(37 days)
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No
The document describes an automated microbiology system that uses a broth microdilution method and a redox indicator to determine bacterial growth and antimicrobial susceptibility. While it is automated and uses software, there is no mention of AI or ML being used in the analysis or interpretation of the results. The performance studies compare the system to a reference method, not to an AI/ML model.
No.
This device is an in vitro diagnostic (IVD) device used for identifying microorganisms and testing their antimicrobial susceptibility. It does not directly treat or diagnose a patient's condition.
Yes
The device is intended for "in vitro quantitative determination of antimicrobial susceptibility by minimal inhibitory concentration (MIC)" and for "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." This directly aligns with the function of a diagnostic device.
No
The device description explicitly states that the system includes hardware components such as the BD Phoenix instrument, panels, broths, and indicator solution, in addition to the software.
Yes, this device is an IVD (In Vitro Diagnostic).
The intended use explicitly states "intended for in vitro quantitative determination of antimicrobial susceptibility". The device description details a system that tests bacterial isolates from pure culture using a broth microdilution method with dried reagents in a panel. This process is performed outside of the living organism ("in vitro") to diagnose or provide information about a condition (antimicrobial susceptibility). The performance studies compare the device's results to a reference method for determining antimicrobial susceptibility, further confirming its diagnostic purpose.
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 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 aztreonam at concentrations of 0.5-64 ug/mL to gram-negative ID/AST or AST only Phoenix panels. Aztreonam 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:
Citrobacter species (including C. freundii) Enterobacter species (including E. cloacae) Escherichia coli Klebsiella oxytoca
Klebsiella pneumoniae Proteus mirabilis Serratia species (including S. marcescens)
Active In Vitro Against:
Aeromonas hydrophila Morganella morganii Pasteurella multocida Proteus vulgaris
Providencia stuartii Providencia rettgeri Yersinia enterocolitica
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 in vitro antimicrobial susceptibility testing (AST) of isolates. The system includes the following components:
- BD Phoenix instrument and software.
- BD Phoenix panels used for organism ID testing and antimicrobial agents for AST determinations.
- BD Phoenix ID Broth for bacterial organism suspension.
- 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.
The Phoenix panel is a sealed and self-inoculating molded polystyrene tray with 136 micro-wells containing dried regents. Organisms for susceptibility testing must be a pure culture and be isolated. For each isolate, an inoculation prepared as a gram 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 optical density and well 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 at predetermined intervals. The readings are interpreted to give Minimum Inhibitory Concentration (MIC) values and category interpretations, S, I, or R (sensitive, intermediate, or resistant).
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
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-negative 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 NCCLS reference broth microdilution method.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The BD Phoenix™ Automated Microbiology System demonstrated substantially equivalent performance when compared with the NCCLS reference broth microdilution method. This premarket notification provides data supporting the addition of this antimicrobial agent to the Gram-Negative Phoenix panels.
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's performance was evaluated as defined in the FDA Draft Guidance, "Guidance for Industry and FDA Reviewers on 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 Phoenix panels containing this antimicrobial agent and associated reagents. The results of the study demonstrate for this antimicrobial agent there was an overall intra-site and inter-site reproducibility greater than 95% for the gram-negative isolates tested.
Clinical Studies: Clinical, stock and challenge isolates were tested across multiple geographically diverse sites across the United States. 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 NCCLS reference broth microdilution method. The performance of the Phoenix System was assessed by calculating Essential Agreement (EA) and Category Agreement (CA) to the expected/reference results for all isolates tested. Essential Agreement 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 for Aztreonam (0.5-64 µg/mL). For EA, n=1470, and EA (%) = 96.2. For CA, n=1470, and CA (%) = 96.2.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Essential Agreement (EA) (%): 96.2
Category Agreement (CA) (%): 96.2
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.
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.
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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).
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§ 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.”
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510(K) SUMMARY
Image /page/0/Picture/3 description: The image shows a sequence of alphanumeric characters, specifically "K033558". The characters are printed in a bold, sans-serif font. The image appears to be a close-up of the characters, possibly extracted from a document or label.
| SUBMITTED BY: | Becton, Dickinson and Company
7 Loveton Circle
Sparks, MD 21152
Phone: 410-316-4206
Fax: (410)-316-4499 |
|------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| CONTACT NAME: | Bradford M Spring
Manager, Regulatory Affairs |
| DATE PREPARED: | November 10, 2003 |
| DEVICE TRADE NAME: | BD Phoenix™ Automated Microbiology System –
Aztreonam 0.5-64 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 Phocnix Automated Microbiology System (Phoenix System) is an automated system for the The BD I nochia Hutomatod Moroletes) = ; = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = isolates. The system includes the following components:
- BD Phoenix instrument and software. .
