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 addition of the antimicrobial agent Norfloxacin at concentrations of 0.25-16 ug/mL to Gram Negative ID/AST or AST only Phoenix panels. Norfloxacin 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:
Citrobacter freundii Enterobacter aerogenes Enterobacter cloacae Escherichia coli
Klebsiella pneumoniae ssp. pneumoniae Proteus mirabilis Proteus vulgaris Pseudomonas aeruginosa

Active In Vitro Against:
Citrobacter koseri (formerly Citrobacter diversus) Edwardsiella tarda Klebsiella oxytoca Morganella morganii Pantoea agglomerans
Providencia alcalifaciens Providencia rettgeri Providencia stuartii
Pseudomonas fluorescens Pseudomonas stutzeri

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 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, or R (sensitive, intermediate, or resistant).

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the BD Phoenix Automated Microbiology System with Norfloxacin, based on the provided text:

Acceptance Criteria and Device Performance

The core of the acceptance criteria for this medical device (An Antimicrobial Susceptibility Test System) is its performance compared to a recognized reference method. The primary metrics are Essential Agreement (EA) and Category Agreement (CA).

Acceptance Criteria (Not Explicitly Stated as Numerical Targets, but Inferred from Performance)	Reported Device Performance
Essential Agreement (EA): The Phoenix System MIC result agrees exactly or within +/- one two-fold dilution to the reference result.	Not explicitly stated as a single numerical value in the summary, but Table 1 would contain this data for each organism/drug combination. The document implies that the overall EA met the requirements of the FDA guidance document.
Category Agreement (CA): The Phoenix System categorical interpretation (Susceptible, Intermediate, Resistant) agrees with the reference method's interpretation.	Not explicitly stated as a single numerical value in the summary, but Table 1 would contain this data for each organism/drug combination. The document implies that the overall CA met the requirements of the FDA guidance document.
Intra-site reproducibility: The consistency of results within the same testing site.	Greater than 90%
Inter-site reproducibility: The consistency of results across different testing sites.	Greater than 95%

Note on Acceptance Criteria: The provided document states that the system "demonstrated substantially equivalent performance when compared with the NCCLS reference broth microdilution method" and "has been evaluated as defined in the FDA Draft guidance document, 'Guidance on Review Criteria for Assessment of Antimicrobial Susceptibility Devices', March 8, 2000." This indicates that the acceptance criteria are implicitly those outlined in the referenced FDA guidance document for substantial equivalence, which typically involves achieving certain thresholds for EA and CA. Specific numerical targets for EA and CA for Norfloxacin are not explicitly stated in the summary table but would have been part of the full submission and detailed in the performance data (Table 1, not fully transcribed).

Study Information

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

Test Set Description: Clinical, stock, and challenge isolates.
Sample Size: Not explicitly stated as a single number. Table 1, which summarizes the performance, would likely contain the number of isolates tested for Norfloxacin against various gram-negative organisms, but this table is incomplete in the provided text.
Data Provenance: Multiple geographically diverse sites across the United States (prospective clinical isolates) and challenge/stock isolates (origin not specified but typically from strain collections). The study is prospective in terms of the clinical isolates.

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

Not applicable. The ground truth for this type of device is established by a reference laboratory method (NCCLS reference broth microdilution method), not by expert consensus in the same way an image interpretation device might use radiologists.

4. Adjudication method for the test set:

Not applicable. The reference method (NCCLS broth microdilution) provides the definitive result, not a human interpretation requiring adjudication.

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 not an MRMC study and does not involve human readers for interpretation in the same way an AI-powered diagnostic imaging device would. The device provides automated results (MIC values and categorical interpretations), and its performance is compared directly to a reference method, not to human readers.

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

Yes, this is a standalone performance study. The BD Phoenix System's (algorithm only, as it's an automated system) results are directly compared to the NCCLS reference broth microdilution method without human intervention in the interpretation of the Phoenix results for the purpose of the comparison.

7. The type of ground truth used:

Reference Method: NCCLS reference broth microdilution method (AST panels prepared according to NCCLS M7). This is a well-established, standardized laboratory method considered the "gold standard" for antimicrobial susceptibility testing.
Expected Results: For challenge set isolates, the Phoenix System results were compared to "expected results," which would be previously determined and validated values for those specific strains.

