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, Enterococcus, and Streptococcus.

This premarket notification is for cefuroxime with additional organism groups and the removal of the limitation for Klebsiella pneumoniae from the original premarket notification (K033362, April 13, 2004).

Cefuroxime 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:

Escherichia coli Enterobacter species Klebsiella species

Active In Vitro Against:

Citrobacter species Enterobacter species Escherichia coli Klebsiella species (including K. pneumoniae) Morganella morganii Proteus mirabilis Salmonella species Shigella species

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 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 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. Phoenix panels are inoculated with a specified organism density and placed into the instrument.

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

The provided document describes the acceptance criteria and study for the BD Phoenix™ Automated Microbiology System for Cefuroxime – 1-64 µg/mL.

Here's the breakdown of the requested information:

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

The document refers to Essential Agreement (EA) and Category Agreement (CA) as performance metrics, comparing the Phoenix System to the CLSI reference broth microdilution method. While the specific numerical acceptance criteria (e.g., "EA > 90%") for these metrics are not explicitly stated as "acceptance criteria" in the text, it can be inferred that they are the benchmarks used for substantial equivalence. The document states a general intra-site reproducibility of "greater than 90%" and inter-site reproducibility of "greater than 95%". For the clinical study, the performance is summarized in a table, but the table itself is corrupted in the input and doesn't show readable performance percentages. However, the text explicitly states: "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." This implies that the device met the acceptance criteria stipulated in that guidance.

Acceptance Criteria (Inferred from regulatory guidance / general statements)	Reported Device Performance (as stated or inferred)
Intra-site Reproducibility > 90%	"overall intra-site reproducibility of greater than 90%"
Inter-site Reproducibility > 95%	"overall inter-site reproducibility greater than 95%"
Essential Agreement (EA) to reference method (specific %)	Not explicitly stated numerically in the readable text/table, but implied to meet FDA guidance for substantial equivalence. The document states: "The performance of the Phoenix System was assessed by calculating Essential Agreement (EA)..."
Category Agreement (CA) to reference method (specific %)	Not explicitly stated numerically in the readable text/table, but implied to meet FDA guidance for substantial equivalence. The document states: "Category Agreement (CA) occurs when the BD Phoenix™ Automated Microbiology System agrees with the reference method..."

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

Sample Size (Test Set): The document mentions "clinical, stock and challenge isolates were tested." The corrupted Table 1 likely contained the specific number of isolates ("htends110" and "0401000" are remnants of what might have been sample counts). Without the readable table, the precise total number of isolates for the test set cannot be determined.
Data Provenance: The study was conducted "across multiple geographically diverse sites across the United States." The data appears to be prospective, collected for the purpose of demonstrating the device's performance.

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)

The document does not explicitly state the number of experts or their qualifications. The ground truth for the test set was established by the CLSI reference broth microdilution method, which is a standardized laboratory procedure, not typically an expert consensus based on individual interpretation.

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

Not applicable. The ground truth for the test set relies on a standardized reference laboratory method (CLSI broth microdilution), not on expert adjudication of diagnostic images or interpretations.

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, an MRMC comparative effectiveness study was not done. This device is an automated microbiology system for antimicrobial susceptibility testing, which directly determines the susceptibility, not an AI to assist human readers in interpreting clinical data. Therefore, the concept of "human readers improve with AI vs without AI assistance" does not apply here.

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

Yes, a standalone performance study was done. The BD Phoenix™ Automated Microbiology System is an automated system designed to provide susceptibility results (MIC values and categorical interpretations S, I, or R) directly. Its performance (Essential Agreement and Category Agreement) was assessed by comparing its results directly against the CLSI reference method. While human involvement is needed to prepare samples and load panels, the interpretation of results by the system itself is automated.

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

The ground truth used was the CLSI 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.

8. The sample size for the training set

The document does not specify a separate "training set" or its size. In the context of AST systems, "training data" often refers to the historical data and expert rules/algorithms built into the system during its development, rather than a distinct, prospectively tested set. The document focuses on the validation or test set performance.

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

Since no distinct "training set" is mentioned, the method for establishing its ground truth is not described. The system's underlying algorithm for determining susceptibility would have been developed based on scientific principles of microbiology and data from historical testing and expert knowledge, which implicitly forms the basis of its "training."

