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 anacrobic 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 Modifications to Phoenix System Software and for the BDXpert System resident on the EpiCenter System.

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 . 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.

Software incorporated into the BD Phoenix™ Automated Microbiology System provides the user with the ability to process Phoenix ID and/or Phoenix AST panels in a walk-away fashion. The software allows for the establishment of a panel test, automated/unattended testing of the panel and the ability to review the panel results. In order to accomplish the overall general purpose of the instrument, the software provides users with the ability to interact with the instrument, when necessary to facilitate the testing that they require. The Phoenix software includes the BDXpert System which is a collection of rules intended to evaluate results for specific organism-drug combinations.

The BDXpert System that is resident on the EpiCenter System is basically the same Expert system that exists on the Phoenix System. However, the BDXpert System utilizes additional information, such as specimen site, to provide the user with a more refined SIR interpretation.

The Phoenix software was developed and tested according to its Software Dcvelopment Plan and Software Verification and Validation Plan. The software test results demonstrated that the software operated in accordance to the software specifications

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 a 0.5 McFarland standard is prepared in Phocnix ID broth.

The Phoenix AST mothod 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 pancls where they are continuously incubated at a nominal temperature of 35°C. The instrument takes readings of the pancls every 20 minutcs. 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

The provided text primarily focuses on the 510(k) submission for modifications to the BD Phoenix™ Automated Microbiology System software and the BDXpert System. It does not contain detailed information about the acceptance criteria or a specific study proving the device meets those criteria.

However, based on the context of a 510(k) submission for an antimicrobial susceptibility test system, we can infer some general acceptance criteria and the type of "study" implied for regulatory clearance.

Here's an attempt to answer your questions based on the available information and general regulatory practices for such devices:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state acceptance criteria or provide a table of performance metrics. For devices of this type, acceptance criteria typically involve demonstrating substantial equivalence to a predicate device, specifically in terms of:

Accuracy of Antimicrobial Susceptibility Testing (AST) results: This usually includes agreement rates for MIC values and categorical interpretations (Sensitive, Intermediate, Resistant) compared to a gold standard method (e.g., CLSI reference broth microdilution).
Accuracy of organism identification (ID): Agreement rates with a reference identification method.
Reliability and functionality of software: Demonstrated through software verification and validation.

The document states:

"The Phoenix software was developed and tested according to its Software Development Plan and Software Verification and Validation Plan. The software test results demonstrated that the software operated in accordance to the software specifications."

This implies that the software met its specified performance, but specific numerical criteria and results are not provided.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify the sample size for any test set or the data provenance. It mentions "The Phoenix AST method is a broth based microdilution test," but does not give details about how many isolates or tests were included in the validation for this specific submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided. For AST systems, the "ground truth" (or reference method) is typically established by trained microbiology laboratory personnel following standardized protocols (e.g., CLSI guidelines for broth microdilution). It doesn't usually involve "experts" in the same way as, for example, image interpretation.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided. Adjudication methods are more common in studies involving subjective interpretations, such as radiology. For AST, the reference method provides a more objective "ground truth."

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

An MRMC study is not mentioned, and such a study is not typically applicable to an automated microbiology system like the BD Phoenix. This device automates the testing process and provides results, reducing direct "human reader" interpretation in the classic sense of a diagnostic image. The BDXpert System provides "a more refined SIR interpretation" by utilizing additional information like specimen site, which is a form of decision support, but not a "human reader improvement with AI" study in the MRMC context.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

The BD Phoenix system itself is essentially a standalone (algorithm only) device in its core function of determining MICs and SIR interpretations. While a human initiates the test and reviews results, the determination of susceptibility is automated. The BDXpert System is described as "a collection of rules intended to evaluate results for specific organism-drug combinations," which is an algorithmic component operating without continuous direct human intervention during the interpretation process. The submission details "Software incorporated... provides the user with the ability to process Phoenix ID and/or Phoenix AST panels in a walk-away fashion." This confirms standalone algorithmic performance for test processing and initial interpretation.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For antimicrobial susceptibility testing, the ground truth is typically established using a Clinical and Laboratory Standards Institute (CLSI) reference broth microdilution method or other recognized reference methods for antimicrobial susceptibility testing. This is the industry standard for validating AST devices. The document states: "The Phoenix AST method is a broth based microdilution test," implying it's designed to align with such standards, and its performance would be compared against a reference method.

8. The sample size for the training set

The document does not provide any information about a "training set." This type of device, particularly the software modifications described, is likely validated against established performance criteria and reference methods rather than through a machine learning training paradigm that requires a distinct training set. The BDXpert System, described as "a collection of rules," suggests a rule-based expert system rather than a machine learning model that would be "trained" on data.

9. How the ground truth for the training set was established

Since no training set is mentioned in the provided text, this question cannot be answered.

