BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-CEFEPIME (GN) 0.5-65 UG/ML

K032675 · Becton, Dickinson & CO · LON · Mar 1, 2004 · Microbiology

Device Facts

• Record ID: K032675
• Device Name: BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-CEFEPIME (GN) 0.5-65 UG/ML
• Applicant: Becton, Dickinson & CO
• Product Code: LON · Microbiology
• Decision Date: Mar 1, 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 in vitro quantitative determination of antimicrobial susceptibility by minimal inhibitory concentration of gram-negative aerobic and facultative anaerobic bacteria belonging to the family Enterobacteriaceae and Non-Enterobacteriaceae and gram-positive bacteria belonging to the genera Staphylococcus and Enterococcus. The BD Phoenix™ GN Panel: The BD Phoenix™ Automated Microbiology System is intended for the in vitro rapid identification (ID) and quantitative determination of antimicrobial susceptibility by minimal inhibitory concentration (MIC) of gram negative aerobic and facultative anaerobic bacteria belonging to the family Enterobacteriaceae and non-Enterobacteriaceae.

Device Story

System performs automated antimicrobial susceptibility testing (AST) and identification (ID) of bacterial isolates. Input: pure bacterial culture suspended in broth, equated to 0.5 McFarland standard. Process: broth microdilution in molded polystyrene trays containing dried reagents and redox indicator; continuous incubation at 35°C; automated optical monitoring of color change (blue to pink/colorless) indicating growth vs. inhibition. Output: MIC values and category interpretations (S/I/R). Used in clinical microbiology laboratories; operated by laboratory technicians. Software-driven 'EXPERT' system interprets reactions based on NCCLS rules. Benefits: rapid, automated determination of antibiotic susceptibility to guide clinical treatment decisions.

Clinical Evidence

Bench testing only. Performance of the BD Phoenix system with cefepime was evaluated by comparing MIC results to a reference method using clinical and challenge isolates. No clinical trial data provided.

Technological Characteristics

Automated microbiology system for ID/AST. Uses disposable panels containing biochemicals and antimicrobial agents (cefepime 0.5-64 ug/mL). Employs growth-based detection using an AST indicator solution. System is networked/integrated with proprietary software for data analysis and reporting. Sterilization method not specified.

Indications for Use

Indicated for in vitro rapid identification and quantitative antimicrobial susceptibility testing (MIC) of gram-negative aerobic and facultative anaerobic bacteria (Enterobacteriaceae and non-Enterobacteriaceae) and gram-positive bacteria (Staphylococcus and Enterococcus). Prescription use only. Proteus species 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 (N50510)

Submission Summary (Full Text)

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# 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: | Monica Evelyn Giguere<br>Regulatory Affairs Specialist |
| DATE PREPARED: | February 23, 2004 |
| DEVICE TRADE NAME: | BD Phoenix ^TM Automated Microbiology System -<br>Cefepime 0.5-64 \[mu]g/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 ^TM<br>Automated Microbiology System with Gatifloxacin<br>(K020321, May 23, 2002), Ofloxacin (K020323, April 14,<br>2002), and Levofloxacin (K020322, March 27, 2002). |
| INTENDED USE: | The BD Phoenix ^TM Automated Microbiology System is<br>intended for the rapid identification and <i>in vitro</i> 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.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wing. The eagle is facing to the right. 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

MAR - 1 2004

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

k032675 Re:

Trade/Device Name: BD Phoenix"14 Automated Microbiology Systems Cefepime (0.5-64 ug/mL) - Gram-Negative ID/AST 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: February 23, 2004 Received: February 24, 2004

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 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). 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,

Saqartys

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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510(k) Number: K032675

Device Name: BD Phoenix™ Automated Microbiology System for use with the antimicrobial agent cefepine (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 cefepime at concentrations of 0.5-64 ug/mL to gram-negative ID/AST or AST only Phoenix panels. Cefepime 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:

Enterobacter species Escherichia coli Klebsiella pneumoniae Pseudomonas aeruginosa

#### Active In Vitro Against:

- Acinetobacter lwoffi Citrobacter koseri Citrobacter freundii Hafnia alvei Klebsiella oxytoca Morganella morganii
Pantoea agglomerans Providencia rettgeri Providencia stuartii Serratia marcescens

Prescription Use
(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) h Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

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10(k) KO 32675