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 and Enterococcus.

This premarket notification is for the antimicrobial agent gentamicin at concentrations of 0.25-16 ug/mL to Gram Negative ID/AST or AST only Phoenix panels. Gentamicin 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 Against:

Aerobic Gram-negative microorganisms

Citrobacter species Enterobacter species Escherichia coli Klebsiella species Proteus species (indole-positive and indole-negative) Pseudomonas aeruginosa Serratia species

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 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

1. Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (from FDA Draft Guidance Document, "Guidance on Review Criteria for Assessment of Antimicrobial Susceptibility Devices", March 8, 2000)	Reported Device Performance (BD Phoenix™ Automated Microbiology System for Gentamicin)
Essential Agreement (EA) for isolates tested (Criterion not explicitly stated but implied by substantial equivalence to reference method)	96.2%
Category Agreement (CA) for isolates tested (Criterion not explicitly stated but implied by substantial equivalence to reference method)	96.3%
Intra-site reproducibility	>90%
Inter-site reproducibility	>95%

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

Test Set Sample Size: 7751 isolates were used for Essential Agreement (EA) calculation and 975 isolates for Category Agreement (CA).
Data Provenance: The isolates were tested across multiple geographically diverse sites across the United States. The study included clinical, stock, and challenge isolates. This indicates the data is prospective and collected from the USA.

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

The document does not explicitly state the number or qualifications of experts used to establish the ground truth. It refers to the "NCCLS reference broth microdilution method" as the gold standard for clinical isolates and "expected results" for challenge isolates. The NCCLS (now CLSI) method is a standardized laboratory procedure, implying trained microbiologists would perform and interpret these reference tests, but specific expert details are not provided.

4. Adjudication method for the test set:

The document does not describe an adjudication method for discrepancies between the Phoenix System results and the reference method. Instead, it measures "Essential Agreement" (agreement within one two-fold dilution) and "Category Agreement" (agreement on S, I, or R interpretation) directly against the reference results. This suggests a direct comparison rather than an adjudication process involving multiple expert reviewers.

5. If a multi-reader, multi-case (MRMC) comparative effectiveness study was done:

No, a multi-reader, multi-case (MRMC) comparative effectiveness study was not done. The study compares the automated device's performance against a reference laboratory method, not against human readers with and without AI assistance.

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

Yes, a standalone performance study was done. The BD Phoenix™ Automated Microbiology System is an automated system that provides identification and antimicrobial susceptibility testing. The reported performance (EA and CA) refers to the system's output (algorithm only) compared to the reference standard. Human input is limited to preparing the inoculum and loading the panels, not interpreting the results generated by the system.

7. The type of ground truth used:

For clinical isolates: The ground truth was established by the NCCLS reference broth microdilution method (NCCLS M7). This is a standardized laboratory method considered the gold standard for antimicrobial susceptibility testing.
For challenge isolates: The ground truth was "expected results." This typically refers to results pre-determined by the manufacturer or expert laboratories for control strains.

8. The sample size for the training set:

The document does not specify a separate training set or its sample size. The study describes "Clinical, stock and challenge isolates" tested to demonstrate performance, implying these might have served as a validation/test set. For a device like the Phoenix System, the "training" (development and calibration) would likely involve extensive in-house testing and refinement before clinical studies, but this information is not provided in a 510(k) summary.

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

As no specific training set is mentioned, the method for establishing its ground truth is not described. However, given the nature of AST devices, the development and calibration of the system would rely on established microbiological methods (like the NCCLS method) for determining reference MICs and interpretations for a wide range of organisms and antimicrobial agents.

Summary

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510(K) SUMMARY

SUBMITTED BY:	Becton, Dickinson and Company7 Loveton CircleSparks, MD 21152Phone: 410-316-4287Fax: 410-316-4499	DEC 2 4 2002
CONTACT NAME:	Michelle B. BandyRegulatory Affairs Specialist
DATE PREPARED:	October 28, 2002
DEVICE TRADE NAME:	BD Phoenix™ Automated Microbiology System –Gentamicin 0.25-16 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 (K020321May 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 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 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 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-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.

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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 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-Negative Organisms by Drug Table 1:

CARDER SEE NOT AND AND AND A LEAR LE STORES OF STREET LE BELLER & BOOK CLASS OF THE LIGHTAntimicrobialThe production of the with of the state of the first the states and and	ConcentrationNO ARE THE COLUMN OF CHIPThe later and comments of the research and the commend of the county of the county of the	EA (n)	EA (%)AL CLASS OF CLEW STATES	CA (n)	CA (%)
(Gentamicın	0.25-16 µg/mL	7751ال ال ال	96.2	975 €l	96.3

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

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 eagle with three curved lines representing its wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

2 4 2002

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

Re: K023634

Trade/Device Name: BD Phoenix 114 Automated Microbiology Systems Gentamicin (0.25-16 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: October 28, 2002 Received: October 29, 2002

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, 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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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 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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BD PHOENIX™ Automated Microbiology System Gentamicin - GN

CONFIDENTIAL AND PROPRIETARY

. Page 1 of 1

510(k) Number:

Device Name: BD Phoenix™ Automated Microbiology System for use with the antimicrobial agent Gentamicin (0.25-16 ug/mL) - Gram Negative ID/AST or AST only Phoenix panels.

Indications for Use:

Active In Vitro Against:

Aerobic Gram-negative microorganisms

Citrobacter species Enterobacter species Escherichia coli Klebsiella species Proteus species (indole-positive and indole-negative) Pseudomonas aeruginosa Serratia species

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use V (Per 21 CFR 801.109)

Sail 1. Xilepal for FMP

()ver-the-Counter Use

Division of Clinical Laboratory Devices 510(k) Number.

BD Diagnostic Systems Becton, Dickinson and Company

Page 10

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.”