8. The sample size for the training set:

Not specified. The document describes a "test set" and emphasizes the comparison to a reference method, but it does not detail the size or composition of any specific training set used for the development of the Phoenix System's algorithms. As this device was cleared in 2002, the development methodologies might predate explicit "training set" and "test set" distinctions as commonly described in modern AI/ML development.

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

Not specified as there is no explicit mention of a training set in the provided summary. However, implicitly, the development of the Phoenix System's algorithms would have involved extensive testing against known reference methods to establish the parameters for accurate MIC determination and categorical interpretation.

Summary

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K023527

DEC 2 3 2002

510(K) SUMMARY

SUBMITTED BY:	Becton, Dickinson and Company7 Loveton CircleSparks, MD 21152Phone: 410-316-4260Fax: 410-316-4499
CONTACT NAME:	Kathryn Babka PowersRegulatory Affairs Specialist
DATE PREPARED:	October 18, 2002
DEVICE TRADE NAME:	BD Phoenix™ Automated Microbiology System –Norfloxacin 0.25-16 µg/mL
DEVICE COMMON NAME:	Antimicrobial susceptibility test system-shortincubation
DEVICE CLASSIFICATION:	Fully Automated Short-Term Incubation CycleAntimicrobial Susceptibility Device, 21 CFR866.1645
PREDICATE DEVICES:	VITEK® System (PMA No. N50510) and BDPhoenix™ 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 MicrobiologySystem is intended for the rapid identification andin vitro antimicrobial susceptibility testing ofisolates from pure culture of most aerobic andfacultative 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 for AST determinations.

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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.

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 negative 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 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 this antimicrobial agent in the BD Phoenix System was evaluated at three sites using a panel of gram-negative isolates. Each site tested the

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isolates in triplicate on three different days using one lot of Gram Negative 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 gram-negative 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 Negative 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 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 + 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, and resistant).

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

Table 1: Performance of BD Phoenix System for Gram-Negative Organisms by Drug

and and the first of the first of the first of the first of the first andCall Concess / Viel I , ( V 16 ) 1 , ( m re aAntimicrobial	Company of the country of the county of the county ofoncentration	M	0	of the later of acres of the property and the property and the1 11	Company of Concession Comparison College of Children College of Children0c
CONSULED AALY (APPR.) SUPREMENT ISSNorfloxacin	The state of the Real College of the Researchtug/m	07001 hours	(). .	07001

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, "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 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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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with three lines forming its body and wings. The eagle is positioned within a circle of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

DEC 23 2002

Food and Drug Administration 098 Gaither Road ockville MD 20850

Ms. Kathryn Babka Powers Regulatory Affairs Specialist Becton, Dickinson and Company 7 Loveton Circle . Sparks, MD 21152

K023527 Re: Trade/Device Name: BD Phoenix ™ Automated Microbiology Systems Norfloxacin (0.25-16 µg/ml) 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: October 18, 2002 Received: October 21, 2002

Dear Ms. Powers:

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 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). 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/cdrh/dsma/dsmamain.html.

Sincerely yours,

Steven Putman

Steven I. Gutman, M.D., M.B.A. Director 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: K623527

Device Name: BD Phoenix™ Automated Microbiology System for use with the antimicrobial agent Norfloxacin (0.25-16 ug/mL) - Gram negative ID/AST or AST only Phoenix panels.

Indications for Use:

Active In Vitro and in Clinical Infections Against:

Citrobacter freundii Enterobacter aerogenes Enterobacter cloacae Escherichia coli

Klebsiella pneumoniae ssp. pneumoniae Proteus mirabilis Proteus vulgaris Pseudomonas aeruginosa

Active In Vitro Against:

Citrobacter koseri (formerly Citrobacter diversus) Edwardsiella tarda Klebsiella oxytoca Morganella morganii Pantoea agglomerans

Providencia alcalifaciens Providencia rettgeri Providencia stuartii

Pseudomonas fluorescens Pseudomonas stutzeri

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

Concurrence of CDRH. Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109) ✓

Sally 7. Delpont In FMP

Division of Clinical Laboratory Devices 510(k) Number_K_U23537

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.”