K Number

Device Name

BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - VANCOMYCIN (0.5-32 UG/ML)

Manufacturer

BECTON, DICKINSON & CO.

Date Cleared

2013-07-10

(62 days)

Product Code

LON

Regulation Number

866.1645

Intended 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, Enterococcus and Streptococcus. This premarket notification is for a modification of the algorithm for Vancomycin (0.5-32 ug/mL) with Enterococcus species and Staphylococcus species and updates for software from the last software cleared by FDA under K040099 through version 6.01. Vancomycin 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: Enterococci (e.g., Enterococcus faecalis) Staphylococci, including Staphylococcus aureus and Staphylococcus epidermidis (including heterogeneous methicillin-resistant strains).

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 PhoenixTM 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° ± 19C. 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).

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

VITEK® System (PMA No. N50510)

Reference Devices

K040099

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes an automated microbiology system that uses a broth microdilution method and a redox indicator to determine bacterial growth and susceptibility. While it uses an "algorithm" for interpretation, there is no mention of AI, ML, deep learning, or any related concepts. The performance evaluation focuses on agreement with reference methods, not on training or testing AI/ML models.

Therapeutic

No
The device is an in vitro diagnostic (IVD) device used for identifying microorganisms and determining their antimicrobial susceptibility, rather than providing direct therapeutic treatment to a patient.

Diagnostic

Yes

The device is intended for the "in vitro quantitative determination of antimicrobial susceptibility by minimal inhibitory concentration (MIC)" and provides "identification of the isolate, minimum inhibitory concentration (MIC) values and category interpretations, S, I, R or N (susceptible, intermediate, resistant or not susceptible)", which are all diagnostic functions determining the presence, absence, or characteristics of a disease or condition.

SaMD (Software as a Medical Device)

The device is described as an automated system that includes hardware components (instrument, panels, broths, indicator solution) in addition to software. While the submission focuses on a software modification, the overall device is not software-only.

IVD (In Vitro Diagnostic)

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)..." and "in vitro quantitative determination of antimicrobial susceptibility...". The term "in vitro" is a key indicator of an IVD.
Device Description: The description details a system that analyzes biological samples (bacterial isolates from pure culture) outside of the body using reagents and instruments to provide diagnostic information (antimicrobial susceptibility).
Performance Studies: The performance studies involve testing bacterial isolates and comparing the results to reference methods, which is typical for validating an IVD.

The device performs tests on biological samples in vitro (outside the living organism) to provide information about the susceptibility of bacteria to antimicrobial agents, which is used for diagnostic purposes in a clinical setting.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

This premarket notification is for a modification of the algorithm for Vancomycin (0.5-32 ug/mL) with Enterococcus species and Staphylococcus species and updates for software from the last software cleared by FDA under K040099 through version 6.01.

Vancomycin 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:

Enterococci (e.g., Enterococcus faecalis)

Staphylococci, including Staphylococcus aureus and Staphylococcus epidermidis (including heterogeneous methicillin-resistant strains).

Product codes (comma separated list FDA assigned to the subject device)

LON

Device Description

. 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 PhoenixTM 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° ± 19C. 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

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

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-positive isolates. Each site tested the isolates in triplicate on three different days using one lot of Gram Positive Phoenix panels containing this antimicrobial agent and associated reagents.

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 a Gram Positive Phoenix Panel 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 CLSI 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 for inoculum prepared manually and inoculum prepared with the BD Phoenix™ AP instrument when compared with the CLSI reference broth microdilution method. This premarket notification is for a modification of a portion of the algorithm for Vancomycin (0.5-32 µg/mL) with Enterococcus species and Staphylococcus species and updates for software from the last software cleared by FDA under K040099 through software version 6.01.

The results of the reproducibility study demonstrate that for this antimicrobial agent and the Gram-positive organisms tested there was an overall reproducibility across test sites of greater than 95% (+/- 1 dilution) agreement when compared to the test mode.

The performance of the Phoenix System was assessed by calculating Essential Agreement (EA) and Category Agreement (CA) to expected/reference results for all isolates tested. Essential Agreement (EA) 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, resistant or not susceptible).

For Vancomycin (0.5-32 µg/mL): EA (n) = 1538, EA (%) = 99.0, CA (n) = 1538, CA (%) = 99.6.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Essential Agreement (EA) and Category Agreement (CA).
For Vancomycin (0.5-32 µg/mL): EA (%) = 99.0, CA (%) = 99.6.

