← Product Code [LON](/submissions/MI/subpart-b%E2%80%94diagnostic-devices/LON) · K250344 # BD Phoenix™ Automated Microbiology System (K250344) _Becton, Dickinson and Company · LON · Mar 6, 2025 · Microbiology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/MI/subpart-b%E2%80%94diagnostic-devices/LON/K250344 ## Device Facts - **Applicant:** Becton, Dickinson and Company - **Product Code:** [LON](/submissions/MI/subpart-b%E2%80%94diagnostic-devices/LON.md) - **Decision Date:** Mar 6, 2025 - **Decision:** SESE - **Submission Type:** Special - **Regulation:** 21 CFR 866.1645 - **Device Class:** Class 2 - **Review Panel:** Microbiology ## Indications for 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. ## Device Story BD Phoenix M50 Automated Microbiology System performs antimicrobial susceptibility testing. Modification introduces BDXpert 2.0, enabling connectivity to BD Synapsys Informatics Solution and codifying previously custom user-defined rules into the system. System operates in clinical microbiology laboratories; used by laboratory personnel to automate susceptibility reporting. Output provides antimicrobial susceptibility results to clinicians for therapeutic decision-making. Modifications are limited to the M50 instrument configuration. ## Clinical Evidence Bench testing only. Software verification and validation activities conducted in accordance with ISO 13485:2016, IEC 62304:2015, and ISO 14971:2019 demonstrate that the BD Phoenix instrument connected to Synapsys performs as intended. ## Technological Characteristics Automated microbiology system for antimicrobial susceptibility testing. Connectivity via BD Synapsys Informatics Solution. Software-based rule engine (BDXpert 2.0) for automated interpretation of susceptibility data. System architecture supports integration with laboratory informatics. ## Regulatory 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. ## Special Controls *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.” ## Predicate Devices - BD Phoenix™ Automated Microbiology System ([K131331](/device/K131331.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0} FDA U.S. FOOD & DRUG ADMINISTRATION # SPECIAL 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ## I Background Information: A 510(k) Number K250344 B Applicant Becton, Dickinson and Company C Proprietary and Established Names BD Phoenix Automated Microbiology System 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 Review Summary: This 510(k) submission contains information/data on modifications made to the submitter's own CLASS II device requiring a 510(k). The following items are present and acceptable: 1. The name and 510(k) number of the SUBMITTER'S previously cleared device. 2. Submitter's statement that the INDICATIONS FOR USE/INTENDED USE of the modified device as described in its labeling HAS CHANGED along with the proposed labeling which includes user manuals. Labeling changes are considered minor and do not affect the intended use/indications for use of the original or modified device. The changes in the Indications for Use statement of the modified device (K250344) aim to: a) Apply minor clarifying changes to the text to simplify the language and remove redundancies. Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993-0002 www.fda.gov {1} 3. A description of the device **MODIFICATION(S)**, including clearly labeled diagrams, engineering drawings, photographs, user's and/or service manuals in sufficient detail to demonstrate that the **FUNDAMENTAL SCIENTIFIC TECHNOLOGY** of the modified device **has not changed**. Changes were made to the BDXpert System to: a) Allow for connectivity to the BD Synapsys Informatics Solution and b) Add utility to BDXpert that codifies functionality previously created by customers using custom rules. The new configuration of BDXpert is referred to as BDXpert 2.0, which is a separate product to BDXpert on standalone Phoenix and on EpiCenter (referred to as Legacy BDXpert). The device modifications under K250344 are only applicable to the BD Phoenix M50 Automated Microbiology System Instrument. The changes in the labeling of the modified device (K250344) aim to provide the End User/Customer with a set of updated operational documents (i.e., BDXpert User’s Manual, BD Phoenix M50 Instrument User’s Manual, and Synapsys User’s Manual). 4. Comparison Information (i.e., similarities and differences) to the submitter's legally marketed predicate device including, labeling, intended use, and physical characteristics. 5. A Design Control Activities Summary which includes: a) Identification of Risk Analysis method(s) used to assess the impact of the modification on the device and its components, and the results of the analysis. b) Based on the Risk Analysis, an identification of the verification and/or validation activities required, including methods or tests used and acceptance criteria to be applied. The labeling for this modified subject device has been reviewed to verify that the indication/intended use for the device is unaffected by the modification. In addition, the submitter's description of the particular modification(s) and the comparative information between the modified and unmodified devices demonstrate that the fundamental scientific technology has not changed. The submitter has provided the design control information as specified in The New 510(k) Paradigm and on this basis, I recommend the device be determined substantially equivalent to the previously cleared device. K250344 - Page 2 of 2 --- **Source:** [https://fda.innolitics.com/submissions/MI/subpart-b%E2%80%94diagnostic-devices/LON/K250344](https://fda.innolitics.com/submissions/MI/subpart-b%E2%80%94diagnostic-devices/LON/K250344) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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