(21 days)
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 Grampositive bacteria of human origin.
The BD Phoenix™ Automated Microbiology System is intended for in vitro quantitative determination of the minimum inhibitory concentration (MIC) of most Gram-negative aerobic and facultative anaerobic bacteria belonging to the family 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 amoxicillin at concentrations of 0.0313-32 ug/mL to the BD Phoenix panels. Amoxicillin has been shown to be active in vitro and in clinical infections against: Streptococcus pneumoniae, Streptococcus spp. (x-and ß-hemolytic strains only).
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 containing dried reagents. Organisms for susceptibility testing must be a pure culture and preliminarily identified as a Gram-negative or Gram-positive isolate. For each isolate, an inoculation equivalent to a 0.5 McFarland standard is prepared in Phoenix ID broth.
The Phoenix AST method is a broth based microdilution test. The Phoenix System utilizes a redox indicator for the detection of organism growth in the presence of an antimicrobial agent. Measurements of 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 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).
Here's a breakdown of the acceptance criteria and study details for the BD PHOENIX™ Automated Microbiology System Amoxicillin - Strep, based on the provided 510(k) summary:
Acceptance Criteria and Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Essential Agreement (EA): The BD Phoenix™ Automated Microbiology System agrees exactly or within ± one two-fold dilution to the reference result for MIC interpretation. | 96.8% Essential Agreement (n=1027) |
| Category Agreement (CA): The BD Phoenix™ Automated Microbiology System agrees with the reference method with respect to the FDA categorical interpretive criteria (susceptible, intermediate, resistant or non-susceptible). | 97.0% Category Agreement (n=1027) |
| Intra-site Reproducibility: Overall reproducibility within a single testing site. | >90% intra-site reproducibility |
| Inter-site Reproducibility: Overall reproducibility across different testing sites. | >95% inter-site reproducibility |
Study Details
1. Sample Size and Data Provenance
- Test Set Sample Size: 1027 isolates (for both EA and CA calculations).
- Data Provenance: Clinical, stock, and challenge isolates were tested across multiple geographically diverse sites across the United States. The study was prospective in nature, as new data was collected to demonstrate performance against a reference method.
2. Number of Experts to Establish Ground Truth and Qualifications
- The document does not specify the number of experts used or their qualifications to establish ground truth.
- However, the ground truth was established using the CLSI reference broth microdilution method, which is a standardized and widely accepted microbiological technique, implying that trained microbiologists performed these reference tests.
3. Adjudication Method
- The document does not explicitly state an adjudication method (like 2+1, 3+1).
- Instead, the comparison was made between the Phoenix System's results and the single, established CLSI reference broth microdilution method results. Discrepancies would likely be investigated, but a specific multi-reader adjudication process for ground truth establishment is not described.
4. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, an MRMC comparative effectiveness study involving human readers and AI assistance was not performed. This device is an automated microbiology system, not an AI-assisted diagnostic tool that augments human interpretation. Its performance is compared to a reference laboratory method rather than human readers.
5. Standalone Performance (Algorithm Only)
- Yes, the study evaluated the standalone performance of the BD Phoenix™ Automated Microbiology System. The device itself is an "algorithm only" system in the context of interpreting bacterial growth and determining MIC values. The reported EA and CA percentages directly reflect the algorithm's performance compared to the reference method.
6. Type of Ground Truth Used
- The ground truth used was the CLSI reference broth microdilution method (AST panels prepared according to NCCLS M7). For challenge isolates, results were compared to "expected results," which would also be derived from established microbiological standards.
7. Sample Size for Training Set
- The document does not provide specific details regarding a training set sample size. This summary focuses on the validation of the system, not the development or training of its internal algorithms.
8. How Ground Truth for Training Set was Established
- The document does not provide information on how ground truth was established for any potential training set. As a commercial system, the development process and initial training data details are typically proprietary and not part of the 510(k) public summary. The focus of the 510(k) is the validation of the final product.
