(70 days)
No
The description focuses on automated broth microdilution and redox indicator technology for bacterial growth detection and MIC determination. There is no mention of AI or ML in the device description, intended use, or performance studies. The system relies on pre-defined algorithms based on growth patterns and indicator changes, not learning from data.
No.
This device is an in vitro diagnostic (IVD) system used to identify bacteria and determine their susceptibility to antimicrobial agents, providing information for clinicians but not directly treating patients.
Yes
Explanation: The device is intended for "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," which are diagnostic procedures. It also explicitly states it is for "in vitro diagnostic antimicrobial susceptibility testing (AST)".
No
The device description explicitly lists hardware components such as 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." The phrase "in vitro" is a key indicator of an IVD.
- Device Description: The "Device Description" section also refers to the system as an "automated system for the in vitro diagnostic antimicrobial susceptibility testing (AST) of clinically relevant bacterial isolates." Again, the term "in vitro diagnostic" is used.
- Function: The system performs tests on biological samples (bacterial isolates from pure culture) outside of the human body to provide information about the susceptibility of those bacteria to antimicrobial agents. This is the core function of an IVD used in clinical microbiology.
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 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 and Enterococcus.
This premarket notification is for the addition of the antimicrobial agent ceftazidime at concentrations of 0.5-64 µg/mL to gram-negative ID/AST or AST only Phoenix panels. Ceftazidime 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:
Citrobacter spp., excluding Citrobacter freundii Enterobacter spp., including Enterobacter cloacae, and Enterobacter aerogenes Escherichia coli
Klebsiella spp., including Klebsiella pneumoniae Proteus mirabilis Proteus vulgaris Pseudomonas spp., including Pseudomonas aeruginosa Serratia spp.
Product codes
LON
Device Description
The BD Phoenix Automated Microbiology System (Phoenix System) is an automated system for the TIF BD I nochiatod Microbial susceptibility testing (AST) of clinically relevant bacterial isolates. The system includes the following components:
- BD Phoenix instrument and software. .
- DD Phoenix markinen wining biochemicals for organism ID testing and antimicrobial agents . for AST determinations.
- 107 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 THE I nooms panel is a scaree and best for susceptibility testing must be a pure culture and comating dried reagents. Organisms for sasoppany was a solate. For each isolate, an inoculation premixalent to a 0.5 McFarland standard is prepared in Phoenix ID Broth.
The Phoenix AST method is a broth based microdilution test. The Phoenix System utilizes a redox I he I nochis 11:51 methou is a crown a growth in the presence of an antimicrobial agent. multicalor for the detection of organism growards as bacterial turbidity are used in the determination Measureinents of Changes to the maneconfiguration 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 I he instrument nouses the panels who of the panels every 20 minutes. The readings are interpreted to give an identification of the isolate, minum 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
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 different days using one lot of gram-negative Phoenix panels containing this antimicrobial agent and associated reagents. Each site tested the isolates in triplicate.
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 this antimicrobial agent. Phoenix System results for clinical isolates were compared to the results obtained from the NCCLS reference broth microdilution method.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Device Comparison: The BD Phoenix™ Automated Microbiology System demonstrated substantially equivalent performance when compared with the NCCLS reference broth microdilution method.
Summary of Substantial Equivalence Testing: The BD Phoenix™ Automated Microbiology System has demonstrated substantially equivalent performance when compared to the NCCLS reference broth microdilution method (AST panels performance when computed to the NO NO evaluated as defined in the FDA guidance propared acconding to NOODS Mr.).
Site Reproducibility: The results of the study demonstrate for the this antimicrobial agent there was an overall intra-site reproducibility greater than 90% and an overall inter-site reproducibility greater than 95% for the gram-negative isolates tested.
Clinical Studies: The performance of the Phoenix System was assessed by calculating Essential Agreement (EA) and Category Agreement (CT) Abomated Microbiology System agrees exactly or within ± (EA) occurs when are as e 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.
Performance of BD Phoenix System for Gram-Negative Organisms by Drug Table 1:
Antimicrobial: Ceftazidime
Concentration: ug/ml
n: 40
Total: 1706
Result: 04 4
Conclusions Drawn from Substantial Equivalence Studies: The data collected from the substantial equivalence studies demonstrate that testing on the BD The una concesse non are abology System with this antimicrobial agent is substantially equivalent as outlined in the FDA guidance document, "Class II Special Controls Guidance Document: as outined in the coptibility 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), Offloxacin (K020323, April 14, 2002), Levofloxacin (K020322, March 27, 2002) and Ceftazidime (K033560).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Essential Agreement (EA)
Category Agreement (CA)
Intra-site reproducibility greater than 90%
Inter-site reproducibility greater than 95%
Predicate Device(s)
VITEK® System (PMA No. N50510), K020321, K020323, K020322, K033560
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
| Ceftazidime - GN | K041384 |
|---|---|
| AUG - 3 2004 | 510(K) SUMMARY |
| SUBMITTED BY: | Becton, Dickinson and Company |
| 7 Loveton Circle | |
| Sparks, MD 21152 | |
| Phone: 410-316-4778 | |
| Fax: (410)-316-4499 | |
| CONTACT NAME: | Michelle Bytheway Bandy |
| Regulatory Affairs Specialist | |
| DATE PREPARED: | May 21, 2004 |
| DEVICE TRADE NAME: | BD Phoenix™ Automated Microbiology System - |
| Ceftazidime 0.5-64 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), | |
| Levofloxacin (K020322, March 27, 2002) and Ceftazidime | |
| (K033560, January 15, 2004). | |
| 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. |
DEVICE DESCRIPTION:
The BD Phoenix Automated Microbiology System (Phoenix System) is an automated system for the TIF BD I nochiatod Microbial susceptibility testing (AST) of clinically relevant bacterial isolates. The system includes the following components:
- BD Phoenix instrument and software. .
