SENSITITRE AIM (TM)

{0} 1 # 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT COMBINATION TEMPLATE A. 510(k) Number: k110331 B. Purpose for Submission: To obtain substantial equivalence for the AutoInoculator 2, AIM™ inoculation system compared to the existing Autoinoculator I. C. Measurand: Antimicrobial susceptibility testing of Gram-Negative organisms on the Sensititre panels inoculated with AIM. D. Type of Test: Quantitative Antimicrobial Susceptibility Test (AST), growth based fluorescence. The minimum inhibitory concentration (MIC) is determined manually based on visual detection of growth or by the aid of an AutoReader or on the VIZION. E. Applicant: Trek Diagnostic Systems. F. Proprietary and Established Names: Sensititre 18 – 24 hour Susceptibility MIC Plates Sensititre AIM™ inoculation system G. Regulatory Information: 1. Regulation section: 21 CFR 866.1640 Antimicrobial Susceptibility Test Powder 2. Classification: Class II {1} 3. Product code: LIE-Reagents/Device, Inoculum Calibration JWY-Manual readings of AST testing of >16 hour incubation LRG-Automated readings of AST of >16 hrs incubation 4. Panel: 83, Microbiology H. Intended Use: 1. Intended use(s): The Sensititre® AIM™ is intended for use with the Sensititre® MIC or BP Susceptibility Test System. The Sensititre® AIM™ is an instrument used to inoculate Sensititre® MIC or BP Susceptibility plates. The Sensititre MIC and Breakpoint Susceptibility system is an in vitro diagnostic product for clinical susceptibility testing of non fastidious Gram negative organisms. 2. Indication(s) for use: The Sensititre® AIM™ is intended for use with the Sensititre® MIC or BP Susceptibility Test System. The Sensititre® AIM™ is an instrument used to inoculate Sensititre MIC or BP Susceptibility plates. The Sensititre MIC or Breakpoint Susceptibility System is an in vitro diagnostic product for clinical susceptibility testing of non fastidious Gram negative organisms. This 510(k) is for the addition of: "AIM™" The Sensititre AIM™ is a microprocessor controlled instrument that delivers inoculum in 50μl multiples to the Sensititre 96 well microtiter plate. The user prepares the inoculum suspension in accordance with the package inert. A Sensititre disposable dosehead is affixed to the glass tube containing the final inoculum density which is placed into the AIM's pump assembly. The inoculum is then dispensed into the microtiter plates. 3. Special conditions for use statement(s): Prescription use only. {2} 4. Special instrument requirements: The Sensititre Autoinoculator The Sensititre AutoReader The Sensititre viewer, VIZION I. Device Description: The Sensititre Autoinoculator 2, AIM™ instrument is an automated pipette system for the delivery of user prepared inoculated media in multiples of 50 and 100 µl into the Sensititre 96 well antimicrobial susceptibility plate. The AIM™ is a bench-top instrument which dispenses bacterial suspension (inoculum) into a 96-well plate (MIC panel). The instrument has a display which presents options to the user graphically. The user may then select the well dose volume (a multiple of 50 µl) specific to each panel section. Different panel sections may be dosed differently. After selection of these parameters, the user loads the inoculum tube, a suitable panel and then starts the