(88 days)
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No
The document describes a "growth-based algorithm" for phenotypic detection, which is a standard computational method in microbiology, not indicative of AI/ML. There are no mentions of AI, ML, deep learning, neural networks, or similar terms.
No.
The device is an in vitro diagnostic (IVD) system used for identifying microorganisms and determining their antimicrobial susceptibility, which provides information for clinicians but does not directly treat or prevent a disease in a patient.
Yes
The device is intended for in vitro rapid identification and quantitative determination of antimicrobial susceptibility, and for phenotypic detection of carbapenemase-production, all of which are diagnostic functions.
No
The device description explicitly lists hardware components including the "BD Phoenix instrument" and "BD Phoenix panels containing biochemicals". While software is mentioned as part of the system, it is not the sole component.
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 the in vitro rapid identification (ID) and quantitative determination of antimicrobial susceptibility..." and the CPO detect test is a "qualitative confirmatory test that uses a growth-based algorithm intended to phenotypically detect carbapenemase-production...". The term "in vitro" is a key indicator of an IVD.
- Device Description: The description details a system that analyzes biological samples (bacterial isolates) outside of the body using reagents and instruments to provide diagnostic information (identification and susceptibility).
- Performance Studies: The document describes clinical studies and performance metrics (PPA, NPA, sensitivity, specificity) which are typical for the validation of IVD devices.
- Predicate Device: The mention of a "Predicate Device(s)" with K numbers (which are FDA premarket notification numbers) further confirms that this device is being submitted as an IVD, as predicate devices are used for comparison in the regulatory process for IVDs.
N/A
Intended Use / Indications for Use
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 Enterobacteriaceae and non-Enterobacteriaceae.
BD Phoenix CPO detect is a qualitative confirmatory test that uses a growth-based algorithm intended to phenotypically detect carbapenemase-production in Enterobacteriaceae, Pseudomonas aeruginosa, and Acinetobacter baumannii on Gram-negative ID/AST or AST only Phoenix panels. The test also provides the Ambler classification (Class B and Class D) of the carbapenemase produced. One of three test configurations are available per panel for carbapenemase detection with/without Ambler classification for the target organism groups. BD Phoenix CPO detect does not report multiple classes of carbapenemases from a single isolate.
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. The system includes the following components:
- BD Phoenix instrument and software.
- BD Phoenix panels containing biochemicals for organism ID testing and antimicrobial agents for 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.
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. Phoenix panels are inoculated with a specified organism density and placed into the instrument. Inoculum for use with the Phoenix system may be prepared either manually or may be automated using the BD Phoenix™ AP System.
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° ± 1°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 not susceptible.
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 fresh and stock isolates were tested across multiple sites. Challenge isolates obtained from domestic and international sources were also tested at these sites. 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 composite reference method. Phenotypic testing to detect the presence of carbapenemase expression included the CLSI-recommended modified Carbapenem Inactivation Method (mCIM) assay and carbapenem MIC results. Genotypic testing was used to assign the Ambler classification of the enzyme based on detection of gene or genes using multiplex PCR.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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 triplicate on three different days using Gram Negative Phoenix panels containing CPO detect and associated reagents. The results of the study demonstrate that for the CPO detect test and the Gram-negative organisms tested there was an overall reproducibility across test sites of greater than 95% agreement when compared to the expected result.
Clinical Studies
Clinical fresh and stock isolates were tested across multiple sites to demonstrate the performance of the BD Phoenix™ CPO detect test with multiple lots of BD Phoenix Gram Negative panels. Challenge isolates obtained from domestic and international sources were also tested at these sites. 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 composite reference method. Phenotypic testing to detect the presence of carbapenemase expression included the CLSI-recommended modified Carbapenem Inactivation Method (mCIM) assay and carbapenem MIC results. Genotypic testing was used to assign the Ambler classification of the enzyme based on detection of gene or genes using multiplex PCR.
Accuracy of the CPO detect test to detect carbapenemase producing organisms was measured by calculating the number of false positive and false negative results. The performance for carbapenemase classification as Ambler Class A, or Class D was evaluated using positive percent agreement (PPA) and negative percent agreement (NPA).
Performance of BD Phoenix™ Automated Microbiology System for Gram-negative Organisms
Total 1452 isolates were tested for detection of carbapenemase.
TP: 476, FN: 10, TN: 932, FP: 34.
PPA: 97.9%, NPA: 96.5%.
BD Phoenix™ CPO detect: Carbapenemase Classification 9 Well Configuration
For N=1357*, Class A PPA = 122/128 = 95.3%, NPA = 1221/1229 = 99.3%.
For N=1357*, Class B PPA = 126/134 = 94.0%, NPA = 1205/1223 = 98.5%.
For N=1357*, Class D PPA = 134/141 = 95.0%, NPA = 1208/1216 = 99.3%.