- DD Phoenix markinen wining biochemicals for organism ID testing and antimicrobial agents . for AST determinations.
- 107 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 panel is a sealed and self-inoculating molded polystyrene tray with 136 micro-wells THE I nooms panel is a scaree and best for susceptibility testing must be a pure culture and comating dried reagents. Organisms for sasoppany was a solate. For each isolate, an inoculation premixalent to a 0.5 McFarland standard is prepared in Phoenix ID Broth.
The Phoenix AST method is a broth based microdilution test. The Phoenix System utilizes a redox I he I nochis 11:51 methou is a crown a growth in the presence of an antimicrobial agent. multicalor for the detection of organism growards as bacterial turbidity are used in the determination Measureinents of Changes to the maneconfiguration 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 I he instrument nouses the panels who of the panels every 20 minutes. The readings are interpreted to give an identification of the isolate, minum 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 NCCLS reference broth microdilution method. This premarket performance when somparting the use of the BD Phoenix™ Automated Microbiology System notification provides and beppendly 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 NCCLS reference broth microdilution method (AST panels performance when computed to the NO NO evaluated as defined in the FDA guidance propared acconding to NOODS Mr.). Cuidance 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 millia- and micr one repression of gram-negative isolates. Each site tested the isolates in evaluated at 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 The results of the starf attem 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 Chined, stock and chance the performance of the Phoenix antimicrobial susceptibility test with the United States to demonstrate the percentaining this antimicrobial agent. Phoenix System results the gran-hegan've i noomix panel to the expected results. Phoenix System results for clinical isolates were compared to the results obtained from the NCCLS reference broth microdilution method.
The performance of the Phoenix System was assessed by calculating Essential Agreement (EA) and The percentialied of the Photomic byted/reference results for all isolates tested. Essential Agreement Category Tigroument (CT) Abomated Microbiology System agrees exactly or within ± (EA) occurs when are as e 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.
Performance of BD Phoenix System for Gram-Negative Organisms by Drug Table 1:
| And States of Children Company of Children Company of Children Company of Children
THE LEAST LE LEASE LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST
Antimicrobial | - Manager of Children
Comprehensive Adon't Research Active Comments of Children Comments of Children
Acres Property
Concentration | 5
r | 101 | n | 10/0 .
( |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------|--------|-----|------|-------------|
| - PA-
1
Ceftazidime | ug/ml
rs/ | ์ | 40 | 1706 | 04 4 |
Conclusions Drawn from Substantial Equivalence Studies
The data collected from the substantial equivalence studies demonstrate that testing on the BD The una concesse non are abology System with this antimicrobial agent is substantially equivalent as outlined in the FDA guidance document, "Class II Special Controls Guidance Document: as outined in the coptibility 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), Offloxacin (K020323, April 14, 2002), Levofloxacin (K020322, March 27, 2002) and Ceftazidime (K033560).
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 consists of a stylized eagle with three curved lines representing its body and wings. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.
Public Health Service
ood and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Michelle Bytheway Bandy Regulatory Affairs Specialist Becton, Dickinson and Company 7 Loveton Circle Sparks, MD 21152
K041384 Re: Ko 1156 .
Trade/Device Name: BD Phoenix™ Automated Microbiology System for use with the antimicrobial agent ceftazidime (0.5-64 µg/mL.) -Gram-Negative ID.AST or AST only Phoenix panels 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 24, 2004 Received: May 25, 2004
AUG - 3 2004
Dear Ms. Bandy:
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 for are waver 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 or any 1 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
Page 2
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 (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Salazar
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
5
BD PHOENIX™ Automated Microbiology System Ceftazidime - GN
Page 1 of 1
510(k) Number: K041384
D
Device Name: BD Phoenix™ Automated Microbiology System for use with the antimicrobial agent ceftazidime (0.5-64 ug/mL) - Gram-Negative ID/AST or AST only Phoenix panels.
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 and Enterococcus.
This premarket notification is for the addition of the antimicrobial agent ceftazidime at concentrations of
0.5-64 µg/mL to gram-negative ID/AST or AST only Phoenix panels. Ceftazidime 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:
Citrobacter spp., excluding Citrobacter freundii Enterobacter spp., including Enterobacter cloacae, and Enterobacter aerogenes Escherichia coli
Klebsiella spp., including Klebsiella pneumoniae Proteus mirabilis Proteus vulgaris Pseudomonas spp., including Pseudomonas aeruginosa Serratia spp.
Prescription Use V (Part 21 CFR 801 Subpart D) AND/OR
Over-the-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Jals
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
KC4 1354 ---------------------------------------------------------------------------------------------------------------------------------------------------------------------510(k) ... .
BD Diagnostic Systems Becton, Dickinson and Company