(30 days)
Not Found
No
The document describes an automated microbiology system that uses a redox indicator and turbidity readings to determine bacterial growth and susceptibility. It does not mention any AI or ML algorithms being used for interpretation or analysis. The performance metrics are based on agreement with reference methods and reproducibility, not typical AI/ML performance metrics like AUC or standalone performance.
No
Explanation: The device is intended for in vitro diagnostic (IVD) use to identify microorganisms and test their susceptibility to antimicrobial agents. It does not directly treat or diagnose a condition in a human patient, which is characteristic of a therapeutic device.
Yes
The device is intended for the rapid identification and in vitro antimicrobial susceptibility testing of isolates from pure cultures to determine minimum inhibitory concentration (MIC) values and category interpretations (susceptible, intermediate, resistant, or not susceptible), which are used to guide treatment decisions.
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 (MIC)". The term "in vitro" is a key indicator of an IVD.
- Device Description: The description details components like "BD Phoenix panels containing biochemicals for organism ID testing and antimicrobial agents" and "BD Phoenix ID Broth" and "BD Phoenix AST-S Broth". These are reagents and materials used to perform tests on biological samples outside of the human body.
- Function: The system performs tests on bacterial isolates from pure culture to determine their identification and susceptibility to antimicrobial agents. This is a diagnostic process performed on a sample taken from a patient, but the testing itself is done in a laboratory setting.
Therefore, based on the provided information, the BD Phoenix™ Automated Microbiology System clearly fits 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 of clinical isolates (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, Enterococcus, and Streptococcus.
This premarket notification is for the addition of the antimicrobial agent Ceftriaxone at concentrations of 0.0625-4 ug/mL to Streptococcus ID/AST or AST only Phoenix panels. Ceftriaxone has been shown to be active in vitro and in clinical infections as described in the FDA-approved package insert for this antimicrobial agent.
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 I no i novel reagents. Organisms for susceptibility testing must be a pure culture and oonlianing arree rugedive or 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. marculer for the actioners 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
Not Found
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 Chilical, stock and chartelly of 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.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Site Reproducibility: The results of the study demonstrate for the this antimicrobial agent there was an overall intra-site reproducibility of ≥98.4% and an overall inter-site reproducibility of ≥99.5% for the streptococcal isolates tested.
Clinical Studies: The performance of the Phoenix System was assessed by calculating Essential Agreement (EA) and I he performance of the I novement of techner results for all isolates tested. Essential Agreement Category Reroment (CT) to enjoy™ Automated Microbiology System agrees exactly or within ± (21) occurs dilution to the reference result. Category Agreement (CA) occurs when the BD one two-rold ununcul to the objology System agrees with the reference method with respect to the FDA categorical interpretive criteria (susceptible, intermediate, resistant or nonsusceptible).
Performance of BD Phoenix System for Streptococcal Organisms by Drug Table 1:
Ceftriaxone concentration 0.0625-4 ug/mL
EA (n) = 2013, EA (%) = 98.3
CA (n) = 2013, CA (%) = 07 11:V
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Essential Agreement (EA), Category Agreement (CA), 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), 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.
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.”
0
3 2005 JUN
CONFIDENTIAL AND PROPRIETARY
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 |
| DATE PREPARED: | May 2, 2005 |
| DEVICE TRADE NAME: | BD Phoenix™ Automated Microbiology System -
Ceftriaxone 0.0625-4 ug/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 PhoenixTM
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 I no i novel reagents. Organisms for susceptibility testing must be a pure culture and oonlianing arree rugedive or 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. marculer for the actioners 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 evaluated as defined in the FDA Draft guidance document, "Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems; Guidance for Industry and FDA," February 5, 2003.
Site Reproducibility
Intra- and inter-site reproducibility of this antimicrobial agent in the BD Phoenix System was evaluated at three sites using a panel 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 ≥98.4% and an overall inter-site reproducibility of ≥99.5% for the streptococcal isolates tested.
2
Clinical Studies
Clinical, stock and challenge isolates were tested across multiple geographically diverse sites across Chilical, stock and chartelly of 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 I he performance of the I novement of techner results for all isolates tested. Essential Agreement Category Reroment (CT) to enjoy™ Automated Microbiology System agrees exactly or within ± (21) occurs dilution to the reference result. Category Agreement (CA) occurs when the BD one two-rold ununcul to the objology 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.
