The BD PhoenixTM 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 aztreonam 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 Pseudomonas aeruginosa, the removal of the truncation for Providencia stuartii and the addition of organism groups. 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
Pseudomonas aeruginosa
Serratia species (including S. marcescens)

Active In Vitro Against:
Aeromonas hydrophila
Morganella morganii
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 (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 in the instrument.

The instrument houses the panels where they are continuously incubated at a nominal temperature of 35℃. 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 BD Phoenix™ Automated Microbiology System for antimicrobial susceptibility testing of aztreonam was evaluated against the CLSI reference broth microdilution method.

Here's an analysis of the acceptance criteria and study details:

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

Performance Metric	Acceptance Criteria (Implicit from Guidance)	Reported Device Performance (Summary)
Site Reproducibility
Intra-site Reproducibility	> 90%	> 90%
Inter-site Reproducibility	> 95%	> 95%
Clinical Performance (Essential Agreement)	Substantially equivalent to reference method (implied high EA)	Not explicitly stated as a percentage, but essential agreement (EA) was calculated and deemed sufficient for substantial equivalence. The table of performance results is unreadable, but the conclusion states "data collected from the substantial equivalence studies demonstrate that testing on the BD Phoenix™ Automated Microbiology System with this antimicrobial agent is substantially equivalent."
Clinical Performance (Category Agreement)	Substantially equivalent to reference method (implied high CA)	Not explicitly stated as a percentage, but category agreement (CA) was calculated and deemed sufficient for substantial equivalence. The table of performance results is unreadable, but the conclusion states "data collected from the substantial equivalence studies demonstrate that testing on the BD Phoenix™ Automated Microbiology System with this antimicrobial agent is substantially equivalent."

Note on Acceptance Criteria: The document refers to the FDA guidance document, "Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems; Guidance for Industry and FDA," February 5, 2003. This guidance document would contain the specific numerical acceptance criteria (e.g., minimum percentages for Essential Agreement and Category Agreement for different organism categories), which are not explicitly replicated in this 510(k) summary beyond the general statement of "substantially equivalent."

2. Sample sized used for the test set and the data provenance:

Sample Size: The exact total number of isolates for the clinical studies (clinical, stock, and challenge isolates combined) is not explicitly stated as a single number. However, Table 1 (though unreadable) would have contained the specific counts for each organism and test type.
Data Provenance:
- Country of Origin: United States. Isolates were tested "across multiple geographically diverse sites across the United States."
- Retrospective/Prospective: Not explicitly stated. However, "clinical isolates" are typically collected retrospectively or prospectively as part of routine clinical practice. "Stock" and "challenge" isolates are likely laboratory-curated.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Number of Experts: Not applicable/not stated.
Qualifications of Experts: This type of study (Antimicrobial Susceptibility Testing) does not rely on human experts to establish ground truth in the same way an imaging or diagnostic AI study would. The ground truth is established by a reference laboratory method (CLSI reference broth microdilution method) which is highly standardized and validated. The "experts" involved would be trained microbiologists following strict protocols.

4. Adjudication method for the test set:

Adjudication Method: Not applicable. The ground truth is determined by a standardized reference method (CLSI broth microdilution). Discrepancies between the Phoenix System and the reference method are analyzed numerically (Essential Agreement and Category Agreement) rather than requiring expert adjudication.

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:

MRMC Study: No, this was not an MRMC comparative effectiveness study involving human readers. This study evaluates the performance of an automated device (BD Phoenix System) against a reference laboratory method (CLSI broth microdilution) for determining antimicrobial susceptibility. It does not involve human interpretation or AI assistance in the context of human readers.

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

Standalone Performance: Yes, this was essentially a standalone performance study. The BD Phoenix™ Automated Microbiology System is an automated system (algorithm only) that provides MIC values and categorical interpretations (S, I, R) without direct human intervention in the interpretation process once the panel is loaded. Its performance was compared directly to the CLSI reference method.

7. The type of ground truth used:

Ground Truth Type: Expert-established reference method. Specifically, the CLSI (formerly NCCLS) reference broth microdilution method was used as the ground truth for clinical isolates. For "challenge isolates," they were compared to "expected results," which would also be based on established reference methods or known phenotypic characteristics.

