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.

This premarket notification is for the addition of the antimicrobial agent moxifloxacin at concentrations of 0.125-8 µg/mL to Gram Positive ID/AST or AST only Phoenix panels. Moxifloxacin has been shown to be active in viro 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: Staphylococcus aureus (methicillin-susceptible strains only)

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 . or 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 isolate, an inoculation 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 a breakdown of the acceptance criteria and the study details for the BD Phoenix™ Automated Microbiology System Moxifloxacin - GP, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The text explicitly refers to "Essential Agreement (EA)" and "Category Agreement (CA)" as performance metrics. While the specific numerical acceptance criteria (e.g., "EA > 90%") are not explicitly stated, the Guidance on Review Criteria for Assessment of Antimicrobial Susceptibility Devices, March 8, 2000 is referenced, which would likely contain these criteria. For this summary, we will assume the reported performance met the implied acceptance criteria, given the overall conclusion of substantial equivalence.

Performance Metric	Acceptance Criteria (Implied by FDA Guidance)	Reported Device Performance
Essential Agreement (EA)	(Not explicitly stated, but typically high, e.g., >90%)	98.0%
Category Agreement (CA)	(Not explicitly stated, but typically high, e.g., >90%)	91.0%
Intra-site Reproducibility	>90% (explicitly stated in the document as a study finding for this agent)	>90%
Inter-site Reproducibility	>95% (explicitly stated in the document as a study finding for this agent)	>95%

2. Sample Size Used for the Test Set and Data Provenance

Test Set Sample Size: The clinical study tested 1242 isolates for Moxifloxacin, as indicated by EA (n) = 1242 and CA (n) = 1242 in Table 1.
Data Provenance:
- Country of Origin: United States ("across multiple geographically diverse sites across the United States").
- Retrospective/Prospective: The text mentions "Clinical, stock and challenge isolates were tested." "Clinical isolates" typically refer to prospectively collected samples from patients, while "stock and challenge isolates" could be a mix of retrospective, well-characterized strains. The study design implies a prospective collection of clinical isolates and possibly predefined challenge strains.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

The document does not explicitly state the number or qualifications of experts used to establish the ground truth. The ground truth (reference method) was the NCCLS reference broth microdilution method. This method is standardized, and while it requires skilled laboratory personnel to perform, it typically does not involve multiple "experts" in the sense of clinical specialists adjudicating results, but rather adherence to a standardized protocol.

4. Adjudication Method for the Test Set

The document does not describe an adjudication method for the test set in the traditional sense (e.g., 2+1, 3+1 for discrepancies). Instead, the performance of the Phoenix System results (MIC values and categorical interpretations) were directly compared to the results obtained from the NCCLS reference broth microdilution method. Discrepancies would be identified and analyzed based on this comparison, leading to the calculation of Essential Agreement and Category Agreement.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No, an MRMC comparative effectiveness study involving human readers with and without AI assistance was not done. This device is an automated microbiology system for antimicrobial susceptibility testing, which replaces or assists traditional manual lab procedures, rather than assisting human readers in interpreting images or complex clinical scenarios directly.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, a standalone performance study was done. The entire study focuses on the performance of the "BD Phoenix™ Automated Microbiology System" itself (i.e., the algorithm/automated system) in determining antimicrobial susceptibility. The system takes readings and interprets them "to give an identification of the isolate, minimum inhibitory concentration (MIC) values and category interpretations." This is a direct measurement of the device's algorithmic performance.

7. The Type of Ground Truth Used

The primary ground truth used for the clinical and stock isolates was the NCCLS reference broth microdilution method. For challenge isolates, performance was compared to "expected results," which implies a curated set of known susceptibility profiles for those specific strains. This reference method 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 provide information about the sample size used for the training set. The focus is on the validation of the existing system with a new antimicrobial agent (Moxifloxacin). The system itself (BD Phoenix) was likely trained or developed using vast amounts of data prior to this specific antimicrobial agent's addition.

9. How the Ground Truth for the Training Set Was Established

Since information about the training set is not provided, the method for establishing its ground truth is also not described in this document. During the initial development of the BD Phoenix System, the ground truth for training would almost certainly have been established using similar reference methods (like NCCLS broth microdilution or agar dilution) performed by expert microbiologists, coupled with broad-spectrum organism identification methods.

Summary

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BD PHOENIX™ Automated Microbiology System Moxifloxacin - GP

CONFIDENTIAL AND PROPRIETARY

510(k) SUMMARY

SUBMITTED BY:	Becton, Dickinson and Company7 Loveton CircleSparks, MD 21152Phone: (410) 316-4778Fax: 410-316-4499
CONTACT NAME:	Michelle B. Bandy,Regulatory Affairs Specialist
DATE PREPARED:	April 23, 2003
DEVICE TRADE NAME:	BD Phoenix™ Automated Microbiology System –Moxifloxacin 0.125-8 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 . or 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 NCCLS reference broth microdilution method. This premarket notification provides data supporting the use of the BD Phoenix™ Automated Microbiology System Gram positive 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 NCCLS reference broth microdilution method (AST panels prepared according to NCCLS M7). The system has been evaluated as defined in the FDA Draft guidance document, "Guidance on Review Criteria for Assessment of Antimicrobial Susceptibility Devices", March 8, 2000.

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-positive isolates. Each site tested the isolates in triplicate on three different days using one lot of Gram Positive 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-positive 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 Positive 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 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.

Performance of BD Phoenix System for Gram-Positive Organisms by Drug Table 1:

Antimicrobial	Concentration	EA (n)	'EA (%)	(CA (n)	I CA (%)
Moxifloxacin	A Comments of the comments of the comments of the control of the consistence of the country of the research and0.125-8 ug/mL	Company of the program and the program and the county of1242	98.0	1242	07 001.0

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, "Guidance on Review Criteria for Assessment of Antimicrobial Susceptibility Devices", March 8, 2000. 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

Public Health Service

Image /page/3/Picture/2 description: The image is a black and white logo for the Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with three curved lines representing its body and wings. The bird is facing towards the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES U.S.A." is arranged in a circular pattern around the bird.

JUN - 2 2003

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Michelle B. Bandy Regulatory Affairs Specialist BD Diagnostics Systems Becton, Dickinson and Company 7 Loveton Circle Sparks, MD 21152-0999

Re: K031306

Trade/Device Name: BD Phoenix™ Automated Microbiology System Moxifloxacin (0.125-8 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: April 23, 2003 Received: April 24, 2003

Dear Ms. Bandy:

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. Drue, 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. Iisting 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 vours.

Steven Putman

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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Page 1 of 1

510(k) Number: _ K031306

Device Name: BD Phoenix™ Automated Microbiology System for use with the antimicrobial agent moxifloxacin (0.125-8 ug/mL) - Gram positive ID/AST or AST only Phoenix panels.

Indications for Use:

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.

Active In Vitro and in Clinical Infections Against: Staphylococcus aureus (methicillin-susceptible strains only)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Freddie H. Poole

ision Sign-Off

Prescription Use (Per 21 CFR 801.109) Office of In Vitro Diagnostic Device Evaluation and Safety

Over-the-Counter Use

510(k) K031306

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.”