BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-MEROPENEM (STREP) 0.03125-2 UG/ML

K050946 · Becton, Dickinson & CO · LON · May 27, 2005 · Microbiology

Device Facts

• Record ID: K050946
• Device Name: BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-MEROPENEM (STREP) 0.03125-2 UG/ML
• Applicant: Becton, Dickinson & CO
• Product Code: LON · Microbiology
• Decision Date: May 27, 2005
• 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

System performs automated antimicrobial susceptibility testing (AST) for Streptococcus species; utilizes sealed, self-inoculating polystyrene trays with 136 micro-wells containing dried reagents. Input: pure culture bacterial isolates suspended in AST-S broth (cation-adjusted, non-blood, with redox indicator). Process: instrument incubates panels at 35°C; monitors colorimetric oxidation-reduction of indicator via optical scanning every 20 minutes; growth in presence of antibiotic prevents indicator reduction (no color change), while growth without antibiotic reduces indicator (blue to colorless). Output: MIC values and categorical interpretations (SIR). Software-driven 'EXPERT' system applies CLSI-derived rules to interpret results. Used in clinical microbiology laboratories; operated by trained technicians. Benefits: rapid, automated determination of antibiotic susceptibility to guide clinical treatment decisions.

Clinical Evidence

Bench testing only. Performance evaluated across four sites using 1,558 clinical and challenge isolates of Streptococcus spp. Primary endpoints: Essential Agreement (EA) and Category Agreement (CA) compared to CLSI broth dilution reference method. Combined results: 97% EA, 99.4% CA. Very major discrepancy (vmj) rate was 0%. Reproducibility study (24 isolates) demonstrated >95% reproducibility. QC testing performed using S. pneumoniae ATCC 49619, showing results within expected CLSI ranges.

Technological Characteristics

Automated microbiology system; molded polystyrene panels (136 wells); redox indicator for growth detection; continuous incubation at 35°C; optical reading every 20 minutes. Software-based interpretation of MIC and susceptibility categories. Standalone instrument.

Indications for Use

Indicated for testing Streptococcus pneumoniae (excluding penicillin-resistant strains) and Viridans group streptococci using meropenem at concentrations of 0.0313 - 2 µg/mL. For 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)

Submission Summary (Full Text)

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# Koso946

# 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: | Linda Dillon,<br>R&D Manager, Pasco Laboratories |
| DATE PREPARED: | April 12, 2005 |
| DEVICE TRADE NAME: | BD Phoenix™ Automated Microbiology System –<br>Meropenem 0.0313-2 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 <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. 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 tray with 136 micro-wells containing dried reagents. Organisms for susceptibility testing must be a pure culture and containing driver organisme or Gram-negative or Gram-positive isolate. For each isolate, an inoculation 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. Indicator for the deterative of 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℃. 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 streptoccal 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 Clinical, stock and chances were mance of the Phoenix antimicrobial susceptibility test with the Streptococcus Phoenix Panel format containing this antimicrobial agent. Phoenix System results the or eprococcas i noums i and romand 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 The portomation of the I novement of the more results for all isolates tested. Essential Agreement Category HEFORMER (OT) To enform Automated Microbiology System agrees exactly or within ± (DA) occurs within to the reference result. Category Agreement (CA) occurs when the BD ono two 1016 unanced Microbiology System agrees with the reference method with respect to the I hoomize - racentated retire (susceptible, intermediate, resistant or nonsusceptible).

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

#### Performance of BD Phoenix System for Streptococcal Organisms by Drug Table 1:

| Antimicrobial | production of the controlled on the comments of the comments of the comments of the comments of the consisted on the consisted on the consistence of the consisted on the cons<br>Concentration | EA (n)<br>was were would the state of the comments of the first and and the bearing the first and | 12 . 1 . 1<br>EA (%)<br>THE REAL PROPERTY CONTRACT CONTRACT CONTRACT CONTRACT CONTRACT CONTRACT CONTRACT CONTRACT CARATION CONTRACT CONTRACT CONTRACT CONTRACT CONTRACT CARATING CONTRACT CARATING CAR | CA (n)<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | CA (%)<br>The Real Property of Children a more a more a |
|------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------|
| The First of Children of Children American Comments of Children Comments of<br>A - For For Act Accomments of Concession - For Portuge<br> Meropenem | The program and the commend of the comments of the comments of the country of the country of the count<br>0.0313-2 ug/mL | 1935 | 1 07 2<br>1 | 1935 | 05 3<br>- - - |

#### 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 MEROPENEM Available Range 0.0313-2 µg/mL

#### Performance

#### Accuracy

| and the comments of the comments of the comments of the many of the many of the many of the many of the many of the many of the many of the many of the many of the many of th<br>Antimicrobial | Concentration<br>and and the many of the country of the country of the county of the<br>THE CHILING OF CHILIFORNIA CONSULTION COLLEGIONAL CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CON | EA (n)<br>The first and the country of the county of the county of the county of the county of the county of the county of the county of the county of the county of the county of the c | A BRICH THE FOR WALL<br><br>EA (%)<br>Status and Children and Children and Children the States of the Sunday of | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>CA (n) | CA (%) |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------|
| Comments of the Research and Children and Children<br>A<br>Meropenem | 0.0313-2 ug/mL* | 1035<br>ﻟﻤﺴﺎﺣﺔ ﺍﻟﻤﺴﺎﺣﺔ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮ | . 07 ?<br>ﮐﺴﻪ » ﺍ | 1025<br>11/2/ | 05 ?<br>ل ه ه له له |

#### Reproducibility

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

#### Breakpoints - CLSI

| Organism | S | I | R |
|---------------------------------------------------------------------------|-------------|-----|----------|
| <i>Streptococcus pneumoniae</i> | $\leq$ 0.25 | 0.5 | $\geq$ 1 |
| <i>Streptococcus</i> spp. Other than<br><i>Streptococcus pneumoniae</i> * | $\leq$ 0.5 | -- | -- |

*Per CLSI Performance Standards for Antimicrobial Susceptibility Testing: Fifteenth Informational Supplement, M100-S15, January 2005, in Table 2H for Streptococcus species other than Streptococcus pneumoniae, under Comment 5, the following statement appears describing meropenem breakpoints for Streptococcus species other than Streptococcus pneumoniae: "For some organism/antimicrobial agent combinations, the absence of resistant strains precludes defining any results categories other than 'susceptible'. For strains yielding results suggestive of a 'nonsusceptible' category, organism identification and antimicrobial susceptibility test results should be confirmed."

#### Recommended Quality Control Organisms

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

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Image /page/4/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal features a stylized eagle with three lines representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.

MAY 2 7 2005

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Linda K. Dillon R&D Manager, Pasco Laboratories BD Diagnostics Systems Becton, Dickinson and Company 7 Loveton Circle Sparks, MD 21152

k050946 Re: Trade/Device Name: BD Phoenix™ Automated Microbiology System Meropenem (0.0313-2 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: April 12, 2005 Received: April 15, 2005

Dear Ms. Dillon:

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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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 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/industry/support/index.html

Sincerely yours.

Sales, a Hogg

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: KC50946

Device Name: BD Phoenix™ Automated Microbiology System for use with the antimicrobial agent meropenem (0.0313-2 ug/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 meropenem at concentrations of 0.0313-2 µg/mL to Streptococcus ID/AST or AST only Phoenix panels. Meropenem 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 pneumoniae (excluding penicillin-resistant strains) Viridans group streptococci

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)


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| BD Diagnostic Systems<br>Becton, Dickinson and Company | 510(k) Page 9 K050946 |
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