BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - ERYTHROMYCIN 0.0625-8 UG/ML

K033784 · Becton, Dickinson & CO · LON · Feb 3, 2004 · Microbiology

Device Facts

• Record ID: K033784
• Device Name: BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - ERYTHROMYCIN 0.0625-8 UG/ML
• Applicant: Becton, Dickinson & CO
• Product Code: LON · Microbiology
• Decision Date: Feb 3, 2004
• 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 System performs automated identification and antimicrobial susceptibility testing (AST) of bacterial isolates. Input: pure culture bacterial isolates inoculated into Phoenix ID/AST broth. System uses molded polystyrene panels with 136 micro-wells containing biochemicals and antimicrobial agents. Principle: broth-based microdilution; redox indicator detects organism growth via turbidity changes in presence of antimicrobial agents. Instrument continuously incubates panels at 35°C, taking optical readings every 20 minutes. Output: organism identification, MIC values, and interpretive categories (S, I, R, N). Used in clinical microbiology laboratories by trained personnel. Results assist clinicians in selecting appropriate antibiotic therapy for patients with bacterial infections.

Clinical Evidence

Performance evaluated via clinical, stock, and challenge isolates across multiple geographically diverse sites. Compared against NCCLS reference broth microdilution method. For erythromycin (0.0625-8 µg/mL) with Gram-positive organisms, study reported 95.7% Essential Agreement (EA) and 95.7% Category Agreement (CA) based on 1132 samples. Reproducibility studies showed >90% intra-site and >95% inter-site reproducibility.

Technological Characteristics

System uses molded polystyrene trays with 136 micro-wells. AST method: broth microdilution with redox indicator (colorimetric oxidation-reduction). Energy source: electrical (automated incubator/reader). Connectivity: barcode scanning, automated data recording. Software: rule-based 'EXPERT' system using NCCLS standards. Sterilization: not specified.

Indications for Use

Indicated for in vitro quantitative determination of antimicrobial susceptibility (MIC) of Staphylococcus and Enterococcus species using erythromycin (0.0625 – 8 µg/mL). Excludes Enterococcus species other than E. faecalis and E. faecium.

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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| FEB - 3 2004 | K033784 |
|------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | 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: | Kathryn Babka Powers,<br>RA Specialist |
| DATE PREPARED: | December 2, 2003 |
| DEVICE TRADE NAME: | BD Phoenix™ Automated Microbiology System -<br>Erythromycin 0.0625-8 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. The system includes the following components:

- BD Phocnix 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 Phocnix pancl is a sealed and self-inoculating molded polystyrene tray with 136 micro-wclls The I nooms panet is a scared and oes for susceptibility testing must be a pure culture and comlaining uried reagents. Organisms for sassephenty volumes
preliminarily identified as a Gram-negative or Gram-positive isolate. For each isolation premimatiry received standard is prepared in Phocnix ID broth.

The Phoenix AST method is a broth based microdilution test. The Phoenix System utilizes a redox The I nochis AST memor is a crown around in the presence of an antimicrobial agent. indicator for the delection of organism growth in the preserial turbidity are used in the determination Measurents of Changes to the marcace ageral 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 mstrument 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 NCCLS reference broth microdilution method. This premarket pertionalice when compared with the No ee of the BD Phoenix™ Automated Microbiology System notheation provides and supportury panels with this antimicrobial agent.

# SUMMARY OF SUBSTANTIAL EQUIVALENCE TESTING:

The BD Phoenix™ Automated Microbiology System has demonstrated substantially cquivalent performance when compared to the NCCLS reference broth microdilution method (AST panels performance with compared to any . The system has been evaluated as defined in the FDA Draft propared according to NOOD 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 mitta and mer are repassing a panel of Gram-positive isolates. Each site tested the isolates in evaluated at three different days using one lot of Gram Positive Phocnix panels containing this antimicrobial agent and associated reagents.

The results of the study domonstrate 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 actoss Chilical, stock and chance were mance of the Phoenix antimicrobial susceptibility test with the Olifical States to demonstrate the perfectntaining this antimicrobial agent. Phoenix System results the Grain Fostive I looms I and I onlines contanting and results. Phoenix System results for clinical Ior Chancing set isonales were compared is the respence broth microdilution method.

The performance of the Phoenix System was assessed by calculating Essential Agreement (EA) and The performance of the Provins Bybenn versults for all isolates tested. Essential Agreement Category Agreemont (OTT) to onported Microbiology System agrees exactly or within ± (EA) occars when the DD Presience result. Category Agreement (CA) occurs when the BD one two-Iold unution to the ferences resume agrees with the reference method with respect to the I hounds - Tutomated interpretive criteria (susceptible, intermediate, resistant or not susceptible).

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:

| Antimicrobial | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>Concentration | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>EA (n) | and the control of the country of the country of the first of the first of the first of the first of the first of the first of the first of the first of the first of the firs<br>EA (%) | CA (n) | CA (%) |
|----------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------|-----------------------|
| Free and the contract and the commend of the comments of the comments of the comments of the comments of<br> Erythromycin | and the contract of the contract and the comments of the comments of the comments of the comments of the comments of the comments of the comments of the comments of the comme<br> 0.0625-8 µg/mL | 1132 | 05 7<br>1211 | 1132 | 05 7<br>ڪيو جو آهي جي |

## Conclusions Drawn from Substantial Equivalence Studies

The data collected from the substantial equivalence studies dcmonstrate that testing on the BD The and voluseted from are abiology System with this antimicrobial agent is substantially equivalent as outlined in the FDA draft guidance document, "Guidance on Review Criteria for Assessment of as outimod in the IDI calling gavices" March 8, 2000. Technological characteristics of this system Amminerobial busephibility Dories from 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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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes extending from its body, representing health and human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Kathryn Babka Powers Regulatory Affairs Specialist Becton, Dickinson and Company 7 Loveton Circle Sparks, MD 21152-0999

FEB - 3 2004

Re: k033784

Trade/Device Name: BD Phoenix™ Automated Microbiology System for use with the antimicrobial agent erythromycin (0.0625-8 µg/mL.) -- Gram-Positive ID/AST or AST only Phoenix panels

Regulation Number: 21 CFR 866.1645

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

Regulatory Class: Class II Product Code: LON Dated: December 2, 2003 Received: December 4, 2003

Dear Ms. Powers:

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 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/dsma/dsmamain.html.

Sincerely yours,

Saqartys

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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### 510(k) Number: K033784

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

This premarket notification is for the addition of the antimicrobial agent erythromycin at concentrations of 0.0625-8 ug/mL to Gram Positive ID/AST or AST only Phoenix panels. Erythromycin 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:

Staphylococcus aureus

| Prescription Use |
|-----------------------------|
| (Part 21 CFR 801 Subpart D) |

AND/OR

Over-The-Counter Use (21 CFR 807 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)

Sall atty

Division Sign-Off

Office of In Vitro Diagnostic Device Office of Safety

510(k) k033784

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