(44 days)
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No
The description focuses on automated microbiology testing using biochemical reactions and turbidity/indicator changes, with no mention of AI or ML algorithms for interpretation or analysis.
No
The device is an in vitro diagnostic (IVD) system used for identifying microorganisms and testing their susceptibility to antimicrobial agents. It does not directly treat or prevent disease, which are functions of a therapeutic device.
Yes.
The device is intended for the rapid identification and in vitro antimicrobial susceptibility testing of isolates to determine if bacteria are susceptible, intermediate, or resistant to certain antimicrobial agents, which is a diagnostic purpose to guide treatment.
No
The device description explicitly lists hardware components such as the BD Phoenix instrument, panels, and broths, 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 term "in vitro" is a key indicator of an IVD.
- Device Description: The description details a system that analyzes biological samples (bacterial isolates) outside of the human body using reagents and instruments to provide diagnostic information (identification and susceptibility to antimicrobial agents).
- 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, further confirming its use in a diagnostic setting.
The entire context of the document describes a system designed to perform tests on biological samples in a laboratory setting to aid in the diagnosis and treatment of infections, which is the definition of an In Vitro Diagnostic device.
No.
A Predetermined Change Control Plan (PCCP) authorizes future modifications to a device without requiring a new 510(k) submission for each change. This clearance letter does not mention or indicate that the BD Phoenix™ Automated Microbiology System is authorized under a PCCP. The current submission is for the addition of a specific antimicrobial agent (cefepime), which is a modification handled through a traditional 510(k) pathway, not under a PCCP umbrella.
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 1 110 DD Invenue entibility by minimal inhibitory concentration (MIC) of most Gram-negative aerobic and annitative 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 , Enterococcus, and Streptococcus.
This premarket notification is for the addition of the antimicrobial agent cefepime at concentrations of 0.0625-4 ug/mL to Streptococcus ID/AST or AST only Phoenix panels. Cefepime has been shown to be active in virro 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:
Streptococcus pneumoniae
Streptococcus pyogenes (Lancefield's Group A streptococci)
Viridans group streptococci
Active In Vitro Against:
Streptococcus agalactiae (Lancefield's Group B streptococci)
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. For testing Streptococcus species the system includes the following components:
- BD Phoenix instrument and software. .
- BD Phoenix panels containing biochemicals for organism ID testing and antimicrobial agents . or AST determinations.
- BD Phoenix ID Broth used for performing ID tests and preparing AST Broth inoculum. .
- BD Phoenix AST-S Broth used for performing AST tests only. .
- BD Phoenix AST-S 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 isolation 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, R or N (susceptible, intermediate, resistant or not susceptible).
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
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 streptoccal isolates. Each site tested the isolates in triplicate on three different days using one lot of Streptococcus Phoenix panels containing this antimicrobial agent and associated reagents.
Clinical Studies:
Clinical, stock and challenge isolates were tested across multiple geographically diverse sites across the United States. 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.
Site Reproducibility:
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 streptococcal isolates tested.
Clinical Studies:
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.
For Cefepime (0.0625-4 μg/mL), EA (n) was 1890 with EA (%) of 97.7, and CA (n) was 1890 with CA (%) of 94.3.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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 PhoenixTM Automated Microbiology System agrees with the reference method with respect to the FDA categorical interpretive criteria (susceptible, intermediate, resistant or nonsusceptible).
For Cefepime (0.0625-4 μg/mL):
Essential Agreement (EA): 97.7% (n=1890)
Category Agreement (CA): 94.3% (n=1890)
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.”
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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 Giguere
Regulatory Affairs Speicalist |
| DATE PREPARED: | May 9, 2005 |
| DEVICE TRADE NAME: | BD Phoenix™ Automated Microbiology System -
Cefepime 0.0625-4 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. For testing Streptococcus species the system includes the following components:
- BD Phoenix instrument and software. .
- BD Phoenix panels containing biochemicals for organism ID testing and antimicrobial agents . or AST determinations.
- BD Phoenix ID Broth used for performing ID tests and preparing AST Broth inoculum. .
- BD Phoenix AST-S Broth used for performing AST tests only. .
