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 ceftazidime at concentrations of 0.5-64 µg/mL to Gram-negative ID/AST or AST only Phoenix panels with the removal of the limitations for Citrobacter freundii and Stenotrophomonas maltophilia. Ceftazidime 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.

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 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 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. Phoenix panels are inoculated with a specified organism density and placed in the instrument.

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

The provided text describes the acceptance criteria and the study that proves the performance of the BD Phoenix™ Automated Microbiology System for the antimicrobial agent Ceftazidime (0.5-64 µg/mL) against Gram-negative organisms.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance (Ceftazidime)
Essential Agreement (EA)	96.6% (n=2388)
Category Agreement (CA)	94.7% (n=2388)

Notes:

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).

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

Sample Size for Test Set: 2388 isolates (for both EA and CA calculations).
Data Provenance: Clinical, stock, and challenge isolates were tested across multiple geographically diverse sites across the United States. This indicates a prospective study design with data collected from various real-world clinical settings, supplemented by controlled stock and challenge isolates.

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

The document does not explicitly state the number of experts or their qualifications used to establish the ground truth.
However, the ground truth was established by comparison to the CLSI (formerly NCCLS) reference broth microdilution method. This implies that the ground truth was determined by trained laboratory personnel following established CLSI guidelines, rather than individual clinical experts.

4. Adjudication Method for the Test Set:

The document does not explicitly mention an adjudication method (like 2+1 or 3+1).
The comparison was directly between the Phoenix System results and the CLSI reference method. For challenge sets, results were compared to "expected results."

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done.
This study focuses on the device's performance compared to a reference method, not on how human readers' performance improves with or without AI assistance. The BD Phoenix system is an automated AST system without direct human interpretation in the susceptibility determination process.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

Yes, this was a standalone (algorithm only) performance study.
The BD Phoenix™ Automated Microbiology System is an automated device designed to determine antimicrobial susceptibility without human subjective interpretation of results, beyond initial setup and reading the instrument's output. The performance metrics (EA and CA) directly reflect the device's accuracy against a gold standard.

7. Type of Ground Truth Used:

The ground truth used was the CLSI (formerly NCCLS) reference broth microdilution method. This is a recognized laboratory standard for antimicrobial susceptibility testing. For challenge isolates, "expected results" were used, which would typically be based on established phenotypic or genotypic characteristics.

8. Sample Size for the Training Set:

The document does not provide information regarding a specific "training set" or its sample size. This type of regulatory submission typically focuses on validation data against a gold standard rather than the developmental or training process of the device which probably uses proprietary data or earlier version's training data.

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

As the document does not mention a specific training set size, it also does not explain how the ground truth for any training set was established.

Summary

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510(K) SUMMARY

	510(K) SUMMARY	K063573
SUBMITTED BY:	Becton, Dickinson and Company7 Loveton CircleSparks, MD 21152Phone: 410-316-4161Fax: (410)-316-4499
		JAN 11 2007
CONTACT NAME:	Vicki Kennedy WhitelyRegulatory Affairs Specialist
DATE PREPARED:	November 28, 2006
DEVICE TRADE NAME:	BD PhoenixTM Automated Microbiology System –Ceftazidime 0.5-64 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 PhoenixTMAutomated Microbiology System with Gatifloxacin (K020321,May 23, 2002), Ceftazidime (K033560, January 14, 2004 andK041384, August 3, 2004).
INTENDED USE:	The BD PhoenixTM 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 . 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 CLSI (formerly NCCLS) reference broth microdilution method. This premarket notification provides data for the limitations for Citrobacter freundii and Stenotrophomonas maltophilia with ceftazidime.

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 CLSI M7). The system has been evaluated as defined in the FDA guidance document, "Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems; Guidance for Industry and FDA'', February 5, 2003.

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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 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, and resistant).

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

Performance of BD Phoenix System for Gram-Negative 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 Phoenix™ Automated Microbiology System with this antimicrobial agent is substantially equivalent as outlined in the FDA 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), and with Ceftazidime (K033560, January 14, 2004 and K041384, August 3, 2004).

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SUMMARY INFORMATION FOR CEFTAZIDIME Available Range 0.5 - 64 µg/mL

Performance

Accuracy

Antimicrobial	Concentration	EA (n)	EA (%)	CA (n)	CA (%)
Ceftazidime	0.5 - 64 μg/mL	2388	96.6	2388	94.7

Breakpoints - CLSI

Organism	S	I	R
Enterobacteriaceae	$ \le 8 $	16	$ \ge32 $
Pseudomonas aeruginosa andother Non-Enterobacteriaceae	$ \le 8 $	16	$ \ge32 $

Recommended Quality Control Organisms

Quality Control Strain	MIC Range	Source
Escherichia coli ATCC 25922	0.06-0.5 $ μg/mL $	CLSI
Pseudomonas aeruginosa ATCC 27853	1-4 $ μg/mL $	CLSI

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/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 wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - U.S.A." is arranged in a circular pattern around the eagle.

Re:

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Vicki Kennedy Whitley Regulatory Affairs Specialist BD Diagnostics Systems Becton, Dickinson and Company 7 Loveton Circle Sparks, MD 21152

JAN 1 1 2007

K063573 Trade/Device Name: BD Phoenix™ Automated Microbiology System Ceftazidime (0.5-64 µg/mL) – Gram-Negative 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 28, 2006 Received: November 29, 2006

Dear Ms. Whitley:

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 1 vire 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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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)276-0450. 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,

Sally, autumn

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: K063573

Device Name: BD Phoenix™ Automated Microbiology System for use with the antimicrobial agent ceftazidime (0.5-64 ug/mL) - Gram-Negative ID/AST or AST only Phoenix panels with the removal of the limitations for Citrobacter freundii and Stenotrophomonas maltophilia.

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, Enterococcus and Streptococcus.

Escherichia coli

Active In Vitro and in Clinical Infections Against:

Citrobacter spp., including Citrobacter freundii and Citrobacter koseri (formerly C. diversus) Enterobacter spp., including Enterobacter cloacae and Enterobacter aerogenes

Active In Vitro:

Acinetobacter spp. Morganella morganii Providencia spp., including Providencia rettgeri

Klebsiella spp., including Klebsiella pneumoniae Proteus mirabilis

Proteus vulgaris Pseudomonas spp., including Pseudomonas aeruginosa Serratia spp.

Salmonella spp. Shigella 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 Device Evaluation (ODE)

Freddie Poole
Division Sign-Off

Division Sign-Off

office of In Vitro Diagnostic Device Evaluation and Safety

K06 3573

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.”