Summary

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MAR 1 9 2004

KC40099

BD PHOENIX™ Automated Microbiology System

CONFIDENTIAL AND PROPRIETARY

Modifications to Phoenix Instrument Software through Version 4.0 and BDXpert System Resident on EpiCcnter System

510(K) SUMMARY

SUBMITTED BY:	Becton, Dickinson and Company7 Loveton CircleSparks, MD 21152Phone: 410-316-4287Fax: 410-316-4499
CONTACT NAME:	Monica E. Giguere,Regulatory Affairs Specialist
DATE PREPARED:	January 16, 2004
DEVICE TRADE NAME:	BD Phoenix™ Automated Microbiology System -Modifications to Phoenix System Software through Version 4.0and BDXpert System resident on the EpiCenter System
DEVICE COMMON NAME:	Antimicrobial susceptibility test system-short incubation
DEVICE CLASSIFICATION:	Fully Automated Short-Term Incubation Cycle AntimicrobialSusceptibility Device, 21 CFR 866.1645
PREDICATE DEVICES:	BD Phoenix™ Automated Microbiology System withGatifloxacin (K020321, May 23, 2002), Ofloxacin (K020323, April 14, 2002), and Levofloxacin (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.

DEVICE DESCRIPTION:

. 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.

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DEVICE COMPARISON:

The modifications to Phoenix Instrument Software through Version 4.0 and the BDXpert System resident on the EpiCenter System, as described in this submission, are substantially equivalent' to BD Phoenix™ Automated Microbiology System with Gatifloxacin (K020321, May 23, 2002), Offloxacin (K020323, April 14, 2002), and I.evofloxacin (K020322, March 27, 2002) (also referred to as previously submitted Phoenix Instrument software).

The term "substantial equivalence" as used in this 510(k) notification is limited to the definition of substantial equivalence as found in the Federal Food, Drug and Cosmetic Act, as amended and as applied under 21 CFR 807, Subpart E under which a device can be marketed without pro-market approval or reclassification. A determination of substantial equivalency under this not ison is not intended to have any bearing whatsoever on the resolution of patent infringement suits or any other patent matterns. related to, or in support of substantial equivalence herein shall be construed as an admission against under tro U.Patint Laws or their application by the courts.

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The modifications to Phoenix Instrument Software through Version 4.0 and the BD Phoenix™ Automated Microbiology System (K020321, K020323, and K020322) are similar in that they have the same intended use and automatically provide the user with antimicrobic minimum inhibitory concentration (MIC) results and SIR interpretations. The modifications to Phoenix Instrument Software through Version 4.0 and the BD Phoenix™ Automated Microbiology System (K020321, K020323, and K020322) are different because of new features introduced into the software as described in this submission.

The BDXpert System resident on the EpiCenter System is similar to the BD Phoenix™ Automated Microbiology System (K020321, K020323, and K020322) in that both automatically provide the user with reports containing antimicrobic minimum inhibitory concentration (MIC) results and SIR interpretations. The BDXpert System resident on the EpiCenter System is different from the BD Phoenix™ Automated Microbiology System (K020321, K020323, and K020322) in that the BDXpert System resident on the EpiCenter System in itself does not actually perform the analysis of the test panels. The BD Phoenix™ Automated Microbiology System actually performs the test analysis. Also the BDXpert System resident on the EpiCenter System utilizes additional information, such as specimen type, to determine the BDXpert SIR interpretation. The BD Phoenix™ Automated Microbiology System does not use this information when determining the BDXpert SIR interpretation.

Although there are some differences between the BD Phoenix™ Automated Microbiology System and the reference method and predicate device, these differences do not raise new issues of safety and effectivencss.

In review of previous 510(k) premarket notifications for the BD Phoenix™ Automated Microbiology System with Gatifloxacin (K020321, May 23, 2002), with Ofloxacin (K020323, April 14, 2002), and with Levofloxacin (K020322, March 27, 2002) the Food and Drug Administration (FDA) has determined the Phocnix system to be substantially equivalent to devices market

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The bird is positioned above a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA".

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

MAR 1 9 2004

Ms. Monica E. Giguere Regulatory Affairs Specialist BD Diagnostics Systems Becton, Dickinson and Company 7 Loveton Circle Sparks, MD 21152

Re: K040099 Trade/Device Name: BD Phoenix™ Automated Microbiology Systems Modifications to Phoenix System Software through Version 4.0 and higher and BDXpert system resident on the EpiCenter System Regulation Number: 21 CFR 866.1645 Regulation Name: Fully Automated Short-Term Incubation Cycle Antimicrobial Susceptibility Devices Regulatory Class: Class II Product Code: LON Dated: January 16, 2004 Received: January 20, 2004

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.

If your device is classified (see above) into either class II (Special Controls) o. class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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Page 2

This letter will allow you to begin marketing your device as described in your Section 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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely vours.

Salazar

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

Enclosure

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REGULATORY AFFAIRS

BD PHOENIX™ Automated Microbiology System

CONFIDENTIAL AND PROPRIETARY

Modifications to Phoenix Instrument Software through Version 4.0 and BDXpert System Resident on EpiCenter System K040099

INDICATIONS FOR USE

510(k) Number (if known): _ KOYOO99

...

BD Phoenix™ Automated Microbiology System - Modifications to Phoenix System Device Name: Software through Version 4.0 and higher and BDXpert system resident on the EpiCenter System

Indications for Use:

This premarket notification is for the Modifications to Phoenix System Software and for the BDXpert System resident on the EpiCenter System.

Prescription Use V (Part 21 CFR 801 Subpart D) AND/OR

Over-the-Counter Use (21 CFR 807 Subpart C)

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

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

Freddie H. Cole

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

Page 1 of 1

510(k) K040099

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.”