(23 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 additional Gram-negative organism groups and Ampicillin -0.5-32 µg/mL on the BD Phoenix Automated Microbiology System.
Ampicillin 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 Salmonella species Shigella 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 . 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.
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).
This document describes the acceptance criteria and study proving the BD Phoenix™ Automated Microbiology System with Ampicillin meets these criteria.
1. Acceptance Criteria and Reported Device Performance
The acceptance criteria for the BD Phoenix™ Automated Microbiology System are based on achieving pre-defined Essential Agreement (EA) and Category Agreement (CA) with a CLSI reference broth microdilution method.
| Metric | Acceptance Criteria (Not explicitly stated as a numerical threshold, but implied by substantial equivalence to CLSI reference method) | Reported Device Performance |
|---|---|---|
| Essential Agreement (EA) | Expected to be high, demonstrating agreement within ± one two-fold dilution to the reference. | Not explicitly quantified in a table but stated "excellent" |
| Category Agreement (CA) | Expected to be high, demonstrating agreement with FDA categorical interpretive criteria (S, I, R). | Not explicitly quantified in a table but stated "excellent" |
| Site Reproducibility | > 90% intra-site, > 95% inter-site | > 90% intra-site reproducibility, > 95% inter-site reproducibility |
2. Sample Size and Data Provenance
- Test Set Sample Size: Not explicitly stated as a single number. The study tested "clinical, stock and challenge isolates."
- Clinical isolates: Number not specified.
- Challenge isolates: Number not specified.
- Data Provenance: Multiple geographically diverse sites across the United States. The study included both retrospective (stock and challenge isolates) and prospective (clinical isolates) data.
3. Number of Experts and Qualifications for Ground Truth
Not applicable. The ground truth was established by a reference laboratory method (CLSI reference broth microdilution method), not by expert consensus.
4. Adjudication Method for Test Set
Not applicable. The primary comparison was against a reference laboratory method (CLSI reference broth microdilution method), not through human adjudication of results.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, an MRMC comparative effectiveness study was not performed. This device is an automated system for antimicrobial susceptibility testing, not a diagnostic imaging or interpretive aid that would typically involve human readers.
6. Standalone Performance (Algorithm Only)
Yes, standalone performance was assessed. The BD Phoenix™ Automated Microbiology System is an automated system that provides results without human intervention in the interpretation of the raw data. Its performance was compared directly to the CLSI reference broth microdilution method.
7. 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, the Phoenix System results were compared to "expected results," which would also be derived from a validated reference method.
8. Sample Size for Training Set
The document does not explicitly mention a "training set" in the context of machine learning. The system's underlying algorithm for growth detection and MIC determination is based on a redox indicator and bacterial turbidity measurements. The development of this algorithm would have involved a large number of diverse isolates, but a specific "training set" size in the modern machine learning sense is not provided. The phrase "Clinical, stock and challenge isolates were tested" refers to the evaluation/validation set discussed.
9. How Ground Truth for Training Set was Established
Given that this is an automated microbiology system, the "training" (development) of the system's algorithm and decision rules would have been based on extensive studies correlating the redox indicator changes and turbidity measurements with MIC values historically determined by established reference methods like CLSI broth microdilution. The document implies that the system's ability to determine MIC values and category interpretations (S, I, or R) was developed based on comparing its output to these reference methods.
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510(K) SUMMARY
| SUBMITTED BY: | Becton, Dickinson and Company7 Loveton CircleSparks, MD 21152Phone: (410) 316 - 4938Fax: 410-316-4499 | JUN - 7 2006 |
|---|---|---|
| CONTACT NAME: | Janine MatlakRegulatory Affairs Specialist | |
| DATE PREPARED: | May 12, 2006 | |
| DEVICE TRADE NAME: | BD Phoenix™ Automated Microbiology System –Ampicillin – 0.5-32 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 (K020321May 23, 2002), Ampicillin (K032299, September 22, 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 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.
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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 Gram-negative organism groups with Ampicillin - 0.5-32 ug/mL and the BD Phoenix™ 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.
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.
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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 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.
| 1 2 25 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2. VA STA SEE SERVICE WA LEAR & SECURALS & FITURAL LE FA 2 1 12 6 12 | |||||
|---|---|---|---|---|---|
| 16.4 | |||||
| 1 | 1 | BALLER A |
Performance of BD Phoenix System by Drug Table 1:
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), and Ampicillin (K032299, September 22, 2003).
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SUMMARY INFORMATION FOR AMPICILLIN
Performance
Accuracy
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Reproducibility
Testing performed at multiple clinical sites demonstrated 95% reproducibility or greater within ± 1 dilution as shown in the previous submission.
Breakpoints - CLSI
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Recommended Quality Control Organisms
| Ampicillin | ||
|---|---|---|
| Quality Control Strain | MIC Range | Source |
| Escherichia coli ATCC 25922 | 2 - 8 µg/mL | CLSI |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/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 its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle. The logo is black and white and appears to be a scanned image.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Janine Matlak Regulatory Affairs Specialist Becton, Dickinson and Company 7 Loveton Circle Sparks, MD 21152
JUN - 7 2006
Re: K061355
Trade/Device Name: BD Phoenix™ Automated Microbiology System antimicrobial agent Ampicillin -0.5-32µg/mL-Gram-negative 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: May 12, 2006 Received: May 15, 2006
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 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,
Sales a Hon
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 PHOENIX™ Automated Microbiology System Ampicillin - GN
Page 1 of 1
510(k) Number: K061355
Device Name: BD Phoenix™ Automated Microbiology System for use with the antimicrobial agent Ampicillin - 0.5-32 ug/mL - Gram-negative 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 additional Gram-negative organism groups and Ampicillin -0.5-32 µg/mL on the BD Phoenix Automated Microbiology System.
Ampicillin 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 Salmonella species Shigella species
Prescription Use 7 (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 Device Evaluation (ODE)
Freddie M. Poole
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Survily
510(k) KD61353
BD Diagnostic Systems Becton, Dickinson and Company
Page 6
§ 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.”