BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFOXITIN GP 1-32 G/ML

K053241 · Becton, Dickinson & CO · LON · Dec 22, 2005 · Microbiology

Device Facts

• Record ID: K053241
• Device Name: BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFOXITIN GP 1-32 G/ML
• Applicant: Becton, Dickinson & CO
• Product Code: LON · Microbiology
• Decision Date: Dec 22, 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

BD Phoenix™ Automated Microbiology System performs in vitro rapid identification and antimicrobial susceptibility testing (AST) of gram-positive bacteria. System utilizes sealed, self-inoculating polystyrene trays containing dried reagents and AST indicator. Pure culture colonies are suspended in broth, equated to 0.5 McFarland standard, and inoculated into panels. Instrument continuously incubates panels at 35°C; optical sensors monitor colorimetric oxidation-reduction of redox indicator in micro-wells every 20 minutes. Growth in presence of antibiotic prevents color change; inhibition results in color change. Software-driven 'EXPERT' system applies CLSI-derived rules to interpret MIC values and categorical results (SIR). System provides automated identification and susceptibility data to clinicians to guide antimicrobial therapy. Cefoxitin addition enables prediction of mecA-mediated resistance in S. aureus.

Clinical Evidence

Performance evaluated via clinical, stock, and challenge isolates across multiple U.S. sites. Comparison against CLSI reference broth microdilution method. Metrics: Essential Agreement (EA) and Category Agreement (CA). Reproducibility: intra-site >90%, inter-site >95% for Gram-positive isolates. No specific p-values or CIs provided in summary.

Technological Characteristics

Automated growth-based system using colorimetric oxidation-reduction redox indicator. Materials: molded polystyrene trays with 136 micro-wells. Energy: 35°C incubation. Connectivity: barcode scanned, automated instrument-based reading. Software: rule-based 'EXPERT' system using CLSI guidelines. Dimensions: micro-well panel format.

Indications for Use

Indicated for in vitro quantitative determination of antimicrobial susceptibility by minimal inhibitory concentration (MIC) of most aerobic and facultative anaerobic bacteria isolates from pure culture, including Gram-negative and Gram-positive bacteria (specifically Staphylococcus and Enterococcus). Used for testing cefoxitin (1-32 µg/mL) against Staphylococcus aureus and Staphylococcus epidermidis. Contraindicated for organisms not listed in the package insert; methicillin/oxacillin-resistant staphylococci are considered resistant to cefoxitin.

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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# 510(k) SUMMARY

K053241

| SUBMITTED BY: | Becton, Dickinson and Company<br>7 Loveton Circle<br>Sparks, MD 21152<br>Phone: [phone]<br>Fax: [phone] |
|------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| CONTACT NAME: | Monica E. Giguere<br>Regulatory Affairs Specialist |
| DATE PREPARED: | November 16, 2005 |
| DEVICE TRADE NAME: | BD Phoenix™ Automated Microbiology System -<br>Cefoxitin 1-32 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 . or 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 contaming drive roughts: 0 Gram-negative or Gram-positive isolate. For cach 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. 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, or R (sensitive, intermediate, or resistant).

### 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 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 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 pancl 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.

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-positive 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 Gram Positive 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 the Essential Agreement (EA) and Category Agreement (CA), and comparing these 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, and resistant).

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

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

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|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| I<br>Concession Commender Comments of Children of<br>---------------------<br>1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1<br>efoxitin | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>. | | VITA | Company | nr |

### Conclusions Drawn from Substantial Equivalence Studies

The data collected from the substantial equivalence studies demonstrate that testing on the BD Phocnix™ Automated Microbiology System with this antimicrobial agent is substantially equivalent as outlined in the FDA draft guidance document, "Guidance on Review Criteria for Assessment of Antimicrobial Susceptibility Devices", March 8, 2000. 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 CEFOXITIN Available Range 1-32 µg/mL

### Performance

#### Accuracy

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### Reproducibility

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

### Breakpoints - CLSI and FDA

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# Recommended Quality Control Organisms - CLSI and FDA

| Quality Control Strain | MIC Range | Source |
|----------------------------------|-------------------------|--------|
| Staphylococcus aureus ATCC 29213 | 1 - 4 $ μ $ g/mL | CLSI |

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

DEC 2 2 2005

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

Re: k053241

Trade/Device Name: BD Phoenix™ Automated Microbiology System Cefoxitin (1-32 µg/mL) - Gram Positive 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: November 16, 2005 Received: November 18, 2005

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 r hat 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,

Sally, a Hon

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 (if known): ____________________________________________________________________________________________________________________________________________________

| Device Name: | BD Phoenix™ Automated Microbiology System for use with the antimicrobial agent cefoxitin |
|-----------------------------------------------------------------|------------------------------------------------------------------------------------------|
| (1-32 µg/mL) - Gram positive ID/AST or AST only Phoenix panels. | |

Indications for Use:

The BD Phoenix™ Automated Microbiology System is intended for in vitro quantiative 11th DD I hooma's antimicrobial susceptibility by minimal inhibitory concentration (MIC) of most decemination of animiero im ultative anaerobic bacteria isolates from pure culture for Oram-hegative acrono and Non-Enteriaceae and most Gram-positive bacteria isolates from pure Enterococcionains to the genera Staphylococcus and Enterococcus.

This premarket notification is for the addition of the antimicrobial agent cefoxitin at concentrations of I ins premation is formeditor is for the addines only Phoenix panels. It will also be used as a test to 1-32 pg mill to Grain Fount Fraphylococcus aureus in these panels. Cefoxitin has been shown to product in vitro against most strains of microorganisms listed below, as described in the FDAapproved package insert for this antimicrobial agent.

### Active In Vitro and in Clinical Infections Against:

Staphylococcus aureus® (including penicillinase-producing strains) Staphylococcus epidermidisª

a Staphylococci resistant to methicillin/oxacillin should be considered resistant to cefoxitin.

Prescription Use X

AND/OR

Over-The-Counter Use

(Per 21 CFR 801 Subpart D)

(Per 21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Luddi Lu Polo

Division Sign-Off

Office of In ' = " "Lagnostic Device Evaluation an

BD Diagnostic Systems Becton, Dickinson and Company

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