(580 days)
The BD Kiestra™ Methicillin-resistant Staphylococcus aureus (MRSA) Application is an in-vitro diagnostic software program that requires the BD Kiestra™ Laboratory Automation Solution in order to operate.
The BD Kiestra™ Methicillin-resistant Staphylococcus aureus (MRSA) Application is applied to digital images of BD BBL™ CHROMagar™ MRSA II culture plates inoculated with anterior nares samples.
Algorithms are applied to digital images to provide a qualitative assessment of colony growth and colorimetric detection of target colonies for the detection of nasal colonization by MRSA and to serve as an aid in the prevention and control of MRSA infection. Applied algorithms provide the following results:
- "No growth", which will be manually released individually or as a batch (with other no growth samples) by . a trained microbiologist upon review of the digital plate images.
- . "Growth - other" (growth without mauve color), which digital plate images will be manually reviewed by a trained microbiologist.
- "Growth MRSA Mauve" (growth with mauve color), which digital plate images will be manually reviewed ● by a trained microbiologist.
The assay is not intended to guide, diagnose, or monitor treatment for MRSA infections. It is not intended to provide results of susceptibility to oxacillin/methicillin.
The BD Kiestra™ Methicillin-resistant Staphylococcus aureus (MRSA) Application is indicated for use in the clinical laboratory.
The BD Kiestra™ Methicillin-resistant Staphylococcus aureus (MRSA) Application will be optional for the BD Kiestra™ Laboratory Automation Solution and will support laboratory technologists in batching no growth on the BD BBL™ CHROMagar™ MRSA II, growth with no key colony color detected for MRSA ("Growth – other"), and growth with key colony color detected for MRSA ("Growth MRSA Mauve"). These classifications will be characterized as "no growth" and "growth with mauve color" from BD BBLTM CHROMagar™ MRSA II media, from anterior nares samples.
The technologist has the ability to create work lists in BD Synapsys™ informatics solution based on the classifications (growth, no growth or growth with mauve color). These work lists will be used for followup work and batching of results, at the sample level.
The BD Kiestra™ Methicillin-resistant Staphylococcus aureus (MRSA) Application will apply Image Algorithms to the digital images to determine if the plate contains "growth" or "no growth". At the individual plate level when the Image Algorithms detects colony growth and potential mauve color the classification will be "growth with mauve color".
When the BD Kiestra™ Methicillin-resistant Staphylococcus aureus (MRSA) Application is not capable of automatically generating the outputs (visual attributes: growth with or without mauve color/no growth), the laboratory technologist will be required to read the digital image of the plate on the computer screen and decide on follow-up action as is the current standard laboratory practice.
Here's a summary of the acceptance criteria and the study details for the BD Kiestra™ Methicillin-resistant Staphylococcus aureus (MRSA) Application, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are not explicitly stated as distinct numerical targets in the provided document. However, the studies demonstrate performance metrics related to agreement with manual interpretation and reproducibility.
| Performance Metric | Acceptance Criteria (Implied by study results being presented) | Reported Device Performance (Combined) |
|---|---|---|
| Digital Quality Image Study | ||
| Agreement: No Growth | High percentage agreement with manual reading | 93.1% (148/159) |
| Agreement: Non-Mauve Growth | High percentage agreement with manual reading | 98.3% (169/172) |
| Agreement: Mauve Growth | High percentage agreement with manual reading | 98.9% (188/190) |
| Digital Image Reproducibility Study | ||
| Reproducibility: No Growth | High percentage agreement among microbiologists | 98.0% (150/153) |
| Reproducibility: Non-Mauve Growth | High percentage agreement among microbiologists | 100.0% (175/175) |
| Reproducibility: Mauve Growth | High percentage agreement among microbiologists | 98.9% (188/190) |
| Reproducibility Study (Seeded Samples) | ||
| Combined Growth (Saline) | High percentage detection of no growth | 99.7% (2082/2089) (99.3%, 99.8% CI) |
| Combined Color (Saline) | High percentage detection of no growth | 99.7% (2082/2089) (99.3%, 99.8% CI) |
| Combined Growth (MRSA strains) | 100% detection of growth for most dilutions | 100% (most dilutions) |
| Combined Color (MRSA strains) | 100% detection of mauve color for most dilutions | 100% (most dilutions) |
| Combined Growth (S. haemolyticus (non-mauve)) | High percentage detection of growth (without mauve) | 94.4% - 100% |
| Combined Color (S. haemolyticus (non-mauve)) | High percentage detection of growth (without mauve) | 94.4% - 100% |
| Clinical Performance Studies (Against Manual Read at Clinical Sites) | ||
| No Growth Percent Agreement | High percentage agreement with manual reading | 75.6% (773/1023) |
| Non-Mauve Percent Agreement | High percentage agreement with manual reading | 84.5% (207/245) |
| Mauve Percent Agreement | High percentage agreement with manual reading | 98.2% (319/325) |
2. Sample sizes used for the test set and the data provenance
- Digital Quality Image Study:
- Sample Size: 521 plate images (across 3 microbiologists, so 174, 172, and 175 plates respectively for each microbiologist's manual review).
- Data Provenance: Internal digital image quality study, using simulated surveillance samples (MRSA, non-MRSA, saline controls). Implies data was generated specifically for this study. The location or country of origin is not explicitly stated, but it's an "internal" study. The nature (simulated surveillance samples) suggests it was a prospective generation of samples for the study.
- Digital Image Reproducibility Study:
- Sample Size: 518 plate images (3 images excluded due to invalid results from at least one microbiologist).
- Data Provenance: Same as the Digital Quality Image Study, as it re-analyzed the results from that study. "Internal" study, likely newly generated for this purpose.
- Reproducibility Study (Seeded Samples):
- Sample Size: Variable, ranging from 55 to 1056 individual observations per dilution/organism combination across two sites. Total observations are in the thousands (e.g., 2089 for saline controls).
- Data Provenance: Internal reproducibility study using seeded samples (bacterial strains grown in saline). Conducted at two internal sites (BD Sparks, MD location). This is also prospective generation of data.
- Clinical Performance Studies:
- Sample Size: Approximately 1,800 clinical anterior nares specimens.
- Data Provenance: Clinical anterior nares specimens. Collected at "three clinical sites." The text does not specify the country of origin, but "clinical sites" generally refer to real-world healthcare settings. This is a prospective collection of real patient samples.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Digital Quality Image Study & Digital Image Reproducibility Study:
- Number of Experts: 3.
