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 aztreonam at concentrations of 0.5-64 ug/mL to gram-negative ID/AST or AST only Phoenix panels. Aztreonam 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 species (including C. freundii) Enterobacter species (including E. cloacae) Escherichia coli Klebsiella oxytoca

Klebsiella pneumoniae Proteus mirabilis Serratia species (including S. marcescens)

Active In Vitro Against:

Aeromonas hydrophila Morganella morganii Pasteurella multocida Proteus vulgaris

Providencia stuartii Providencia rettgeri Yersinia enterocolitica

Device Description

The BD Phoenix Automated Microbiology System (Phoenix System) is an automated system 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 system includes the following components:

BD Phoenix instrument and software. .
DD Phoenix maudinent and between cals for organism ID testing and antimicrobial agents t for AST determinations.
for AD Coternmantene .
BD Phoenix AST Broth used for performing AST tests only. .
DD Fhoonix AST Drom
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 reagens. Organisms for susception is solate. For each isolate, an inoculation premimarily (defirmed as a gratis candard 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 withing on wood in the de inclicator for the detection of organism grown in the proseiled unbidty are used in the clotenination Measurements of changes to the mulcator as welr as ouctory 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 %. The mstullient takes readings of the panels of copy 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 the study that proves the BD Phoenix™ Automated Microbiology System meets them for aztreonam, based on the provided text:

Acceptance Criteria and Reported Device Performance

Acceptance Criterion	Reported Device Performance (Aztreonam)
Essential Agreement (EA)	96.2%
Category Agreement (CA)	96.2%
Intra-site reproducibility	Greater than 95%
Inter-site reproducibility	Greater than 95%

Study Details

Sample sizes used for the test set and data provenance:
- Test set size: 1470 isolates (as indicated by 'n' for both EA and CA in Table 1).
- Data provenance: Clinical, stock, and challenge isolates were tested across multiple geographically diverse sites across the United States. This indicates a retrospective and prospective mixture of data (stock and challenge isolates can be considered pre-defined/retrospective, while clinical isolates would be prospectively collected from patient samples).
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. The ground truth method involved comparison to the NCCLS reference broth microdilution method and expected results for challenge isolates.
Adjudication method for the test set:
- The document does not explicitly describe an adjudication method for disagreements between the BD Phoenix system and the reference method. The performance metrics (EA and CA) are calculated based on agreement/disagreement with the reference method.
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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This study is for an automated microbiology system, which replaces human interpretation in the final reading of MIC values and categorical interpretations, rather than assisting human readers. The comparison is against a reference laboratory method (NCCLS broth microdilution), not human readers.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, this study is a standalone performance study of the BD Phoenix™ Automated Microbiology System. The Phoenix System is an automated system providing quantitative MIC values and categorical interpretations (S, I, or R) without human intervention in the interpretation process once the panel is loaded and reading begins. The results are compared directly to a "reference method."
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For clinical isolates, the ground truth was the NCCLS reference broth microdilution method.
- For challenge isolates, the ground truth was expected results.
The sample size for the training set:
- The document does not specify the sample size for a training set. The descriptions focus on the performance evaluation against the reference method. The device is a system that utilizes a redox indicator and optical density readings, with its algorithms likely developed and validated previously, and this submission focuses on adding a new antimicrobial agent.
How the ground truth for the training set was established:
- The document does not provide information on how the ground truth for a training set was established. Given the nature of a 510(k) for adding an antimicrobial agent to an existing system, the focus is on the performance of the new agent, not on the fundamental development of the system's core algorithms.

Summary

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510(K) SUMMARY

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SUBMITTED BY:	Becton, Dickinson and Company7 Loveton CircleSparks, MD 21152Phone: 410-316-4206Fax: (410)-316-4499
CONTACT NAME:	Bradford M SpringManager, Regulatory Affairs
DATE PREPARED:	November 10, 2003
DEVICE TRADE NAME:	BD Phoenix™ Automated Microbiology System –Aztreonam 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:

The BD Phocnix Automated Microbiology System (Phoenix System) is an automated system for the The BD I nochia Hutomatod Moroletes) = ; = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = isolates. The system includes the following components:

BD Phoenix instrument and software. .
DD Phoenix maudinent and between cals for organism ID testing and antimicrobial agents t for AST determinations.
for AD Coternmantene .
BD Phoenix AST Broth used for performing AST tests only. .
DD Fhoonix AST Drom
BD Phoenix AST Indicator solution added to the AST Broth to aid in bacterial growth . determination.

