(51 days)
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No
The summary describes a traditional automated microbiology system that uses a redox indicator and turbidity measurements to determine bacterial growth and susceptibility. There is no mention of AI, ML, or related concepts in the device description, intended use, or performance studies. The performance metrics are standard for this type of device (Essential Agreement and Category Agreement) and do not suggest the use of AI/ML algorithms for interpretation.
No.
The device is intended for in vitro diagnostic use, specifically for identifying and performing antimicrobial susceptibility testing of bacterial isolates. It does not directly treat or diagnose a disease in a patient.
Yes
Explanation: The device is explicitly stated to be intended for "rapid identification and in vitro antimicrobial susceptibility testing of isolates from pure culture... of human origin," which are diagnostic activities. It determines "minimal inhibitory concentration (MIC)" and provides "category interpretations (susceptible, intermediate, resistant or not susceptible)," all of which are used to aid in the diagnosis and treatment of infections.
No
The device description clearly lists multiple hardware components including the instrument, panels, broths, and indicator solution, in addition to the software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the system is intended for "in vitro antimicrobial susceptibility testing of isolates from pure culture of most aerobic and facultative anaerobic Gram-negative and Gram-positive bacteria of human origin." The term "in vitro" is a key indicator of an IVD.
- Device Description: The description details a system that analyzes biological samples (bacterial isolates from pure culture) outside of the human body to provide information about their characteristics (identification and susceptibility to antimicrobial agents). This is the core function of an IVD.
- Performance Studies: The performance studies describe testing the system's ability to accurately determine antimicrobial susceptibility by comparing its results to a reference method (NCCLS reference broth microdilution method) using bacterial isolates. This type of testing is conducted to validate the performance of an IVD.
- 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 document describes a system designed to perform tests on biological samples in vitro to provide diagnostic information about those samples, specifically regarding bacterial identification and antimicrobial susceptibility. 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 at concentrations of 0.0625 - 32 µg/mL to Gram Positive ID/AST or AST only Phoenix pancls. Ampicillin has been shown to be active in vitro 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:
Enterococcus spp.
Product codes (comma separated list FDA assigned to the subject device)
LON
Device Description
The BD Phocnix Autornated Microbiology System (Phoenix System) is an automated system for the TIK DD Thounk Halonated Microbial susceptibility testing (AST) of clinically relevant bacterial isolates. The system includes the following components:
- BD Phocnix instrument and software. .
- BD Phoenix panels containing biochemicals for organism ID testing and antimicrobial agents g 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 Phocnix AST Indicator solution added to the AST Broth to aid in bacterial growth . determination.
The Phoenix panel is a scaled and sclf-inoculating molded polystyrene tray with 136 micro-wells The I noomis punct is a ve. Organisms for susceptibility testing must be a purc culture and contaning dreatified as a Gram-negative or Gram-positive isolate. For cach isolate, an inoculation couivalent to a 0.5 McFarland standard is prepared in Phoenix ID broth.
The Phocnix AST mcthod 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. murcator for the decours on the indicator as well as bacterial turbidity are used in the determination Measurements of backers and configuration contains several antimicrobial agents with a wide range of two-fold doubling dilution concentrations.
The instrument houses :he panels where they are continuously incubated at a nominal temperature of 35°C. The instrument takes readings of the panels every 20 minutes. The readings are interpreted to give an identification of the isolate, minimum inhibitory concentration (MIC) values and category interpretations, S, I, R or N (susceptible, intermediate, resistant or not susceptible).
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
Site Reproducibility
Intra- and inter-site reproducibility of this antimicrobial agent in the BD Phoenix System was evaluated at three sites using a panel of 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 Chilical, stock and charlorige and 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 isolates were compared to the results obtained from the NCCLS reference broth microdilution method.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The BD Phoenix™ Automated Microbiology System demonstrated substantially equivalent performance when compared with the NCCLS reference broth microdilution method. This premarket portermines rovides data supporting the use of the BD Phoenix™ Automated Microbiology System Gram positive ID/AST or AST only 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 periored according to NCCLS M7). The system has been evaluated as defined in the FDA Draft propa ed abournment, "Guidance on Review Criteria for Assessment of Antimicrobial Susceptibility Devices", March 8, 2000.
Site Reproducibility
The results of the study demonstrate for the this antimicrobial agent there was an overall intra-site reproducibility of greater than 90% and an overall inter-site reproducibility greater than 95% for the Gram-positive isolates tested.
Clinical Studies
The performance of the Phocnix System was assessed by calculating Essential Agreement (EA) and The percommance of the I no cxpected/reference results for all isolates tested. Essential Agreement (EA) occurs when the ED Phoenix™ Automated Microbiology System agrees exactly or within ± (Ex) occurs when and the reference result. Category Agreement (CA) occurs when the BD one two the arrated Microbiology System agrees with the reference rncthod with respect to the FDA categorical interpretive criteria (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
Concentration: 0.0625 - 32 µg/mL
EA (n): 175
EA (%): 03 - - - - -
CA (n): 475
CA (%): 98.5
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Essential Agreement (EA)
Category Agreement (CA)
Ampicillin:
EA (%): 03
CA (%): 98.5
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.”