dosing cycle. The AIM™ is a stand-alone device and requires no connections to other equipment in normal use. It currently provides no support for sample tracking. J. Substantial Equivalence Information: 1. Predicate device name(s): Autoinoculator I 2. Predicate K number(s): k081063 3. Comparison with predicate: | Similarities | | | | --- | --- | --- | | Item | Device | Predicate | | Intended Use | Delivery of prepared inoculum media in multiples of 50 µl into 96 microplate wells | Same | | Inoculation and test | Isolated colonies from | Same | | Test | Isolated colonies from | Same | {3} | Similarities | | | | --- | --- | --- | | Item | Device | Predicate | | organism | culture are used to prepare the inoculum | | | Dosing system /Technology | Automated pipette system using TREK dosehead consumables | Same. | | Well indexing method | Microplate wells are indexed beneath the dose head | Same | | Calibration method | System is calibrated by weighing dosed plates | Same | | Type of test | Automated or manual | Same | | Differences | | | | --- | --- | --- | | Item | Device | Predicate | | Size | 250 mm wide/350 mm deep | 413 mm wide/464 mm deep | | Cycle speed | Between 27 and 35 seconds | 35 seconds | | Dose head drive system | Single stepper motor articulating mechanically slaved rotation and thrusting movements of dose head drive spigot | Two stepper motors. First stepper motor articulating rotation movement of dose head drive spigot. Second stepper motor articulating thrusting movements of dose head drive spigot | | User interface | Single line LED display with keypad | Touch screen display with icon driven menu system. | # K. Standard/Guidance Document Referenced (if applicable): 1. Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems; Guidance for Industry and FDA http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm071462.pdf 2. Clinical and Laboratory Standards Institute (CLSI). Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria that Grow Aerobically, Approved Standard -8th Edition, Document M7-A8. {4} 3. CLSI. Performance Standards for Antimicrobial Susceptibility Testing – 19th Informational Supplement, Document M100-S19. L. Test Principle: Sensititre susceptibility plates are multi-well plastic microtiter plates that contain doubling dilutions of antibacterial agents. Each plate is dosed with antimicrobial agents at appropriate dilutions. Results can be read manually by visual reading of growth or automatically on an AutoReader using fluorescence. The Sensititre AutoReader system utilizes fluorescence technology which involves the detection of bacterial growth by monitoring the activity of specific surface enzymes produced by the test organism. Growth is determined by generating a fluorescent product from a non-fluorescent (fluorogenic) substrate. The substrate can be added to the inoculum broth and dispensed into the test plates at the same time as the test organism or the plates can be prepared with the substrate already added to the plate. The non-fluorescent substrate is prepared by conjugating a fluorescent compound to the specific enzyme substrates with a bond, which prevents fluorescence (i.e. the fluorophore is quenched in this state). Enzymatic action of the bacterial surface enzymes on the specific substrates cleaves this bond releasing the