(75 days)
PMA No. N50510
No
The description focuses on automated processes, redox indicators, and turbidity measurements for bacterial growth determination, which are standard automated microbiology techniques, not indicative of AI/ML. There is no mention of AI, ML, or related terms in the document.
No.
The device is an automated microbiology system intended for identifying microorganisms and performing antimicrobial susceptibility testing, which provides information for diagnosis and treatment decisions but does not directly treat a disease or condition.
Yes
The device is intended for "rapid identification and in vitro antimicrobial susceptibility testing of isolates from pure culture... of human origin," which directly indicates its use in diagnosing and guiding treatment for infections.
No
The device description explicitly lists hardware components such as the "BD Phoenix instrument" and "BD Phoenix panels," indicating it is not solely 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 how the system analyzes biological samples (bacterial isolates from pure culture) using reagents (biochemicals, antimicrobial agents, broths, indicator solution) to provide diagnostic information (identification and susceptibility testing). This aligns with the definition of an IVD, which is used to examine specimens derived from the human body to provide information for diagnostic purposes.
- Performance Studies: The performance studies compare the device's results to a "CLSI reference broth microdilution method," which is a standard laboratory method for determining antimicrobial susceptibility. This further confirms its role in providing diagnostic information.
- Key Metrics: The use of metrics like Essential Agreement (EA) and Category Agreement (CA) are standard performance measures for IVD devices that assess the accuracy of the device's results compared to a reference method.
In summary, the BD Phoenix Automated Microbiology System is designed to perform tests on biological samples outside of the human body (in vitro) to provide information about bacterial identification and susceptibility to antimicrobial agents, which is used for diagnostic purposes. This clearly fits the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The BD PhoenixTM 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-Enteriaceae and most Gram-positive bacteria isolates from pure culture belonging to the genera Staphylococcus, Enterococcus, and Streptococcus.
This premarket notification is for the BD Phoenix™ Automated Microbiology System with Moxifloxacin (0.125-8 ug/mL) and additional Gram-positive organism groups and Ciprofloxacin (0.25-4 ug/mL) and additional Gram-negative organism groups.
Moxifloxacin 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:
Enterococcus faecalis (many strains are only moderately susceptible)
Staphylococcus aureus (methicillin-susceptible strains only)
Active In Vitro Against:
Staphylococcus epidermidis (methicillin-susceptible strains only)
Cirpofloxacin 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 koseri
Citrobacter freundii
Enterobacter cloacae
Escherichia coli
Klebsiella pneumoniae
Morganella morganii
Proteus mirabilis
Proteus vulgaris
Providencia rettgeri
Active In Vitro Against:
- Acinetobacter Iwoffi
Aeromonas hydrophila
Edwardsiella tarda
Enterobacter aerogenes
Klebsiella oxytoca
Salmonella enteritidis
Yersinia enterocolitica - Providencia stuartii
Pseudomonas aeruginosa
Salmonella typhi
Serratia marscescens
Shigella boydii
Shigella dysenteriae
Shigella flexneri
Shigella sonnei
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 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°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
Not Found
Input Imaging Modality
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Anatomical Site
Not Found
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
Reproduction of test results were analyzed for intra-site and inter-site reproducibility. Each site tested the isolates in triplicate on three different days using one lot of Phoenix panels containing the antimicrobial agents and associated reagents.
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 Phoenix panel formats containing antimicrobial agents. 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 when compared with the CLSI reference broth microdilution method. This premarket notification provides data for the BD Phoenix™ Automated Microbiology System with Moxifloxacin (0.125-8 ug/mL) and Gram-positive organism groups and Ciprofloxacin (0.25-4 ug/mL) and additional Gram-negative organism groups.
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 NCCLS M7). The system has been evaluated as defined in the FDA Draft guidance document, "Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems; Guidance for Industry and FDA," February 5, 2003.
Intra- and inter-site reproducibility of this antimicrobial agent in the BD Phoenix System was evaluated at three sites using a panel chosen isolates. Each site tested the isolates in triplicate on three different days using one lot of Phoenix panels containing the antimicrobial agents and associated reagents.
The results of the study demonstrate for each antimicrobial agent there was an overall intra-site reproducibility of greater than 90% and an overall inter-site reproducibility greater than 95% for the isolates tested.
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 Phoenix panel formats containing antimicrobial agents. 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).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Essential Agreement (EA) and Category Agreement (CA) were reported.
