(49 days)
No
The description focuses on automated processes, redox indicators, and turbidity measurements for bacterial growth and identification, without mentioning AI or ML algorithms for interpretation or decision-making. The performance studies compare results to reference methods and expected outcomes, not to the performance of an AI/ML model.
No
The device is an in vitro diagnostic (IVD) system used for identifying microorganisms and testing their antimicrobial susceptibility, which provides information for diagnosis and treatment but does not directly treat or prevent disease in a patient.
Yes
The BD Phoenix™ Automated Microbiology System is intended for the rapid identification and in vitro antimicrobial susceptibility testing of isolates. This process involves identifying microorganisms and determining their susceptibility to antimicrobial agents, which are crucial steps in diagnosing infections and guiding treatment.
No
The device description explicitly lists multiple hardware components including the "BD Phoenix instrument" and "BD Phoenix panels," in addition to the 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 antimicrobial susceptibility testing of isolates from pure culture of most aerobic and facultative anaerobic Gram-negative and Gram-positive bacteria of human origin." and "in vitro quantitative determination of the antimicrobial susceptibility... of bacteria isolates from pure culture". 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 human body to provide diagnostic information (identification and antimicrobial susceptibility).
- Performance Studies: The performance studies described involve testing bacterial isolates and comparing the results to reference methods, which is typical for validating an IVD.
- Key Metrics: The key metrics mentioned (Essential Agreement and Category Agreement) are standard measures used to evaluate the performance of IVD devices that determine antimicrobial susceptibility.
- Predicate Device(s): The listed predicate devices are also IVD systems used for similar purposes.
All of these points strongly indicate that the BD Phoenix™ Automated Microbiology System is an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The BD Phoenix™ Automated Microbiology System is intended for the rapid identification and in vitro antimicrobial susceptibility testing of isolates from pure culture of most aerobic and facultative anaerobic Gram-negative and Gram-positive bacteria of human origin.
The BD Phoenix™ Automated Microbiology System is intended for in vitro quantitative determination of THE DD I nochia antimicrobial susceptionity of minute in the for Enterobacteriaceae and Non-Enterobacteriaceae Inculture analone bacteria isolates from pure culture belonging to the genera Staphylococcus, Enterococcus and Streptococcus.
This premarket notification is for cefazolin at concentrations of 0.5-32 µg/mL to Gram-negative ID/AST or I ms premarks nonicalloris to: exemoval of the limitations for Klebsiella oxytoca and Proteus AS 1 only 1 nocher panolo was active in vitro against most strains of microorganisms listed mindow, as described in the FDA-approved package insert for this antimicrobial agent.
Product codes
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.
111 - 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 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 in the instrument.
The instrument houses the panels where they are continuously incubated at a nominal temperature of 35°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, or R (sensitive, intermediate, or resistant).
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
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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-negative isolates. Each site tested the isolates in triplicate on three different days using one lot of Gram-negative 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 the Gram-negative Phoenix panel format 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)
Site Reproducibility Study:
Type: Reproducibility study (Intra- and Inter-site)
Sample Size: Panel of Gram-negative isolates tested in triplicate on three different days.
Key Results: The results of the study demonstrate for the this antimicrobial agent there was an overall intra-site reproducibility of greater than 90% and an overall inter-site reproducibility greater than 95% for the gram-negative isolates tested.
Clinical Studies:
Type: Clinical performance study comparing to expected/reference results.
Sample Size: Not explicitly stated, but included clinical, stock, and challenge isolates from multiple geographically diverse sites.
Key Results: 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, and resistant).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Essential Agreement (EA)
Category Agreement (CA)
Intra-site reproducibility: >90%
Inter-site reproducibility: >95%
Predicate Device(s)
VITEK® System (PMA No. N50510), K020321, K020323, K020322
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.”
