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 Grampositive bacteria of human origin.

This premarket notification is for the addition of the antimicrobial agent doxycycline at concentrations of (0.25 - 16 ug/mL) to Gram-positive ID/AST or AST only Phoenix panels. Doxycycline 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*

Doxycycline is not the drug of choice in the treatment of any type of staphylococcal infection.

Active In Vitro
Enterococcus group (Streptococcus faecalis and Streptococcus faecium)

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. Phoenix panels are inoculated with a specified organism density and placed into the instrument.

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 summary of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Device: BD Phoenix™ Automated Microbiology System - Doxycycline (0.25 - 16 ug/mL)

Intended Use: 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 specific submission adds Doxycycline (0.25 - 16 ug/mL) to Gram-positive ID/AST or AST only Phoenix panels.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (from FDA guidance)	Reported Device Performance (for this antimicrobial agent)
Site Reproducibility:
Intra-site reproducibility > 90%	Overall intra-site reproducibility > 90%
Inter-site reproducibility > 95%	Overall inter-site reproducibility > 95%
Clinical Studies (Performance vs. Reference Method):
Essential Agreement (EA) meets FDA guidance for AST systems	Achieved (Implicitly, as the study concluded substantial equivalence based on EA and CA)
Category Agreement (CA) meets FDA guidance for AST systems	Achieved (Implicitly, as the study concluded substantial equivalence based on EA and CA)

Note: The exact numerical thresholds for Essential Agreement (EA) and Category Agreement (CA) as stated in the FDA guidance document "Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems; Guidance for Industry and FDA", March 5, 2007, are not explicitly provided in this 510(k) summary but are understood to be the acceptance criteria. The document states that the system "has demonstrated substantially equivalent performance" based on these metrics.

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

Sample Size for Test Set:
- Site Reproducibility: A "panel of Gram-positive isolates" was tested. The exact number of isolates is not specified, but each isolate was tested in triplicate on three different days at each of three sites.
- Clinical Studies: "Clinical, stock and challenge isolates" were tested. The overall number of isolates (clinical, stock, and challenge combined) used for performance evaluation (EA and CA) is summarized in a table, but the specific breakdown is not provided. The table heading "e of RD Phoenix System for Gram-Positive Organisms by Drug" does not contain numbers, but implies that data was presented.
Data Provenance: "Multiple geographically diverse sites across the United States" for clinical studies. Retrospective/Prospective information is not explicitly stated, but "clinical isolates" usually refers to samples collected from patients, which can be either. "Stock and challenge isolates" are typically laboratory-maintained strains.

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

The document does not mention the use of experts to establish a "ground truth" through consensus for the test set. Instead, the ground truth for clinical isolates was established by comparison to the CLSI (formerly NCCLS) reference broth microdilution method. For challenge isolates, they were compared to "expected results," which would be predetermined ground truth for those specific strains.

4. Adjudication Method for the Test Set

No explicit adjudication method (like 2+1 or 3+1) is described. The device's results (MICs and category interpretations) were directly compared to the results from the CLSI reference broth microdilution method or "expected results" for challenge isolates. Discrepancies would be evaluated against the definitions of Essential Agreement and Category Agreement.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No Multi-Reader Multi-Case (MRMC) comparative effectiveness study was mentioned. This type of study is more common for imaging devices where human interpretation is a primary component. For an automated AST system, the focus is on the agreement with a standardized reference method rather than human improvement with assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance Study

Yes, the primary study described is a standalone performance evaluation. The BD Phoenix™ Automated Microbiology System's performance was assessed by comparing its automated results (MIC values and category interpretations) against a reference method (CLSI broth microdilution) or expected results, without human interpretation of the device's output influencing the direct comparison to the ground truth.

7. Type of Ground Truth Used

Clinical Isolates: CLSI (formerly NCCLS) reference broth microdilution method.
Challenge Isolates: "Expected results" (typically pre-established values for these known strains).

8. Sample Size for the Training Set

The document does not explicitly state the sample size for a "training set." This type of 510(k) summary focuses on the validation of the device's performance against a reference standard, not necessarily on detailing the development or training of the internal algorithms. The system likely uses established algorithms and breakpoints, and the studies described are for validation of the performance with the new antimicrobial agent.