fluorophore which is now capable of fluorescence. The amount of fluorescence detected is directly related to the activity of the bacterial surface enzymes and, therefore, to bacterial growth. M. Performance Characteristics (if/when applicable): 1. Analytical performance: a. Precision/Reproducibility: A reproducibility study was conducted at three study sites. Twenty five Gram negative isolates (6 E. coli, 5 K. pneumoniae, 3 E. cloacae, 3 S. marcescens, 2 S. maltophilia, 2 A. baumannii, and 4 P. aeruginosa) were tested at each site. The panels used included the following antimicrobial agents as representatives of the various classes: These were tested one time at each of the three sites and results were read by both the AutoReader and the VIZION. Ampicillin, Ticarcillin, Piperacillin/Tazobactam, Chloramphenicol, Cefazolin, Cefepime, Ceftazidime, Ertapenem, Tetracycline, Levofloxacin, Gentamicin, and Trimethoprim/Sulfamethoxazole. For each drug tested, reproducibility was evaluated by comparing MIC results obtained from Sensititre plates inoculated with the new inoculator, AIM to those inoculated with the existing Autoinoculator I. Results were read on both the AutoReader and on the VIZION. Reproducibility was calculated as the percent of combined results were within +/- one doubling dilution of the mode MIC value for all sites. 5 {5} The original AIM/Gram-Negative reproducibility studies included some drug/organism combinations that did not have sufficient number of on-scale MIC results. Another reproducibility study was conducted and included 10 isolates with on-scale MIC values for the following antimicrobials: Cefazolin, Cefepime, Ceftazidime and Trimethoprim/Sulfamethoxazole. Cumulative reproducibility data is shown below. Overall Reproducibility of AIM vs. Autoinoculator I for non-fastidious Gram negative organisms | | % Reproducibility (AIM vs. Autoinoculator I) | | | | --- | --- | --- | --- | | | Best Case (assuming off scale result is within one well from the mode) | On-Scale (on-scale values only) | Worst-case* (assuming off scale result is greater than one well from the mode) | | AutoReader | 99.5 | 99.7 | 71.2 | | VIZION | 99.6 | 99.8 | 74.4 | * Off-scale isolates were used due to unavailability or insufficient number of isolates with on-scale MIC values for some drug/organism combinations Even though the MIC values were off-scale for a large number of isolates, which has resulted in low performance based on "worst-case" calculation, the overall reproducibility was considered acceptable, since very high essential agreement was observed based on "best-case" calculation and when calculations were made using on-scale MIC values only. b. Linearity/assay reportable range: Not applicable c. Traceability, Stability, Expected values (controls, calibrators, or methods): The FDA and CLSI recommended QC isolates were tested on every test occasion. The QC results obtained using Autoinoculator I and AIM were in range for every day tested. Quality Control was performed at all sites during the studies using the existing Autoinoculator I and the new Autoinoculator, AIM. Results were read on the AutoReader and the VIZION. The QC MIC values obtained by the AIM/Autoinoculator I were generally comparable. Summary of the results are shown in the table below for $E$ coli ATCC 25922 