(38 days)
Not Found
No
The description focuses on automated processes, redox indicators, and turbidity measurements for bacterial growth determination, without mentioning AI or ML algorithms for interpretation or analysis.
No
The device is described as an in vitro diagnostic device for identifying and testing the susceptibility of bacterial isolates. It does not directly treat or diagnose a disease in a living organism.
Yes
The BD Phoenix™ Automated Microbiology System is intended for the rapid identification and in vitro antimicrobial susceptibility testing of isolates. This information is used to determine the minimum inhibitory concentration (MIC) values and categorize bacteria as susceptible, intermediate, resistant, or nonsusceptible to antimicrobial agents. These results provide critical information for guiding treatment decisions, which is a diagnostic function.
No
The device description explicitly lists hardware components like the "BD Phoenix instrument" and "BD Phoenix panels," indicating it is not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the system is intended for "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." and "in vitro quantitative determination of the antimicrobial susceptibility of isolates". The term "in vitro" is a key indicator of an IVD.
- Device Description: The description details a system that analyzes biological samples (bacterial isolates from pure culture) outside of the human body using reagents and an automated instrument to provide diagnostic information (identification and susceptibility to antimicrobial agents).
- Performance Studies: The performance studies compare the device's results to a "CLSI reference broth microdilution method," which is a standard laboratory method for determining antimicrobial susceptibility. This further confirms its use in a diagnostic laboratory setting.
The entire context of the document describes a system designed to perform tests on biological samples in vitro to aid in the diagnosis and treatment of bacterial infections by determining their susceptibility to various antimicrobial agents. This aligns perfectly with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for 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.
The BD Phoenix™ Automated Microbiology System is intended for in vitro quantitative determination of The BD Phoenix™ Automated microbiology Uystem is mation (MIC) of most Gram-negative aerobice aetobic and antimicrobial susceptibility of inimal inincitory obiteriaceae and Non-Enterobacteriaceae facultative anaerobic bacteria isolates from pure culture for Execuences of Starbul iacultative anaeroone bacteria isolates from pure culture belonging to the genera Staphylococcus, Enterococcus and Streptococcus.
This premarket notification is for the addition of the untinue of the other his been shown to be 0.25-16 ug/mL to Streptococcus DIAST of AST only I notime parties "Every Lesseribed in the FDA-approved package insert for this antimicrobial agent.
Product codes (comma separated list FDA assigned to the subject device)
LON
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. For testing streptococcal species 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-S Broth used for performing AST tests only. .
- BD Phoenix AST-S Indicator solution added to the AST Broth to aid in bacterial growth determination.
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. 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. 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, R or N (susceptible, intermediate, resistant or nonsusceptible).
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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 streptococcal isolates. Each site tested the isolates in triplicate on three different days using one lot of Streptococcus Phoenix panels containing this antimicrobial agent and associated reagents.
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 Streptococcus 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.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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, "Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems; Guidance for Industry and FDA," February 5, 2003.
Site Reproducibility: 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 streptococcal isolates tested.
Clinical Studies: 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 nonsusceptible).
Accuracy: Levofloxacin (0.75-17 ug/mL): EA (n)=1055, EA (%)=07, CA (n)=1055, CA (%)=0.QQ ~.
Reproducibility: Testing performed at multiple clinical sites demonstrated 95% reproducibility or greater within ± 1 dilution.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Essential Agreement (EA) and Category Agreement (CA).
The results for Levofloxacin at 0.75-17 ug/mL were 1055 for EA(n), 07 for EA(%), 1055 for CA(n), and .QQ ~ for CA(%).
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
VITEK® System (PMA No. N50510), K020321, K020323, K020322
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 866.1645 Fully automated short-term incubation cycle antimicrobial susceptibility system.
(a)
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.(b)
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.”
