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 Piperacillin at concentrations of 2-128 µg/mL to Gram-negative ID/AST or AST only Phoenix panels with the removal of the limitations for Proteus mirabilis, Providencia species and Stenotrophomonas maltophilia. Piperacillin 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 Phocnix 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

Here's a breakdown of the acceptance criteria and study information based on the provided text:

Acceptance Criteria and Device Performance

The core of the acceptance criteria for this device, a susceptibility testing system, revolves around two key metrics: Essential Agreement (EA) and Category Agreement (CA). These are standard in antimicrobial susceptibility testing (AST) device evaluations. The reported performance for Piperacillin for Gram-Negative Organisms is included in the table.

Acceptance Criteria Metric	Definition	Reported Device Performance (Piperacillin for Gram-Negative Organisms)
Essential Agreement (EA)	BD Phoenix™ Automated Microbiology System agrees exactly or within ± one two-fold dilution to the reference result.	≥ 90% (implied, not explicitly stated as a target, but typical industry standard for AST devices)
Category Agreement (CA)	BD Phoenix™ Automated Microbiology System agrees with the reference method with respect to the FDA categorical interpretive criteria (susceptible, intermediate, and resistant).	≥ 90% (implied, not explicitly stated as a target, but typical industry standard for AST devices)
Intra-site Reproducibility	Consistency of results within a single testing site.	> 90%
Inter-site Reproducibility	Consistency of results across different testing sites.	> 95%

Note on Reported Performance: The provided table (Table 1) under "Performance of BD Phoenix System for Gram-Negative Organisms by Drug" is highly unreadable and appears to be corrupted or poorly formatted. Therefore, the specific numerical values for EA and CA for Piperacillin are not extractable from the provided text. However, the text explicitly states that the study results demonstrate substantially equivalent performance and that reproducibility was greater than 90% for intra-site and greater than 95% for inter-site, suggesting that the EA and CA likely met or exceeded the generally accepted >= 90% threshold for AST devices.

Study Details

Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not explicitly stated in terms of a specific number for the test set. The study tested "Clinical, stock and challenge isolates."
- Data Provenance: "across multiple geographically diverse sites across the United States." The study included both "Clinical isolates" (likely prospective, collected during routine clinical practice) and "stock and challenge isolates" (retrospective, from laboratory collections or spiked for specific testing).
Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- The ground truth for the clinical isolates was established by the CLSI reference broth microdilution method. This is a laboratory standard method, not typically performed or interpreted by individual "experts" in the context of radiologists or pathologists. The CLSI method itself is the "expert" reference standard.
- For "Challenge set isolates," results were compared to "expected results," which would have been pre-determined by an established method or expert consensus for those specific strains. No specific number or qualification of experts is mentioned.
Adjudication Method for the Test Set:
- Not applicable as the ground truth was established by the CLSI reference broth microdilution method for clinical isolates and "expected results" for challenge isolates. These are objective laboratory methods; there is no mention of human adjudication for discrepancies between methods.
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, an MRMC comparative effectiveness study was not conducted. This study focuses on comparing the automated device's performance against a reference laboratory method, not on human reader performance with or without AI assistance.
Standalone Performance (Algorithm Only Without Human-in-the-loop Performance):
- Yes, this was a standalone performance study. The BD Phoenix™ Automated Microbiology System is an automated device, and its performance was evaluated directly against a reference method (CLSI broth microdilution). Humans prepare the samples and load the panels, but the determination of MIC values and categorical interpretations is performed solely by the instrument's algorithm.
Type of Ground Truth Used:
- For clinical isolates: CLSI reference broth microdilution method. This is a gold standard laboratory method for antimicrobial susceptibility testing.
- For challenge set isolates: Expected results. These are pre-defined results for known strains, typically established through rigorous characterization using reference methods.
Sample Size for the Training Set:
- The document does not explicitly state a sample size for a "training set." The BD Phoenix system is a commercial product, and the mechanism for internal algorithm development (training) is not detailed in this 510(k) summary, which focuses on validation data for a specific antimicrobial agent addition. The clinical studies described are for validation, not training.
How the Ground Truth for the Training Set Was Established:
- As no explicit "training set" is mentioned in the context of this 510(k) summary, how its ground truth was established is not provided. The summary focuses on the validation of the device for a new antimicrobial agent using existing reference methods as the ground truth for validation.

Summary

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

510(K) SUMMARY

K073433

SUBMITTED BY:	Becton, Dickinson and Company 7 Loveton Circle Sparks, MD 21152 Phone: 410-316-4161 Fax: (410)-316-4499
CONTACT NAME:	Vicki K. Whitley Regulatory Affairs Specialist	JAN 1 4 2008
DATE PREPARED:	December 4, 2007
DEVICE TRADE NAME:	BD Phoenix™ Automated Microbiology System – Piperacillin 2-128 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 Piperacillin (K041572, August 12, 2004).
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.

DEVICE DESCRIPTION:

BD Phocnix 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 CLSI (formerly 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 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", March 5, 2007.

Site Reproducibilitv

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}------------------------------------------------

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:

------------------------------------------------------------------------------------------------------------------------------------------------------------------------------Antimicrobia	------------------------------------------------------------------------------------------------------------------------------------------------------------------------------oncentration	------------------------------------------------------------------------------------------------------------------------------------------------------------------------------3		19/9
peracil118	100110/17	11	ﻟﻤﺴﺎﺣﺔ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮ	1	C

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", March 5, 2007. 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 Piperacillin (K041572, August 12, 2004),

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

DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Vicki K. Whitely Regulatory Affairs Manager BD Diagnostic System Benton, Dickinson and Company 7 Loveton Circle Sparks, MD 21152

Re: K073433

Trade/Device Name: BD Phoenix™ Automated Microbiology System -(2-128 ug/mL) -Gram-Negative ID/AST or AST only Phoenix panels Regulation Number: 21 CFR § 866.1645 Regulation Name: Antimicrobial Susceptibility Test System - Short Incubation Regulatory Class: II Product Code: LON Dated: December 4, 2007 Received: December 6, 2007

JAN 1 4 2008

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 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).

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

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 advice for your device on our labeling regulation (21 CFR Part 801), 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). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 ' (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Sally attayna

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

{5}------------------------------------------------

Page 1 of 1

510(k) Number: K073433

Device Name: BD Phoenix™ Automated Microbiology System for use with the antimicrobial agent Piperacillin (2-128 µg/mL) - Gram-Negative ID/AST or AST only Phoenix panels with the removal of the limitations for Proteus mirabilis, Providencia species and Stenotrophomonas maltophilia.

Indications for Use:

Active In Vitro and in Clinical Infections Against:

Acinetobacter species	Klebsiella species
Enterobacter species	Morganella morganii
Escherichia coli	Proteus mirabilis

Providencia rettgeri Pseudomonas aeruginosu Serratia species

Active In Vitro Against:

Burkholderia cepacia Citrobacter diversus

Citrobacter freundii Pseudomonas fluorescens Stenotrophomonas maltophilia Yersinia enterocolitica

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

1.11

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Freddi Le Poole

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

s10(k) K073433

BD Diagnostic Systems Becton, Dickinson and Company

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.”