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 erythromycin at concentrations of 0.0625-8 ug/mL to Gram Positive ID/AST or AST only Phoenix panels. Erythromycin 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

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 Phocnix 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 Phocnix pancl is a sealed and self-inoculating molded polystyrene tray with 136 micro-wclls The I nooms panet is a scared and oes for susceptibility testing must be a pure culture and comlaining uried reagents. Organisms for sassephenty volumes
preliminarily identified as a Gram-negative or Gram-positive isolate. For each isolation premimatiry received standard is prepared in Phocnix ID broth.

The Phoenix AST method is a broth based microdilution test. The Phoenix System utilizes a redox The I nochis AST memor is a crown around in the presence of an antimicrobial agent. indicator for the delection of organism growth in the preserial turbidity are used in the determination Measurents of Changes to the marcace ageral 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 110 mstrument 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

The acceptance criteria for the BD Phoenix™ Automated Microbiology System for use with erythromycin were established by comparing its performance against the NCCLS reference broth microdilution method. The study aimed to demonstrate substantial equivalence to this reference method.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the "Essential Agreement (EA)" and "Category Agreement (CA)" metrics. For the device to be considered substantially equivalent, these agreements should generally be high. While specific numeric thresholds for acceptance are not explicitly stated, the summary of substantial equivalence concludes that the device demonstrated substantially equivalent performance.

Metric	Acceptance Criteria (Implied)	Reported Device Performance (Erythromycin)
Essential Agreement (EA)	High agreement with reference method	95.7% (n=1211)
Category Agreement (CA)	High agreement with reference method	95.7% (n=1132)

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

Sample Size for Test Set:
- For Essential Agreement (EA): 1211 isolates.
- For Category Agreement (CA): 1132 isolates.
Data Provenance: Clinical, stock, and challenge isolates were tested across multiple geographically diverse sites within the United States. The study compared the Phoenix System results to the NCCLS reference broth microdilution method. This indicates a prospective collection of data, likely collected specifically for this validation study, using a mix of real-world (clinical) and controlled (stock, challenge) samples.

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

The document does not specify the number or qualifications of experts used to establish the ground truth. It states that the "NCCLS reference broth microdilution method" was used as the comparator, which is a standardized laboratory procedure, not typically an expert consensus per se. The implementation and interpretation of this reference method would be carried out by trained laboratory personnel.

4. Adjudication Method for the Test Set

The document does not describe an adjudication method for the test set. The comparison is directly between the Phoenix System results and the NCCLS reference method. Discrepancies between the two would be analyzed as part of the Essential and Category Agreement calculations, but there's no mention of a separate expert adjudication process to resolve disagreements.

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

This is not applicable. The device described (BD Phoenix™ Automated Microbiology System) is an automated system for antimicrobial susceptibility testing, which does not involve human "readers" in the interpretation of results in the way a diagnostic imaging AI might. It is designed to provide automated interpretations (S, I, R, or N). Therefore, an MRMC study with human readers assessing AI assistance is not relevant here.

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

Yes, a standalone performance study was done. The entire study describes the performance of the "BD Phoenix Aotomated Microbiology System" (which contains the "BD Phoenix instrument and software") in isolation, comparing its automated results directly to the reference method. There is no mention of human-in-the-loop performance being part of this primary evaluation.

7. The Type of Ground Truth Used

The ground truth used was the NCCLS reference broth microdilution method. This is a reference standard method for antimicrobial susceptibility testing, widely accepted in microbiology.

8. The Sample Size for the Training Set

The document does not provide information about a separate training set. The study describes "Clinical, stock and challenge isolates" used for the performance evaluation. For devices like this, the "training" (i.e., algorithm development and optimization) would have been conducted prior to this substantial equivalence study, and the data used for that would typically not be part of the regulatory submission's clinical performance evaluation. This document focuses on the validation of the finalized device.

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

Since information on a specific training set size is not provided, the method for establishing its ground truth is also not detailed. However, it is highly probable that if a training set were used to develop the Phoenix System's algorithms, the ground truth would have similarly been established using a recognized reference method like the broth microdilution method or other validated laboratory techniques.

