(34 days)
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No
The description focuses on the automated system's use of biochemical reactions, turbidity, and redox indicators to determine identification and susceptibility, without mentioning AI or ML algorithms for interpretation or analysis.
No.
The device is described as an in vitro diagnostic (IVD) system intended for the identification and antimicrobial susceptibility testing of bacterial isolates, not for direct therapeutic intervention on a patient.
Yes
The device is intended for "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," which falls under the definition of diagnostic testing.
No
The device description explicitly lists multiple hardware components (BD Phoenix instrument, BD Phoenix panels, BD Phoenix ID Broth, BD Phoenix AST Broth, BD Phoenix AST Indicator solution) in addition to 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 from pure culture) outside of the human body using reagents and a specialized instrument to provide diagnostic information (identification and susceptibility to antimicrobial agents). This aligns with the definition of an IVD.
- Performance Studies: The performance studies describe testing the device's ability to accurately determine antimicrobial susceptibility compared to reference methods, which is a standard evaluation for IVDs used in clinical microbiology.
The entire context of the document describes a device designed to perform tests on biological samples in vitro to provide information relevant to the diagnosis and treatment of infections.
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 cephalothin at concentrations of 0.5-64 µg/mL to Gram Positive ID/AST or AST only Phoenix panels. Cephalothin has demonstrated in vitro activity against Staphylococcus species.
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. .
- DD 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 reagens. 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 bacterial turbidity are used in the determination of MIC. Each Phoenix panel 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
Site Reproducibility: Intra- and inter-site reproducibility of this antimicrobial agent in the BD Phoenix System was evaluated at three different 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.
Clinical Studies: Clinical, stock and challenge isolates were tested across multiple geographically diverse sites across 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. Results for Challenge set isolates were compared to the expected results.
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 NCCLS reference broth microdilution method. This premarket notification provides performance data for the BD Phoenix™ Automated Microbiology System only with Phoenix panels with this antimicrobial agent.
The BD Phoenix™ Automated Microbiology System has demonstrated substantially equivalent performance when compared to the NCCLS reference broth microdilution method (AST panels performance with this system has been evaluated as defined in the FDA Draft "Guidance for Industry and FDA - Guidance for the Submission of Premarket Notifications for Antimicrobial Susceptibility Devices", prepared according to NCCLS M7-A5 "Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria That Grow Aerobically; Approved Standard – Fifth Edition" and NCCLS M100-S11 "Performance Standards for Antimicrobial Susceptibility Testing; Eleventh Informational Supplement").
Site Reproducibility: The results of the study demonstrate for the this antimicrobial agent there was an overall intra-site reproducibility greater than 95% for the conditions tested and an overall inter-site reproducibility greater than 95% for the Gram-positive 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. Essential Agreement (EA) occurs when the BD Phoenix System agrees exactly or within ± one two-fold dilution to the reference result. Category Agreement (CA) occurs when the BD Phoenix System agrees with the interpretation of the reference method with respect to the FDA categorical interpretive criteria (susceptible, intermediate, and resistant).
Table 1: Performance of BD Phoenix System for Gram-Positive Organisms by Drug
Cephalothin 0.5-64 µg/mL; EA (n): 1220; EA (%): 90.8; CA (n): 1220; CA (%): 93.2.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Essential Agreement (EA)
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), BD Phoenix™ Automated Microbiology System with Gatifloxacin (K020321), Ofloxacin (K020323), Levofloxacin (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.
Not Found
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.”
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| MAR 2 2 2005 | 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 Gigucre, |
| RA Specialist | |
| DATE PREPARED: | February 15, 2005 |
| DEVICE TRADE NAME: | BD Phoenix™ Automated Microbiology System - |
| Cephalothin 0.5-64 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. .
- DD 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 polystyrene tray with 136 micro-wells I he Filoemix panel is a searce and bell for susceptibility testing must be a pure culture and conliating dried reagens. Organisms for basephensy volumes
preliminarily identified as a Gram-negative or Gram-positive isolate. For each isolate, an inoculation prominatity - 00.5 McFarland standard is prepared in Phoenix ID broth.
