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 ticarcillin at concentrations of 1-128 ug/mL to Gram-negative ID/AST or AST only Phoenix panels. Ticarcillin 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:

Pseudomonas aeruginosa Escherichia coli Proteus mirabilis Morganella morganii

Providencia rettgeri Enterobacter species Salmonella 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

The provided 510(k) summary describes the BD Phoenix™ Automated Microbiology System for susceptibility testing of Ticarcillin against Gram-negative isolates. Here's a breakdown of the acceptance criteria and study details:

1. Table of Acceptance Criteria and Reported Device Performance:

Performance Metric	Acceptance Criteria (FDA Guidance*)	Reported Device Performance (%)
Essential Agreement (EA)	Not explicitly stated as a numerical threshold in the document, but good performance is expected.	94.0
Category Agreement (CA)	Not explicitly stated as a numerical threshold in the document, but good performance is expected.	97.1
Intra-site Reproducibility	Greater than 90%	Greater than 90%
Inter-site Reproducibility	Greater than 95%	Greater than 95%

*The document refers to the FDA Draft guidance document, "Guidance on Review Criteria for Assessment of Antimicrobial Susceptibility Devices", March 8, 2000, for acceptance criteria. Specific numerical thresholds for EA and CA for this type of device are typically outlined in such guidance documents, but they are not explicitly presented as pass/fail criteria in the provided text. The provided EA and CA percentages represent the device's performance.

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

Sample Size for Test Set:
- Clinical isolates (for EA/CA): 2294 (This is the 'n' value reported for EA and CA in Table 1).
- Reproducibility study: A "panel of Gram-negative isolates" was tested, but a specific number is not provided.
Data Provenance: The isolates were tested "across multiple geographically diverse sites across the United States." The data is prospective, as it involves testing isolates using the Phoenix system and comparing them to a reference method.

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

The document does not explicitly state the number of experts or their qualifications for establishing ground truth. However, the ground truth for clinical isolates was established by the NCCLS reference broth microdilution method (AST panels prepared according to NCCLS M7). This method itself is a standardized and recognized "expert" method. For challenge set isolates, the Phoenix System results were compared to "expected results," which implies pre-defined or externally verified ground truth, likely from expert consensus or established references.

4. Adjudication Method for the Test Set:

The document does not describe an explicit adjudication method (like 2+1 or 3+1). The comparison was made against a single reference method (NCCLS broth microdilution) for clinical isolates, and against "expected results" for challenge isolates. Discrepancies would likely be investigated, but a multi-expert adjudication process isn't detailed.

5. If a Multi-reader Multi-case (MRMC) Comparative Effectiveness Study was done:

No, an MRMC comparative effectiveness study involving human readers is not described. This device is an automated system for antimicrobial susceptibility testing, not an imaging or diagnostic device that typically involves human interpretation. The study focuses on the device's performance compared to a reference standard, not on human reader improvement with AI assistance.

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

Yes, this was a standalone study. The BD Phoenix™ Automated Microbiology System is an automated system. Its performance (MIC values and categorical interpretation) was evaluated directly against the reference method without human interpretation being the primary variable. Human input is involved in preparing the inoculum and loading the panels, but the interpretive algorithm is standalone from that point.

7. The Type of Ground Truth Used:

Clinical Isolates: The ground truth was established using the NCCLS reference broth microdilution method (AST panels prepared according to NCCLS M7). This is a well-established and recognized laboratory standard for antimicrobial susceptibility testing, often considered the gold standard.
Challenge Isolates: The ground truth for these isolates was "expected results," implying pre-determined or reference values.

8. The Sample Size for the Training Set:

The document does not explicitly state a sample size for a training set. The Phoenix system's underlying algorithms and models would have been developed and trained using a large dataset, but this 510(k) summary focuses on the validation study for this specific antimicrobial agent (Ticarcillin) and its performance against the reference method. It's common for 510(k) submissions to not detail the training set unless modifications to the core algorithm are being made that necessitate re-training or re-validation that is different from previous submissions.

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

Since a training set is not explicitly mentioned or detailed in this document, the method for establishing its ground truth is also not described. For the type of device, a training set would likely involve isolates with known antimicrobial susceptibility results determined by reference methods (like NCCLS broth microdilution) to train the automated system's algorithms for growth detection and MIC determination.

Summary

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K031984

AUG 2 7 2003

BD PHOENIX™ Automated Microbiology System Ticarcillin - GN

CONFIDENTIAL AND PROPRIETARY

510(K) SUMMARY

SUBMITTED BY:	Becton, Dickinson and Company7 Loveton CircleSparks, MD 21152Phone: (410)-316-4260Fax: 410-316-4499
CONTACT NAME:	Kathryn Babka PowersRegulatory Affairs Specialist
DATE PREPARED:	June 25, 2003
DEVICE TRADE NAME:	BD Phoenix™ Automated Microbiology System -Ticarcillin 1-128 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 . 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

Antimicrobial	Concentration	EA (n)	EA (%)	CA (n)	CA (%)
COLLECTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTIOicarcillin	1-128 ug/mL	2294	94.0	2294	07 -1

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 circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, with three curved lines representing the wings and a wavy line representing the body.

Public Health Service

AUG 2 7 2003

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

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

K031984 Re:

Trade/Device Name: BD Phoenix™ Automated Microbiology System Ticarcillin (1-128 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: June 25, 2003 Received: June 26, 2003

Dear Ms. Powers:

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. 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 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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Page 1 of 1

510(k) Number: K031984

Device Name: /BD Phoenix™ Automated Microbiology System for use with the antimicrobial agent ticarcillin (1-128 ug/mL) - Gram-negative ID/AST or AST only Phoenix panels.

Indications for Use:

Active In Vitro Against:

Pseudomonas aeruginosa Escherichia coli Proteus mirabilis Morganella morganii

Providencia rettgeri Enterobacter species Salmonella species

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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Division Sign-Off

Office of In Vitro Diagnostic Evaluation and Safety

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KO31984 510(k).

Over-the-Counter Use

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.”