(67 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 ampicillin-sulbactam at concentrations of 1/0.5-32/16 µg/mL to Gramnegative ID/AST or AST only Phoenix panels with the removal of the limitations for Acinetobacter species and Proteus mirabilis. Ampicillin-sulbactam 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:
Beta-lactamase producing strains of: Acinetobacter calcoaceticus Enterobacter spp. Escherichia coli
Active In Vitro Against:
Escherichia coli (Beta-lactamase and non-beta-lactamase producing) Klebsiella species (all know strains are beta-lactamase producing) Morganella morganii Proteus mirabilis (Beta-lactamase and non-beta-lactamase producing) Beta-lactamase producing strains of: Klebsiella spp. (including K. pneumoniae) Proteus mirabilis
Providencia rettgeri Providencia stuartii
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. 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 in 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).
Acceptance Criteria and Device Performance Study for BD Phoenix™ Automated Microbiology System – Ampicillin-sulbactam
1. Acceptance Criteria and Reported Device Performance
The acceptance criteria are implied by the "Essential Agreement (EA)" and "Category Agreement (CA)" metrics, compared against the CLSI reference broth microdilution method. While explicit pass/fail thresholds are not stated here, regulatory guidance documents for AST systems typically require high percentages for both EA and CA (e.g., >90%).
| Metric | Acceptance Criteria (Implied) | Reported BD Phoenix Performance (n=1106) |
|---|---|---|
| Essential Agreement (EA) | High percentage (e.g., >90%) | Not explicitly stated but indicated as sufficient for substantial equivalence |
| Category Agreement (CA) | High percentage (e.g., >90%) | 86.6% |
Note: The table in the original document has non-English text in the EA (%) column, making the exact reported percentage for EA unclear. However, the overall conclusion of "substantial equivalence" suggests that the EA met the required performance.
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: 1106 isolates for clinical studies.
- Data Provenance:
- Country of Origin: United States. Isolates were tested "across multiple geographically diverse sites across the United States."
- Retrospective/Prospective: Not explicitly stated as either purely retrospective or prospective. The use of "clinical, stock and challenge isolates" suggests a mix. "Clinical isolates" would likely have been prospectively collected for the study or clinical practice, while "stock and challenge isolates" are laboratory-maintained collections.
3. Number of Experts Used to Establish Ground Truth and Qualifications
- Number of Experts: Not applicable, as expert consensus was not the method used for establishing ground truth for AST results.
- Qualifications of Experts: Not applicable.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. The ground truth for antimicrobial susceptibility testing is typically established by a standardized reference method, not through consensus of human readers.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Was an MRMC study done? No. This study evaluates the performance of an automated device against a reference method, not the improvement of human readers with AI assistance.
6. Standalone Performance Study
- Was a standalone study done? Yes. The study directly compares the BD Phoenix™ System's results (algorithm only, without human-in-the-loop performance influencing the MIC determination) against the CLSI reference broth microdilution method.
7. Type of Ground Truth Used
- Type of Ground Truth: The CLSI reference broth microdilution method was used as the ground truth for clinical isolates. For "challenge set isolates," the Phoenix System results were compared to "expected results," which are typically pre-determined by the reference method.
8. Sample Size for the Training Set
- The document does not explicitly state the sample size for a training set. This product is an AST system for a specific antimicrobial agent (Ampicillin-sulbactam), and its development likely involved internal data for algorithm training and optimization, but this information is not provided in this 510(k) summary. The clinical studies described are for validation, not training.
9. How the Ground Truth for the Training Set Was Established
- The document does not provide information on how the ground truth for any potential training set was established. This information is typically proprietary to the device manufacturer and not always included in a 510(k) summary focused on validation data. However, it would logically follow similar principles as the validation ground truth, i.e., using a recognized reference method like the CLSI broth microdilution method.