- Qualifications: "Three trained clinical microbiologists." Specific years of experience or board certifications are not provided.
- Reproducibility Study (Seeded Samples):
- The ground truth for seeded samples is inherently defined by the known organisms and dilutions used to create the samples. The study then assesses the automated system's agreement with this known "ground truth" for growth and color. Human experts here are likely involved in verifying the initial seeding and later in the interpretation of the results, but the definition of "mauve" or "non-mauve" for specific strains is pre-defined.
- Clinical Performance Studies:
- Number of Experts: Not explicitly stated as a fixed number, but the images were "manually read by trained microbiologists at those sites." This implies multiple microbiologists across the three clinical sites.
- Qualifications: "Trained microbiologists." Specific years of experience or board certifications are not provided.
4. Adjudication method for the test set
- Digital Image Reproducibility Study: The "final digital image result" was "determined by 2/3 majority microbiologist result." This indicates a form of consensus-based adjudication, specifically a majority vote among the three microbiologists.
- Other studies (Digital Quality Image, Reproducibility with Seeded Samples, Clinical Performance): The primary comparison for these studies appears to be between the device's output and individual manual reads by microbiologists or known characteristics of seeded samples. Explicit adjudication methods for generating a single "ground truth" reference for these specific studies are not detailed, though for the clinical study, the manual read at each site serves as the reference.
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
- A MRMC comparative effectiveness study, where human readers' performance with and without AI assistance is quantitatively measured and compared, is not explicitly described in the provided text.
- The studies focus on the agreement of the device with manual reads (Digital Quality Image, Clinical Performance) and the reproducibility of human reads of digital images (Digital Image Reproducibility). While these demonstrate the device's capability to produce similar results to human reads, they don't directly quantify the improvement of human readers due to AI assistance. The device's stated purpose is to "aid in the prevention and control of MRSA infection" and to support laboratory technologists in "batching" and "streamline and optimize the reading workflow," suggesting an assistive role. However, the magnitude of this assistance in terms of effect size on human reader performance is not presented.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Yes, a standalone performance analysis was conducted. The tables in the "Analytical Performance" and "Clinical Performance Studies" sections (e.g., Table 1, Table 6, and the final clinical performance table on page 17) directly compare the BD Kiestra™ MRSA App's output to the manual plate reads or ground truth. The "Percent Agreement" values (e.g., "No Growth Percent Agreement 75.6% (773/1023)") represent the algorithm's performance against those references.
- It's important to note that even when the app provides results, the indications for use state that "No growth", "Growth - other", and "Growth MRSA Mauve" classifications "will be manually reviewed by a trained microbiologist." This means that while the algorithm provides a classification, a human-in-the-loop is always part of the final release process. However, the data presented directly assesses the algorithm's standalone accuracy in classifying the images.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Expert Consensus: Used in the "Digital Image Reproducibility Study," where a 2/3 majority microbiologist result formed the ground truth for comparing individual microbiologist reproducibility.
- Manual Expert Reading: For the "Digital Quality Image Study" and the "Clinical Performance Studies," the ground truth was established by the manual interpretation of the plates (or digital images of plates) by trained microbiologists. This acts as the "gold standard" for comparison.
- Known Sample Characteristics: For the "Reproducibility Study (Seeded Samples)," the ground truth was defined by the known bacterial strains, dilutions, and expected growth/color characteristics of the seeded samples.
8. The sample size for the training set
- The document does not provide information on the sample size used for the training set. It focuses solely on the performance of the already-trained and developed algorithm.
9. How the ground truth for the training set was established
- The document does not describe how the ground truth for the training set was established. Information regarding the training data, annotation process, or expert involvement in labeling training data is not included in the provided text.
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May 4, 2023
BD Kiestra B.V. Karin Brands Manager Regulatory Affairs Marconilaan 6 Drachten, Frisia 9207 JC Netherlands
Re: K213280
Trade/Device Name: BD Kiestra Methicillin-resistant Staphylococcus aureus (MRSA) Application, BD Kiestra MRSA App Regulation Number: 21 CFR 866.2190 Regulation Name: Automated Image Assessment System For Microbial Colonies On Solid Culture Media Regulatory Class: Class II Product Code: QQY Dated: September 30, 2021 Received: October 1, 2021
Dear Karin Brands:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. 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
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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 Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Ribhi Shawar -S
Ribhi Shawar, Ph.D. (ABMM) Branch Chief, General Bacteriology and Antimicrobial Susceptibility Branch Division of Microbiology Devices OHT7: Office of In Vitro Diagnostics Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
510(k) Number (if known) K213280
Device Name
BD Kiestra™ Methicillin-resistant Staphylococcus aureus (MRSA) Application
Indications for Use (Describe)
The BD Kiestra™ Methicillin-resistant Staphylococcus aureus (MRSA) Application is an in-vitro diagnostic software program that requires the BD Kiestra™ Laboratory Automation Solution in order to operate.
The BD Kiestra™ Methicillin-resistant Staphylococcus aureus (MRSA) Application is applied to digital images of BD BBL™ CHROMagar™ MRSA II culture plates inoculated with anterior nares samples.
Algorithms are applied to digital images to provide a qualitative assessment of colony growth and colorimetric detection of target colonies for the detection of nasal colonization by MRSA and to serve as an aid in the prevention and control of MRSA infection. Applied algorithms provide the following results:
- "No growth", which will be manually released individually or as a batch (with other no growth samples) by . a trained microbiologist upon review of the digital plate images.
- . "Growth - other" (growth without mauve color), which digital plate images will be manually reviewed by a trained microbiologist.
- "Growth MRSA Mauve" (growth with mauve color), which digital plate images will be manually reviewed ● by a trained microbiologist.
The assay is not intended to guide, diagnose, or monitor treatment for MRSA infections. It is not intended to provide results of susceptibility to oxacillin/methicillin.
The BD Kiestra™ Methicillin-resistant Staphylococcus aureus (MRSA) Application is indicated for use in the clinical laboratory.
Type of Use (Select one or both, as applicable) □ Over-The Counter Use (21 CFR 801 Subpart C) 区 Prescription Use (Part 21 CFR 801 Subpart D)
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Image /page/3/Picture/0 description: The image shows the title of a document, which is a 510(k) Summary. The document is an application for the BD Kiestra system for Methicillin-resistant Staphylococcus aureus (MRSA). The BD logo is on the left side of the text.
