(88 days)
Not Found
No
The device description details a broth-based microdilution test with automated reading and interpretation based on redox indicator changes and turbidity. While it uses a "software-driven expert system (BDXpert)" for additional comments, this is described as using "rules derived from CLSI documentation and/or the FDA-approved drug labeling," which is characteristic of a rule-based expert system, not necessarily AI/ML. There is no mention of training data, algorithms, or other indicators of AI/ML.
No.
This device is an in vitro diagnostic (IVD) system used to determine antimicrobial susceptibility, which informs diagnosis and treatment, but it does not directly provide therapy or act as a therapeutic agent itself.
Yes
This device is a diagnostic device as its intended use is for "in vitro quantitative determination of antimicrobial susceptibility by minimal inhibitory concentration (MIC)" to guide treatment decisions for bacterial infections.
No
The device description clearly outlines hardware components including a molded polystyrene tray with wells, dried reagents, a nephelometer device, an instrument for incubation and reading, and associated broths and indicators. While software is mentioned for interpretation and expert system comments, the core functionality relies on physical components and chemical reactions.
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 quantitative determination of antimicrobial susceptibility by minimal inhibitory concentration (MIC)". This clearly indicates that the device is used to test samples outside of the body to diagnose or provide information about a medical condition (in this case, bacterial susceptibility to antibiotics).
- Device Description: The description details a system that analyzes bacterial cultures in a laboratory setting using reagents and a specialized instrument. This is consistent with the nature of an in vitro diagnostic device.
- Regulatory Information: The "Intended User / Care Setting" is listed as "Prescription Use (Part 21 CFR 801 Subpart D)", which is a regulatory classification for medical devices, including IVDs.
- Performance Studies: The performance studies involve testing bacterial isolates against antimicrobial agents, which is a standard practice for evaluating the performance of IVD devices used for antimicrobial susceptibility testing.
The entire description points to a device designed and used for diagnostic purposes in a laboratory setting, which is the definition of an In Vitro Diagnostic device.
Yes
The letter explicitly states, "FDA's substantial equivalence determination also included the review and clearance of your Predetermined Change Control Plan (PCCP)." This confirms the FDA has cleared the PCCP for this device.
Intended Use / 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 and facultative anaerobic bacteria isolates from pure culture for Enterobacteriaceae and most Gram-positive bacteria isolates from pure culture belonging to the genera Staphylococcus, and Streptococcus, This premarket notification is for the BD Phoenix™ Automated Microbiology System with Ciprofloxacin at a concentration of 0.0156-4 ug/mL. Ciprofloxacin 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 koseri
Citrobacter freundii
Enterobacter cloacae
Escherichia coli
Klebsiella pneumoniae
Morganella morganii
Proteus mirabilis
Proteus vulgaris,
Providencia rettgeri
Providencia stuartii
Pseudomonas aeruginosa
Salmonella typhi
Serratia marscescens
Shigella boydii
Shigella dysenteriae
Shigella flexneri
Shigella sonnei
Active In Vitro but clinical significance is unknown
Edwardsiella tarda
Klebsiella aerogenes (formerly Enterobacter aerogenes)
Klebsiella oxytoca
Salmonella enteritidis
Product codes (comma separated list FDA assigned to the subject device)
LON
Device Description
This submission is for a range extension of a single antimicrobial cleared for use on BD Phoenix ID/AST or AST only panels. The ID portion of the ID/AST combination panel was not subject to review in this submission.
The Phoenix AST method is a broth-based microdilution test. The Phoenix panel is a sealed and self-inoculating molded polystyrene tray with 136 micro-wells containing dried reagents. The ID/AST combination panel includes an ID side (51 wells) with dried substrates for bacterial identification and an AST side (85 wells). The AST panel contains a wide range of two-fold doubling dilution concentrations of antimicrobial agents and growth and fluorescent controls at appropriate well locations. The AST panel does not include wells for isolate identification.
