(45 days)
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No
The summary describes an automated system for microbial identification and susceptibility testing based on biochemical reactions and growth detection using a redox indicator. There is no mention of AI, ML, or related technologies in the device description, performance studies, or key metrics. The system appears to rely on established microbiological methods and automated reading of results.
No
This device is an in vitro diagnostic (IVD) system used for identifying and determining the antimicrobial susceptibility of bacterial isolates. It does not directly treat or diagnose a patient, but rather provides information used by clinicians for diagnostic and therapeutic decisions.
Yes
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, and for in vitro quantitative determination of antimicrobial susceptibility. This is a diagnostic function because it identifies pathogens and determines their susceptibility to antimicrobials, which are crucial steps in diagnosing and treating infections.
No
The device description explicitly lists hardware components like the "BD Phoenix instrument" and "BD Phoenix panels," in addition to the software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the system is intended for "in vitro antimicrobial susceptibility testing of isolates from pure culture of most aerobic and facultative anaerobic Gram-negative and Gram-positive bacteria of human origin." and "in vitro quantitative determination of antimicrobial susceptibility". 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 body using reagents and instruments to provide diagnostic information (identification and susceptibility).
- Performance Studies: The document describes clinical studies and reproducibility studies conducted to demonstrate the performance of the device in determining antimicrobial susceptibility, which is a diagnostic function.
- Predicate Devices: The listed predicate devices are also automated microbiology systems used for identification and susceptibility testing, which are well-established categories of IVDs.
The entire context of the document describes a device designed to perform tests on biological samples in vitro to aid in the diagnosis and treatment of infections by determining bacterial identification and their susceptibility to antimicrobial agents. This aligns perfectly with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The BD Phoenix™ Automated Microbiology System is intended for the rapid identification and in vitro antimicrobial susceptibility testing of isolates from pure culture of most aerobic and facultative anaerobic Gram-negative and Gram-positive bacteria of human origin.
The BD Phoenix™ Automated Microbiology System is intended for in vitro quantitative determination of antimicrobial susceptibility by minimal inhibitory concentration (MIC) of most Gram-negative aerobic and facultative anaerobic bacteria isolates from pure culture for Enterobacteriaceae and Non-Enterobacteriaceae and most Gram-positive bacteria isolates from pure culture belonging to the genera Staphylococcus and Enterococcus.
This premarket notification is for the addition of the antimicrobial agent ampicillin-sulbactam at concentrations of 2/1 - 32/16 µg/mL to Gram Positive ID/AST or AST only Phoenix panels. Ampicillin-sulbactam has been shown to be active 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:
Staphylococcus aureus (beta-lactamase producing)
Active In Vitro Against:
Staphylococcus aureus (beta-lactamase and non-beta-lactamase producing)
Staphylococcus epidermidis (beta-lactamase and non-beta-lactamase producing)
Staphylococcus saprophyticus (beta-lactamase and non-beta-lactamase producing)
Enterococccus faecalis (formally Streptococcus faecalis)
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 or 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 Staphylococcus or Enterococcus isolate. For each isolate, an inoculation suspension 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 the turbidity and the redox indicator are used in the determination of bacterial growth. The Phoenix panels contain a wide range of two-fold doubling dilution concentrations of antimicrobial agents.
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 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
Clinical, stock and challenge isolates were tested across multiple geographically diverse clinical sites within the United States. Phoenix System results for clinical isolates were compared to the National Committee for Clinical Laboratory Standards (NCCLS) reference broth microdilution method. The results for Challenge set isolates were compared to the expected results for the NCCLS reference broth microdilution method.
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-positive isolates. Each site tested the isolates in triplicate on three different days using one lot of Gram Positive Phoenix panels containing this antimicrobial agent and associated reagents.
The results of the study demonstrate for 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-positive isolates tested.
Clinical Studies
Clinical, stock and challenge isolates were tested across multiple geographically diverse clinical sites within the United States to demonstrate the performance of this antimicrobial agent. Phoenix System results for clinical isolates were compared to the NCCLS reference broth microdilution method. The results for Challenge set isolates were compared to the expected results for the NCCLS reference broth microdilution method.
The performance of the Phoenix System was assessed by calculating Essential Agreement (EA) and Category Agreement (CA) for the 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 interpretation of susceptible, intermediate, resistant or not susceptible.
Table 1 summarizes the performance for the isolates tested in this study.
Performance of BD Phoenix System for Gram-Positive Organisms by Drug Table 1:
Antimicrobial: Ampicillin-sulbactam, Concentration: 2/1-32/16 µg/mL, EA (n): 1616, EA (%): 97.4, CA (n): 1616, CA (%): 88.7.