0
| 510(k) SUMMARY | APR 2 9 2005
K050747 |
|------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| SUBMITTED BY: | Becton, Dickinson and Company
7 Loveton Circle
Sparks, MD 21152
Phone: 410-316-4287
Fax: 410-316-4499 |
| CONTACT NAME: | Monica Evelyn Giguere,
RA Specialist |
| DATE PREPARED: | March 18, 2005 |
| DEVICE TRADE NAME: | BD Phoenix™ Automated Microbiology System -
Levofloxacin 0.25-16 µg/mL |
| DEVICE COMMON NAME: | Antimicrobial susceptibility test system-short incubation |
| DEVICE CLASSIFICATION: | Fully Automated Short-Term Incubation Cycle Antimicrobial
Susceptibility Device, 21 CFR 866.1645 |
| PREDICATE DEVICES: | VITEK® System (PMA No. N50510) and BD Phoenix™
Automated Microbiology System with Gatifloxacin (K020321,
May 23, 2002), Ofloxacin (K020323, April 14, 2002), and
Levofloxacin (K020322, March 27, 2002). |
| 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 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. For testing streptococcal species 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-S Broth used for performing AST tests only. .
- BD Phoenix AST-S Indicator solution added to the AST Broth to aid in bacterial growth � determination.
1
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. 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. 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, R or N (susceptible, intermediate, resistant or nonsusceptible).
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 Streptococcus 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, "Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems; Guidance for Industry and FDA," February 5, 2003.
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 streptococcal isolates. Each site tested the isolates in triplicate on three different days using one lot of Streptococcus 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 streptococcal isolates tested.
BD Diagnostic Systems Becton, Dickinson and Company
2
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 Streptococcus 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 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 nonsusceptible).
Table 1 summarizes the performance for the isolates tested in this study.
Performance of BD Phoenix System for Streptococcal Organisms by Drug Table 1:
| THE REAL PROPERTY OF CHARACT THE COLUMN OF CLAIM OF CLAIM OF CLAIM OF CLAIM OF CLAIM OF CLAIM OF CLAIM OF CLAIM OF CLAIM OF CLAIM OF CLAIM OF CLAIM OF CLAIM OF CLAIM OF CLEAN
PRODUCT OF COLLECTION OF COLLECTION
Antimicrobial | LAND L BOLL CONTRACT THE FILM I 1
Concentration | LALE SECTION COLL OF C. OPEN CO. OF C.
B-8000 - Book Tournal Comments of Children Come of
EA (n)
PROPERTY LIGHT LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEA | Company Come Come Come Come Come Come Come Come Come Come Come Come Come Come Come Come Come Come Come Come Come Come Come Come Come Come Come Come Come Come Come Come Come C
10/
10 A
11/2017
Canadian Call A C . A | (n
CA '
worker from annual or
The later an an an an an an an an an an an an an an an an an an an an an an an an an an an an an an an an an an an an- | ())
C
70 |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------|
| 1000 000 000 000 000 000 000 000 000 000 0000 0000 0000 0000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000
and would and the mille as
Carreral
Levolloxacin | THE COLLECT COLLEGION COLL
STATIST I W . I
. 0 75 1 7
10 ug/mL | 1055
1 VW | C | 1055 | 00 -
سنڌ جي جي جي |
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," 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).
3
SUMMARY INFORMATION FOR LEVOFLOXACIN Available Range 0.25-16 µg/mL
Performance
Accuracy
| Antimicrobial | Concentration | EA (n) | EA (%) | CA (n) | CA (%) |
|---|---|---|---|---|---|
| Levotloxacın | 0 75-17 | 1055 | 07 | 1055 | . QQ ~ |
| 16 ug/mL | A 2011 11/2 11/2017 11/2017 11/11/2017 11/11/2017 11/11/2017 11/11/2017 11/11/2017 11/11/2017 11/11/2017 11/11/2017 11/11/2017 11/11/2017 11/11/2017 11/11/2017 11/11/2017 11/ | 11.6 | پ پ پ مم | 1100 |
Reproducibility
Testing performed at multiple clinical sites demonstrated 95% reproducibility or greater within ± 1 dilution.
