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 the antimicrobial susceptibility of isolates (minimum inhibitory concentration (MIC)) of most Gram-negative aerobic and facultative anaerobic bacteria isolates from pure culture for Enterobacteriaceae and Non-Enterobacteriaceae and Gram-positive aerobic and facultative anaerobic bacteria isolates from pure culture belonging to the genera Staphylococcus, Enterococcus and Streptococcus.

This premarket notification is for the addition of the antimicrobial agent levofloxacin at concentrations of 0.25-16 ug/mL to Streptococcus ID/AST or AST only Phoenix Panels. Levofloxacin has been shown to be active in vitro and in clinical infections against Streptococcus pneumoniae (including penicillin-resistant strains) and Streptococcus pyogenes. Levofloxacin has been shown to be active in vitro against Streptococcus (Group C), Streptococcus (Group G), Streptococcus agalactiae, and Streptococcus viridans group (Viridans group streptococci, Streptococcus (Group F), and Streptococcus milleri).

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. For testing streptococcal species 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-S Broth used for performing AST tests only.
BD Phoenix AST-S 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 isolate, an inoculation equivalent to a 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, R or N (susceptible, intermediate, resistant or nonsusceptible).

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the BD Phoenix™ Automated Microbiology System - Levofloxacin 0.25-16 µg/mL, based on the provided 510(k) summary:

Acceptance Criteria and Device Performance

Acceptance Criteria	Reported Device Performance
Essential Agreement (EA)	97% for Levofloxacin at 0.25-16 µg/mL (n=1055)
Category Agreement (CA)	99.8% for Levofloxacin at 0.25-16 µg/mL (n=1055)
Intra-site reproducibility	Greater than 90%
Inter-site reproducibility	Greater than 95%
Reproducibility (overall)	95% or greater within ± 1 dilution

Study Details

2. Sample size used for the test set and the data provenance:

Test Set Sample Size: 1055 isolates were tested for Levofloxacin. This includes "Clinical, stock and challenge isolates."
Data Provenance: The isolates were tested "across multiple geographically diverse sites across the United States." The study used a combination of:
- Clinical isolates: Compared to the CLSI reference broth microdilution method.
- Stock isolates: Likely reference strains from culture collections.
- Challenge isolates: Compared to expected results.
  The study is therefore prospective in nature, as it involves testing isolates on the device and comparing them to a reference method, rather than analyzing pre-existing data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

The document does not specify the number or qualifications of experts involved in establishing the ground truth.
The ground truth for clinical isolates was established by the CLSI reference broth microdilution method.
The ground truth for challenge isolates was established by "expected results," implying pre-determined characteristics.

4. Adjudication method for the test set:

The document does not explicitly describe an adjudication method involving multiple experts for the test set results.
The comparison is primarily a direct comparison of the Phoenix System results to either the CLSI reference method or expected results for challenge isolates.

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:

No. This is an automated microbiology system for antimicrobial susceptibility testing. The effectiveness study performed is a comparison of the automated device's performance against a reference laboratory method, not an assessment of human readers with or without AI assistance. Therefore, an MRMC study and effect size for human readers are not applicable.

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

Yes. The study evaluates the "BD Phoenix™ Automated Microbiology System" as a standalone device. Its performance (MIC values and category interpretations) is directly compared to a reference method without human interpretation of the device's raw output. The system is designed to provide automated results.

7. The type of ground truth used:

Expert Consensus / Reference Method: For clinical isolates, the ground truth was established by the CLSI reference broth microdilution method, which is a standardized, expert-defined method.
Expected Results: For challenge isolates, the ground truth was "expected results," meaning pre-defined and verified characteristics of the strains.

8. The sample size for the training set:

The document does not explicitly state the sample size for a training set. This is typical for a microbiology susceptibility test where the "training" usually involves establishing the parameters and algorithms based on extensive prior knowledge of microbial growth and drug interaction, rather than an explicit machine learning training set in the contemporary sense. The system's underlying algorithms are likely developed and validated using a large body of historical data and microbiological principles, which are not detailed as a "training set" in this type of submission.

