The BD PhoenixTM 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-Enteriaceae and most Gram-positive bacteria isolates from pure culture belonging to the genera Staphylococcus, Enterococcus, and Streptococcus.

This premarket notification is for the BD Phoenix™ Automated Microbiology System with Moxifloxacin (0.125-8 ug/mL) and additional Gram-positive organism groups and Ciprofloxacin (0.25-4 ug/mL) and additional Gram-negative organism groups.

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 the study details based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance:

The document refers to Essential Agreement (EA) and Category Agreement (CA) as metrics for performance. The acceptance criteria for these are implied by the FDA guidance document referenced, which typically requires high percentages. The reported performance for the BD Phoenix System is that it has "demonstrated substantially equivalent performance when compared to the CLSI reference broth microdilution method." Specifically, "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)."

While a precise numerical table of acceptance criteria and the exact reported performance for each drug/organism combination is not fully provided in the extract (the presented "Table 1" is fragmented and unreadable), the text states:

Metric	Acceptance Criteria (Implied by FDA Guidance)	Reported Device Performance
Site Reproducibility (Intra-site)	>90%	>90%
Site Reproducibility (Inter-site)	>95%	>95%
Essential Agreement (EA)	Not explicitly stated in a percentage, but implied to be high for "substantial equivalence." EA occurs when the BD Phoenix™ Automated Microbiology System agrees exactly or within + one two-fold dilution to the reference result.	Demonstrated "substantially equivalent performance" when compared to the CLSI reference method. The excerpt from "Table 1" is unreadable but likely shows specific EA percentages for different organisms/drugs, indicating they met an internal or FDA-specified threshold for substantial equivalence.
Category Agreement (CA)	Not explicitly stated in a percentage, but implied to be high for "substantial equivalence." 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).	Demonstrated "substantially equivalent performance" when compared to the CLSI reference method. The excerpt from "Table 1" is unreadable but likely shows specific CA percentages for different organisms/drugs, indicating they met an internal or FDA-specified threshold for substantial equivalence.

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

Test Set Sample Size: The document mentions that isolates were tested, but it does not provide a specific numerical sample size for the test set (clinical, stock, and challenge isolates). "Table 1" would presumably contain this information, but it is unreadable.
Data Provenance: The data was collected from multiple geographically diverse sites across the United States. The study included clinical, stock, and challenge isolates. This indicates a mix of prospective (new clinical isolates) and retrospective (stock and challenge isolates) data.

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

The ground truth for clinical isolates in the test set was established by the CLSI reference broth microdilution method. This is a standardized laboratory method, not typically performed by "experts" in the sense of physicians or radiologists making interpretations for AI.
For challenge set isolates, the Phoenix System results were compared to "expected results." The document does not specify how these "expected results" were established or the number/qualifications of experts involved in determining them.

4. Adjudication Method for the Test Set:

None directly applicable in the traditional sense. The ground truth for clinical isolates was the CLSI reference broth microdilution method, which is an objective measurement. For challenge isolates, it was "expected results," which would pre-exist. This isn't a scenario where multiple human readers are adjudicating a case.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:

No, an MRMC comparative effectiveness study was not done. This device is an automated laboratory instrument for antimicrobial susceptibility testing, not an imaging device or AI for human interpretation. Therefore, there is no "human readers improve with AI vs without AI assistance" component. The comparison is between the automated system and a reference lab method.

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

Yes, this was a standalone performance study. The BD Phoenix™ Automated Microbiology System is itself a standalone device (an "algorithm only," if you consider its integrated software for interpretation) that provides MIC values and categorical interpretations. Its performance was directly compared to the CLSI reference method.

7. The Type of Ground Truth Used:

Reference Method/Standard Laboratory Procedure:
- For clinical isolates: CLSI reference broth microdilution method (AST panels prepared according to NCCLS M7).
- For challenge isolates: Expected results.

