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 agents gentamicin synergy at a concentration of 500 ug/mL and streptomycin synergy at a concentration of 1000 ug/mL to Gram Positive ID/AST or AST only Phoenix panels. Gentamicin synergy and streptomycin synergy are used to predict synergy between ampicillin, penicillin or vancomycin and an aminoglycoside with enterococci.

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 ● or 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, 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 twofold 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 provided text, outlining the acceptance criteria and study details for the BD Phoenix™ Automated Microbiology System for Gentamicin Synergy and Streptomycin Synergy.

1. Table of Acceptance Criteria and Reported Device Performance

The text explicitly compares the BD Phoenix System's performance to the NCCLS reference broth microdilution method. While the document doesn't present a formal "acceptance criteria" table with pre-defined thresholds, it implicitly uses the concept of "substantially equivalent performance" to the reference method. The reported performance is as follows:

Antimicrobial	Performance Metric	Reported Value	Implicit Acceptance Criteria (based on "substantially equivalent performance")
Gentamicin Synergy	Overall Agreement (CA)% *	98.6%	Based on the FDA Draft guidance document, "Guidance on Review Criteria for Assessment of Antimicrobial Susceptibility Devices", March 8, 2000, which defines criteria for "substantially equivalent."
Streptomycin Synergy	Overall Agreement (CA)% *	97.8%	Based on the FDA Draft guidance document, "Guidance on Review Criteria for Assessment of Antimicrobial Susceptibility Devices", March 8, 2000, which defines criteria for "substantially equivalent."
Gentamicin Synergy	Essential Agreement (EA)% *	--	Expected to be high, but not explicitly stated for this particular antimicrobial in the table.
Streptomycin Synergy	Essential Agreement (EA)% *	--	Expected to be high, but not explicitly stated for this particular antimicrobial in the table.
Intra-site Reproducibility	>90%	>90%
Inter-site Reproducibility	>95%	>95%

Note: The document uses "CA%" (Category Agreement) as the primary reported metric in Table 1 for both Gentamicin Synergy and Streptomycin Synergy. "EA%" (Essential Agreement) is listed in the table header but no values are provided for these specific agents in this summary.

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

Test Set Sample Size:
- Gentamicin Synergy: 763 isolates (for Category Agreement)
- Streptomycin Synergy: 756 isolates (for Category Agreement)
- Reproducibility study: "a panel of Gram-positive isolates" (exact number not specified beyond "panel")
Data Provenance: Clinical, stock, and challenge isolates were tested across multiple geographically diverse sites across the United States. This indicates a prospective collection and testing approach and data from the United States.

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

The document does not mention the use of experts to establish ground truth for the test set. Instead, the ground truth was established by comparison to a reference method.

4. Adjudication Method for the Test Set

The document does not describe an adjudication method involving experts for discrepancies. The comparison is made directly with the NCCLS reference broth microdilution method.

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 that human readers would use. Therefore, the concept of human readers improving with AI assistance is not applicable in this context.

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

Yes, a standalone performance study was done. The entire study evaluates the performance of the "BD Phoenix™ Automated Microbiology System" (an automated device/algorithm) against a reference method without human interpretation of the system's raw output. The system produces MIC values and S, I, or R interpretations directly.

7. The Type of Ground Truth Used

The ground truth used for the clinical studies was the NCCLS reference broth microdilution method. For challenge isolates, the ground truth was "expected results."

8. The Sample Size for the Training Set

The document does not provide information regarding a separate "training set" or its sample size. This is typical for traditional in vitro diagnostic devices where the "training" (development and validation of the algorithms and reagents) likely happened iteratively with internal data and was robust prior to formal clinical validation described here.

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

Since no specific "training set" is mentioned, the method for establishing its ground truth is also not described. However, it can be inferred that developers would use similar reference methods (like NCCLS broth microdilution) to establish the ground truth for any data used during the development and optimization phases of the device.

Summary

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510(k) SUMMARY

SUBMITTED BY:	Becton, Dickinson and Company7 Loveton CircleSparks, MD 21152Phone: 410-316-4206Fax: 410-316-4499
CONTACT NAME:	Bradford Spring,Manager, Regulatory Affairs
DATE PREPARED:	July 15, 2003
DEVICE TRADE NAME:	BD Phoenix™ Automated Microbiology System –Gentamicin Synergy (500 µg/mL) and Streptomycin Synergy(1000 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 is intendedfor the rapid identification and in vitro antimicrobialsusceptibility testing of isolates from pure culture of most aerobicand facultative anaerobic Gram-negative and Gram-positivebacteria 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 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 positive 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-positive isolates. Each site tested the isolates in triplicate on three different days using one lot of Gram Positive 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-positive 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 Positive 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.

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

Table 1: Performance of BD Phoenix System for Gentamicin Synergy and Streptomycin Synergy

ANTIMICROBIAL	CODE	EAN	EA%	CAN	CA%
Gentamicin Synergy	GMS	--	--	763	98.6
Streptomycin Synergy	STS	--	--	756	97.8

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

Public Health Service

Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services (HHS). The logo features a stylized caduceus, which is a symbol often associated with healthcare. The caduceus is depicted with three diagonal lines representing the snakes intertwined around a staff. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the caduceus.

JUL 16 2003

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Mr. Bradford M. Spring Manager, Regulatory Affairs BD Diagnostics Systems Becton, Dickinson and Company Post Office Box 999 Sparks, MD 21152-0999

Re: K031679

Trade/Device Name: BD Phoenix 11 Automated Microbiology System Gentamicin Synergy (500 ug/ml) and Streptomycin Synergy (1000 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: May 30, 2003 Received: May 30, 2003

Dear Mr. Spring:

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 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: JKO31679

Device Name: BD Phoenix™ Automated Microbiology System for use with the antimicrobial agents gentamicin synergy (500 µg/mL) and streptomycin synergy (1000 µg/mL)- Gram positive ID/AST or AST only Phoenix panels.

Indications for Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Sall, attorney 7/16/03
Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K031679

Prescription Use
(Per 21 CFR 801.109)

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.”