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.

This premarket notification is for the addition of the antimicrobial agent daptomycin at concentrations of 0.0313-16 ug/mL to Streptococcus ID/AST or AST only Phoenix panels. Daptomycin 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:

Streptococcus agalactiae Streptococcus dysgalactiae Streptococcus pyogenes

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 isolation 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 a breakdown of the acceptance criteria and study details based on the provided 510(k) summary:

Acceptance Criteria and Device Performance

The acceptance criteria for the BD Phoenix™ Automated Microbiology System for the antimicrobial agent daptomycin, when compared to the CLSI reference broth microdilution method, are based on Essential Agreement (EA) and Category Agreement (CA).

Performance Metric	Acceptance Criteria (Implicit)	Reported Device Performance (Table 1 - Incomplete)
Essential Agreement (EA)	Not explicitly stated, but typically ≥ 90.0%	Not explicitly stated in Table 1; a placeholder `(0)` and `11` are present.
Category Agreement (CA)	Not explicitly stated, but typically ≥ 90.0%	Not explicitly stated in Table 1; a placeholder `0/0` is present.
Intra-site Reproducibility	> 90%	> 90%
Inter-site Reproducibility	> 95%	> 95%

Note on Table 1: The provided Table 1 is incomplete and practically unreadable due to formatting issues and garbled text. It's impossible to extract the precise reported Essential Agreement and Category Agreement percentages for daptomycin from this table. However, the summary concludes that "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," implying that the acceptance criteria for EA and CA were met.

Study Details

2. Sample size used for the test set and the data provenance:

Test Set Sample Size: The document mentions "clinical, stock and challenge isolates were tested." No specific numbers are provided for the total test set. However, for reproducibility studies, a "panel of streptococcal isolates" was used.
Data Provenance: The studies were conducted "across multiple geographically diverse sites across the United States." This indicates prospective data collection.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Number of Experts: Not specified.
Qualifications of Experts: Not specified. The ground truth was established by comparing to the CLSI reference broth microdilution method, which is a standardized laboratory method, not typically relying on expert interpretation in the same way as, for example, image analysis.

4. Adjudication method for the test set:

Not applicable/Not specified. The comparison is between the device's quantitative MIC values and categorical interpretations and the CLSI reference method. There is no mention of human adjudication for discrepancies.

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:

No, an MRMC comparative effectiveness study was not done. This device is an automated system for antimicrobial susceptibility testing, not an AI-assisted diagnostic imaging or interpretation tool for human readers.

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

Yes, the study describes a standalone performance evaluation of the BD Phoenix™ Automated Microbiology System. The system automatically measures changes to an indicator and bacterial turbidity to determine MIC values and categorical interpretations. These results are then compared directly to the CLSI reference method. While human lab technicians operate the instrument and prepare samples, the interpretation and determination of susceptibility are automated by the device's algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

The ground truth was the CLSI (Clinical and Laboratory Standards Institute) reference broth microdilution method. This is a recognized gold standard laboratory method for determining antimicrobial susceptibility. For challenge set isolates, "expected results" were used, which would typically be predetermined MICs for control strains.

8. The sample size for the training set:

Not applicable/Not specified. This document describes a validation study for a specific antimicrobial agent (daptomycin) on an established automated system. The system's underlying algorithms would have been developed and "trained" previously using extensive data, but this specific submission does not detail the training set for the core Phoenix system or for the addition of this new agent.

9. How the ground truth for the training set was established:

Not applicable/Not specified, as no training set for this specific submission is detailed. For the development of the broader Phoenix system algorithms, the ground truth would have been established using reference methods like CLSI broth microdilution on a large scale.

Summary

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510(k) SUMMARY

K073589

SUBMITTED BY:	Becton, Dickinson and Company7 Loveton CircleSparks, MD 21152Phone: 410-316-4287Fax: 410-316-4499		MAR - 5 2007
CONTACT NAME:	Monica GiguereRA Specialist
DATE PREPARED:	December 19, 2007
DEVICE TRADE NAME:	BD Phoenix™ Automated Microbiology System -Daptomycin (0.0313-16 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 and K060324, May 25, 2006), Ofloxacin(K020323, April 14, 2002), and Levofloxacin (K020322, March27, 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 guidance document, "Class II Special Controls Guidance Document: Antimierobial Susceptibility Test (AST) Systems; Guidance for Industry and FDA", March 5, 2007.

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 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 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 PhoenixTM 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.

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

AntimicrobialThe was and the was and on an an an an an an an an an a manufacturer	ConcentrationCART A CLAIM CLAIM CLAIM AN AND AN A BREAK A LA BELLER A BEACH A CLAIM A CLAIM A CLAIM A CLAIM A CLAIM A CLAIM A CLAIM A CLAIM A CLAIM A CLAIM A CLAIM A CLAIM A CLAIM A CLAIM	nA	.(0)	11	AN ENTERNATION WANNES LAND LAND0/0
DaptomveinMARKETE LA BEREAL	20313-110/ml			---------------------------------------008	00 7

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," March 5, 2007. 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 and K060324, May 25, 2006), Ofloxacin (K020323, April 14, 2002), and Levofloxacin (K020322, March 27, 2002),

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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 to promote health, well-being, and human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

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

MAR - 5 2008

Re: K073589

Trade/Device Name: BD Phoenix™ Automated Microbiology System Daptomycin (0.03-16 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 Devices Regulatory Class: Class II Product Code: LON Dated: December 19, 2007 Received: December 20, 2007

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 udications 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, brug, 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 1 ... The general controls provisions of the Act include requirements for annual registration, insting of devices, good manufacturing practice, labeling, and prohibitions against misburanding 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 Begister.

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 Party 20).

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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 advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at 240-276-0450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html. .

Sincerely yours,

Sally attaym

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: K0735 89

Device Name: BD Phoenix™ Automated Microbiology System for use with the antimicrobial agent daptomycin (0.0313-16 µg/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 antimicrobial susceptibility by minimal inhibitory concentration (MIC) of most Gram-negative aerobic and facultative anaerobic bacteria isolates from pure culture for Enterobacteriaceae and Non-Enteriaceae and most Gram-positive bacteria isolates from pure culture belonging to the genera Staphylococcus , Enterococcus, and Streptococcus.

Active In Vitro and in Clinical Infections Against:

Streptococcus agalactiae Streptococcus dysgalactiae Streptococcus pyogenes

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)

Freddie L. Poole
Division Sign-Off

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

:10(k) K073589

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.”