The Phoenix System utilizes a redox indicator for the detection of organism growth in the presence of an antimicrobial agent. The organism to be tested must be a pure culture and be preliminarily identified as Gram-positive or Gram-negative. Colonies are then suspended in ID broth and equated to a 0.5 McFarland suspension using a nephelometer device. A further dilution is made into AST broth (a cation-adjusted formulation of Mueller-Hinton broth containing 0.010% Tween 80), to which the redox-buffered oxidation-reduction AST indicator solution is added producing a blue color in the wells. The concentration of organisms in the final AST broth suspension is approximately 5 X 10^5 CFU/mL.
The Phoenix AST Broth is poured into the inoculation port of the AST panel and the inoculum flows into the panel, filling panel wells. Polyethylene caps are applied to seal the inoculation ports. An air admittance port is located in the panel lid to ensure adequate oxygen tension in the panel for the duration of the test. Inoculated panels are barcode scanned and loaded into the BD Phoenix Automated Microbiology System instrument where panels are continuously incubated at 35 degrees C +/- 1 degree C.
Continuous measurements of changes to the indicator as well as bacterial turbidity are used in the determination of bacterial growth. The instrument takes readings every 20 minutes. Organisms growing in the presence of a given antimicrobial agent reduce the indicator (changing it to a pink color). This signals organism growth and resistance to that antimicrobial agent. Organisms killed or inhibited by the antimicrobial agent do not cause reduction of the indicator and therefore do not produce a color change. The Phoenix instrument reads and records the results of the antimicrobial tests contained in the panel and interprets the reactions (based on the organism identification) to give a minimal inhibitory concentration (MIC) value and category interpretations (susceptible, intermediate, resistant, or not susceptible). AST results are available within 16 hours. This is an auto read result; no manual readings are possible with this system.
Additional comments concerning specific organism/antimicrobial combinations are provided from the software-driven expert system (BDXpert), using rules derived from CLSI documentation and/or the FDA-approved drug labeling.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use (Part 21 CFR 801 Subpart D)
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Reproducibility Study:
- Sample Size: 14 isolates of non-fastidious Gram-negative organisms.
- Data Source: Isolates were tested at three clinical sites.
- Annotation Protocol: Each isolate was tested in triplicate over three different days using both inoculation methods (manual and BD Phoenix AP). This resulted in 378 data points. Reproducibility was calculated based on MIC values falling within +/-1 dilution of the predetermined mode of the reference MIC values.
Quality Control (QC) Testing:
- Sample Size: CLSI recommended QC organisms (E.coli ATCC 25922 and P. aeruginosa ATCC 27853) were tested a sufficient number of times (at least 20/site).
- Data Source: Tested at each of three testing sites.
- Annotation Protocol: Tested using both manual (PhoenixSpec) and Phoenix AP inoculation methods and read by the BD Phoenix instrument.
Clinical Study:
- Sample Size: 47 clinical isolates (7 fresh and 40 stock Salmonella organisms).
- Data Source: Tested at three U.S. sites.
- Annotation Protocol: Results were compared to the CLSI frozen broth microdilution reference panel. The BD Phoenix Spec Nephelometer (manual inoculation) was used.
Challenge Study:
- Sample Size: 82 Salmonella organisms (stock challenge isolates).
- Data Source: Tested at each study site.
- Annotation Protocol: Results were compared to the CLSI frozen broth microdilution reference panel. The BD Phoenix Spec Nephelometer (manual inoculation) was used for initial testing. One clinical site also tested these organisms using suspensions prepared by the BD Phoenix AP instrument.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
1. Precision/Reproducibility:
- Study Type: Reproducibility study.
- Sample Size: 14 strains of Gram-negative organisms (Pseudomonas aeruginosa (1), Salmonella enterica sso. enterica serovar Paratyphi A (1), and Salmonella species (11)). Tested in triplicate over 3 days at 3 sites using two inoculation methods (manual and BD Phoenix AP), totaling 378 data points.
