The BD Phoenix™ Automated Microbiology System is intended for the in vitro rapid identification (ID) and quantitative determination of antimicrobial susceptibility by minimal inhibitory concentration (MIC) of Gram Negative aerobic and facultative anaerobic bacteria belonging to the family Enterobacteriaceae and non-Enterobacteriaceae.

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 antimicrobial agent meropenem at concentrations of 0.125-32 us/mL to Gram-negative ID/AST or AST only Phoenix panels. Meropenem has been shown to be active in vitro against most strains of microorganisms listed below, as described in the FDAapproved package inserts for this antimicrobial agent.

Active In Vitro and in Clinical Infections Against:
Escherichia coli
Klebsiella pneumoniae
Pseudomonas aeruginosa

Active In Vitro
Citrobacter koseri (formerly diversus)
Citrobacter freundii
Enterobacter cloacae
Klebsiella oxytoca
Morganella morganii
Proteus vulgaris
Serratia marcescens

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 o 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. Inoculum for use with the Phoenix system may be prepared either manually or may be automated using the BD Phoenix™ AP System.

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° ± 1°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, R or N (susceptible, intermediate, resistant or not susceptible).

AI/ML Overview

Here's a breakdown of the acceptance criteria and study details for the K132674 submission, based on the provided text:

Acceptance Criteria and Device Performance

Measure	Acceptance Criteria (Implied)	Reported Device Performance
Site Reproducibility	> 95% (+/- 1 dilution) agreement across test sites	> 95% (+/- 1 dilution) agreement
Essential Agreement (EA)	Not explicitly stated, but high EA is a standard for AST systems.	97.8% (n=1202)
Category Agreement (CA)	Not explicitly stated, but high CA is a standard for AST systems.	98.5% (n=1202)

Note: The document states that the system "demonstrated substantially equivalent performance when compared to the CLSI reference broth microdilution method" and "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, 'Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems; Guidance for Industry and FDA', August 28, 2009." This implies that the acceptance criteria are based on meeting the performance thresholds outlined in that FDA guidance, which typically requires high percentages for EA and CA.

Study Details

Sample Size used for the test set and the data provenance:
- Test Set Sample Size: 1202 isolates (combined Clinical and Challenge isolates for Meropenem, as indicated by 'n=1202' for EA and CA).
- Data Provenance: The study used "Clinical, stock and challenge isolates across multiple geographically diverse sites across the United States." This indicates a prospective and/or retrospective collection of isolates from clinical settings and possibly curated stock/challenge collections within the US.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The document does not specify the number or qualifications of experts used to establish ground truth.
- Ground truth for clinical isolates was "compared to the results obtained from the CLSI reference broth microdilution method." The CLSI method itself is a standardized laboratory procedure, not typically an expert consensus per se, though it is executed by trained laboratory personnel.
- Ground truth for challenge isolates was compared to "expected results," which would be internally validated results for those specific strains.
Adjudication method for the test set:
- The document does not explicitly state an adjudication method (like 2+1, 3+1). The comparison is directly between the BD Phoenix results and the CLSI reference method or "expected results" for challenge strains. This suggests a direct comparison rather than a multi-expert adjudication process for each case.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly mentioned or performed. This device is an automated system for antimicrobial susceptibility testing, which essentially replaces manual interpretation of susceptibility, rather than assisting human readers in an interpretive task like image analysis. The "comparison" is to an established reference method (CLSI broth microdilution), not to human readers.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, this was a standalone performance evaluation. The BD Phoenix System is an automated device designed to produce MIC values and categorical interpretations (S, I, R) without human intervention in the interpretation process once the panel is loaded. The "Phoenix System results" were directly compared to the reference method.
The type of ground truth used:
- For clinical isolates: The ground truth was established by the CLSI reference broth microdilution method. This is a laboratory-based, standardized, quantitative method considered the gold standard for antimicrobial susceptibility testing.
- For challenge isolates: The ground truth was "expected results," implying predefined, validated results for these specific strains.
The sample size for the training set:
- The document does not specify the sample size for any training set. It focuses on the performance evaluation against the reference method using clinical and challenge isolates. For an AST system, the "training" (if it even applies in the traditional sense) would likely refer to the development and optimization of the algorithms within the system using various bacterial strains and antimicrobial combinations, but this information is not provided for this specific submission.
How the ground truth for the training set was established:
- This information is not provided in the document as no specific "training set" and its ground truth establishment are detailed.