Performance of BD Phoenix System for Streptococcal Organisms by Drug Table 1:
| The first of the same of the camperation of the country
Antimicrobial | AND OR STORE FOR STATES OF THE FORM OF THE FORM OF THE FORM OF THE FORM OF THE FORM OF THE FORM OF THE FORM OF THE FORM OF THE FORM OF THE FORM OF THE FOR
CALLER ALL WITH CHILIN COLLEGE
.
Concentration | The Call of Children of Children of Children
Acres of the property
EA (n) | (0/0)
EA . | CA (n) | CA
(%) |
|--------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------|---------------|--------|------------|
| The County of
Ceftriaxone | AND AND THE FORMING CHANAL CHARAL CHARACT CHEARTH CHEARTH CHEARTH CHEARTH CHEARTH CHEARTH CHEARTH CHEARTH CHEARTH CHEARTH CHEARTH CHEARTH CHEARTH CHEARTH CHEARTH AND THE CHEA
0.0625-4 ug/mL | I
2013 | 98.3 | 2013 | 07
11:V |
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 r noutlined in the FDA draft guidance document, "Class II Special Controls Guidance Document: a vimicrobial 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).
3
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 caduceus, which is a symbol often associated with medicine and healthcare. The caduceus is depicted with a staff entwined by two snakes and topped with wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
3 2005 Jun
Ms. Monica E. Giguere Regulatory Affairs Specialist BD Diagnostics Systems Becton, Dickinson and Company 7 Loveton Circle Sparks, MD 21152
Received: May 4, 2005
K051138 Re:
Rose Device Name: BD Phoenix TM Automated Microbiology System Ceftriaxone (0.0625-4 ug/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 2, 2005
Dear Ms. Giguere:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your be determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to conninered pror to May 20, 1978, in occordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). and Costieter rever (110) that as novice, subject to the general controls provisions of the Act. The I ou may, aferere, maxis of the Act include requirements for annual registration, listing of general controll profice wing 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 your device is easoned (660 as 1 controls. Existing major regulations affecting your device it may be subject to back of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA can oc found in The Brouncements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean I Trass oc advised that I Dristian that your device complies with other requirements of the Act that I Dr Has Intervand regulations administered by other Federal agencies. You must or uny I cathe all the Act's requirements, including, but not limited to: registration and listing (21 comply with an allering (21 CFR Parts 801 and 809); and good manufacturing practice OFF Part 867), tabelies 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 5 10(k) I his letter will anow you to oegin marketing your intial equivalence of your device to a legally premarket notification. "The PDF Imaning of backand"
marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific information about the application of labeling requirements to your device, of fu If you desire specific intornation actual 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 regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Tou may outain other general meethanel 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 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
5
Page 1 of 1
Ko 5 113 8 510(k) Number: __
Device Name: BD Phoenix™ Automated Microbiology System for use with the antimicrobial agent Device Name. BDTHoomx
Indications for Use:
The BD Phoenix™ Automated Microbiology System is intended for in vitro quantitative determination of The BD Phoenix™ Automated Michology System is manton (MIC) of most Gram-negative aerobic and antimicrobial susceptionity of initial innoltory obitoriacere and Non-Enterobacteriaceae
facultative anaerobic bacteria isolates from pure culture for Exercess Sterbulosecou facultative anactoric bacteria isolates from pure culture belonging to the genera Staphylococcus ,
and most Gram-positive bacteria isolates from pure culture belonging to the Enterococcus, and Streptococcus.
This premarket notification is for the addition of the antimicrobial agent offrisance at concernations of I his premarket notification is for the addition of the mix panels. Ceftriaxone has been shown to be 0.06.25-4 ig/mL to Sireplococcus IDAS I of AGT only Filocally as described in the FDA-approved package insert for this antimicrobial agent.
Active In Vitro and in Clinical Infections Against:
Streptococcus pneumoniae Streptococcus pyogenes Viridans group streptococci
Active In Vitro Against: Streptococcus agalactiae
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)
| Division Sign-Off | ||
|---|---|---|
| -- | ------------------------------------------------------------------------- | -- |
| Prescription Use
| (Per 21 CFR 801.109) | Office of In Vitro Diagnostic Device Evaluation and Safety | Over-the-Counter Use |
|---|---|---|
| ------------------------------------------ | ------------------------------------------------------------ | ---------------------- |
| BD Diagnostic Systems
| Becton Dickinson and Company | 510(k) K051138 page 9 |
|---|---|
| ------------------------------------------------------- | ----------------------- |