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 gram-positive aerobic and facultative anaerobic bacteria isolates from pure culture belonging to the genera Staphylococcus and Enterococcus.

This premarket notification is for the addition of the antimicrobial agent cefotetan at concentrations of 2-64 µg/mL to the gram-negative ID/AST or AST only Phoenix panels. Cefotetan 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 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, or R (sensitive, intermediate, or resistant).

AI/ML Overview

Here's a breakdown of the acceptance criteria and study details for the BD Phoenix™ Automated Microbiology System - Cefotetan 2-64 µg/mL, based on the provided text:

1. Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied)	Reported Device Performance
Overall intra-site reproducibility > 90% (for this antimicrobial agent)	greater than 90%
Overall inter-site reproducibility > 95% (for this antimicrobial agent)	greater than 95%
Substantial equivalence to NCCLS reference broth microdilution method	The BD Phoenix™ Automated Microbiology System demonstrated substantially equivalent performance when compared with the NCCLS reference broth microdilution method. (The document doesn't provide specific quantitative metrics for substantial equivalence beyond the reproducibility percentages, but states it was evaluated as defined in the FDA Draft guidance document, "Guidance on Review Criteria for Assessment of Antimicrobial Susceptibility Devices", March 8, 2000.)

2. Sample Size and Data Provenance

Sample Size for Test Set: The document mentions a "panel of gram-negative isolates" was used. The exact number of isolates is not explicitly stated.
Data Provenance: Not explicitly stated, but given the context of a 510(k) submission to the FDA in the US, it's highly likely the studies were conducted in the US. The study involved "three sites," implying a prospective data collection directly for this validation.

3. Number of Experts and Qualifications for Ground Truth

The document describes the NCCLS reference broth microdilution method as the comparative "ground truth." This is a standardized laboratory procedure, not an assessment by human experts in the traditional sense of image or clinical interpretation. Therefore, the concept of "experts" to establish ground truth in this context is not directly applicable. The method itself is the gold standard.

4. Adjudication Method

None (as traditionally understood for human interpretation). The comparison is against a standardized laboratory reference method (NCCLS broth microdilution), which has established protocols for interpretation.

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

No. This type of study is not applicable as the device is an automated microbiology system for determining antimicrobial susceptibility (MIC values and categories), not a diagnostic imaging aid for human readers.

6. Standalone (Algorithm Only) Performance

Yes. The entire study described evaluates the standalone performance of the BD Phoenix™ system against the reference method. The system is designed to provide automated interpretations without human intervention in the susceptibility determination process.

7. Type of Ground Truth Used

Standardized Reference Method: The ground truth was established using the NCCLS reference broth microdilution method (AST panels prepared according to NCCLS M7). This is a widely accepted laboratory standard for antimicrobial susceptibility testing.

8. Sample Size for Training Set

The provided text does not explicitly state the sample size used for the training set. This document focuses on the validation of a specific antimicrobial agent (Cefotetan) for an existing system. The core system itself would have been developed and trained prior to this specific 510(k) submission.

9. How Ground Truth for Training Set Was Established

The document does not describe how the ground truth for the training set was established. Similar to the above, the training would have occurred during the initial development of the BD Phoenix System, well before this specific submission for Cefotetan. However, it's safe to assume that a similar approach, involving comparison to established reference methods (like NCCLS broth microdilution), would have been used during the development and training phases of the broader system.

Summary

{0}------------------------------------------------

K043458

CONFIDENTIAL AND PROPRIETARY

MAR 1 5 2005

510(K) SUMMARY

SUBMITTED BY:	Becton, Dickinson and Company7 Loveton CircleSparks, MD 21152Phone: 410-316-4287Fax: (410)-316-4499
CONTACT NAME:	Monica Evelyn GiguereRegulatory Affairs Specialist
DATE PREPARED:	December 13, 2004
DEVICE TRADE NAME:	BD Phoenix TM Automated Microbiology System -Cefotetan 2-64 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 Phoenix TMAutomated Microbiology System with Gatifloxacin (K020321,May 23, 2002), Ofloxacin (K020323, April 14, 2002), andLevofloxacin (K020322, March 27, 2002).
INTENDED USE:	The BD Phoenix TM 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.

{1}------------------------------------------------

DEVICE COMPARISON:

The BD Phoenix™ Automated Microbiology System demonstrated substantially equivalent performance when compared with the NCCLS 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 NCCLS 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.

{2}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized graphic of four wavy lines that resemble a human figure.

MAR 1 5 2005

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

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

K043458 Re:

Ro 15 150
Trade/Device Name: BD Phoenix TM Automated Microbiology System Cefotetan (2-64 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: March 8, 2005 Received: March 9, 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 for ass barbaion 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 n may 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).

{3}------------------------------------------------

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 Hogg

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

{4}------------------------------------------------

Page 1 of 1

510(k) Number: K043458

Device Name: BD Phoenix™ Automated Microbiology System for use with the antimicrobial agent cefotetan Device Name: - Gram-Negative ID/AST or AST only Phoenix panels.

Indications for Use:

The BD Phoenix™ Automated Microbiology System is intended for in vitro quantitative determination of The DD Filocillity by minimal inhibitory concentration (MIC) of most gram-negative aerobic and antimicrobial susceptionity by immial innones Julure for Enterobacteriaceae and Non-Enterobacteriaceae laculative anaeloote bacteria isolates from pure culture belonging to the genera Staphylococcus and Enterococcus.

This premarket notification is for the addition of the antimicrobial agent cefotetan at concentrations of 2-64 I his premative ID/AST or AST only Phoenix panels. Cefotetan 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 Klebsiella species (including K. pneumoniae) Proteus mirabilis Proteus vulgaris

Providencia rettgeri Serratia marcescens

Active In Vitro Against:

Citrobacter species (including C. koseri (diversus) and C. freundii) Klebsiella oxytoca Serratia species Yersinia enterocolitica

Prescription Use (Pcr 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)

tudulin. tex |~
B.i. 9. 38

Division Sign-Off

Office of in Vitro Diagnostic Device Evaluation and Safety

BD Diagnostic Systems Becton, Dickinson and Company

10(k) K043 Page 9

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.”