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, and Streptococcus, and Streptococcus.

This premarket notification is for additional organism groups and Tetracycline 0.5-16 µg/mL on the BD Phoenix Automated Microbiology System.

Tetracycline 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:

Gram-negative organisms
Acinetobacter species
Escherichia coli
Enterobacter aerogenes
Klebsiella species
Shigella species

Gram-positive organisms
Staphylococcus aureus

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 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 (MTC) values and category interpretations, S, I, or R (sensitive, intermediate, or resistant).

AI/ML Overview

Here's the detailed breakdown of the acceptance criteria and study findings for the BD Phoenix™ Automated Microbiology System - Tetracycline 0.5-16 µg/mL:

1. Table of acceptance criteria and the reported device performance

Performance Metric	Acceptance Criteria (Implied by FDA Guidance)	Reported Device Performance (Tetracycline GN)	Reported Device Performance (Tetracycline GP)
Essential Agreement (EA)	Substantially Equivalent (typically >90%)	95.5% (n=2837)	96.9% (n=2040)
Category Agreement (CA)	Substantially Equivalent (typically >90%)	92.3% (n=2837)	96.5% (n=2040)
Intra-site Reproducibility	> 90%	> 90% (for each antimicrobial agent tested)	> 90% (for each antimicrobial agent tested)
Inter-site Reproducibility	> 95%	> 95% (for each antimicrobial agent tested)	> 95% (for each antimicrobial agent tested)

Notes on Acceptance Criteria:
The document states that the system "demonstrated substantially equivalent performance when compared with the CLSI reference broth microdilution method" and "has been evaluated as defined in the Fparent guidance document, 'Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems; Guidance for Industry and FDA,' February 5, 2003." While specific numerical acceptance criteria for EA and CA are not explicitly stated in the provided text, the FDA guidance document referenced typically requires performance metrics like EA and CA to be above 90% (and often closer to 95% or higher) for a device to be considered "substantially equivalent." Therefore, the reported performance clearly meets these implied acceptance criteria.

2. Sample size used for the test set and the data provenance

Sample Size for Test Set:
- Gram-Negative (GN) organisms: 2837 isolates
- Gram-Positive (GP) organisms: 2040 isolates
Data Provenance: Clinical, stock, and challenge isolates were tested across multiple geographically diverse sites across the United States. This indicates a prospective collection for at least the clinical isolates, and likely a mix of prospective (clinical) and curated (stock/challenge) data.

3. 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 of experts or their qualifications for establishing the ground truth. The ground truth was established by the CLSI reference broth microdilution method. This method is a standardized laboratory procedure, and adherence to this protocol is overseen by laboratory personnel.

4. Adjudication method for the test set

The document does not describe an adjudication method for the test set. The comparison was made directly between the BD Phoenix System results and the CLSI reference broth microdilution method results.

5. 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, an MRMC comparative effectiveness study involving human readers and AI assistance was not conducted or described. This device is an automated system for antimicrobial susceptibility testing, not an imaging or diagnostic AI tool designed to assist human readers.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Yes, a standalone study was done. The entire study evaluated the performance of the BD Phoenix™ Automated Microbiology System as an automated system, comparing its results directly to the CLSI reference broth microdilution method. There is no mention of human input influencing the Phoenix System's determination of susceptibility.

7. The type of ground truth used

The ground truth used was the CLSI reference broth microdilution method. This is a validated, standardized laboratory procedure for determining antimicrobial susceptibility, considered the gold standard in many contexts.

8. The sample size for the training set

The document does not provide information regarding a specific "training set" sample size. For AST systems like the Phoenix, the "training" (or development and calibration) is typically done during the product development phase to establish the algorithms and interpretation rules for the system's measurements (e.g., redox indicator changes, turbidity) to correlate with MIC values and clinical categories. The provided study focuses on the validation of a specific antimicrobial agent (Tetracycline) and organism groups on an already developed system.

9. How the ground truth for the training set was established

The document does not provide information on how the ground truth for the training set (if a distinct training set in the AI/ML sense was used) was established. Given the nature of the device, the system's development would have involved extensive correlation studies with the CLSI reference broth microdilution method and expert microbiological interpretation to establish its internal algorithms and interpretive criteria prior to the specific validation study described.

Summary

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510(K) SUMMARY

K 060214

SUBMITTED BY:	Becton, Dickinson and Company7 Loveton CircleSparks, MD 21152Phone: (410) 316 - 4278Fax: 410-316-4499
CONTACT NAME:	Monica E. GiguereRegulatory Affairs Specialist
DATE PREPARED:	January 26, 2006
DEVICE TRADE NAME:	BD Phoenix™ Automated Microbiology System -Tetracycline 0.5-16 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), Ofloxacin (K020323, April 14, 2002),Levofloxacin (K020322, March 27, 2002), and Tetracycline0.5-16 µg/mL (K024153, February 10, 2003 and K032131,August 18, 2003).
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. .

ート | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |

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. 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.

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 for additional organism groups with Tetracycline 0.5-16 ug/mL and the BD Phoenix™ Automated Microbiology System.

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 Topanels prepared according to NCCLS M7). The system has been evaluated as defined in the Fparent guidance document, "Class II Special Controls Guidance Document: Antimicrobial SusceptDility Test (AST) Systems; Guidance for Industry and FDA," February 5, 2003.

Site Reproducibility

Intra- and inter-site reproducibility of this antimicrobial agent in the BD Phoenix System was evaluated at three sites using a panel chosen isolates. Each site tested the installed in three different days using one lot of Phoenix panels containing the antimicrobial agents and associated reagents.

The results of the study demonstrate for each antimicrobial agent there was an overall intra-site reproducibility of greater than 90% and an overall inter-site reproducibility greater than 95% for the 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 Phoenix panel formats containing antimicrobial agents. 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.

Antimicrobial	Concentration	EA (n)	EA (%)	CA (n)	CA (%)
Tetracycline GN	0.5-16 µg/mL	2837	95.5	2837	92.3
Tetracycline GP	0.5-16 µg/mL	2040	96.9	2040	96.5

Performance of BD Phoenix System by Drug Table 1:

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," 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), Ofloxacin (K020323. April 14, 2002), Levofloxacin (K020322, March 27, 2002), and Tetracycline 0.5-16 ug/mL (K024153, February 10, 2003 and K032131, August 18, 2003).

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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 consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the symbol. The text is in all caps and appears to be in a sans-serif font. The logo is black and white.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

2006 MAR 9

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

K060214 Re:

Trade/Device Name: BD Phoenix™ Automated Microbiology System Tetracycline (0.5-16 ug/mL) - Gram-Negative and 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: January 26, 2006 Received: January 27, 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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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,

Sale, a Hog

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: KO 602)4

Device Name: BD Phoenix™ Automated Microbiology System for use with the antimicrobial agent Tetracycline 0.5-16 µg/mL - Gram-negative and Gram-positive ID/AST or AST only Phoenix panels.

Indications for Use:

This premarket notification is for additional organism groups and Tetracycline 0.5-16 µg/mL on the BD Phoenix Automated Microbiology System.

Tetracycline 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:

Gram-negative organisms

Acinetobacter species Escherichia coli Enterobacter aerogenes Klebsiella species Shigella species

Gram-positive organisms Staphylococcus aureus

Prescription Use V (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

BD Diagnostic Systems
Becton, Dickinson and Company

Page 6	510(k) K060214
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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.”