BD PHOENIX AUTOMATED MICROIOLOGY SYSTEM- ERTAPENEM 0.0625-8 UG/ML-GN

K123266 · Becton, Dickinson and Company · LON · Jun 26, 2013 · Microbiology

Device Facts

• Record ID: K123266
• Device Name: BD PHOENIX AUTOMATED MICROIOLOGY SYSTEM- ERTAPENEM 0.0625-8 UG/ML-GN
• Applicant: Becton, Dickinson and Company
• Product Code: LON · Microbiology
• Decision Date: Jun 26, 2013
• 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 Automated Microbiology System performs antimicrobial susceptibility testing (AST) on bacterial isolates. System uses molded polystyrene panels containing dried antimicrobial agents (ertapenem 0.0625–8.0 µg/mL) and growth/fluorescent controls. Pure culture colonies are suspended in broth, standardized via nephelometer (PhoenixSpec or Phoenix AP), and inoculated into panels. Instrument continuously incubates panels at 35°C, taking readings every 20 minutes. System utilizes redox indicator (colorimetric oxidation-reduction) to detect bacterial growth; growth in presence of antibiotic reduces indicator (color change to pink), signaling resistance. Instrument software interprets reactions to provide MIC values and categorical interpretations (S, I, R). Expert system provides additional interpretive rules based on CLSI documentation. Results assist clinicians in selecting appropriate antibiotic therapy for moderate to severe infections.

Clinical Evidence

Performance evaluated via clinical, stock, and challenge isolates across multiple U.S. sites. Comparison against CLSI reference broth microdilution method. For Ertapenem (0.0625-8 µg/mL), study included 1201 isolates. Results: Essential Agreement (EA) 98.7% (1201/1201), Category Agreement (CA) 97.9% (1201/1201). Reproducibility study across three sites showed >95% agreement (+/- 1 dilution).

Technological Characteristics

System consists of instrument, software, and sealed polystyrene panels with 136 micro-wells. Uses redox indicator and turbidity sensing for growth detection. Incubation at 35°C ± 1°C. Automated or manual inoculum preparation. Connectivity via BD Phoenix instrument software. AST method is broth-based microdilution.

Indications for Use

Indicated for in vitro quantitative determination of antimicrobial susceptibility by MIC of Gram-negative aerobic and facultative anaerobic bacteria (Enterobacteriaceae and Non-Enterobacteriaceae) and Gram-positive bacteria (Staphylococcus, Enterococcus, Streptococcus) from pure culture. 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)

Submission Summary (Full Text)

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K123266

## 510(K) SUMMARY

JUN 2 6 2013 SUBMITTED BY: Becton, Dickinson and Company 7 Loveton Circle Sparks, MD 21152 Phone: [phone] Fax: [phone] CONTACT NAME: Monica E Giguere, RAC Senior Regulatory Affairs Specialist DATE PREPARED: May 28, 2013 DEVICE TRADE NAME: BD Phoenix™ Automated Microbiology System -Ertapenem (0.0625-8 µg/mL) DEVICE COMMON NAME: Automated microbiology system DEVICE CLASSIFICATION: 21 CFR 866.1645 Fully Automated Short-Term Incubation Cycle Antimicrobial Susceptibility System. (Product Code LON) VITEK® System (PMA No. N50510) PREDICATE DEVICES: INTENDED USE: 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 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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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 preliminarily identified as a Gram-negative or Gram-positive isolate. Phoenix panels are inoculated with a specified organism density and placed into the instrument. Inoculum for use with the Phoenix system may be prepared either manually or may be automated using the BD Phoenix™ AP System.

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° ± 1°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 for inoculum prepared manually and inoculum prepared with the BD Phoenix™ AP instrument when compared with the CLSI reference broth microdilution method. This premarket notification provides data supporting the use of the BD Phoenix™ Automated Microbiology System Gram negative ID/AST or AST only Phoenix panels with this antimicrobial agent.

## SUMMARY OF 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", August 28, 2009. Shelf-life (stability) data is being collected and will be maintained on file at BD. There have been no previous submissions for this formulation of drug for which FDA has provided feedback related to data or information needed to support substantial equivalence.

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

The results of the study demonstrate that for this antimicrobial agent and the Gram-negative organisms tested there was an overall reproducibility across test sites of greater than 95% (+/- 1 dilution) agreement when compared to the test mode.

#### 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 a Gram Negative Phoenix Panel 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 not susceptible).

The following table summarizes the performance for Clinical and Challenge isolates tested

| Antimicrobial | Concentration | EA (n) | EA (%) | CA (n) | CA (%) |
|---------------|----------------|--------|--------|--------|--------|
| Ertapenem | 0.0625-8 μg/mL | 1201 | 98.7 | 1201 | 97.9 |

## Performance of BD Phoenix System for Gram-Negative Organisms by Ertapenem

#### 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", August 28, 2009. 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. .

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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 features a stylized eagle with three wing segments, representing health, human services, and the USA. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

## MONICA GIGUERE RAC, SENIOR REGULATORY AFFAIRS SPECIALIST BECTON, DICKINSON AND COMPANY 7 LOVETON CIRCLE - MC 614 SPARKS MD 21152

June 26, 2013

Re: K123266

Trade/Device Name: BD Phoenix Automated Microbiology System - Ertapenem 0.0625 -8ug/mL

Regulation Number: 21 CFR 866.1645

Regulation Name: Fully automated short-term incubation cycle antimicrobial susceptibility system

Regulatory Class: II Product Code: LON Dated: May 28, 2013

Received: June 3, 2013

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the

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Page 2-Ms. Giguere

electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact 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/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803). please go to

http://www.fda.gov/MedicalDcvices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometries/Division of Postmarket Surveillance.

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/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours.

# Uwe Scherf -S for

Sally Hojvat. M.Sc., PhD. Director, Division of Microbiology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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510(k) Number:

Device Name: BD Phoenix™ Automated Microbiology System for use with the antimicrobial agent Ertapenem (0.0625-8 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, Enterococcus and Streptococcus.

Ertapenem 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:

Escherichia coli Klebsiella pneumoniae Proteus mirabilis

Active In Vitro Citrobacter freundii Citrobacter koseri Enterobacter cloacae Klebsiella oxytoca (excluding ESBL producing isolates)

Morganella morganii Proteus vulgaris Providencia rettgen Providencia stuartii Serratia marcescens

Prescription Use Over-the-Counter Use V (Per 21 CFR 801.109) (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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