0
510(K) SUMMARY
| SUBMITTED BY: | Becton, Dickinson and Company
7 Loveton Circle
Sparks, MD 21152
Phone: 410-316-4938
Fax: (410)-316-4499 |
|------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| CONTACT NAME: | Janine Matlak
Regulatory Affairs Specialist |
| DATE PREPARED: | December 20, 2006 |
| DEVICE TRADE NAME: | BD Phoenix™ Automated Microbiology System -
Cefazolin 0.5-32 µg/mL |
| DEVICE COMMON NAME: | Antimicrobial susceptibility test system-short incubation |
| DEVICE CLASSIFICATION: | Fully Automated Short-Term Incubation Cycle Antimicrobial
Susceptibility Device, 21 CFR 866.1645 |
| PREDICATE DEVICES: | VITEK® System (PMA No. N50510) and BD Phoenix™
Automated Microbiology System with Gatifloxacin (K020321,
May 23, 2002), Ofloxacin (K020323, April 14, 2002), and
Levofloxacin (K020322, March 27, 2002). |
| INTENDED USE: | The BD Phoenix™ Automated Microbiology System is
intended for the rapid identification and in vitro antimicrobial
susceptibility testing of isolates from pure culture of most
aerobic and facultative anaerobic Gram-negative and Gram-
positive bacteria of human origin. |
FEB $ 2007### 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.
111 -
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.
1
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 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 in the instrument.
The instrument houses the panels where they are continuously incubated at a nominal temperature of 35°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, or R (sensitive, intermediate, or resistant).
DEVICE COMPARISON:
The BD Phoenix™ Automated Microbiology System demonstrated substantially equivalent performance when compared with the CLSI (formerly NCCLS) reference broth microdilution method. This premarket notification provides data supporting the use of the BD Phoenix™ Automated Microbiology System Gram-negative 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", February 5, 2003.
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 one lot of Gram-negative Phoenix panels containing this antimicrobial agent and associated reagents.
The results of the study demonstrate for the this antimicrobial agent there was an overall intra-site reproducibility of greater than 90% and an overall inter-site reproducibility greater than 95% for the gram-negative isolates tested.
BD Diagnostic Systems Becton, Dickinson and Company
2
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 the Gram-negative Phoenix panel format 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, and resistant).
Table 1 summarizes the performance for the isolates tested in this study.
Table 1: Performance of BD Phoenix System for Gram-Negative Organisms by Drug
| Antimicrobia | THE LEART THE FREE LER
Concentration | 197
15
Carl College | 0 | 11
- A | 0 |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------|---------------------------|--------|-------------------|----|
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Comments of Children and Children and Children and
र्
Sefazolın | e on
118/mr | 145 "
Vall | OK
| 1 0 P .
. Vall | 05 |
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", February 5, 2003. 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 and BD Phoenix™ Automated Microbiology System with Gatifloxacin (K020321, May 23, 2002), and Cefazolin (K061867, August 10, 2006).
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with outstretched wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" is arranged in a circular fashion around the emblem.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Janine Matlak Regulatory Affairs Specialist BD Diagnostics Systems Becton, Dickinson and Company 7 Loveton Circle Sparks, MD 21152
FEB $ 2007
Re: K063811 Trade/Device Name: BD Phoenix™ Automated Microbiology System Cefazolin (0.5-32 µg/mL) - Gram-Negative ID/AST or AST only with the removal of the limitations for Klebsiella oxytoca and Proteus mirabilis Regulation Number: 21 CFR 866.1645 Regulation Name: Fully Automated Short-Term Incubation Cycle Antimicrobial Susceptibility Devices Regulatory Class: Class II Product Code: LON Dated: December 20, 2006 Received: December 20, 2006
Dear Ms. Matlak:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
4
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240)276-0450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its tolli alle (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Sally, anton
Sally A. Hojvat, M.Sc., Ph.D. Director Division of Microbiology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Page 1 of 1
510(k) Number: KO6381
Device Name: BD Phoenix™ Automated Microbiology System for use with the antimicrobial agent cefazolin Device Natie. "DDT Hounds" Adoministration of AST only Phoenix panels with the removal of the limitations for Klebsiella oxytoca and Proteus mirabilis.
Indications for Use:
The BD Phoenix™ Automated Microbiology System is intended for in vitro quantitative determination of THE DD I nochia antimicrobial susceptionity of minute in the for Enterobacteriaceae and Non-Enterobacteriaceae Inculture analone bacteria isolates from pure culture belonging to the genera Staphylococcus, Enterococcus and Streptococcus.
This premarket notification is for cefazolin at concentrations of 0.5-32 µg/mL to Gram-negative ID/AST or I ms premarks nonicalloris to: exemoval of the limitations for Klebsiella oxytoca and Proteus AS 1 only 1 nocher panolo was active in vitro against most strains of microorganisms listed mindow, as described in the FDA-approved package insert for this antimicrobial agent.
Active In Vitro and in Clinical Infections Against:
Escherichia coli Proteus mirabilis Klebsiella species Enterobacter aerogenes
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 Device Evaluation (ODE)
Freddie Poole
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
KDb3811