Summary

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K132674

DEC 2 7 2013

510(k) SUMMARY

SUBMITTED BY:	Becton, Dickinson and Company 7 Loveton Circle Sparks, MD 21152 Phone: 410-316-4827 Fax: 410-316-4499
CONTACT NAME:	Monica Giguere, RAC Regulatory Affairs Project Manager
DATE PREPARED:	August 22, 2013
DEVICE TRADE NAME:	BD Phoenix™ Automated Microbiology System - Meropenem (0.125-32 µg/mL)
DEVICE COMMON NAME:	Antimicrobial susceptibility test system-short incubation
DEVICE CLASSIFICATION:	21 CFR 866.1645 Fully Automated Short-Term Incubation Cycle Antimicrobial Susceptibility System. (Product Code LON)
PREDICATE DEVICES:	VITEK® System (PMA No. N50510)
INTENDED USE:	The BD Phoenix Automated Microbiology System is intended for the in vitro rapid identification (ID) and quantitative determination of antimicrobial susceptibility by minimal inhibitory concentration (MIC) of Gram Negative aerobic and facultative anaerobic bacteria belonging to the family Enterobacteriaceae and non-Enterobacteriaceae.

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 o determination.

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DEVICE COMPARISON:

The BD Phoenix™ Automated Microbiology System demonstrated substantially equivalent performance for inoculum prepared manually and inoculum prepared with the BD Phoenix™ AP instrument 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 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", August 28, 2009. Shelf life (stability data) for the drug is being collected and will be maintained on file at BD as indicated in the guidance document.

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.

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The results of the study demonstrate that for this antimicrobial agent and the Gram-negative organisms tested there was an overall reproducibility across test sites of greater than 95% (+/- 1 dilution) agreement when compared to the test mode.

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 a Gram Negative Phoenix Panel 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, resistant or not susceptible).

The following table summarizes the performance for Clinical and Challenge isolates tested in this study.

Antimicrobial	Concentration	EA (n)	EA (%)	CA (n)	CA (%)
Meropenem	0.125-32 µg/mL	1202	97.8	1202	98.5

Performance of BD Phoenix System for Gram-Negative Organisms by Meropenem

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, "Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems; Guidance for Industry and FDA", August 28, 2009. 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.

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Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

December 27 2013

BECTON DICKINSON AND COMPANY MONICA GIGUERE REGULATORY AFFAIRS PROJECT MANAGER 7 LOVETON CIRCLE - MC 614 SPARKS, MD 21152 USA

Re: K132674

Trade/Device Name: BD Phoenix Automated Microbiology System -Meropenem (0.125-32 ug/mL) Regulation Number: 21 CFR 866.1645 Regulation Name: Fully Automated Short-Term Incubation Cycle Antimicrobial Susceptibility System Regulatory Class: Class II Product Code: LON, JWY, LRG, LTT, LTW Dated: November 14, 2013 Received: November 20, 2013

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. 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

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Page 2 - Ms. Giguere

CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Sally A - Dolivat -S

Sally A. Hojvat, M.Sc., Ph.D. Director Division of Microbiology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

BD Phoenix™ Automated Microbiology System for use with the antimicrobial agent Device Name: Meropenem (0.125-32 ug/mL) - Gram-negative ID/AST or AST only Phoenix Panels,

Indications For Use:

Active In Vitro and in Clinical Infections Against:

Escherichia coli Klebsiella pneumoniae Pseudomonas aeruginosa

Active In Vitro Citrobacter koseri (formerly diversus) Citrobacter freundii Enterobacter cloacae Klebsiella oxytoca

Morganella morganii Proteus vulgaris Serratia marcescens

Prescription Use ਮ (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH; Office of In Vitro Diagnostics and Radiological Health (OIR)

Page 1 of

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.”