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BD PHOENIX™ Automated Microbiology System Amoxicillin - Strep
CONFIDENTIAL AND PROPRIETARY
510(k) SUMMARY
JUL 1 4 2005 Becton, Dickinson and Company SUBMITTED BY: 7 Loveton Circle Sparks. MD 21152 Phone: 410-316-4287 410-316-4499 Fax: Monica Giguere, CONTACT NAME: RA Specialist DATE PREPARED: June 21, 2005 BD Phoenix™ Automated Microbiology System -DEVICE TRADE NAME: Amoxicillin 0.0313-32 µg/mL Antimicrobial susceptibility test system-short incubation DEVICE COMMON NAME: Fully Automated Short-Term Incubation Cycle Antimicrobial DEVICE CLASSIFICATION: Susceptibility Device, 21 CFR 866.1645 VITEK® System (PMA No. N50510) and BD Phoenix™ PREDICATE DEVICES: Automated Microbiology System with Gatifloxacin (K020321, May 23, 2002), Ofloxacin (K020323, April 14, 2002), and Levofloxacin (K020322, March 27, 2002). The BD Phoenix™ Automated Microbiology System is INTENDED USE: 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 Grampositive 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.
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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. For each isolate, an inoculation equivalent to a 0.5 McFarland standard is prepared in Phoenix ID broth.
The Phoenix AST method is a broth based microdilution test. The Phoenix System utilizes a redox indicator for the detection of organism growth in the presence of an antimicrobial agent. Measurements of 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 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 streptococcal 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 greater than 90% and an overall inter-site reproducibility greater than 95% for the streptococcal isolates tested.
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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 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 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, 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:
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------Antimicrobial | Concentration | EA (n) | EA (%) | CA (n) | CA (%) |
|---|---|---|---|---|---|
| 11. 1 am annual consumer on 1 moreState Canadian Carder CarderAmoxicillin | A Comments of the last in Comments of Canadian and Concession and Concession and Concession and Concession Concession and Concession Come of Concession Comercial Concession aAnd Market In A 16 11 11 1000.0313-32 ug/mL | 1027and for the forme of the first of the first of the first of the first and the first and the first and the final the final the final the final the final the final the final th | 96.8% | 10271 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - | 97.0% |
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 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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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is an abstract image of an eagle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JUL 1 4 2005
Ms. Monica E. Giguere Regulatory Affairs Specialist BD Diagnostics Systems Becton, Dickinson and Company 7 Loveton Circle Sparks, MD 21152
K051692 Re: Ros 1072
Trade/Device Name: BD Phoenix™ Automated Microbiology System Amoxicillin (0.0313-32 µg/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: June 21, 2005 Received: June 23, 2005
Dear Ms. Giguere:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your bection be device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreations) it the enactment date of the Medical Device Amendments, or to commerce prior to May 20, 1977, tive excordance with the provisions of the Federal Food, Drug, de necs that have been recise and require approval of a premarket approval application (PMA). alle Cosmetic rice (71ct) market the device, subject to the general controls provisions of the Act. The I ou may, therefore, market are as act include requirements for annual registration, listing of general controls proficiouring 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 elassified (div a controls. Existing major regulations affecting your device It may be subject to Submittederal Regulations (CFR), Parts 800 to 895. In addition, FDA can be found in The BT, occements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean I lease of actived that I Dr Breasan that your device complies with other requirements of the Act that IDA has inade a determinations administered by other Federal agencies. You must of any I coclar statutes und regaranents .including, but not limited to: registration and listing (21 Comply with an the Free 5 require 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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Page 2 -
This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter witi anow you wo ough finding of substantial equivalence of your device to a legally premation notification. "Thesels 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 or questions on the promie Evaluation and Safety at (240)276-0484. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Tou may obtain other gefacturers, 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,
Sally a story
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: Ko 516 92
Device Name: BD Phoenix™ Automated Microbiology System for use with the antimicrobial agent amoxicillin (0.0313-32 ug/mL) - Streptococcus 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 DD I hoonix - Automation inhibitory concentration (MIC) of most Gram-negative aerobic and annincrobat susceptions of minute for Enterobacteriaceae and Non-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 amoxicillin at concentrations of 1 ms premarker nounced to county Phoenix panels. Amoxicillin has been shown to be 0.01.5-52 pg milli it on encoded in 10 r or an and in the FDA-approved package insert for this antimicrobial agent.
Active In Vitro and in Clinical Infections Against:
Streptococcus pneumoniae Streptococcus spp. (x-and ß-hemolytic strains only)
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)
Ludde A. Poole
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K051692
§ 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.”