(52 days)
No
The description focuses on automated measurements of turbidity and redox indicators, and comparison to reference methods, without mentioning AI or ML.
No.
The device is for in vitro diagnostic (IVD) use, specifically for identifying bacteria and testing their susceptibility to antimicrobials, which are functions performed outside of the body to aid in diagnosis, not to treat or prevent disease.
Yes
The device is intended for the rapid identification and antimicrobial susceptibility testing of bacterial isolates from human origin, which directly aids in diagnosing infections and guiding treatment decisions.
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 to provide information about their characteristics (identification and susceptibility to antimicrobial agents). This aligns with the definition of an IVD.
- Testing Method: The description of the broth-based microdilution test and the use of a redox indicator to detect bacterial growth in the presence of antimicrobial agents are all typical methods used in in vitro diagnostic testing.
- Output: The system provides "identification of the isolate, minimum inhibitory concentration (MIC) values and category interpretations, S, I, or R (sensitive, intermediate, or resistant)". These are diagnostic results obtained from testing a sample outside the body.
- Performance Studies: The performance studies described involve testing bacterial isolates and comparing the results to reference methods (CLSI reference broth microdilution method) and expected results. This is standard practice for validating the performance of an IVD.
- Predicate Devices: The listed predicate devices are also automated microbiology systems used for identification and susceptibility testing, which are generally classified as IVDs.
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 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, Enterococcus, and Streptococcus.
This premarket notification is for additional organism groups and Amoxicillin-clavulanate (0.5/0.25 – 32/16 µg/mL), Ampicillin-sulbactam (0.5/0.25-32/16 µg/mL), and Ticarcillin (1-128 µg/mL), on the BD Phoenix Automated Microbiology System.
Product codes (comma separated list FDA assigned to the subject device)
LON
Device Description
The BD Phoenix Automated Microbiology System (Phoenix System) is an automated system for the rapid identification (ID) and antimicrobial susceptibility testing (AST) of clinically relevant bacterial isolates. The system includes the following components:
- . BD Phoenix instrument and software.
- BD Phoenix panels containing biochemicals for organism ID testing and antimicrobial agents . 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 solution added to the AST Broth to aid in bacterial growth . determination.
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 bacterial growth. Each AST panel configuration contains several antimicrobial agents with a wide range of two-fold doubling dilution concentrations.
The Phoenix panel is a sealed and self-inoculating molded polystyrene tray with 136 micro-wells containing dried reagents. Organisms for susceptibility testing must be a pure culture and preliminarily identified as a Gram-negative or Gram-positive isolate. Phoenix panels are inoculated with a specified organism density and placed into the instrument.
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 sites using a panel chosen isolates. Each site tested the isolates in triplicate on three different days using one lot of Phoenix panels containing the antimicrobial agents and ansociated reagents.
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 Phoenix panel formats containing antimicrobial agents. Phoenix System results for ChalJewee wet 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)
The BD Phoenix™ Automated Microbiology System demonstrated substantially equivalent performance when compared with the CLSI reference broth microdilution method. This premarket notification provides data for additional organism groups with Amoxicillin-clavulanate (0.5/0.25 -32/16 µg/mL, Ampicillin-sulbactam (0.5/0.25-32/16 µg/mL), and Ticarcillin- 1-128 µg/mL (K031984, August 27, 2003) and the BD Phoenix™ Automated Microbiology System.
The results of the study demonstrate for each antimicrobial agent there was an overall intra-site reproducibility of greater than 90% and an overall inter-site reproducibility greater than 95% for the isolates tested.
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).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Essential Agreement (EA) and Category Agreement (CA) are reported.
Amoxicillin-clavulanate: EA (n) 2249, EA (%) 96.7, CA (n) 2249, CA (%) 90.9
Ampicillin-sulbactam: EA (n) 1305, EA (%) 97.2, CA (n) 1305, CA (%) 87.5
Ticarcillin: EA (n) 2882, EA (%) 94.7, CA (n) 2882, CA (%) 92.7
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, K031912, K043389, K031984
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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Image /page/0/Picture/1 description: The image shows the text "K061327" in a handwritten style, likely a code or identifier. Below this, the phrase "CONFIDENTIAL AND PROPRIETARY" is printed in a clear, block-letter font. The text suggests the document or item associated with the code is private and protected.
510(K) SUMMARY
JUL - 3 2006
| SUBMITTED BY: | Becton, Dickinson and Company
7 Loveton Circle
Sparks, MD 21152
Phone: (410) 316-4161
Fax: 410-316-4499 |
|------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| CONTACT NAME: | Vicki L. Kennedy
Regulatory Affairs Specialist |
| DATE PREPARED: | May 11, 2006 |
| DEVICE TRADE NAME: | BD Phoenix™ Automated Microbiology System –
Amoxicillin-clavulanate (0.5/0.25 – 32/16 µg/mL), Ampicillin-
sulbactam (0.5/0.25-32/16 µg/mL), and Ticarcillin
(1-128 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), Amoxicillin-clavulanate (K031912,
July 21, 2003), Ampicillin-sulbactam (K043389,
January 21, 2005), and Ticarcillin (K031984, August 27, 2003) |
| INTENDED USE: | The BD Phoenix™ Automated Microbiology System is
intended for the rapid identification and in vitro antimicrobial
susceptibility testing of isolates from pure culture of most
aerobic and facultative anaerobic Gram-negative and Gram-
positive bacteria of human origin |
DEVICE DESCRIPTION:
The BD Phoenix Automated Microbiology System (Phoenix System) is an automated system for the rapid identification (ID) and antimicrobial susceptibility testing (AST) of clinically relevant bacterial isolates. The system includes the following components:
- . BD Phoenix instrument and software.