Breakpoints - CLSI, FDA
| Organism | S | I | R |
|---|---|---|---|
| Streptococcus pneumoniae | $\leq2$ | 4 | $\geq8$ |
| Streptococcus spp. Other than | |||
| Streptococcus pneumoniae | $\leq2$ | 4 | $\geq8$ |
Recommended Quality Control Organisms
| Quality Control Strain | MIC Range | Source |
|---|---|---|
| Streptococcus pneumoniae ATCC 49619 | 0.5-2 $ μg/mL $ | NCCLS |
4
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three horizontal lines above it, representing the agency's mission to promote health and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle symbol. The logo is in black and white.
APR 2 9 2005
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Monica Evelyn Giguere Regulatory Affairs Specialist BD Diagnostics Systems Becton, Dickinson and Company 7 Loveton Circle Sparks, MD 21152
K050747 Re:
R0507 . .
Trade/Device Name: BD PhoenixTM Automated Microbiology System Levofloxacin (0.25-16 µg/mL) - Streptococcus 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: March 18, 2005 Received: March 22, 2005
Dear Ms. Giguere:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your bector of the device is substantially equivalent (for the indications felerenced above and have acterimes as a microse devices marketed in interstate for use stated in the encrosule) is regars and ment date of the Medical Device Amendments, or to comments proc to May 20, 1978, the occordance with the provisions of the Federal Food, Drug, devices that have occh recuire approval of a premarket approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a premarket approval application (PM allu Cosmetic Act (1101) that do not requesable to the general controls provisions of the Act. The r ou may, therefore, market and act include requirements for annual registration, listing of general controls provisions or ractice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), If your device is classified (860 as 10) throls. Existing major regulations affecting your device It may be subject to Such additional come Regulations (CFR), Parts 800 to 895. In addition, FDA can be found in Thic 21, Cours ents concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that 1 Dri 3 issuated or woulder complies with other requirements of the Act that I DA has made a doted regulations administered by other Federal agencies. You must of ally if ederal statutes and regulance and limited to: registration and listing (21 Comply with the Free 5 require Parts 801 and 809); and good manufacturing practice CFR Part 807), labeling (21 CF quality systems (QS) regulation (21 CFR Part 820).
5
Page 2 -
This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to ogin manismig of substantial equivalence of your device to a legally premarket notification: "The PDT Intamig cification 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, of f If you desire specific information assuments of your device, please contact the Office of In of questions on the promotion and Safety at (240)276-0484. Also, please note the ville Diagnostic Device Device by reference to premarket notification" (21 CFR Part 807.97). Tegulation other general information on your responsibilities under the Act from the You may of amall Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html
Sincerely yours,
Sally 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
6
Page 1 of 1
510(k) Number: K050742
Device Name: BD Phoenix™ Automated Microbiology System for use with the antimicrobial agent Device Name: " BDTHochix" - Tureptococcus ID/AST or AST only Phoenix Panels.
Indications for Use:
The BD Phoenix™ Automated Microbiology System is intended for in vitro quantitative determination of The BD Phoenix™ Automated witchology Uystem is mation (MIC) of most Gram-negative aerobice aetobic and antimicrobial susceptibility of inimal inincitory obiteriaceae and Non-Enterobacteriaceae
facultative anaerobic bacteria isolates from pure culture for Execuences of Starbul iacultative anaeroone bacteria isolates from pure culture belonging to the genera Staphylococcus, Enterococcus and Streptococcus.
Enterococcus and Streplococcus.
This premarket notification of the antimicrobial agent levolfoxacin at concern has been have to This premarket notification is for the addition of the untinue of the other his been shown to be 0.25-16 ug/mL to Streptococcus DIAST of AST only I notime parties "Every Lesseribed in the FDA-approved package insert for this antimicrobial agent.
Active In Vitro and in Clinical Infections Against:
Streptococcus pneumoniae (including penicillin-resistant strains) Streptococcus pyogenes
Active In Vitro Against:
Streptococcus (Group C) Streptococcus (Group G) Streptococcus agalactiae Streptococcus viridans group (Viridans group streptococci, Streptococcus (Group F), and Streptococcus milleri)
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)
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K050747