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, Enterococcus, and Streptococcus.

This premarket notification is for the addition of the antimicrobial agent penicillin at concentrations of 0.0156-32 ug/mL to Streptococcus ID/AST or AST only Phoenix panels. Penicillin has been shown to be active in viro 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:

Beta hemolytic streptococci group ACG Streptococcus agalactiae Streptococcus viridans group Streptococcus pneumoniae (per drug package insert- streptococci groups A, C, G, H, L and M and pneumococci)

Active In Vitro Against:

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. For testing Streptococcus species 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-S Broth used for performing AST tests only. .
BD Phoenix AST-S 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, R or N (susceptible, intermediate, resistant or not susceptible).

AI/ML Overview

Here's an analysis of the provided text to extract the acceptance criteria and study details for the BD Phoenix™ Automated Microbiology System for Penicillin.

Acceptance Criteria and Device Performance Study for BD Phoenix™ Automated Microbiology System (Penicillin)

1. Table of Acceptance Criteria and Reported Device Performance

The provided document doesn't explicitly state numerical acceptance criteria (e.g., "Essential Agreement must be ≥ 90%"). However, it does state the overall intra-site reproducibility and overall inter-site reproducibility as key performance metrics. The goal of the study was to demonstrate Substantial Equivalence to the CLSI reference broth microdilution method based on Essential Agreement (EA) and Category Agreement (CA).

Performance Metric	Acceptance Criteria (Implied)	Reported Device Performance (Penicillin)
Overall Intra-site Reproducibility	Acceptable (not explicitly numerical, but ≥99.1% was achieved)	≥99.1%
Overall Inter-site Reproducibility	Acceptable (not explicitly numerical, but 99.4% was achieved)	99.4%
Essential Agreement (EA)	Demonstrated substantial equivalence	("Performance of BD Phoenix System for Streptococcal Organisms by Drug Table 1" seems to display the results, but the table itself isn't legible or properly formatted in the provided text for extraction of specific values)
Category Agreement (CA)	Demonstrated substantial equivalence	(As above, values are not extractable from the provided table)

Note on EA and CA: The provided text indicates that Table 1 summarizes the performance for the isolates tested in this study, including EA and CA. However, the table itself is corrupted and unreadable, preventing the extraction of specific numerical values for EA and CA. The conclusion states that the data demonstrate that testing on the BD Phoenix™ Automated Microbiology System with this antimicrobial agent is substantially equivalent.

2. Sample Size Used for the Test Set and Data Provenance

Test Set Sample Size: Not explicitly stated as a single number. The study utilized "clinical, stock, and challenge isolates."
Data Provenance:
- Country of Origin: "multiple geographically diverse sites across the United States."
- Retrospective or Prospective: Not explicitly stated. However, the nature of "clinical isolates" usually implies prospective collection during the study period, while "stock and challenge isolates" are typically existing, characterized strains.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts

Not provided in the document. The ground truth method is specified, but not the human experts involved in its establishment.

4. Adjudication Method for the Test Set

Not applicable. The ground truth method (CLSI reference broth microdilution) is a standardized laboratory method, not typically requiring expert adjudication in the same way an image analysis might.

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

Not applicable. This is an automated microbiology system that performs in vitro antimicrobial susceptibility testing. It is not an AI-assisted diagnostic tool for human readers, but rather an automated system designed to replace or augment manual laboratory methods.

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

Yes, this was a standalone performance study. The BD Phoenix™ Automated Microbiology System is an automated device designed to generate results (ID, MIC values, and category interpretations) without direct human interpretation in the results generation phase. Its performance was compared against a reference method (CLSI broth microdilution), which is a form of standalone evaluation.

7. The Type of Ground Truth Used

For Clinical Isolates: The ground truth was established by the CLSI reference broth microdilution method (AST panels prepared according to CLSI M7).
For Challenge Set Isolates: The ground truth was based on "expected results." This typically refers to pre-determined, highly characterized results for control strains.