- BD Phoenix AST-S 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 isolation 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, R or N (susceptible, intermediate, resistant or not susceptible).
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 supporting the use of the BD Phoenix™ Automated Microbiology System Streptococcus ID/AST or AST only Phoenix panels with this antimicrobial agent.
SUMMARY OF SUBSTANTIAL EQUIVALENCE TESTING:
The BD Phoenix™ Automated Microbiology System has demonstrated substantially equivalent performance when compared to the CLSI reference broth microdilution method (AST panels prepared according to NCCLS M7). The system has been eyaluated 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 of streptoccal isolates. Each site tested the isolates in triplicate on three different days using one lot of Streptococcus 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 streptococcal isolates tested.
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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 Streptococcus Phoenix Panel format containing this antimicrobial agent. Phoenix System results for Challenge set isolates were compared to the expected results. Phoenix System results for clinical isolates were compared to the results obtained from the CLSI reference broth microdilution method.
The performance of the Phoenix System was assessed by calculating Essential Agreement (EA) and Category Agreement (CA) to expected/reference results for all isolates tested. Essential Agreement (EA) occurs when the BD Phoenix™ Automated Microbiology System agrees exactly or within + one two-fold dilution to the reference result. Category Agreement (CA) occurs when the BD PhoenixTM Automated Microbiology System agrees with the reference method with respect to the FDA categorical interpretive criteria (susceptible, intermediate, resistant or nonsusceptible).
Table 1 summarizes the performance for the isolates tested in this study.
Table 1: Performance of BD Phoenix System for Streptococcal Organisms by Drug
| Antimicrobial | Concentration | EA (n) | EA (%) | CA (n) | CA (%) |
|---|---|---|---|---|---|
| Cefepime | 0.0625-4 μg/mL | 1890 | 97.7 | 1890 | 94.3 |
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), Ofloxacin (K020323, April 14, 2002), and Levofloxacin (K020322, March 27, 2002),
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle with three lines forming its body and wings. The eagle faces right and is positioned within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged around the upper portion of the circle.
JUN 2 4 2005
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Monica Giguere Regulatory Affairs Specialist BD Diagnostics Systems Becton, Dickinson and Company 7 Loveton Circle Sparks, MD 21152
K051204 Re:
Trade/Device Name: BD Phoenix™ Automated Microbiology System Cefepime (0.0625-4 µg/mL) - Streptococcus 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: May 9, 2005 Received: May 11, 2005
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 for associated in the 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 r ou may, utcher sever 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).
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Page 2 -
This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter witi anow you to oogin manies.ing , a substantial equivalence of your device to a legally premarket normodion: "The sults 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 (c.v. If you desire specific intornialion as advertising of your device, please contact the Office of In of questions on the promotion and Safety at (240)276-0484. Also, please note the Pill o Daglessio Dorros Londing by reference to premarket notification" (21 CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the r ou may other built butter generational 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 Horr
Sally A. Hojvat, M.Sc., Ph.D. Director Division of Microbiology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Page 1 of 1
510(k) Number: Ko51204
Device Name: BD Phoenix™ Automated Microbiology System for use with the antimicrobial agent cefepine (0.0625-4 ug/mL) - Streptococcus ID/AST or AST only Phoenix Panels.
Indications for Use:
The BD Phoenix™ Automated Microbiology System is intended for in vitro quantitative determination of 1 110 DD Invenue entibility by minimal inhibitory concentration (MIC) of most Gram-negative aerobic and annitative 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 , Enterococcus, and Streptococcus.
This premarket notification is for the addition of the antimicrobial agent cefepime at concentrations of 0.0625-4 ug/mL to Streptococcus ID/AST or AST only Phoenix panels. Cefepime has been shown to be active in virro 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:
Streptococcus pneumoniae Streptococcus pyogenes (Lancefield's Group A streptococci) Viridans group streptococci
Active In Vitro Against:
Streptococcus agalactiae (Lancefield's Group B streptococci)
Prescription Use (Per 21 CFR 801.109) Over-the-Counter Use
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Luddiate Poole
Division Sign-O
BD Diagnostic Systems Becton, Dickinson and Company Office of In Vitro Diagnostic Device
510(k) K051204