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 aerobic and facultative anaerobic bacteria isolates from pure culture for Gram-negative aerobic and Non-Enteriaceae and most Gram-positive bacteria isolates from pure Enterococcionains to the genera Staphylococcus and Enterococcus.

This premarket notification is for the addition of the antimicrobial agent cefoxitin at concentrations of 1-32 µg/mL to Gram Positive ID/AST or AST only Phoenix panels. It will also be used as a test to detect methicillin/oxacillin resistance in Staphylococcus aureus in these panels. Cefoxitin has been shown to product 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:
Staphylococcus aureus® (including penicillinase-producing strains)
Staphylococcus epidermidisª

a Staphylococci resistant to methicillin/oxacillin should be considered resistant to cefoxitin.

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 containing dried reagents: 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 study for the BD Phoenix™ Automated Microbiology System - Cefoxitin 1-32 µg/mL.

1. Table of Acceptance Criteria and Reported Device Performance:

The document explicitly states acceptance criteria are based on Essential Agreement (EA) and Category Agreement (CA) when compared to the CLSI reference broth microdilution method. While the exact numerical acceptance thresholds for EA and CA are not present in the provided text, the overall conclusion states "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." This implies the performance met the criteria set forth in that guidance document.

Acceptance Criterion	Reported Device Performance
Essential Agreement (EA)	Not explicitly stated in numerical percentage, but concluded to be "substantially equivalent" when compared to the CLSI reference broth microdilution method, implying it met the FDA guidance. EA is defined as agreement exactly or within +/- one two-fold dilution to the reference result.
Category Agreement (CA)	Not explicitly stated in numerical percentage, but concluded to be "substantially equivalent" when compared to the CLSI reference broth microdilution method, implying it met the FDA guidance. CA is defined as agreement with the reference method with respect to FDA categorical interpretive criteria (susceptible, intermediate, and resistant).
Intra-site Reproducibility	Greater than 90%
Inter-site Reproducibility	Greater than 95%

Note: The provided "Table 1: Performance of BD Phoenix System for Gram-Positive Organisms by Drug" is missing critical data points, making it impossible to extract specific numerical EA and CA percentages for Cefoxitin from this table as presented in the document. The table's content is largely unreadable due to formatting issues in the input.

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

Test Set Sample Size:
- Clinical Isolates: Not explicitly stated, but clinical isolates were a component of the testing.
- Stock and Challenge Isolates: Not explicitly stated, but these were also tested.
- Reproducibility Study: "a panel of Gram-positive isolates" tested in triplicate on three different days. The exact number of isolates is not specified.
Data Provenance: Clinical, stock, and challenge isolates were tested across "multiple geographically diverse sites across the United States." This indicates a prospective study (for the clinical isolates, at least) with data originating from the United States.

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

This information is not provided in the document. The ground truth (reference method) was established by the CLSI reference broth microdilution method, which is a standardized laboratory procedure, not typically relying on "experts" in the sense of human readers.

4. Adjudication Method for the Test Set:

This information is not applicable as the ground truth was established by a standardized laboratory method (CLSI reference broth microdilution) rather than expert review that would require adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance:

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is an automated microbiology system, not an AI assisting human readers. Its performance is evaluated independently against a reference method.

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

Yes, the study represents a standalone evaluation of the BD Phoenix™ Automated Microbiology System. The device performs the rapid identification and antimicrobial susceptibility testing automatically, and its results are compared directly to the CLSI reference method. There is no human reader "in-the-loop" for interpreting the device's output and then comparing that to human interpretation of another modality.

7. The Type of Ground Truth Used:

The primary ground truth used was the CLSI reference broth microdilution method, which is a standardized laboratory procedure for determining minimum inhibitory concentrations (MICs) of antimicrobial agents. For Challenge set isolates, the Phoenix System results were compared to "expected results," which would also be pre-defined reference values.

8. The Sample Size for the Training Set:

This information is not applicable/not provided. The BD Phoenix system is an automated instrument with predefined algorithms and reagent-based testing, not a machine learning or AI model that undergoes a "training phase" in the conventional sense. The "training set" concept is typically relevant for AI/ML algorithms where data is used to optimize the model parameters. The development of such systems usually involves extensive R&D and validation but not in the format of a distinct "training set" as described for AI.