and $P$ aeruginosa ATCC 27853. For some drugs, the concentration range was not sufficiently broad to provide definite MIC value for both QC {6} organisms. However, the concentration range was sufficient to evaluate at least one QC organism per drug. | E. coli ATCC 25922 | | AutoReader | | VIZION | | | --- | --- | --- | --- | --- | --- | | Drug (Acceptable MIC range, μg/mL) | Concentration (μg/mL) | Autoinoculator I | AIM | Autoinoculator I | AIM | | TMP/SMX (≤0.5/9.5) | ≤0.25 | 60 | 60 | 60 | 60 | | | 0.5 | | | | | | | 1 | | | | | | | | | | | | | Ticarcillin (4-16) | ≤2 | | | | | | | 4 | 18 | 13 | 10 | 6 | | | 8 | 41 | 45 | 49 | 52 | | | 16 | 1 | 2 | 1 | 2 | | | 32 | | | | | | | | | | | | | Tetracycline (0.5-2) | ≤0.25 | | | | | | | 0.5 | 1 | | | | | | 1 | 59 | 60 | 60 | 60 | | | 2 | | | | | | | 4 | | | | | | | | | | | | | Piperacillin/Tazob actam (1-4) | ≤0.5 | | | | | | | 1 | | | | | | | 2 | 60 | 60 | 60 | 60 | | | 4 | | | | | | | 8 | | | | | | | | | | | | | Levofloxacin (0.008-0.06) | ≤0.004 | | | | | | | 0.008 | | | | | | | 0.015 | 36 | 38 | 18 | 35 | | | 0.03 | 24 | 22 | 42 | 25 | | | 0.06 | | | | | | | 0.12 | | | | | | | | | | | | | Gentamicin (0.25-1) | ≤0.12 | | | | | | | 0.25 | 3 | | 2 | | | | 0.5 | 57 | 59 | 57 | 59 | | | 1 | | 1 | 1 | 1 | | | 2 | | | | | | | | | | | | | Ertapenem (0.004-0.015) | ≤0.002 | | | | | | | 0.004 | | | | | | | 0.008 | 60 | 60 | 60 | 60 | | | 0.015 | | | | | {7} | E. coli ATCC 25922 | | AutoReader | | VIZION | | | --- | --- | --- | --- | --- | --- | | Drug (Acceptable MIC range, μg/mL) | Concentration (μg/mL) | Autoinoculator I | AIM | Autoinoculator I | AIM | | | 0.03 | | | | | | | | | | | | | Chloramphenicol (2-8) | 1 | | | | | | | 2 | | | | | | | 4 | 53 | 55 | 48 | 52 | | | 8 | 7 | 5 | 12 | 8 | | | 16 | | | | | | | | | | | | | Ceftazidime (≤0.25-1) | ≤0.25 | 59 | 60 | 58 | 59 | | | 0.5 | 1 | | 2 | 1 | | | 1 | | | | | | | | | | | | | Cefepime (≤0.5) | ≤0.5 | 60 | 60 | 60 | 60 | | | | | | | | | | | | | | | | Ampicillin (2-8) | ≤1 | | | | | | | 2 | 1 | | | | | | 4 | 59 | 60 | 60 | 60 | | | 8 | | | | | | | 16 | | | | | | | | | | | | | Cefazolin (0.5-4) | ≤1 | 49 | 48 | 48 | 46 | | | 2 | 11 | 12 | 12 | 14 | | | 4 | | | | | | | 8 | | | | | {8} | P. aeruginosa ATCC 27853 | | AutoReader | | VIZION | | | --- | --- | --- | --- | --- | --- | | Drug | Concentration (μg/mL) | Autoinoculator I | AIM | Autoinoculator I | AIM | | TMP/SMX (8-32) | 4 | | | | | | | 8 | 3 | 1 | | 1 | | | 16 | 55 | 58 | 60 | 59 | | | 32 | 2 | 1 | | | | | | | | | | | | | | | | | | Ticarcillin (8-32) | 4 | | | | | | | 8 | 2 | 1 | 16 | 19 | | | 16 | 57 | 56 | 42 | 38 | | | 32 | 1 | 3 | 2 | 3 | | | 64 | | | | | | | | | | | | | Tetracycline (8-32) | 4 | | | | | | | 8 | 21 | 29 | 28 | 30 | | | 16 | 39 | 31 | 32 | 30 | | | 32 | | | | | | | 64 | | | | | | | | | | | | | Piperacillin/Tazob actam (1-8) | ≤0.5 | | | | | | | 1 | 2 | 1 | 12 | | | | 2 | 34 | 37 | 42 | 48 | | | 4 | 21 | 21 | 5 | 10 | | | 8 | 3 | 1 | 1 | 2 | | | 16 | | | | | | | | | | | | | Levofloxacin (0.5-4) | 0.25 | | | | | | | 0.5 | 11 | 11 | 29 | 32 | | | 1 | 49 | 49 | 31 | 27 | | | 2 | | | | 1 | | | 4 | | | | | | | 8 | | | | | | | | | | | | | Gentamicin (0.5- 2) | 0.25 | | | | | | | 0.5 | 22 | 21 | 16 | 18 | | | 1 | 38 | 39 | 44 | 42 | | | 2 | | | | | | | 4 | | | | | | | | | | | | | Ertapenem | 1 | | | | | {9} | P. aeruginosaATCC 27853 | | AutoReader | | VIZION | | | --- | --- | --- | --- | --- | --- | | Drug | Concentration (μg/mL) | Autoinoculator I | AIM | Autoinoculator I | AIM | | (2-8) | 2 | 24 | 26 | 46 | 44 | | | 4 | 36 | 34 | 13 | 15 | | | 8 | | | 1 | 1 | | | 16 | | | | | | | | | | | | | Ceftazidime(1-4) | 0.5 | | | | | | | 1 | 56 | 59 | 52 | 59 | | | 2 | 4 | 1 | 8 | 1 | | | 4 | | | | | | | 8 | | | | | | | | | | | | | Cefepime(1-8) | ≤0.5 | | | | | | | 1 | 55 | 56 | 54 | 55 | | | 2 | 5 | 4 | 6 | 5 | | | 4 | | | | | | | 8 | | | | | | | 16 | | | | | | | | | | | | MIC results were in range for each drug for at least one Quality Control organism tested. Quality Control results for the Sensititre Susceptibility System using AIM as the inoculator or the existing Autoinoculator I demonstrated that the system could produce the expected quality control results whether results are read on the AutoReader or on the VIZION. Inoculum density control for QC organisms ranged between a minimum of $0.5 \times 10^{5} \mathrm{CFU/mL}$ and a maximum of $3.1 \times 10^{5} \mathrm{CFU/mL}$ . These colony count values were the result of 17 density evaluation tests with $E.$ coli ATCC 25922, 12 density evaluation tests with $E.$ coli ATCC 35218 and 15 density evaluation tests with $P.$ aeruginosa ATCC 27853. All results were within the expected range. d. Detection limit: Not applicable. e. Analytical specificity: Not applicable. {10} f. Assay cut-off: Not applicable 2. Comparison studies: a. Method comparison with predicate device: Performance was established through a clinical study which was conducted at three sites. The studies were designed to evaluate performance of the updated version of the Autoinoculator, AIM to the existing Autoinoculator I using the Sensititre 18-24 hour susceptibility plates. Specially prepared MIC susceptibility panels containing serial dilutions of selected antimicrobial agents representing various classes of antimicrobial agents were inoculated by either the AIM or the Autoinoculator I. Duplicate plates were inoculated. One was inoculated using the Autoinoculator I and the other using the AIM. Plates were read after 18-24 hours of incubation at 35°C. The readings were done on the AutoReader and on the VIZION. The MIC results obtained for plates inoculated with Autoinoculator I were compared to those obtained for plates inoculated with the AIM. The criteria outlined in the AST Special Controls Guidance Document were used in evaluation of performance of AIM as follows: AutoReader results comparing AIM versus Autoinoculator I VIZION results comparing AIM versus Autoinoculator I Clinical testing was performed on 222 Gram negative isolates (161 Enterobacteriaceae, 22 non-Enterobacteriaceae, 27 Pseudomonas aeruginosa and 12 Acinetobacter baumannii). The growth rate for the 222 clinical and challenge isolates was 100%. The performance evaluations are shown in the table below. {11} Summary Table (AutoReader) | Drug | Organism Group | Clinical | Challenge | Total | Total Evaluable | %EA Total | % EA of Evaluable | %CA | S | I | R or NS | VMJ | MAJ | Minor | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | Ampicillin | Enterobacteriaceae | 104 | 57 | 161 | 58 | 100 | 100 | 97.5 | 41 | 11 | 109 | 0 | 0 | 4 | | Ticarcillin | Acinetobacter baumanni | 12 | 0 | 12 | 