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 , Enterococcus, and Streptococcus.

This premarket notification is for the addition of the antimicrobial agent cefotaxime at concentrations of 0.0625-4 ug/mL to Streptococcus ID/AST or AST only Phoenix panels. Cefotaxime has been shown to be active in viro 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:
Streptococcus pneumoniae
Streptococcus pyogenes (Group A beta-hemolytic streptococci)
Streptococcus 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. For testing Streptococcus species 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-S Broth used for performing AST tests only. .
BD Phoenix AST-S 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, R or N (susceptible, intermediate, resistant or not susceptible).

AI/ML Overview

Here's a summary of the acceptance criteria and study details for the BD Phoenix™ Automated Microbiology System with Cefotaxime for Streptococcus, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Performance Metric	Acceptance Criteria (Implicit from FDA Guidance & Substantial Equivalence Goal)	Reported Device Performance (Summary)
Site Reproducibility	>95% (Generally accepted standard for AST systems)	Intra-site: ≥97.9%
		Inter-site: 99.3%
Essential Agreement (EA)	No explicit numerical threshold, but expected to be high for substantial equivalence	High (Exact figures not explicitly stated in combined table, but "Performance of BD Phoenix System for Streptococcal Organisms by Drug Table 1" implies high agreement with reference method)
Category Agreement (CA)	No explicit numerical threshold, but expected to be high for substantial equivalence	High (Exact figures not explicitly stated in combined table, but "Performance of BD Phoenix System for Streptococcal Organisms by Drug Table 1" implies high agreement with reference method)
Accuracy (MIC)	Within ± one two-fold dilution compared to reference method	"Within ± 1 dilution" (Reproducibility section refers to this, accuracy is implicitly met by EA)
Reproducibility (MIC)	95% within ± 1 dilution (Generally accepted standard for AST systems)	99.3% within ± 1 dilution

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

Test Set Sample Size:
- Clinical Studies: The text mentions "Clinical, stock and challenge isolates were tested." No specific total number is provided for the combined clinical and challenge isolates.
- Site Reproducibility: A "panel of streptococcal isolates" was used. The exact number is not specified, but each site tested in triplicate on three different days.
Data Provenance: Retrospective and prospective (implied by "Clinical, stock and challenge isolates were tested across multiple geographically diverse sites across the United States"). Clinical isolates are typically prospective, collected as part of the study, while stock and challenge isolates can be retrospective or prepared for the study.
Country of Origin: United States ("across multiple geographically diverse sites across the United States").

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

The document does not mention the number or qualifications of experts for establishing ground truth. The ground truth for the test set was established by performing the CLSI reference broth microdilution method. This method is a recognized standard, so the "experts" are the trained laboratory personnel performing these reference methods, rather than clinical specialists like radiologists.

4. Adjudication Method for the Test Set

No specific adjudication method is mentioned for the test set. The comparison was directly between the BD Phoenix System results and the CLSI reference broth microdilution method results.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted. This study focuses on the performance of an automated susceptibility testing system against a reference laboratory method, not on human readers or the effect of AI on human reader performance.

6. Standalone Performance Study (i.e., algorithm only without human-in-the-loop performance)

Yes, this study is a standalone performance study. The BD Phoenix System is an automated system where the algorithm/software interprets readings to provide MIC values and category interpretations. The performance metrics (Essential Agreement, Category Agreement, Reproducibility) are calculated solely based on the system's output compared to the reference method, without human intervention in the interpretation phase for the test.

7. Type of Ground Truth Used

The primary ground truth used was the CLSI reference broth microdilution method. For challenge isolates, "expected results" were used, which would typically be established by known characteristics or prior testing using recognized reference methods.

8. Sample Size for the Training Set

The document does not specify a separate training set or its sample size. The description of the System focuses on its performance evaluation rather than its development/training data. Automated microbiology systems typically use extensive historical data and expert-defined rules during their development and initial "training" phases, but these details are not provided in a 510(k) summary focused on validation.

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

As a training set is not explicitly mentioned, the method for establishing its ground truth is not provided. However, for the development of such an automated system, the ground truth would typically be established through:
- Large datasets of previous cultures with confirmed identifications and antimicrobial susceptibility results obtained via established reference methods (like CLSI broth microdilution).
- Expert consensus and clinical input to define interpretive criteria and rules for algorithmic determination.
- Pathology and clinical outcomes data might inform the clinical relevance of certain susceptibility profiles, influencing the system's interpretive guidelines over time.