510(k) Summary Preparation Date: 4 May 2023
Submitted by:
BD Kiestra BV Marconilaan 6 9207 JC Drachten The Netherlands
Contact:
Karin Brands Manager Regulatory Affairs Tel: +31 646 804 924 Email: Karin.brands(@bd.com
Proprietary Names: BD Kiestra™ Methicillin-resistant Staphylococcus aureus (MRSA) Application
Common Names:
BD Kiestra™ MRSA App MRSA App
Regulatory Information
Regulation section: Automated image assessment system for microbial colonies on solid 866.2190 culture media
Classification: Class II
Panel: Microbiology
Product Code(s): QQY
Predicate Device
APAS Independence with IC Chromogenic MRSA BD Analysis Module; APAS Independence with IC Chromogenic MRSA TFS/S Analysis Module, Clever Culture Systems AG
Device Establishment
BD Kiestra B.V. Marconilaan 6 9207 JC Drachten, The Netherlands Registration Number: 3010141591
Performance Standards
N/A
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Intended Use
The BD Kiestra™ Methicillin-resistant Staphylococcus aureus (MRSA) Application is an in-vitro diagnostic software program that requires the BD Kiestra™ Laboratory Automation Solution in order to operate.
The BD Kiestra™ Methicillin-resistant Staphylococcus aureus (MRSA) Application is applied to digital images of BD BBL™ CHROMagar™ MRSA II culture plates inoculated with anterior nares samples.
Algorithms are applied to digital images to provide a qualitative assessment of colony growth and colorimetric detection of target colonies to screen for nasal colonization by MRSA, and to serve as an aid in the prevention and control of MRSA infection. Applied algorithms provide the following results:
- "No growth", which will be manually released individually or as a batch (with other no growth . samples) by a trained microbiologist upon review of the digital plate images.
- . "Growth - other" (growth without mauve color), which digital plate images will be manually reviewed by a trained microbiologist.
- "Growth MRSA Mauve" (growth with mauve color), which digital plate images will be manually reviewed by a trained microbiologist.
The assay is not intended to guide, diagnose, or monitor treatment for MRSA infections. It is not intended to provide results of susceptibility to oxacillin/methicillin.
The BD Kiestra™ Methicillin-resistant Staphylococcus aureus (MRSA) Application is indicated for use in the clinical laboratory.
Special Conditions for Use Statement: For prescription use
Special Instrument Requirements: Integrated into the BD Kiestra™ Laboratory Automation Solution
Device Description
The BD Kiestra™ Methicillin-resistant Staphylococcus aureus (MRSA) Application will be optional for the BD Kiestra™ Laboratory Automation Solution and will support laboratory technologists in batching no growth on the BD BBL™ CHROMagar™ MRSA II, growth with no key colony color detected for MRSA ("Growth – other"), and growth with key colony color detected for MRSA ("Growth MRSA Mauve"). These classifications will be characterized as "no growth" and "growth with mauve color" from BD BBLTM CHROMagar™ MRSA II media, from anterior nares samples.
The technologist has the ability to create work lists in BD Synapsys™ informatics solution based on the classifications (growth, no growth or growth with mauve color). These work lists will be used for followup work and batching of results, at the sample level.
The BD Kiestra™ Methicillin-resistant Staphylococcus aureus (MRSA) Application will apply Image Algorithms to the digital images to determine if the plate contains "growth" or "no growth". At the individual plate level when the Image Algorithms detects colony growth and potential mauve color the classification will be "growth with mauve color".
When the BD Kiestra™ Methicillin-resistant Staphylococcus aureus (MRSA) Application is not capable of automatically generating the outputs (visual attributes: growth with or without mauve color/no
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growth), the laboratory technologist will be required to read the digital image of the plate on the computer screen and decide on follow-up action as is the current standard laboratory practice.
Test Principle
The BD Kiestra™ Methicillin-resistant Staphylococcus aureus (MRSA) Application will be used by trained laboratory technologists. Anterior nares specimens will be inoculated manually or automated by use of the BD Kiestra™ InoqulA+TM or the BD Kiestra™ InoqulA, which are part of the BD Kiestra™ Laboratory Automation Solution, onto BD BBLTM CHROMagar™ MRSA II plates.
The BD Kiestra™ InoqulA+™ or BD Kiestra™ Inoculates and streaks the specimen onto the BD BBL™ CHROMagar™ MRSA II plates. The plates are automatically transferred to the BD Kiestra™ ReadA™ Compact or BD Kiestra™ ReadA where they are incubated at 35°C in O2.
Following a short incubation period (typically 1.5 - 3.5 hours), the plate is imaged by the camera onboard the BD Kiestra™ ReadA™ Compact or BD Kiestra™ ReadA, to obtain a baseline image when no significant bacterial growth can be observed. By the 1.5 - 3.5 hours incubation time point, the plate temperature has reached the incubator temperature and condensation under the plate has dissipated, enabling a clear image of the media to serve as the reference image (T0). This T0 image is used as the baseline comparison for all subsequent images taken to ensure artifacts in the image are not considered growth and to evaluate differential contrast from growing colonies. At all timepoints, in order to maximize colony contrast to their background, the images include illumination from the top, side and bottom of the plate using black (top and side illumination) or white (bottom illumination) contrasting background.
The camera resides on the BD Kiestra™ ReadA™ Compact/BD Kiestra™ ReadA. When an image is scheduled to be taken, the plate is moved to the camera and a digital image is captured. The plate is immediately returned to its designated place, so the plate never leaves the BD Kiestra™ ReadA™ Compact/BD Kiestra™ ReadA. The plate is aligned each time an image is taken by utilizing the plate barcode for the alignment.
The camera produces raw data, pixel values, which are processed by the Optis Image Software resident on the BD Kiestra™ ReadA™ Compact/BD Kiestra™ ReadA. The BD Kiestra™ ReadA™ Compact/BD Kiestra™ ReadA software handles only the mechanical movements within the BD Kiestra™ ReadA™ Compact/BD Kiestra™ ReadA and interacts with the Image Software. The Image Software analyzes the plate pixel values to determine the optimal image acquisition sequence maximizing the signal to noise ratio and dynamic range. The image is further processed and corrections for chromatic aberrations and geometrical distortions are applied, which creates a high quality and normalized image.
