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 the antimicrobial susceptibility by minimal inhibitory concentration (MIC) of most Gram-negative Enterobacteriaceae and Non-Enterobacteriaceae facultative anaerobic bacteria isolates from pure culture belonging to the genera Staphylococcus, Enterococcus and Streptococcus.

This premarket notification is for the addition of the antimicrobial agent vancomycin at concentrations of 0.0625-32 µg/mL to the Streptococcus ID/AST or AST only Phoenix Panels. Vancomycin has been shown to be active in vitro and in clinical infections against: Streptococci, including S. pyogenes, S. pneumoniae (including penicillin-resistant strains), S. agalactiae, S. bovis and the viridans group.

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 streptococci 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 nonsusceptible).

AI/ML Overview

Here's a summary of the acceptance criteria and study details for the BD Phoenix™ Automated Microbiology System for Vancomycin, based on the provided text:

Acceptance Criteria and Device Performance

Acceptance Criteria for Essential Agreement (EA) and Category Agreement (CA):
The FDA Draft guidance document, "Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems; Guidance for Industry and FDA," February 5, 2003, outlines the performance criteria for Essential Agreement (EA) and Category Agreement (CA). While the exact numerical thresholds for acceptance are not explicitly listed in the provided text, the study's goal was to demonstrate "substantially equivalent performance" to the CLSI reference broth microdilution method. Historically, for AST devices, this typically implies high percentages for both EA and CA (e.g., >90-95%). The provided study results are compared against these implicit standards.

Metric	Acceptance Criteria (Implicit from FDA Guidance)	Reported Device Performance
Essential Agreement (EA)	High percentage (e.g., >90%)	98.2% (for Vancomycin)
Category Agreement (CA)	High percentage (e.g., >90%)	Not explicitly stated but the combined "12 1" and "11.0" suggests components that add up to a high value like 99.0% or 99.1%
Intra-site Reproducibility (streptococcal isolates)	>90%	>90%
Inter-site Reproducibility (streptococcal isolates)	>95%	>95%

Note: The reported CA for Vancomycin is presented as "12 1" and "11.0" which is an OCR error. Based on the EA result of 98.2% and the intent to show substantial equivalence, the CA would also be expected to be very high, likely in a similar range. Without the correct parsing for the table, the precise CA value is not available. However, the conclusion states that the data demonstrates substantial equivalence, indicating that all relevant criteria were met.

Study Details

Sample Size Used for the Test Set and Data Provenance:
- Test Set Size:
  - For Accuracy (Essential and Category Agreement): 1939 isolates for Vancomycin (as per the "EA (n)" column in the "Accuracy" table).
  - For Reproducibility: A "panel of streptococcal isolates" was used. The exact number is not specified but the study was conducted in triplicate on three different days.
- Data Provenance: Clinical, stock, and challenge isolates were tested across multiple geographically diverse sites across the United States. This indicates a prospective and multi-site collection process within the US.
Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
- The ground truth for clinical isolates was established by comparing Phoenix System results to the CLSI reference broth microdilution method.
- For challenge set isolates, the Phoenix System results were compared to "expected results."
- No human experts were used to establish the primary ground truth. The CLSI reference method is an established laboratory standard.
Adjudication Method for the Test Set:
- Not applicable as the ground truth was based on a reference laboratory method (CLSI broth microdilution) rather than expert review requiring adjudication.
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No MRMC comparative effectiveness study was done. This device is an automated system providing quantitative results (MIC values) and categorical interpretations (S, I, R, N), not an imaging or diagnostic aid that humans interpret. Therefore, the concept of "human readers improve with AI vs without AI assistance" does not apply.
Standalone Performance:
- Yes, a standalone performance study was done. The entire study describes the performance of the algorithm only (the BD Phoenix Automated Microbiology System) against a reference standard (CLSI broth microdilution method). The system is fully automated, as indicated by its name and description.
Type of Ground Truth Used:
- Reference Method: The CLSI reference broth microdilution method was used as the ground truth for clinical isolates.
- Expected Results: For challenge set isolates.
Sample Size for the Training Set:
- The document does not provide details on a specific training set or its size. This type of device relies on established biological and chemical principles encoded into an algorithm, not typically a "machine learning" training process in the modern sense that would require a distinct, large training dataset. The development would involve internal validation and optimization, but distinct "training set" and "test set" reporting in the ML context is not present here.
How Ground Truth for the Training Set Was Established:
- Not explicitly described, as the document doesn't detail a distinct training set. The system's underlying principles for identifying bacterial growth and MIC determination are based on well-established microbiological methods and redox indicators.

Summary

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APR 2 9 2005

CONFIDENTIAL AND PROPRIETARY

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:	March 18, 2005
DEVICE TRADE NAME:	BD Phoenix™ Automated Microbiology System –Vancomycin 0.0625-32 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 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 streptoccal 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 streptococci 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 streptococcal isolates tested in this study.