- BD Phoenix panels containing biochemicals for organism ID testing and antimicrobial agents . for AST determinations.
- BD Phoenix ID Broth used for performing ID tests and preparing AST Broth inoculum. .
1
- 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 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 bacterial growth. Each AST panel configuration contains several antimicrobial agents with a wide range of two-fold doubling dilution concentrations.
The Phoenix panel is a sealed and self-inoculating molded polystyrene tray with 136 micro-wells containing dried reagents. Organisms for susceptibility testing must be a pure culture and preliminarily identified as a Gram-negative or Gram-positive isolate. Phoenix panels are inoculated with a specified organism density and placed into the instrument.
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).
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 for additional organism groups with Amoxicillin-clavulanate (0.5/0.25 -32/16 µg/mL, Ampicillin-sulbactam (0.5/0.25-32/16 µg/mL), and Ticarcillin- 1-128 µg/mL (K031984, August 27, 2003) and the BD Phoenix™ Automated Microbiology System.
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 chosen isolates. Each site tested the isolates in triplicate on three different days using one lot of Phoenix panels containing the antimicrobial agents and ansociated reagents.
The results of the study demonstrate for each antimicrobial agent there was an overall intra-site reproducibility of greater than 90% and an overall inter-site reproducibility greater than 95% for the 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 Phoenix panel formats containing antimicrobial agents. Phoenix System results for ChalJewee wet 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 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.
| Table 1: | Performance of BD Phoenix System by Drug |
|---|---|
| ---------- | ------------------------------------------ |
| Antimicrobial | Concentration | EA (n) | EA (%) | CA (n) | CA (%) |
|---|---|---|---|---|---|
| Amoxicillin-clavulanate | 0.5/0.25 – 32/16 µg/mL | 2249 | 96.7 | 2249 | 90.9 |
| Ampicillin-sulbactam | 0.5/0.25 – 32/16 µg/mL | 1305 | 97.2 | 1305 | 87.5 |
| Ticarcillin | 1 – 128 µg/mL | 2882 | 94.7 | 2882 | 92.7 |
Conclusions Drawn from Substantial Equivalence Studies
The data collected from the substantial equivalence studies demonstrate that testing on the BD Phoenix™ Automated Microbiology System with this antimicrobial agent is substantially equivalent as outlined in the FDA draft guidance document, "Class II Special Controls Guidance Document: Antimicrobial 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 N505 and BD Phoenix™ Automated Microbiology System with Gatifloxacin (K020321, May 23, 2002), Amoxicillin-clavulanate (K031912, July 21, 2003), Ampicillin-sulbactam (K043389, January 21, 2005), and Ticarcillin (K031984, August 27, 2003)
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines forming its body and wings. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Re:
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Vicki L. Kennedy Regulatory Affairs Specialist BD Diagnostics Systems Becton, Dickinson and Company 7 Loveton Circle Sparks, MD 21152
K061327 Trade/Device Name: BD Phoenix™ Automated Microbiology System Amoxicillin-clavulanate (0.5/0.25 - 32/16 ug/mL), Ampicillinsulbactam (0.5/0.25 - 32/16 µg/mL), and Ticarcillin (1-128 ug/mL), - Gram-negative 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 11, 2006 Received: May 12, 2006
JUL - 3 2006
Dear Ms. Kennedy:
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 idence) ons 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 Amendonates, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Or ug, 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 I he general controls provisions of the Act include requirements for annual registration, lusting of devices, good manufacturing practice, labeling, and prohibitions against misbaranting and adulteration.
If your device is classified (sce 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 FFA may publish further announcements concerning your device in the Federal 07-2. ' w a
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. Your 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 pratis c requirements as set forth in the quality systems (QS) regulation (21 CFR Parts process
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Page 2 -
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 Intel Vitro Diagnostic Device Evaluation and Safety at (240)276-0484. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Pan 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/industry/support/index.html
Sincerely yours.
Sale, a 100%
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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510(k) Number: K061327
Device Name: BD Phoenix™ Automated Microbiology System for use with the antimicrobial agent Amoxicillin-clavulanate (0.5/0.25 – 32/16 µg/mL), Ampicillin-sulbactam (0.5/0.25-32/16 µg/mlgc. and Ticarcillin (1-128 µg/mL), – Gram-negative ID/AST or AST only Phoenix panels.
Indications for Use:
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, Enterococcus, and Streptococcus.
This premarket notification is for additional organism groups and Amoxicillin-clavulanate (0.5/0.25 – 32/16 µg/mL), Ampicillin-sulbactam (0.5/0.25-32/16 µg/mL), and Ticarcillin (1-128 µg/mL), on the BD Phoenix Automated Microbiology System.
Amoxicillin-clavulanate 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:
Active In Vitro Against:
Enterobacter species Escherichia coli Klebsiella species
Proteus mirabilis
Ampicillin-sulbactam 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:
Beta-lactamase producing strains of: Escherichiu coli Klebsiella spp. (including K. pneumoniae)
Active In Vitro Against:
Escherichia coli (Beta-lactamase and non-beta-lactamase producing) Klebsiella species (all known strains are beta-lactamase producing) Morganella morganii Providencia rettgeri Providencia stuarti Division Sign-Off
BD Diagnostic Systems Becton. Dickinson and Company
Page S
Office of In Vitro Diagnostic Device Evaluation and Sufery
6
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Ticarcillin has been shown to be active in virro against most strains of microorganisms listed below, as described in the FDA-approved package insert for this antimicrobial agence
Active In Vitro Against:
Pseudomonas aeruginosa (and other species) Escherichia coli Proteus mirabilis Morganella morganii
Providencia rettgeri Enterobacter species Salmonella species
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 Device Evaluation (ODE)
Fuddi Pacci
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K061327
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