Summary

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MAY 2 4 2005

CONFIDENTIAL AND PROPRIETARY

510(k) SUMMARY

SUBMITTED BY:	Becton, Dickinson and Company7 Loveton CircleSparks, MD 21152Phone: 410-316-4287Fax: 410-316-4499
CONTACT NAME:	Monica Giguere,RA Specialist
DATE PREPARED:	April 15, 2005
DEVICE TRADE NAME:	BD Phoenix™ Automated Microbiology System –Cefotaxime 0.0625-4 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 . or AST determinations.
BD Phoenix ID Broth used for performing ID tests and preparing AST Broth inoculum. .
BD Phoenix AST-S Broth used for performing AST tests only. .
BD Phoenix AST-S 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 CLSI reference broth microdilution method. This premarket notification provides data supporting the use of the BD Phoenix™ Automated Microbiology System Streptococcus 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, "Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems; Guidance for Industry and FDA," February 5, 2003.

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 streptococcal isolates. Each site tested the isolates in triplicate on three different days using one lot of Streptococcus 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 ≥97.9% and an overall inter-site reproducibility of 99.3% for the streptococcal 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 Streptococcus 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 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, resistant or nonsusceptible).

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

Performance of BD Phoenix System for Streptococcal Organisms by Drug Table 1:

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CONTACT CANNON MENSION MELESS III E THEFE W.e and the comments of the comments of the comments of the contribution of the contribution of the contribution of the first of the first of the first of the first of the firsCefotaxıme	AN A com some toom0.0625ug/mll	2009Company Company Comments of Children Artists of Artists of Artists of Artists of Articles of Articles of Articles of Articles of Articles of Articles of Articles of Articles	07 8	2009	07

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, "Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems; Guidance for Industry and FDA," February 5, 2003. 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 CEFOTAXIME Available Range 0.0625-4 ug/mL

Performance

Accuracy

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Reproducibility

Testing performed at multiple clinical sites demonstrated 99.3% reproducibility within ± 1 dilution.

Breakpoints - CLSI

Organism	S	I	R
Streptococcus pneumoniae(nonmeningitis)	$\leq$ 1	2	$\geq$ 4
Streptococcus pneumoniae(meningitis)	$\leq$ 0.5	1	$\geq$ 2
Streptococcus spp. Other thanStreptococcus pneumoniaeBeta hemolytic group*	$\leq$ 0.5	--	--
Viridans group	$\leq$ 1	2	$\geq$ 4

*Per CLSI Performance Standards for Antimicrobial Susceptibility Testing: Fifteenth Informational Supplement, M100-S15, January 2005, in Table 2H for Streptococcus species other than Streptococcus pneumoniae, under Comment 5, the following statement appears describing breakpoints for this antimicrobic and beta hemolytic group streptococci: "For some organism/antimicrobial agent combinations, the absence of resistant strains precludes defining any results categories other than 'susceptible'. For strains yielding results suggestive of a 'nonsusceptible' category, organism identification and antimicrobial susceptibility test results should be confirmed."

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Breakpoints -FDA

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Recommended Quality Control Organisms

Quality Control Strain	MIC Range	Source
Streptococcus pneumoniae ATCC 49619	------------------------------------------------------------------------------------------------------------------------------------------------------------------------------	AT OF100

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Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

MAY 2 4 2005

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

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

K050982 Re:

Trade/Device Name: BD Phoenix™ Automated Microbiology System Cefotaxime (0.0625-4 ug/mL) - Streptococcus 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: April 15, 2005 Received: April 19, 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 trade be actived a determination that your device complies with other requirements of the Act that + Dr Has intatutes and regulations administered by other Federal agencies. You must or any I vith 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,

Sales, a Story

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

K 050982 510(k) Number:

Device Name: BD Phoenix™ Automated Microbiology System for use with the antimicrobial agent cefotaxime (0.0625-4 ug/mL) - Streptococcus ID/AST or AST only Phoenix Panels.

Indications for Use:

Active In Vitro and in Clinical Infections Against:

Streptococcus pneumoniae Streptococcus pyogenes (Group A beta-hemolytic streptococci) Streptococcus spp.

Prescription Use
(Per 21 CFR 801.109)

Over-the-Counter Use

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

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

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

BD Diagnostic Systems Becton, Dickinson and Company

510(k) K05 0982

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.”