8. The sample size for the training set:

Training Set Sample Size: The document does not explicitly state the sample size of a training set. For AST systems, the "training" (i.e., algorithm development and optimization) typically occurs during the initial development of the instrument and its interpretation algorithms using a large, diverse set of organisms with known susceptibility profiles. The data presented in this 510(k) summary are for validation/testing, not explicit "training" of a machine learning model as might be seen today.

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

Training Set Ground Truth Establishment: Similar to the test set, the ground truth for any underlying development/training of the Phoenix system's interpretation algorithms would have been established using CLSI (or equivalent) reference broth microdilution methods. This is the gold standard for antimicrobial susceptibility testing.

Summary

{0}------------------------------------------------

K063824
CONFIDENTIAL AND PROPRIETARY

SUBMITTED BY:

510(K) SUMMARY

Becton, Dickinson and Company

7 Loveton Circle FEB 1 4 2007 Sparks. MD 21152 Phone: 410-316-4938 (410)-316-4499 Fax: CONTACT NAME: Janine Matlak Regulatory Affairs Specialist DATE PREPARED: December 22, 2006 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 Antimicrobial Susceptibility 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), and Levofloxacin (K020322, March 27, 2002). INTENDED USE: The BD Phoenix™ Automated Microbiology System is intended for the rapid identification and in vitro antimicrobial

DEVICE DESCRIPTION:

positive bacteria of human origin.

susceptibility testing of isolates from pure culture of most aerobic and facultative anaerobic Gram-negative and Gram-

. 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.

{1}------------------------------------------------

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 prepared according 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.

Page I l

{2}------------------------------------------------

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) 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

AND AND A A AND ANDREAL AN AND AN AND AN AND AN AND AN AND AN AND AN AND AN AND AN AND AN AND AN AND AN AND AN AND AN------------------------------------------------------------------------------------------------------------------------------------------------------------------------------The new neems and can an	2403 88 00 89		------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------	.
STATE AND I AND COLLEGIAN AND ANDREW. 7treonam. M. I. S. I. I. I. S. MARK MI. MARK METH B. IN MONT E. IN MENSEL E. IN T	------------------------------------------------------------------------------------------------------------------------------------------------------------------------------MARK I W - SHER MANAGE A BRILAN AND PERSONALI may 1 he man an	ADC	A ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------- A 4000 ---------------------------------------------------------------------------------------------------------------------------------------------------------------------1------------------------------------------------------------------------------------------------------------------------------------------------------------------------------	------------------------------------------------------------------------------------------------------------------------------------------------------------------------------MARKET PARK F. I FAR I

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 Aztreonam (K033558, December 19, 2003).

{3}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, which is a symbol often associated with medicine and healthcare. The caduceus is depicted with a simple, flowing design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.

Public Health Service

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

FEB 1 4 2007

Re: K063824 Trade/Device Name: BD Phoenix™ Automated Microbiology System Aztreonam (0.5-64 ug/mL) - Gram-Negative ID/AST or AST only with the removal of the limitations for Pseudomonas aeruginosa, the removal of the truncation for Providencia stuartii and the addition of organism groups 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: December 22, 2006 Received: December 26, 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).

{4}------------------------------------------------

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, anthony

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

{5}------------------------------------------------

Page 1 of 1

KO63824 510(k) Number:

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 with the removal of the limitations for Pseudomonas aeruginosa, the removal of the truncation for Providencia stuartii and the addition of organism groups.

Indications for Use:

This premarket notification is for aztreonam 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 Pseudomonas aeruginosa, the removal of the truncation for Providencia stuartii and the addition of organism. groups. 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 Pseudomonas aeruginosa Serratia species (including S. marcescens)

Active In Vitro Against:

Aeromonas hydrophila Morganella morganii

Proteus vulgaris Providencia stuartii Providencia rettgeri Yersinia enterocolitica

Prescription Use (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)

Sauce
Division Sign Off

Division Sign-Off

Office of In Vitro Diagnostic
Device Evaluation and Safety

ESMOKY K083824

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.”