BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEN - TICARCILLIN-CLAVULANATE (GN) 1/2 - 128/2UG/ML

K062687 · Becton, Dickinson & CO · LON · Oct 24, 2006 · Microbiology

Device Facts

• Record ID: K062687
• Device Name: BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEN - TICARCILLIN-CLAVULANATE (GN) 1/2 - 128/2UG/ML
• Applicant: Becton, Dickinson & CO
• Product Code: LON · Microbiology
• Decision Date: Oct 24, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.1645
• Device Class: Class 2

Intended Use

Ticarcillin/clavulanate at 1/2 – 128/2 µg/mL on the Gram Negative (GN) ID/AST or AST only Phoenix panels is intended for use with the BD Phoenix Automated Microbiology System 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, Enterococcus, and Streptococcus.

Device Story

BD Phoenix System performs automated identification and antimicrobial susceptibility testing (AST) of bacterial isolates. Input: pure culture bacterial isolates inoculated into molded polystyrene panels containing biochemicals and antimicrobial agents. Operation: panels incubated at 35°C; instrument performs continuous monitoring via redox indicator and turbidity measurements every 20 minutes. Output: MIC values and categorical interpretations (S, I, R). Used in clinical microbiology laboratories by trained personnel. Results assist clinicians in selecting appropriate antimicrobial therapy for patients with bacterial infections.

Clinical Evidence

Performance evaluated using clinical and challenge isolates across multiple U.S. sites. Results compared to CLSI reference broth microdilution method. Metrics included Essential Agreement (EA) and Category Agreement (CA). Data demonstrated substantial equivalence for ticarcillin/clavulanate testing in Gram-negative panels, including expanded organism claims for Pseudomonas species and Stenotrophomonas maltophilia.

Technological Characteristics

Broth-based microdilution AST system. Materials: molded polystyrene trays. Sensing: colorimetric oxidation-reduction redox indicator. Energy: 35°C incubation. Connectivity: barcode scanning, automated instrument reading. Software: EXPERT system rule-based interpretation. Sterilization: not specified.

Indications for Use

Indicated for ticarcillin/clavulanate susceptibility testing of Gram-negative aerobic/facultative anaerobic bacteria (Enterobacteriaceae, non-Enterobacteriaceae) and Gram-positive bacteria (Staphylococcus, Enterococcus, Streptococcus) from pure culture. Prescription use only.

Regulatory Classification

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.

Special Controls

*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.”

Predicate Devices

• VITEK® System (PMA No. N50510)
• BD Phoenix™ Automated Microbiology System with Gatifloxacin (K020321)
• BD Phoenix™ Automated Microbiology System with Ofloxacin (K020323)
• BD Phoenix™ Automated Microbiology System with Levofloxacin (K020322)
• BD Phoenix™ Automated Microbiology System with Ticarcillin/clavulanate (K033557)

Submission Summary (Full Text)

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# 510(K) SUMMARY

OCT 2 4 2006

| SUBMITTED BY: | Becton, Dickinson and Company<br>7 Loveton Circle<br>Sparks, MD 21152<br>Phone: [phone]<br>Fax: [phone] |
|------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| CONTACT NAME: | Janine Matlak<br>Regulatory Affairs Specialist |
| DATE PREPARED: | October 23, 2006 |
| DEVICE TRADE NAME: | BD Phoenix™ Automated Microbiology System -<br>Ticarcillin/clavulanate 1/2 - 128/2 µg/mL |
| DEVICE COMMON NAME: | Antimicrobial susceptibility test system-short incubation |
| DEVICE CLASSIFICATION: | Fully Automated Short-Term Incubation Cycle Antimicrobial<br>Susceptibility Device, 21 CFR 866.1645 |
| PREDICATE DEVICES: | VITEK® System (PMA No. N50510) and BD Phoenix™<br>Automated Microbiology System with Gatifloxacin (K020321<br>May 23, 2002), Ofloxacin (K020323, April 14, 2002), and<br>Levofloxacin (K020322, March 27, 2002). |
| INTENDED USE: | The BD Phoenix™ Automated Microbiology System is<br>intended for the rapid identification and in vitro antimicrobial<br>susceptibility testing of isolates from pure culture of most<br>aerobic and facultative anaerobic Gram-negative and Gram-<br>positive bacteria of human origin. |

#### 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 for 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.

BD Diagnostic Systems Becton, Dickinson and Company

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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 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 in the instrument.

