BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFTAZIDIME - GRAM NEGATIVE

K041384 · Becton, Dickinson & CO · LON · Aug 3, 2004 · Microbiology

Device Facts

• Record ID: K041384
• Device Name: BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFTAZIDIME - GRAM NEGATIVE
• Applicant: Becton, Dickinson & CO
• Product Code: LON · Microbiology
• Decision Date: Aug 3, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.1645
• Device Class: Class 2

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.

Device Story

The BD Phoenix System is an automated microbiology platform for antimicrobial susceptibility testing (AST) of bacterial isolates. The system uses molded polystyrene panels containing dried antimicrobial agents and growth indicators. Input consists of a pure bacterial culture inoculum (0.5 McFarland standard) prepared in Phoenix broth. The instrument continuously incubates panels and performs optical measurements every 20 minutes using a redox indicator to detect bacterial growth via turbidity changes. The system interprets these measurements to determine the Minimum Inhibitory Concentration (MIC) and categorical results (S, I, or R). Used in clinical microbiology laboratories by trained technicians. The output provides clinicians with susceptibility data to guide antibiotic therapy, potentially improving patient outcomes by enabling targeted treatment.

Clinical Evidence

Performance evaluated via method comparison against NCCLS broth dilution reference panels. Study included 1,707 clinical isolates and 130 challenge isolates (total 1,837). Combined results showed 96.5% Essential Agreement (EA) and 94.3% Category Agreement (CA). Very major discrepancy rate was 9/410 (2.2%). Reproducibility testing across three sites demonstrated >95% reproducibility. Quality control testing using ATCC strains (E. coli 25922, P. aeruginosa 27853, P. aeruginosa 35032) confirmed system performance within recommended ranges.

Technological Characteristics

Automated colorimetric oxidation-reduction growth-based system. Uses 136-well molded polystyrene trays with dried reagents. AST broth is cation-adjusted Mueller-Hinton with 0.01% Tween 80 and redox indicator. Incubation at 35°C. Connectivity: automated instrument with barcode scanning. Software: rule-based 'EXPERT' system using NCCLS standards. Dimensions/form factor: micro-well tray format.

Indications for Use

Indicated for in vitro rapid identification and quantitative antimicrobial susceptibility testing (MIC) of gram-negative aerobic and facultative anaerobic bacteria, including Pseudomonas aeruginosa, in the family Enterobacteriaceae and non-Enterobacteriaceae. Prescription use only. Results for Citrobacter freundii and Stenotrophomonas maltophilia are excluded.

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 Ceftazidime (K033560)

Submission Summary (Full Text)

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| Ceftazidime - GN | K041384 |
|------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| AUG - 3 2004 | 510(K) SUMMARY |
| SUBMITTED BY: | Becton, Dickinson and Company<br>7 Loveton Circle<br>Sparks, MD 21152<br>Phone: [phone]<br>Fax: [phone] |
| CONTACT NAME: | Michelle Bytheway Bandy<br>Regulatory Affairs Specialist |
| DATE PREPARED: | May 21, 2004 |
| DEVICE TRADE NAME: | BD Phoenix™ Automated Microbiology System -<br>Ceftazidime 0.5-64 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),<br>Levofloxacin (K020322, March 27, 2002) and Ceftazidime<br>(K033560, January 15, 2004). |
| 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 TIF BD I nochiatod Microbial susceptibility testing (AST) of clinically relevant bacterial isolates. The system includes the following components:

- BD Phoenix instrument and software. .
- DD Phoenix markinen wining biochemicals for organism ID testing and antimicrobial agents . for AST determinations.
- 107 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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The Phoenix panel is a sealed and self-inoculating molded polystyrene tray with 136 micro-wells THE I nooms panel is a scaree and best for susceptibility testing must be a pure culture and comating dried reagents. Organisms for sasoppany was a solate. For each isolate, an inoculation premixalent 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 I he I nochis 11:51 methou is a crown a growth in the presence of an antimicrobial agent. multicalor for the detection of organism growards as bacterial turbidity are used in the determination Measureinents of Changes to the maneconfiguration 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 I he instrument nouses the panels who of the panels every 20 minutes. The readings are interpreted to give an identification of the isolate, minum 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 NCCLS reference broth microdilution method. This premarket performance when somparting the use of the BD Phoenix™ Automated Microbiology System notification provides and beppendly 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 performance when computed to the NO NO evaluated as defined in the FDA guidance propared acconding to NOODS Mr.). Cuidance Document: Antimicrobial Susceptibility Test (AST) Systems, Guidance for Industry and FDA', February 5, 2003.