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

As no specific training set size is mentioned, the method for establishing its ground truth is also not detailed. However, for such a system, the underlying algorithms for interpreting growth and determining MICs would have been developed and "trained" using extensive datasets of known isolates with their corresponding reference method results, likely following CLSI guidelines.

Summary

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082913

510(k) SUMMARY

SUBMITTED BY:

Becton, Dickinson and Company 7 Loveton Circle Sparks, MD 21152 Phone: 410-316-4161 410-316-4499 Fax:

Vicki K. Whitley Regulatory Affairs Specialist

September 29, 2008

DATE PREPARED:

CONTACT NAME:

DEVICE TRADE NAME:

DEVICE COMMON NAME:

DEVICE CLASSIFICATION:

PREDICATE DEVICES:

INTENDED USE:

BD Phoenix™ Automated Microbiology System -Doxycycline (0.25 - 16 ug/mL)

Antimicrobial susceptibility test system-short incubation

Fully Automated Short-Term Incubation Cycle Antimicrobial Susceptibility Device, 21 CFR 866.1645

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, March 27, 2002).

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. .

DEC 0 5 2008

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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. Phoenix panels are inoculated with a specified organism density and placed into the instrument.

DEVICE COMPARISON:

The BD Phoenix™ Automated Microbiology System demonstrated substantially equivalent performance when compared with the CLSI (formerly 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 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: Antimicrobial 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 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.

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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 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 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).

The following table summarizes the performance for the isolates tested in this study.

T CT ASS WITH THE THE T THE TITUTION COLORES TO CONNELL COLLECT OF CHIEFFECT	------------------------------------------------------------------------------------------------------------------------------------------------------------------------------	12.00 10.00

e of RD Phoenix System for Gram-Positive Organisms by Drug

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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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services, USA. The seal features a stylized eagle with outstretched wings, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" are arranged in a circular pattern around the eagle.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Vicki K. Whitley Regulatory Affairs Specialist BD Diagnostic System Becton, Dickinson and Company 7 Loveton Circle Sparks, MD 21152

DEC 0 5 2008

K082913 Re:

K062313
Trade/Device Name: BD Phoenix TM Automated Microbiology System- Doxycycline (GP) 0.25-16 ug/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 Device Regulatory Class: II Product Code: LON Dated: September 29, 2008 Received: September 30, 2008

Dear Ms. Whitley:

We have reviewed your Section 510(k) premarket notification of intent to market the device indication we nave reviewed your Security premained is substantially equivalent (for the indications ferenced above and have determined the as researced predicate devices marketed in interstate for use stated in the encrosule) to regary manetee to of the Medical Device American Food Devel Food Devel commerce proc to May 20, 1970, the exactines with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). and Cosment Act (Act) that to hot require approvil controls provisions of the Act. The Act. The You may, therefore, market the device, sucjeer to urements for annual registration, listing of general controls provisions of the rice, 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 classified (sec above) into existing major regulations affecting your device it may be subject to such additional controlial controls. "Datang increase on to 895. In addition, FDA can be found in Thic 21, Courserning 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 DA s issuated of a subscripties with other requirements of the Act that FDA has made a decemmanon administered by other Federal agencies. You must of ally Federal slatutes and regulations, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice CFK Part 807), labeling (21 OF N Fility 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 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: K082913

Device Name: BD Phoenix™ Automated Microbiology System for use with the antimicrobial agent doxycvcline (0.25 - 16 ug/mL) - Gram-positive 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 acrobic 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.

This premarket notification is for the addition of the antimicrobial agent doxycycline at concentrations of

(0.25 - 16 ug/mL) to Gram-positive ID/AST or AST only Phoenix panels. Doxycycline 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*

Doxycycline is not the drug of choice in the treatment of any type of staphylococcal infection.

Active In Vitro

Enterococcus group (Streptococcus faecalis and Streptococcus faecium)

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)

Vass
Division Sign-Off

Office of In Vitro Diagnostla Device Evaluation and Safety

510/k

BD Diagnostic Systems Becton, Dickinson and Company

Page 8

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.”