Accuracy
Antimicrobial: Ampicillin-sulbactam, Concentration: 2/1-32/16 µg/mL, EA (n): 1616, EA (%): 97.4, CA (n): 1616, CA (%): 88.7
Reproducibility
Testing performed at multiple clinical sites demonstrated 95% reproducibility or greater within ± 1 dilution.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Essential Agreement (EA)
Category Agreement (CA)
Intra-site reproducibility
Inter-site reproducibility
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), K020323, 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 | FEB 2 2005 |
|------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| CONTACT NAME: | Monica Evelyn Giguere,
RA Specialist | |
| DATE PREPARED: | January 12, 2005 | |
| DEVICE TRADE NAME: | BD Phoenix™ Automated Microbiology System -
Ampicillin-sulbactam 2/1-32/16 $\mu$ g/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 (K020323
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 . or 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 polystyrent tray with 136 micro-wells The Phoenix panel is a seated and self-movations allows ship must be a pure culture and containing dried reagents. Organisms for succeptive solate. For each isolate, an inoculation premimatily nonthrou as a Sean dard is prepared in Phoenix ID broth.
The Phoenix AST method is a broth based microdilution test. The Phoenix System uilizes a redox I he Phoenix AST method is a broth bases intention of an antimicrobial agent.
indicator for the detection of organism growth in the presence of an antimicrobial agent. indicator for the uelection of organism growsin growsing turbidity are used in the determination Measurements of the material to the material 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 Its instrument takes readings of the panels every 20 minutes. The readings are interpreted to 55 ℃. THe instrument takes roading of unimum 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 NCCLS reference broth microdilution method. This premarket periormance which comporting the use of the BD Phoenix™ Automated Microbiology System Gram positive 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 performance with volung to NCCLS M7). The system has been evaluated as defined in the FDA Draft propared according "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-positive isolates. Each site tested the isolates in ttriplicate on three different days using one lot of Gram Positive 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-positive isolates tested.
2
Clinical Studies
Clinical, stock and challenge isolates were tested across multiple geographically diverse itsearch Climical, stock and chances were coroes were corben antimicrobial susceptibility test with the United States to demonstrate the performation of this antimicrobial agent. Phoenix System results for clinical the Gram Positive Photon's I and formal contained to the expected results for clinical for Chailenge set isolates were compared to the new the NCCLS reference broth microdilution method.
The performance of the Phoenix System was assessed by calculating Essential Agreement (EA) and I he periormance of the Phoenix System was assessed on the solates tested. Essential Agreement Calegory Agreement (CT) to exports Automated Microbiology System agrees exactly or within ± (CA) occurs when are DD Do reference result. Category Agreement (CA) occurs when the BD one two-rold diration to the reference with the reference method with respect to the I hound - Tatomated Microsoftop (susceptible, intermediate, resistant or not susceptible).
Table 1 summarizes the performance for the isolates tested in this study.
Performance of BD Phoenix System for Gram-Positive Organisms by Drug Table 1:
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
| Antimicrobial | Concentration | EA (n) | EA (%) | CA (n) | CA (%) |
|---|---|---|---|---|---|
| Ampicillin- | 2/1-32/16 µg/mL | 1616 | 97.4 | 1616 | 88.7 |
| sulbactam |
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, "Guidance on Review Criteria for Assessment of Antimicrobial Susceptibility Devices", March 8, 2000. 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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SUMMARY INFORMATION FOR AMPICILLIN-SULBACTAM Available Range 2/1-32/16 µg/mL
Performance
Accuracy
| and the contraction of the contraction of the comments of the comments of the comments of the comments of the comments of the comments of
Antimicrobial | Concentration | EA (n) | EA (%) | CA (n) | " CA (%)
Concession of Concession of School |
|------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------|--------|--------|--------|------------------------------------------------|
| A
Ampicillin- | 2/1-32/16 µg/mL | 1616 | 97.4 | 1616 | 88.7 |
| sulbactam | | | | | |
Reproducibility
Testing performed at multiple clinical sites demonstrated 95% reproducibility or greater within ± 1 dilution.
Breakpoints - NCCLS, FDA
| Organism | S | I | R |
|---|---|---|---|
| Staphylococcus aureus | $\leq$ 8/4 | 16/8 | $\geq$ 32/16 |
| Staphylococcus spp, coagulase- | |||
| negative | $\leq$ 8/4 | 16/8 | $\geq$ 32/16 |
NCCLS Quality Control Organisms
| Quality Control Strain | MIC Range | Source |
|---|---|---|
| Escherichia coli ATCC 25922* | 2/1 - 8/4 $\u03bc$ g/mL | NCCLS |
| Escherichia coli ATCC 35218* | 8/4 - 32/16 $\u03bc$ g/mL | NCCLS |
*Testing of Gram-negative QC strains in the Phoenix Gram-positive panel is not appropriate.
