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 cefepime at concentrations of 0.5-64 ug/mL to Gram-negative ID/AST or AST only Phoenix panels with the removal of the limitations for Proteus species. Cefepime has been shown to be active in vitro against most strains of microorganisms listed below, as described in the FDAapproved package insert for this antimicrobial agent.

Active In Vitro and in Clinical Infections Against:
Enterobacter species
Escherichia coli
Klebsiella pneumoniae
Proteus mirabilis
Pseudomonas aeruginosa

Active In Vitro Against:
Acinetobacter lwoffi
Citrobacter koseri
Citrobacter freundii
Hafnia alvei
Klebsiella oxytoca
Morganella morganii
Pantoea agglomerans
Proteus vulgaris
Providencia rettgeri
Providencia stuartii
Serratia marcescens

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 optical density and turbidity are used in the determination of results. The 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 paired 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 in the instrument.

The instrument houses the panels where they are continuously incubated at a nominal temperature of 35 degrees Celsius. The instrument monitors the growth of the organisms in 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 for Cefepime, based on the provided text:

Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Acceptance Criteria	Reported Device Performance (Cefepime 0.5-64 µg/mL)
Accuracy (Clinical Studies)	Essential Agreement (EA) > 90% (implied by comparing to predicate)	98.0%
	Category Agreement (CA) > 90% (implied by comparing to predicate)	96.7%
Reproducibility (Intra-site)	> 90%	> 90%
Reproducibility (Inter-site)	> 95%	> 95%

Study Details

Sample Size Used for the Test Set and Data Provenance:
- Test Set Sample Size: 1384 isolates (as per the "EA (n)" and "CA (n)" columns in Table 1).
- Data Provenance: Clinical, stock, and challenge isolates from "multiple geographically diverse sites across the United States." This indicates a prospective and real-world data collection approach.
Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- The document does not specify the number of experts or their qualifications for establishing ground truth. Instead, it compares the device's performance to the "CLSI reference broth microdilution method" or "expected results" for challenge isolates. The CLSI method itself is a standardized laboratory procedure, not an expert consensus per se, though it's assumed to be performed by qualified microbiologists.
Adjudication Method for the Test Set:
- The document does not describe an explicit adjudication method (like 2+1 or 3+1). The comparison is directly between the BD Phoenix System's results and the CLSI reference method or expected results for challenge isolates.
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, a MRMC comparative effectiveness study was not done. This study focuses on the performance of the automated system against a reference laboratory method, not on human readers' performance with and without AI assistance.
Standalone Performance (Algorithm-only without human-in-the-loop performance):
- Yes, the performance reported is a standalone performance of the BD Phoenix™ Automated Microbiology System. The device is a fully automated system for determining antimicrobial susceptibility, and its results are directly compared to a reference method.
Type of Ground Truth Used:
- The ground truth for clinical isolates was established using the CLSI (Clinical and Laboratory Standards Institute) reference broth microdilution method.
- For challenge isolates, the ground truth was "expected results," which typically refers to results obtained from known strains or established testing protocols.
Sample Size for the Training Set:
- The document does not explicitly separate and report a "training set" sample size. The studies described are for validation and comparison to a reference standard, not for the training of a new AI model in the conventional sense. The "clinical, stock, and challenge isolates" described for the performance study are used for evaluating the system, which would likely represent a test set. The system itself is an automated instrument, not a 'learned' AI model in the contemporary sense that requires a distinct training dataset from the user's perspective. Its "knowledge" is embedded in its design and detection algorithms.
How the Ground Truth for the Training Set Was Established:
- Given that a distinct "training set" in the context of machine learning is not explicitly mentioned or applicable in the way modern AI is developed, the document does not describe how ground truth for a training set was established. The system's underlying methodology (broth microdilution with redox indicator and turbidity measurements) is based on established microbiological principles, not on a machine learning training process with a labeled dataset.

Summary

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510(K) SUMMARY

iCC-330/

SUBMITTED BY:	Becton, Dickinson and Company7 Loveton CircleSparks, MD 21152Phone: 410-316-4938Fax: (410)-316-4499	DEC - 8 2006
CONTACT NAME:	Janine MatlakRegulatory Affairs Specialist
DATE PREPARED:	October 31, 2006
DEVICE TRADE NAME:	BD Phoenix™ Automated Microbiology System -Cefepime 0.5-64 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 (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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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. murculor for the detection of the indicator as well as bacterial turbidity are used in the determination Maasurements of enailyou to T 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 The I nooms paired 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 in the instrument.

The instrument houses the panels where they are continuously incubated at a nominal temperature of 110 mortalism now 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).

DEVICE COMPARISON:

The BD Phoenix™ Automated Microbiology System demonstrated substantially equivalent performance when compared with the CLSI (formerly 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 CLSI reference broth microdilution method (AST panels personalises rding to CLSI M7). The system has been evaluated as defined in the FDA 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 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 r linical 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 for Gram-Negative Organisms by Drug

Antimicrobial------------------------------------------------------------------------------------------------------------------------------------------------------------------------------	ConcentrationAnd A . ACompany of Children to Children the Children of Children the Children	EA (nTWY	10/0EA	CA (n)	CA(0/0)
range of the comments ofCefepime	0.5-64 µg/mL	1384	STATIST THE OWNER OF THE FOR98.0	1384	96.7

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 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 Cefepime (K032675, March 1, 2004 and K060444, April 12, 2006).

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SUMMARY INFORMATION FOR CEFEPIME Available Range 0.5-64 µg/mL

Performance

Accuracy

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tefenimeN REE IN	1.00 1	(1 Bar	of Personal A 16		ﮨﺎﺋﺮ

Reproducibility

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

Breakpoints - CLSI, FDA

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Recommended Quality Control Organisms

Quality Control Strain	MIC Range	Source
Escherichia coli ATCC 25922	0.015-0.12 µg/mL	CLSI
	0.016-0.12 µg/mL	FDA
Pseudomonas aeruginosa ATCC 27853	1.0-8.0 µg/mL	CLSI
	1.0-4.0 µg/mL	FDA

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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 curved lines representing its wings or feathers. The eagle faces to the right. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Janine Matlak Regulatory Affairs Specialist BD Diagnostics Systems Becton, Dickinson and Company 7 Loveton Circle Sparks, MD 21152

DEC - 8 2006

Re: K063301 Trade/Device Name: BD Phoenix™ Automated Microbiology System Cefepime (0.5-64 µg/mL) -- Gram-Negative 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: October 31, 2006 Received: November 1, 2006

Dear Ms. Matlak:

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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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 yours,

Sally, anton

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: LDU3301

Device Name: BD Phoenix™ Automated Microbiology System for use with the antimicrobial agent cefepine (0.5-64 µg/mL) - Gram-Negative ID/AST or AST only Phoenix panels with the removal of the limitations for Proteus species.

Indications for Use:

Active In Vitro and in Clinical Infections Against:

Enterobacter species	Proteus mirabilis
Escherichia coli	Pseudomonas aeruginosa
Klebsiella pneumoniae

Active In Vitro Against:

Acinetobacter lwoffi Citrobacter koseri Citrobacter freundii Hafnia alvei

Prescription Use イ (Per 21 CFR 801.109)

Klebsiella oxytoca Morganella morganii Pantoea agglomerans Proteus vulgaris

Providencia rettgeri Providencia stuartii Serratia marcescens

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)

Signature

Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
BD Diagnostic Systems
Becton, Dickinson and Company
K06 3301

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.”