8. The Sample Size for the Training Set

Not applicable. This document describes the validation of an automated system (BD Phoenix™) that utilizes a defined methodology (broth microdilution with redox indicator). It is not an AI/Machine Learning model that undergoes a distinct "training phase" on a dataset, then a "testing phase." The "system" itself is the product, and its performance is evaluated against a gold standard.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there isn't a traditional "training set" in the context of an AI/ML model. The device's internal algorithms and parameters would have been developed and refined over time by the manufacturer, likely using historical data and expert knowledge, but this isn't described in terms of a specific "training set" and associated ground truth in this submission.

Summary

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MAY 1 2 2005

510(k) SUMMARY

SUBMITTED BY:	Becton, Dickinson and Company7 Loveton CircleSparks, MD 21152Phone: 303-390-3240Fax: 410-316-4499
CONTACT NAME:	Linda Dillon,R&D Manager, Pasco Laboratories
DATE PREPARED:	March 25, 2005
DEVICE TRADE NAME:	BD Phoenix™ Automated Microbiology System –Penicillin 0.0156-32 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), andLevofloxacin (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-S Broth used for performing AST tests only. .
BD Phoenix AST-S 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 CLSI reference broth microdilution method. This premarket notification provides data supporting the use of the BD Phoenix™ Automated Microbiology System Streptococcus 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 Draft guidance document, "Class II Special Controls Guidance Document: Antimicrobial Susceptibility 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 of streptococcal isolates. Each site tested the isolates in triplicate on three different days using one lot of Streptococcus Phoenix panels containing this antimicrobial agent and associated reagents.

The results of the study demonstrate for this antimicrobial agent there was an overall intra-site reproducibility of ≥99.1% and an overall inter-site reproducibility of 99.4% for the streptococcal 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 Streptococcus 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 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).

Table 1 summarizes the performance for the isolates tested in this study.

Performance of BD Phoenix System for Streptococcal Organisms by Drug Table 1:

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The Court of Canadian Comments of Canadian Comments of ConcessionPENTER SEP POS ISLANIE ALLEGIANlPenicillinSECT COLLECT CARDER LEAR CONNECT & A	Comments of the first of the first and the first and the first and the first andC1	AN RANTE & A117	Property of the lastﻟ	104"	01

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), Offloxacin (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 stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle symbol. The logo is presented in black and white.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

MAY 1 2 2005

Ms. Linda Dillon R&D Manager, Pasco Laboratories Becton, Dickinson and Company 7 Loveton Circle Sparks, MD 21152

K050780 Re: Roso roo
Trade/Device Name: BD Phoenix™ Automated Microbiology System Penicillin (0.0156-32 µg/mL)- Streptococcus ID/AST or AST only Phoenix Panels Regulation Number: 21 CFR 866.1645 Regulation Name: Fully automated short-term incubation cycle antimicrobial susceptibility system Regulatory Class: Class II Product Code: LON Dated: March 25, 2005 Received: March 28, 2005

Dear Ms. Dillon:

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 for association to May 28, 1976, the enactment date of the Medical Device Amendments, or to conimered prior to thay 2005 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 r ou may, meres or ovisions 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 it may be subject it bach additions (CFR), Parts 800 to 895. In addition, FDA oun of the rine announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean r lease oc advisou that I Drivedan that your device complies with other requirements of the Act that I Dri has made a and regulations administered by other Federal agencies. You must of any it catal statutes and registments, including, but not limited to: registration and listing (21

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Page 2 -

This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter will and in your to ough finding of substantial equivalence of your device to a legally promatics nedicate 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" (21 CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the I va may of and 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,

Sales, a Story

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: K050780

Device Name: BD Phoenix™ Automated Microbiology System for use with the antimicrobial agent penicillin (0.0156-32 ug/mL) - Streptococcus ID/AST or AST only Phoenix Panels.

Indications for Use:

Active In Vitro and in Clinical Infections Against:

Beta hemolytic streptococci group ACG Streptococcus agalactiae Streptococcus viridans group Streptococcus pneumoniae (per drug package insert- streptococci groups A, C, G, H, L and M and pneumococci)

Active In Vitro Against:

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)

Ludali M. Pool.
Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Survily

BD Diagnostic Systems Becton, Dickinson and Company

K050780

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.”