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 antinicrobial 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 addition of the antimicrobial agent tobramycin at concentrations of 0.5-16 ug/mL to Gram Positive ID/AST or AST only Phoenix panels. tobramycin 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 (including penicillin-resistant strains)

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 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 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 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, or resistant).

AI/ML Overview

This submission describes the BD Phoenix™ Automated Microbiology System for the identification and antimicrobial susceptibility testing of isolates. The summary focuses on the addition of Tobramycin (0.5-16 µg/mL) to the Gram Positive ID/AST or AST only Phoenix panels.

Here's an analysis of the provided information, structured around your requested points:

Acceptance Criteria and Device Performance

The acceptance criteria for the BD Phoenix™ Automated Microbiology System, when compared to the NCCLS reference broth microdilution method, are typically defined by Essential Agreement (EA) and Category Agreement (CA). While specific numerical thresholds for "acceptance" are not explicitly stated as bullet points with percentages, the study's conclusion is that the device demonstrated "substantially equivalent performance" and "overall intra-site reproducibility of greater than 90% and an overall inter-site reproducibility greater than 95%." This implies that the observed EA and CA values, along with reproducibility, met the internal or FDA-specified thresholds for substantial equivalence.

Table 1: Acceptance Criteria and Reported Device Performance

Metric	Acceptance Criteria (Implied)	Reported Device Performance (Tobramycin)
Essential Agreement (EA)	Substantially equivalent performance to NCCLS reference method (agrees exactly or within +/- one two-fold dilution). Exact numerical target not specified, but implied to be high for acceptance.	"The performance of the Phoenix System was assessed by calculating Essential Agreement (EA)..." The specific numerical EA value for Tobramycin is not presented in the provided text, but the conclusion states "substantially equivalent performance," indicating it met the implied target. The truncated "Table 1" would presumably contain this data.
Category Agreement (CA)	Substantially equivalent performance to NCCLS reference method (agrees with FDA categorical interpretive criteria: susceptible, intermediate, resistant). Exact numerical target not specified, but implied to be high for acceptance.	"The performance of the Phoenix System was assessed by calculating [...] Category Agreement (CA) to expected/reference results for all isolates tested." The specific numerical CA value for Tobramycin is not presented in the provided text, but the conclusion states "substantially equivalent performance," indicating it met the implied target. The truncated "Table 1" would presumably contain this data.
Intra-site Reproducibility	Greater than 90%	Greater than 90%
Inter-site Reproducibility	Greater than 95%	Greater than 95%

Note: The actual numerical values for EA and CA for Tobramycin are missing from the provided "Table 1" in the extract. The "conclusion" section indicates that the data collected from the studies "demonstrate that testing on the BD Phoenix™ Automated Microbiology System with this antimicrobial agent is substantially equivalent."

Study Details

Sample sizes used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated in terms of a total number of isolates for the clinical studies. It mentions "a panel of Gram-positive isolates" for reproducibility and "clinical, stock and challenge isolates" for the performance study.
- Data Provenance: The studies were conducted "across multiple geographically diverse sites across the United States." This indicates the data is from the United States and is likely prospective for the clinical isolates, as they were tested against a reference method. The "challenge set isolates" would also be tested prospectively.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided in the document. The ground truth for AST is typically established by laboratory methods, not expert consensus in the same way an image interpretation might be.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- This concept of "adjudication method" is typically used for subjective interpretations (e.g., grading medical images by multiple readers). For Antimicrobial Susceptibility Testing (AST), the "ground truth" is determined by a chemical/biological reference method, not by human expert agreement. Therefore, none is applicable in the traditional sense. The comparison is against a well-defined reference standard.
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 was not done. This study is for an automated system's performance against a reference method, not for assessing human reader improvement with AI assistance. The BD Phoenix System is an automated device, not an AI assistant for human readers.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, a standalone study was done. The entire study evaluates the performance of the "BD Phoenix™ Automated Microbiology System" itself (the algorithm and instrument) against the NCCLS reference broth microdilution method. There is no human interaction with the interpretation of the Phoenix system's results for the purpose of the comparison.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The ground truth used was the NCCLS reference broth microdilution method. This is a laboratory-based, standardized, quantitative microbiological method for determining minimum inhibitory concentrations (MICs). For the "challenge set isolates," the ground truth was "expected results," which would also be derived from established microbiological methods.
The sample size for the training set:
- The document does not provide information about a specific "training set" sample size. The BD Phoenix system is based on established biochemical and susceptibility testing principles, not a machine learning model that requires a distinct training set in the modern AI sense. The development of such systems involves extensive internal validation and optimization, but the concept of a "training set" as defined for contemporary AI models isn't directly applicable or described here.
How the ground truth for the training set was established:
- As there is no explicit mention of a "training set" in the context of typical machine learning, this information is not provided. The "ground truth" for the development and optimization of the system would have inherently been established through biochemical and microbiological principles and comparison to established reference methods during the device's development phase.

Summary

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510(k) SUMMARY

SUBMITTED BY:	Becton, Dickinson and Company7 Loveton CircleSparks, MD 21152Phone: 410-316-4287Fax: 410-316-4499
CONTACT NAME:	Monica Evelyn Giguere,RA Specialist
DATE PREPARED:	September 23, 2005
DEVICE TRADE NAME:	BD Phoenix™ Automated Microbiology System –Tobramycin 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), 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 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 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 this antimicrobial agent.

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 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 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.

Performance of BD Phoenix System for Gram-Positive Organisms by Drug Table 1:

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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), 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 logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines extending from its head, representing the department's mission to protect the health of all Americans and provide essential human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle symbol.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

SEP 3 0 2005

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

Re: K052250

Trade/Device Name: BD Phoenix 11 Automated Microbiology System Tobramycin (0.5-16 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: August 16, 2005 Received: August 18, 2005

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 For

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: K052250

Device Name: BD Phoenix™ Automated Microbiology System for use with the antimicrobial agent tobramycin (0.5-16 ug/mL) - Gram positive ID/AST or AST only Phoenix panels.

Indications for Use:

Active In Vitro and in Clinical Infections Against:

Staphylococcus aureus (including penicillin-resistant strains)

Prescription Use (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 In Vitro Diagnostic Devices (OIVD)

Kidaln M. Poole
Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) KD5 2252

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.”