(64 days)
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 BD Phoenix™ Automated Microbiology System with Nitrofurantoin (8-512 ug/mL), Trimethoprim-sulfamethoxazole (0.5/9.5-16/304 µg/ mL) and Nalidixic Acid (2-32µg/mL) on Gram-negative ID/AST or AST only Phoenix panels.
Nitrofurantoin 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:
Escherichia coli
Active In Vitro Against:
Citrobacter amalonaticus
Citrobacter koseri (diversus)
Citrobacter freundii
Klebsiella oxytoca
Klebsiella pneumoniae (ozaenae)
Trimethoprim-sulfamethoxazole 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:
Escherichia coli
Klebsiella species
Enterobacter species
Morganella morganii
Proteus mirabilis
Proteus vulgaris
Shigella flexneri
Shigella sonnei
Nalidixic Acid 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:
Enterobacter species
Escherichia coli
Morganella morganii
Proteus mirabilis
Proteus vulgaris
Providencia rettgeri
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 t 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).
The provided document describes the performance of the BD Phoenix™ Automated Microbiology System for antimicrobial susceptibility testing (AST) of Nitrofurantoin, Trimethoprim-sulfamethoxazole, and Nalidixic Acid against certain bacterial isolates.
Here's the breakdown of the acceptance criteria and study details:
1. Table of Acceptance Criteria and Reported Device Performance:
The document implicitly refers to the FDA Draft Guidance Document, "Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems; Guidance for Industry and FDA," February 5, 2003, for defining acceptance criteria. While explicit numerical acceptance thresholds (e.g., "EA must be > 90%") are not stated in the provided text, the study's aim was to demonstrate "substantially equivalent performance" to the CLSI reference method as outlined in this guidance. The performance metrics reported are Essential Agreement (EA) and Category Agreement (CA).
| Antimicrobial | Concentration | Performance Metric | Acceptance Criteria (Implicit from guidance for substantial equivalence) | Reported Device Performance |
|---|---|---|---|---|
| Nitrofurantoin | 8-512 $\mu$ g/mL | EA (%) | High agreement with reference method | 95.8% (n=2130) |
| CA (%) | High agreement with reference method | 84.4% (n=2130) | ||
| Trimethoprim-sulfamethoxazole | 0.5/9.5-16/304 $\mu$ g/mL | EA (%) | High agreement with reference method | 96.0% (n=2212) |
| CA (%) | High agreement with reference method | 97.7% (n=2212) | ||
| Nalidixic Acid | 2-32 $\mu$ g/mL | EA (%) | High agreement with reference method | 96.2% (n=2103) |
| CA (%) | High agreement with reference method | 98.6% (n=2103) | ||
| Site Reproducibility | N/A | Intra-site | >90% | >90% |
| N/A | Inter-site | >95% | >95% |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size for Test Set:
- Nitrofurantoin: 2130 isolates
- Trimethoprim-sulfamethoxazole: 2212 isolates
- Nalidixic Acid: 2103 isolates
- Data Provenance: Clinical, stock, and challenge isolates were tested. The clinical isolates were collected from "multiple geographically diverse sites across the United States." The study also included "challenge isolates" to compare against expected results, implying a controlled set of strains with known characteristics. The study is prospective in the sense that the testing was performed specifically for this submission, although the source of the clinical isolates themselves could be retrospective collections.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
The document does not specify the number of experts or their qualifications for establishing ground truth. The ground truth for clinical isolates was established by the CLSI reference broth microdilution method. For challenge isolates, it was compared to "expected results," which would be based on predefined characteristics of those strains.
4. Adjudication Method for the Test Set:
Not applicable. This type of study (Antimicrobial Susceptibility Testing) does not typically involve human adjudication of results in the way, for example, a radiology AI study might. The "ground truth" is determined by a standardized laboratory reference method (CLSI broth microdilution).
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance:
This type of study was not performed. The BD Phoenix™ Automated Microbiology System is an automated device designed to perform AST, not to assist human readers in interpreting images or other complex data. It provides interpreted results directly (MIC values and S/I/R categories).
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
Yes, a standalone performance study was conducted. The "BD Phoenix™ Automated Microbiology System" is the device being evaluated, and its results (MIC and S/I/R interpretations) are directly compared to the reference method. There is no human intervention mentioned as part of the system's performance assessment or result generation.
7. The Type of Ground Truth Used:
The ground truth used was:
- For clinical isolates: CLSI reference broth microdilution method (a laboratory reference standard).
- For challenge isolates: Expected results, which implies a predefined standard for these specific strains.
8. The Sample Size for the Training Set:
The document does not provide information regarding a separate training set. The descriptions focus on the validation (clinical evaluation) of the device. It's common for such commercial systems, especially those that have predicate devices, to leverage extensive prior development data and methodologies rather than detail a single "training set" for a new submission of additional antimicrobial agent/organism combinations.
