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 belonging to the genera Staphylococcus, Enterococcus, and Streptococcus.

This premarket notification is for the addition of the antimicrobial agent tetracycline at concentrations of 0.0625 - 16 µg/mL to the Streptococcus ID/AST or AST only Phoenix panels. Tetracycline has been shown to be active in vitro and in clinical infections against Streptococcus species, including S. pneumoniae as described in the FDA-approved package insert for this antimicrobial agent.

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 veliminarily 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. Mercurements 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 a breakdown of the acceptance criteria and study details for the BD Phoenix™ Automated Microbiology System for Tetracycline, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the "Essential Agreement (EA)" and "Category Agreement (CA)" metrics, which are industry standards for AST system performance compared to a reference method. While explicit percentage targets for acceptance aren't stated directly in the summary, regulatory guidance documents typically require high percentages for substantial equivalence. The reported performance demonstrates strong agreement.

Metric (Implied Acceptance Criterion)	Reported Device Performance (Tetracycline)
Essential Agreement (EA)	95.7% (with n=1268 isolates)
Category Agreement (CA)	97.8% (with n=1568 isolates)
Intra-site Reproducibility	> 90%
Inter-site Reproducibility	> 95%

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

Sample Size (Test Set):
- For Essential Agreement (EA): n = 1268 isolates
- For Category Agreement (CA): n = 1568 isolates
- For Reproducibility (Intra- and Inter-site): A panel of streptococcal isolates. (Specific number not provided in the summary, but tested in triplicate on three different days at three sites).
Data Provenance:
- Clinical, stock, and challenge isolates were tested.
- Across multiple geographically diverse sites (implies prospective and multi-site data collection).

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

This document does not specify the number or qualifications of experts used to establish the ground truth. It states that the Phoenix System results were compared to the CLSI reference broth microdilution method for clinical isolates, and to expected results for challenge set isolates. The CLSI method itself is a standardized, expert-approved methodology for AST, but not individual experts for this specific study.

4. Adjudication Method for the Test Set

The document does not describe an explicit adjudication method (e.g., 2+1, 3+1). Instead, the performance is assessed by comparing the Phoenix System results directly to the established CLSI reference broth microdilution method results or "expected results" for challenge isolates. Discrepancies would be identified through this comparison, but the process for resolving disagreements between the device and the reference standard, if any, is not detailed.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and 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 device is an automated system for antimicrobial susceptibility testing, not an imaging or diagnostic aid that typically involves human "readers" interpreting results that AI would assist with. The comparison is between an automated system's performance and a standard reference method.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, this study is inherently a standalone performance evaluation. The BD Phoenix System is an automated device designed to autonomously perform identification (ID) and antimicrobial susceptibility testing (AST). The performance metrics (EA, CA, Reproducibility) directly reflect the algorithm's output compared to a reference standard, without human intervention in the interpretation process of the device's results.

7. The Type of Ground Truth Used

The ground truth used was:

CLSI reference broth microdilution method: For clinical isolates. This is a standardized, internationally recognized laboratory method considered the gold standard for antimicrobial susceptibility testing.
Expected results: For challenge isolates. This implies known or pre-determined susceptibility profiles for these specific strains, often used to test the device's ability to accurately identify known resistant or susceptible patterns.

8. The Sample Size for the Training Set

The document does not provide any information regarding the sample size used for the training set. This is typical for a 510(k) submission for an established automated system, where the focus is on the validation of a specific antimicrobial agent addition rather than the initial development of the core algorithm.

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

The document does not provide any information on how the ground truth for any potential training set was established. As mentioned above, the submission focuses on validating the performance for the addition of a new antimicrobial agent (Tetracycline) to an already cleared system.

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:	April 5, 2005
DEVICE TRADE NAME:	BD Phoenix™ Automated Microbiology System -Tetracycline 0.0625-16 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), 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 NCCLS 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 streptococal 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 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 streptococcal isolates tested.

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Clinical Studies

Clinical, stock and challenge isolates were tested across multiple geographically diverse sites across Onlival, extransmate 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 nonsusceptible).

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

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

The deliver been and commend on and TableA STATE AND LATER AND A LETT A LETT COLLECTION OF CONSULTION OF CONSULTION OF CONSULTION OF CONSULTION OF CONSULTION OF CONSULTION OF CONSULTION OF CONSULTION OF CONSULTION OAntimicrobial	------------------------------------------------------------------------------------------------------------------------------------------------------------------------------and and a second and supportunities which and the sameConcentration	the submit of the same of the same the mail the mail the maint of the maint of the maint of the maint of the maint of the maint of the maint of the maint of the mail of the mCA( m	STATUTE POSSIVE PERSONAL ASL N. N. NOT FOR LT . PLANE OF L. PLANE OF10/0 .15 11, A	A Comments of Concession CONCRECT COLLA COLLEGEไCA (n177	( 1 ) = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 110/01and the state of the same of the different of the different of
And The Frances of Children Comments of ChildrenCompany Controlled College Compression a no and more and an and any and any andTetracycline	A------------------------------------------------------------------------------------------------------------------------------------------------------------------------------0.062511/2/19/10/11/11/1	A1 268------------------------------------------------------------------------------------------------------------------------------------------------------------------------------	05 7a a a bood	1 268	07The Tall Tarres We The Page Accelly-divide Advisor

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), and Levofloxacin (K020322, March 27, 2002).

