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 cefazolin at concentrations of I mis promiser nombre ID/AST or AST only Phoenix panels. Cefazolin 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:

Escherichia coli Proteus mirabilis Klebsiella species Enterobacter acrogenes

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

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

Acceptance Criteria and Study for BD Phoenix™ Automated Microbiology System – Cefazolin

This summary describes the acceptance criteria and the study that proves the BD Phoenix™ Automated Microbiology System, specifically for Cefazolin (0.5-32 µg/mL) with Gram-Negative ID/AST or AST only Phoenix panels, meets these criteria.

1. Table of Acceptance Criteria and Reported Device Performance

The core acceptance criteria for antimicrobial susceptibility testing systems are Essential Agreement (EA) and Category Agreement (CA) with a reference method.

Acceptance Criteria (against CLSI Reference Broth Microdilution)	Reported Device Performance (Summary)
Essential Agreement (EA): The BD Phoenix™ Automated Microbiology System agrees exactly or within ± one two-fold dilution to the reference result.	Demonstrated performance by calculating EA. Specific percentage not provided in the excerpt for Cefazolin.
Category Agreement (CA): The BD Phoenix™ Automated Microbiology System agrees with the reference method with respect to the FDA categorical interpretive criteria (susceptible, intermediate, and resistant).	Demonstrated performance by calculating CA. Specific percentage not provided in the excerpt for Cefazolin.
Intra-site Reproducibility: Overall intra-site reproducibility of greater than 90%.	> 90% forgram-negative isolates tested.
Inter-site Reproducibility: Overall inter-site reproducibility greater than 95%.	> 95% for gram-negative isolates tested.

Note: While the document states that performance was "assessed by calculating Essential Agreement (EA) and Category Agreement (CA)," and presents a "Table 1: Performance of BD Phoenix System for Gram-Negative Organisms by Drug," the table content provided is garbled and does not show specific numerical performance results for Cefazolin. Therefore, only the general statement of assessment and the qualitative result of "substantially equivalent" can be reported based on the provided text.

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

The document does not explicitly state the exact sample size for the test set. It mentions "Clinical, stock and challenge isolates were tested."

Clinical isolates: These are typically fresh isolates obtained from patient samples.
Stock isolates: Likely reference strains or strains maintained in a collection.
Challenge isolates: These are often strains with known resistance mechanisms or unusual susceptibility patterns used to challenge the system's performance.

Data Provenance: The study was conducted "across multiple geographically diverse sites across the United States." This indicates prospective data collection in a multi-center setting within the United States.

3. Number of Experts Used to Establish Ground Truth and Qualifications

The document does not specify the number of experts used or their qualifications for establishing the ground truth for the test set.

4. Adjudication Method for the Test Set

The document does not describe a specific adjudication method beyond comparing Phoenix System results to the CLSI reference broth microdilution method. For challenge set isolates, results were compared "to the expected results." For clinical isolates, results were compared "to the results obtained from the CLSI reference broth microdilution method." This implies the reference method's result is taken as the ground truth without further expert adjudication mentioned.

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

No Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done. This study is focused on the device's accuracy against a recognized reference method, not on human reader performance with or without AI assistance.

6. Standalone Performance Study

Yes, a standalone performance study was done. The entire study describes the performance of the BD Phoenix™ Automated Microbiology System as an algorithm-only device (without human intervention in the MIC determination process) against the CLSI reference broth microdilution method. The instrument automatically interprets readings to give MIC values and category interpretations.

7. Type of Ground Truth Used

The primary ground truth used for performance evaluation was the CLSI reference broth microdilution method for clinical isolates. For "challenge set isolates," the ground truth was referred to as "expected results." This typically implies results obtained through a highly accurate and carefully controlled reference method or known characteristics of the challenge strains.

8. Sample Size for the Training Set

The document does not provide information about a separate "training set" or its sample size. This type of device's development typically involves an internal development and validation phase, but the provided text focuses on the pivotal substantial equivalence clinical study against the reference standard. The "training set" for the Phoenix system's internal algorithms would have been developed prior to this submission study.

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

As no explicit training set is mentioned in the provided text, the method for establishing its ground truth is not described. However, given the nature of AST device development, it is highly probable that the ground truth for any internal training data would have also been established using recognized reference methods for antimicrobial susceptibility testing, such as broth microdilution or agar dilution.

Summary

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510(K) SUMMARY

SUBMITTED BY:	Becton, Dickinson and Company7 Loveton CircleSparks, MD 21152Phone: 410-316-4938Fax: (410)-316-4499
	AUG 10 2006
CONTACT NAME:	Janine MatlakRegulatory Affairs Specialist
DATE PREPARED:	June 29 2006
DEVICE TRADE NAME:	BD Phoenix™ Automated Microbiology System –Cefazolin 0.5-32 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, and K060324, May 25, 2006), Ofloxacin(K020323, April 14, 2002), and Levofloxacin (K020322, March27, 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 . 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 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 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 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 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.

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

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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 K 060324, May 25, 2006), 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 features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The text is written in all capital letters. The logo is black and white.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Janine Matlak Regulatory Affairs Specialist BD Diagnostics Systems Becton, Dickinson and Company 7 Loveton Circle Sparks, MD 21152

AUG 1 0 2006

Re: K061867 Trade/Device Name: BD Phoenix TM Automated Microbiology System cefazolin (0.5-32 ug/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: June 29, 2006 Received: July 3, 2006

Dear Ms. Matlak:

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 (OS) 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, anthony

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: KOVI 865

BD Phoenix™ Automated Microbiology System for use with the antimicrobial agent cefazolin Device Name: (0.5-32 µg/mL) - Gram-Negative ID/AST or AST only Phoenix panels.

Indications for Use:

Active In Vitro and in Clinical Infections Against:

Escherichia coli Proteus mirabilis Klebsiella species Enterobacter acrogenes

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)

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K061867

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.”