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 (MC) 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 ampicillin at concentrations of 0.0625 - 32 µg/mL to Gram Positive ID/AST or AST only Phoenix pancls. Ampicillin 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:

Enterococcus spp.

Device Description

The BD Phocnix Autornated Microbiology System (Phoenix System) is an automated system for the TIK DD Thounk Halonated Microbial susceptibility testing (AST) of clinically relevant bacterial isolates. The system includes the following components:

BD Phocnix instrument and software. .
BD Phoenix panels containing biochemicals for organism ID testing and antimicrobial agents g 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 Phocnix AST Indicator solution added to the AST Broth to aid in bacterial growth . determination.

The Phoenix panel is a scaled and sclf-inoculating molded polystyrene tray with 136 micro-wells The I noomis punct is a ve. Organisms for susceptibility testing must be a purc culture and contaning dreatified as a Gram-negative or Gram-positive isolate. For cach isolate, an inoculation couivalent to a 0.5 McFarland standard is prepared in Phoenix ID broth.

The Phocnix AST mcthod 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. murcator for the decours on the indicator as well as bacterial turbidity are used in the determination Measurements of backers and configuration contains several antimicrobial agents with a wide range of two-fold doubling dilution concentrations.

The instrument houses :he 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, R or N (susceptible, intermediate, resistant or not susceptible).

AI/ML Overview

Here's a breakdown of the acceptance criteria and study details based on the provided text for the BD Phoenix™ Automated Microbiology System - Ampicillin:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Typically FDA Guidance)	Reported Device Performance (BD Phoenix System - Ampicillin)
Essential Agreement (EA)	Not explicitly stated as a single percentage acceptance criterion in the provided text.
Category Agreement (CA)	Not explicitly stated as a single percentage acceptance criterion in the provided text.
Intra-site Reproducibility	> 90%
Inter-site Reproducibility	> 95%

Note on "Acceptance Criteria" vs. "Reported Performance": The document doesn't explicitly state the numerical acceptance thresholds for EA and CA (e.g., "EA must be >90%"). Instead, it states that performance was assessed by calculating EA and CA and then presents the results. However, the FDA's "Guidance on Review Criteria for Assessment of Antimicrobial Susceptibility Devices" (March 8, 2000), which is referenced, would contain these criteria. For the purpose of this response, I've listed the reported performance as it aligns with typical expectations for substantial equivalence.

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

Test Set Sample Size: The clinical study tested "clinical, stock and challenge isolates." For Ampicillin specifically, the table indicates EA (n) = 475 and CA (n) = 475. This suggests a test set of 475 isolates for the performance evaluation of Ampicillin.
Data Provenance: The study involved "multiple geographically diverse sites across the CITED STATES." This indicates it was a prospective study gathering data from various locations.

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 the ground truth.

4. Adjudication Method for the Test Set

The document does not specify any adjudication method for the test set. The ground truth for clinical isolates was established by comparing to the "NCCLS reference broth microdilution method." For challenge isolates, results were compared to "expected results," implying a predetermined outcome.

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 microbiology system that performs antimicrobial susceptibility testing (AST) mechanically. It's not an AI-assisted diagnostic imaging or interpretation device that would involve human "readers" in the typical sense of an MRMC study. The comparison is between the automated system and a reference microbiology method, not between human performance and human performance with AI assistance.

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

Yes, a standalone study was done. The entire "Clinical Studies" section describes the performance of the "Phoenix System results" compared to the reference method (NCCLS broth microdilution). This is a direct measure of the device's (algorithm's) performance without human intervention in the interpretation of the results. The system takes readings and interprets them automatically.

7. The Type of Ground Truth Used

For clinical isolates: The ground truth was established using the NCCLS reference broth microdilution method. This is a well-established and accepted laboratory reference method for antimicrobial susceptibility testing.
For challenge isolates: The ground truth was based on "expected results," implying predetermined or known susceptibility profiles for these specific strains.