## Site Reproducibility

Intra- and inter-site reproducibility of this antimicrobial agent in the BD Phoenix System was millia- and micr one repression of gram-negative isolates. Each site tested the isolates in evaluated at three different days using one lot of gram-negative 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 The results of the starf attem 90% and an overall inter-site reproducibility greater than 95% for the gram-negative isolates tested.

#### BD Diagnostic Systems Becton, Dickinson and Company

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## Clinical Studies

Clinical, stock and challenge isolates were tested across multiple geographically diverse sites across Chined, stock and chance the performance of the Phoenix antimicrobial susceptibility test with the United States to demonstrate the percentaining this antimicrobial agent. Phoenix System results the gran-hegan've i noomix panel 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 The percentialied of the Photomic byted/reference results for all isolates tested. Essential Agreement Category Tigroument (CT) Abomated Microbiology System agrees exactly or within ± (EA) occurs when are as e 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.

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

| And States of Children Company of Children Company of Children Company of Children<br>THE LEAST LE LEASE LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST<br>Antimicrobial | - Manager of Children<br>Comprehensive Adon't Research Active Comments of Children Comments of Children<br>Acres Property<br>Concentration | 5<br>r | 101 | n | 10/0 .<br>( |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------|--------|-----|------|-------------|
| - PA-<br>1<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>Ceftazidime | ug/ml<br>rs/ | ์ | 40 | 1706 | 04 4 |

### Conclusions Drawn from Substantial Equivalence Studies

The data collected from the substantial equivalence studies demonstrate that testing on the BD The una concesse non are abology System with this antimicrobial agent is substantially equivalent as outlined in the FDA guidance document, "Class II Special Controls Guidance Document: as outined in the coptibility 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), Offloxacin (K020323, April 14, 2002), Levofloxacin (K020322, March 27, 2002) and Ceftazidime (K033560).

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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 curved lines representing its body and wings. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.

Public Health Service

ood and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Michelle Bytheway Bandy Regulatory Affairs Specialist Becton, Dickinson and Company 7 Loveton Circle Sparks, MD 21152

k041384 Re: Ko 1156 .
Trade/Device Name: BD Phoenix™ Automated Microbiology System for use with the antimicrobial agent ceftazidime (0.5-64 µg/mL.) -Gram-Negative 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: May 24, 2004 Received: May 25, 2004

AUG - 3 2004

Dear Ms. Bandy:

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 for are waver 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 or any 1 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). 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Salazar

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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BD PHOENIX™ Automated Microbiology System Ceftazidime - GN

Page 1 of 1

510(k) Number: K041384

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Device Name: BD Phoenix™ Automated Microbiology System for use with the antimicrobial agent ceftazidime (0.5-64 ug/mL) - Gram-Negative 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-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 ceftazidime at concentrations of

0.5-64 µg/mL to gram-negative ID/AST or AST only Phoenix panels. Ceftazidime 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:

Citrobacter spp., excluding Citrobacter freundii Enterobacter spp., including Enterobacter cloacae, and Enterobacter aerogenes Escherichia coli

Klebsiella spp., including Klebsiella pneumoniae Proteus mirabilis Proteus vulgaris Pseudomonas spp., including Pseudomonas aeruginosa Serratia spp.

Prescription Use V (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)

Jals
Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

KC4 1354 ---------------------------------------------------------------------------------------------------------------------------------------------------------------------510(k) ... .

BD Diagnostic Systems Becton, Dickinson and Company