Aside from the T0 baseline image time point (1.5 - 3.5 hours) and intermediate time point (10 - 14 hours), the imaging times are also set for at least one endpoint reading of 20 - 26 hours. Users can configure other time points in the BD Kiestra™ database manager, at the time of installation. Final incubation time is configured by the user based on the plated media formulation and the user's standard operation procedures. The BD Kiestra™ Methicillin-resistant Staphylococcus aureus (MRSA) Application compares each image to the corresponding baseline image for comparison for new growth and to rule out artifacts in the media such as dust or air bubbles, see Figure 1.
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Image /page/6/Picture/0 description: The image shows the text "510(k) Summary BD Kiestra™ Methicillin-resistant Staphylococcus aureus (MRSA) Application". The text is left-aligned and in a sans-serif font. The first line is slightly smaller than the second and third lines.
Baseline image showing artifacts such as ink jet printing, dust and frosted marker Figure 1:
Image /page/6/Picture/2 description: The image shows a petri dish with a clear agar medium. A piece of tape is on the top right of the dish. There is some text on the right side of the dish that says "LOT 5034358 201". The dish is sitting on a black surface.
The time series images are collected for each plate to allow for growth determination and the presence of mauve colored growth by the BD Kiestra™ Methicillin-resistant Staphylococcus aureus (MRSA) Application.
Based on these results, growth and mauve, the images can be sorted in order to streamline and optimize the reading workflow. Plates with no growth can be grouped in a batch list where the user can screen the proposed no growth results in a batch and report with one click. Images that show growth without any trace of mauve can be shown in a different list for single or batch evaluation, and the samples that show the presence of the mauve color will be shown in a separate list for review and further work up so that the user can prioritize those cases.
Patient demographics that are provided via the Laboratory Information System (LIS) can be used to further sort the results, through the user of user-defined expert rules.
The BD Kiestra™ Methicillin-resistant Staphylococcus aureus (MRSA) Application supports all features including reporting to the LIS by way of BD Synapsys™ informatics solution.
Substantial Equivalence1
Predicate Device Name: APAS Independence with IC Chromogenic MRSA BD Analysis Module; APAS Independence with IC Chromogenic MRSA TFS/S Analysis Module
Predicate 510(k) Number: K200839
1 The term "substantial equivalence" as used in this 510(k) notification is limited to the definition of substantial equivalence as found in the Federal Food, Drug and Cosmetic Act, as amended and as applied under which a device can be marketed without pre-market approval or reclassification. A determination of substantial equivalency under this not intended to have any bearing whatsoever on the resolution of patent infringement suits or any other patent matters. No statements related to, or in support of substantial equivalence herein shall be construed as an admission against interest under the US Patent Laws or the courts.
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Substantial Equivalence Comparison
| BD KiestraTM Methicillin-resistantStaphylococcus aureus (MRSA) ApplicationSubject of this 510(k) | APAS Independence with ICChromogenic MRSA BD AnalysisModule; APAS Independence with ICChromogenic MRSA TFS/S AnalysisModuleK200839 (Predicate Device) | |
|---|---|---|
| Device TradeName | BD KiestraTM Methicillin-resistantStaphylococcus aureus (MRSA) Application | APAS Independence with IC ChromogenicMRSA BD Analysis Module; APASIndependence with IC ChromogenicMRSA TFS/S Analysis Module |
| General Device Characteristic Similarities | ||
| Intended Use | BD KiestraTM Methicillin-resistantStaphylococcus aureus (MRSA) Application is anin vitro diagnostic system comprised ofinstruments (BD KiestraTM solution) and asoftware application for specific indications thatare used to automate imaging and interpretationof microbial colonies on plated media | The APAS Independence is in vitrodiagnostic system comprised of aninstrument and software analysis module(s)for specific indications that are used toautomate imaging and interpretation ofmicrobial colonies on plates of solidculture media. |
| Indications forUse | The BD KiestraTM Methicillin-resistantStaphylococcus aureus (MRSA) Application is anin-vitro diagnostic software program that requiresthe BD KiestraTM Laboratory AutomationSolution in order to operate.The BD KiestraTM Methicillin-resistantStaphylococcus aureus (MRSA) Application isapplied to digital images of BD BBLCHROMagar MRSA II culture plates inoculatedwith anterior nares samples.Algorithms are applied to digital images toprovide a qualitative assessment of colony growthand colorimetric detection of target colonies toscreen for nasal colonization by MRSA and toserve as an aid in the prevention and control ofMRSA infection. Applied algorithms provide thefollowing results:"No growth", which will be manuallyreleased individually or as a batch (with otherno growth samples) by a trainedmicrobiologist upon review of the digitalplate images."Growth – other" (growth without mauvecolor), which digital plate images will bemanually reviewed by a trainedmicrobiologist."Growth MRSA Mauve" (growth withmauve color), which digital plate images will | The APAS Independence is an in vitrodiagnostic system comprised of aninstrument for automated imaging of agarculture plates and a software analysismodule for the following use:1. The APAS Independence, when usingits IC MRSA Chromogenic BD analysismodule, automates culture plateimaging and interpretation to detect thepresence or absence of colonies withcolors suggestive of methicillin-resistant Staphylococcus aureus(MRSA) growth on Beckton DicksonBBLTM CHROMagarTM MRSA II agarthat has been inoculated with anteriornares swabs and incubated at 36°C ±1°C for 24 hours.The APAS Independence, when usingits IC MRSA Chromogenic BD analysismodule, provides an aid in routinescreening for colonization with MRSA.It provides one of two screening results:Presumptive MRSA or Negative. Allculture plates that are identified asPresumptive MRSA by the APASIndependence, when using the ICMRSA Chromogenic BD analysismodule require review by a trainedmicrobiologist.2. The APAS Independence, when usingits IC MRSA Chromogenic TFS/Sanalysis module, automates culture |
| BD KiestraTM Methicillin-resistantStaphylococcus aureus (MRSA) ApplicationSubject of this 510(k) | APAS Independence with ICChromogenic MRSA BD AnalysisModule; APAS Independence with ICChromogenic MRSA TFS/S AnalysisModuleK200839 (Predicate Device) | |