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

As a specific "training set" is not detailed, the establishment of ground truth for any underlying algorithm development would have been based on established microbiological principles, reference methods (like CLSI microbroth dilution), and extensive empirical data collected over time during the development of the Phoenix system. This involves correlating phenotypic growth responses to known antimicrobial concentrations and clinical outcomes. This information is not explicitly provided in the 510(k) summary for a "training set."

Summary

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510(k) SUMMARY	APR 2 9 2005K050747
SUBMITTED BY:	Becton, Dickinson and Company7 Loveton CircleSparks, MD 21152Phone: 410-316-4287Fax: 410-316-4499
CONTACT NAME:	Monica Evelyn Giguere,RA Specialist
DATE PREPARED:	March 18, 2005
DEVICE TRADE NAME:	BD Phoenix™ Automated Microbiology System -Levofloxacin 0.25-16 µg/mL
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:	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.

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-S Broth used for performing AST tests only. .
BD Phoenix AST-S 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 CLSI reference broth microdilution method. This premarket notification provides data supporting the use of the BD Phoenix™ Automated Microbiology System Streptococcus ID/AST or AST only Phoenix panels with this antimicrobial agent.

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 NCCLS M7). The system has been evaluated as defined in the FDA Draft guidance document, "Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems; Guidance for Industry and FDA," February 5, 2003.

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 streptococcal isolates. Each site tested the isolates in triplicate on three different days using one lot of Streptococcus Phoenix panels containing this antimicrobial agent and associated reagents.

The results of the study demonstrate for the this antimicrobial agent there was an overall intra-site reproducibility of greater than 90% and an overall inter-site reproducibility greater than 95% for the streptococcal isolates tested.

BD Diagnostic Systems Becton, Dickinson and Company

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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 the Streptococcus Phoenix Panel format 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 nonsusceptible).

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

Performance of BD Phoenix System for Streptococcal Organisms by Drug Table 1:

THE REAL PROPERTY OF CHARACT THE COLUMN OF CLAIM OF CLAIM OF CLAIM OF CLAIM OF CLAIM OF CLAIM OF CLAIM OF CLAIM OF CLAIM OF CLAIM OF CLAIM OF CLAIM OF CLAIM OF CLAIM OF CLEANPRODUCT OF COLLECTION OF COLLECTIONAntimicrobial	LAND L BOLL CONTRACT THE FILM I 1------------------------------------------------------------------------------------------------------------------------------------------------------------------------------Concentration	LALE SECTION COLL OF C. OPEN CO. OF C.B-8000 - Book Tournal Comments of Children Come ofEA (n)PROPERTY LIGHT LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEA	Company Come Come Come Come Come Come Come Come Come Come Come Come Come Come Come Come Come Come Come Come Come Come Come Come Come Come Come Come Come Come Come Come Come C10/10 A11/2017Canadian Call A C . A	(nCA 'worker from annual orThe later an an an an an an an an an an an an an an an an an an an an an an an an an an an an an an an an an an an an-	())C70
1000 000 000 000 000 000 000 000 000 000 0000 0000 0000 0000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000and would and the mille asCarreralLevolloxacin	THE COLLECT COLLEGION COLLSTATIST I W . I. 0 75 1 710 ug/mL	10551 VW	C	1055	00 -سنڌ جي جي جي

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 draft guidance document, "Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems; Guidance for Industry and FDA," February 5, 2003. 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 and 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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SUMMARY INFORMATION FOR LEVOFLOXACIN Available Range 0.25-16 µg/mL

Performance

Accuracy

Antimicrobial	Concentration	EA (n)	EA (%)	CA (n)	CA (%)
Levotloxacın	0 75-17	1055	07	1055	. QQ ~
	16 ug/mL	A 2011 11/2 11/2017 11/2017 11/11/2017 11/11/2017 11/11/2017 11/11/2017 11/11/2017 11/11/2017 11/11/2017 11/11/2017 11/11/2017 11/11/2017 11/11/2017 11/11/2017 11/11/2017 11/	11.6	پ پ پ مم	1100

Reproducibility

Testing performed at multiple clinical sites demonstrated 95% reproducibility or greater within ± 1 dilution.