The Phoenix AST method is a broth based microdilution test. The Phoenix system utilizes a redox I he Fiochis AST memor is a crown saver wth in the presence of an antimicrobial agent. Indicator for the delection of organism growin in as procerial turbidity are used in the determination Measurements of Changes to the moreation 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 The instrument takes readings of the panels every 20 minutes. The eadings 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 performatics when compared with also reason the BD Phoenix™ Automated Microbiology System notification provides and bepp 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 compared to the system has been evaluated as defined in the FDA Draft prepared according to NCCDB 117). The of 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 mitu and more one reproducioning a panel of Gram-positive isolates. Each site tested the isolates in evaluated at 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 I he results of the study demonstances 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 geographicaly diverse sites across Climical, stock and challenge isolates were tested antimicrobial susceptibility test with the United States to demonstrate the performance of this antimicrobial agent. Phoenix System results for clinical the Gram Positive Phoemix I and I ontacted to the expected results. Phoenix System results for clinical
for Challenge set isolates were compared to the expected results mig for Challenge set Isolates were compared to the exposed rooth 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 Category Agreement (CA) to cxpected releveloped Microbiology System agrees exactly or within ± (EA) occurs wilen inc DD Friodinates good . Category Agreement (CA) occurs when the BDD one two-loid thinking to the reference rosan. Savegary of 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-Positive Organisms by Drug Table 1:
| TECHNICAL CONSULTION COLLECTION COLLECTION CONTROLLERS CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTIO
Antimicrobial | Concentration | EA (n)
with the same of the same of the same of the same of the same of the same of the same of | EA (%) | CA (n)
The first of the country of the country of the first and
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | (CA (%) |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------|--------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|
| I was a more and the state of the state to contribution of the
Cephalothin | Comments of the control of the production of the contribution of the contribution of the contribution of the contribution of the contribution of the contribution of the contr
' 0.5-64 µg/mL | STATUTE AND THE
1220 | 90.8 | 1220 | 93.2 |
Conclusions Drawn from Substantial Equivalence Studies
The data collected from the substantial equivalence studies demonstrate that testing on the BD The data concected from the substantial capartmicrobial agent is substantially equivalent Phoemix --- Automated Microololegy Byocum Was "Guidance on Review Criteria for Assessment of Antimicrobial Susceptibility Devices", March 8, 2000. Technological characteristics of this system Annimicrobial Susceptionity Devices , March of 2000. " system, which received approval by the ate substantially equivalent to alsos as a manufact Microbiology System with FDA under FMA mamber 190310 and DD Theoma (K020323, April 14, 2002), and Levofloxacin (K020322, March 27, 2002).
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines forming its body and head. The eagle is facing right, and its wings are curved upwards. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.
MAR 2 2 2005
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Monica Evelyn Giguere Nis. Natory Affairs Specialist BD Diagnostics Systems BD Diagnobuse by and Company 7 Loveton Circle Sparks, MD 21152
K050400
Trade/Device Name: BD Phoenix™ Automated Microbiology System
Trade/Device Name: BD Phoenix (1) Re: BD Phoenix - Automated Microsoft - Gram-Positive ID/AST Regulation Number: 21 CFR 866.1645 Regulation Number: 21 CFF 866.1645
Regulation Name: Fully Automated Short-Term Incubation Cycle Antimicrobial
Province Callery Callery of Callibre Devices Susceptibility Devices Regulatory Class: Class II Product Code: LON Dated: February 15, 2005 Datod: February 16, 2005
Dear Ms. Giguere:
We have reviewed your Section 510(k) premarket notification of intent to market the device is a
nd indication of the county and the dayice is substantially equivalent (for th We have reviewed your Section 510(k) premarket in enews ve the indications
referenced above and have determined the device is substantially equivalent in interstate referenced above and have determined the devices marketed in interstate
for use stated in the enclosure) to legally marketed in interstate for use stated in the enclosure) to legally market predical Device Amendments, or to
commerce prior to May 28, 1976, the enactment date of the Medice Amendments, or to commerce prior to May 28, 1976, the enactment and of the Federal Food, Drug, devices that have been reclassified in accordance with the proval application (PMA).
