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 addition of the antimicrobial agent Oxacillin at concentrations of 0.0625-4 ug/mL to Gram Positive ID/AST or AST only Phoenix panels. Oxacillin 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:

Aerobic Gram-positive microorganisms Staphylococcus spp.

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 breakdown of the acceptance criteria and study details based on your input:

Acceptance Criteria and Device Performance

The provided document describes a premarket notification for the BD Phoenix™ Automated Microbiology System for use with Oxacillin. The acceptance criteria are framed in terms of "Essential Agreement (EA)" and "Category Agreement (CA)" with a reference method.

Table 1: Acceptance Criteria and Reported Device Performance

Measure	Acceptance Criteria (Implied)	Reported Device Performance
Overall Essential Agreement (EA)	Not explicitly stated, but typically high (e.g., >90% or >95% for AST devices).	Table 1 shows a value under "CAA" which is likely the Category Agreement or a combination. The direct EA percentage value is obscured/not fully legible in the "Antimicrobial" row for Oxacillin.
Overall Category Agreement (CA)	Not explicitly stated, but typically high (e.g., >90% or >95% for AST devices).	Table 1 shows a value under "CAA". The direct CA percentage value is obscured/not fully legible in the "Antimicrobial" row for Oxacillin.
Intra-site Reproducibility	Not explicitly stated, but typically high (e.g., >90%).	Greater than 90%
Inter-site Reproducibility	Not explicitly stated, but typically high (e.g., >95%).	Greater than 95%

Note: The exact numerical acceptance criteria for EA and CA are not explicitly stated in the provided text, but these values are typically established in FDA guidance documents for antimicrobial susceptibility devices. The "CAA" column in Table 1 is partially obscured and its precise meaning (e.g., combined EA and CA, or just CA) is not fully clear from this snippet, but it represents the device's performance against the reference for agreement.

Study Details:

Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated as a single number. The study involved "Clinical, stock and challenge isolates." The results are summarized for "all isolates tested" in Table 1, but the total count of isolates for Oxacillin is obscured.
- Data Provenance: Multiple geographically diverse sites across the United States. Retrospective and Prospective nature is not explicitly stated, but "Clinical isolates" generally imply prospective collection, while "stock and challenge isolates" could be historical or specifically prepared for the study.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/not specified. The ground truth for antimicrobial susceptibility testing (AST) is established through a standardized laboratory method (NCCLS reference broth microdilution method), not by expert consensus on interpretation of images or clinical findings.
Adjudication method for the test set:
- Not applicable. As described above, the ground truth is a laboratory reference method, not an expert-based interpretation requiring adjudication.
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 done. This study focuses on the performance of an automated microbiology system against a laboratory reference method, not on human reader performance or AI assistance.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, this study represents a standalone performance evaluation. The BD Phoenix™ Automated Microbiology System is an automated system where the "algorithm" (its internal processing) determines the MIC values and category interpretations, which are then compared to the reference method. While a human might load the panels, the interpretation itself is automated and does not involve human-in-the-loop decision-making during the reading process for comparison purposes in this context.
The type of ground truth used:
- Reference Laboratory Method: The ground truth for antimicrobial susceptibility was established using the NCCLS reference broth microdilution method (AST panels prepared according to NCCLS M7).
The sample size for the training set:
- Not specified. The document describes the validation of a specific AST device rather than the training of an AI algorithm. While the device certainly relies on an "algorithm" for interpretation, the details of its development and any specific "training set" (in the machine learning sense) are not provided. The study is a regulatory submission for device performance comparison.
How the ground truth for the training set was established:
- Not applicable/not specified. As mentioned, the document doesn't detail the training of a machine learning model but rather the validation of an automated laboratory instrument. The "ground truth" during development would have been based on similar reference microbiology methods.

Summary

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1023301

CONFIDENTIAL

510(k) SUMMARY

SUBMITTED BY:	Becton, Dickinson and Company7 Loveton CircleSparks, MD 21152Phone: 410-316-4287Fax: 410-316-4499
CONTACT NAME:	Monica E. GiguereRegulatory Affairs Specialist
DATE PREPARED:	October 2, 2002
DEVICE TRADE NAME:	BD Phoenix™ Automated Microbiology System –Oxacillin 0.625-4.0 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 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 Oxacillin.

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 Oxacillin 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 Oxacillin and associated reagents.

The results of the study demonstrate for the antimicrobial Oxaciullin 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 Oxacillin. 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

Antimicrobial	oncentration1 8 8 2 1 0 3 0 1 0 3 1 0 3 1 1 1 1 1 1 1 1 1 1 1	t	C		9
xacıllın	0 0675	CAA------------------------------------------------------------------------------------------------------------------------------------------------------------------------------	AH	1 AA 4A for and

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 Oxacillin 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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines beneath them that resemble water or fabric.

Re:

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

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

NOV 12 2002

K023301 Trade/Device Name: BD Phoenix™ Automated Microbiology Systems Oxacillin (0.0625-4.0 µg/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: October 2, 2002 Received: October 3, 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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Page 2 -

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 i 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/cdrb/dsma/dsmamain.html".

Sincerely yours,

Steven Sutman

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:

Device Name: BD Phoenix™ Automated Microbiology System for use with the antimicrobial agent Oxacillin (0.0625-4.0 µg/mL) - Gram positive ID/AST or AST only Phoenix panels.

Indications for Use:

Active In Vitro and in Clinical Infections Against:

Aerobic Gram-positive microorganisms Staphylococcus spp.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Roxanne Shively /s. Denise H. Poole
(Division Sign Off)

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K02 3301

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

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.”