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| MAR 11 2004 | 510(k) SUMMARY | K040106 |
|---|---|---|
| SUBMITTED BY: | Becton, Dickinson and Company | |
| 7 Loveton Circle | ||
| Sparks, MD 21152 | ||
| Phone: 410-316-4778 | ||
| Fax: 410-316-4499 | ||
| CONTACT NAME: | Michelle Bytheway Bandy, | |
| RA Specialist | ||
| DATE PREPARED: | January 16, 2004 | |
| DEVICE TRADE NAME: | BD Phoenix™ Automated Microbiology System - | |
| Ampicillin 0.0625 - 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 Phocnix Autornated Microbiology System (Phoenix System) is an automated system for the TIK DD Thounk Halonated Microbial susceptibility testing (AST) of clinically relevant bacterial isolates. The system includes the following components:
- BD Phocnix instrument and software. .
- BD Phoenix panels containing biochemicals for organism ID testing and antimicrobial agents g 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 Phocnix AST Indicator solution added to the AST Broth to aid in bacterial growth . determination.
1
The Phoenix panel is a scaled and sclf-inoculating molded polystyrene tray with 136 micro-wells The I noomis punct is a ve. Organisms for susceptibility testing must be a purc culture and contaning dreatified as a Gram-negative or Gram-positive isolate. For cach isolate, an inoculation couivalent to a 0.5 McFarland standard is prepared in Phoenix ID broth.
The Phocnix AST mcthod 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. murcator for the decours on the indicator as well as bacterial turbidity are used in the determination Measurements of backers and configuration contains several antimicrobial agents with a wide range of two-fold doubling dilution concentrations.
The instrument houses :he 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 NCCLS reference broth microdilution method. This premarket portermines rovides data supporting 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 periored according to NCCLS M7). The system has been evaluated as defined in the FDA Draft propa ed abournent, "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 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 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 sites across Chilical, stock and charlorige and 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 isolates were compared to the results obtained from the NCCLS reference broth microdilution method.
The performance of the Phocnix System was assessed by calculating Essential Agreement (EA) and The percommance of the I no cxpected/reference results for all isolates tested. Essential Agreement (EA) occurs when the ED Phoenix™ Automated Microbiology System agrees exactly or within ± (Ex) occurs when and the reference result. Category Agreement (CA) occurs when the BD one two the arrated Microbiology System agrees with the reference rncthod with respect to the FDA categorical interpretive criteria (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 | The first and the contract and the comments of the comments of the comments of the comments of the comments of the comments of the comments of the comments of the contributio
Concentration | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
I
EA (n) | EA (%) | CA (n) | CA (%) |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------|--------|--------|
| A
Ampicillin | The Children and Children And Children Children Children Children Children Children Children
Call Concession of Children and Children and Children and Children
0.0625 - 32 µg/mL | 175
W | 03 -
-
-
-
-
- | 475 | 98.5 |
-
-
-
Conclusions Drawn from Substantial Equivalence Studies
The data collected from the substantial equivalence studies demonstrate that testing on the BD I ho utal concered iren are abology System with this antimicrobial agent is substantially equivalent as outlined in the FDA draft guidance document, "Guidance on Review Criteria for Assessment of Antimicrobial Susceptioility Devices", March 8, 2000. Technological characteristics of this system Annumerovan buseoplivalent to those sed 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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DEPARTMENT OF HEALTH & HUMAN SERVICES
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 or bird-like figure with three curved lines representing its body and wings. The bird is facing to the right. Encircling the bird is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES U.S.A.", arranged in a circular fashion around the bird.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
MAR 1 1 2904
Ms. Michelle Bytheway Bandy Regulatory Affairs Specialist BD Diagnostics Systems Becton, Dickinson and Company 7 Loveton Circle Sparks. MD 21152
K040106 Re:
Trade/Device Name: BD Phoenix" Automated Microbiology Systems Ampicillin (0.0625-32 ug/mL) Regulation Number: 21 CFR 866.1645 Regulation Name: Fully Automated Short-Term Incubation Cycle Anumicrobial Susceptibility Devices Regulatory Class: Class II Product Code: LON Dated: January 16, 2004 Received: January 20, 2004
Dear Ms. Bandy:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally 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, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. 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 Division of Small Manufacturers, International 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/dsma/dsmamain.html.
Sincerely yours,
Salazar
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: 1 40106
Device Name: BD Phoenix™ Automated Microbiology System for use with the antimicrobial agent ampicillin (0.0625 - 32 p.g/mL) - Gram positive ID/AST or AST only Phoenix Pancls.
Indications for Use:
The BD Phoenix™ Automated Microbiology System is intended for in vitro quantitative determination of antimicrobial susceptibility by minimal inhibitory concentration (MC) 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 at concentrations of 0.0625 - 32 µg/mL to Gram Positive ID/AST or AST only Phoenix pancls. Ampicillin has been shown to be active in vitro 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:
Enterococcus spp.
... V Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-the-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Freddie L. Roche
Billing Sign Off
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K040106
BI) Diagnostic Svstems Becton, Dickinson and Company
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