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.

VITEK® System (PMA No. N50510)

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

Regulation Number and Section

§ 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.”

Summary

K/3/331

BD Phoenix™ Automated Microbiology System Vancomycin (VA_18, 0.5-32 µg/mL) - GP and Phoenix Instrument SW Update through Version 6.01

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510(k) SUMMARY

SUBMITTED BY:	Becton, Dickinson and Company 7 Loveton Circle Sparks, MD 21152 Phone: 410-316-4287 Fax: 410-316-4499	JUL 1 0 2013
CONTACT NAME:	Monica E. Giguere, RAC Regulatory Affairs Project Manager
DATE PREPARED:	May 3, 2013
DEVICE TRADE NAME:	BD Phoenix™ Automated Microbiology System - Vancomycin (0.5-32 µg/mL) and Software Update through Version 6.01
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:	VITEK® System (PMA No. N50510)
INTENDED USE:	The BD Phoenix Automated Microbiology System is intended for the in vitro rapid identification (ID) of gram positive bacteria from pure culture belonging to the genera Staphylococcus, Enterococcus, other gram positive cocci and gram positive bacilli. The BD Phoenix Automated Microbiology System is also intended for the quantitative determination of antimicrobial susceptibility by minimal inhibitory concentration (MIC) of most gram positive bacteria isolates from pure culture belonging to the genera Staphylococcus and Enterococcus.

DEVICE DESCRIPTION:

. 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. .

BD Phoenix™ Automated Microbiology System Vancomycin (VA 18, 0.5-32 µg/mL) ~ GP and Phoenix Instrument SW Update through Version 6.01

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DEVICE COMPARISON:

SUMMARY OF SUBSTANTIAL EQUIVALENCE TESTING:

The BD Phoenix™ Automated Microbiology System has demonstrated substantially equivalent performance when compared to the CLSI reference broth microdilution method (AST panels prepared according to CLSI M7). The system has been evaluated as defined in the FDA guidance document. "Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems; Guidance for Industry and FDA)", August 28, 2009. Shelf life (stability data) for the drug is being collected and will be maintained on file at BD as indicated in the guidance document.

Site Reproducibility

The results of the study demonstrate that for this antimicrobial agent and the Gram-positive organisms tested there was an overall reproducibility across test sites of greater than 95% (+/- 1 dilution) agreement when compared to the test mode.

Clinical Studies

The following table summarizes the performance for Clinical and Challenge isolates tested in this study.

Antimicrobial	Concentration	EA (n)	EA (%)	CA (n)	CA (%)
Vancomycin	0.5-32 $µg/mL$	1538	99.0	1538	99.6

Performance of BD Phoenix System for Gram-Positive Organisms by Vancomvein

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", August 28, 2009. 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.

Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three legs, representing the department's mission to protect the health of all Americans and provide essential human services. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

Becton, Dickinson and Company c/o Monica Giguere Regulatory Affairs Project Manager BD Diagnostic System 7 Loveton Circle- MC614 Sparks, MD. 21152

July 10, 2013

Re: K131331

Trade/Device Name: BD Phoenix™ Automated Microbiology System- Vancomycin (0.5-32ug/mL) - Gram Positive ID/AST or AST only Phoenix Panels and update to the BD Phoenix Software through Version 6.01 Regulation Number: 21 CFR §866.1645 Regulation Name: Fully Automated Short-Term Incubation Cycle Antimicrobial Susceptibility System Regulatory Class: II Product Code: LON Dated: May 3, 2013 Received: May 13, 2013

Dear Ms. 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. 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 Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements

Page 2-Ms. Giguere

as set forth in the quality systems (QS) regulation (21 CFR Part 820): and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYowIndustry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincercly yours.

Uwe Scherf -S for

Sally A. Hojvat, M.Sc., Ph.D Director Division of Microbiology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

Page 1_of 1

INDICATIONS FOR USE

510(k) Number: K131331

Device Name: Vancomycin (VA - Gram-Positive ID/AST or AST only Phoenix Panels) and update to the BD Phoenix Software through Version 6.01.

Indications for Use:

Vancomycin 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:

Enterococci (e.g., Enterococcus faecalis)

Staphylococci, including Staphylococcus aureus and Staphylococcus epidermidis (including heterogeneous methicillin-resistant strains).

Prescription Use (Per 21 CFR 801.109) Over-the-Counter Use

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

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BD Diagnostic Systems Becton, Dickinson and Company