BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM -AMPICILLIN-SULBACTAM (GN) 0.5/0.25-32/16UG/ML

K043389 · Becton, Dickinson & CO · LON · Jan 21, 2005 · Microbiology

Device Facts

• Record ID: K043389
• Device Name: BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM -AMPICILLIN-SULBACTAM (GN) 0.5/0.25-32/16UG/ML
• Applicant: Becton, Dickinson & CO
• Product Code: LON · Microbiology
• Decision Date: Jan 21, 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

The BD Phoenix System is an automated microbiology platform for rapid identification and antimicrobial susceptibility testing (AST) of bacterial isolates. The system utilizes molded polystyrene panels containing biochemicals and antimicrobial agents. Inputs consist of pure culture bacterial isolates inoculated into Phoenix ID or AST broth at a 0.5 McFarland standard. The system uses a redox indicator and turbidity measurements to detect bacterial growth in the presence of antimicrobial agents. The instrument continuously incubates panels at a nominal temperature, performing readings every 20 minutes. Software interprets these readings to provide MIC values and categorical interpretations (S, I, or R). Used in clinical microbiology laboratories by trained technicians. The output assists clinicians in selecting appropriate antibiotic therapy by determining the susceptibility profile of the patient's bacterial isolate, potentially improving patient outcomes through targeted treatment.

Clinical Evidence

Performance evaluated using clinical, stock, and challenge isolates. Study compared Phoenix System results to NCCLS reference broth microdilution method. For ampicillin-sulbactam, 1052 isolates were tested, achieving 88.3% Category Agreement. Reproducibility studies at three sites demonstrated >90% intra-site and >95% inter-site reproducibility.

Technological Characteristics

Automated microbiology system using colorimetric oxidation-reduction redox indicator. Materials: molded polystyrene trays with 136 micro-wells. Energy: thermal (35°C incubation). Connectivity: barcode scanning, automated instrument processing. Software: rule-based 'EXPERT' system for result interpretation. Inoculum: 5 × 10⁵ CFU/ml final concentration in cation-adjusted Mueller-Hinton broth with 0.01% Tween 80.

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). This submission adds ampicillin-sulbactam (0.5/0.25–32/16 ug/mL) for Enterobacteriaceae. Proteus spp. and Acinetobacter spp. are 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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#### 043389 i (

## 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: | December 7, 2004 |
| DEVICE TRADE NAME: | BD Phoenix™ Automated Microbiology System –<br>Ampicillin-sulbactam 0.5/0.25-32/16 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. 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. t
- 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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BD PHOENIX™ Automated Microbiology System Ampicillin-sulbactam - GN

The Phoenix panel is a sealed and self-inoculating molded polystyrene tray with 136 micro-wells The I nooms panel 10 a cc. Organisms for susceptibility testing must be a pure culture and containing urica reagence. Organisms its 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. murcator of the detection 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 110 minutent nowers we preadings 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, or R (sensitive, intermediate, or resistant).

#### DEVICE COMPARISON:

The BD Phoenix™ Automated Microbiology System demonstrated substantially equivalent performance when compared with the NCCLS reference broth microdilution method. This premarket periormance rovides 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 SUBSTANTIAL EQUIVALENCE TESTING:

The BD Phoenix™ Automated Microbiology System has demonstrated substantially equivalent performance when compared to the NCCLS reference broth microdilution method (AST panels prepared according to NCCLS M7). The system has been evaluated as defined in the FDA Draft guidance document, "Guidance on Review Criteria for Assessment of Antimicrobial Susceptibility Devices", March 8, 2000.

#### 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 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 gram-negative isolates tested.

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#### Clinical Studies

Clinical, stock and challenge isolates were tested across multiple geographically diversitiity transs Climical, stock and chances were teres were were as antimicrobial susceptibility test with the United States to demonstrate the performation of this antimicrobial agent. Phoenix System results of the gram-negative I nooms panel tonnal containing and the expected results. Phoenix System results for clinical 101 Charlenge set isolates were comparetained from the NCCLS reference broth microdilution method.

The performance of the Phoenix System was assessed by calculating Essential Agreement (EA) and The performatic of the Phoenix Gystem was accessed of Calegory Agreement (CTF) to enprim Automated Microbiology System agrees exactly or within ± one two-fold dilution to the reference result. Category Agreement (CA) occurs when the BD one two-lou unution to the objology System agrees with the reference method with respect to the FDA categorical interpretive criteria (susceptible, intermediate, and resistant).