- Standalone Performance/Key Results: Overall reproducibility across test sites was greater than 95% (± 1 dilution) agreement when compared to the test mode.
- Manual BD PhoenixSpec Nephelometer:
- Best Case: 100% (378/378)
- Worst Case: 99.7% (377/378)
- BD Phoenix AP Instrument:
- Best Case: 100% (378/378)
- Worst Case: 99.7% (377/378)
- Manual BD PhoenixSpec Nephelometer:
2. Quality Control Testing:
- Study Type: Quality control testing.
- Sample Size: E. coli ATCC 25922 (N=171 manual, N=173 Phoenix AP) and P. aeruginosa ATCC 27853 (N=171 manual, N=173 Phoenix AP) across 3 sites.
- Standalone Performance/Key Results: Results were acceptable for greater than 95% of tests performed using both inoculation methods. Specific results are in Table 3.
- E. coli ATCC 25922: Manual Inoculation (PhoenixSpec) 89%, Phoenix AP Inoculation 82%.
- Pseudomonas aeruginosa ATCC 27853: Manual Inoculation (PhoenixSpec) 87%, Phoenix AP Inoculation 80%.
3. Method Comparison Studies (Clinical and Challenge):
- Study Type: Method comparison against CLSI frozen broth microdilution reference panel.
- Sample Size:
- Clinical: 47 Salmonella organisms (7 fresh, 40 stock).
- Challenge: 82 Salmonella organisms (including those with known resistance mechanisms).
- Combined: 129 isolates.
- Key Results (Combined Performance, Manual Inoculation Method):
- Ciprofloxacin (Salmonella)
- EA Total: 129
- EA N: 127
- %EA Total: 98.4%
- Eval EA Tot: 89
- Eval EA N: 87
- %EA Eval: 97.8%
- CA Total: 129
- CA N: 122
- %CA: 94.6%
- #R: 15
- Min (Minor Discrepancies): 7
- Maj (Major Discrepancies): 0
- Vmj (Very Major Discrepancies): 0
- Ciprofloxacin (Salmonella)
- Inoculum Preparation Methods Comparison (Challenge Isolates Only):
- The overall % EA and % CA consistently met the acceptance criteria of greater than or equal to 90%. No very major or major discrepancies with either inoculation method.
- Manual (PhoenixSpec): %EA Total 100%, %EA Eval 100%, %CA 91.5% (7 Min, 0 Maj, 0 Vmj)
- Phoenix AP: %EA Total 100%, %EA Eval 100%, %CA 95.1% (4 Min, 0 Maj, 0 Vmj)
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Essential Agreement (EA), Category Agreement (CA), Minor Discrepancies (Min), Major Discrepancies (Maj), Very Major Discrepancies (Vmj). See "Summary of Performance Studies" for specific values.
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.
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).
Establish a Pre-Determined Change Control Plan (PCCP) to address future revisions to device labeling in response to breakpoint changes that are recognized on the FDA STIC webpage.
The PCCP outlined the specific procedures and acceptance criteria that BD intends to use to evaluate the cleared BD Phoenix antimicrobial Ciprofloxacin when revised breakpoints are published on the FDA STIC webpage. The PCCP included with the submission indicated that if specific criteria are met, BD will update the device label to include (1) the new breakpoints, (2) an updated performance section after re-evaluation of data in this premarket notification with the new breakpoints, and (3) any new limitations as determined by their evaluation.
