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.

This premarket notification is for the addition of the antimicrobial agent Amikacin at concentrations of 0.5-64 ug/mL to Gram Negative ID/AST or AST only Phoenix panels. Amikacin 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:

Acinetobacter spp. Citrobacter freundii Enterobacter spp. Escherichia coli Klebsiella spp. Proteus spp. Providencia spp. Pseudomonas spp. Serratia spp.

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 provided text regarding the acceptance criteria and the study proving the device meets those criteria:

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

1. Table of Acceptance Criteria and Reported Device Performance

Metric	Acceptance Criteria	Reported Device Performance (Amikacin)
Site Reproducibility (Intra-site)	Greater than 90% reproducibility for the antimicrobial agent	Greater than 90%
Site Reproducibility (Inter-site)	Greater than 95% reproducibility for the antimicrobial agent	Greater than 95%
Essential Agreement (EA)	Not explicitly stated as a numerical threshold in the provided text, but implied to be "substantially equivalent" to the NCCLS reference method. Typically, this is 90% or higher for AST devices.	95.3% (n=2598)
Category Agreement (CA)	Not explicitly stated as a numerical threshold in the provided text, but implied to be "substantially equivalent" to the NCCLS reference method. Typically, this is 90% or higher for AST devices.	96.7% (n=2598)

Note: The document states that performance was evaluated as defined in the FDA Draft guidance document, "Guidance on Review Criteria for Assessment of Antimicrobial Susceptibility Devices", March 8, 2000. While explicit numerical acceptance criteria for EA and CA are not present in the provided text, the reported values are in line with what is generally considered acceptable for "substantially equivalent" AST devices (typically >90%).

2. Sample Size and Data Provenance

Test Set Sample Size:
- Clinical Isolates: 2598 (based on the 'n' value in the EA and CA performance table for Amikacin).
- Stock and Challenge Isolates: The exact number is not explicitly stated, but they were also included in the overall clinical study alongside clinical isolates.
Data Provenance: The study was conducted across "multiple geographically diverse sites across the United States." The data is prospective, generated specifically for this study.

3. Number of Experts and Qualifications for Ground Truth

The document does not explicitly state the number or qualifications of experts used to establish the ground truth. However, the ground truth for clinical isolates was established by the NCCLS reference broth microdilution method. This method itself is a standardized, expert-approved laboratory procedure, implicitly relying on the expertise of trained microbiologists to perform and interpret. For challenge isolates, "expected results" were used, implying pre-established, known resistance/susceptibility profiles.

4. Adjudication Method for the Test Set

The document does not mention an adjudication method (like 2+1, 3+1, etc.) for the test set. The comparison for clinical isolates was directly against the NCCLS reference method, and for challenge isolates, against expected results. This suggests direct comparison rather than a human consensus-based adjudication process for the device's output.

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

No. This study is not an MRMC comparative effectiveness study involving human readers. It evaluates the performance of an automated device against a reference method, not an AI's impact on human reader effectiveness.

6. Standalone Performance Study

Yes, this is a standalone performance study. The BD Phoenix™ Automated Microbiology System is an algorithm-only (automated device) without human-in-the-loop performance being a primary endpoint or evaluation criterion. Its results (MIC values and categorical interpretations) are compared directly to a gold standard.

7. Type of Ground Truth Used

Clinical Isolates: NCCLS reference broth microdilution method.
Challenge Isolates: "Expected results," which are typically pre-determined susceptibility profiles for known strains, often established by reference laboratories or expert panels.

8. Sample Size for the Training Set

The document does not provide information on the sample size used for the training set. This is typical for medical device submissions that focus on the validation (test set) performance for regulatory clearance, often assuming the training and development were internal and proprietary.

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

The document does not specify how the ground truth for the training set (if any explicit training was done for an underlying algorithm) was established. Given the nature of the device (an automated microbiology system based on physical and chemical reactions), the "training" might be less about a deep learning model's training data and more about the extensive development and calibration of the instrument and its reagent panels using known bacterial strains and reference methods.

Summary

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510(K) SUMMARY

23444

SUBMITTED BY:	Becton, Dickinson and Company
	7 Loveton Circle
	Sparks, MD 21152
	Phone: 410-316-4287
	Fax: 410-316-4499
	NOV 12 2002
CONTACT NAME:	Bradford M. Spring
	Manager, Regulatory Affairs
DATE PREPARED:	October 14, 2002
DEVICE TRADE NAME:	BD Phoenix™ Automated Microbiology System -
	Amikacin 0.5-64 µg/mL
DEVICE COMMON NAME:	Antimicrobial susceptibility test system-short incubation
DEVICE CLASSIFICATION:	Fully Automated Short-Term Incubation Cycle Antimicrobial
	Susceptibility 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), and
	Levofloxacin (K020322, March 27, 2002).
INTENDED USE:	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.

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 (%)
Amikacin	0.5-64 μg/mL	2598	95.3	2598	96.7

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 is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or other bird-like figure with three lines representing its body and wings.

ood and Drug Administration 198 Gaither Road Rockville MD 20850

Mr. Bradford M. Spring Manager. Regulatory Affairs BD Diagnostic Systems Becton, Dickinson and Company 7 Loveton Circle Sparks, MD 21152-0999

NOV 12 2002

Re: K023444

Trade/Device Name: BD Phoenix™ Automated Microbiology Systems Amikacin (0.5-64 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 14, 2002 Received: October 15, 2002

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 the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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This letter will allow you to begin marketing your device as described in your 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 advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Autman

Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page 1 of 1

510(k) Number: Ko2344

Device Name: BD Phoenix™ Automated Microbiology System for use with the antimicrobial agent Amikacin (0.5-64 ug/mL) - Gram negative ID/AST or AST only Phoenix panels.

Indications for Use:

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.

Active In Vitro and in Clinical Infections Against:

Acinetobacter spp. Citrobacter freundii Enterobacter spp. Escherichia coli Klebsiella spp. Proteus spp. Providencia spp. Pseudomonas spp. Serratia spp.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Roscoe Smith, for Freddie H. Porte

Division of Clinical Laboratory Devices 510ik) Number_DOA

Prescription Use
(Per 21 CFR 801.109) ✓

Over-the-Counter Use

BD Diagnostic Systems Becton, Dickinson and Company

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.”