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 removal of limitations for Enterobacter cloacae and Serratia species from the original premarket notification [K023895, 1/8/2003] for the antimicrobial agent ciprofloxacin at concentrations of 0.25-4 ug/ml to Gram-negative ID/AST or AST only Phoenix panels. The concentration range has been reduced by one dilution from the range of 0.125-4ug/ml in the original 510(k). Ciprofloxacin 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.

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 summary of the acceptance criteria and study details for the BD Phoenix™ Automated Microbiology System's Ciprofloxacin 0.25-4 µg/ml update, based on the provided text:

Acceptance Criteria and Reported Device Performance

Metric	Acceptance Criteria (Implicit from FDA Guidance)	Reported Device Performance (Ciprofloxacin, Gram-negative)
Essential Agreement (EA)	Not explicitly stated but expected to be high. The FDA guidance document "Guidance on Review Criteria for Assessment of Antimicrobial Susceptibility Devices" (March 8, 2000) would define acceptable limits, typically >90%.	90.6%
Category Agreement (CA)	Not explicitly stated but expected to be high. The FDA guidance document "Guidance on Review Criteria for Assessment of Antimicrobial Susceptibility Devices" (March 8, 2000) would define acceptable limits, typically >90%.	97.4%
Intra-site Reproducibility	>90%	>90%
Inter-site Reproducibility	>95%	>95%

Note: The exact numerical acceptance criteria for EA and CA are not explicitly stated in the provided text. However, medical device submissions for antimicrobial susceptibility systems typically aim for values well above 90% for both essential and category agreement when compared to a reference method, as indicated by the reference to "substantial equivalence" and FDA guidance. The reported performance of 90.6% EA and 97.4% CA suggests these values met the internal and regulatory acceptance thresholds. The reproducibility criteria are explicitly stated and met.

Study Details

Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated as a single number. The study involved "clinical, stock and challenge isolates."
- Data Provenance: Multiple geographically diverse sites across the United States. Retrospective and prospective status is not explicitly stated, but clinical isolates typically refer to prospectively collected samples from patients, while stock and challenge isolates are curated for specific testing purposes.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided in the document. The ground truth for clinical isolates was established by the CLSI reference broth microdilution method, which is a standardized laboratory procedure, not typically relying on expert interpretation in the same way as, for example, image analysis. For challenge isolates, the "expected results" served as the ground truth, implying pre-determined results for these strains.
Adjudication method for the test set:
- Not applicable in the traditional sense. The comparison was against the CLSI reference broth microdilution method or "expected results" for challenge isolates. Discrepancies would be analyzed according to the definitions of Essential Agreement (within +/- one two-fold dilution) and Category Agreement (matching FDA categorical interpretive criteria). This is a direct comparison to a gold standard method, not an adjudication among human readers.
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 that performs antimicrobial susceptibility testing (AST). It is not an AI system designed to assist human readers in interpretation. The output is already an interpretation (MIC values, S/I/R categories).
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, this was a standalone performance evaluation of the BD Phoenix™ Automated Microbiology System. The device automatically reads and interprets the results to provide MIC values and categorical interpretations (S, I, R). Human intervention is limited to preparing the inoculum and loading the panels.
The type of ground truth used:
- For clinical isolates: CLSI (Clinical and Laboratory Standards Institute) reference broth microdilution method. This is a recognized gold standard laboratory method for antimicrobial susceptibility testing.
- For challenge isolates: "Expected results," implying pre-established, known susceptibility profiles for these specific strains.
The sample size for the training set:
- This information is not provided. The document describes a "device" (BD Phoenix Automated Microbiology System), not an AI algorithm that would typically have a distinct training set. The system's "training" or development would have been part of its initial design and validation, prior to this specific antimicrobial agent's clearance, and involved developing its underlying algorithms for growth detection and MIC determination.
How the ground truth for the training set was established:
- This information is not provided because a distinct "training set" for an AI algorithm is not explicitly mentioned or applicable in the context of this device's submission. The system's foundational algorithms would have been developed and validated against established microbiological methods, similar to how the test set's ground truth was established, but over a much broader range of organisms and antimicrobials during the initial design and development phases.

Summary

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OCT 3 - 2005

CONFIDENTIAL AND

510(K) SUMMARY

SUBMITTED BY:	Becton, Dickinson and Company7 Loveton CircleSparks, MD 21152Phone: 410-316-4287Fax: 410-316-4499
CONTACT NAME:	Monica Evelyn GiguereRegulatory Affairs Specialist
DATE PREPARED:	August 17, 2005
DEVICE TRADE NAME:	BD Phoenix™ Automated Microbiology System --Ciprofloxacin 0.25-4 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 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 CLSI 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 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, "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 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.

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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 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 CLSI reference broth microdilution method.

The performance of the Phoenix System was assessed by calculating Essential Agreement (EA) and Category Agreement (CA) as compared to the 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

[212.2018 11:22 PM 111 11 111 8111 111 8111 111 8111 111 111 111 111 111 111 111 111 1111 1111 1111 1111 1111 1111 1111 1111 1111 1111 1111 1111 1111Antimicrohia.	oncentration	Continued and the contribution of the land-	T LE FREE T ON FREE LAND011.7	1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1.	------------------------------------------------------------------------------------------------------------------------------------------------------------------------------10/01(
Comments of the charges of therıprofloxacın	C AP117ﺎ ﻣﻦ ﺍﻟﻤﺴﺎﺣﺔ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ	00020.30------------------------------------------------------------------------------------------------------------------------------------------------------------------------------	990.6---------------------------------------------------------------------------------------	חסריﻟﻤﺴﺎﺣﺔ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------	05 7and a last

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 seal for the Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. In the center of the seal is a stylized image of an eagle with its wings spread.

Public Health Service

OCT 3 - 2005

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

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

Re: K052269

Trade/Device Name: BD Phoenix™ Automated Microbiology System for use with Ciprofloxacin (0.25-4ug/ml) Gram-negative ID/AST or AST only Phoenix panels Regulation Number: 21 CFR 866.1645 Regulation Name: Fully automated short-term incubation cycle antimicrobial susceptibility system Regulatory Class: Class II Product Code: LON Dated: August 17, 2005 Received: August 19, 2005

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

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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" (21 CFR 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 For

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: KU52249

Device Name: BD Phoenix™ Automated Microbiology System for use with the antimicrobial agent ciprofloxacin (0.25-4 ug/ml) - Gram-negative ID/AST or AST only Phoenix panels.

Indications for Use:

Active In Vitro and in Clinical Infections Against:

Aerobic Gram-negative microorganisms

Citrobacter koseri	Proteus mirabilis	Serratia marcescens
Citrobacter freundii	Proteus vulgaris	Shigella boydii
Enterobacter cloacae	Providencia rettgeri	Shigella dysenteriae
Escherichia coli	Providencia stuartii	Shigella flexneri
Klebsiella pneumoniae	Pseudomonas aeruginosa	Shigella sonnei
Morganella morganii	Salmonella typhi

Active In Vitro Against:

Aerobic Gram-negative microorganisms

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

Prescription Use V (Per 21 CFR 801.109)

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)

BD Diagnostic Systems Becton, Dickinson and Company Office of In Vitro Diagnostic Device Evaluation and Salety 1105226

Treader Division Sign-Off

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.”