§ 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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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
March 15, 2024
Becton, Dickinson and Company Kamisha Gray Senior Regulatory Affairs Specialist 7 Loveton Circle Sparks, Maryland 21152
Re: K233986
Trade/Device Name: BD Phoenix Automated Microbiology System - GN Ciprofloxacin (0.0156-4 ug/mL) 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 15, 2023 Received: December 18, 2023
Dear Kamisha Gray:
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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
FDA's substantial equivalence determination also included the review and clearance of your Predetermined Change Control Plan (PCCP). Under section 515C(b)(1) of the Act, a new premarket notification is not required for a change to a device cleared under section 510(k) of the Act, if such change is consistent with an
1
established PCCP granted pursuant to section 515C(b)(2) of the Act. Under 21 CFR 807.81(a)(3), a new premarket notification is required if there is a major change or modification in the intended use of a device, or if there is a change or modification in a device that could significantly affect the safety or effectiveness of the device, e.g., a significant change or modification in design, material, chemical composition, energy source, or manufacturing process. Accordingly, if deviations from the established PCCP result in a major change or modification in the intended use of the device, or result in a change or modification in the device that could significantly affect the safety or effectiveness of the a new premarket notification would be required consistent with section 515C(b)(1) of the Act and 21 CFR 807.81(a)(3). Failure to submit such a premarket submission would constitute adulteration and misbranding under sections 501(f)(1)(B) and 502(o) of the Act, respectively.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (OS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safetyreporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatory
2
assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Ribhi Shawar -S
Ribhi Shawar, Ph.D. (ABMM) Branch Chief General Bacteriology and Antimicrobial Susceptibility Branch Division of Microbiology Devices OHT7: Office of In Vitro Diagnostics Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K233986
Device Name
BD Phoenix™ Automated Microbiology System - GN Ciprofloxacin (0.0156-4 ug/mL)
Indications for Use (Describe)
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 and facultative anaerobic bacteria isolates from pure culture for Enterobacteriaceae and most Gram-positive bacteria isolates from pure culture belonging to the genera Staphylococcus, and Streptococcus, This premarket notification is for the BD Phoenix™ Automated Microbiology System with Ciprofloxacin at a concentration of 0.0156-4 ug/mL. Ciprofloxacin 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 koseri | Citrobacter freundii |
|---|---|
| Enterobacter cloacae | Escherichia coli |
| Klebsiella pneumoniae | Morganella morganii |
| Proteus mirabilis | Proteus vulgaris, |
| Providencia rettgeri | Providencia stuartii |
| Pseudomonas aeruginosa | Salmonella typhi |
| Serratia marscescens | Shigella boydii |
| Shigella dysenteriae | Shigella flexneri |
| Shigella sonnei |
Active In Vitro but clinical significance is unknown
| Edwardsiella tarda | Klebsiella aerogenes (formerly Enterobacter aerogenes) |
|---|---|
| Klebsiella oxytoca | Salmonella enteritidis |
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
Summary Preparation Date: March 15, 2024
Background Information: I
A 510(k) Number
B Applicant
BD Diagnostic Systems Becton, Dickinson and Company 7 Loveton Circle Sparks, Maryland 21152 Establishment Registration Number: 1119779 Contact: Kamisha Gray Telephone: 410-316-4000
C Proprietary and Established Names
BD Phoenix™ Automated Microbiology System - GN Ciprofloxacin (0.0156-4 µg/mL)
D Regulatory Information
| Product
Code(s) | Classification | Regulation
Section | Panel |
|--------------------|----------------|----------------------------------------------------------------------------------------------------------|-------------------|
| LON | Class II | 21 CFR 866.1645 - Fully Automated Short-
Term Incubation Cycle Antimicrobial
Susceptibility System | MI - Microbiology |
II Submission/Device Overview:
A Purpose for Submission:
Range extension of Ciprofloxacin to the BD Phoenix Gram negative ID/AST and AST only Phoenix panels for Salmonella species to accommodate the updated FDA-recognized breakpoints for Salmonella as published in the FDA STIC website.
Update the BD Phoenix Gram negative ID/AST and AST only Phoenix panels (0.25 - 4 ug/mL) for the current reporting range to include updated FDA-recognized breakpoints for Enterobacterales and Pseudomonas aeruginosa, as published in the FDA STIC website.