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SUMMARY INFORMATION FOR TETRACYCLINE Available Range 0.0625-16 µg/mL

Performance

Accuracy

The first of the country of the country of the county of the county of the county of the county of the county of the county of the county of the county of the county of the c-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------Antimicrobial	------------------------------------------------------------------------------------------------------------------------------------------------------------------------------come count an oth Actually por-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------Concentration	Comments of the Comments of Children of Children and Children and Children and Children and Children and Children Children------------------------------------------------------------------------------------------------------------------------------------------------------------------------------EA (n)TY TH Y L And Collection of theNo. of Cattle College of------------------------------------------------------------------------------------------------------------------------------------------------------------------------------	------------------------------------------------------------------------------------------------------------------------------------------------------------------------------(0/0)" EA .The Real and Children and the	THE LAND AND AND MICH CHICA CART AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AThe ChildrenCA (n)THE TEX LIFERANTA The Callery of Children the States of the states of the states of the states of the states of the states of the states of the states of the states of the states of the s	For War Wall Comment of the comments ofCA .(%)and the the hall hand has he in
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------Tetracycline	And and and a second and the comments of the control ofSTATUTE AND AND AND AND A PROPERTY OF IT THE' 0.0625-16 ug/mL------------------------------------------------------------------------------------------------------------------------------------------------------------------------------	1 268	05 71 - 1 love	1 568	078.0

Reproducibility

Testing performed at multiple clinical sites demonstrated 95% reproducibility or greater within ± 1 dilution.

Breakpoints - CLSI , FDA

Organism	S	I	R
Streptococcus pneumoniae	≤2	4	≥8
Streptococcus spp. Other thanStreptococcus pneumoniae	≤2	4	≥8

Recommended Quality Control Organisms

Quality Control Strain	MIC Range	Source
Streptococcus pneumoniae ATCC 49619	0.12 – 0.5	CLSI

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal features a stylized eagle-like symbol with three curved lines representing its wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the symbol.

Public Health Service

MAY 1 2 2005

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

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

K050881 Re:

K050001
Trade/Device Name: BD Phoenix™ Automated Microbiology System Tetracycline (0.0625-16 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: April 5, 2005

Dear Ms. Giguere:

Received: April 7, 2005

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave teviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate 101 use stated in the encrebute) 70 ttg=227 1976, the Medical Device Amendments, or to connine.co pror to may 2017 2017 11:12 provisions of the Federal Food, Drug, devices mat have been recuire in avere approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The I ou may, merceroro, mance are act include requirements for annual registration, listing of general controls pro firstiving 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), If your device is elassified (boo aco v) trols. Existing major regulations affecting your device it may be subject to Satin additions (CFR), Parts 800 to 895. In additions (CFR), Parts 800 to 895 can be found in Ther announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean I loase oc advisou that I Drivian that your device complies with other requirements of the Act that IDA has made a deceminations administered by other Federal agencies. You must of any I cach sutures and regulations and limited to: registration and listing (21 Comply with an the Free S require.nemans, 01 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) I his letter witi anon you to cognifinding of substantial equivalence of your device to a legally premarket notification: "The sults 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, If you destre spotition and advertising of your device, please contact the Office of In of quotions on 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 I va may obtain other generers, 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 Form

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: _ Ko50 881

Device Name: BD Phoenix™ Automated Microbiology System for use with the antimicrobial agent Dovice Name: "DD 11 0 p/mL) - Streptococcus ID/AST or AST only Phoenix Panels.

Indications for Use:

The BD Phoenix™ Automated Microbiology System is intended for in vitro quantitative determination of 1116 DD Friotial susceptibility by minimal inhibitory concentration (MIC) of most Gram-negative aerobic and animicrobial Susceptionity by innumal inforce , Uture for Enterobacteriaceae and Non-Enterobacteriaceae laculant vo anaoroosi bacteria isolates from pure culture belonging to the genera Staphylococcus, Enterococcus, and Streptococcus.

This premarket notification is for the addition of the antimicrobial agent tetracycline at concentrations of I fills promation of to the assist only Phoenix panels. Tetracycline has been shown to be 0.0025 - 10.011111 to brepoodess 127 is 2019 as described in the FDA-approved package insert for this antimicrobial agent.

Active In Vitro and in Clinical Infections Against:

Streptococcus species, including S. pneumoniae.

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 In Vitro Diagnostic Devices (OIVD)

Luddiette Poole

Division Sign-Off

Prescription Use (Per 21 CFR 801.109) Office of In Vitro Diagnostic Device Evaluation and Safety

Over-the-Counter Use

510(k) K050881

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.”