(97 days)
VITEK® System (PMA No. N50510)
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No
The description focuses on automated broth microdilution, redox indicators, and turbidity measurements for bacterial growth determination and MIC calculation. There is no mention of AI or ML algorithms being used for interpretation or analysis.
No
The device is an in vitro diagnostic (IVD) system used to determine antimicrobial susceptibility of bacterial isolates. It does not directly treat or diagnose a disease in a patient.
Yes.
The device is intended for in vitro quantitative determination of antimicrobial susceptibility by minimal inhibitory concentration (MIC) of various bacterial isolates, which is a diagnostic purpose. It performs rapid identification (ID) and antimicrobial susceptibility testing (AST) of clinically relevant bacterial isolates, providing information used for diagnosis and treatment decisions.
No
The device description explicitly lists hardware components such as the "BD Phoenix instrument" and "BD Phoenix panels," in addition to 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 quantitative determination of antimicrobial susceptibility... of most Gram-negative aerobic and facultative anaerobic bacteria isolates from pure culture... and most Gram-positive bacteria isolates from pure culture..." This clearly indicates that the device is used to test samples outside of the body (in vitro) to diagnose or provide information about a medical condition (bacterial susceptibility to antimicrobial agents).
- Device Description: The description details the components and methodology used to perform these tests on bacterial isolates in a laboratory setting. This aligns with the nature of an in vitro diagnostic device.
- Performance Studies: The performance studies describe testing bacterial isolates in a laboratory setting and comparing the results to reference methods, which is typical for evaluating the performance of an IVD.
- Predicate Device: The mention of a "Predicate Device" (VITEK® System) which is also an automated microbiology system for identification and susceptibility testing, further supports the classification of this device as an IVD. Predicate devices are used to demonstrate substantial equivalence for new IVDs.
N/A
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 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 the antimicrobial agent ceftaroline at concentrations of 0.0625-4 ug/ml. to Gram-positive ID/AST or AST only Phoenix panels. Ceftaroline has been shown to be active in vitro against most strains of microorganisms listed below, as described in the FDA-approved package inserts for this antimicrobial agent.
Active In Vitro and in Clinical Infections Against:
Staphylococcus aureus (including methicillin-susceptible and -resistant isolates)
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 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
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 provides data supporting the use of the BD Phoenix™ Automated Microbiology System Gram positive ID/AST or AST only Phoenix panels with this antimicrobial agent.
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 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).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Performance of BD Phoenix System for Gram-Positive Organisms by Ceftaroline:
Antimicrobial: Ceftaroline (0.0625-4 µg/mL)
EA (n): 866
EA (%): 94.7
CA (n): 866
CA (%): 98.2
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).
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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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510(k) SUMMARY
JUN 0 2 2014
SUBMITTED BY: Becton, Dickinson and Company 7 Loveton Circle Sparks, MD 21152 Phone: 410-316-4287 Fax: 410-316-4188 CONTACT NAME: Monica E. Giguere, RAC Regulatory Affairs Project Manager May 22, 2014 DATE PREPARED: BD Phoenix™ Automated Microbiology System -DEVICE TRADE NAME: Ceftaroline (0.0625-4 ug/mL) Antimicrobial susceptibility test system-short incubation DEVICE COMMON NAME: DEVICE CLASSIFICATION: 21 CFR 866.1645 Fully Automated Short-Term Incubation Cycle Antimicrobial Susceptibility System. (Product Code LON) VITEK® System (PMA No. N50510) PREDICATE DEVICES: The BD Phoenix™ Automated Microbiology System is INTENDED USE: 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.
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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JURY TO WEIGH
። 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™ 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 provides data supporting the use of the BD Phoenix™ Automated Microbiology System Gram positive ID/AST or AST only Phoenix panels with this antimicrobial agent.
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
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.
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.
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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.
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).
The following table summarizes the performance for Clinical and Challenge isolates tested in this study.
| Performance of BD Phoenix System for Gram-Positive Organisms by Ceftaroline | |||||
|---|---|---|---|---|---|
| Antimicrobial | Concentration | EA (n) | EA (%) | CA (n) | CA (%) |
| Ceftaroline | 0.0625-4 µg/mL | 866 | 94.7 | 866 | 98.2 |
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------D ~~*** く ens bi n.
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.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G60 Silver Spring, MD 20993-0002
June 2nd 2014
BECTON, DICKINSON AND COMPANY MONICA E. GIGUERE REGULATORY AFFAIRS PROJECT MANAGER 7 LOVETON CIRCLE-MC 694 SPARKS. MD 21152
Rc: K140468
Trade/Device Name: BD Phoenix™ Automated Microbiology System-Ceflaroline (0.0625-4 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: May 20, 2014 Received: May 22, 2014
Dear Ms. Giguere:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave leviewed your Section 310(t) promation is substantially equivalent (for the indications feterenced above and have acternined the actreed predicate devices marketed in interstate for use stated in the encry to tegany manologic of the Medical Device Amendments, or to commerce prior to May 26, 1976, the endomine with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). alle Cosment Act (7tel) market the device, subject to the general controls provisions of the Act. You may, therefore, market the de ried, shorted, shortements for annual registration, listing of The general controls provisions 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 If your device is classified (Sec above) into time major regulations affecting your device can be may be subject to additions, Title 21. Parts 800 to 898. In addition, FDA may found in the Code of reading 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 that I DA has made a decermination an administered by other Federal agencies. You must or any Federal Statures and regulations annunbive, but not limited to: registration and listing (2 l
ess and the Act 's requirements, including, but not limited to: registrat comply with an the Act 3 requiremons, money, or ever reporting (reporting of medical
4
Page 2 - Ms. Giguere
device-related adverse events) (21 CFR 803); good manufacturing practice requirements 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 regulation (21 CFR Part 801), please It you active bivision of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part the regulations 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 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 r ou may obtain other general internation 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.
Sincerely yours,
Sally A. Hojvat -S
Sally Hojvat, M.Sc., PhD. Director, Division of Microbiology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.
510(k) Number (if known)
Device Name
BD Phoenix™ Automated Microbiology System for use with the antimicrobial agent Ceftaroline (0.0625-4 pg/ml.) -Gram-positive ID/AST or AST only Phoenix Panels.
Indications for Use (Describe)
The BD Phoenix™ Automated Microbiology System is intended for in viro quantitative devermination of animicrobial susceptibility by minimal inhibitory concentration (MIC) of most Gram-negative and facultative anaerobic bacteria isslates from pure culture for Enterobacteriaceae and most Gram-positive hacteria isolates from pure culture belonging to the genera Staphylococcus, Enterococcus and Streptococcus.
This premarket notification is for the antimicrobial agent ceftaroline at concentrations of 0.0625-4 ug/ml. to Gram-positive ID/AST or AST only Phoenix panels. Ceffaroline has been shown to be active in vitro against most strains of microorganisms listed below, as described in the FDA-approved package inserts for this antimierobial agent.
Active In Vitro and in Clinical Infections Against:
Staphylococcus aurens (including methicillin-susceptible and -resistant isolates)
Type of Use (Select one or both, as applicable)
IXI Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Ribhi Shawar -S 2014.05.29 22:09:07 -04'00'
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