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 (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 the addition of the antimicrobial agent Ceftriaxone at concentrations of 0.0625-4 ug/mL to Streptococcus ID/AST or AST only Phoenix panels. Ceftriaxone has been shown to be active clinically as described in the FDA-approved package insert for this antimicrobial agent.

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. For testing Streptococcus species 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-S Broth used for performing AST tests only. .
BD Phoenix AST-S 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 I no i novel reagents. Organisms for susceptibility testing must be a pure culture and oonlianing arree rugedive or 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. marculer for the actioners 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, R or N (susceptible, intermediate, resistant or not susceptible).

AI/ML Overview

Here's an analysis of the provided text, outlining the acceptance criteria and study details for the BD Phoenix™ Automated Microbiology System - Ceftriaxone 0.0625-4 ug/mL.

1. Table of Acceptance Criteria and Reported Device Performance

The document implicitly defines acceptance criteria through its comparison to the CLSI reference method. The key performance indicators are Essential Agreement (EA) and Category Agreement (CA). While explicit percentage thresholds for acceptance aren't provided in the "Acceptance Criteria" column, the document states "substantially equivalent performance" and shows high agreement rates, implying these rates met the FDA's criteria, which are typically defined in guidance documents like the one referenced.

Acceptance Criterion (Implicit)	Reported Device Performance (Ceftriaxone)
Essential Agreement (EA): The BD Phoenix™ Automated Microbiology System agrees exactly or within +/- one two-fold dilution to the reference result.	98.3% (n=2013)
Category Agreement (CA): The BD Phoenix™ Automated Microbiology System agrees with the reference method with respect to the FDA categorical interpretive criteria (susceptible, intermediate, resistant or nonsusceptible).	97.7% (n=2013)
Intra-site Reproducibility	≥98.4%
Inter-site Reproducibility	≥99.5%

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

Test Set Sample Size: 2013 isolates for the Essential Agreement (EA) and Category Agreement (CA) analysis.
Data Provenance: Clinical, stock, and challenge isolates were tested across multiple geographically diverse sites. The study design is prospective in nature, comparing the investigational device to a reference method, mimicking a clinical setting for the "clinical isolates" portion.

3. 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 used to establish the ground truth. It states that the Phoenix System results were compared to the CLSI reference broth microdilution method. This method itself is a standardized laboratory procedure, and adherence to it is the primary "ground truth" for susceptibility testing, rather than expert interpretation of results.

4. Adjudication Method for the Test Set

The document does not describe an explicit adjudication method involving multiple human readers for discrepancies. The comparison is primarily between the automated system's output and the standardized CLSI reference method. Discrepancies would likely be investigated within the framework of the CLSI method's established quality control and interpretation guidelines.

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?

No. This study is a standalone performance comparison of an automated system against a reference method. It does not involve human readers, nor does it assess the improvement of human readers with or without AI assistance. The BD Phoenix™ system is an automated device, not an AI-assisted diagnostic tool for human interpretation.

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

Yes, a standalone study was done. The entire evaluation described in the "Clinical Studies" section compares the BD Phoenix™ Automated Microbiology System (an automated device/algorithm) directly to the CLSI reference broth microdilution method. This evaluates the system's performance without human intervention in the interpretation process once the system has processed the sample.

7. The Type of Ground Truth Used

The primary ground truth used is the CLSI reference broth microdilution method. This is a well-established, standardized laboratory method for determining antimicrobial susceptibility, considered the gold standard for AST. For "Challenge set isolates," the ground truth was "expected results," implying predefined, known susceptibility profiles for those specific isolates.

8. The Sample Size for the Training Set

The document does not specify a separate training set or its sample size. This is common for automated diagnostic systems like this, where the "training" (development and calibration) of the internal algorithms for identifying MICs and categories would have occurred during the system's initial development and prior to these validation studies. The studies described are primarily for validation and regulatory submission.

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

Since a dedicated training set is not explicitly mentioned, the document does not detail how its ground truth was established. However, based on the nature of the device, the ground truth for any internal development and calibration would typically be established using CLSI reference broth microdilution methods or similar gold standard laboratory techniques, performed by trained microbiologists.

Summary

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3 2005 JUN

CONFIDENTIAL AND PROPRIETARY

510(k) SUMMARY

SUBMITTED BY:	Becton, Dickinson and Company7 Loveton CircleSparks, MD 21152Phone: 410-316-4287Fax: 410-316-4499
CONTACT NAME:	Monica Giguere,RA Specialist
DATE PREPARED:	May 2, 2005
DEVICE TRADE NAME:	BD Phoenix™ Automated Microbiology System -Ceftriaxone 0.0625-4 ug/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 PhoenixTMAutomated 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-S Broth used for performing AST tests only. .
BD Phoenix AST-S 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 supporting the use of the BD Phoenix™ Automated Microbiology System Streptococcus 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 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 of streptoccal isolates. Each site tested the isolates in triplicate on three different days using one lot of Streptococcus 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 ≥98.4% and an overall inter-site reproducibility of ≥99.5% for the streptococcal isolates tested.