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The Phoenix panel is a sealed and self-inoculating molded polystyrene tray with 136 micro-wells The Phoemx panel Is a seated and self mocalating slitty testing must be a pure culture and containing dried reagens. Organisms for susception is solate. For each isolate, an inoculation premimarily (defirmed as a gratis candard is prepared in Phoenix ID Broth.

The Phoenix AST method is a broth based microdilution test. The Phoenix System utilizes a redox I he Phoenix AST methou is a brom oused into resence of an antimicrobial agent.
indicator for the detection of organism growth in the presence withing on wood in the de inclicator for the detection of organism grown in the proseiled unbidty are used in the clotenination Measurements of changes to the mulcator as welr as ouctory
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 The instrument nouses the panels where they are continued as "The readings are interpreted to 35 %. The mstullient takes readings of the panels of copy 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 NCCLS reference broth microdilution method. This premarket was a fastam performance when compared with the NCCLS felerence of the BD Phoenix™ Automated Microbiology System nonineation provides cata napperving morels with this antimicrobial agent.

SUMMARY OF SUBSTANTIAL EQUIVALENCE TESTING:

The BD Phoenix™ Automated Microbiology System has demonstrated substantially qquivalent performance when compared to the NCCLS reference broth microdilution method (AST panels . FINA Develo performance which compared to the NCCLS foreited on evaluated as defined in the FDA Draft prepared according to NCCL2 MF7. The system inde over of Antimicrobial Susceptibility Devices", March 8, 2000.

Site Reproducibility

Intra- and inter-site reproducibility of this antimicrobial agent in the BD Phoenix System was Intra- and mee-sites using a panel of gram-negative isolates. Each site tested the isolates in evaluated at three shes using a parel of gram-negative Phoenix pancls containing this antimicrobial agent and associated reagents.

The results of the study demonstrate for the this antimicrobial agent there was an overal intra-site I he results of the study demonstrate for the united 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 NCCLS reference broth microdilution method.

The performance of the Phoenix System was assessed by calculating Essential Agrcement (EA) and The portunities of the 1100 expected/reference results for all isolates tested. Essential Agrocment Cutegory rigroemix (21) Phocnix™ 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 for Gram-Negative Organisms by Drug Table 1:

Antimicrobial	Concentration	and and the first and the many of the same of the first of the first ofEA (n)	Commend Canadian Comments of Children Comments(%EA (	CA (n)	CA (%)
Comments of the control control control control control concession of the consistence ofAnd Concession of ChildrenAztreonam	0.5-64 µg/mL	1470	96.2	1470	96.2

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), 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 U.S. Department of Health and Human Services. The logo is a stylized depiction of an eagle with three bars representing its wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter of the circle.

Public Health Service

DEC 1 9 2003

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Mr. Bradford M. Spring Manager, Regulatory Affairs BD Diagnostics Systems Becton, Dickinson and Company 7 Loveton Circle Sparks, MD 21152

Re: K033558

Trade/Device Name: BD Phoenix™ Automated Microbiology System Aztreonam (0.5-64 ug/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: November 10, 2003 Received: November 12, 2003

Dear Mr. Spring:

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 Sutman

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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INDICATIONS FOR USE

510(k) Number (if known): K033558

Device Name: BD Phoenix™ Automated Microbiology System for use with the antimicrobial agent aztreonam (0.5-64 ug/mL) - Gram-Negative ID/AST or AST only Phoenix panels.

Indications for Use:

Active In Vitro and in Clinical Infections Against:

Citrobacter species (including C. freundii) Enterobacter species (including E. cloacae) Escherichia coli Klebsiella oxytoca

Klebsiella pneumoniae Proteus mirabilis Serratia species (including S. marcescens)

Active In Vitro Against:

Aeromonas hydrophila Morganella morganii Pasteurella multocida Proteus vulgaris

Providencia stuartii Providencia rettgeri Yersinia enterocolitica

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-the-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Freddie Root

Division Sign-Off

fice of In Vitro Diagnostic Device valuation and Safety

510(k) K033558

Page 1 of 1

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.”