Establish a Pre-Determined Change Control Plan (PCCP) to address future revisions to device labeling in response to breakpoint changes that are recognized on the FDA STIC webpage.
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B Measurand:
Ciprofloxacin (0.0156-4 ug/mL)
C Type of Test:
Antimicrobial Susceptibility Test (Quantitative) colorimetric, oxidation-reduction, growth based.
III Intended use/Indications for Use:
A Intended Use(s):
The BD Phoenix Automated Microbiology System is intended for the in vitro rapid identification (ID) and quantitative determination of antimicrobial susceptibility by minimal inhibitory concentration (MIC) of Gram Negative aerobic and facultative anaerobic bacteria belonging to the family Enterobacterales and non-Enterobacterales.
B Indication(s) 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 Streptococcus, and Streptococcus.
This premarket notification is for the BD Phoenix™ Automated Microbiology System with Ciprofloxacin at a concentration of 0.0156-4 ug/mL. Ciprofloxacin has been shown to be active 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:
Citrobacter koseri Citrobacter freundii Enterobacter cloacae Escherichia coli Klebsiella pneumoniae Morganella morganii Proteus mirabilis Proteus vulgaris Providencia rettgeri Providencia stuartii Pseudomonas aeruginosa Salmonella typhi Serratia marscescens Shigella boydii
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Shigella dysenteriae Shigella flexneri Shigella sonnei
Active In Vitro but clinical significance is unknown:
Edwardsiella tarda Klebsiella aerogenes (formerly Enterobacter aerogenes) Klebsiella oxytoca Salmonella enteritidis
C Special Conditions for Use Statements(s):
Rx - For Prescription Use Only
D Special Instrument Requirements:
BD Phoenix™ Automated Microbiology System and software (V2.20.0.0 or higher) PhoenixSpec™ Nephelometer BD Phoenix™ AP Instrument
IV Device/System Characteristics:
A Device Description:
This submission is for a range extension of a single antimicrobial cleared for use on BD Phoenix ID/AST or AST only panels. The ID portion of the ID/AST combination panel was not subject to review in this submission.
The Phoenix AST method is a broth-based microdilution test. The Phoenix panel is a sealed and self-inoculating molded polystyrene tray with 136 micro-wells containing dried reagents. The ID/AST combination panel includes an ID side (51 wells) with dried substrates for bacterial identification and an AST side (85 wells). The AST panel contains a wide range of two-fold doubling dilution concentrations of antimicrobial agents and growth and fluorescent controls at appropriate well locations. The AST panel does not include wells for isolate identification.
The Phoenix System utilizes a redox indicator for the detection of organism growth in the presence of an antimicrobial agent. The organism to be tested must be a pure culture and be preliminarily identified as Gram-positive or Gram-negative. Colonies are then suspended in ID broth and equated to a 0.5 McFarland suspension using a nephelometer device. A further dilution is made into AST broth (a cation-adjusted formulation of Mueller-Hinton broth containing 0.010% Tween 80), to which the redox-buffered oxidation-reduction AST indicator solution is added producing a blue color in the wells. The concentration of organisms in the final AST broth suspension is approximately 5 X 105 CFU/mL.
The Phoenix AST Broth is poured into the inoculation port of the AST panel and the inoculum flows into the panel, filling panel wells. Polyethylene caps are applied to seal the
CONFIDENTIAL AND PROPRIETARY
7
inoculation ports. An air admittance port is located in the panel lid to ensure adequate oxygen tension in the panel for the duration of the test. Inoculated panels are barcode scanned and loaded into the BD Phoenix Automated Microbiology System instrument where panels are continuously incubated at 35 ℃ ± 1 ℃.