| be manually reviewed by a trainedmicrobiologist.The assay is not intended to guide, diagnose, ormonitor treatment for MRSA infections. It is notintended to provide results of susceptibility tooxacillin/methicillin.The BD KiestraTM Methicillin-resistantStaphylococcus aureus (MRSA) Application isindicated for use in the clinical laboratory. | plate imaging and interpretation todetect the presence or absence ofcolonies with colors suggestive ofmethicillin-resistant Staphylococcusaureus (MRSA) growth on Thermo-Fisher SpectraTM MRSA agar that hasbeen inoculated with anterior naresswabs and incubated at 36°C ± 1°C for24 hours.The APAS Independence, when usingits IC MRSA Chromogenic TFS/Sanalysis module, provides an aid inroutine screening for colonization withMRSA. It provides one of threescreening results: Presumptive MRSA,Presumptive non-MRSA, or Negative.All culture plates that are identified asPresumptive MRSA or Presumptivenon-MRSA by the APASIndependence, when using the ICMRSA Chromogenic TFS/S analysismodule, require review by a trainedmicrobiologist. | |
| Imaging Station | BD KiestraTM ReadA and the BD KiestraTMReadATM Compact are equipped with the imagingstation using Light Emitting Diode (LED)illumination of plated media and image captureusing High Speed CMOS Image Sensor camera | Light Emitting Diode (LED) illuminationof culture plates and image capture using aCharged Coupled Device (CCD) camera |
| Controller PC | BD KiestraTM ReadA and the BD KiestraTMReadATM Compact, has its own controller PC thatcontrols the image capturing and images storing | Control image capture, analysis, reportgeneration and result storage |
| Analysis Module | On the SCU a virtual server is hosted, on whichamongst others the APP (Plate Image Analyzerand Plate Algorithm libraries) are running. Theseservices process the images and meta data foranalysis. These results are sent to BD SynapsysTMinformatics solutionBD SynapsysTM informatics solution is installedon the BD KiestraTM Solution to provide userconfiguration of image visualization and userconfigurable workflow rules for imaging resultinterpretation. Results are sent to LIS by BDSynapsysTM informatics solution after beingmanually reviewed and released individually or as | Installed on the APAS Controller PC toprovide the configuration and instructionsfor image capture and analysis |
| BD Kiestra™ Methicillin-resistantStaphylococcus aureus (MRSA) ApplicationSubject of this 510(k) | APAS Independence with ICChromogenic MRSA BD AnalysisModule; APAS Independence with ICChromogenic MRSA TFS/S AnalysisModuleK200839 (Predicate Device) | |
| a batch by a trained microbiologist upon reviewof the digital plate images | ||
| Calibration | In order to keep the camera working optimally, inboth the BD Kiestra™ ReadA and the BDKiestra™ ReadA™ Compact, it is necessary forthe user to occasionally calibrate the camera whenalerted to do so and after cleaning. Calibrationneeds to be performed with BD providedcalibration plates. | Performed daily using a manufacturer-provided Color Check Tool |
| BiologicalQuality Control | Performed per BD BBL™ CHROMagar™MRSA II media package insert instructions. | Performed daily using standardizedsuspensions of Staphylococcus aureusATCC 43300 (MRSA positive strain) |
| General Device Characteristics Differences | ||
| Plate Handling | Automatic | Automated |
| InstrumentController PC | Provides the user interface for the BD Kiestra™Methicillin-resistant Staphylococcus aureus(MRSA) Application powered by BD Synapsys™informatics solution | Provides the user interface for the APASIndependence and controls plate movement |
| LaboratoryInformationSystem (LIS)Data import | Data import through BD Synapsys™ informaticssolution | Analysis result for each plate sent to theLIS. Sample ID details retrieved from theLIS |
| Result Reporting | Results are sent to LIS by BD Synapsys™informatics solution after being manuallyreviewed and released individually or as a batchby a trained microbiologist upon review of thedigital plate images. | Consists of software for image analysis andpresentation of reports. When APASIndependence with IC MRSAChromogenic BD analysis modulecompletes the analysis of each plate, theAPAS-generated result is sent to the LIS |
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Image /page/9/Picture/0 description: The image shows the BD logo. The logo consists of an orange circle with a white design inside, and the letters "BD" in blue. The design inside the circle looks like a stylized sun with rays emanating from the center.
Analytical Performance
Digital Quality Image Study
An internal digital image quality study was performed using simulated surveillance samples including MRSA, non-MRSA, and saline controls to show equivalency between a microbiologist interpreting a digital image and interpreting a plate manually (direct in hand).
Samples were plated on BD BBL™ CHROMagar™ MRSAII agar, incubated, and imaged using the BD Kiestra™ Laboratory Automation Solution. Digital images of the plates were acquired using the BD Kiestra™ ReadA Compact with 5 MP camera. Following image collection, three trained clinical microbiologists evaluated plates manually and from the digital image. Samples were randomized and readers did not have access to the direct plate when reading digital images. Results were categorized as
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mauve growth, non-mauve growth, or no growth. Manual plate results were compared to the digital image results to calculate overall percent agreement. Further stratification is provided by microbiologist.
Tables 1 - 5 summarize the study results.
Table 1: Spread of Results between Manual Plate Reading and Digital Image Reading
| MANUAL PLATE | |||||
|---|---|---|---|---|---|
| No Growth | Non-MauveGrowth | MauveGrowth | Total | ||
| DIGITAL IMAGE | No Growth | 148 | 2 | 1 | 151 |
| Non- MauveGrowth | 8 | 169 | 1 | 178 | |
| Mauve Growth | 3 | 1 | 188 | 192 | |
| Total | 159 | 172 | 190 | 521 | |
| Percent Agreement | 148/159(93.1%) | 169/172(98.3%) | 188/190(98.9%) |
Table 2: Microbiologist Manual Plate Reading Result (Percent Agreement) with Digital Image Reading Result
| No. ofResults | Percent Agreement1 | |||
|---|---|---|---|---|
| No Growth | Non-Mauve Growth | Mauve Growth | ||
| Microbiologist 1 | 174 | 48/51 (94.1%) | 56/58 (96.6%) | 64/65 (98.5%) |
| Microbiologist 2 | 172 | 49/55 (89.1%) | 55/55 (100%) | 61/62 (98.4%) |
| Microbiologist 3 | 175 | 51/53 (96.2%) | 58/59 (98.3%) | 63/63 (100%) |
| Combined | 521 | 148/159 (93.1%) | 169/172 (98.3%) | 188/190 (98.9%) |
1 Percent agreement determined by dividing number of digital image results by the number of the manual plate read results from the same microbiologist for each designation.
