(42 days)
No
The summary describes an automated system for microbial identification and susceptibility testing based on broth microdilution and redox indicators. It mentions software for interpreting readings but does not indicate the use of AI or ML algorithms for this interpretation. The performance studies compare the system to a reference method, not to a model's performance metrics like AUC or standalone performance.
No.
The device is intended for the identification and antimicrobial susceptibility testing of bacterial isolates, which is an in vitro diagnostic (IVD) purpose, not a therapeutic one.
Yes
This device is intended for the rapid identification and in vitro antimicrobial susceptibility testing of isolates, which provides diagnostic information about microbial infections.
No
The device description explicitly lists hardware components such as 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 from pure culture) outside of the human body using reagents and a specialized instrument to provide diagnostic information (identification and susceptibility to antimicrobial agents).
- Performance Studies: The performance studies compare the device's results to a reference method (NCCLS reference broth microdilution method) for determining antimicrobial susceptibility, which is a diagnostic test.
- Predicate Device(s): The listed predicate devices are also automated microbiology systems used for identification and susceptibility testing, which are typically classified as IVDs.
The entire context of the document describes a system designed to perform tests on biological samples in vitro to aid in the diagnosis and treatment of bacterial infections by determining the susceptibility of bacteria to antimicrobial agents. This aligns directly 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 Enterobacteriaeae and Non-Enterobacteriaceae, and for Gram-positive aerobic and facultative anaerobic bacteria isolates from pure culture belonging to the genera Staphylococcus and Enterococcus.
This premarket notification is for the addition of the antimicrobial agent cefazolin at concentrations of 2-32 µg/mL to Gram Positive ID/AST or AST only Phoenix panels. Cefazolin has been shown to be active in vitro and in clinical infections against: Staphylococcus aureus (including penicillinase-producing strains) and Staphylococcus epidermidis.
Product codes
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 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 which is 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 can be a Gram-negative or Gram-positive isolate. For each isolate, an inoculation suspension 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 MIC values for a variety of general 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 degrees C. The instrument takes readings of the panels every 20 minutes. The readings are interpreted to give an identification of the isolate, minimum inhibitory concentration (MIC) values and category interpretations, S, I, or R (sensitive, intermediate, or resistant).
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
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 supporting the use of the BD Phoenix™ Automated Microbiology System with Phoenix panels containing 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 has been evaluated as defined in the FDA Draft Guidance document, "Guidance on Review Criteria for Assessment of Antimicrobial Susceptibility Devices", March 8, 2000).
Intra- and inter-site reproducibility of this antimicrobial agent in the BD Phoenix System was evaluated using 10 Gram-positive isolates. Each site tested the isolates in triplicate for 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 greater than 95% and an overall inter-site reproducibility greater than 95% for the Gram-positive 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 Gram Positive Phoenix Panel format containing this antimicrobial agent. Phoenix System results for clinical isolates were compared to the reference results obtained from the NCCLS reference broth microdilution method. Phoenix System results for Challenge set isolates were compared to the expected results.
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 for Gram-Positive Organisms by Drug - Cefazolin (2-32 ug/mL)
EA (n): 507
EA (%): 99.5
CA (n): 507
CA (%): 99.7
Key Metrics
Cefazolin (2-32 ug/mL)
Essential Agreement (EA) (n): 507
Essential Agreement (EA) (%): 99.5
Category Agreement (CA) (n): 507
Category Agreement (CA) (%): 99.7
Predicate Device(s)
VITEK® System (PMA No. N50510), K020321, K020323, K020322
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 Giguere
RA Specialist, Regulatory Affairs |
| DATE PREPARED: | April 11, 2005 |
| DEVICE TRADE NAME: | BD Phoenix™ Automated Microbiology System -
Cefazolin 2-32 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 The BD Phoenix Automated Microbiology of Steeting (AST) of clinically relevant bacterial isolates. The system includes the following components:
- BD Phoenix instrument and software. .
- BD Flioenix instrument and solvirals for organism ID testing and antimicrobial agents . or AST determinations.