Continuous measurements of changes to the indicator as well as bacterial turbidity are used in the determination of bacterial growth. The instrument takes readings every 20 minutes. Organisms growing in the presence of a given antimicrobial agent reduce the indicator (changing it to a pink color). This signals organism growth and resistance to that antimicrobial agent. Organisms killed or inhibited by the antimicrobial agent do not cause reduction of the indicator and therefore do not produce a color change. The Phoenix instrument reads and records the results of the antimicrobial tests contained in the panel and interprets the reactions (based on the organism identification) to give a minimal inhibitory concentration (MIC) value and category interpretations (susceptible, intermediate, resistant, or not susceptible). AST results are available within 16 hours. This is an auto read result; no manual readings are possible with this system.
Additional comments concerning specific organism/antimicrobial combinations are provided from the software-driven expert system (BDXpert), using rules derived from CLSI documentation and/or the FDA-approved drug labeling.
B Principle of Operation:
The BD Phoenix Automated Microbiology System is a broth-based microdilution method that utilizes a redox indicator (colorimetric oxidation-reduction) to enhance detection of organism growth. The MIC is determined by comparing growth in wells containing serial two-fold dilutions of an antibiotic to the growth in "growth control wells" that contain no antibiotic.
V Substantial Equivalence Information:
A Predicate Device Names(s):
BD Phoenix™ Automated Microbiology System - Moxifloxacin-0.125-8 and Ciprofloxacin-0.25-4 µg/mL
B Predicate 510(k) Numbers(s):
C Comparison with Predicate(s):
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| Device & Predicate
Device(s): | Device
K233986 | Predicate
K060217 |
|--------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------|
| | Ciprofloxacin Extended Range
(0.0156-4 μg/mL) | Ciprofloxacin (0.25-4 μg/mL) |
| Device Trade Name | BD Phoenix™ Automated Microbiology System – GN Ciprofloxacin (0.0156-4 μg/mL) | BD Phoenix™ Automated
Microbiology System – GN
Ciprofloxacin (0.25-4 μg/mL) |
| General Device Characteristic Similarities | | |
| Antimicrobial Agent | Ciprofloxacin | Same |
| Intended
Use/Indications for
Use | Determination of in vitro antimicrobial
susceptibility testing of aerobic and facultative
anaerobic Gram- negative, Gram-positive, and
Streptococcus bacteria. | Same |
| Source of
Microorganisms for
Testing | Bacterial colonies isolated from culture. | Same |
| Technology | Automated growth-based detection | Same |
| Methodology | Determination of MIC using serial two-fold
dilution format | Same |
| Read Method | Automated | Same |
| Inoculation Methods | Manual: BD PhoenixSpec nephelometer
Automated: BD Phoenix AP Instrument | Same |
| Result Reported | Report results as minimum inhibitory
concentration (MIC) and categorical
interpretation (S, I, R) | Same |
| Incubation Time | In Vitro and in Clinical Infections
Against:
Citrobacter koseri
Citrobacter freundii
Enterobacter cloacae
Escherichia coli
Klebsiella pneumoniae
Morganella morganii
Proteus mirabilis
Proteus vulgaris ,
Providencia rettgeri
Providencia stuartii
Pseudomonas aeruginosa
Salmonella typhi
Serratia marscescens
Shigella boydii
Shigella dysenteriae
Shigella flexneri
Shigella sonnei | Gram negative aerobic and
facultative anaerobic bacteria
belonging to Enterobacterales and
non-Enterobacterales |
| Device & Predicate | Device
K233986 | Predicate
K060217 |
| Device(s): | Ciprofloxacin Extended Range
(0.0156-4 µg/mL) | Ciprofloxacin (0.25-4 µg/mL) |
| | Active In Vitro but clinical significance is
unknown: | |
| | Edwardsiella tarda
Klebsiella aerogenes (formerly Enterobacter | |
| | aerogenes)
Klebsiella oxytoca
Salmonella enteritidis | |
| Breakpoints | Enterobacterales:
(S/I/R) ≤0.25 / 0.5 / ≥1
Pseudomonas aeruginosa:
(S/I/R) ≤0.5 / 1 / ≥2
Salmonella species:
(S/I/R) ≤0.0625 / 0.125-0.5 / ≥1 | Enterobacterales:
(S/I/R) ≤1 / 2 / ≥4
Pseudomonas aeruginosa:
(S/I/R) ≤1 / 2 / ≥4
Salmonella species:
(S/I/R) ≤1 / 2 / ≥4 |
| Reporting Range | Salmonella spp.