- DD Phoenix maudinent and between cals for organism ID testing and antimicrobial agents t for AST determinations.
- for AD Coternmantene .
- BD Phoenix AST Broth used for performing AST tests only. .
- DD Fhoonix AST Drom
BD Phoenix AST 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 The Phoemx panel Is a seated and self mocalating slitty testing must be a pure culture and containing dried reagens. Organisms for susception is solate. For each isolate, an inoculation premimarily (defirmed as a gratis candard is prepared in Phoenix ID Broth.
The Phoenix AST method is a broth based microdilution test. The Phoenix System utilizes a redox I he Phoenix AST methou is a brom oused into resence of an antimicrobial agent.
indicator for the detection of organism growth in the presence withing on wood in the de inclicator for the detection of organism grown in the proseiled unbidty are used in the clotenination Measurements of changes to the mulcator as welr as ouctory
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 The instrument nouses the panels where they are continued as "The readings are interpreted to 35 %. The mstullient takes readings of the panels of copy 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 was a fastam performance when compared with the NCCLS felerence of the BD Phoenix™ Automated Microbiology System nonineation provides cata napperving morels with this antimicrobial agent.
SUMMARY OF SUBSTANTIAL EQUIVALENCE TESTING:
The BD Phoenix™ Automated Microbiology System has demonstrated substantially qquivalent performance when compared to the NCCLS reference broth microdilution method (AST panels . FINA Develo performance which compared to the NCCLS foreited on evaluated as defined in the FDA Draft prepared according to NCCL2 MF7. The system inde over of Antimicrobial Susceptibility Devices", March 8, 2000.
Site Reproducibility
Intra- and inter-site reproducibility of this antimicrobial agent in the BD Phoenix System was Intra- and mee-sites using a panel of gram-negative isolates. Each site tested the isolates in evaluated at three shes using a parel of gram-negative Phoenix pancls containing this antimicrobial agent and associated reagents.
The results of the study demonstrate for the this antimicrobial agent there was an overal intra-site I he results of the study demonstrate for the united inter-site reproducibility greater than 95% for the gram-negative isolates tested.
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 gram-negative 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 NCCLS reference broth microdilution method.
The performance of the Phoenix System was assessed by calculating Essential Agrcement (EA) and The portunities of the 1100 expected/reference results for all isolates tested. Essential Agrocment Cutegory rigroemix (21) Phocnix™ 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-Negative Organisms by Drug Table 1:
| Antimicrobial | Concentration | and and the first and the many of the same of the first of the first of
EA (n) | Commend Canadian Comments of Children Comments
(%
EA ( | CA (n) | CA (%) |
|-------------------------------------------------------------------------------------------------------------------------------------|---------------|-----------------------------------------------------------------------------------|--------------------------------------------------------------|--------|--------|
| Comments of the control control control control control concession of the consistence of
And Concession of Children
Aztreonam | 0.5-64 µg/mL | 1470 | 96.2 | 1470 | 96.2 |
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: 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).
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is a stylized depiction of an eagle with three bars representing its wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter of the circle.
Public Health Service
DEC 1 9 2003
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Mr. Bradford M. Spring Manager, Regulatory Affairs BD Diagnostics Systems Becton, Dickinson and Company 7 Loveton Circle Sparks, MD 21152
Re: K033558
Trade/Device Name: BD Phoenix™ Automated Microbiology System Aztreonam (0.5-64 ug/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: November 10, 2003 Received: November 12, 2003
Dear Mr. Spring:
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 (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small 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/dsma/dsmamain.html.
Sincerely yours,
Steven Sutman
Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE
510(k) Number (if known): K033558
Device Name: BD Phoenix™ Automated Microbiology System for use with the antimicrobial agent aztreonam (0.5-64 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 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 aztreonam at concentrations of 0.5-64 ug/mL to gram-negative ID/AST or AST only Phoenix panels. Aztreonam 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:
Citrobacter species (including C. freundii) Enterobacter species (including E. cloacae) Escherichia coli Klebsiella oxytoca
Klebsiella pneumoniae Proteus mirabilis Serratia species (including S. marcescens)
Active In Vitro Against:
Aeromonas hydrophila Morganella morganii Pasteurella multocida Proteus vulgaris
Providencia stuartii Providencia rettgeri Yersinia enterocolitica
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)
Freddie Root
Division Sign-Off
fice of In Vitro Diagnostic Device valuation and Safety
510(k) K033558
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