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 additional Gram-negative organism groups and Gatifloxacin (0.25-8 ug/mL) on the BD Phoenix Automated Microbiology System. Gatifloxacin 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:
Aerobic Gram-negative microorganisms Escherichia coli Klebsiella pneumoniae Proteus mirabilis

Active In Vitro Against:
Aerobic Gram-negative microorganisms Acinetobacter lwoffii Citrobacter koseri Citrobacter freundii Enterobacter aerogenes Enterobacter cloacae Klebsiella oxytoca Morganella morganii Proteus vulgaris

Results for Enterobacteriaceae tested with Gatifloxacin should only be reported for isolates recovered from the urinary tract.

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 isolation 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 an analysis of the provided text, focusing on the acceptance criteria and the study proving the device meets them:

Acceptance Criteria and Device Performance

Acceptance Criteria Description	Reported Device Performance
Site Reproducibility: Overall intra-site reproducibility > 90% for each antimicrobial agent.	Result: Overall intra-site reproducibility > 90% for the isolates tested.
Site Reproducibility: Overall inter-site reproducibility > 95% for each antimicrobial agent.	Result: Overall inter-site reproducibility > 95% for the isolates tested.
Clinical Performance (Essential Agreement - EA): Performance of BD Phoenix System should demonstrate Essential Agreement to expected/reference results. (Though not explicitly stated as a numerical threshold, the context implies a high level of agreement is necessary for "substantial equivalence").	Result: Gatifloxacin GN: 98.8% Essential Agreement (n=2213)
Clinical Performance (Category Agreement - CA): Performance of BD Phoenix System should demonstrate Category Agreement to expected/reference results. (Similar to EA, a high level of agreement is implied for "substantial equivalence").	Result: Gatifloxacin GN: 95.8% Category Agreement (n=2213)
Substantial Equivalence: Performance equivalent to CLSI reference broth microdilution method and guidance outlined in "Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems; Guidance for Industry and FDA," February 5, 2003.	Result: "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..."

Study Details

Sample sizes used for the test set and the data provenance:
- Test Set Sample Size: 2213 isolates for Gatifloxacin GN (Gram-Negative).
- Data Provenance: Clinical, stock, and challenge isolates were tested. The studies were conducted across "multiple geographically diverse sites across the United States." This indicates the data is retrospective as it uses existing isolates, but the testing itself would be prospective with these isolates.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The document does not specify the number or qualifications of experts used to establish the ground truth. It states that Phoenix System results for clinical isolates were compared to "results obtained from the CLSI reference broth microdilution method," which is a standardized laboratory method. For "Challenge set isolates," they were compared to "expected results." This implies the ground truth is derived from established laboratory protocols and potentially expert determination for the challenge set, but no specific expert involvement is detailed.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- The document does not explicitly mention an adjudication method for the test set. The comparison is made against a "CLSI reference broth microdilution method" or "expected results," which are typically objective laboratory findings or pre-defined results for challenge isolates, not usually subject to human adjudication in the same way, for example, a medical imaging interpretation might be.
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 not an MRMC study. The device (BD Phoenix™ Automated Microbiology System) is an automated system for antimicrobial susceptibility testing, which directly provides an output (MIC values and category interpretations: S, I, or R). It is not an AI-assisted diagnostic tool designed to be used by human readers for interpretation. Therefore, the concept of "human readers improve with AI vs without AI assistance" does not apply to this type of device.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes. The study describes the performance of the "BD Phoenix™ Automated Microbiology System" itself, against a reference method. The system is designed to provide results automatically ("Phoenix AST method is a broth based microdilution test. The Phoenix System utilizes a redox indicator for the detection of organism growth... Measurements of changes to the indicator as well as bacterial turbidity are used... The instrument takes readings of the panels every 20 minutes. The readings are interpreted to give an identification..."). This is a standalone performance evaluation of the automated algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The ground truth used was the CLSI reference broth microdilution method for clinical isolates, and "expected results" for challenge isolates. This is a laboratory-based, standardized reference method considered the gold standard for antimicrobial susceptibility testing.
The sample size for the training set:
- The document does not specify a sample size for a training set. The description implies that the system's underlying methodology for determining AST (redox indicator, bacterial turbidity measurements) is inherent to its design and based on established microbiological principles, rather than being "trained" in the typical machine learning sense with a distinct training dataset. The studies described are performance validation studies.
How the ground truth for the training set was established:
- As there is no mention of a traditional "training set" in the context of machine learning, the question of how ground truth for it was established is not directly applicable. The device's operation is based on physicochemical measurements and pre-programmed interpretations adhering to microbiological standards.

Summary

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510(K) SUMMARY

SUBMITTED BY:	Becton, Dickinson and Company 7 Loveton Circle Sparks, MD 21152 Phone: (410) 316-4278 Fax: 410-316-4499
	MAY 25 2006
CONTACT NAME:	Monica E Giguere Regulatory Affairs Specialist
DATE PREPARED:	May 11, 2006
DEVICE TRADE NAME:	BD Phoenix™ Automated Microbiology System - Gatifloxacin 0.25-8 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 susceptibility testing of isolates from pure culture of most aerobic 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 with Gatifloxacin 0.25-8 ug/mL and the BD PhoenixTM 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 PhoenixTM 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.

Antimicrobial	Concentration	EA (n)	EA (%)	CA (n)	CA (%)
Gatifloxacin GN	0.25-8 $ µg/mL $	2213	98.8	2213	95.8

Table 1: Performance of RD Phoenix System by Drug

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), 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 consists of a stylized eagle or bird-like figure with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird-like figure.

Public Health Service

Food and Drug Administration

2098 Gaither Road Rockville MD 20850

MAY 2 5 2006

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

K060324 Re:

Trade/Device Name: BD Phoenix™ Automated Microbiology System Gatifloxacin 0.25-8 ug/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: May 11, 2006 Received: May 16, 2006

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 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 (240)276-0484. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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,

Sally, a story

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: K060324

Device Name: BD Phoenix™ Automated Microbiology System for use with the antimicrobial agent Gatifloxacin 0.25-8 ug/mL - Gram-negative ID/AST or AST only Phoenix panels.

Indications for Use:

This premarket notification is for additional Gram-negative organism groups and Gatifloxacin (0.25-8 ug/mL) on the BD Phoenix Automated Microbiology System. Gatifloxacin 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:

Aerobic Gram-negative microorganisms Escherichia coli Klebsiella pneumoniae Proteus mirabilis

Active In Vitro Against:

Aerobic Gram-negative microorganisms Acinetobacter Iwoffii Citrobacter koseri Citrobacter freundii Enterobacter aerogenes Enterobacter cloacae Klebsiella oxytoca Morganella morganii Proteus vulgaris

Results for Enterobacteriaceae tested with Gatifloxacin should only be reported for isolates recovered from the urinary tract.

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)

Luddite Lade

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K060324

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.”