BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEPHALOTHIN (GP) 0.5-64 UG/ML

K050400 · Becton, Dickinson & CO · LON · Mar 22, 2005 · Microbiology

Device Facts

• Record ID: K050400
• Device Name: BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEPHALOTHIN (GP) 0.5-64 UG/ML
• Applicant: Becton, Dickinson & CO
• Product Code: LON · Microbiology
• Decision Date: Mar 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

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 in two-fold doubling dilutions. Input consists of a pure culture bacterial isolate, prepared as a 0.5 McFarland standard in Phoenix ID or AST broth. The system uses a redox indicator to detect bacterial growth via turbidity measurements. Panels are incubated within the instrument, which performs automated readings every 20 minutes. The system software interprets these readings to provide organism identification, MIC values, and categorical interpretations (S, I, or R). Results are used by clinicians to guide antimicrobial therapy decisions. The system is intended for use in clinical laboratory settings.

Clinical Evidence

Performance was evaluated using clinical, stock, and challenge isolates across multiple geographically diverse U.S. sites. The study compared Phoenix System results to the NCCLS reference broth microdilution method. For cephalothin, testing yielded 90.8% Essential Agreement (EA) and 93.2% Category Agreement (CA) across 1220 isolates. Reproducibility studies (intra- and inter-site) demonstrated >95% reproducibility for Gram-positive isolates.

Technological Characteristics

Automated microdilution system using molded polystyrene panels with 136 micro-wells. Employs redox indicator-based growth detection and turbidity measurements. Operates via continuous incubation and automated optical reading every 20 minutes. System includes instrument, software, ID/AST panels, and specific broth/indicator reagents. Connectivity and software details are integrated into the proprietary BD Phoenix instrument platform.

Indications for Use

Indicated for testing Staphylococcus spp. using cephalothin at concentrations of 0.5 – 64 µg/mL in gram-positive susceptibility panels. 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)
• 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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| MAR 2 2 2005 | 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 Gigucre,<br>RA Specialist |
| DATE PREPARED: | February 15, 2005 |
| DEVICE TRADE NAME: | BD Phoenix™ Automated Microbiology System -<br>Cephalothin 0.5-64 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. .
- DD 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 I he Filoemix panel is a searce and bell for susceptibility testing must be a pure culture and conliating dried reagens. Organisms for basephensy volumes
preliminarily identified as a Gram-negative or Gram-positive isolate. For each isolate, an inoculation prominatity - 00.5 McFarland standard is prepared in Phoenix ID broth.

The Phoenix AST method is a broth based microdilution test. The Phoenix system utilizes a redox I he Fiochis AST memor is a crown saver wth in the presence of an antimicrobial agent. Indicator for the delection of organism growin in as procerial turbidity are used in the determination Measurements of Changes to the moreation 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 The instrument takes readings of the panels every 20 minutes. The eadings 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 performatics when compared with also reason the BD Phoenix™ Automated Microbiology System notification provides and bepp 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 performance with compared to the system has been evaluated as defined in the FDA Draft prepared according to NCCDB 117). The of 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 mitu and more one reproducioning a panel of Gram-positive isolates. Each site tested the isolates in evaluated at 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 I he results of the study demonstances 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 geographicaly diverse sites across Climical, stock and challenge isolates were tested antimicrobial susceptibility test with the United States to demonstrate the performance of this antimicrobial agent. Phoenix System results for clinical the Gram Positive Phoemix I and I ontacted to the expected results. Phoenix System results for clinical
for Challenge set isolates were compared to the expected results mig for Challenge set Isolates were compared to the exposed rooth 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 Category Agreement (CA) to cxpected releveloped Microbiology System agrees exactly or within ± (EA) occurs wilen inc DD Friodinates good . Category Agreement (CA) occurs when the BDD one two-loid thinking to the reference rosan. Savegary of 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:

| TECHNICAL CONSULTION COLLECTION COLLECTION CONTROLLERS CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTIO<br>Antimicrobial | Concentration | EA (n)<br>with the same of the same of the same of the same of the same of the same of the same of | EA (%) | CA (n)<br>The first of the country of the country of the first and<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | (CA (%) |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------|--------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|
| I was a more and the state of the state to contribution of the<br>Cephalothin | Comments of the control of the production of the contribution of the contribution of the contribution of the contribution of the contribution of the contribution of the contr<br>' 0.5-64 µg/mL | STATUTE AND THE<br>1220 | 90.8 | 1220 | 93.2 |

## Conclusions Drawn from Substantial Equivalence Studies

The data collected from the substantial equivalence studies demonstrate that testing on the BD The data concected from the substantial capartmicrobial agent is substantially equivalent Phoemix --- Automated Microololegy Byocum Was "Guidance on Review Criteria for Assessment of Antimicrobial Susceptibility Devices", March 8, 2000. Technological characteristics of this system Annimicrobial Susceptionity Devices , March of 2000. " system, which received approval by the ate substantially equivalent to alsos as a manufact Microbiology System with FDA under FMA mamber 190310 and DD Theoma (K020323, April 14, 2002), and Levofloxacin (K020322, March 27, 2002).

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines forming its body and head. The eagle is facing right, and its wings are curved upwards. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.