and Cosmetic Act (Act) that do not require approval of a previsions of the Act. The and Cosmetic Act (Act) that do not require approval on the general optisions of the Act. The
You may, therefore, market the device, subject to the general ontrols provision You may, therefore, market the device, subject to the eventual registration, listing of
general controls provisions of the Act include requirements misbranding and general controls provisions of the Act include requirements to thirds beginst misbranding and adulteration.
lf your device is classified (see above) into either class II (Special Controls) or class III (PMA), If your device is classified (see above) nto embritias in (specultions affecting your device, it may be subject to such additional controls. Existing major and solo to 895. In addition, FDA
can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 80 can be found in Title 21, Code of Federal Regulations (e) 11), and 11 and 11 and 11 and 11 and
may |
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA's issuance of a substantial equivalence determanirements of the Act
that FDA has made a determination that your device complises with of the Act that FDA has made a determination that your device comples frederal agencies. You must
or any Federal statutes and regulations administered by other to: negistration and li or any Federal statutes and regulations administered by out a gesitudion and listing (21
comply with all the Act's requirements, including, but not limited to: registration a comply with all the Act's requirements, including, out more and manufacturing practice
CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice CFR Part 807); labeling (21 CFR Paris 801 and 807); and good as and as and and 120 CFR Part 820).
requirements as set forth in the quality systems (QS) regulation (21 CFR Par
4
This letter will allow you to begin marketing your device as described in your Scetion 510(k)
Children and the TDA Coding of gubstantial equivalence of your device to a lega This letter will allow you to begin marketing your device of your device of your device to a legally
premarket notification. The FDA finding of substantial equir device and t premarket notification. The FDA finding of substantial equivalion of 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, please contact the Office of In If you desire specific information about the application of your device, please contact the Office of In
or questions on the promotion and advertising of your device, please or questions on the promotion and Safety at (240)276-0484. Also, please note the Vitro Diagnostic Device Evaluation and Salety at 12-0727 of 10 FF . Rios" (21 CFR Part 807.97).
regulation entitled, "Misbranding by reference to premarket motification the regulation entitled, "Misbranding by telefence to premation interest the Act from the You may obtain other general informational onlyour Assistance at its toll-free number
Division of Small Manufacturers, International and Consumer Assistance at its toll-free Division of Sman Manufacts or st its Internet address.
(800) 638-2041 or (301) 443-6597 or at its Internet address (600) 056-2041 of (50 th/industry/support/index.html
Sincerely yours,
Sale, a Form
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: K C 50400
Device Name: BD Phoenix™ Automated Microbiology System for use with the antimicrobial agent
s of the country of the Camparitive ID/AST or AST only Phoenix panels. Device Name: BD Phoenix™ Automated Microsions provinsion of the enix panels.
Indications for Use:
The BD Phoenix™ Automated Microbiology System is intended for in vitro quantitative determination of The BD Phoenix™ Automated Microbiology System is miro qualimator (MC) of most Cramenegative aerobic and antimicrobial susceptibility by mimilian promotion (vinc) or nove orderioseriaceae and Non-Enterobacteriaceae
facultative anaerobic bacteria it also transport culture belopme facultative anaerobic bacteria isolates from pure culture for Eneros and 2
and most Gram-positive bacteria isolates from pure culture belonging to the genera Staphylococcus a Enterococcus.
This premarket notification is for the addition of the antimicrobial agent cephalothin at concentrations of This premarket notification is for the administration in the annological of the mastern the morn to be 0.5-64 μg/mL to Gram Positive ID/AST or AST only Phoelix panels. Copilatorin has over and over and package insert for this antimicrobial agent.
Active In Vitro and in Clinical Infections Against:
Staphylococcus species
Active In Vitro Against:
Over-the-Counter Use
Prescription Use (Per 21 CFR 801.109)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Sally at Arm
Division Sign-Off
Office of In Vitro Prasmostic Device Evaluation and Safety
1 0 80400 =