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).

# 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 for additional organism groups and the removal of the limitations for Pseudomonas species and Stenotrophomonas maltophilia.

### 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", February 5, 2003.

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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-negative 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, and resistant).

Table 1 summarizes the performance for the isolates tested in this study.

#### Table 1: Performance of BD Phoenix System for Gram-Negative Organisms by Drug

| Antimicrobial<br>Confinitial control contribution to the first to the fiction and a real a seas of a real a | oncentration | Comments of the promote of the count of the charge of the charges of the closed on the program and proposes of the program and proportion of the program and proportion of the | 5 | 1 79 | 01 |
|-------------------------------------------------------------------------------------------------------------|------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---|------|----|
| icarcillin/clavulanate | 190/7<br>(<br>11/11/11 | | C | | OC |

#### 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 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), and with Ticarcillin/clavulanate (K033557, January 14, 2004).

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with its wings spread, and three horizontal bars below it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Janine Matlak BD Diagnostic Systems Becton, Dickinson and Company 7 Loveton Circle Sparks. Maryland 21152

OCT 2 4 2006

Re: k062687 Trade/Device Name: BD PhoenixTM Automated Microbiology System -Ticarcillin/clavulanate 1/2 - 128/2 ug/mL Regulation Number: 21 CFR & 866.1645 Regulation Name: Antimicrobial susceptibility test short incubation Regulatory Class: II Product Code: LON Dated: September 7, 2006 Received: September 8, 2006

Dear Ms. Matlak:

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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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 [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours.

Sally artman

Sally A. Hoivat. 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: _K0626 87

Device Name: BD Phoenix™ Automated Microbiology System for use with the antimicrobial agent ticarcillin/clavulanate (1/2 - 128/2 ug/mL) - Gram-Negative ID/AST or AST only Phoenix panels with additional organisms and the removal of the limitations for Pseudomonas species and Stenotrophomonas maltophilia.

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-Enterobacteriaceae and most Gram-positive bacteria isolates from pure culture belonging to the genera Staphylococcus, Enterococcus and Streptococcus.

This premarket notification is for ticarcillin/clavulanate at concentrations of 1/2 - 128/2 µg/mL to Gramnegative ID/AST or AST only Phoenix panels with additional organisms and the removal of the limitations for Pseudomonas species and Stenotrophomonas maltophilia. Ticarcillin/clavulanate has been shown to be active in vitro against most strains of microorganisms listed below, as described in the FDAapproved package insert for this antimicrobial agent.

#### Active In Vitro and in Clinical Infections Against:

| (both β-lactamase producing and non β-lactamase producing): | | |
|-------------------------------------------------------------|----------------------|------------------------------|
| Citrobacter species | Escherichia coli | Pseudomonas species |
| Enterobacter species | Klebsiella species | Serratia marcescens |
| Active In Vitro Against: | | |
| (both β-lactamase producing and non β-lactamase producing): | | |
| Acinetobacter baumannii | Morganella morgannii | Providencia rettgeri |
| Acinetobacter calcoaceticus | Proteus mirabilis | Providencia stuartii |
| Acinetobacter haemolyticus | Proteus penneri | Stenotrophomonas maltophilia |
| Acinetobacter lwoffi | Proteus vulgaris | |
| Prescription Use √ | | Over-the-Counter Use |

(Per 21 CFR 801.109)

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

| Concurrence of CDRH, Office of Device Evaluation (ODE) |
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Freddie M. Cole
Division Sign-OffOffice of In Vitro Diagnostic Device Evaluation and Safety

BD Diagnostic Systems 510(k) K062687
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