(122 days)
The BD Phoenix™ Automated Microbiology System is intended for in vitro quantitative determination of antinicrobial susceptibility by minimal inhibitory concentration (MIC) of most Gram-negative aerobic and anultative an ourobic bacteria isolates from pure culture for Enterobacieriaceae 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 nitrofurantoin at the concentration of 4 - 128 ug/mL to Gram-Positive ID/AST or AST only BD Phoenix panels. Nitrofirantoin 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:
Staphylococcus aureus Enterococci (e.g., Enterococcus faecalis)
Active In Vitro
Coagulase-negative staphylococci (including Staphylococcus epidermidis and Staphylococcus saprophyticus)
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 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 Phoenix AST 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. Phoenix panels are inoculated with a specified organism density and placed into the instrument.
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℃. 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 - Nitrofurantoin, based on the provided 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria (Implied by FDA Guidance) | Reported Device Performance (Nitrofurantoin) |
|---|---|---|
| Essential Agreement (EA) | Not explicitly stated, but generally >90% is expected for AST systems | 98.5% (n=979) |
| Category Agreement (CA) | Not explicitly stated, but generally >90% is expected for AST systems | 100.0% (n=979) |
| Intra-site Reproducibility | >90% | >90% |
| Inter-site Reproducibility | >95% | >95% |
Note: While specific numerical acceptance criteria for EA and CA are not explicitly listed in this document, the FDA guidance for AST systems typically expects high agreement (e.g., >90%). The presented data demonstrates performance exceeding these general expectations.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: 979 isolates were tested for Essential Agreement (EA) and Category Agreement (CA) for Nitrofurantoin.
- Data Provenance: The isolates included "Clinical, stock and challenge isolates" tested across "multiple geographically diverse sites across the United States." The study design indicates a prospective approach for collecting clinical isolates for comparison, and a retrospective or curated approach for stock and challenge isolates.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not explicitly state the number or qualifications of experts used to establish the ground truth. However, the ground truth was established by a "CLSI reference broth microdilution method" which implies adherence to standardized laboratory procedures, performed by trained laboratory personnel, rather than expert interpretation of images or observations.
4. Adjudication Method for the Test Set
The document does not mention an adjudication method in the traditional sense, as the comparison is against an objective reference method (CLSI broth microdilution) rather than subjective expert interpretations that would require adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, an MRMC comparative effectiveness study was not performed. This study focuses on the performance of an automated diagnostic system compared to a reference method, not on human reader performance with or without AI assistance.
6. Standalone (Algorithm Only) Performance Study
Yes, a standalone performance study was done. The BD Phoenix™ Automated Microbiology System operates as an automated device ("algorithm only") to determine antimicrobial susceptibility. The study compared the results generated by this automated system directly against the CLSI reference broth microdilution method without human intervention in the interpretation process of the Phoenix system's output.
7. Type of Ground Truth Used
The type of ground truth used was the CLSI reference broth microdilution method. This is a laboratory-based, gold-standard method for determining antimicrobial susceptibility, providing a highly objective and quantitative measure (Minimum Inhibitory Concentration - MIC).
- For Clinical Isolates: Phoenix System results were compared to the results obtained from the CLSI reference broth microdilution method.
- For Challenge Isolates: Phoenix System results were compared to "expected results," which would also be derived from the CLSI reference method or other validated methods.
8. Sample Size for the Training Set
The document does not explicitly state the sample size used for the training set. It describes the evaluation of the performance of the device, not the development or training of its underlying algorithms.
9. How the Ground Truth for the Training Set Was Established
Since the document does not mention a training set or algorithm development (it's focused on performance evaluation against a reference), it does not describe how ground truth for a training set was established. The "ground truth" referenced throughout the performance evaluation is the CLSI reference broth microdilution method.
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510(k) SUMMARY
| SUBMITTED BY: | Becton, Dickinson and Company7 Loveton CircleSparks, MD 21152Phone: 410-316-4938Fax: 410-316-4499 | JAN 29 2009 |
|---|---|---|
| CONTACT NAME: | Janine MatlakRegulatory Affairs Specialist | |
| DATE PREPARED: | December 15, 2008 | |
| DEVICE TRADE NAME: | BD Phoenix ™ Automated Microbiology System -Nitrofurantoin (4 – 128 µg/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 and K060324, May 25, 2006), Ofloxacin(K020323, April 14, 2002), Levofloxacin (K020322, March 27,2002) and Nitrofurantoin (K031589, July 11, 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- |
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:
positive bacteria of human origin.
- 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 Broth used for performing AST tests only. .
- BD Phoenix AST 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. Phoenix panels are inoculated with a specified organism density and placed into the instrument.
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℃. 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 (formerly NCCLS) reference broth microdilution method. This premarket notification provides 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 CLSI reference broth microdilution method (AST panels prepared according to CLSI M7). The system has been evaluated as defined in the FDA guidance document, "Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems; Guidance for Industry and FDA", March 5, 2007.
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.
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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 Gram Positive 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 not susceptible).
The following table summarizes the performance for the isolates tested in this study.
| Antimicrobial | Concentration | EA (n) | EA (%) | CA (n) | CA (%) |
|---|---|---|---|---|---|
| Nitrofurantoin | 4 – 128 µg/mL | 979 | 98.5 | 979 | 100.0 |
Performance of BD Phoenix System for Gram-Positive Organisms by Drug
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", March 5, 2007. 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 and K060324, May 25, 2006), Ofloxacin (K020323, April 14, 2002), Levofloxacin (K020322, March 27, 2002) and Nitrofurantoin ((K031589, July 11, 2003).
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Image /page/3/Picture/0 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo features a stylized eagle with three overlapping wings, symbolizing health, services, and people. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Janine Matlak Regulatory Affairs Specialist BD Diagnostics Systems Becton, Dickinson and Company 7 Loveton Circle Sparks, MD 21152
JAN 2 9 2009
K082852 Re:
Trade/Device Name: BD Phoenix™ Automated Microbiology System Nitrofurantoin (4 - 128 µg/mL) - Gram - positive ID/AST or AST only Phoenix Panels
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: January 5, 2009 Received: January 6, 2009
Dear Ms. Matlak:
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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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 advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at 240-276-0450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Sally attayma
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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BD PHOENIXTS! Automated Microbiology System Nitrofurantoin (FM 16) - GP K082852
Page 1 of 1
510(k) Number: K082852
Device Name: BD Phoenix™ Automated Microbiology System for use with the antimicrobial agent Nitrofurantoin 4 - 128 ug/mL - Gram-positive ID/AST or AST only Phoenix Panels.
Indications for Use:
The BD Phoenix™ Automated Microbiology System is intended for in vitro quantitative determination of antinicrobial susceptibility by minimal inhibitory concentration (MIC) of most Gram-negative aerobic and anultative an ourobic bacteria isolates from pure culture for Enterobacieriaceae 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 nitrofurantoin at the concentration of 4 - 128 ug/mL to Gram-Positive ID/AST or AST only BD Phoenix panels. Nitrofirantoin 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:
Staphylococcus aureus Enterococci (e.g., Enterococcus faecalis)
Active In Vitro
Coagulase-negative staphylococci (including Staphylococcus epidermidis and Staphylococcus saprophyticus)
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)
Fleddu L. Pool
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) KD82852
BD Diagnostic Systems Becton, Dickinson and Company
§ 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.”