MAR 2 2 2005

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Monica Evelyn Giguere Nis. Natory Affairs Specialist BD Diagnostics Systems BD Diagnobuse by and Company 7 Loveton Circle Sparks, MD 21152

k050400
Trade/Device Name: BD Phoenix™ Automated Microbiology System
Trade/Device Name: BD Phoenix (1) Re: BD Phoenix - Automated Microsoft - Gram-Positive ID/AST Regulation Number: 21 CFR 866.1645 Regulation Number: 21 CFF 866.1645
Regulation Name: Fully Automated Short-Term Incubation Cycle Antimicrobial
Province Callery Callery of Callibre Devices Susceptibility Devices Regulatory Class: Class II Product Code: LON Dated: February 15, 2005 Datod: February 16, 2005

Dear Ms. Giguere:

We have reviewed your Section 510(k) premarket notification of intent to market the device is a
nd indication of the county and the dayice is substantially equivalent (for th We have reviewed your Section 510(k) premarket in enews ve the indications
referenced above and have determined the device is substantially equivalent in interstate referenced above and have determined the devices marketed in interstate
for use stated in the enclosure) to legally marketed in interstate for use stated in the enclosure) to legally market predical Device Amendments, or to
commerce prior to May 28, 1976, the enactment date of the Medice Amendments, or to commerce prior to May 28, 1976, the enactment and of the Federal Food, Drug, devices that have been reclassified in accordance with the proval application (PMA).
and Cosmetic Act (Act) that do not require approval of a previsions of the Act. The and Cosmetic Act (Act) that do not require approval on the general optisions of the Act. The
You may, therefore, market the device, subject to the general ontrols provision You may, therefore, market the device, subject to the eventual registration, listing of
general controls provisions of the Act include requirements misbranding and general controls provisions of the Act include requirements to thirds beginst misbranding and adulteration.

lf your device is classified (see above) into either class II (Special Controls) or class III (PMA), If your device is classified (see above) nto embritias in (specultions affecting your device, it may be subject to such additional controls. Existing major and solo to 895. In addition, FDA
can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 80 can be found in Title 21, Code of Federal Regulations (e) 11), and 11 and 11 and 11 and 11 and

may |
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA's issuance of a substantial equivalence determanirements of the Act
that FDA has made a determination that your device complises with of the Act that FDA has made a determination that your device comples frederal agencies. You must
or any Federal statutes and regulations administered by other to: negistration and li or any Federal statutes and regulations administered by out a gesitudion and listing (21
comply with all the Act's requirements, including, but not limited to: registration a comply with all the Act's requirements, including, out more and manufacturing practice
CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice CFR Part 807); labeling (21 CFR Paris 801 and 807); and good as and as and and 120 CFR Part 820).
requirements as set forth in the quality systems (QS) regulation (21 CFR Par

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This letter will allow you to begin marketing your device as described in your Scetion 510(k)
Children and the TDA Coding of gubstantial equivalence of your device to a lega This letter will allow you to begin marketing your device of your device of your device to a legally
premarket notification. The FDA finding of substantial equir device and t premarket notification. The FDA finding of substantial equivalion of 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, please contact the Office of In If you desire specific information about the application of your device, please contact the Office of In
or questions on the promotion and advertising of your device, please or questions on the promotion and Safety at [phone]. Also, please note the Vitro Diagnostic Device Evaluation and Salety at 12-0727 of 10 FF . Rios" (21 CFR Part 807.97).
regulation entitled, "Misbranding by reference to premarket motification the regulation entitled, "Misbranding by telefence to premation interest the Act from the You may obtain other general informational onlyour Assistance at its toll-free number
Division of Small Manufacturers, International and Consumer Assistance at its toll-free Division of Sman Manufacts or st its Internet address.
[phone] or [phone] or at its Internet address [phone] of (50 th/industry/support/index.html

Sincerely yours,

Sale, a Form

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: K C 50400

Device Name: BD Phoenix™ Automated Microbiology System for use with the antimicrobial agent
s of the country of the Camparitive ID/AST or AST only Phoenix panels. Device Name: BD Phoenix™ Automated Microsions provinsion of the enix panels.

Indications for Use:

The BD Phoenix™ Automated Microbiology System is intended for in vitro quantitative determination of The BD Phoenix™ Automated Microbiology System is miro qualimator (MC) of most Cramenegative aerobic and antimicrobial susceptibility by mimilian promotion (vinc) or nove orderioseriaceae and Non-Enterobacteriaceae
facultative anaerobic bacteria it also transport culture belopme facultative anaerobic bacteria isolates from pure culture for Eneros and 2
and most Gram-positive bacteria isolates from pure culture belonging to the genera Staphylococcus a Enterococcus.

This premarket notification is for the addition of the antimicrobial agent cephalothin at concentrations of This premarket notification is for the administration in the annological of the mastern the morn to be 0.5-64 μg/mL to Gram Positive ID/AST or AST only Phoelix panels. Copilatorin has over and over and package insert for this antimicrobial agent.

# Active In Vitro and in Clinical Infections Against:

Staphylococcus species

Active In Vitro Against:

Over-the-Counter Use

Prescription Use (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)

Sally at Arm
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