(128 days)
The MicroScan Dried Gram-Negative MIC/Combo Panel is used to determine quantitative and/or qualitative antimicrobial agent susceptibility of colonies grown on solid media of rapidly and facultative anaerobic gram-negative bacilli. After inoculation, panels are incubated for 16 - 20 hours at 35°C +/ - 1°C in a non-CO2 incubator, and read either visually or with MicroScan instrumentation, according to the Package Insert. This particular submission is for the antimicrobial ceftolozane/tazobactam at concentrations of 0.25/4 to 16/4 ug/mL to the test panel.
Ceftolozane/azobactam has been shown to be active both clinically and in vitro against the following organisms: Enterobacter cloacae, Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, and Pseudomonas aeruginosa
In vitro data is available for the following organisms, but their clinical significance is unknown: Citrobacter koseri, Morganii, Proteus vulgaris, Providencia retteeri, Providencia stuartii, Serratia liquefaciens, and Serratia marcescens
MicroScan Dried Gram-Neqative MIC/Combo Panels are designed for use in determining quantitative and/or qualitative antimicrobial agent susceptibility of colonies grown on solid media of rapidly growing aerobic and facultative anaerobic gram-negative bacilli.
The antimicrobial susceptibility tests are miniaturizations of the broth dilution susceptibility test that have been diluted in broth and dehydrated. Various antimicrobial agents are diluted in broth to concentrations bridging the range of clinical interest. Panels are rehydrated with water after inoculation with a standardized suspension of the organism. After incubation in a non-CO2 incubator for 16-20 hours, the minimum inhibitory concentration (MIC) for the test organism is read by determining the lowest antimicrobial concentration showing inhibition of growth.
This document describes the premarket notification (510(k)) for the MicroScan Dried Gram-Negative MIC/Combo Panels with Ceftolozane/Tazobactam. Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the MicroScan Dried Gram-Negative MIC/Combo Panel with Ceftolozane/Tazobactam are based on "Essential Agreement" (EA) with a CLSI frozen Reference Panel. While a specific numerical threshold for "acceptable performance" from the guidance document is not explicitly stated in this summary, it's implied that the achieved 92.8% EA is considered acceptable.
| Acceptance Criteria (from "Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems; Guidance for Industry and FDA") | Reported Device Performance (MicroScan Dried Gram-Negative MIC/Combo Panel with Ceftolozane/Tazobactam) |
|---|---|
| Aspirational Goal: Overall Essential Agreement (EA) of ≥ 90% (based on standard AST guidance for new antimicrobial agents) with a CLSI frozen Reference Panel. | 92.8% Essential Agreement (EA) |
| Acceptable reproducibility and precision for inoculum and instrument testing. | Demonstrated acceptable reproducibility and precision. |
| Acceptable Quality Control results. | Demonstrated acceptable Quality Control results. |
2. Sample Size Used for the Test Set and Data Provenance
The exact sample size (number of isolates) for the test set is not explicitly stated in the provided summary. However, it mentions:
- Data Provenance: The external evaluations were conducted with:
- "fresh, recent and stock Efficacy isolates"
- "stock Challenge strains"
- This suggests a mix of clinical (retrospective or prospective depending on "recent") and curated laboratory strains.
- The country of origin is not specified, but typically, these studies are conducted in the country where the device is being submitted for approval (e.g., USA for FDA submission).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. For antimicrobial susceptibility testing, the "ground truth" is typically established by the CLSI frozen Reference Panel, which is itself a standardized and highly quality-controlled method. The "experts" in this context are the trained laboratory personnel performing the reference method, rather than "experts" in specific specialties like radiologists.
4. Adjudication Method for the Test Set
This information is not provided in the document. For AST, adjudication as described (e.g., 2+1) is typically not applicable as the reference method (CLSI frozen panel) is considered the gold standard, and the device's results are compared directly to it. Discrepant results would likely be retested rather than adjudicated by multiple expert readers.
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 Multi-Reader Multi-Case (MRMC) comparative effectiveness study is not applicable and was not done for this device. This device is an automated in vitro diagnostic for determining antimicrobial susceptibility, not an AI-assisted diagnostic imaging or interpretation tool that assists human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, a standalone performance evaluation was completed. The device, MicroScan Dried Gram-Negative MIC/Combo Panels with Ceftolozane/Tazobactam, is an automated system (though it can also be read visually) that performs the susceptibility test independent of human interpretation for the primary results. The performance is assessed by comparing its output (MIC values) directly to the CLSI frozen Reference Panel.
7. The Type of Ground Truth Used
The type of ground truth used is a CLSI frozen Reference Panel. This is a recognized gold standard method for antimicrobial susceptibility testing, providing quantitative Minimum Inhibitory Concentration (MIC) values.
8. The Sample Size for the Training Set
The document does not explicitly mention a "training set" as this is not a machine learning or AI-based diagnostic device in the contemporary sense. The "training" of such a device generally refers to the initial development and optimization of the reagent formulations and reading algorithms (if applicable) against known strains, but the specific sample sizes for such internal development are not typically reported in regulatory summaries like this. The data presented here ("external evaluations") would be considered the validation or test set.