Table 3: Microbiologist 1 Manual Plate Reading Result with Digital Image Reading Result
| Microbiologist 1 | Manual Plate | ||||
|---|---|---|---|---|---|
| No Growth | Non-Mauve Growth | Mauve Growth | Total | ||
| Digital Image | No Growth | 48 | 2 | 0 | 59 |
| Non-Mauve Growth | 3 | 56 | 1 | 60 | |
| Mauve Growth | 0 | 0 | 64 | 64 | |
| Total | 51 | 58 | 65 | 174 | |
| No Growth Agreement: 94.1% (48/51) | |||||
| Non-Mauve growth Agreement: 96.6% (56/58) | |||||
| Mauve growth Agreement: 98.5% (64/65) |
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| Microbiologist 2 | Manual Plate | ||||
|---|---|---|---|---|---|
| No Growth | Non-MauveGrowth | Mauve Growth | Total | ||
| Digital Image | No Growth | 49 | 0 | 1 | 50 |
| Non-MauveGrowth | 4 | 55 | 0 | 59 | |
| Mauve Growth | 2 | 0 | 61 | 63 | |
| Total | 55 | 55 | 62 | 172 | |
| No Growth Agreement: | 89.1% (49/55) | ||||
| Non-Mauve growth Agreement: | 100.0% (55/55) | ||||
| Mauve growth Agreement: | 98.4% (61/62) |
Table 4: Microbiologist 2 Manual Plate Reading Result with Digital Image Reading Result
Table 5: Microbiologist 3 Manual Plate Reading Result with Digital Image Reading Result
| Microbiologist 3 | Manual Plate | ||||
|---|---|---|---|---|---|
| Digital Image | No Growth | Non-Mauve Growth | Mauve Growth | Total | |
| No Growth | 52 | 0 | 0 | 52 | |
| Non-Mauve Growth | 1 | 58 | 0 | 59 | |
| Mauve Growth | 1 | 1 | 63 | 65 | |
| Total | 53 | 59 | 63 | 175 | |
| No Growth Agreement: | 96.2% (51/53) | ||||
| Non-Mauve growth Agreement: | 98.3% (58/59) | ||||
| Mauve growth Agreement: | 100.0% (63/63) |
Digital Image Reproducibility
Results from the internal digital image quality study (Table 6 - 10) were used to evaluate reproducibility among a panel of microbiologists for the digital image read. Analysis was performed by comparing the microbiologist's interpretation to the final digital image result (determined by 2/3 majority microbiologist result) to calculate percent agreement.
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| Manual | |||||
|---|---|---|---|---|---|
| No Growth | Non-Mauve Growth | Mauve Growth | Total | ||
| DigitalImage | No Growth | 150 | 2 | 1 | 153 |
| Non-MauveGrowth | 0 | 175 | 0 | 175 | |
| Mauve Growth | 1 | 1 | 188 | 190 | |
| Total | 151 | 178 | 189 | 518 | |
| Percent Agreement | |||||
| 150/153 (98.0%) | 175/175 (100%) | 188/190 (98.9%) |
Table 6: Reproducibility of Digital Image Reading Results
Table 7: Microbiologist Reproducibility (Percent Agreement) with Digital Image Reading Result
| No. ofResults1 | Percent Agreement2 | |||
|---|---|---|---|---|
| No Growth | Non-MauveGrowth | Mauve Growth | ||
| Microbiologist 1 | 173 | 50/51 (98.0%) | 58/58 (100%) | 63/64 (98.4%) |
| Microbiologist 2 | 171 | 49/51 (96.1%) | 58/58 (100%) | 61/62 (98.4%) |
| Microbiologist 3 | 174 | 51/51 (100%) | 59/59 (100%) | 64/64 (100%) |
| Combined | 518 | 150/153 (98.0%) | 175/175 (100%) | 188/190 (98.9%) |
1 Three results were excluded from the reproducibility analysis since results from at least one microbiologist was determined to be invalid. 2 Percent agreement determined by dividial microbiologist digital read results by the number of panel digital image microbiologist results for each designation (i.e., "no growth", "non-mauve growth").
Table 8: Microbiologist 1 Reproducibility of Digital Image Reading Result
| Microbiologist 1 | Manual Read | ||||
|---|---|---|---|---|---|
| No Growth | Non-Mauve Growth | Mauve Growth | Total | ||
| DigitalImage | No Growth | 50 | 1 | 0 | 51 |
| Non-Mauve Growth | 0 | 58 | 0 | 58 | |
| Mauve Growth | 0 | 1 | 63 | 64 | |
| Total | 50 | 60 | 63 | 173 | |
| No Growth Agreement: | 98.0% (50/51) | ||||
| Non-Mauve GrowthAgreement: | 100% (58/58) | ||||
| Mauve Growth Agreement: | 98.4% (63/64) |
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| Microbiologist 2 | Manual Read | Total | |||
|---|---|---|---|---|---|
| No Growth | Non-MauveGrowth | MauveGrowth | |||
| Digital Image | No Growth | 49 | 1 | 1 | 51 |
| Non-MauveGrowth | 0 | 58 | 0 | 58 | |
| Mauve Growth | 1 | 0 | 61 | 62 | |
| Total | 50 | 59 | 62 | 171 | |
| No Growth Agreement: | 96.1% (49/51) | ||||
| Non-Mauve GrowthAgreement: | 100% (58/58) | ||||
| Mauve Growth Agreement: | 98.4% (61/62) |
Table 9: Microbiologist 2 Reproducibility of Digital Image Reading Result
Table 10: Microbiologist 3 Reproducibility of Digital Image Reading Result
| Microbiologist 3 | Manual Read | ||||
|---|---|---|---|---|---|
| NoGrowth | Non-MauveGrowth | MauveGrowth | Total | ||
| DigitalImage | No Growth | 51 | 0 | 0 | 51 |
| Non-Mauve Growth | 0 | 59 | 0 | 59 | |
| Mauve Growth | 0 | 0 | 64 | 64 | |
| Total | 51 | 59 | 64 | 174 | |
| No Growth Agreement: | 100.0% (51/51) | ||||
| Non-Mauve GrowthAgreement: | 100.0% (59/59) | ||||
| Mauve Growth Agreement: | 100.0% (64/64) |
Reproducibility
An internal reproducibility study was conducted with seeded samples representing MRSA positive (mauve) and MRSA negative (non-mauve) isolates. Seeded samples were created with saline using 18-24-hour bacterial strains on TSAII obtained from clinical and ATCC® strains. The Reproducibility Study was conducted at two internal sites at the BD Sparks, MD location with two different automated systems. A panel of 7 simulated clinical nares samples (5 mauve and 2 non-mauve) as well as saline control samples (expected no growth) were evaluated including the following:
