(28 days)
Not Found
No
The device description mentions a "rule-based software tool" (BDXpert™ System) and standard software verification and validation, but does not mention AI or ML.
No.
The device is intended for in vitro rapid identification and antimicrobial susceptibility testing, which provides diagnostic information rather than directly treating a disease or condition.
Yes
The device is intended for in vitro rapid identification (ID) and quantitative determination of antimicrobial susceptibility, providing minimal inhibitory concentration (MIC) values and category interpretations (susceptible, intermediate, resistant) for bacterial isolates, which are diagnostic activities.
No
The device description clearly outlines a system that includes the BD Phoenix instrument, which is an automated system utilizing physical components (redox indicator, turbidity measurements) to perform identification and susceptibility testing. While the BDXpert and Synapsys components are software-based, they are integrated with and rely on the data generated by the hardware instrument. The 510(k) summary describes a system that includes both hardware and software.
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 rapid identification (ID) and the quantitative determination of antimicrobial susceptibility... of most Gram-positive bacteria... and of most Gram-negative aerobic and facultative anaerobic bacteria isolates from pure culture". The term "in vitro" is a key indicator of an IVD.
- Device Description: The description details how the system analyzes bacterial growth in the presence of antimicrobial agents using a redox indicator and turbidity measurements. This process is performed on biological samples (bacterial isolates) outside of the human body, which is the definition of an in vitro diagnostic test.
- Care Setting: The intended user is in a "Clinical lab setting", which is where IVD testing is typically performed.
The information provided clearly aligns with the definition and function of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The BD Phoenix Automated Microbiology System is intended for the in vitro rapid identification (ID) and the quantitative determination of antimicrobial susceptibility by minimal inhibitory concentration (MIC) of most Gram-positive bacteria from pure culture belonging to the genera Staphylococcus, other gram positive cocci and gram positive bacilli and of most Gram-negative aerobic and facultative anaerobic bacteria isolates from pure culture for Enterobacteriaceae and Non-Enterobacteriaceae.
Product codes (comma separated list FDA assigned to the subject device)
LON
Device Description
BD Phoenix is an automated system for the rapid identification (ID) and antimicrobial susceptibility testing (AST) of clinically relevant bacterial isolates. The BD Phoenix System utilizes a redox indicator to detect 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 Phoenix instrument reads and records 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).
The BDXpert™ System is a rule-based software tool that provides expert advice based on organism ID and AST results obtained by broth micro-dilution on the BD Phoenix Instruments. BDXpert rule development is based on published information available through standards organizations, current scientific literature, and FDA's STIC; custom rules may be user defined if desired. The BDXpert System rule logic is applied to the susceptible, intermediate, and resistant (SIR) result, which is based on the breakpoint table and interpretation rule set included either in the BDXpert System on the standalone Phoenix instruments or through the BDXpert System on the connected BD EpiCenter™ data management system (EpiCenter) or BD Synapsys™ Informatics Solution (Synapsys). The resulting instrument report contains information such as: MIC interpretation, BDXpert rules, special messaging, resistance markers, etc. The expert results can then be sent to the Laboratory Information System (LIS).
Synapsys is a browser-based software platform operating in the clinical lab setting, offering secure connectivity and data storage, integrated workflows, and analytics tools. Synapsys consists of software servers operating the application and database, securely networked through a facility IT infrastructure to diagnostic instrumentation, external healthcare IT systems such as the LIS, and browser-enabled client devices for operating the system. Synapsys connects BD lab automation and diagnostic instruments to a common database and provides a single user interface to integrate laboratory workflows. Synapsys provides bi-directional communication with BD Phoenix and is able to process ID and AST results received from a BD Phoenix instrument. The system will automatically associate a known organism ID result, regardless of source, to any ID/AST or AST only Phoenix panel(s) that have the same accession/isolate number and lack an organism ID.
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
Not Found
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance testing was conducted to verify compliance with specified design requirements in accordance with ISO 13485:2016, IEC 62304:2015, ISO 14971:2019 and FDA guidance for the "Content of Premarket Submissions for Device Software Functions" (issued June 14, 2023). Software verification and validation activities demonstrate that BD Phoenix Instrument connected to Synapsys will perform as intended when used in accordance with device labeling.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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).
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.”
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March 6, 2025
Becton, Dickinson and Company Katherine Cicala Senior Regulatory Affairs Specialist 7 Loveton Circle Sparks, Maryland 21152
Re: K250344
Trade/Device Name: BD Phoenix™ Automated Microbiology System 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: February 6, 2025 Received: February 6, 2025
Dear Katherine Cicala:
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/cdrb/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.
