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 tetracycline at concentrations of 0.5-16 µg/mL to Gram Positive ID/AST or AST only Phoenix panels. Tetracycline 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 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 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 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, or R (sensitive, intermediate, or resistant).

AI/ML Overview

Here's a summary of the acceptance criteria and study details for the BD Phoenix™ Automated Microbiology System (Tetracycline 0.5-16 µg/mL), based on the provided text:

Acceptance Criteria and Device Performance

Acceptance Criteria Category	Acceptance Criteria (from FDA Draft Guidance Document "Guidance on Review Criteria for Assessment of Antimicrobial Susceptibility Devices", March 8, 2000)	Reported Device Performance
Essential Agreement (EA)	Not explicitly stated but generally indicates agreement within +/- one two-fold dilution compared to the reference method.	1549 (n); 97.0% (Tetracycline)
Category Agreement (CA)	Not explicitly stated but generally indicates agreement with the reference method regarding susceptible, intermediate, or resistant categories.	1549 (n); 96.6% (Tetracycline)
Intra-site Reproducibility	Greater than 90%	Greater than 90%
Inter-site Reproducibility	Greater than 95%	Greater than 95%

Study Details

Sample sizes used for the test set and the data provenance:
- Test Set Sample Size: 1549 isolates for Tetracycline (this number represents the 'n' for both EA and CA).
- Data Provenance:
  - Country of Origin: United States ("multiple geographically diverse sites across the United States").
  - Retrospective or Prospective: Not explicitly stated as retrospective or prospective. However, the study involved testing "Clinical, stock and challenge isolates," which suggests a mix of existing isolates (stock/challenge) and potentially newly collected clinical isolates.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided in the document. The ground truth (reference method) is the NCCLS reference broth microdilution method, not expert consensus.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Adjudication methods involving multiple human readers are not applicable here, as the comparison is between an automated system (BD Phoenix) and a standardized reference laboratory method (NCCLS broth microdilution). Therefore, "none" in the context of human reader 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, an MRMC comparative effectiveness study was not done. This study evaluates the performance of an automated susceptibility testing system against a reference method, not the performance of human readers with or without AI assistance.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, a standalone study was done. The BD Phoenix System is an "Automated Microbiology System" and its performance was assessed directly against the NCCLS reference method. This represents the algorithm (system) performance without direct human interpretation in the determination of the MIC values and category interpretations from the Phoenix system readings, though human operators are involved in preparing samples and loading the system.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Reference Laboratory Method: The ground truth was established using the NCCLS reference broth microdilution method (AST panels prepared according to NCCLS M7). This is a standardized, recognized laboratory method for determining antimicrobial susceptibility.
The sample size for the training set:
- The document does not provide information about a separate training set or its sample size. The study describes the evaluation of the "Phoenix antimicrobial susceptibility test" and does not detail the development or training phase of the algorithm itself.
How the ground truth for the training set was established:
- Since information about a specific training set is not provided, the method for establishing its ground truth is also not available in this document.

Summary

{0}------------------------------------------------

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 E. Giguere,Regulatory Affairs Specialist
DATE PREPARED:	July 10, 2003
DEVICE TRADE NAME:	BD Phoenix™ Automated Microbiology System –Tetracycline 0.5-16 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 Broth used for performing AST tests only. .
BD Phoenix AST Indicator solution added to the AST Broth to aid in bacterial growth . determination.

{1}------------------------------------------------

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 this antimicrobial agent.

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 this antimicrobial agent 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 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 Gram-positive isolates tested.

{2}------------------------------------------------

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 Gram Positive 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 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	ставляется продавания с седерения с полность с светенные с сементальные поведника с товарии с ставникConcentrationThe first and the commend of the comments of the comments of the comments of the comments of	EA (n)	EA (%)THE PERSONAL PROPERTY CONSULTION CONCELLENCE CONTRACT CONTRACT CONTRACT CONTRACT CONTRACT CONTRACT CONTRACT CONTRACT CONTRACT CONTRACT CONTRACT CONTRACT CONTRACT CARDED CONTR	Company Franchise Line Land Controller Company Company Concession Company Concession Compares CA (n)FREE OF COLL BOOK THE RESEARCE PARTY OF COLLECTION OF COLLECTION OF CLASS OF CLASS OF CLASS OF CLASS OF CLASS OF CLASS OF CLASS OF CLASS OF CLASS OF CLASS OF CLASS OF COLLECT	Contrôlection of the Art.CA (%)CONSULERS & COLL Christon Corp.
Survey.Tetracycline	0.5-16 ug/mL	1549	07 0	1549	96.6

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, "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).

{3}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows a logo with a stylized bird-like figure composed of three curved lines, suggesting movement or flight. The lines are thick and black, creating a bold visual impact. The bird-like figure is encircled by a dotted line, forming a circular border around the central design. The logo appears to be simple and abstract, possibly representing an organization or company related to aviation, nature, or environmental conservation.

Public Health Service

AUG 1 8 2003

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

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

Re: K032131

· Trade/Device Name: BD Phoenix™ Automated Microbiology Systems Tetracyline (0.5-16 ug/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: July 10, 2003 Received: July 11, 2003

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 vour 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).

{4}------------------------------------------------

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). 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/cdrh/dsma/dsmamain.html.

Sincerely yours.

Steven Sutman

Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

{5}------------------------------------------------

Page 1_of 1

510(k) Number: 4032131

Device Name: BD Phoenix™ Automated Microbiology System for use with the antimicrobial agent tetracycline (0.5-16 ug/mL) - Gram positive ID/AST or AST only Phoenix panels.

Indications for Use:

Active In Vitro and in Clinical Infections Against:

Staphylococcus aureus

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

Concurrence of CDRH, Office of Device Evaluation (ODE) Division Sign-Office of In Vitro Diagnostic Device Evaluation and Safety Prescription Use Over-the-Counter Use (Per 21 CFR 801.109) KO32131 510(k) BD Diagnostic Systems Becton, Dickinson and Company

Page 9

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.”