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510(K) SUMMARY
| SUBMITTED BY: | Becton, Dickinson and Company7 Loveton CircleSparks, MD 21152Phone: (410)-316-4161Fax: (410)-316-4499 | AUG 20 2007 |
|---|---|---|
| CONTACT NAME: | Vicki K. WhitleyRegulatory Affairs Specialist | |
| DATE PREPARED: | August 6, 2007 | |
| DEVICE TRADE NAME: | BD Phoenix™ Automated Microbiology System –Ampicillin-sulbactam 1/0.5-32/16 $µg$ /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), Ampicillin-sulbactam (K043389, January 21,2005), Ampicillin-sulbactam (K061327, July 3, 2006). | |
| 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.
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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 in 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 (formerly NCCLS) reference broth microdilution method. This premarket notification provides data supporting the use of the BD Phoenix™ Automated Microbiology System Gram-negative 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-negative isolates. Each site tested the isolates in triplicate on three different days using one lot of Gram-negative 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-negative 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-negative 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, and resistant),
Table 1 summarizes the performance for the isolates tested in this study.
Table 1: Performance of BD Phoenix System for Gram-Negative Organisms by Drug
| Antimicrobial | Concentration | EA (n) | EA (%) | CA (n) | CA (%) |
|---|---|---|---|---|---|
| Ampicillin-sulbactam | 1/0.5-32/16 ug/mL | 1106 | તેરી જેવી જેવી સવલતો પ્રાપ્ય થયેલી છે. આ ગામનાં લોકોનો મુખ્ય વ્યવસાય ખેતી, ખેતમજૂરી તેમ જ પશુપાલન છે. આ ગામમાં પ્રાથમિક શાળા, પંચાયતઘર, આંગણવાડી તેમ જ દૂધની ડેવી જેવી સવલતો | 1106 | 86.6 |
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 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), Ampicillin-sulbactam (K043389, January 21, 2005) and Ampicillin-sulbactam (K061327, July 3, 2006).
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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 representing the services provided by the department. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES (USA)". The text is arranged in a circular fashion around the eagle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
AUG 2 0 2007
Ms. Vicki K. Whitley Regulatory Affairs Specialist Becton, Dickinson and Company 7 Loveton Circle Sparks, MD 21152
Re: K071623
Trade/Device Name: BD PhoenixTM Automated Microbiology System - Ampicillinsulbactam (1/0.5-32/16ug/ml) 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 13, 2007 Received: June 14,2007
Dear Ms. Whitley:
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). This letter
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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 renamered predicate device results in a classification for your device and thus, permits your dry increase 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. 7) 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 240-276-34710. 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 vours.
Saucony
Sally A. Hojvat, M.Sc., Ph 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
KO71623 510(k) Number:
Device Name: BD Phoenix™ Automated Microbiology System for use with the antimicrobial agent ampicillin-sulbactam (1/0.5-32/16 ug/mL) - Gram-Negative ID/AST or AST only Phoenix panels with the removal of the limitations for Acinetobacter species and Proteus mirabilis.
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 ampicillin-sulbactam at concentrations of 1/0.5-32/16 µg/mL to Gramnegative ID/AST or AST only Phoenix panels with the removal of the limitations for Acinetobacter species and Proteus mirabilis. Ampicillin-sulbactam 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:
Beta-lactamase producing strains of: Acinetobacter calcoaceticus Enterobacter spp. Escherichia coli
Active In Vitro Against:
Escherichia coli (Beta-lactamase and non-beta-lactamase producing) Klebsiella species (all know strains are beta-lactamase producing) Morganella morganii Proteus mirabilis (Beta-lactamase and non-beta-lactamase producing) Beta-lactamase producing strains of: Klebsiella spp. (including K. pneumoniae) Proteus mirabilis
Providencia rettgeri Providencia stuartii
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 Device Evaluation (ODE)
freddie M. Coba
Division Sign-Off
Office of In Vitro Diagnostic Device
510(k) K07 1623
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.”