- of AST deceminations:
BD Phoenix ID Broth used for performing ID tests and preparing AST Broth inoculum. . - BD Phoenix AST Broth used for performing AST tests only. .
- DD Fhoenix AST Brom assurrer posseded 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 The Filocins panel is a secured and over for susceptibility testing must be a pure culture and containing urica reagens. Organisms ion or Gram-positive isolate. For each isolate, an inoculation premimatiry tooners of the Farland 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 I noonia AST method if a ganism growth in the presence of an antimicrobial agent. Indicator for the detection of organism go as well as bacterial turbidity are used in the determination Measurents of thanges to the marcates ageral 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 readings are interpreted to give an identification of the isolate, minimum inhibitory concentration (MIC) values and category interpretations, S, I, or R (sensitive, intermediate, or resistant).
DEVICE COMPARISON:
The BD Phoenix™ Automated Microbiology System demonstrated substantially equivalent performance when compared with the NCCLS reference broth microdilution method. This premarket performatics when somporting the use of the BD Phoenix™ Automated Microbiology System hourieanon provides and cappermise hoenix 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 research has been evaluated as defined in the FDA Draft prepared according to FFOOD 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 millia- and micr-site reproductions) of Gram-positive isolates. Each site tested the isolates in e valuated 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 The results of the study demonentals to: 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 sites across the United States to demonstrate the performance of the Phoenix antimicrobial susceptibility test with the Gram Positive Phoenix Panel format containing this antimicrobial agent. Phoenix System results the Challenge set isolates were compared to the expected results. Phoenix System results for clinical ior Charlenge bot bolates nor results obtained from the NCCLS reference broth microdilution method.
The performance of the Phoenix System was assessed by calculating Essential Agreement (EA) and The performance of the I no expected/reference results for all isolates tested. Essential Agreement Calegory Agreement (OT) to expected Microbiology System agrees exactly or within ± one two-fold dilution to the reference result. Category Agreement (CA) occurs when the BD oncenix™ 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 for Gram-Positive Organisms by Drug Table 1:
| a different of the same of the said the same of the same of the same of the
Antimicrobial | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
The contract and particular procession in accession in accession in accession in accession in accession in accession in accession in accession in accession in accession in ac
Concentration | The first of the many of the comments of the first of the first of
EA (n) | Free of Canadian Cases on and Concession of Concession of Concession of Concession of Concessional Concessional Concession of Concessional of Concessional of Concessional of
EA (%)
. | House and can and and
CA (n)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | The family of the first of the first
| CA (%) |
|---|
| -------------------------------------------------------------------------------------------------------------------------- |
| Carren Comments of Children Comments of Children |
| The Comments and College and College of Concess of |
| A |
| Cefazolin |
| THE LEAST LE LEASE LEASE LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST |
| And Concession Company of Children |
2-32 ug/mL | Children assess as compare of concession in any
507 | 00 5
1 - 1 - 1 - | 507 | 00 7 |
Conclusions Drawn from Substantial Equivalence Studies
The data collected from the substantial equivalence studies demonstrate that testing on the BD The udia conceded from the odiolany System with this antimicrobial agent is substantially equivalent as outlined in the FDA draft guidance document, "Guidance on Review Criteria for Assessment of as outined in the I Dri drit garames" March 8, 2000. Technological characteristics of this system Amilificantially 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 I Dri under 1 (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 consists of a stylized eagle with three curved lines representing its wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
APR 1 4 2005
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Monica Giguere RA Specialist, Regulatory Affairs BD Diagnostics Systems Becton, Dickinson and Company 7 Loveton Circle Sparks, MD 21152
K050555 Re: K050335
Trade/Device Name: BD Phoenix™ Automated Microbiology System Cefazolin (2-32 µg/mL) - Gram-Postive ID/AST or AST Regulation Number: 21 CFR 866.1645 Regulation Name: 21 CFTC 000.1015
Regulation Name: Fully Automated Short-Term Incubation Cycle Antimicrobial Susceptibility Devices Regulatory Class: Class II Product Code: LON Dated: March 1, 2005 Received: March 3, 2005
Dear Ms. Giguere:
We have reviewed your Section 510(k) premarket notification of intent to market the indication We have reviewed your Section >10(x) premation is suivalent (for the indications
referenced above and have determined the device is subscreen in interstate referenced above and have delemined the devices marketed in interstate
for use stated in the enclosure) to legally marketed president device Amendments for use stated in the enclosure) to legally manced production Device Amendments, or to
commerce prior to May 28, 1976, the enactment as ansieral of the Federal Food. Drug commerce prior to May 28, 1970, the chaculteners with the provisions of the Federal Food, Drug, devices that have been recuire approval of a proval at a proval application (PMA).