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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 (QS) 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 OS 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.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
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 mediation-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) K250344
Device Name
BD Phoenix™ Automated Microbiology System
Indications for Use (Describe)
The BD Phoenix Automated Microbiology System is intended for the in vitro rapid identification (ID) and the quantitative determination of antimicrobial susceptibility by minimal inhibitory concentration (MIC) of most Gram-positive bacteria from pure culture belonging to the genera Staphylococcus, other gram positive cocci and gram positive bacilli and of most Gram-negative aerobic and facultative anaerobic bacteria isolates from pure culture for Enterobacteriaceae and Non-Enterobacteriaceae.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov |
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
,
1. Special 510(k) Summary
Summary Preparation Date
03 Feb 2025
I. Background Information:
-
510(k) Number A. K250344
-
B. Applicant
BD Diagnostic Systems Becton, Dickinson and Company 7 Loveton Circle Sparks, Maryland 21152
Establishment Registration Number: 1119779
Contact: Katherine Cicala Telephone: 908-517-6281
- C. Proprietary and Established Names
BD Phoenix™ Automated Microbiology System
D. Regulatory Information
Table 1 - Regulatory Information
| Product Name | Product
Code(s) | Classification | Regulation Section | Panel |
|-------------------------------------------------|--------------------|----------------|------------------------------------------------------------------------------------------------------------|--------------|
| BD Phoenix™
Automated
Microbiology System | LON | Class II | 21 CFR 866.1645 - Fully
Automated Short-Term
Incubation Cycle Antimicrobial
Susceptibility System | Microbiology |
Common name: Automated microbiology system
II. Intended use/Indications for Use:
- A. Indications for Use:
The BD Phoenix Automated Microbiology System is intended for the in vitro rapid identification (ID) and the quantitative determination of antimicrobial susceptibility by minimal inhibitory concentration (MIC) of most gram-positive bacteria from pure culture belonging to the genera Staphylococcus, Enterococcus, other Gram positive cocci and gram positive bacilli and of most Gram-negative aerobic and facultative anaerobic bacteria isolates from pure culture for Enterobacteriaceae and Non-Enterobacteriaceae.
5
B. Intended Use
The BD Phoenix™ Automated Microbiology System is intended for the rapid identification (ID) and antimicrobial susceptibility testing (AST) of clinically significant bacteria. The BD Phoenix™ System provides rapid results for most aerobic and facultative anaerobic Gram-positive bacteria as well as most aerobic and facultative anaerobic Gramnegative bacteria of human origin. The BD Phoenix System is also intended for the rapid identification of yeast and yeast-like organisms.
- C. Special Conditions for Use Statements(s):
Rx- For Prescription Use Only
III. Device/System Characteristics:
- A. Device Description:
BD Phoenix is an automated system for the rapid identification (ID) and antimicrobial susceptibility testing (AST) of clinically relevant bacterial isolates. The BD Phoenix System utilizes a redox indicator to detect 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 Phoenix instrument reads and records 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).
The BDXpert™ System is a rule-based software tool that provides expert advice based on organism ID and AST results obtained by broth micro-dilution on the BD Phoenix Instruments. BDXpert rule development is based on published information available through standards organizations, current scientific literature, and FDA's STIC; custom rules may be user defined if desired. The BDXpert System rule logic is applied to the susceptible, intermediate, and resistant (SIR) result, which is based on the breakpoint table and interpretation rule set included either in the BDXpert System on the standalone Phoenix instruments or through the BDXpert System on the connected BD EpiCenter™ data management system (EpiCenter) or BD Synapsys™ Informatics Solution (Synapsys). The resulting instrument report contains information such as: MIC interpretation, BDXpert rules, special messaging, resistance markers, etc. The expert results can then be sent to the Laboratory Information System (LIS).
Synapsys is a browser-based software platform operating in the clinical lab setting, offering secure connectivity and data storage, integrated workflows, and analytics tools. Synapsys consists of software servers operating the application and database, securely networked through a facility IT infrastructure to diagnostic instrumentation, external healthcare IT systems such as the LIS, and browser-enabled client devices for operating the system. Synapsys connects BD lab automation and diagnostic instruments to a common database and provides a single user interface to integrate laboratory workflows. Synapsys provides bi-directional communication with BD Phoenix and is able to process ID and AST results received from a BD Phoenix instrument. The system will automatically associate a known organism ID result, regardless of source, to any ID/AST or AST only Phoenix panel(s) that have the same accession/isolate number and lack an organism ID.
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-
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 the detection of organism growth. The MIC is determined by comparing growth in wells containing serial two-fold dilutions of an antibiotic to the growth control wells" that contain no antibiotic. -
Substantial Equivalence Information: IV.
- Predicate Device Names(s): A.
BD Phoenix™ Automated Microbiology System
-
B. Predicate 510(k) Numbers(s):
K131331 -
C. Comparison with Predicate(s):
Table 2 - Comparison with the Predicate
| Device &
Predicate
Device(s): | Device: K250344
BD Phoenix™ Automated Microbiology System
(Synapsys connectivity) | Predicate: K131331
BD Phoenix™ Automated
Microbiology System
(EpiCenter connectivity) |
|--------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------|
| Device Trade
Name | BD Phoenix™ Automated Microbiology System | Same |
| General Device Characteristic Similarities | | |
| Intended
Use/Indications
for Use | Rapid identification (ID) and antimicrobial
susceptibility testing (AST) of clinically significant
bacteria | 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 minimal inhibitory concentration
(MIC) and categorical interpretation (S, I, R) | Same |
| Incubation Time |