0 | 100 | na | 100 | 0 | 0 | 12 | 0 | 0 | 0 | | | Enterobacteriaceae | 104 | 57 | 161 | 52 | 99.4 | 98.1 | 97.5 | 81 | 7 | 73 | 0 | 0 | 4 | | | Non-Enterobacteriaceae | 16 | 6 | 22 | 9 | 100 | 100 | 95.5 | 6 | 1 | 15 | 0 | 0 | 1 | | | P. aeruginosa | 15 | 12 | 27 | 21 | 100 | 100 | 100 | 17 | 0 | 10 | 0 | 0 | 0 | | Piperacillin/Tazobactam | Acinetobacter baumanni | 12 | 0 | 12 | 0 | 100 | na | 100 | 0 | 0 | 12 | 0 | 0 | 0 | | | Enterobacteriaceae | 104 | 57 | 161 | 109 | 99.4 | 99.1 | 98.8 | 126 | 15 | 20 | 0 | 0 | 2 | | | Non-Enterobacteriaceae | 16 | 6 | 22 | 15 | 100 | 100 | 100 | 13 | 6 | 3 | 0 | 0 | 0 | | | P. aeruginosa | 15 | 12 | 27 | 21 | 100 | 100 | 100 | 23 | 0 | 4 | 0 | 0 | 0 | | Chloramphenicol | Acinetobacter baumanni | 12 | 0 | 12 | 0 | 100 | na | 100 | 0 | 0 | 12 | 0 | 0 | 0 | | | Enterobacteriaceae | 104 | 57 | 161 | 125 | 100 | 100 | 96.9 | 97 | 15 | 49 | 0 | 0 | 5 | | | Non-Enterobacteriaceae | 16 | 6 | 22 | 12 | 100 | 100 | 90.9 | 4 | 5 | 13 | 0 | 0 | 2 | | Cefazolin | Enterobacteriaceae | 104 | 57 | 161 | 49 | 100 | 100 | 100 | 76 | 3 | 82 | 0 | 0 | 0 | | Cefepime | Acinetobacter baumanni | 12 | 0 | 12 | 4 | 100 | 100 | 91.7 | 2 | 2 | 8 | 0 | 0 | 1 | | | Enterobacteriaceae | 104 | 57 | 161 | 29 | 100 | 100 | 99.4 | 156 | 1 | 4 | 0 | 0 | 1 | | | Non-Enterobacteriaceae | 16 | 6 | 22 | 10 | 95.5 | 100 | 100 | 16 | 3 | 3 | 0 | 0 | 0 | | | P. aeruginosa | 15 | 12 | 27 | 21 | 100 | 100 | 100 | 21 | 6 | 0 | 0 | 0 | 0 | | Ceftazidime | Acinetobacter baumanni | 12 | 0 | 12 | 1 | 100 | 100 | 100 | 1 | 0 | 11 | 0 | 0 | 0 | | | Enterobacteriaceae | 104 | 57 | 161 | 34 | 99.4 | 97.1 | 98.8 | 129 | 4 | 28 | 0 | 0 | 2 | | | Non-Enterobacteriaceae | 16 | 6 | 22 | 16 | 100 | 100 | 95.5 | 15 | 3 | 4 | 0 | 0 | 1 | | | P. aeruginosa | 15 | 12 | 27 | 18 | 100 | 100 | 100 | 21 | 1 | 5 | 0 | 0 | 0 | | Ertapenem | Enterobacteriaceae | 104 | 57 | 161 | 154 | 100 | 100 | 100 | 152 | 3 | 6 | 0 | 0 | 0 | | Tetracycline | Enterobacteriaceae | 104 | 57 | 161 | 129 | 100 | 100 | 98.1 | 94 | 4 | 63 | 0 | 0 | 3 | | Levofloxacin | Enterobacteriaceae | 104 | 57 | 161 | 138 | 100 | 100 | 99.4 | 126 | 7 | 28 | 0 | 0 | 1 | | Gentamicin | Acinetobacter baumanni | 12 | 0 | 12 | 2 | 100 | 100 | 91.7 | 2 | 1 | 9 | 0 | 0 | 1 | | | Enterobacteriaceae | 104 | 57 | 161 | 144 | 100 | 100 | 98.8 | 143 | 4 | 14 | 0 | 0 | 2 | | | Non-Enterobacteriaceae | 16 | 6 | 22 | 13 | 100 | 100 | 100 | 17 | 0 | 5 | 0 | 0 | 0 | | | P. aeruginosa | 15 | 12 | 27 | 18 | 100 | 100 | 100 | 16 | 2 | 9 | 0 | 0 | 0 | | Trimepthoprim/Sulfamethoxazole | Acinetobacter baumanni | 12 | 0 | 12 | 6 | 100 | 100 | 100 | 1 | 0 | 11 | 0 | 0 | 0 | | | Enterobacteriaceae | 104 | 57 | 161 | 26 | 100 | 100 | 100 | 129 | 0 | 32 | 0 | 0 | 0 | | | Non-Enterobacteriaceae | 16 | 6 | 22 | 9 | 100 | 100 | 100 | 15 | 0 | 7 | 0 | 0 | 0 | {12} Summary Table (VIZION) | Drug | Organism Group | Clinical | Challenge | Total | Total Evaluable | %EA Total | % EA of Evaluable | %CA | S | I | R or NS | VMJ | MAJ | Minor | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | Ampicillin | Enterobacteriaceae | 104 | 57 | 161 | 58 | 100 | 100 | 97.5 | 40 | 16 | 105 | 0 | 0 | 4 | | Ticarcillin | Acinetobacter baumannii | 12 | 0 | 12 | 0 | 100 | na | 100 | 0 | 0 | 12 | 0 | 0 | 0 | | | Enterobacteriaceae | 104 | 57 | 161 | 53 | 100 | 100 | 98.8 | 80 | 7 | 74 | 0 | 0 | 2 | | | Non-Enterobacteriaceae | 16 | 6 | 22 | 10 | 100 | 100 | 100 | 6 | 2 | 14 | 0 | 0 | 0 | | | P. aeruginosa | 15 | 12 | 27 | 22 | 100 | 100 | 100 | 17 | 0 | 10 | 0 | 0 | 0 | | Piperacillin/Tazobactam | Acinetobacter baumannii | 12 | 0 | 12 | 0 | 100 | na | 100 | 0 | 0 | 12 | 0 | 0 | 0 | | | Enterobacteriaceae | 104 | 57 | 161 | 110 | 100 | 100 | 98.8 | 126 | 15 | 20 | 0 | 0 | 2 | | | Non-Enterobacteriaceae | 16 | 6 | 22 | 14 | 95.5 | 100 | 95.5 | 14 | 4 | 4 | 0 | 0 | 1 | | | P. aeruginosa | 15 | 12 | 27 | 21 | 100 | 100 | 100 | 23 | 0 | 4 | 0 | 0 | 0 | | Chloramphenicol | Acinetobacter baumannii | 12 | 0 | 12 | 0 | 100 | na | 100 | 0 | 0 | 12 | 0 | 0 | 0 | | | Enterobacteriaceae | 104 | 57 | 161 | 123 | 100 | 100 | 96.3 | 96 | 17 | 48 | 0 | 0 | 6 | | | Non-Enterobacteriaceae | 16 | 6 | 22 | 12 | 100 | 100 | 95.5 | 4 | 3 | 15 | 0 | 0 | 1 | | Cefazolin | Enterobacteriaceae | 104 | 57 | 161 | 50 | 100 | 100 | 100 | 76 | 3 | 82 | 0 | 0 | 0 | | Cefepime | Acinetobacter baumannii | 12 | 0 | 12 | 3 | 100 | 100 | 91.7 | 0 | 3 | 9 | 0 | 0 | 1 | | | Enterobacteriaceae | 104 | 57 | 161 | 29 | 100 | 100 | 99.4 | 156 | 1 | 4 | 0 | 0 | 1 | | | Non-Enterobacteriaceae | 16 | 6 | 22 | 11 | 100 | 100 | 100 | 15 | 4 | 3 | 0 | 0 | 0 | | | P. aeruginosa | 15 | 12 | 27 | 19 | 100 | 100 | 100 | 21 | 5 | 1 | 0 | 0 | 0 | | Ceftazidime | Acinetobacter baumannii | 12 | 0 | 12 | 1 | 100 | 100 | 100 | 1 | 0 | 11 | 0 | 0 | 0 | | | Enterobacteriaceae | 104 | 57 | 161 | 35 | 99.4 | 97.1 | 98.8 | 129 | 4 | 28 | 0 | 0 | 2 | | | Non-Enterobacteriaceae | 16 | 6 | 22 | 16 | 100 | 100 | 100 | 15 | 3 | 4 | 0 | 0 | 0 | | | P. aeruginosa | 15 | 12 | 27 | 18 | 100 | 100 | 100 | 21 | 1 | 5 | 0 | 0 | 0 | | Ertapenem | Enterobacteriaceae | 104 | 57 | 161 | 153 | 100 | 100 | 100 | 152 | 2 | 7 | 0 | 0 | 0 | | Tetracycline | Enterobacteriaceae | 104 | 57 | 161 | 127 | 100 | 100 | 98.8 | 92 | 5 | 64 | 0 | 0 | 2 | | Levofloxacin | Enterobacteriaceae | 104 | 57 | 161 | 140 | 100 | 100 | 100 | 126 | 7 | 28 | 0 | 0 | 0 | | Gentamicin | Acinetobacter baumannii | 12 | 0 | 12 | 3 | 100 | 100 | 100 | 2 | 1 | 9 | 0 | 0 | 0 | | | Enterobacteriaceae | 104 | 57 | 161 | 143 | 100 | 100 | 98.1 | 142 | 5 | 14 | 0 | 0 | 3 | | | Non-Enterobacteriaceae | 16 | 6 | 22 | 13 | 100 | 100 | 100 | 16 | 1 | 5 | 0 | 0 | 0 | | | P. aeruginosa | 15 | 12 | 27 | 17 | 100 | 100 | 100 | 16 | 1 | 10 | 0 | 0 | 0 | | Trimepthoprim/Sulfamethoxazole | Acinetobacter baumannii | 12 | 0 | 12 | 5 | 100 | 100 | 100 | 1 | 0 | 11 | 0 | 0 | 0 | | | Enterobacteriaceae | 104 | 57 | 161 | 29 | 100 | 100 | 100 | 131 | 0 | 30 | 0 | 0 | 0 | | | Non-Enterobacteriaceae | 16 | 6 | 22 | 8 | 100 | 100 | 100 | 15 | 0 | 7 | 0 | 0 | 0 | {13} Essential agreement (EA) is when the Sensititre panels inoculated with Autoinoculator I agree with the Sensititre panels inoculated with AIM results are either identical or within one doubling dilution of each other. Category agreement (CA) is when the Sensititre panel inoculated with Autoinoculator I result interpretation agrees exactly with the Sensititre panels inoculated with AIM. Evaluable EA is when the MIC result is on scale for both inoculation methods. The EA% is acceptable when compared to the reference method as described in the FDA guidance document, "Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems; Guidance