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 antimicrobial agent amoxicillin/clavulanate at concentrations of 0.5/0.25-32/16 ug/mL to Gram-negative ID/AST or AST only Phoenix panels. Amoxicillin/clavulanate 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:
Enterobacter species
Escherichia coli
Klebsiella species

Active In Vitro Against:
Proteus mirabilis

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 an analysis of the acceptance criteria and study detailed in the provided text:

Acceptance Criteria and Device Performance

Criteria	Reported Device Performance (BD Phoenix™ Automated Microbiology System - Amoxicillin/Clavulanate 0.5/0.25-32/16 µg/mL)
Site Reproducibility (Intra-site)	Greater than 90% for Gram-negative isolates
Site Reproducibility (Inter-site)	Greater than 95% for Gram-negative isolates
Essential Agreement (EA)	96.5% (n=1919 isolates)
Category Agreement (CA)	90.3% (n=1919 isolates)

Study Details

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

Sample Size: 1919 (total for both EA and CA calculations and across clinical, stock, and challenge isolates).
Data Provenance:
- Country of Origin: United States (across multiple geographically diverse sites).
- Retrospective or Prospective: Not explicitly stated as retrospective or prospective, but clinical isolates were tested and compared to a reference method, suggesting this was part of a prospective evaluation for the device's performance.

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 for establishing ground truth.
The ground truth for clinical isolates was established by the NCCLS reference broth microdilution method.
The ground truth for challenge isolates was "expected results." The method for determining these "expected results" is not detailed, nor is the involvement of experts for these isolates.

4. Adjudication Method for the Test Set:

The document does not explicitly state an adjudication method (such as 2+1 or 3+1).
For clinical isolates, the BD Phoenix System results were compared to the NCCLS reference broth microdilution method as the gold standard. For challenge isolates, they were compared to "expected results." This suggests a direct comparison method rather than an adjudication process between multiple readers/interpretations of the Phoenix results themselves.

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, an MRMC comparative effectiveness study was NOT done.
This device is an automated system for antimicrobial susceptibility testing, not an AI-assisted diagnostic tool for human readers. Therefore, the concept of human readers improving with AI assistance is not applicable here.

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

Yes, a standalone performance evaluation was done. The entire study is a standalone evaluation of the BD Phoenix Automated Microbiology System. The system itself determines the MIC values and category interpretations (S, I, or R) without human intervention in the interpretation process of the readings. Human involvement is primarily for preparing the inoculum and loading the panels, but the interpretive results are generated by the automated system.

7. The Type of Ground Truth Used:

Clinical Isolates: NCCLS reference broth microdilution method (a standardized laboratory method).
Challenge Isolates: "Expected results" (details not provided on how these "expected results" were determined).

8. The Sample Size for the Training Set:

The document does not provide information regarding a separate training set. The study describes the validation of the system's performance, but it does not detail its development or any training data used to build its algorithms.

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

Since a training set is not explicitly mentioned, no information is provided on how its ground truth would have been established.

Summary

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510(K) SUMMARY

SUBMITTED BY:	Becton, Dickinson and Company7 Loveton CircleSparks, MD 21152Phone: (410) 316 - 4778Fax: 410-316-4499
CONTACT NAME:	Michelle B. BandyRegulatory Affairs Specialist
DATE PREPARED:	June 19, 2003
DEVICE TRADE NAME:	BD Phoenix™ Automated Microbiology System -Amoxicillin/Clavulanate 0.5/0.25-32/16 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 (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.

BD Diagnostic Systems Becton, Dickinson and Company

Page 1 1

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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:

and the controlled on the controlled to the controllation of the comments of the comments of the comments of the comments of the comments of the comments of the comments of t Antimicrobial	Concentration	EA (n)	EA (%) CA (n) CA (%)
Amoxicillin/Clavulanate 0.5/0.25-32/16 ug/mL		1919	96.5	1919	90.3

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).

BD Diagnostic Systems Becton, Dickinson and Company

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Public Health Service

od and Drug Administration 2098 Gaither Road Rockville MD 20850

JUL 2 1 2003

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

Re: K031912

Trade/Device Name: BD Phoenix™ Automated Microbiology Systems Amoxicillin/clavulanate (0.5/0.25-32/16 µg/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 19, 2003

Received: June 20, 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, 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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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 Sutman

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: Ko 31912

Device Name: BD Phoenix™ Automated Microbiology System for use with the antimicrobial agent amoxicillin/clavulanate (0.5/0.25-32/16 ug/mL) - Gram-negative ID/AST or AST only Phoenix panels.

Indications for Use:

Active In Vitro and in Clinical Infections Against:

Enterobacter species Escherichia coli Klebsiella species

Active In Vitro Against:

Proteus mirabilis

Prescription Use

(Per 21 CFR 801.109)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Sagatt
Division Sigh-Off
7/17/2003

Over-the-Counter Use

e of In Vitro Diagnostic Device Fireliation and No

:(n(.) K031912

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.”