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Mauve
Staphylococcus aureus methicillin resistant (Collection: POS 9246, Source: clinical) Staphylococcus aureus methicillin resistant (Collection: POS 3890, Source: ATCC® 43300™) Staphylococcus aureus methicillin resistant (Collection: POS 8161, Source: clinical) Staphylococcus aureus methicillin resistant (Collection: POS 8214, Source: clinical) Staphylococcus aureus methicillin resistant (Collection: POS 10575, Source: clinical)
Non-Mauve
Staphylococcus haemolyticus (Collection: POS 3441, Source: clinical) Staphylococcus haemolyticus (Collection: POS 8113, Source: clinical)
The samples were plated on BD BBL™ CHROMagar™ MRSAII media. Four dilutions were prepared for each strain in saline at dilutions of 1 × 102, 1-5 × 104, and 0 CFU/mL (saline). The following table shows the results per site and organism:
| Seededorganism | Dilution | Site 1001Growth | Site 1001Color | Site 4002Growth | Site 4002Color | CombinedGrowth(95% CI) | CombinedColor(95% CI) |
|---|---|---|---|---|---|---|---|
| N/A (Saline) | 0 | 99.6%(1029/1033) | 99.6%(1029/1033) | 99.7%(1053/1056) | 99.7%(1053/1056) | 99.7%(2082/2089)(99.3%, 99.8%) | 99.7%(2082/2089)(99.3%, 99.8%) |
| 10^2 | 100.0%(55/55) | 100.0%(55/55) | 100.0%(45/45) | 100.0%(45/45) | 100.0%(100/100)(96.3%, 100.0%) | 100.0%(100/100)(96.3%, 100.0%) | |
| MRSASTAAUEPOS 10575 | 10^3 | 100.0%(45/45) | 100.0%(45/45) | 100.0%(45/45) | 100.0%(45/45) | 100.0%(90/90)(95.9%, 100.0%) | 100.0%(90/90)(95.9%, 100.0%) |
| 10^4 | 100.0%(75/75) | 100.0%(75/75) | 100.0%(73/73) | 100.0%(73/73) | 100.0%(148/148)(97.5%, 100.0%) | 100.0%(148/148)(97.5%, 100.0%) | |
| 10^2 | 100.0%(35/35) | 100.0%(35/35) | 100.0%(45/45) | 100.0%(45/45) | 100.0%(80/80)(95.4%, 100.0%) | 100.0%(80/80)(95.4%, 100.0%) | |
| MRSASTAAUEATCC 43300 | 10^3 | 100.0%(59/59) | 100.0%(59/59) | 100.0%(60/60) | 100.0%(60/60) | 100.0%(119/119)(96.9%, 100.0%) | 100.0%(119/119)(96.9%, 100.0%) |
| 10^4 | 100.0%(60/60) | 100.0%(60/60) | 100.0%(55/55) | 100.0%(55/55) | 100.0%(115/115)(96.8%, 100.0%) | 100.0%(115/115)(96.8%, 100.0%) | |
| MRSA | 10^2 | 100.0%(60/60) | 100.0%(60/60) | 100.0%(59/59) | 100.0%(59/59) | 100.0%(119/119)(96.9%, 100.0%) | 100.0%(119/119)(96.9%, 100.0%) |
| STAAUE | 10^3 | 100.0%(45/45) | 100.0%(45/45) | 100.0%(45/45) | 100.0%(45/45) | 100.0% (90/90)(95.9%, 100.0%) | 100.0% (90/90)(95.9%, 100.0%) |
| POS 8161 | 10^4 | 100.0%(75/75) | 100.0%(75/75) | 100.0%(90/90) | 100.0%(90/90) | 100.0%(165/165)(97.7%, 100.0%) | 100.0%(165/165)(97.7%, 100.0%) |
| MRSASTAAUEPOS 8214 | 10^2 | 100.0%(50/50) | 100.0%(50/50) | 100.0%(35/35) | 100.0%(35/35) | 100.0%(85/85)(95.7%, 100.0%) | 100.0%(85/85)(95.7%, 100.0%) |
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| Seededorganism | Dilution | Site 1001Growth | Site 1001Color | Site 4002Growth | Site 4002Color | CombinedGrowth(95% CI) | CombinedColor(95% CI) |
|---|---|---|---|---|---|---|---|
| 10^3 | 100.0%(59/59) | 100.0%(59/59) | 100.0%(59/59) | 100.0%(59/59) | 100.0%(118/118)(96.8%, 100.0%) | 100.0%(118/118)(96.8%, 100.0%) | |
| 10^4 | 100.0%(45/45) | 100.0%(45/45) | 100.0%(45/45) | 100.0%(45/45) | 100.0%(90/90)(95.9%, 100.0%) | 100.0%(90/90)(95.9%, 100.0%) | |
| 10^2 | 100.0%(40/40) | 100.0%(40/40) | 100.0%(45/45) | 100.0%(45/45) | 100.0%(85/85)(95.7%, 100.0%) | 100.0%(85/85)(95.7%, 100.0%) | |
| MRSASTAAUEPOS 9246 | 10^3 | 100.0%(45/45) | 100.0%(45/45) | 100.0%(45/45) | 100.0%(45/45) | 100.0%(90/90)(95.9%, 100.0%) | 100.0%(90/90)(95.9%, 100.0%) |
| 10^4 | 100.0%(45/45) | 100.0%(45/45) | 100.0%(45/45) | 100.0%(45/45) | 100.0%(90/90)(95.9%, 100.0%) | 100.0%(90/90)(95.9%, 100.0%) | |
| 10^2 | 100.0%(25/25) | 100.0%(25/25) | 100.0%(30/30) | 100.0%(30/30) | 100.0%(55/55)(93.5%, 100.0%) | 100.0%(55/55)(93.5%, 100.0%) | |
| S. haemolyticusSTAHAEPOS 3441 | 10^3 | 88.9% (40/45) | 88.9% (40/45) | 100.0%(45/45) | 100.0%(45/45) | 94.4%(85/90)(87.6%, 97.6%) | 94.4%(85/90)(87.6%, 97.6%) |
| 10^4 | 100.0%(45/45) | 100.0%(45/45) | 100.0%(45/45) | 100.0%(45/45) | 100.0%(90/90)(95.9%, 100.0%) | 100.0%(90/90)(95.9%, 100.0%) | |
| 10^2 | 100.0%(40/40) | 100.0%(40/40) | 97.8% (40/40) | 97.8% (40/40) | 100.0%(80/80)(95.4%, 100.0%) | 100.0%(80/80)(95.4%, 100.0%) | |
| S. haemolyticusSTAHAEPOS 8113 | 10^3 | 100.0%(45/45) | 100.0%(45/45) | 100.0%(45/45) | 100.0%(45/45) | 100.0%(90/90)(95.9%, 100.0%) | 100.0%(90/90)(95.9%, 100.0%) |
| 10^4 | 100.0%(45/45) | 100.0%(45/45) | 100.0%(45/45) | 100.0%(45/45) | 100.0%(90/90)(95.9%, 100.0%) | 100.0%(90/90)(95.9%, 100.0%) |
Average Mauve CFU Diameter When First Detected
To determine the average CFU diameter of a mauve colony when first detected, an unlocked version of the application (Not available for commercial use) was used to process digital images of plates with MRSA isolates in 1-hour increments starting at hour 2 and ending at hour 22. These images were then evaluated by 3 microbiologists to measure the diameter of the mauve colonies at first detection by the application. A total of 857 CFUs were evaluated throughout the full 22-hour incubation time.
