(43 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-positive bacterial isolates from pure culture belonging to the genera Staphylococcus and Enterococcus.
This premarket notification is for the addition of the antimicrobial agent Daptomycin at concentrations of 0.125-32 ug/mL to Gram Positive ID/AST or AST only Phoenix panels. Daptomycin 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:
Enterococcus faecalis (vancomycin-susceptible strains only) Staphylococcus aureus (including methicillin-resistant strains)
Active In Vitro Against:
Enterococcus faecalis (vancomycin-resistant strains) Enterococcus faecium (including vancomycin-resistant strains) Staphylococcus epidermidis (including methicillin-resistant strains) Staphylococcus haemolyticus
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 The Phoenix paller is a scaled and sell first and sen interacting must be a purch issues and containing dried reagents. Organisms for susceptime isolate. For each isolate. For each isolation premimarily idontified as a cistandard is prepared in Phoenix ID broth.
The Phoenix AST method is a broth based microdilution test. The Phoenix System uilizes a redox I he Phoenix AST memor is a broaism growth in the presence of an antimicrobial agent.
Indicator for the detection of organism growth in the presence of an the de indicator for the delection of organism growth in als prosectial turbidity are used in the determination Measurements of Changes to the marcator as were as ontains 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 I he unstrument 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 based on the provided text:
Acceptance Criteria and Device Performance
| Acceptance Criteria (Measured by) | Reported Device Performance (BD Phoenix™ System) |
|---|---|
| Essential Agreement (EA) | 97.4% (n=1568 isolates tested) |
| Categorical Agreement (CA) | 98.8% (n=1268 isolates tested) |
| Intra-site Reproducibility | >95% |
| Inter-site Reproducibility | >95% |
Study Details
2. Sample size used for the test set and the data provenance:
- Test Set Size:
- Essential Agreement (EA): 1568 isolates
- Categorical Agreement (CA): 1268 isolates (This discrepancy might indicate that not all isolates yielding EA also had a defined categorical interpretation that could be compared, or simply a reporting choice).
- Data Provenance: Clinical, stock, and challenge isolates were tested across multiple geographically diverse sites. This suggests a mix of "real-world" clinical samples and controlled laboratory strains, with a prospective element (testing performed for the study). The country of origin is not explicitly stated but implied to be the US given the FDA submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
The ground truth was established by the CLSI reference broth microdilution method. No human experts are explicitly mentioned as establishing the ground truth for the test set in the way a diagnostic imaging study would use radiologists. The CLSI method itself is the "expert" ground truth.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not applicable. The ground truth was established by the CLSI reference broth microdilution method, which is a standardized laboratory procedure, not a human consensus process.
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 microbiology system for antimicrobial susceptibility testing, not an AI-assisted diagnostic imaging or human-read interpretation system. 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, the study was a standalone evaluation of the BD Phoenix™ System. Its performance (MIC values and categorical interpretations) was directly compared to the CLSI reference method. The device is described as "fully automated" and the study evaluates its performance as such.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The ground truth used was the CLSI reference broth microdilution method. This is a well-established, standardized laboratory method recognized as the gold standard for antimicrobial susceptibility testing.
8. The sample size for the training set:
The document does not explicitly state a separate "training set" size. The development and validation of an automated microbiology system like the Phoenix System typically involve extensive internal testing and refinement before formal clinical studies for regulatory submission. The provided study focuses on the performance validation for regulatory submission, where the system is evaluated against a reference method using the described test set.
9. How the ground truth for the training set was established:
Not applicable, as a distinct training set with explicitly defined ground truth establishment methods is not detailed in this regulatory submission for the addition of a new antimicrobial agent to an existing device. For an algorithm-based device, the ground truth for training would typically be established using the same CLSI reference method or similar gold standard laboratory techniques on a large, diverse collection of bacterial isolates.
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AUG 5 - 2005
CONFIDENTIAL AND PROPRIETARY
510(k) SUMMARY
| SUBMITTED BY: | Becton, Dickinson and Company 7 Loveton Circle Sparks, MD 21152 Phone: 410-316-4287 Fax: 410-316-4499 |
|---|---|
| CONTACT NAME: | Monica Giguere Regulatory Affairs Specialist |
| DATE PREPARED: | June 21, 2005 |
| DEVICE TRADE NAME: | BD Phoenix™ Automated Microbiology System – Daptomycin 0.125-32 µg/mL |
| DEVICE COMMON NAME: | Antimicrobial susceptibility test system-short incubation |
| DEVICE CLASSIFICATION: | Fully Automated Short-Term Incubation Cycle Antimicrobial Susceptibility 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), and Levofloxacin (K020322, March 27, 2002). |
| INTENDED USE: | 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. |
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 The Phoenix paller is a scaled and sell first and sen interacting must be a purch issues and containing dried reagents. Organisms for susceptime isolate. For each isolate. For each isolation premimarily idontified as a cistandard is prepared in Phoenix ID broth.