Summary

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Kao2207

510(K) SUMMARY

SUBMITTED BY:	Becton, Dickinson and Company7 Loveton CircleSparks, MD 21152Phone: 410-316-4161Fax: 410-316-4499
CONTACT NAME:	Vicki L. KennedyRegulatory Affairs SpecialistSEP 1 3 2006
DATE PREPARED:	July 31, 2006
DEVICE TRADE NAME:	BD Phoenix™ Automated Microbiology System –Cefuroxime – 1-64 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 (K020321May 23, 2002), Cefuroxime (K033362, April 13, 2004)
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 for additional organism groups and removal of the limitation for Klebsiella pneumoniae with Cefuroxime - 1-64 µg/mL (K033362, April 13, 2004) on the BD Phoenix™ Automated Microbiology System.

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.

Table 1: Performance of BD Phoenix System by Drug

Antimicrobial	oncentration	"htends110	1	14	10,C
0eturoxime	And Income of the commended to commended to the contributed to theug/ml-134	0401000	ﮨﺎ ﮨﮯ ﮐﮧ ﺍﺱ ﮐﮯ ﺍﺱ ﮐﮯ ﺳﺎﺗﮫ ﺍﻭﺭ ﺍﺱ ﮐﮯ ﺍﺱ ﮐﮯ ﺍﺱ ﮐﮯ ﺍﺱ ﮐﮯ ﺍﺱ ﮐﮯ ﺳﺎﺗﮫ ﺍﺱ ﮐﮯ ﺍﺱ ﮐﮯ ﺍﺱ ﮐﮯ ﺍﺱ ﮐﮯ ﺳﺎﺗﮫ ﺍﺱ ﮐﮯ ﺍﺱ ﮐﮯ ﺍﺱ ﮐﮯ ﺳﺎﺗﮫ ﺍﺱ ﮐﮯ ﺍﺱ ﮐﮯ ﺍﺱ ﮐﮯ ﺳﺎﺗﮫ ﺍﺱ ﮐﮯ ﺍﺱ ﮐﮯ ﺍﺱ ﮐﮯ ﺳﺎﺗﮫ ﺍﺱ ﮐﮯ ﺳﺎﺗﮫ	0 CO1000	CﻟWALL BE BEACH AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND

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), and Cefuroxime (K033362, April 13, 2004).

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SUMMARY INFORMATION FOR CEFUROXIME

Performance

Accuracy

Comments of the control controlled in the consideration of the required in the registerial ofPan & 10 m annik . Bli 1 . W 100 mntimicrobial	The make "Concentration	11And and Artists and 12 cars of the country of the country of the Research of Section of the Section of Section of Section of Section of Section of Section of Section of Secti			T STENTLER "SUBANCHIAL CALL BECOLLEGO DE PLANE AND IN THE LEAST COLLEGIAL THEﺭ
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Reproducibility

Testing performed at multiple clinical sites demonstrated 95% reproducibility or greater within ± 1 dilution as shown in the previous submission.

Breakpoints - CLSI

PHOTO CHIP CHIRICHER & REPORT CHILING LEAST LE L. M. M. C. L. M. C. L. C. C. C. C. C. C. C. C. C. C. C. C. C. C. C. C. C. C. C. C. C. C. C. C. C. C. C. C. C. C. C. C. C. C. CCefuroxime
Irganism
Enterobacteriaceae			ﻟﺴﻴﺎﺳﻴﺔ ﺍﻟﻤﺴﺘﻘﻠﺔ

Recommended Quality Control Organisms

Cefuroxime
Quality Control Strain	MIC Range	Source
Escherichia coli ATCC 25922	2 - 8 µg/mL	CLSI

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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 caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES, USA" arranged in a circular pattern around the symbol. The logo is black and white.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Vicki L. Kennedy Regulatory Affairs Specialist Becton, Dickinson and Company 7 Loveton Circle Sparks. Maryland 21152

SFP 1 3 2006

K062207 Re:

Trade/Device Name: BD Phoenix™ Automated Microbiology System for use with the antimicrobial agent Cefuroxime - 1-64 ug/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: II Product Code: LON Dated: July 31, 2006 Received: August 1, 2006

Dear Ms. Kennedy:

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 (sec 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, Codc 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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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)276-0450. 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 vours,

Sally, axtorp

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: K062207

Device Name: BD Phoenix™ Automated Microbiology System for use with the antimicrobial agent Cefuroxime - 1-64 ug/mL - Gram-negative ID/AST or AST only Phoenix panels.

Indications for Use:

Cefuroxime 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:

Escherichia coli Enterobacter species Klebsiella species

Active In Vitro Against:

Citrobacter species Enterobacter species Escherichia coli Klebsiella species (including K. pneumoniae) Morganella morganii Proteus mirabilis Salmonella species Shigella species

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)

DRH. Office of Device Evaluation (ODE)

Sally Allegood R. S. Higuet
Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) 062207

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.”