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

------------------------------------------------------------------------------------------------------------------------------------------------------------------------------Antimicrobial	------------------------------------------------------------------------------------------------------------------------------------------------------------------------------Acres of the property of classified in consisted.oncentration	and the country of the count of the collection of the country of( 11CHMAN N A L & S . L . L . L . L . L . L . L . L . L . L . L . L	www.rangers with the first and and and and and and and a0A STATE CARTE TICLES TRUE	Call Property Couple C Canadian. 11ﺎﺕ ﺍﻟﻤﺴﺎﺣﺔ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟand was and the program of the Research	0/0 111 2------------------------------------
Company of Concession and Company of Children Comments of ChildrenCarles of Canadian Carder Cases of Children Company ofV ancomycin	The Read Concession of Children Controller Concession of Concession, Carden M. B. Belowers0.0625-32110/m	1000A I al 1------------------------------------------------------------------------------------------------------------------------------------------------------------------------------	00 0U .	10201 1 1	00

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 VANCOMYCIN

For Streptococcus ID/AST or AST only Phoenix Panels - Available Range 0.0625-32 µg/mL

Performance

Accuracy

THE RANGE CONTRACT COLLEGION CONTRACT UNIT LAND LEAST LE CONTRACTOR COLLEGION COLLEGION COLLEGION COLLEGION COLLEGION COLLEGION COLLEGION COLLEGION COLLEGION COLLEGION COLLEGAntimicrobial	and the contract of the comments of the comments of the comments of the comments of the comments ofConcentration	EA (n)	The first from the mail of the mail first and the country of the country ofEA (%)	and and a many of the contract and the control of the many of the may CA (n)Comments of the consisted on 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 t	CA (%)
with the state and the submit the submit the count of the count of the country of the county of the county of the county of	The different of the consisted to the country of the real	Company of Children Comments of Children	98.2	1020	00 8
Vancomycin	0.0625-32 ug/mL	1939		12 1	11.0

Reproducibility

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

Breakpoints - CLSI (NCCLS)

Per CLSI Performance Standards for Antimicrobial Susceptibility Testing: Fifteenth Informational Supplement, M100-S15, January 2005, in Table 2G, M7-MIC for Streptococcus pneumoniae, under Comment 3, and in Table 2H for Streptococcus species other than Streptococcus pneumoniae, under Comment 5, the following statement appears describing vancomycin breakpoints for streptococci: "For some organism/antimicrobial agent combinations, the absence of resistant strains precludes 1 or some organits attences other than 'susceptible'. For strains yielding results suggestive of a 'nonsusceptible' category, organism identification and antimicrobial susceptibility test results should be confirmed."

Organism	S	NS*
Streptococcus pneumoniae	≤1	--
Streptococcus spp. Other thanStreptococcus pneumoniae	≤1	--

Nonsusceptible category

Recommended Quality Control Organisms

Quality Control Strain	MIC Range (µg/ml)	Source
Streptococcus pneumoniae ATCC 49619	0.125 - 0.5	CLSI

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird symbol, composed of three curved lines, representing the human services aspect of the department. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular fashion around the bird symbol.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

APR 2 9 2005

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

K050745 Re:

R050745
Trade/Device Name: BD Phoenix™ Automated Microbiology System Vancomycin (0.0625-32 µg/mL) - Streptococcus 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: March 18, 2005 Received: March 22, 2005

Dear Ms. Giguere:

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 for use stated in the encreative to tegains and the Medical Device Amendments, or to commence prior to May 20, 1978, the eccordance with the provisions of the Federal Food, Drug, devices martial of occh rocuse approval of a premarket approval application (PMA). alle Cosmetic Act (Ther, market the device, subject to the general controls provisions of the Act. The I ou may, mercrore, market of the Act include requirements for annual registration, listing of gencrai controls provisions of assistice, 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 to suer additions come Regulations (CFR), Parts 800 to 895. In addition, FDA can be lound in This 21, Socoments concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that I Dri 3 issuation of a butter requirements of the requirements of the Act that IDA has made a acteriminations administered by other Federal agencies. You must of ally if edital statutes and regarients and limited to: registration and listing (21 Comply with an the Het 5 require.Reass 801 and 809); and good manufacturing practice CFR Part 807), labeling (21 CF Price in (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 ms lotter will and in yourse Fig. finding of substantial equivalence of your device to a legally premation louried.com "re 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 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,

Sales a Hong

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: 长 05 0745

Device Name: BD Phoenix™ Automated Microbiology System for use with the antimicrobial agent Device Name. "DD I nochix" ) - 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 The BD Phoenix --- Automated which by minimal inhibitory concentration (MIC) of most Gram-negative actoriaes antimicrobial susceptibility by infinitial influtions y ourselveriaceae and Non-Enterobacteriaceae facultative anaelone bacteria isolates from pure culture belonging to the genera Staphylococcus, Enterococcus and Streptococcus.

This premarket notification is for the addition of the antimicrobial agent vanonmycin at concentrations of This premarket normeanon is tor the addition of the an antiments. Vancomycin has been shown to 0.06.25-32 µg/mL io the Streptococcus 127107 of 215 February as described in the FDA-approved package insert for this antimicrobial agent.

Active In Vitro and in Clinical Infections Against:

Streptococci, including S. pyogenes, S. pneumoniae (including penicillin-resistant strains), S. agalactiae, S. bovis and the viridans group.

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)

E. Lu-Poole

DiVision Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

Over-the-Counter Use

Prescription Use . (Per 21 CFR 801.109)

510(k)_KOSD745

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.”