Summary

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FEB - 3 2004	K033784
	510(k) SUMMARY
SUBMITTED BY:	Becton, Dickinson and Company7 Loveton CircleSparks, MD 21152Phone: 410-316-4260Fax: 410-316-4499
CONTACT NAME:	Kathryn Babka Powers,RA Specialist
DATE PREPARED:	December 2, 2003
DEVICE TRADE NAME:	BD Phoenix™ Automated Microbiology System -Erythromycin 0.0625-8 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 Phocnix 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 pertionalice when compared with the No ee of the BD Phoenix™ Automated Microbiology System notheation provides and supportury panels with this antimicrobial agent.

SUMMARY OF SUBSTANTIAL EQUIVALENCE TESTING:

The BD Phoenix™ Automated Microbiology System has demonstrated substantially cquivalent performance when compared to the NCCLS reference broth microdilution method (AST panels performance with compared to any . The system has been evaluated as defined in the FDA Draft propared according to NOOD 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 mitta and mer are repassing a panel of Gram-positive isolates. Each site tested the isolates in evaluated at three different days using one lot of Gram Positive Phocnix panels containing this antimicrobial agent and associated reagents.

The results of the study domonstrate 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 actoss Chilical, stock and chance were mance of the Phoenix antimicrobial susceptibility test with the Olifical States to demonstrate the perfectntaining this antimicrobial agent. Phoenix System results the Grain Fostive I looms I and I onlines contanting and results. Phoenix System results for clinical Ior Chancing set isonales were compared is the respence broth microdilution method.

The performance of the Phoenix System was assessed by calculating Essential Agreement (EA) and The performance of the Provins Bybenn versults for all isolates tested. Essential Agreement Category Agreemont (OTT) to onported Microbiology System agrees exactly or within ± (EA) occars when the DD Presience result. Category Agreement (CA) occurs when the BD one two-Iold unution to the ferences resume agrees with the reference method with respect to the I hounds - Tutomated 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 Gram-Positive Organisms by Drug Table 1:

Antimicrobial	------------------------------------------------------------------------------------------------------------------------------------------------------------------------------Concentration	------------------------------------------------------------------------------------------------------------------------------------------------------------------------------EA (n)	and the control of the country of the country of the first of the first of the first of the first of the first of the first of the first of the first of the first of the firsEA (%)	CA (n)	CA (%)
Free and the contract and the commend of the comments of the comments of the comments of the comments of Erythromycin	and the contract of the contract and 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 comme 0.0625-8 µg/mL	1132	05 71211	1132	05 7ڪيو جو آهي جي

Conclusions Drawn from Substantial Equivalence Studies

The data collected from the substantial equivalence studies dcmonstrate that testing on the BD The and voluseted from are abiology System with this antimicrobial agent is substantially equivalent as outlined in the FDA draft guidance document, "Guidance on Review Criteria for Assessment of as outimod in the IDI calling gavices" March 8, 2000. Technological characteristics of this system Amminerobial busephibility Dories from 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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Image /page/3/Picture/0 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 extending from its body, representing health and human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Kathryn Babka Powers Regulatory Affairs Specialist Becton, Dickinson and Company 7 Loveton Circle Sparks, MD 21152-0999

FEB - 3 2004

Re: K033784

Trade/Device Name: BD Phoenix™ Automated Microbiology System for use with the antimicrobial agent erythromycin (0.0625-8 µg/mL.) -- Gram-Positive 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: December 2, 2003 Received: December 4, 2003

Dear Ms. Powers:

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 (301) 594-3084. 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/dsma/dsmamain.html.

Sincerely yours,

Saqartys

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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510(k) Number: K033784

Device Name: BD Phoenix™ Automated Microbiology System for use with the antimicrobial agent erythromycin (0.0625-8 µg/mL) - Gram positive ID/AST or AST only Phoenix Panels.

Indications for Use:

Active In Vitro and in Clinical Infections Against:

Staphylococcus aureus

Prescription Use
(Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Sall atty

Division Sign-Off

Office of In Vitro Diagnostic Device Office of Safety

510(k) K033784

Page 1 of 1

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.”