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

#### Performance of BD Phoenix System for Gram-Negative Organisms by Drug Table 1:

| And Court of Children Comer of Children<br>Antimicrobial | A 14 September 20 Comments of the Land of<br>Concentration | EA (n) | EA (%) | CA (n) | CA (%) |
|---------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------|--------|-------------|--------|--------|
| Company of the comments of the first and the first and the county of the county of the county of the county of the county of<br>Ampicillin- | 0.5/0.25-32/16 | 1052 | . 07 ?<br>- | 1052 | 88.3 |
| sulbactam | ug/mL | | | | |

## 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 guidance document, "Class II Special Controls Guidance Document: as timicrobial 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 AMPICILLIN-SULBACTAM Available Range 0.5/0.25-32/16 µg/mL

#### Performance

#### Accuracy

| Antimicrobial | Concentration | EA (n) | EA (%) | CA (n) | CA (%) |
|----------------------------------------------------------------------------------------------------------|-----------------------------------------------------|--------|-------------|--------|--------|
| Status and States of Canadian Cases of Canadian Cases of Canadian Cases of Canadian Cases<br>Ampicillin- | Property of any from The Comments<br>0.5/0.25-32/16 | 1052 | . 07 ?<br>1 | 1052 | 88.3 |
| sulbactam | ug/mL | | | | |

## Reproducibility

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

#### Breakpoints - NCCLS

| Organism | S | I | R |
|------------------------|------------|------|--------------|
| Enterobacteriaceae | $\leq$ 8/4 | 16/8 | $\geq$ 32/16 |
| Non-Enterobacteriaceae | $\leq$ 8/4 | 16/8 | $\geq$ 32/16 |

## Recommended Quality Control Organisms

| Quality Control Strain | MIC Range | Source |
|-----------------------------|-------------------|--------|
| Escherichia coli ATCC 25922 | 2/1 - 8/4 µg/mL | NCCLS |
| Escherichia coli ATCC 35218 | 8/4 - 32/16 µg/mL | NCCLS |

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

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JAN 2 1 2005

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

k043389 Re:

K043389
Trade/Device Name: BD Phoenix™ Automated Microbiology System Ampicillin-sulbactam (0.5/0.25-32/16 µg/mL) 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: December 7, 2004 Received: December 9, 2004

Dear Ms. Giguere:

We have reviewed your Section 510(k) premarket notification of intent to market the device wt nave reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate Ior use stated in the encrosals) to the enactment date of the Medical Device Amendments, or to commerce prior to rites 2011-17-11, accordance with the provisions of the Federal Food, Drug, de nees mat have been require approval of a premarket approval application (PMA). and Cosmetic rece (110) that to nevice, subject to the general controls provisions of the Act. The 1 ou may, dicrerere, mains of the Act include requirements for annual registration, listing of general controls provision 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 your device is thabitional controls. Existing major regulations affecting your device it may oc subject to Juden and Federal Regulations (CFR), Parts 800 to 895. In addition, FDA can be found in ther announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean I loase of acrisod alla i Drimination that your device complies with other requirements of the Act that I DA has made a avid regulations administered by other Federal agencies. You must or any I ederal the Act's requirements, including, but not limited to: registration and listing (21 comply with and many (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) I his letter will anow you to begin maneting your maneting of your device to a legally prematic notification: "The PDA midning of casification 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, 11 you desire specific intornation as advertising of your device, please contact the Office of In of quostions on the promotion and Safety at [phone]. Also, please note the v in o Diagnostic Device Branding by reference to premarket notification" (21 CFR Part 807.97). Tegulation entition, "Wherehaling of your responsibilities under the Act from the Tou may ootan other general meethanetional 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,

Sale, a Story

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: K043389

Device Name: BD PhoenixTM Automated Microbiology System for use with the antimicrobial agent ampicillin-sulbactam (0.5/0.25-32/16 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 antineroual susceptionity of intension 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 ampicillin-sulbactam at I his prendined of 0.5/0.25-32/16 µg/mL to gram-negative ID/AST or AST only Phoenix panels. Ampicillinsulbactam 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:

Beta-lactamase producing strains of: Escherichia coli Klebsiella spp. (including K. pneumoniae)

#### Active In Vitro Against:

Escherichia coli (Beta-lactamase and non-beta-lactamase producing) Klebsiella species (all known strains are beta-lactamase producing) Morganella morganii Providencia rettgeri Providencia stuartii

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

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