(79 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 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 the addition of the Phoenix Inducible Macrolide Resistance (iMLSb) Test in Staphylococcus species to Gram-positive ID/AST or AST only Phoenix panels. The Phoenix Inducible Macrolide Resistance Test is used to detect inducible macrolide-lincosamide-streptogramin B resistance in Staphylococcus species.
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 polystyrenc 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. Measurcments 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).
The provided text describes the BD Phoenix™ Automated Microbiology System for detecting inducible macrolide resistance (iMLSb) in Staphylococcus species. Here's a breakdown of the acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Site Reproducibility | Overall intra-site reproducibility > 90% | Overall intra-site reproducibility of greater than 90% for the Gram-positive isolates tested. |
| Overall inter-site reproducibility > 95% | Overall inter-site reproducibility of greater than 95% for the Gram-positive isolates tested. | |
| Clinical Performance | Substantial equivalence to the CLSI reference broth microdilution method and the CLSI Disk Approximation Test for iMLSb detection. Specific performance metrics (e.g., Categorical Agreement, Essential Agreement) would be expected based on FDA guidance, but only Categorical Agreement (CA) is explicitly stated for the iMLSb test. | For the Phoenix Inducible Macrolide Resistance Test in Staphylococcus species, the Clinical Agreement (CA) was 97.6% (n=295). The study concludes "substantially equivalent performance when compared with the CLSI (formerly NCCLS) reference broth microdilution method" and "substantially equivalent to the CLSI Disk Approximation Test reference method" for iMLSb detection. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set:
- Clinical Study Isolates: Not explicitly stated as a single number for the entire test set. However, for the Phoenix Inducible Macrolide Resistance Test, the reported "CA (n)" is 295, indicating 295 isolates were used for this specific test within the clinical study.
- Site Reproducibility: A "panel of Gram-positive isolates" was used. Each site tested these isolates in triplicate on three different days. The exact number of isolates in this panel is not specified.
- Data Provenance: Clinical, stock, and challenge isolates were tested at multiple geographically diverse sites across the United States. The study type for clinical isolates was comparative against a reference method, which is typical for prospective data collection in such studies, though not explicitly stated. Challenge sets are typically retrospective (known results).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
The document does not explicitly state the number of experts and their qualifications used to establish the ground truth for the test set. The ground truth for clinical isolates was established by comparing to the "CLSI reference broth microdilution method". For challenge isolates, results were compared to "expected results," implying a pre-defined ground truth. The interpretation of these reference methods would typically be performed by trained laboratory personnel, but no specific expert qualifications are provided.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
The document does not describe any specific adjudication method (like 2+1 or 3+1) for resolving discrepancies in the test set. It mentions comparison to a reference method, suggesting that the reference method's result served as the definitive interpretation.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done in the context of human readers with or without AI assistance. This device is an automated system (BD Phoenix Automated Microbiology System) for in vitro susceptibility testing, not an AI-assisted diagnostic tool that aids human interpretation of images or other data. The comparison is between the automated system and a reference laboratory method.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, this was a standalone performance study. The BD Phoenix Automated Microbiology System is an "algorithm only" type of device in the sense that it automatically performs the susceptibility testing and provides results (MIC values and category interpretations S, I, R, or N) without direct human interpretation within the measurement process itself. The study evaluates the performance of this automated system against reference methods.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The primary type of ground truth used was:
- Reference Method Results: For clinical isolates, the "CLSI reference broth microdilution method" was used as the ground truth. This is a laboratory-based, standardized method considered the gold standard for antimicrobial susceptibility testing.
- Expected Results: For challenge isolates, "expected results" were used. This typically refers to isolates with well-characterized resistance profiles, often obtained from reference laboratories or collections.
8. The sample size for the training set
The document does not specify a separate "training set" for the BD Phoenix Automated Microbiology System in the context of this 510(k) submission. This is an antimicrobial susceptibility testing (AST) system; its "training" fundamentally involves the development and calibration of the instrument and its reagent panels to accurately detect bacterial growth and interpret MICs according to established microbiological principles and CLSI guidelines. The performance data presented (site reproducibility and clinical studies) is primarily for verification/validation.