and Cosmetic Act (Act) that do not require approval of a provisions of the Act . The and Cosmetic Act (Act) that do not require approval controls provisions of the Act. The Act. The You may, therefore, market the device, sayler to tire gents for annual registration, listing of
general controls provisions of the Act include required withing and general controls provisions of the receined requirements of the management 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 (See adove) ntrols. Existing major regulations affecting your device.
It may be subject to such additional controls. Existing major regulation it may be subject to such additional controls. Existing mayor regals.800 to 895. In addition, FDA
can be found in Title 21, Code of Federal Regulations (CFR), Parts Registe can be found in Title 21, Code of Pederal Regaralises (1) (1) = ) = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = =
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s issualited on a substitution with other requirements of the Act
that FDA has made a determination that your device and two Edgerains. You must that FDA has made a determination inal your devices by other Federal agencies. You must
or any Federal statutes and regulations administered by other registration and listi or any Federal statures and regilations annings, but not lied to: registration and listing (21
comply with all the Act's requirements, including, on anonomonomonmonmonmentice comply with all the Act s requirements, including, and good manufacturing practice
CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice CFR Part 807); labeling (21 CFR Parts 601 and 607);
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)
the same of the secure of alience for betweenes of your device to a legal This letter will allow you to begin marketing your advice of your device of your device to a legally
premarket notification. The FDA finding of substantial equivale and this premarket notification. The IDA inding of Justillation 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, a If you desire spectile information and advertising of your device, please contact the Office of In
or questions on the promotion and advertising of your device, please pote t or questions on the promotion and advertising of Jour 2015-0484. Also, please note the Vitro Diagnostic Device Evaluation and Barey at (210-210).
regulation entitled, "Misbranding by reference to premarket notification weder the Ast from the regulation entitled, "Misoranding of reichers on your responsibilities under the Act from the You may obtain other general informational and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address (000) 050-2012 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11
Sincerely yours,
Sales 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 05 05 5 5
Device Name: BD Phoenix™ Automated Microbiology System for use with the antimicrobial agent Device Name. " DD Frioomira - 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 The BD Phoenix™ Automatics witchoology Bystem in ation (MIC) of most Gram-negative aerobic
antimicrobial susceptibility by minimal inhibitory concentration (MIC) of most Nega and facultative anaerobic bacteria isolates from pure culture for Enterobacteriaeae and Nonand facultative anactoric bacteria isolates from pure culture belonging to the genera Staphylococcus and Enterococcus.
This premarket notification is for the addition of the antimicrobial agent oefarzolin at concentrations of This premarket nothcation is for the addition of the animalized and only of the many of 2-32 µgmL to Grain Fostive D7701 of NOT off Processions is described in the FDA-approved package insert for this antimicrobial agent.
Active In Vitro and in Clinical Infections Against:
Staphylococcus aureus (including penicillinase-producing strains) Staphylococcus epidermidis
Prescription Use _ ブ (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 Device Evaluation (ODE)
| Division Signature | |
|---|---|
| -------------------- | -- |
Office of In Vitro Diagnostic Device Evaluation and Safety
Page 1
| BD Diagnostic Systems
| Becton, Dickinson and Company | 510(k) K05 0555 |
|---|---|
| -------------------------------------------------------- | ----------------- |