9. How the Ground Truth for the Training Set Was Established:
As no training set is explicitly described, the method for establishing its ground truth is not provided.
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$$\text{מאַראַנדיני}$$
510(K) SUMMARY
| SUBMITTED BY: | Becton, Dickinson and Company7 Loveton CircleSparks, MD 21152Phone: (410) 316 - 4278Fax: 410-316-4499APR 2 6 2006 |
|---|---|
| CONTACT NAME: | Monica E GiguereRegulatory Affairs Specialist |
| DATE PREPARED: | April 19, 2006 |
| DEVICE TRADE NAME: | BD Phoenix™ Automated Microbiology System –Nitrofurantoin (8-512 $μ$ g/mL), Trimethoprim-sulfamethoxazole (0.5/9.5-16/304 $μ$ g/ mL) and Nalidixic Acid(2-32 $μ$ g/mL) |
| DEVICE COMMON NAME: | Antimicrobial susceptibility test system-short incubation |
| DEVICE CLASSIFICATION: | Fully Automated Short-Term Incubation Cycle AntimicrobialSusceptibility Device, 21 CFR 866.1645 |
| PREDICATE DEVICES: | VITEK® System (PMA No. N50510) and BD Phoenix™Automated Microbiology System with Gatifloxacin(K020321, May 23, 2002), Nitrofurantoin (K031530, July 10,2003), Trimethoprim-sulfamethoxazole (K033907, April 9,2004) and Nalidixic Acid (K030579, March 21, 2003). |
| INTENDED USE: | The BD Phoenix™ Automated Microbiology System isintended for the rapid identification and in vitro antimicrobialsusceptibility testing of isolates from pure culture of mostaerobic 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 t agents for AST determinations.
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- 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).
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 Nitrofurantoin (8-512 ug/mL), Trimethoprim-sulfamethoxazole (0.5/9.5-16/304 ug/ mL) and Nalidixic Acid (2-32µg/mL) and the BD PhoenixTM 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 associated reagents.
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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.
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 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, 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 (%) |
|---|---|---|---|---|---|
| Nitrofurantoin | 8-512 $\mu$ g/mL | 2130 | 95.8 | 2130 | 84.4 |
| Trimethoprim-sulfamethoxazole | 0.5/9.5-16/304 $\mu$ g/mL | 2212 | 96.0 | 2212 | 97.7 |
| Nalidixic Acid | 2-32 $\mu$ g/mL | 2103 | 96.2 | 2103 | 98.6 |
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), Nitrofurantoin (K031530, July 10, 2003), Trimethoprim-sulfamethoxazole (K033907, April 9, 2004) and Nalidixic Acid (K030579, March 21, 2003).
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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 tail feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Monica E. Giguere Regulatory Affairs Specialist BD Diagnostics Systems Becton, Dickinson and Company 7 Loveton Circle Sparks, MD 21152
APR 2 6 2006
Re: K060447 Trade/Device Name: BD Phoenix™ Automated Microbiology System Nitrofurantion (8-512 µg/mL), Trimethoprim-sulfamethoxazole (0.5/9.5-16/304 µg/mL) and Nalidixic Acid (2-32 µg/mL) on 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: April 19, 2006 Received: April 20, 2006
Dear Ms. Giguere:
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 (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 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 Forg
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: K060447
BD Phoenix™ Automated Microbiology System for use with the antimicrobial Device Name: agent Nitrofurantoin (8-512 ug/mL), Trimethoprim-sulfamethoxazole (0.5/9.5-16/304 ug/ mL) and Nalidixic Acid (2-32μg/mL) on Gram-negative ID/AST or AST only Phoenix panels with additional organism groups
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 BD Phoenix™ Automated Microbiology System with Nitrofurantoin (8-512 ug/mL), Trimethoprim-sulfamethoxazole (0.5/9.5-16/304 µg/ mL) and Nalidixic Acid (2-32µg/mL) on Gram-negative ID/AST or AST only Phoenix panels.
Nitrofurantoin 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:
Escherichia coli
Active In Vitro Against:
Citrobacter amalonaticus Citrobacter koseri (diversus) Citrobacter freundii Klebsiella oxytoca Klebsiella pneumoniae (ozaenae)
Fuddie L. Pool
Vision Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safery
510(k) K060447 - Page
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Trimethoprim-sulfamethoxazole 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:
| Escherichia coli | Proteus mirabilis |
|---|---|
| Klebsiella species | Proteus vulgaris |
| Enterobacter species | Shigella flexneri |
| Morganella morganii | Shigella sonnei |
Nalidixic Acid 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:
Enterobacter species Escherichia coli
Morganella morganii Proteus mirabilis
Proteus vulgaris Providencia rettgeri B
Prescription Use V (Per 21 CFR 801 109)
Over-the-Counter Use
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Concurrence of CDRH, Office of Device Evaluation (ODE)
Fuddute Cook
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K060447
§ 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.”