NCCLS reference method. Typically, FDA guidance for AST devices implies high percentages for both EA and CA to achieve substantial equivalence.

Performance Metric	Acceptance Criteria (Implicit from FDA Guidance)	Reported Device Performance (Quinupristin/dalfopristin)
Essential Agreement (EA)	High percentage (e.g., >90% or 95% indicated by "substantially equivalent performance")	93.8% (n=1456)
Category Agreement (CA)	High percentage (e.g., >90% or 95% indicated by "substantially equivalent performance")	96.8% (n=1456)
Intra-site Reproducibility	Greater than 90%	Greater than 90%
Inter-site Reproducibility	Greater than 95%	Greater than 95%

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

Test Set Sample Size: 1456 isolates for the combined clinical and challenge set for Essential Agreement (EA) and Category Agreement (CA) calculations.
Data Provenance: The isolates were sourced from "Clinical, stock and challenge isolates across multiple geographically diverse sites across the United States." This indicates the data is prospective for clinical isolates (compared to a reference method) and potentially retrospective for stock and challenge isolates (with known "expected results"). The country of origin for the clinical data is the United States.

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

The document does not specify the number or qualifications of experts used to establish the ground truth. The ground truth for clinical isolates was established by the "NCCLS reference broth microdilution method," which is a standardized laboratory procedure, not typically an expert panel. For challenge isolates, the "expected results" were used, implying a pre-defined or confirmed susceptibility profile, though the method of establishment is not detailed.

4. Adjudication Method for the Test Set:

The document does not describe an adjudication method involving multiple readers. The comparison is between the BD Phoenix System's results and the NCCLS reference method or expected results for challenge isolates. It's a direct comparison against a gold standard method rather than an adjudicated consensus among human readers.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance:

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed. This study focuses on the performance of an automated system (BD Phoenix) compared to a reference laboratory method (NCCLS broth microdilution), not on human reader performance with or without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

Yes, a standalone study was performed. The BD Phoenix™ Automated Microbiology System is an automated device designed to determine antimicrobial susceptibility without human interpretative intervention in the final result generation beyond initial sample preparation and system loading. The reported performance metrics (EA, CA, reproducibility) are for the algorithm's output directly compared to the NCCLS reference method.

7. The Type of Ground Truth Used:

For clinical isolates: The ground truth was established by the NCCLS reference broth microdilution method. This is a recognized laboratory gold standard for antimicrobial susceptibility testing.
For challenge and stock isolates: The ground truth was "expected results," which typically refers to pre-determined or established susceptibility profiles for known strains.

8. The Sample Size for the Training Set:

The document does not specify a sample size for a training set. As this is an automated microbiology system that determines MIC values and categories based on a redox indicator and turbidity changes within a defined panel, it's not a machine learning model in the typical sense that would require a distinct "training set" of images or data for algorithm development. The system's underlying principles are based on established microbiological reactions and spectrophotometric measurements. Any "training" would likely refer to the initial development and calibration of the instrument and its interpretation algorithms, rather than a data-driven machine learning model trained on a specific dataset.

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

As no explicit "training set" in the context of a machine learning algorithm is described, the method for establishing its ground truth is also not applicable or detailed in the document. The system's fundamental operational parameters and interpretation algorithms would have been developed and validated against known microbiological reference standards and growth characteristics.

Summary

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510(k) SUMMARY

SUBMITTED BY:	Becton, Dickinson and Company7 Loveton CircleSparks, MD 21152Phone: 410-316-4778Fax: 410-316-4499
CONTACT NAME:	Michelle Bytheway BandyRegulatory Affairs Specialist
DATE PREPARED:	June 24, 2002
DEVICE TRADE NAME:	BD Phoenix™ Automated Microbiology System -Quinupristin/dalfopristin 0.25 - 4 µg/mL
DEVICE COMMON NAME:	Antimicrobial susceptibility test system-short incubation
DEVICE CLASSIFICATION:	In accordance with FDA's reclassification order issuedDecember 28, 2001, Docket # 97P-0313, the BD Phoenix™Automated Microbiology System has been classified as a ClassII device, Automated Antimicrobial Susceptibility System Testshort incubation (Product Code LON).
PREDICATE DEVICES:	VITEK® System (PMA No. N50510) and BD Phoenix™Automated Microbiology System with Gatifloxacin (K020321,May 23, 2002), Ofloxacin (K020323, April 14, 2002), andLevofloxacin (K020322, March 27, 2002).
INTENDED USE:	The BD Phoenix™ Automated Microbiology System isintended for the rapid identification and in vitro antimicrobialsusceptibility testing of isolates from pure culture of mostaerobic and facultative anaerobic gram-negative and gram-positive bacteria of human origin.

