BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - MOXIFLOXACIN (STREP) 0.0625 - 8UG/ML

K062206 · Becton, Dickinson & CO · LON · Sep 8, 2006 · Microbiology

Device Facts

• Record ID: K062206
• Device Name: BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - MOXIFLOXACIN (STREP) 0.0625 - 8UG/ML
• Applicant: Becton, Dickinson & CO
• Product Code: LON · Microbiology
• Decision Date: Sep 8, 2006
• 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 (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. System uses sealed, self-inoculating polystyrene panels with 136 micro-wells containing dried biochemicals and antimicrobial agents. Inoculum prepared to 0.5 McFarland standard in broth. Instrument continuously incubates panels at 35°C; takes optical readings every 20 minutes. System utilizes redox indicator and turbidity measurements to detect bacterial growth in presence of antimicrobial agents. Software interprets growth data to provide MIC values and categorical interpretations (S, I, R, N). Used in clinical microbiology laboratories by trained technicians. Output assists clinicians in selecting appropriate antibiotic therapy for patients with bacterial infections.

Clinical Evidence

Performance evaluated via clinical, stock, and challenge isolates compared to CLSI reference broth microdilution method. Study assessed Essential Agreement (EA) and Category Agreement (CA). Reproducibility testing at three sites showed >90% intra-site and >95% inter-site reproducibility. Results demonstrate substantial equivalence to reference methods.

Technological Characteristics

Automated microbiology system; polystyrene panels with 136 micro-wells; redox indicator for growth detection; turbidity measurement; continuous incubation at 35°C; automated optical reading every 20 minutes; software-based interpretation of MIC and categorical results.

Indications for Use

Indicated for in vitro quantitative MIC determination of antimicrobial susceptibility for Gram-negative and Gram-positive bacteria (Staphylococcus, Enterococcus, Streptococcus) from pure culture. Specifically supports addition of moxifloxacin (0.0625-8 µg/mL) for Streptococcus species including S. anginosus, S. constellatus, S. pneumoniae (including MDRSP), S. pyogenes, S. agalactiae, and S. viridans group.

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)
• BD Phoenix™ Automated Microbiology System with Gatifloxacin (K020321)
• BD Phoenix™ Automated Microbiology System with Ofloxacin (K020323)
• BD Phoenix™ Automated Microbiology System with Levofloxacin (K020322)

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] | SEP - 8 2006 |
|------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| CONTACT NAME: | Janine Matlak,<br>RA Specialist | |
| DATE PREPARED: | July 31, 2006 | |
| DEVICE TRADE NAME: | BD Phoenix™ Automated Microbiology System --<br>Moxifloxacin 0.0625-8 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. 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.

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The Phoenix panel is a sealed and self-inoculating molded polystyrene trav 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).

### 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 NCCLS M7). The system has been evaluated as defined in the FDA Draft guidance document, "Class II Special Controls Guidance 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 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 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 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

| Antimicrobia<br>Partified on the state the first for the first for the first for the first for any the | A COLLECT AND A COLLEGION COLUMN COLLEGION COLLEGION<br>Concentration<br>1 11 1 | and and the comments of the first of the first of the first of the first and<br>11<br>---------------------------------------------------------------------------------- | ਦ | 10<br>- A | 1<br>0<br>C |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| <br>Moxitloxacın<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | 0 0625-<br>10/m | 1050<br>A M | And Concession Comments of Children<br>t Children Charles Charles Children Charles (Children) (Children) (Children) (Children) (Children) (Children) (Children) (Children) (Children) (Children) (Children) (Children<br>.<br>STATUS AND THE WORLD CONSULT AND THE CONTRACT CONTRACT CARTER OF CHARGE OF CHART CONTRACT CARTER OF CHART CONTRACT CARTER OF CHART CONTRACT CARTER OF CHARGE OF CHART CONTRACT | 1050<br>. | 00<br>ﻣﺘﺎ ﮨﮯ ﮐﮧ ﻣﯿﮟ ﻣﯿﮟ ﻣﯿﮟ ﺍﻭﺭ ﺍﺱ ﮐﮯ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍ |

#### 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," 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), Ofloxacin (K020323, April 14, 2002), and Levofloxacin (K020322, March 27, 2002).

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## SUMMARY INFORMATION FOR MOXIFLOXACIN Available Range 0.0625-8 µg/mL

#### Performance

#### Accuracy

| .<br>Antimicrobial<br>And would considered the The Art the Production of the Production of the Comments of Children | CART THE CARRENT MICH MICH MICH MILLERS COLLECT CARDED MILL BELL BELL BELL BELL BELL BELL BELL BELL BELL BELL BELL BELL BELL BELL BELL BELL BELL BELL BELL BELL BELL BELL BELL<br>Concentration | The Court of the first of the first of the first of the first of the first of the first the first the first the first the first the first the first the first the first the fi | AND A BOLL CONSULT OF CHART OF CHILIP OF CHILING<br>C | STATUTE AND THE OWNER OF CHARACT AND THE FORCESS OF CHARGE OF CHARGE OF CHARGE OF CHARGE OF CHARGE OF CHARGE OF CHARGE OF CHARGE OF CHARGE OF CHARGE OF CHARGE OF CHARGE OF CH | The County of Children of Children Comments of Children Comments of Children Comments of Children<br>1 |
|---------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------|
| Moxifloxacır | . 0675<br>and and and and the commend of the commend of the comments of the comments of the comments of the comments of the comments of the comments of the comments of the comments of<br>to of Address and a minimal and commended on the manufactures of the more of the more of the more of the management | . ೧೯೯<br>11/11 | ( | 1050<br>" " " "<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | 00 |

#### Reproducibility

Testing performed at multiple clinical sites demonstrated 95% reproducibility or greater within ± 1 dilution.

#### Breakpoints

| Organism | S | I | R | Source |
|-------------------------------------------------------------------------|------|-----|------|-----------|
| <i>Streptococcus pneumoniae</i> | ≤1.0 | 2.0 | ≥4.0 | FDA, CLSI |
| <i>Streptococcus</i> spp. Other than<br><i>Streptococcus pneumoniae</i> | ≤1.0 | 2.0 | ≥4.0 | FDA |

#### Recommended Quality Control Organisms

| Quality Control Strain | MIC Range | Source |
|--------------------------------------------|-------------|-----------|
| <i>Streptococcus pneumoniae</i> ATCC 49619 | 0.06 – 0.25 | FDA, CLSI |
| | | |

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol on the right side. To the left of the symbol, the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular fashion.

#### Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

SEP - 8 2006

Ms. Janine Matlak R A Specialist BD Diagnostics Systems Becton, Dickinson and Company 7 Loveton Circle Sparks, MD 21152

Re: k062206

Trade/Device Name: BD Phoenix™ Automated Microbiology System Moxifloxacin (0.0625-8 µg/mL) - Streptococcus ID/AST or 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: July 31, 2006 Received: August 1, 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 vour 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, author

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: K Olz 2206

, ,

Device Name: BD Phoenix™ Automated Microbiology System for use with the antimicrobial agent moxifloxacin (0.0625-8 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-Enterobacteriaceae 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 moxifloxacin at concentrations of 0.0625-8 ug/mL to Streptococcus ID/AST or AST only Phoenix panels. Moxifloxacin 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 anginosus Streptococcus constellatus Streptococcus pneumoniae (including multi-drug resistant strains [MDRSP]) Streptococcus pyogenes

#### Active In Vitro Against:

Streptococcus agalactiae Streptococcus viridans group

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 Poole
Division Sign-Off

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

10(k) K0622Db

BD Diagnostic Systems Becton, Dickinson and Company

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