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 Enterococcus.

This premarket notification is for the antimicrobial Clindamycin at concentrations of 0.125-8 µg to Gram positive ID/AST or AST only Phoenix panels. Clindamycin 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 antimicrobic.

Active In Vitro and in Clinical Infections Against:

Aerobic Gram-positive microorganisms Staphylococcus aureus

Active In Vitro Against:

Aerobic Gram-positive microorganisms Staphylococcus epidermidis

Results for Clindamycin should not be reported for staphylococci recovered from the urinary tract.

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 isolation equivalent to 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, and resistant).

AI/ML Overview

Here's a summary of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Metric)	Target Performance	Reported Device Performance	Comments
Essential Agreement (EA)	Not explicitly stated, implied to be high for "substantially equivalent"	98.2%	EA occurs when the BD Phoenix™ System agrees exactly or within ± one two-fold dilution to the reference result.
Category Agreement (CA)	Not explicitly stated, implied to be high for "substantially equivalent"	98.7%	CA occurs when the BD Phoenix™ System agrees with the reference method with respect to FDA categorical interpretive criteria (S, I, R).
Intra-site Reproducibility	> 90%	> 90%	For Clindamycin in the BD Phoenix System, tested at three sites.
Inter-site Reproducibility	> 95%	> 95%	For Clindamycin in the BD Phoenix System, tested at three sites.

Study Details

Sample size used for the test set and the data provenance:
- Test Set Sample Size: 1242 isolates (combined clinical, stock, and challenge isolates).
- Data Provenance: The study used "clinical, stock and challenge isolates" tested "across multiple geographically diverse sites across the United States." This indicates a prospective data collection from various locations within the United States.
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.
- The ground truth for clinical isolates was established by comparison to the NCCLS reference broth microdilution method. For challenge isolates, the ground truth was "expected results." This implies that the reference method itself (NCCLS broth microdilution) is considered the gold standard, overseen by trained lab personnel, rather than interpretation by individual "experts" in the typical clinical sense (e.g., radiologists).
Adjudication method for the test set:
- The document does not explicitly mention an adjudication method like 2+1 or 3+1. The performance was assessed by direct comparison of the Phoenix System results to the reference NCCLS method or expected results.
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 study was not done. This study assesses the performance of an automated microbiology system (BD Phoenix) against a reference laboratory method (NCCLS broth microdilution), not the performance of human readers with or without AI assistance. This is an in vitro diagnostic device, not an image interpretation AI.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, a standalone study was done. The entire evaluation focuses on the performance of the "BD Phoenix™ Automated Microbiology System" (the device/algorithm) in determining antimicrobial susceptibility. The results (EA and CA) are presented for the system itself, without direct human intervention in the result interpretation once the system processes the sample.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The ground truth for clinical isolates was established by comparison to the NCCLS reference broth microdilution method.
- The ground truth for challenge isolates was based on "expected results," which are typically derived from well-characterized strains with known susceptibility profiles.
The sample size for the training set:
- The document does not specify the sample size for a training set. This type of device (an automated microbiology system based on microdilution and redox indicators) likely uses a pre-defined algorithm and measurement thresholds, rather than being "trained" in the machine learning sense on a large dataset of isolates. Its "training" would be more akin to defining the physical and chemical parameters for detection and interpretation.
How the ground truth for the training set was established:
- As noted above, a distinct "training set" in the machine learning context is not explicitly mentioned. The system's operational principles (redox indicator, turbidity changes, two-fold dilution concentrations) are based on established microbiological principles. The validation against the NCCLS reference method serves as the primary performance demonstration, rather than a separate training and testing paradigm typical of machine learning.

Summary

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AUG 0 1 2002

510(k) SUMMARY

SUBMITTED BY:	Becton, Dickinson and Company7 Loveton CircleSparks, MD 21152Phone: 410-316-4287Fax: 410-316-4499
CONTACT NAME:	Monica E. Giguere,Regulatory Affairs Specialist
DATE PREPARED:	June 11, 2002
DEVICE TRADE NAME:	BD Phoenix™ Automated Microbiology System –Clindamycin 0.125-8.0 mcg/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), and Levofloxacin (K020322, March 27, 2002).
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.
. 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 NCCLS 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 Clindamycin.

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 Clindamycin 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 with Clindamycin and associated reagents.

The results of the study demonstrate for the antimicrobial Clindamvcin an overall intra-site reproducibility greater than 90% and an overall inter-site reproducibility greater than 95% for the gram-positive isolates tested.

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

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the Gram Positive Phoenix Panel format containing Clindamycin. 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 NCCLS 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

Antimicrobialand the same of the same of the same of the same of the same of the same of	and the contraction of the comments of the comments of the comments of the comments of the comments of the comments of the comments of the comments of the comments of the comConcentrationComments of the consisted on the consisted to the consisted to the consisted to the control of	EA (n)	EA (%)Company of Children Comments of Children Comments of Children Comments of Children Comments of Children	CA (n)	CA (%)
Clindamvcin	0.125-8 mcg/mL	1242	98.2%	1242	98.7%

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 Clindamycin 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), Ofloxacin (K020323, April 14, 2002), and Levofloxacin (K020322, March 27, 2002).

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes representing health, human services, and well-being. The eagle is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA", which is arranged in a circular fashion around the left side of the logo.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

AUG 01 2002

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

Re: K021954

Trade/Device Name: BD Phoenix™ Automated Microbiology System for use with the antimicrobial Clindamycin (0.125-8 ug/mL) 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 12, 2002 Received: June 14, 2002

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

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This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/dsmaldsmamain.html".

Sincerely yours,

Steven Butman

Steven I. Gutman, M.D., M.B.A. . Director Division of Clinical Laboratory-Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page 1 of 1

510(k) Number: KO2 1954

Device Name: BD Phoenix™ Automated Microbiology System for use with the antimicrobial Clindamycin (0.125-8 mcg/mL) Gram positive ID/AST or AST only Phoenix panels.

Indications for Use:

Active In Vitro and in Clinical Infections Against:

Active In Vitro Against:

Aerobic Gram-positive microorganisms Staphylococcus aureus

Aerobic Gram-positive microorganisms Staphylococcus epidermidis

Results for Clindamycin should not be reported for staphylococci recovered from the urinary tract.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Freddie M. Poole

Over-The-Counter Use Optional Format 1-2-96

(Division Sign-Off)
Division of Clinical Laborator, Devices
510(k) Number K021954

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.”