BD Recommended Quality Control Organisms
| Quality Control Strain | MIC Range | Source |
|---|---|---|
| Staphylococcus aureus ATCC 29213 | $\le$ 2 $\mu$ g/mL | BD |
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Image /page/4/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal is circular and contains the department's emblem in the center. The emblem consists of a stylized caduceus, a symbol of medicine, with three wavy lines representing the department's mission to promote health, well-being, and human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the emblem within the circle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
FEB 2 8 2005
Ms. Monica Evelyn Giguere Regulatory Affairs Specialist BD Diagnostics Systems Becton, Dickinson and Company 7 Loveton Circle Sparks, MD 21152
K050089 Re:
R050089
Trade/Device Name: BD Phoenix™ Automated Microbiology System BD Friocillin-sulbactam (2/1-32/16 µg/mL) - Gram-Positive ID/AST Regulation Number: 21 CFR 866.1645 Regulation Name: 21 CFR 000.1016
Regulation Name: Fully Automated Short-Term Incubation Cycle Antimicrobial Susceptibility Devices Regulatory Class: Class II Product Code: LON Dated: January 12, 2005 Received: January 14, 2005
Dear Ms. Giguere:
We have reviewed your Section 510(k) premarket notification of intent to market the device indicati we have reviewed your Section 9 ro(x) premained is substantially equivalent (for the indications referenced and nave decemblied the are are are are are as a marketed in interstate for use stated in the encrosule for legally manated produce Americal Device American be of Drug commerce prior to May 28, 1776, the enations with the provisions of the Federal Food. Drug, devices that have been recure approval of a premarket approval approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a premarket approval of the and Cosmelle ACt (Act) that do not require approvin controls provisions of the Act. The Y ou may, therefore, market the device, basjoct of the more in the manual registration, listing of general controls provisions of the fiel labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), , If your device is Classified (Sec adove) into c. Existing major regulations affecting your device in it may be subject to such additional controllar Enting Might of the one of to 895. In addition, FDA can be found in The 21, Code of I costs and subject in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination and mean Please be advised that FDA s issualled of a butters. In the requirements of the Act that FDA has made a decemination administered by other Federal agencies. You must of any Federal Statutes and regulations adminding, but not limited to: registration and listing (21 comply with an the Act 3 requirements, moraling good manufacturing practice CFR Fall 807), labeling (21 CF 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 PFR 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)
The same of the success of the same of the suisely of your device to a legal This letter will allow you to begin marketing your uevice of your device of your device to a legally
premarket notification. The FDA finding of substantial equivales of your premarket notification. The PDA Intonig of substantal organ 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, of In If you desire specific information adounting of your device, please contact the Office of In
or questions on the promotion and advertising of your device, please poterse pote or questions on the promotion and advertising of Jour 2011-0484. Also, please note the Vifro Diagnosic Device Evaluation and Barey at (217). " (210FR Part 807.97).
regulation entitled, "Misbranding by reference to premarket notification Ast from the regulation entitled, "Wisofananing of reference to presponsibilities under the Act from the You may obtain other general information. on your Copsumer 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,
Sally a Hom
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: Ko50089
Device Name: BD Phoenix™ Automated Microbiology System for use with the antimicrobial agent ampicillin-sulbactam (2/1-32/16 ug/mL) - Gram positive ID/AST or AST only Phoenix Panels.
Indications for Use:
The BD Phoenix™ Automated Microbiology System is intended for in vitro quantitative determination of I III BD I Iioliii - Ausceptibility by minimal inhibitory concentration (MIC) of most Gram-negative aerobic and antinutional suscepating of immer manene 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 ampicillin-sulbactam at This prenance for the abon is for alle assume Positive ID/AST or AST only Phoenix panels. Ampicillinconcentions of 21 - 92 10 pg nize to Chairro 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:
Staphylococcus aureus (beta-lactamase producing)
Active In Vitro Against:
Staphylococcus aureus (beta-lactamase and non-beta-lactamase producing) Staphylococcus epidermidis (beta-lactamase and non-beta-lactamase producing) Staphylococcus saprophyticus (beta-lactamase and non-beta-lactamase producing) Enterococccus faecalis (formally Streptococcus faecalis)
Prescription Use V (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) | |
|---|---|
| Division Sign-Off | |
| Office of In Vitro Diagnostic Device | |
| Evaluation and Safety |
BD Diagnostic Systems Becton, Dickinson and Company
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