AUG 1 2 2002

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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DEVICE COMPARISON:

The BD Phoenix™ Automated Microbiology System demonstrated substantially equivalent performance when compared with the NCCLS reference broth microdilution method. This premarket notification provides data supporting the use of the BD Phoenix™ Automated Microbiology System Gram-positive ID/AST or AST only Phoenix panels with quinupristin/dalfopristin.

SUMMARY OF SUBSTANTIAL EQUIVALENCE TESTING:

The BD Phoenix™ Automated Microbiology System has demonstrated substantially equivalent performance when compared to the NCCLS reference broth microdilution method (AST panels prepared according to NCCLS M7). The system has been evaluated as defined in the FDA Draft guidance document, "Guidance on Review Criteria for Assessment of Antimicrobial Susceptibility Devices", March 8, 2000.

Site Reproducibility

Intra- and inter-site reproducibility of quinupristin/dalfopristin 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 with quinupristin/dalfopristin and associated reagents.

The results of the study demonstrate for the antimicrobial agent quinupristin/dalfopristin an overall intra-site reproducibility greater than 90% and an overall inter-site reproducibility greater than 95% for the gram-positive isolates tested.

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 the Gram-Positive Phoenix Panel format containing quinupristin . Phoenix System results for Challenge set isolates were compared to the expected results. Phoenix System results for clinical

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isolates were compared to the results obtained from the NCCLS 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 + on 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, and resistant).

Table 1 summarizes the performance for the isolates tested in this study.

Table 1: Performance of BD Phoenix System for Gram-Positive Organisms with Quinupristin/dalfopristin

Antimicrobial Agent	Concentration	EA (n)	EA (%)	CA (n)	CA (%)
Quinupristin/dalfopristin	0.25-4 µg/mL	1456	93.8%	1456	96.8%

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 quinupristin is substantially equivalent as outlined in the FDA draft guidance document, "Guidance on Review Criteria for Assessment of Antimicrobial Susceptibility Devices", March 8, 2000. Technological characteristics of this system are substantially equivalent to those used in both the VITEK® system, which received approval by the FDA under PMA number N50510 and the BD Phoenix™ Automated Microbiology System with Gatifloxacin (K020321, May 23, 2002), Ofloxacin (K020323, April 14, 2002), and Levofloxacin (K020322, March 27, 2002).

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Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, stacked on top of each other, with flowing lines suggesting movement or connection. The profiles are enclosed within a circular border, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the upper half of the circle.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

AUG 1 2 2002

Ms. Michelle Bytheway Bandy Regulatory Affairs Specialist Becton, Dickinson and Company 7 Loveton Circle Sparks. MD 21152

Re: K022172

Trade/Device Name: BD Phoenix™ Automated Microbiology System Regulation Number: 21 CFR 866. 1645 Regulation Name: Automated Short-Term Incubation AST Regulatory Class: Class II Product Code: LON Dated: July 2, 2002 Received: July 3, 2002

Dear Ms. Bandy:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 Part 801); good manufacturing practice requirements 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.

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Page 2 -

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and i additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrb/dsmaldsmamain.html".

Sincerely yours,

Steven Butman

Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory-Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number: K022172

Device Name: BD PhoenixTM Automated Microbiology System for use with the antimicrobial agent Quinupristin/dalfopristin (0.25-4 µg/mL) - Gram positive ID/AST or AST only Phoenix panels.

Indications for Use:

Active In Vitro and in Clinical Infections Against:

Aerobic Gram-positive microorganisms

Enterococcus faecium (vancomycin-resistant and multi-drug resistant strains only) Staphylococcus aureus (methicillin-susceptible strains only)

Active In Vitro Against:

Aerobic Gram-positive microorganisms

Staphylococcus aureus (methicillin-resistant strains) Staphylococcus epidermidis (including methicillin-resistant strains)

Synercid is not active against Enterococcus faecalis. Differentiation of enterococcal species is important to avoid misidentification of Enterococcus faecalis as Enterococcus faecium.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Division Sign-

510(k) Number K022172

Prescription Device

(Optional Format 3-10-98)

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.”