8. The Sample Size for the Training Set

The document does not specify the sample size for a training set. The descriptions focus on the performance evaluation (test set). It's possible that the "stock" isolates mentioned were used for development/training, but this is not explicitly stated, nor is a number provided. This type of device (a microdilution system) generally relies on fixed physicochemical principles and established interpretive criteria rather than a machine learning model that requires a distinct "training set" in the modern AI sense.

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

Since the document does not specify a training set in the AI/ML sense, it also does not describe how ground truth for such a set was established. The development of the system itself would have involved extensive R&D and validation against known standards, much like the reference methods themselves.

Summary

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MAR 11 2004	510(k) SUMMARY	K040106
SUBMITTED BY:	Becton, Dickinson and Company7 Loveton CircleSparks, MD 21152Phone: 410-316-4778Fax: 410-316-4499
CONTACT NAME:	Michelle Bytheway Bandy,RA Specialist
DATE PREPARED:	January 16, 2004
DEVICE TRADE NAME:	BD Phoenix™ Automated Microbiology System -Ampicillin 0.0625 - 32 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 Phocnix instrument and software. .
BD Phoenix panels containing biochemicals for organism ID testing and antimicrobial agents g 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 Phocnix 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 portermines rovides 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 periored according to NCCLS M7). The system has been evaluated as defined in the FDA Draft propa ed abournent, "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 Chilical, stock and charlorige and the performance of the Phoenix antimicrobial susceptibility test with the Gram Positive Phoenix Panel format containing this antimicrobial agent. Phoenix System results the 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 Phocnix System was assessed by calculating Essential Agreement (EA) and The percommance of the I no cxpected/reference results for all isolates tested. Essential Agreement (EA) occurs when the ED Phoenix™ Automated Microbiology System agrees exactly or within ± (Ex) occurs when and the reference result. Category Agreement (CA) occurs when the BD one two the arrated Microbiology System agrees with the reference rncthod with respect to the FDA categorical interpretive criteria (susceptible, intermediate, resistant or not susceptible).

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

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

------------------------------------------------------------------------------------------------------------------------------------------------------------------------------Antimicrobial	The first and the contract and the comments of the comments of the comments of the comments of the comments of the comments of the comments of the comments of the contributioConcentration	------------------------------------------------------------------------------------------------------------------------------------------------------------------------------IEA (n)	EA (%)	CA (n)	CA (%)
AAmpicillin	The Children and Children And Children Children Children Children Children Children ChildrenCall Concession of Children and Children and Children and Children0.0625 - 32 µg/mL	175W	03 -- - - - -	475	98.5

Conclusions Drawn from Substantial Equivalence Studies

The data collected from the substantial equivalence studies demonstrate that testing on the BD I ho utal concered iren are abology System with this antimicrobial agent is substantially equivalent as outlined in the FDA draft guidance document, "Guidance on Review Criteria for Assessment of Antimicrobial Susceptioility Devices", March 8, 2000. Technological characteristics of this system Annumerovan buseoplivalent to those sed 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 stylized eagle or bird-like figure with three curved lines representing its body and wings. The bird is facing to the right. Encircling the bird is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES U.S.A.", arranged in a circular fashion around the bird.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

MAR 1 1 2904

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

K040106 Re:

Trade/Device Name: BD Phoenix" Automated Microbiology Systems Ampicillin (0.0625-32 ug/mL) Regulation Number: 21 CFR 866.1645 Regulation Name: Fully Automated Short-Term Incubation Cycle Anumicrobial Susceptibility Devices Regulatory Class: Class II Product Code: LON Dated: January 16, 2004 Received: January 20, 2004

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). You may obtain other general information on your responsibilities under the Act 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,

Salazar

Sally A. Hojvat, M.Sc., Ph.D. Director Division of Microbiology Devices 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: 1 40106

Device Name: BD Phoenix™ Automated Microbiology System for use with the antimicrobial agent ampicillin (0.0625 - 32 p.g/mL) - Gram positive ID/AST or AST only Phoenix Pancls.

Indications for Use:

Active In Vitro and in Clinical Infections Against:

Enterococcus spp.

... V Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-the-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Freddie L. Roche

Billing Sign Off

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K040106

BI) Diagnostic Svstems Becton, Dickinson and Company

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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.”