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

This information is not applicable/not provided for the reasons stated above (not an AI/ML system with a conventional training set). The development of the system would have involved internal validation and calibration using various bacterial strains and reference methods.

Summary

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510(k) SUMMARY

K053241

SUBMITTED BY:	Becton, Dickinson and Company7 Loveton CircleSparks, MD 21152Phone: 410-316-4287Fax: 410-316-4499
CONTACT NAME:	Monica E. GiguereRegulatory Affairs Specialist
DATE PREPARED:	November 16, 2005
DEVICE TRADE NAME:	BD Phoenix™ Automated Microbiology System -Cefoxitin 1-32 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 (K020321May 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 . 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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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 contaming drive roughts: 0 Gram-negative or Gram-positive isolate. For cach isolate, an inoculation equivalent to a 0.5 McFarland standard is prepared in Phoenix ID broth.

DEVICE COMPARISON:

The BD Phoenix™ Automated Microbiology System demonstrated substantially equivalent performance when compared with the CLSI 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 CLSI 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 pancl 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 CLSI reference broth microdilution method.

The performance of the Phoenix System was assessed by calculating the Essential Agreement (EA) and Category Agreement (CA), and comparing these 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-Positive Organisms by Drug Table 1:

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Conclusions Drawn from Substantial Equivalence Studies

The data collected from the substantial equivalence studies demonstrate that testing on the BD Phocnix™ 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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SUMMARY INFORMATION FOR CEFOXITIN Available Range 1-32 µg/mL

Performance

Accuracy

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Reproducibility

Testing performed at multiple clinical sites demonstrated >95% reproducibility or greater within ± 1 dilution.

Breakpoints - CLSI and FDA

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Recommended Quality Control Organisms - CLSI and FDA

Quality Control Strain	MIC Range	Source
Staphylococcus aureus ATCC 29213	1 - 4 $ μ $ g/mL	CLSI

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular pattern around the symbol. The text is in all caps and is evenly spaced around the circle.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

DEC 2 2 2005

Ms. Monica E. Giguere Regulatory Affairs Specialist BD Diagnostics Systems Becton, Dickinson and Company 7 Loveton Circle Sparks, MD 21152

Re: K053241

Trade/Device Name: BD Phoenix™ Automated Microbiology System Cefoxitin (1-32 µg/mL) - Gram Positive ID/AST or AST 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: November 16, 2005 Received: November 18, 2005

Dear Ms. Giguere:

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 r hat 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 (240)276-0484. 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/industry/support/index.html

Sincerely yours,

Sally, a Hon

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 (if known): ____________________________________________________________________________________________________________________________________________________

Device Name:	BD Phoenix™ Automated Microbiology System for use with the antimicrobial agent cefoxitin
(1-32 µg/mL) - Gram positive ID/AST or AST only Phoenix panels.

Indications for Use:

The BD Phoenix™ Automated Microbiology System is intended for in vitro quantiative 11th DD I hooma's antimicrobial susceptibility by minimal inhibitory concentration (MIC) of most decemination of animiero im ultative anaerobic bacteria isolates from pure culture for Oram-hegative acrono and Non-Enteriaceae and most Gram-positive bacteria isolates from pure Enterococcionains to the genera Staphylococcus and Enterococcus.

This premarket notification is for the addition of the antimicrobial agent cefoxitin at concentrations of I ins premation is formeditor is for the addines only Phoenix panels. It will also be used as a test to 1-32 pg mill to Grain Fount Fraphylococcus aureus in these panels. Cefoxitin has been shown to product in vitro against most strains of microorganisms listed below, as described in the FDAapproved package insert for this antimicrobial agent.

Active In Vitro and in Clinical Infections Against:

Staphylococcus aureus® (including penicillinase-producing strains) Staphylococcus epidermidisª

a Staphylococci resistant to methicillin/oxacillin should be considered resistant to cefoxitin.

Prescription Use X

AND/OR

Over-The-Counter Use

(Per 21 CFR 801 Subpart D)

(Per 21 CFR 801 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)

Luddi Lu Polo

Division Sign-Off

Office of In ' = " "Lagnostic Device Evaluation an

BD Diagnostic Systems Becton, Dickinson and Company

Page 1
5100(k) K053241

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.”