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 the addition of the antimicrobial agent piperacillin-tazobactam at concentrations of 1/4-128/4 ug/mL to Gram Positive ID/AST or AST only Phoenix panels. Piperacillin-tazobactam 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:
Staphylococcus aureus (excluding methicillin and oxacillin-resistant isolates)

Active In Vitro Against:
Enterococcus faecalis (ampicillin or penicillin-susceptible isolates only) Staphylococcus epidermidis (excluding methicillin and oxacillin-reistant isolates)

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 t 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 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

Here's a summary of the acceptance criteria and study details for the BD Phoenix™ Automated Microbiology System for piperacillin-tazobactam:

1. Acceptance Criteria and Device Performance

Acceptance Criteria (Essential Agreement / Category Agreement)	Reported Device Performance (Essential Agreement / Category Agreement)
Not explicitly stated in a quantitative manner as "acceptance criteria" but described as "substantially equivalent performance when compared with the CLSI reference broth microdilution method." The FDA draft guidance document, "Guidance on Review Criteria for Assessment of Antimicrobial Susceptibility Devices," March 8, 2000, establishes the framework for this assessment.	Essential Agreement (EA): Not provided numerically in the summary table, but assessed by whether the Phoenix System agrees exactly or within ± one two-fold dilution to the reference result.
	Category Agreement (CA): 100.0% (for Piperacillin-tazobactam)

2. Sample Size and Data Provenance

Test Set Sample Size: "1949" isolates were tested for the Piperacillin-tazobactam drug. The text also mentions a "panel of Gram-positive isolates" for reproducibility studies, but a specific number for that panel isn't provided beyond discussing the clinical and challenge isolates.
Data Provenance: Clinical, stock, and challenge isolates were tested across multiple geographically diverse sites across the United States. This indicates a mix of retrospective (stock and some clinical) and prospective (new clinical isolates) data collection.

3. Number of Experts and Qualifications for Ground Truth (Test Set)

The document does not explicitly state the number of experts used to establish ground truth.
It refers to "CLSI reference broth microdilution method" and "expected results" for challenge isolates as the ground truth. While these methods are performed by trained personnel, the document doesn't detail the qualifications of individuals performing these reference methods for this specific study.

4. Adjudication Method (Test Set)

The document does not describe an adjudication method for disagreements between the device and the reference method or discrepancies amongst multiple expert readers. The comparison is directly between the Phoenix System's results and the CLSI reference method or expected results.

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

No MRMC comparative effectiveness study was done. This study focuses on the performance of the automated system against a reference method, not on human reader performance with or without AI assistance.

6. Standalone (Algorithm Only) Performance Study

Yes, a standalone performance study was done. The entire study describes the performance of the BD Phoenix™ Automated Microbiology System (an algorithm-driven automated device) in determining antimicrobial susceptibility. It compares the device's output directly to the CLSI reference broth microdilution method.

7. Type of Ground Truth Used

Clinical Isolates: The ground truth for clinical isolates was the CLSI reference broth microdilution method.
Challenge Isolates: The ground truth for challenge isolates was their expected results.

8. Sample Size for the Training Set

The document does not explicitly state the sample size for a training set. This is a 510(k) submission focusing on substantial equivalence testing of a specific antimicrobial agent for an already established system. The underlying algorithms would have been developed and trained using data prior to this specific submission.

9. How Ground Truth for the Training Set Was Established

The document does not provide details on how the ground truth for any training set was established. As mentioned above, this submission concerns the addition of a new antimicrobial agent to an existing system, rather than the initial development and training of the system's core algorithms.

Summary

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510(k) SUMMARY

SUBMITTED BY:	Becton, Dickinson and Company 7 Loveton Circle Sparks, MD 21152 Phone: 410-316-4287 Fax: 410-316-4499
CONTACT NAME:	Monica Giguere, Regulatory Affairs Specialist
DATE PREPARED:	August 10, 2006
DEVICE TRADE NAME:	BD Phoenix™ Automated Microbiology System – Piperacillin-tazobactam 1/4-128/4 µg/mL
DEVICE COMMON NAME:	Antimicrobial susceptibility test system-short incubation
DEVICE CLASSIFICATION:	Fully Automated Short-Term Incubation Cycle Antimicrobial Susceptibility 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, March 27, 2002).
INTENDED USE:	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.

AUG 1 8 2006## DEVICE DESCRIPTION:

BD Phoenix instrument and software. .
BD Phoenix panels containing biochemicals for organism ID testing and antimicrobial agents t 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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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 panel 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 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-Positive Organisms by Drug

Antimicrobial	Concentration	CA	101
Piperacillin-	/4-128/4 ug/mL	1949में की में बाद में कि में बाद में कि में बाद में कि में बाद में कि में बाद में कि में बाद में कि में बाद में कि में कि में कि में कि में कि में कि में कि में कि में कि में क	0513.0	COL00.	100.0
tazobactam

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, "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 and K060324, 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 seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

AUG 1 8 2006

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

ﮨﮯ ﮨﺮ ﮨﮯ ﺍﻭﺭ ﺍﺱ ﻣﯿﮟ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍ

1061869 Re:

Trade/Device Name: BD Phoenix™ Automated Microbiology System piperacillin-tazobactam (1/4-128/4 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: June 29, 2006 Received: July 3, 2006

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 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, artton

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: Ko61868

Device Name: BD Phoenix™ Automated Microbiology System for use with the antimicrobial agent piperacillin-tazobactam (1/4-128/4 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 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 piperacillin-tazobactam at concentrations of 1/4-128/4 ug/mL to Gram Positive ID/AST or AST only Phoenix panels. Piperacillintazobactam 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:

Staphylococcus aureus (excluding methicillin and oxacillin-resistant isolates)

Active In Vitro Against:

Enterococcus faecalis (ampicillin or penicillin-susceptible isolates only) Staphylococcus epidermidis (excluding methicillin and oxacillin-reistant isolates)

Prescription Use V (Per 21 CFR 801.109) Over-the-Counter Use

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Concurrence of CDRH, Office of Device Evaluation (ODE)

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K061869

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.”