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Clinical Studies

Clinical, stock and challenge isolates were tested across multiple geographically diverse sites across Chilical, stock and chartelly of the performance of the Phoenix antimicrobial susceptibility test with the Streptococcus 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 I he performance of the I novement of techner results for all isolates tested. Essential Agreement Category Reroment (CT) to enjoy™ Automated Microbiology System agrees exactly or within ± (21) occurs dilution to the reference result. Category Agreement (CA) occurs when the BD one two-rold ununcul to the objology System agrees with the reference method with respect to the FDA categorical interpretive criteria (susceptible, intermediate, resistant or nonsusceptible).

Table 1 summarizes the performance for the isolates tested in this study.

Performance of BD Phoenix System for Streptococcal Organisms by Drug Table 1:

The first of the same of the camperation of the countryAntimicrobial	AND OR STORE FOR STATES OF THE FORM OF THE FORM OF THE FORM OF THE FORM OF THE FORM OF THE FORM OF THE FORM OF THE FORM OF THE FORM OF THE FORM OF THE FORCALLER ALL WITH CHILIN COLLEGE.Concentration	The Call of Children of Children of ChildrenAcres of the propertyEA (n)	(0/0)EA .	CA (n)	CA(%)
The County ofCeftriaxone	AND AND THE FORMING CHANAL CHARAL CHARACT CHEARTH CHEARTH CHEARTH CHEARTH CHEARTH CHEARTH CHEARTH CHEARTH CHEARTH CHEARTH CHEARTH CHEARTH CHEARTH CHEARTH CHEARTH AND THE CHEA0.0625-4 ug/mL	I2013	98.3	2013	0711:V

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 r noutlined in the FDA draft guidance document, "Class II Special Controls Guidance Document: a vimicrobial 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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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus, which is a symbol often associated with medicine and healthcare. The caduceus is depicted with a staff entwined by two snakes and topped with wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

3 2005 Jun

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

Received: May 4, 2005

K051138 Re:

Rose Device Name: BD Phoenix TM Automated Microbiology System Ceftriaxone (0.0625-4 ug/mL) - Streptococcus 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 2, 2005

Dear Ms. Giguere:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your be 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 conninered pror to May 20, 1978, in occordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). and Costieter rever (110) that as novice, subject to the general controls provisions of the Act. The I ou may, aferere, maxis of the Act include requirements for annual registration, listing of general controll profice wing 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 your device is easoned (660 as 1 controls. Existing major regulations affecting your device it may be subject to back of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA can oc found in The Brouncements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean I Trass oc advised that I Dristian that your device complies with other requirements of the Act that I Dr Has Intervand regulations administered by other Federal agencies. You must or uny I cathe all the Act's requirements, including, but not limited to: registration and listing (21 comply with an allering (21 CFR Parts 801 and 809); and good manufacturing practice OFF Part 867), tabelies 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 5 10(k) I his letter will anow you to oegin marketing your intial equivalence of your device to a legally premarket notification. "The PDF Imaning of backand"
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, of fu If you desire specific intornation actual advertising of your device, please contact the Office of In of questions on the promotion 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 Tou may outain other general meethanel 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,

Sales a Form

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

Ko 5 113 8 510(k) Number: __

Device Name: BD Phoenix™ Automated Microbiology System for use with the antimicrobial agent Device Name. BDTHoomx

Indications for Use:

The BD Phoenix™ Automated Microbiology System is intended for in vitro quantitative determination of The BD Phoenix™ Automated Michology System is manton (MIC) of most Gram-negative aerobic and antimicrobial susceptionity of initial innoltory obitoriacere and Non-Enterobacteriaceae
facultative anaerobic bacteria isolates from pure culture for Exercess Sterbulosecou facultative anactoric bacteria isolates from pure culture belonging to the genera Staphylococcus ,
and most Gram-positive bacteria isolates from pure culture belonging to the Enterococcus, and Streptococcus.

This premarket notification is for the addition of the antimicrobial agent offrisance at concernations of I his premarket notification is for the addition of the mix panels. Ceftriaxone has been shown to be 0.06.25-4 ig/mL to Sireplococcus IDAS I of AGT only Filocally as described in the FDA-approved package insert for this antimicrobial agent.

Active In Vitro and in Clinical Infections Against:

Streptococcus pneumoniae Streptococcus pyogenes Viridans group streptococci

Active In Vitro Against: Streptococcus agalactiae

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 In Vitro Diagnostic Devices (OIVD)

	Division Sign-Off
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Prescription Use(Per 21 CFR 801.109)	Office of In Vitro Diagnostic Device Evaluation and Safety	Over-the-Counter Use
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BD Diagnostic SystemsBecton Dickinson and Company	510(k) K051138 page 9
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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.”