The Phoenix AST method is a broth based microdilution test. The Phoenix System uilizes a redox I he Phoenix AST memor is a broaism growth in the presence of an antimicrobial agent.
Indicator for the detection of organism growth in the presence of an the de indicator for the delection of organism growth in als prosectial turbidity are used in the determination Measurements of Changes to the marcator as were as ontains 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 I he unstrument 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 reference broth microdilution method. This premarket periormance when compared with and of the BD Phoenix™ Automated Microbiology System nottheanon provides and sapp 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 parels performance whole volipare to the system has been evaluated as defined in the FDA Draff propared according to NOOD 2117) Periew Criteria for Assessment of Antimicrobial Susceptibility Devices", March 8, 2000.
Site Reproducibility
Intra- and inter-site reproducibility of this antimicrobial agent in the BD Phoenix System was millial at three sites using a panel of Gram-positive isolates. Each site tested the isolates in evaluated at 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 r no results of the states 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 diversitilities and Offical, slock and chancilly were word word of the Phoenix antimicrobial susceptibility test with the Gram Positive Phoenix Panel format containing this antimicrobial agent. Phoenix System results the Chain Fostive I hould I and Former on 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 The performatice of the I nooms Gysten wad assesses of the isolates tested. Essential Calegorical Agreement (Cr) to the enploanix™ Automated Microbiology System agress exactly of Agreement (EA) occurs which the DD sference result. Category Agreement (CA) occurs when the BD within I one two 1018 anaton is agy System agrees with the reference method with respect to the I hounds - Tratemated Microsoftop, - 3
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:
| 1 | Acres of a la propose | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | EA (%) | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | (%) |
|---|---|---|---|---|---|
| Antimicrobial | Concentration | CA (n' | CA (n) | CA | |
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------Daptomycin | CALL LE CANNO CHAND0.125-32 ug/mL | 1568 | 07 / | 1 268 | 98.8 |
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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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized caduceus-like symbol, which is a modern interpretation of the Rod of Asclepius, a traditional symbol associated with medicine and healing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the symbol.
AUG 5 - 2005
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
Re: K051689 Trade/Device Name: BD PhoenixTM Automated Microbiology System Daptomycin (0.125-32 µg/mL) - Gram-Positive ID/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: June 21, 2005 Received: June 23, 2005
Dear Ms. Giguere:
We have reviewed your Section 510(k) premarket notification of intent to market the device we ferenced 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 for associated in the May 28, 1976, the enactment date of the Medical Device Amendments, or to conninered pror to may 2011 11:12 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 I ou mayy arovisions 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 your device to such additional controls. Existing major regulations affecting your device it may 60 babject to accurations (CFR), Parts 800 to 895. In additions (CFR), Parts 800 to 895 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 I hat FDA has made a determination that your device complies with other requirements of the Act that I Directeral statutes and regulations administered by other Federal agencies. You must or any I vith 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) This letter will anow you to organ mailing of substantial equivalence of your device to a legally premaired 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 you destre specific internation and advertising of your device, please contact the Office of In of questions on the promotion and Safety at (240)276-0484. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the I ou may obtain other general ers, 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 For
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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INDICATIONS FOR USE
510(k) Number (if known): 1.021689
Device Name: BD Phoenix™ Automated Microbiology System for use with the antimicrobial agent Daptomycin (0.125-32 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-positive bacterial isolates from pure culture belonging to the genera Staphylococcus and Enterococcus.
This premarket notification is for the addition of the antimicrobial agent Daptomycin at concentrations of 0.125-32 ug/mL to Gram Positive ID/AST or AST only Phoenix panels. Daptomycin 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:
Enterococcus faecalis (vancomycin-susceptible strains only) Staphylococcus aureus (including methicillin-resistant strains)
Active In Vitro Against:
Enterococcus faecalis (vancomycin-resistant strains) Enterococcus faecium (including vancomycin-resistant strains) Staphylococcus epidermidis (including methicillin-resistant strains) Staphylococcus haemolyticus
V Prescription Use _ (Part 21 CFR 801 Subpart D)
AND/OR
Over-the-Counter Use (Part 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
HaseAts
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K051689
Page 9
§ 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.”