(59 days)
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No
The description focuses on automated processes, broth microdilution, and redox indicators for growth detection, without mentioning AI or ML. The performance studies compare results to reference methods and assess reproducibility, not AI/ML model performance.
No
Explanation: The device is an in vitro diagnostic microbiology system used for identification and antimicrobial susceptibility testing of bacterial isolates. It does not directly treat or prevent a disease, which is the definition of a therapeutic device.
Yes
The device is intended for "rapid identification and in vitro antimicrobial susceptibility testing of isolates" and "in vitro quantitative determination of antimicrobial susceptibility," which are diagnostic purposes for bacterial infections.
No
The device description explicitly lists hardware components such as the "BD Phoenix instrument" and "BD Phoenix panels containing biochemicals and antimicrobial agents," 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 antimicrobial susceptibility". The term "in vitro" is a key indicator of an IVD.
- Device Description: The description details components like "BD Phoenix panels containing biochemicals for organism ID testing and antimicrobial agents for AST determinations," "BD Phoenix ID Broth," "BD Phoenix AST Broth," and "BD Phoenix AST Indicator solution." These are all reagents and materials used for testing biological samples outside of the body.
- Testing Method: The description explains that the system uses a "broth based microdilution test" and a "redox indicator for the detection of organism growth in the presence of an antimicrobial agent." This is a standard laboratory method for determining the susceptibility of bacteria to antibiotics, performed in vitro.
- Results: The system provides "identification of the isolate, minimum inhibitory concentration (MIC) values and category interpretations, S, I, or R (sensitive, intermediate, or resistant)." These are diagnostic results derived from testing the bacterial isolates in vitro.
- Performance Studies: The performance studies compare the system's results to the "NCCLS reference broth microdilution method," which is another in vitro diagnostic method.
All of these points strongly indicate that the BD Phoenix™ Automated Microbiology System is designed and used for diagnostic testing performed in vitro.
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 Nonand ractive 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 Piperacillin at concentrations of I this premarks normounter is to the SST only Phoenix panels. Piperacillin has been shown to 0.5-120 pg miro against most strains of microorganisms listed below, as described in the FDA-approved package insert for this antimicrobial agent.
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 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. For each isolate, an inoculation 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 well as bacterial turbidity are used in the determination Macterial 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°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
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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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
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 United States to delivinate the parcomtaining this antimicrobial agent. Phoenix System results me grant-hogan ve i noomir pared 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 performance of the Procedireference results for all isolates tested. Essential Agreement Category Agreement (CTT) to enported Microbiology System agrees exactly or within ± (EA) occurs when and 22 22 and 11 Category Agreement (CA) occurs when the BD one two Total unution to the obiology 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:
Piperacillin 0.5-128 ug/mL: EA (n) 1781, EA (%) 94.3, CA (n) 1701, CA (%) 93.8
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Essential Agreement (EA) and Category Agreement (CA)
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), K020321, K020323, K020322
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.
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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.”
0
| AUG 1 2 2004 | 510(K) SUMMARY |
|---|---|
| SUBMITTED BY: | Becton, Dickinson and Company |
| 7 Loveton Circle | |
| Sparks, MD 21152 | |
| Phone: 410-316-4287 | |
| Fax: (410)-316-4499 | |
| CONTACT NAME: | Monica Evelyn Giguere |
| Regulatory Affairs Specialist | |
| DATE PREPARED: | June 10, 2004 |
| DEVICE TRADE NAME: | BD Phoenix™ Automated Microbiology System - |
| Piperacillin 0.5-128 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. |
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.
1
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. For each isolate, an inoculation 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 well as bacterial turbidity are used in the determination Macterial 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°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 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 NCCLS reference broth microdilution method (AST panels prepared according to NCCLS M7). The system has been evaluated as defined in the FDA Draft guidance document, "Guidance on Review Criteria for Assessment of Antimicrobial Susceptibility Devices", March 8, 2000.
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.
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 United States to delivinate the parcomtaining this antimicrobial agent. Phoenix System results me grant-hogan ve i noomir pared 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 performance of the Procedireference results for all isolates tested. Essential Agreement Category Agreement (CTT) to enported Microbiology System agrees exactly or within ± (EA) occurs when and 22 22 and 11 Category Agreement (CA) occurs when the BD one two Total unution to the obiology 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 | Comments of the control of the control of the control of the contribution of the contribution of the contribution of the contribution of the contribution of the contribution
Concentration | A market of the contract and the contract and the comments of the comments of the comments of the comments of the contribution of the comments of the contribution of the cont
EA (n) | and the same of the management of the minutes of the many of
EA (%) | CA (n) | CA (%) |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------|--------------|--------|
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
A
and the comments of the first of the first of the first of
.
Pıperacılın | · Please with a comments of the promote of the province of the proposes of the control of the contribution of the contribution of the contribution of the contribution of the
0.5-128 ug/mL | Acres of the Lands Labor Labor one the v
1781 | 94.3 | 1701
10 - | 93.8 |
Conclusions Drawn from Substantial Equivalence Studies
The data collected from the substantial equivalence studies demonstrate that testing on the BD The cata concected from als about with this antimicrobial agent is substantially equivalent i nooms - Pratemate document, "Class II Special Controls Guidance Document: as outined in Susceptibility Test (AST) Systems; Guidance for Industry and FDA", February 5, 1 connectorial barceptions 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), Ofloxacin (K020323, April 14, 2002), and Levofloxacin (K020322, March 27, 2002).
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows a logo with a circular design on the left and a stylized bird-like figure on the right. The circular part contains text that appears to be the company name, though the letters are not very clear. The bird-like figure is composed of three curved lines that converge at the bottom, creating a sense of movement or flight. The logo is simple and uses a monochrome color scheme.
Public Health Service
AUG 1 2 2004
Food and Drug Administratio 2098 Gaither Road Rockville MD 20850
Ms. Monica Evelyn Giguere Regulatory Affairs Specialist BD Diagnostics Systems Becton, Dickinson and Company 7 Loveton Circle Sparks, MD 21152
Re: K041572
Trade/Device Name: BD Phoenix™ Automated Microbiology Systems Piperacillin (0.5-128 µg/mL) - Gram-Negative ID/AST 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: June 10, 2004 Received: June 14, 2004
Dear Ms. Giguere:
We have reviewed your Section 510(k) premarket notification of intent to market the device w 6 have a revea 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 ass stated on to May 28, 1976, the enactment date of the Medical Device Amendments, or to conninered pror to 1125 2011 11 accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). and Cosmetic Prer (110) that the device, subject to the general controls provisions of the Act. The I ou may, aterest, mains 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 r that FDA has made a determination that your device complies with other requirements of the Act man regulations and regulations administered by other Federal agencies. You must or any I odetar statuated and equirements, 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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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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Indications for Use
510(k) Number: K041572 --------
Device Name: BD Phoenix™ Automated Microbiology System for use with the antimicrobial agent Device Name: 5-128 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 Nonand ractive 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 Piperacillin at concentrations of I this premarks normounter is to the SST only Phoenix panels. Piperacillin has been shown to 0.5-120 pg miro 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:
Acinetobacter species Enterobacter species Escherichia coli Klebsiella species Morganella morganii
Pseudomonas aeruginosa Serratia species
Active In Vitro Against:
Citrobacter koseri Citrobacter freundii Pseudomonas fluorescens Yersinia enterocoloitica
Prescription Use V (Part 21 CFR 801 Subpart D)
Over-the-Counter Use (21 CFR 807 Subpart C)
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