8. The Sample Size for the Training Set:

The document does not explicitly mention a separate "training set" or its sample size. The "clinical studies" section describes data collected for performance evaluation, implying these isolates serve as the test set against the reference method. In the context of AST systems, the "training" (i.e., development and optimization) of the system's interpretive algorithms would typically involve extensive internal data, but this is not detailed in the summary.

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

Since a distinct "training set" with established ground truth is not specified, this information cannot be provided from the given text. The development of such systems often relies on large internal datasets where ground truth is established using the same reference methods as the validation studies.

Summary

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510(K) SUMMARY

SUBMITTED BY:	Becton, Dickinson and Company7 Loveton CircleSparks, MD 21152Phone: (410) 316 - 4287Fax: 410-316-4499
CONTACT NAME:	Monica E GiguereRegulatory Affairs Specialist
DATE PREPARED:	March 29, 2006
DEVICE TRADE NAME:	BD PhoenixTM Automated Microbiology System -Moxifloxacin-0.125-8 $\mu$ g/mL - GP and Ciprofloxacin-0.25 - 4 $\mu$ g/mL - GN
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 PhoenixTMAutomated Microbiology System with Gatifloxacin(K020321, May 23,2002, Moxifloxacin (K031306June 2, 2003) and Ciprofloxacin (K052269,October 3, 2005).
INTENDED USE:	The BD PhoenixTM 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 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. .

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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.

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 for the BD Phoenix™ Automated Microbiology System with Moxifloxacin (0.125-8 ug/mL) and Gram-positive organism groups and Ciprofloxacin (0.25-4 ug/mL) and additional Gram-negative organism groups.

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 chosen isolates. Each site tested the isolates in triplicate on three different days using one lot of Phoenix panels containing the antimicrobial agents and associated reagents.

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

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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 Phoenix panel formats containing antimicrobial agents. 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, and resistant).

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

Performance of BD Phoenix System by Drug Table 1:

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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), Moxifloxacin (K031306 June 2, 2003) and Ciprofloxacin (K052269, October 3, 2005).

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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 and Human Services. The logo consists of a stylized eagle with three wing-like shapes, representing health, services, and people. The eagle is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", which is arranged in a circular fashion around the eagle.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

APR 1 2 2006

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

Re: K060217 Trade/Device Name: BD Phoenix TM Automated Microbiology System Moxifloxacin (0.125-8 ug/mL) and Ciprofloxacin (0.25-4 ug/mL) on 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: January 26, 2006 Received: January 27, 2006

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) 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 (240)276-0484. 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/industry/support/index.html

Sincerely yours,

Sales a Hogg

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 2

510(k) Number: K060217

Device Name: BD Phoenix™ Automated Microbiology System for use with the antimicrobial agent Moxifloxacin (0.125-8 ug/mL) and Ciprofloxacin (0.25-4 ug/mL) on ID/AST or AST only Phoenix panels.

Indications for Use:

Moxifloxacin 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:

Enterococcus faecalis (many strains are only moderately susceptible) Staphylococcus aureus (methicillin-susceptible strains only)

Active In Vitro Against:

Staphylococcus epidermidis (methicillin-susceptible strains only)

Freddie tu Rady

vision Sign-Off

Office of In Vitro - Device Evaluation and

Kb60217

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Cirpofloxacin 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 koseri Citrobacter freundii Enterobacter cloacae Escherichia coli Klebsiella pneumoniae Morganella morganii Proteus mirabilis Proteus vulgaris Providencia rettgeri

Active In Vitro Against:

Acinetobacter Iwoffi Aeromonas hydrophila Edwardsiella tarda Enterobacter aerogenes Klebsiella oxytoca Salmonella enteritidis Yersinia enterocolitica
1

Prescription Use

(Per 21 CFR 801.109)

Providencia stuartii Pseudomonas aeruginosa Salmonella typhi Serratia marscescens Shigella boydii Shigella dysenteriae Shigella flexneri Shigella sonnei
Over-the-Counter Use

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Seigale V
Division Si:-Off

Office of - Vitro Diagnostic Device Evaluatio and Sefety

4060217 510(k)________________________________________________________________________________________________________________________________________________________________________

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.”