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Testing included:
- 3 MRSA isolates × 5 replicates per dilution × 2 dilutions ●
- 1 media type (BD BBL™ CHROMagar™ MRSAII media) evaluated ●
- total of 30 plates evaluated using images collected every hour from 2-22 hours of incubation (30 plates × 21 images per plate = approximately 630 images)
The following table shows the average mauve CFU diameter when first detected:
| Strainname | ReferenceNumber | BD TestMedia | TrackedCFU count | Average Mauve CFU Diameter(mm) When First Detected | Mauve CFU Diameter WhenFirst Detected StandardDeviation (mm) |
|---|---|---|---|---|---|
| MRSA 1 | ATCC® 43300TM | CHROMMRSAII | 277 | 0.42 | 0.12 |
| MRSA 2 | ATCC® 33591TM | CHROMMRSAII | 236 | 0.38 | 0.10 |
| MRSA 3 | POS3679* | CHROMMRSAII | 344 | 0.39 | 0.09 |
*Internal reference number
Clinical Performance Studies
Approximately 1,800 clinical anterior nares specimens were plated, incubated, and imaged on the BD Kiestra™ Laboratory Automation Solution at three clinical sites. To establish performance of the MRSA app, the images were manually read by trained microbiologists at those sites for the following requirements:
- "No growth" .
- . "Growth - other" (growth without mauve color)
- "Growth MRSA Mauve"
Clinical anterior nares specimens were plated and incubated in air (O2) for 24 hours on BD BBL™ CHROMagar™ MRSA II media. The Percent Agreement for each interpretation are listed in the following table:
| No Growth | Non-MauveGrowth | Mauve Growth | Grand Total | ||
|---|---|---|---|---|---|
| BD KiestraTMMRSA App | No Growth | 773 | 9 | 1 | 784 |
| Non-MauveGrowth | 237 | 207 | 5 | 456 | |
| Mauve Growth | 13 | 29 | 319 | 369 | |
| Grand Total | 1023 | 245 | 325 | 1593 | |
| No Growth Percent Agreement 75.6% (773/1023)Non-Mauve Percent Agreement: 84.5% (207/245)Mauve Percent Agreement: 98.2% (319/325) |
§ 866.2190 Automated image assessment system for microbial colonies on solid culture media.
(a)
Identification. An automated image assessment system for microbial colonies on solid culture media is a system that is intended to assess the presence or absence of microbial colonies on solid microbiological culture medium, and to interpret their number, and phenotypic and morphologic characteristics through analysis of two dimensional digital images as an aid in diagnosis of infectious disease.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Premarket notification submissions must include a detailed description of the device, including the technology employed, components and software modules, as well as a detailed explanation of the result algorithms and any expert rules that are used to assess colony characteristics and enumerate colonies from image capture through end result.
(2) Premarket notification submissions must include detailed documentation of the analytical studies performed to characterize device performance to support the intended use, as appropriate.
(3) Premarket notification submissions must include detailed documentation from clinical studies performed on a population that is consistent with the intended use population.
(i) The clinical studies must establish the device performance based on comparison to results obtained by an acceptable reference method, as appropriate.
(ii) The clinical study documentation must include the study protocol with a predefined statistical analysis plan and the final report documenting support for the Indications for Use and the results of the statistical analysis, as appropriate.
(4) Premarket notification submissions must include detailed documentation for device software, including but not limited to software applications and hardware based components that incorporate software, and any decision-making thresholds used to generate results for the device. If a part of a Total Laboratory Automation System, the premarket notification submission must include detailed documentation addressing the instrument and software system integration.
(5) Premarket notification submissions must include detailed documentation of appropriate instructions for use regarding the intended user's device quality control procedures for the instrument system and components, as appropriate.
(6) The 21 CFR 809.10 compliant device labeling must include:
(i) Detailed user instructions to mitigate the risk of failure to operate the instrument correctly.
(ii) A detailed explanation of the interpretation of results and limitations regarding the need for review of culture plates by a qualified microbiologist, as appropriate.
(iii) A summary of performance data obtained from the analytical studies used to support device performance, as appropriate.
(iv) A summary of performance data obtained from clinical studies performed on a population that is consistent with the intended use population, as appropriate.
(7) Under 21 CFR 820.30 compliant design control, device manufacturers must, as appropriate:
(i) Conduct human factors/usability validation testing with the final version of the labeling and related materials to adequately mitigate the risk of failure to operate the instrument correctly.
(ii) Document a device training program that will be offered to the end user to adequately mitigate the risk of failure to operate the instrument correctly.