BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-PHOENIX INDUCIBLE MACROLIDE RESISTANCE TEST

K082538 · Becton, Dickinson & CO · LON · Nov 20, 2008 · Microbiology

Device Facts

• Record ID: K082538
• Device Name: BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-PHOENIX INDUCIBLE MACROLIDE RESISTANCE TEST
• Applicant: Becton, Dickinson & CO
• Product Code: LON · Microbiology
• Decision Date: Nov 20, 2008
• 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 in vitro rapid identification (ID) of gram positive bacteria from pure culture belonging to the genera Staphylococcus, Enterococcus, other gram positive cocci and gram positive bacilli. The BD Phoenix™ Automated Microbiology System is also intended for the quantitative determination of antimicrobial susceptibility by minimal inhibitory concentration (MIC) of most gram positive bacterial isolates from pure culture belonging to the genera Staphylococcus and Enterococcus.

Device Story

System uses colorimetric oxidation-reduction, growth-based AST in molded polystyrene trays. Input: pure culture bacterial colonies suspended in broth, equated to 0.5 McFarland. Instrument incubates at 35°C; monitors color change from blue to pink/colorless via automated optical readings every 20 minutes. Software-driven 'EXPERT' system interprets growth patterns against CLSI-derived rules to determine MIC and resistance phenotypes. Output: ID, MIC values, and categorical interpretations (SIR). Used in clinical microbiology labs; operated by technicians. Benefits: rapid (4-16 hours) detection of inducible clindamycin resistance (iMLSb) in Staphylococcus, distinguishing it from macrolide-only efflux resistance, aiding antibiotic selection.

Clinical Evidence

Performance evaluated using clinical, stock, and challenge isolates at multiple US sites. Comparison against CLSI reference broth microdilution method. For the Phoenix Inducible Macrolide Resistance Test, Categorical Agreement (CA) was 97.6% (n=295). Reproducibility studies showed >90% intra-site and >95% inter-site reproducibility for Gram-positive isolates.

Technological Characteristics

Colorimetric oxidation-reduction, growth-based AST. Molded polystyrene trays with 136 micro-wells. Cation-adjusted Mueller-Hinton broth with 0.01% Tween 80. Automated optical reading system. Software-driven 'EXPERT' system for rule-based interpretation. Connectivity: Automated instrument integration.

Indications for Use

Indicated for in vitro quantitative determination of antimicrobial susceptibility (MIC) of Gram-negative and Gram-positive bacterial isolates (Staphylococcus, Enterococcus, Streptococcus) from pure culture. Specifically includes detection of inducible macrolide-lincosamide-streptogramin B (iMLSb) resistance in Staphylococcus species.

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

• Sensititre® Dtest (k073653)

Submission Summary (Full Text)

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Kof2538

# 510(k) SUMMARY

| SUBMITTED BY: | Becton, Dickinson and Company<br>7 Loveton Circle<br>Sparks, MD 21152<br>Phone: [phone]<br>Fax: [phone] | NOV 20 2008 |
|------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| CONTACT NAME: | Monica E. Giguere<br>Regulatory Affairs Specialist | |
| DATE PREPARED: | November 17, 2008 | |
| DEVICE TRADE NAME: | BD Phoenix™ Automated Microbiology System –<br>Phoenix Inducible Macrolide Resistance (iMLSb) Test in<br><i>Staphylococcus</i> species | |
| DEVICE COMMON NAME: | Antimicrobial susceptibility test system-short incubation | |
| DEVICE CLASSIFICATION: | Fully Automated Short-Term Incubation Cycle<br>Antimicrobial Susceptibility Device, 21 CFR 866.1645 | |
| PREDICATE DEVICES: | Sensititre® Dtest (K073653) and BD Phoenix™ Automated<br>Microbiology System with Gatifloxacin (K020321, May<br>23, 2002 and K060324, May 25, 2006), Ofloxacin<br>(K020323, April 14, 2002), and Levofloxacin (K020322,<br>March 27, 2002). | |
| INTENDED USE: | The BD Phoenix™ Automated Microbiology System is<br>intended for the rapid identification and <i>in vitro</i><br>antimicrobial susceptibility testing of isolates from pure<br>culture of most aerobic and facultative anaerobic Gram-<br>negative and Gram-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 or AST determinations.
- BD Phoenix ID Broth used for performing ID tests and preparing AST Broth inoculum. .

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- 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.

The Phoenix panel is a sealed and self-inoculating molded polystyrenc 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 into the instrument.

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. Measurcments 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 (formerly NCCLS) reference broth microdilution method. This premarket notification provides data supporting the use of the BD Phoenix™ Automated Microbiology System Gram positive 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 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", March 5, 2007.

# 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 Gram-positive isolates. Each site tested the isolates in triplicate on three different days using one lot of Gram Positive Phoenix panels containing this antimicrobial agent and associated reagents.

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The results of the study demonstrate for the this antimicrobial agent there was an overall intrasite reproducibility of greater than 90% and an overall inter-site reproducibility greater than 95% for the Gram-positive isolates tested.

## Clinical Studies

Clinical, stock and challenge isolates were tested at multiple geographically diverse sites across the United States to demonstrate the performance of the Phoenix antimicrobial susceptibility test with the Gram Positive Phoenix Panel format containing this test. Phoenix System results for Challenge set isolates were compared to the expccted results. Phoenix System results for clinical isolates were compared to the results obtained from the reference test.

The following performance was obtained for the isolates tested in the study.

Performance of BD Phoenix System for Gram-Positive Organisms by Drug

| Antimicrobial | CA (n) | CA (%) |
|---------------------------------------------|--------|--------|
| Phoenix Inducible Macrolide Resistance Test | 295 | 97.6 |

### Conclusions Drawn from Substantial Equivalence Studies

The data collected from the substantial equivalence studies demonstrate that the Phoenix Inducible Macrolide Resistance (iMLSb) Test in Staphylococcus species on the BD Phoenix™ Automated Microbiology System is substantially equivalent to the CLSI Disk Approximation Test reference method as defined in the FDA draft guidance document, "Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems; Guidance for Industry and FDA", March 5, 2007. Technological characteristics of this system are substantially equivalent to those used in the Sensititre® Dtest (K073653, March 20, 2008 and BD Phoenix™ Automated Microbiology System with Gatifloxacin (K020321, May 23, 2002 and K060324, May 25, 2006), Ofloxacin (K020323, April 14, 2002), and Levofloxacin (K020322, March 27, 2002).

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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 graphic of an eagle or bird-like figure with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the graphic.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

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

NOV 2 0 2008

Re: k082538

Trade/Device Name: BD Phoenix™ Automated Microbiology System - Phoenix Inducible Macrolide resistance (iMLSb) Test in Staphylococcus species 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: August 29, 2008 Received: September 2, 2008

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 advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at 240-276-0450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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,

Sally attayma

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: K082538

Device Name: BD PhoenixTM Automated Microbiology System - Phoenix Inducible Macrolide Resistance (iMLSb) in Staphylococcus species (erythromycin in amounts required to detect inducible macrolide resistance)- Gram-positive 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 Phoenix Inducible Macrolide Resistance (iMLSb) Test in Staphylococcus species to Gram-positive ID/AST or AST only Phoenix panels. The Phoenix Inducible Macrolide Resistance Test is used to detect inducible macrolide-lincosamide-streptogramin B resistance in Staphylococcus species.

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 hi. Poole

vision Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) KD82538

BD Diagnostic Systems Becton, Dickinson and Company

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