for Industry and FDA". Overall, results for all the drugs evaluated were comparable whether the inoculation method was with the existing Autoinoculator I or with the AIM. As shown in the table below, the EA and CA rates were greater than 90% for each group of organisms for all drugs combined. | Organism/Group | Number of isolates tested | EA | CA | | --- | --- | --- | --- | | | AutoReader | | | | Enterobacteriaceae | 161 | 99.8% | 98.7% | | Non-Enterobacteriaceae | 22 | 99.3% | 97.4% | | P. aeruginosa | 27 | 100% | 100% | | Acinetobacter baumanni | 12 | 100% | 97.6% | | | VIZION | | | | Enterobacteriaceae | 161 | 99.9% | 98.4% | | Non-Enterobacteriaceae | 22 | 99.3% | 98.7% | | P. aeruginosa | 27 | 100% | 100% | | Acinetobacter baumanni | 12 | 100% | 98.8% | b. Matrix comparison: Not Applicable 3. Clinical Studies: a. Clinical Sensitivity: Not Applicable b. Clinical specificity: Not Applicable c. Other clinical supportive data (when a. and b. are not applicable): {14} Not Applicable 4. Clinical cut-off: Not Applicable 5. Expected values/Reference range: Not applicable? N. Instrument Name: Sensititre® AIM™ O. System Descriptions: 1. Modes of Operation: The AutoInoculator 2/AIM is a bench-top instrument which dispenses bacterial suspension (inoculum) into the Sensititre 96-well plate. The instrument has a display which presents options to the End User graphically. After making a selection of the panel layout/configuration, the user may then select the well dose volume (a multiple of 50 µl) specific to each panel section (note that different panel sections may be dosed differently). Having selected these parameters, the user loads the sample, loads a suitable plate and then starts the dosing cycle. The AutoInoculator 2/AIM is a stand-alone device and requires no connections to other equipment in normal use. It currently provides no support for sample tracking. 2. Software: FDA has reviewed applicant’s Hazard Analysis and software development processes for this line of product types: Yes ☐ X ☐ or No ☐ 3. Specimen Identification: The specimen is identified manually by the user. The AIM instrument provides no support for sample tracking. 4. Specimen Sampling and Handling: The bacterial suspension (inoculum) is prepared by the user. A Sensititre disposable dosehead is affixed to the glass tube containing the final inoculum 15 {15} density which is placed into the instrument's pump assembly. The AIM instrument then dispenses the inoculum into the Sensititre 96-well plate. 5. Calibration: The AIM instrument is calibrated by weighing inoculated plates. It is recommended that calibration should be carried out at intervals of no less than 1 year. 6. Quality Control: The AIM instrument uses a built-in routine allowing the adjustment and calibration of the plate dosing. The QC is performed by measuring the weight of a panel before and after dosing, to establish the weight and thus volume of the dosing droplets. P. Other Supportive Instrument Performance Characteristics Data Not Covered In The "Performance Characteristics" Section above: Q. Proposed Labeling: The labeling is sufficient and satisfies the requirements of 21 CFR Part 809.10. R. Conclusion: The submitted information in this premarket notification is complete and supports a substantial equivalence decision. 16