(49 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 and Enterococcus.
This premarket notification is for the addition of the antimicrobial agent chloramphenicol at concentrations of 1 - 32 µg/mL to Gram Positive ID/AST or AST only Phoenix panels. Chloramphenicol 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.
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. For each isolation 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. Mcasurements 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 summary of the acceptance criteria and study details for the BD Phoenix™ Automated Microbiology System Chloramphenicol - GP, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implied by the "Guidance on Review Criteria for Assessment of Antimicrobial Susceptibility Devices", March 8, 2000, which requires demonstration of "substantially equivalent performance" to a reference method. The primary metrics for this equivalence are Essential Agreement (EA) and Category Agreement (CA). While the specific numerical thresholds for acceptance (e.g., >90% EA, >95% CA) are not explicitly stated as "acceptance criteria" within the provided text, they are the standard performance targets for such devices.
| Metric | Acceptance Criteria (Implied/Standard) | Reported Device Performance (Gram-Positive Organisms) |
|---|---|---|
| Essential Agreement (EA) | High percentage (typically >90%) | Not explicitly stated in Table 1; overall deemed "substantially equivalent" |
| Category Agreement (CA) | High percentage (typically >95%) | Not explicitly stated in Table 1; overall deemed "substantially equivalent" |
| Intra-site Reproducibility | >90% | >90% |
| Inter-site Reproducibility | >95% | >95% |
Note: Table 1 in the document is incomplete and does not show the specific EA and CA percentages for chloramphenicol against Gram-positive organisms. It only mentions that performance was assessed by calculating EA and CA.
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not explicitly stated as a single number.
- It included "Clinical, stock and challenge isolates."
- "Challenge set isolates" were compared to expected results.
- "Clinical isolates" were compared to the NCCLS reference broth microdilution method.
- Data Provenance: Multiple geographically diverse sites across the United States. The study design included both "clinical" and "stock and challenge" isolates, suggesting a mix of prospectively collected (clinical) and retrospectively curated (stock/challenge) data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not explicitly stated. The ground truth for clinical isolates was established by the NCCLS reference broth microdilution method, which is a standardized laboratory procedure, not typically dependent on individual expert interpretation in the same way an imaging study would be. For challenge set isolates, "expected results" implies a predetermined, validated reference.
4. Adjudication Method for the Test Set
Not applicable in the human reader sense. The comparison was primarily against a reference laboratory method (NCCLS broth microdilution) for clinical isolates and "expected results" for challenge isolates. The process is a direct comparison of quantitative MIC values and categorical interpretations.
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
Not applicable. This device is an automated system for antimicrobial susceptibility testing, replacing manual methods or providing rapid results. It is not an AI-assisted diagnostic device where human readers are interpreting outputs. Therefore, an MRMC study and effects on human reader improvement are not relevant to this submission.
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 System is an automated device designed to determine antimicrobial susceptibility independently. Its performance was directly compared to the NCCLS reference method.
7. The Type of Ground Truth Used
- For clinical isolates: NCCLS reference broth microdilution method. This is a well-established, standardized laboratory method considered the gold standard for antimicrobial susceptibility testing.
- For challenge isolates: "Expected results." These are typically results obtained from a well-characterized set of strains with known resistance patterns, often by multiple validated methods.
8. The Sample Size for the Training Set
Not applicable. This document describes the validation of a deterministic automated system, not a machine learning or AI algorithm in the contemporary sense that would require a distinct "training set" for model development. The system utilizes dried reagents and a redox indicator for growth detection based on established microbiological principles.
9. How the Ground Truth for the Training Set Was Established
Not applicable for the reasons stated in point 8.
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BD PHOENIX™ Automated Microbiology System Chloramphenicol - GP
CONFIDENTIAL AND PROPRIETARY
510(k) SUMMARY
| SUBMITTED BY: | Becton, Dickinson and Company7 Loveton CircleSparks, MD 21152Phone: 410-316-4619Fax: 410-316-4499 |
|---|---|
| CONTACT NAME: | David Streett,RA Specialist |
| DATE PREPARED: | December 15, 2003 |
| DEVICE TRADE NAME: | BD Phoenix™ Automated Microbiology System -Chloramphenicol 1 - 32 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), Ofloxacin (K020323, April 14, 2002), andLevofloxacin (K020322, March 27, 2002). |
| 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 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. For each isolation 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. Mcasurements 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 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 Phocnix"M Automated Microbiology System has demonstrated substantially equivalent performance when compared to the NCCLS reference broth microdilution method (AST panels prepared according to NCCLS M7). The system has been evaluated as defined in the FDA Draft guidance document, "Guidance on Review Criteria for Assessment of Antimicrobial Susceptibility Devices", March 8, 2000.
Site Reproducibility
Intra- and inter-site reproducibility of this antimicrobial agent in the BD Phocnix 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 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 NCCLS 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 ± onc two-fold dilution to the reference result. Catcgory 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).
Table 1 summarizes the performance for the isolates tested in this study.
Performance of BD Phoenix System for Gram-Positive Organisms by Drug Table 1:
| A Box 1 - 1 - 1 - 1 - 1 - 1 - 1 -PARTY LE LE CONSULTIONof Real & Loss andAntimierobia | 1Company of Children come andAND REAL CONNECT OF CLEANoncentration------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | THE FOR FARIN THE FOR THE FORn.------------ | 0 | No. of Children a manage of the counter of the count19--------------------------------------- | |
|---|---|---|---|---|---|
| THE THE THE LINE BEAR WATERaloramnenice | AutoMond would been andAnd The First of Children of14.40 | 4 mm | t C | 1 50 | r------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
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, "Guidance on Review Criteria for Assessment of Antimicrobial Susceptibility Devices", March 8, 2000. 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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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 eagle with three stripes forming its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
FEB - 3 2004
Mr. David Streett Regulatory Affairs Specialist Becton, Dickinson and Company 7 Loveton Circle Sparks, MD 21152-0999
Re: K033889
Trade/Device Name: BD Phoenix™ Automated Microbiology System for use with the antimicrobial agent chloramphenicol (1-32 ug/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 system.
Regulatory Class: Class II Product Code: LON Dated: December 15, 2003 Received: December 16, 2003
Dear Mr. Streett:
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 (OS) 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 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 (301) 594-3084. 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/dsma/dsmamain.html.
Sincerely yours,
Salazar
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: K033889
Device Name: BD Phoenix™ Automated Microbiology System for use with the antimicrobial agent chloramphenicol (1 - 32 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 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 and Enterococcus.
This premarket notification is for the addition of the antimicrobial agent chloramphenicol at concentrations of 1 - 32 µg/mL to Gram Positive ID/AST or AST only Phoenix panels. Chloramphenicol 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
Prescription Usc V (Part 21 CFR 801 Subpart D) AND/OR
Over-the-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Sagatha 2/3/04
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
ku338rg 510(k) _______________________________________________________________________________________________________________________________________________________________________
§ 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.”