For N=1452**, Class A PPA = 123/147 = 83.7%, NPA = 1290/1305 = 98.9%.
For N=1452**, Class B PPA = 128/168 = 76.2%, NPA = 1265/1284 = 98.5%.
For N=1452**, Class D PPA = 135/157 = 86.0%, NPA = 1282/1295 = 99.0%.
BD Phoenix™ CPO detect: Carbapenemase Classification 6 Well Configuration*
For N=1039*, Class A PPA = 106/112 = 94.6%, NPA = 927/927 = 100.0%.
For N=1039*, Class B PPA = 81/84 = 96.4%, NPA = 942/955 = 98.6%.
For N=1039*, Class D PPA = 97/98 = 99.0%, NPA = 938/941 = 99.7%.
For N=1099**, Class A PPA = 107/128 = 83.6%, NPA = 964/971 = 99.3%.
For N=1099**, Class B PPA = 82/108 = 75.9%, NPA = 978/991 = 98.7%.
For N=1099**, Class D PPA = 97/105 = 92.4%, NPA = 991/994 = 99.7%.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Positive Percent Agreement (PPA), Negative Percent Agreement (NPA).
For detection of carbapenemase: PPA = 97.9%, NPA = 96.5% (N=1452).
Also reported for Ambler Classification (Class A, Class B, Class D) for 9-well and 6-well configurations, with various sample sizes (N=1357, N=1452, N=1039, N=1099). Please refer to the "Summary of Performance Studies" for the detailed PPA and NPA values for each class and configuration.
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.
BD Phoenix™ Automated Microbiology System – GN, BD Phoenix™ Confirmatory ESBL Test (K033458, May 28, 2004)
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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September 21, 2018
Becton,Dickinson and Company Monica Giguere Regulatory Affairs Project Manager 7 Loveton Circle MC 694 Sparks, Maryland 21152
Re: K181665
Trade/Device Name: BD Phoenix Automated Microbiology System - BD Phoenix CPO detect - GN 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: June 19, 2018 Received: June 25, 2018
Dear Monica Giguere:
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. 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 located 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.
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
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- for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Steven R. Gitterman -S for
Uwe Scherf, M.Sc., Ph.D. Director Division of Microbiology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K181665
Device Name
BD Phoenix™ Automated Microbiology System - BD Phoenix™ CPO detect - GN
Indications for Use (Describe)
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 Enterobacteriaceae and non-Enterobacteriaceae.
BD Phoenix CPO detect is a qualitative confirmatory test that uses a growth-based algorithm intended to phenotypically detect carbapenemase-production in Enterobacteriaceae, Pseudomonas aeruginosa, and Acinetobacter baumannii on Gram-negative ID/AST or AST only Phoenix panels. The test also provides the Ambler classification (Class B and Class D) of the carbapenemase produced. One of three test configurations are available per panel for carbapenemase detection with/without Ambler classification for the target organism groups. BD Phoenix CPO detect does not report multiple classes of carbapenemases from a single isolate.
| 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
| SUBMITTED BY: | Becton, Dickinson and Company
7 Loveton Circle MC 694
Sparks, MD 21152
Phone: 410-316-4827
Fax: 410-316-4499 |
|------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| CONTACT NAME: | Monica Giguere, RAC
Regulatory Affairs Project Manager |
| DATE PREPARED: | June 19, 2018 |
| DEVICE TRADE NAME: | BD Phoenix™ Automated Microbiology System –
BD Phoenix™ CPO detect - GN |
| DEVICE COMMON NAME: | Antimicrobial susceptibility test system-short incubation |
| DEVICE CLASSIFICATION: | 21 CFR 866.1645
Fully Automated Short-Term Incubation Cycle
Antimicrobial Susceptibility System.
(Product Code LON) |
| PREDICATE DEVICES: | BD Phoenix™ Automated Microbiology System – GN
BD Phoenix™ Confirmatory ESBL Test |
| INTENDED USE: | 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
Enterobacteriaceae and non-Enterobacteriaceae. |
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.
- BD Phoenix panels containing biochemicals for organism ID testing and antimicrobial agents for 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 containing dried reagents. Organisms for susceptibility testing must be a pure culture and preliminarily identified as a Gram-negative or Gram-positive isolate. Phoenix panels are inoculated with a specified organism density and placed into the instrument. Inoculum for use with the Phoenix system may be prepared either manually or may be automated using the BD Phoenix™ AP System.
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° ± 1°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 not susceptible.
DEVICE COMPARISON:
The BD Phoenix CPO detect test and the predicate device (BD Phoenix™ Confirmatory ESBL Test, K033458, May 28, 2004) have the following similarities:
- . Both tests are included on BD Phoenix™ GN panels
- Both use isolated colonies taken from culture
- . Both are prepared from colonies using the direct inoculation method
- Both use the same inoculum concentration
- Both tests use automated growth-based technology
- . Both incubate for