(70 days)
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.
The BD Phoenix Automated Microbiology System (Phoenix System) is an automated system for the in vitro diagnostic 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 equivalent 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 indicator for the detection of organism growth in the presence of an antimicrobial agent. Measurements of changes to the indicator as bacterial turbidity are used in the determination of MIC values. Each Phoenix 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 degrees C. The instrument monitors the growth in each well 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).
The provided text describes the performance of the BD Phoenix™ Automated Microbiology System when testing the antimicrobial agent Ceftazidime against gram-negative organisms.
Here's an analysis of the acceptance criteria and study details:
1. A table of acceptance criteria and the reported device performance:
The study refers to the FDA guidance document "Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems; Guidance for Industry and FDA," February 5, 2003, for establishing the acceptance criteria. The performance is assessed using Essential Agreement (EA) and Category Agreement (CA).
| Performance Metric | Acceptance Criteria (Implied by FDA Guidance) | Reported Device Performance |
|---|---|---|
| Essential Agreement (EA) | Not explicitly stated, but typically >90% | 94.4% (for Ceftazidime) |
| Category Agreement (CA) | Not explicitly stated, but typically >90% | 100% (for Ceftazidime) |
| Intra-site Reproducibility | >90% | >90% |
| Inter-site Reproducibility | >95% | >95% |
Note: While the exact numerical acceptance criteria for EA and CA are not explicitly stated in the provided text, they are generally established to be high (e.g., above 90%) for substantial equivalence in AST device submissions according to FDA guidance documents. The document states that performance was "substantially equivalent as outlined in the FDA guidance document."
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size:
- Clinical Isolates: The table shows
n = 1706for Ceftazidime, which likely represents the total number of clinical isolates tested. - Reproducibility Studies: "one lot of gram-negative Phoenix panels containing this antimicrobial agent and associated reagents" was tested across three different days for intra- and inter-site reproducibility. The exact number of isolates used in these reproducibility studies is not explicitly stated, but they involved "gram-negative isolates."
- Clinical Isolates: The table shows
- Data Provenance: "Clinical, stock and challenge isolates were tested across multiple geographically diverse sites across the United States." This indicates prospective and retrospective data (clinical isolates, stock and challenge isolates) from multiple locations within the United States.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
The text does not specify the "number of experts" or their "qualifications." The ground truth was established by the NCCLS reference broth microdilution method, which is a standardized laboratory procedure rather than an expert consensus based on individual human interpretation.
4. Adjudication method for the test set:
Not applicable. The ground truth was based on the NCCLS reference broth microdilution method, which is a quantitative laboratory test. There was no need for human expert adjudication in the context of interpreting the reference method results.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable. This device is an automated microbiology system and not an AI-assisted diagnostic tool that human readers would use. The comparison is between the automated system's performance and a standardized reference laboratory method, not human reader performance.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
Yes, a standalone performance study was done. The entire study focuses on the performance of the BD Phoenix™ Automated Microbiology System (an automated device/algorithm) in determining antimicrobial susceptibility. Its results are compared directly to the NCCLS reference method without human interpretation being part of the Phoenix system's performance evaluation.
7. The type of ground truth used:
The ground truth used was the NCCLS reference broth microdilution method, which is a standardized, established laboratory test for antimicrobial susceptibility. This is a reference standard method rather than expert consensus, pathology, or outcomes data.
8. The sample size for the training set:
The document does not explicitly mention a "training set" or its size. This type of submission (510(k) for an AST system) typically focuses on the device's validation against a reference method rather than describing an AI model's training process. The system is likely based on established principles of bacterial growth and redox indicators, not a machine learning model that requires a discrete training set in the conventional sense.
9. How the ground truth for the training set was established:
Not applicable, as a distinct training set (in the machine learning sense) is not described or implied for this automated system. The device's underlying principles are based on known biological and chemical reactions for bacterial growth and metabolism.
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| Ceftazidime - GN | K041384 |
|---|---|
| AUG - 3 2004 | 510(K) SUMMARY |
| SUBMITTED BY: | Becton, Dickinson and Company7 Loveton CircleSparks, MD 21152Phone: 410-316-4778Fax: (410)-316-4499 |
| CONTACT NAME: | Michelle Bytheway BandyRegulatory 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 AntimicrobialSusceptibility 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 isintended for the rapid identification and in vitro antimicrobialsusceptibility testing of isolates from pure culture of mostaerobic 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.
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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
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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 ChildrenTHE 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 LEASTAntimicrobial | - Manager of ChildrenComprehensive Adon't Research Active Comments of Children Comments of ChildrenAcres PropertyConcentration | 5r | 101 | n | 10/0 .( |
|---|---|---|---|---|---|
| - PA-1------------------------------------------------------------------------------------------------------------------------------------------------------------------------------Ceftazidime | ug/mlrs/ | ์ | 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).
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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).
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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
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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
§ 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.”