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 addition of the antimicrobjal agent Tobramycin at concentrations of 0.125-16 ug/mL to Gram-negative ID/AST cr AST only Phoenix panels. Tobramycin 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 Enterobacter species Escherichia coli Klebsiella species Morganella morganii
Pseudomonas aeruginosa Proteus mirabilis Proteus vulgaris Providencia species (excluding Providencia stuartii) 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

Here's a breakdown of the acceptance criteria and study information for the BD Phoenix™ Automated Microbiology System for Tobramycin, based on the provided text:

Acceptance Criteria and Device Performance Study for BD Phoenix™ Automated Microbiology System Tobramycin

1. Table of Acceptance Criteria and Reported Device Performance

The study evaluated two primary performance metrics: Essential Agreement (EA) and Category Agreement (CA). The acceptance criteria are based on those outlined in the FDA Draft Guidance Document, "Guidance on Review Criteria for Assessment of Antimicrobial Susceptibility Devices", March 8, 2000. While the exact numerical criteria from the guidance document are not explicitly stated in the provided text, the document indicates that the system "demonstrated substantially equivalent performance" when compared to the NCCLS reference method. Typically, acceptable Essential Agreement (EA) is generally >90% and acceptable Category Agreement (CA) is generally >90%, with specific allowances for minor discrepancies.

Metric	Acceptance Criteria (Implied by FDA Guidance)	Reported Device Performance (Tobramycin for Gram-negative organisms)
Essential Agreement (EA)	Substantially Equivalent to Reference (>90%)	92.2%
Category Agreement (CA)	Substantially Equivalent to Reference (>90%)	95.0%

Note: The actual acceptance criteria percentages from the FDA guidance are not directly stated, but "substantially equivalent performance" implies meeting or exceeding recognized performance thresholds, typically >90% for both EA and CA in AST device evaluations.

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

Sample Size for Test Set: 2658 isolates (n=2658 for both EA and CA calculations).
Data Provenance: Clinical, stock, and challenge isolates were tested across multiple geographically diverse sites across the United States. The clinical isolates were compared to the NCCLS reference broth microdilution method, while challenge set isolates were compared to expected results.

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

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 comparator for clinical isolates and "expected results" for challenge isolates. This implies that the ground truth was established by laboratory personnel following standardized NCCLS protocols, which are expert-driven methodologies, rather than individual expert adjudication of pre-existing images or data.

4. Adjudication Method for the Test Set

Not applicable in the traditional sense of multiple human readers adjudicating an output. The "ground truth" for clinical isolates was the NCCLS reference broth microdilution method, which is a standardized laboratory procedure, not an adjudication process requiring multiple human experts to resolve discrepancies. For challenge isolates, results were compared to "expected results," which are predefined.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This study focuses on the standalone performance of the automated system compared to a reference method, not on how the system assists human readers.

6. Standalone Performance Study

Yes, a standalone performance study was done. The BD Phoenix™ Automated Microbiology System's performance was directly compared to the NCCLS reference broth microdilution method and expected results for challenge isolates, without a human-in-the-loop component.

7. Type of Ground Truth Used

Clinical Isolates: The ground truth was established by the NCCLS reference broth microdilution method.
Challenge Isolates: The ground truth was established by expected results.

8. 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" used for performance evaluation, but does not detail a distinct training phase. This type of device (Antimicrobial Susceptibility Testing system) typically relies on pre-programmed algorithms based on known biological responses rather than machine learning models that require distinct training and test sets in the same way an image recognition AI might.

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

As no explicit training set is described in the provided text, the method for establishing its ground truth is not available. The system's underlying technology would have been developed based on extensive microbiological principles and data, but the text focuses on the validation of the specific device and antimicrobial agent.

Summary

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KC0238558
DEC 20 2002

BD PHOENIX™ Automated Microbiology System Tobramycin - GN

CONFIDENTIAL AND PROPRIETARY

SUBMITTED BY:	Becton, Dickinson and Company7 Loveton CircleSparks, MD 21152Phone: 410-316-4260410-316-4499Fax:
CONTACT NAME:	Kathryn Babka PowersRegulatory Affairs Specialist
DATE PREPARED:	November 19, 2002
DEVICE TRADE NAME:	BD Phoenix™ Automated Microbiology System -Tobramycin 0.125-16 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 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.

510(K) SUMMARY

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.

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

Comments of the most of the commended to the commended to the comments ofAntimicrobialAnd Income of the program and any and the program and the arrants of the arrants of the arrants of the arrants of the warrest	Concentration	EA (n)	EA (%)	CA (n)	CA (%)
tl obram vein	0.125-16 ug/mL	2658	02 2ل وال ال	2658	05 ?1 4 14

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 features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Kathryn Babka Powers Regulatory Affairs Specialist Becton, Dickinson and Company Post Office Box 999 Sparks, MD 21152-0999

Re: K023858 Trade/Device Name: BD Phoenix™ Automated Microbiology Systems Tobramycin (0.125-16 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: November 19, 2002 Received: November 20, 2002

Dear Ms. Smith:

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 vour 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 (OS) 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 yours,

Steven Butman

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: K02 3858

Device Name: BD Phoenix™ Automated Microbiology System for use with the antimicrobial agent Tobramycin (0.125-16 ug/mL) - Gram-negative ID/AST or AST only Phoenix panels.

Indications for Use:

Active In Vitro and in Clinical Infections Against:

Citrobacter species Enterobacter species Escherichia coli Klebsiella species Morganella morganii
Pseudomonas aeruginosa Proteus mirabilis Proteus vulgaris Providencia species (excluding Providencia stuartii) Serratia species

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Freddie L. Poole

(Dision Sign-Off) Division of Clinical Laboratory Devices

510(k) Number K02 3858

Prescription Use √
(Per 21 CFR 801.109)

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.”