Intra-site reproducibility: greater than 90%
Inter-site reproducibility: greater than 95%
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.
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.
PMA No. N50510
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).
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 - 4287
Fax: 410-316-4499 |
|------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| CONTACT NAME: | Monica E Giguere
Regulatory Affairs Specialist |
| DATE PREPARED: | March 29, 2006 |
| DEVICE TRADE NAME: | BD PhoenixTM Automated Microbiology System -
Moxifloxacin-0.125-8 $\mu$ g/mL - GP and Ciprofloxacin-
0.25 - 4 $\mu$ g/mL - GN |
| 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 PhoenixTM
Automated Microbiology System with Gatifloxacin
(K020321, May 23,2002, Moxifloxacin (K031306
June 2, 2003) and Ciprofloxacin (K052269,
October 3, 2005). |
| INTENDED USE: | The BD PhoenixTM 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. .
1
- 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 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°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 reference broth microdilution method. This premarket notification provides data for the BD Phoenix™ Automated Microbiology System with Moxifloxacin (0.125-8 ug/mL) and Gram-positive organism groups and Ciprofloxacin (0.25-4 ug/mL) and additional Gram-negative organism groups.
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 NCCLS M7). The system has been evaluated as defined in the FDA Draft 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 chosen isolates. Each site tested the isolates in triplicate on three different days using one lot of Phoenix panels containing the antimicrobial agents and associated reagents.
The results of the study demonstrate for each antimicrobial agent there was an overall intra-site reproducibility of greater than 90% and an overall inter-site reproducibility greater than 95% for the 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 Phoenix panel formats containing antimicrobial agents. 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.
Performance of BD Phoenix System by Drug Table 1:
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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 draft 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), Moxifloxacin (K031306 June 2, 2003) and Ciprofloxacin (K052269, October 3, 2005).
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three wing-like shapes, representing health, services, and people. The eagle is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", which is arranged in a circular fashion around the eagle.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
APR 1 2 2006
Ms. Monica E. Giguere Regulatory Affairs Specialist BD Diagnostics Systems Becton, Dickinson and Company 7 Loveton Circle Sparks, MD 21152
Re: K060217 Trade/Device Name: BD Phoenix TM Automated Microbiology System Moxifloxacin (0.125-8 ug/mL) and Ciprofloxacin (0.25-4 ug/mL) on ID/AST or 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: January 26, 2006 Received: January 27, 2006
Dear Ms. Giguere:
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
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 (240)276-0484. 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/industry/support/index.html
Sincerely yours,
Sales a Hogg
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
Page 1 of 2
510(k) Number: K060217
Device Name: BD Phoenix™ Automated Microbiology System for use with the antimicrobial agent Moxifloxacin (0.125-8 ug/mL) and Ciprofloxacin (0.25-4 ug/mL) on 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-Enteriaceae and most Gram-positive bacteria isolates from pure culture belonging to the genera Staphylococcus, Enterococcus, and Streptococcus.
This premarket notification is for the BD Phoenix™ Automated Microbiology System with Moxifloxacin (0.125-8 ug/mL) and additional Gram-positive organism groups and Ciprofloxacin (0.25-4 ug/mL) and additional Gram-negative organism groups.
Moxifloxacin 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:
Enterococcus faecalis (many strains are only moderately susceptible) Staphylococcus aureus (methicillin-susceptible strains only)
Active In Vitro Against:
Staphylococcus epidermidis (methicillin-susceptible strains only)
Freddie tu Rady
vision Sign-Off
Office of In Vitro - Device Evaluation and
Kb60217
6
Page 2 of 2
Cirpofloxacin 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 koseri Citrobacter freundii Enterobacter cloacae Escherichia coli Klebsiella pneumoniae Morganella morganii Proteus mirabilis Proteus vulgaris Providencia rettgeri
Active In Vitro Against:
- Acinetobacter Iwoffi Aeromonas hydrophila Edwardsiella tarda Enterobacter aerogenes Klebsiella oxytoca Salmonella enteritidis Yersinia enterocolitica
1
Prescription Use
(Per 21 CFR 801.109)
- Providencia stuartii Pseudomonas aeruginosa Salmonella typhi Serratia marscescens Shigella boydii Shigella dysenteriae Shigella flexneri Shigella sonnei
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)
Seigale V
Division Si:-Off
Office of - Vitro Diagnostic Device Evaluatio and Sefety
4060217 510(k)________________________________________________________________________________________________________________________________________________________________________