0.0156-4 µg/mL
Enterobacterales and P. aeruginosa
0.25 - 4 µg/mL | 0.25-4 µg/mL |
| Breakpoint Change
Evaluation Procedure | Procedure added | None |
Table 1. Comparison with the Predicate
9
Standards/Guidance Documents Referenced VI
- Guidance for Industry and FDA, Class II Special Controls Guidance Document: 1. Antimicrobial Susceptibility Test (AST) Systems, August 28, 2009.
-
- CLSI. Performance Standards for Antimicrobial Susceptibility Testing. 33rd ed. CLSI supplement M100. Clinical and Laboratory Standards Institute; 2023.
-
- CLSI. Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria that Grow Aerobically. 11th ed. CLSI supplement M07. Clinical Laboratory Standards Institute; 2018.
VII Performance Characteristics (if/when applicable):
A Analytical Performance
-
- Precision/Reproducibility:
Reproducibility was conducted at three clinical sites using 14 isolates of non-fastidious Gram-negative organisms. The isolates were tested at each site in triplicate over three different days using both inoculation methods (i.e., manual, BD Phoenix AP) resulting in 378 data points (14 strains x 3 replicates x 3 sites x 3 days = 378). The isolates tested in the reproducibility study included Pseudomonas aeruginosa (1). Salmonella enterica sso. enterica serovar Paratyphi A (1), and Salmonella species (11). The reproducibility was calculated based on MIC values falling within ±1 dilution of the predetermined mode of
- Precision/Reproducibility:
10
the reference MIC values. There were no "off-scale" MIC results with manually prepared inocula and one "off-scale" result with inocula prepared using the BD Phoenix AP. The best- and worst-case reproducibility was calculated as described in the AST Special Controls Guidance document. The results of the study demonstrate that for this antimicrobial agent and the Gram-negative organisms tested, there was an overall reproducibility across test sites of greater than 95% (± 1 dilution) agreement when compared to the test mode. The reproducibility results for each inoculation method are shown in Table 2.
Note: The testing for the BD Phoenix AP instrument was performed at three internal BD sites.
Table 2. Summary of Reproducibility Studies - BD Phoenix Ciprofloxacin Inoculation Method Best Case Worst Case 100% (378/378)
- Manual BD PhoenixSpec Nephelometer 100% (378/378) 99.7% (377/378) 99.7% (377/378) BD Phoenix AP Instrument
-
- Linearity:
Not applicable
-
- Analytical Specificity/Interference:
Not applicable
- Analytical Specificity/Interference:
-
- Assay Reportable Range:
Not applicable
- Assay Reportable Range:
-
- Traceability, Stability, Expected Values (Controls, Calibrators, or Methods):
Quality Control Testing:
The CLSI recommended QC organisms (E. coli ATCC 25922 and P. aeruginosa ATCC 27853) were tested a sufficient number of times (i.e., at least 20/site) at each of three testing sites. It was tested using both manual and Phoenix AP inoculation methods and read by the BD Phoenix instrument. The results are summarized in Table 3. Results were acceptable for greater than 95% of tests performed using both inoculation methods.
Note: The lower end range extension only applies to the Salmonella species. Therefore, the BD Phoenix instrument will not report an MIC below 0.25 ug/mL for E. coli or Pseudomonas aeruginosa. The expected range for Escherichia coli remains ≤0.25 µg/mL and Pseudomonas aeruginosa remains