9. How the ground truth for the training set was established
Since a distinct "training set" as understood in machine learning (where ground truth is typically assigned by experts for algorithm learning) is not explicitly mentioned or applicable in the traditional sense for this type of automated microbiology system, the method for establishing ground truth for a training set is not described. The system's underlying design and calibration would have relied on extensive microbiological knowledge and reference methods, ensuring its programmed interpretations align with CLSI standards.
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Kof2538
510(k) SUMMARY
| SUBMITTED BY: | Becton, Dickinson and Company7 Loveton CircleSparks, MD 21152Phone: 410-316-4287Fax: 410-316-4499 | NOV 20 2008 |
|---|---|---|
| CONTACT NAME: | Monica E. GiguereRegulatory Affairs Specialist | |
| DATE PREPARED: | November 17, 2008 | |
| DEVICE TRADE NAME: | BD Phoenix™ Automated Microbiology System –Phoenix Inducible Macrolide Resistance (iMLSb) Test inStaphylococcus species | |
| DEVICE COMMON NAME: | Antimicrobial susceptibility test system-short incubation | |
| DEVICE CLASSIFICATION: | Fully Automated Short-Term Incubation CycleAntimicrobial Susceptibility Device, 21 CFR 866.1645 | |
| PREDICATE DEVICES: | Sensititre® Dtest (K073653) and BD Phoenix™ AutomatedMicrobiology System with Gatifloxacin (K020321, May23, 2002 and K060324, May 25, 2006), Ofloxacin(K020323, April 14, 2002), and Levofloxacin (K020322,March 27, 2002). | |
| INTENDED USE: | The BD Phoenix™ Automated Microbiology System isintended for the rapid identification and in vitroantimicrobial susceptibility testing of isolates from pureculture 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 or AST determinations.
- BD Phoenix ID Broth used for performing ID tests and preparing AST Broth inoculum. .
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- 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 polystyrenc 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. Measurcments 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 (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.
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The results of the study demonstrate for the this antimicrobial agent there was an overall intrasite reproducibility of greater than 90% and an overall inter-site reproducibility greater than 95% for the Gram-positive isolates tested.
Clinical Studies
Clinical, stock and challenge isolates were tested at 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 test. Phoenix System results for Challenge set isolates were compared to the expccted results. Phoenix System results for clinical isolates were compared to the results obtained from the reference test.
The following performance was obtained for the isolates tested in the study.
Performance of BD Phoenix System for Gram-Positive Organisms by Drug
| Antimicrobial | CA (n) | CA (%) |
|---|---|---|
| Phoenix Inducible Macrolide Resistance Test | 295 | 97.6 |
Conclusions Drawn from Substantial Equivalence Studies
The data collected from the substantial equivalence studies demonstrate that the Phoenix Inducible Macrolide Resistance (iMLSb) Test in Staphylococcus species on the BD Phoenix™ Automated Microbiology System is substantially equivalent to the CLSI Disk Approximation Test reference method as defined 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 Sensititre® Dtest (K073653, March 20, 2008 and BD Phoenix™ Automated Microbiology System with Gatifloxacin (K020321, May 23, 2002 and K060324, May 25, 2006), 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 graphic of an eagle or bird-like figure with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the graphic.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Monica Giguere Regulatory Affairs Specialist BD Diagnostics Systems Becton, Dickinson and Company 7 Loveton Circle Sparks, MD 21152
NOV 2 0 2008
Re: K082538
Trade/Device Name: BD Phoenix™ Automated Microbiology System - Phoenix Inducible Macrolide resistance (iMLSb) Test in Staphylococcus species 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: August 29, 2008 Received: September 2, 2008
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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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. Hoivat. 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: K082538
Device Name: BD PhoenixTM Automated Microbiology System - Phoenix Inducible Macrolide Resistance (iMLSb) in Staphylococcus species (erythromycin in amounts required to detect inducible macrolide resistance)- 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 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 the addition of the Phoenix Inducible Macrolide Resistance (iMLSb) Test in Staphylococcus species to Gram-positive ID/AST or AST only Phoenix panels. The Phoenix Inducible Macrolide Resistance Test is used to detect inducible macrolide-lincosamide-streptogramin B resistance in Staphylococcus 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 In Vitro Diagnostic Devices (OIVD)
Freddie hi. Poole
vision Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) KD82538
BD Diagnostic Systems Becton, Dickinson and Company
Page 1
§ 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.”