Breakpoints - CLSI, FDA

Organism	S	I	R
Streptococcus pneumoniae	$\leq2$	4	$\geq8$
Streptococcus spp. Other thanStreptococcus pneumoniae	$\leq2$	4	$\geq8$

Recommended Quality Control Organisms

Quality Control Strain	MIC Range	Source
Streptococcus pneumoniae ATCC 49619	0.5-2 $ μg/mL $	NCCLS

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three horizontal lines above it, representing the agency's mission to promote health and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle symbol. The logo is in black and white.

APR 2 9 2005

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

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

K050747 Re:

R0507 . .
Trade/Device Name: BD PhoenixTM Automated Microbiology System Levofloxacin (0.25-16 µg/mL) - Streptococcus ID/AST or AST 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: March 18, 2005 Received: March 22, 2005

Dear Ms. Giguere:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your bector of the device is substantially equivalent (for the indications felerenced above and have acterimes as a microse devices marketed in interstate for use stated in the encrosule) is regars and ment date of the Medical Device Amendments, or to comments proc to May 20, 1978, the occordance with the provisions of the Federal Food, Drug, devices that have occh recuire approval of a premarket approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a premarket approval application (PM allu Cosmetic Act (1101) that do not requesable to the general controls provisions of the Act. The r ou may, therefore, market and act include requirements for annual registration, listing of general controls provisions or ractice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), If your device is classified (860 as 10) throls. Existing major regulations affecting your device It may be subject to Such additional come Regulations (CFR), Parts 800 to 895. In addition, FDA can be found in Thic 21, Cours ents concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that 1 Dri 3 issuated or woulder complies with other requirements of the Act that I DA has made a doted regulations administered by other Federal agencies. You must of ally if ederal statutes and regulance and limited to: registration and listing (21 Comply with the Free 5 require Parts 801 and 809); and good manufacturing practice CFR Part 807), labeling (21 CF 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) I his letter will anow you to ogin manismig of substantial equivalence of your device to a legally premarket notification: "The PDT Intamig cification 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, of f If you desire specific information assuments of your device, please contact the Office of In of questions on the promotion and Safety at (240)276-0484. Also, please note the ville Diagnostic Device Device by reference to premarket notification" (21 CFR Part 807.97). Tegulation other general information on your responsibilities under the Act from the You may of amall 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/industry/support/index.html

Sincerely yours,

Sally a Form

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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Page 1 of 1

510(k) Number: K050742

Device Name: BD Phoenix™ Automated Microbiology System for use with the antimicrobial agent Device Name: " BDTHochix" - Tureptococcus ID/AST or AST only Phoenix Panels.

Indications for Use:

The BD Phoenix™ Automated Microbiology System is intended for in vitro quantitative determination of The BD Phoenix™ Automated witchology Uystem is mation (MIC) of most Gram-negative aerobice aetobic and antimicrobial susceptibility of inimal inincitory obiteriaceae and Non-Enterobacteriaceae
facultative anaerobic bacteria isolates from pure culture for Execuences of Starbul iacultative anaeroone bacteria isolates from pure culture belonging to the genera Staphylococcus, Enterococcus and Streptococcus.

Enterococcus and Streplococcus.
This premarket notification of the antimicrobial agent levolfoxacin at concern has been have to This premarket notification is for the addition of the untinue of the other his been shown to be 0.25-16 ug/mL to Streptococcus DIAST of AST only I notime parties "Every Lesseribed in the FDA-approved package insert for this antimicrobial agent.

Active In Vitro and in Clinical Infections Against:

Streptococcus pneumoniae (including penicillin-resistant strains) Streptococcus pyogenes

Active In Vitro Against:

Streptococcus (Group C) Streptococcus (Group G) Streptococcus agalactiae Streptococcus viridans group (Viridans group streptococci, Streptococcus (Group F), and Streptococcus milleri)

Over-the-Counter Use

Prescription Use (Per 21 CFR 801.109)

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

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

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K050747

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.”