9. How the Ground Truth for the Training Set Was Established
As no explicit "training set" is mentioned in the context of machine learning, this question is not directly applicable. However, the foundational methods for establishing ground truth in AST (whether for development or validation) rely on established microbiological techniques, primarily the broth microdilution method as standardized by the Clinical and Laboratory Standards Institute (CLSI). This involves precise preparation of antimicrobial dilutions and bacterial inoculums, followed by incubation and visual determination of the lowest concentration inhibiting visible growth.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
December 1, 2017
Beckman Coulter, Inc Shannon Popson Staff Regulatory Affairs 1584 Enterprise Blvd West Sacramento, CA 95691
Re: K172255
Trade/Device Name: MicroScan Dried Gram Negative MIC/Combo Panels with Ceftolozane/tazobactam (0.25/4 - 16/4 ug/mL) Regulation Number: 21 CFR 866.1640 Regulation Name: Antimicrobial susceptibility test powder Regulatory Class: Class II Product Code: LTT, LRG, JWY Dated: July 25, 2017 Received: July 26, 2017
Dear Ms. Popson:
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. 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 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
{1}------------------------------------------------
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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/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
For
Uwe Scherf, M.Sc., Ph.D. Director Division of Microbiology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
Indications for Use
510(k) Number (if known) K172255
Device Name
MicroScan Dried Gram-Negative MIC/Combo Panels with Ceftolozane/Tazobactam (0.25/4 - 16/4 µg/mL)
Indications for Use (Describe)
The MicroScan Dried Gram-Negative MIC/Combo Panel is used to determine quantitative and/or qualitative antimicrobial agent susceptibility of colonies grown on solid media of rapidly and facultative anaerobic gram-negative bacilli. After inoculation, panels are incubated for 16 - 20 hours at 35°C +/ - 1°C in a non-CO2 incubator, and read either visually or with MicroScan instrumentation, according to the Package Insert. This particular submission is for the antimicrobial ceftolozane/tazobactam at concentrations of 0.25/4 to 16/4 ug/mL to the test panel.
Ceftolozane/azobactam has been shown to be active both clinically and in vitro against the following organisms: Enterobacter cloacae, Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, and Pseudomonas aeruginosa
In vitro data is available for the following organisms, but their clinical significance is unknown: Citrobacter koseri, Morganii, Proteus vulgaris, Providencia retteeri, Providencia stuartii, Serratia liquefaciens, and Serratia marcescens
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | |
| Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{3}------------------------------------------------
Image /page/3/Picture/0 description: The image shows the logo for Beckman Coulter. The logo consists of a red circular symbol on the left, with two curved white lines inside. To the right of the symbol is the text "BECKMAN" in bold, followed by "COULTER" in a larger, bolder font. The text is black.
510(k) Summarv
510(k) Submission Information:
| Device Manufacturer: | Beckman Coulter |
|---|---|
| Contact name: | Shannon Popson, Staff Regulatory Affairs |
| Phone: | 916-374-3330 |
| Fax: | 916-374-2119 |
| Date prepared: | October 23, 2017 |
| Product Name: | Microdilution Minimum Inhibitory Concentration (MIC) Panels |
| Trade Name: | MicroScan Dried Gram-Negative MIC/Combo Panels with Ceftolozane/Tazobactam(0.25/4 — 16/4 µg/mL) |
| Intended Use: | To determine antimicrobial agent susceptibility |
| Classification: | Class II |
| Product Code: | LTT |
| 510(k) Notification: | New antimicrobial agent - Ceftolozane/Tazobactam |
| Predicate device: | MicroScan Dried Gram-Negative MIC/Combo Panels - Imipenem (K162740) |
510(k) Summary:
MicroScan Dried Gram-Neqative MIC/Combo Panels are designed for use in determining quantitative and/or qualitative antimicrobial agent susceptibility of colonies grown on solid media of rapidly growing aerobic and facultative anaerobic gram-negative bacilli.
The antimicrobial susceptibility tests are miniaturizations of the broth dilution susceptibility test that have been diluted in broth and dehydrated. Various antimicrobial agents are diluted in broth to concentrations bridging the range of clinical interest. Panels are rehydrated with water after inoculation with a standardized suspension of the organism. After incubation in a non-CO2 incubator for 16-20 hours, the minimum inhibitory concentration (MIC) for the test organism is read by determining the lowest antimicrobial concentration showing inhibition of growth.
The proposed MicroScan Dried Gram-Negative MIC/Combo Panel demonstrated substantially equivalent performance when compared with a CLSI frozen Reference Panel, as defined in the FDA document " Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems; Guidance for Industry and FDA", dated August 28, 2009. The Premarket Notification (510[k]) presents data in support of the MicroScan Dried Gram-Negative MIC/Combo Panel with ceftolozane/tazobactam.
The external evaluations were conducted with fresh, recent and stock Efficacy isolates and stock Challenge strains. The external evaluations were designed to confirm the acceptability of the proposed Dried Gram-Negative Panel by comparing its performance with a CLSI frozen Reference panel. The Dried Gram-Negative Panel demonstrated acceptable performance with an overall Essential Agreement of 92,8% for ceftolozane/ tazobactam when compared with the frozen Reference panel.
Inoculum and instrument reproducibility testing demonstrated acceptable reproducibility and precision with ceftolozane/tazobactam, regardless of which inoculum method (i.e., Turbidity or Prompt™), or instrument (autoSCAN-4 instrument or WalkAway system) was used.
Quality Control testing demonstrated acceptable results for ceftolozane/tazobactam.
Beckman Coulter, the stylized logo, MicroScan, and WalkAway are trademarks of Beckman Coulter and the stylized logo are registered with the USPTO.
Prompt™ is a trademark of 3M Company, St. Paul, MN USA
§ 866.1640 Antimicrobial susceptibility test powder.
(a)
Identification. An antimicrobial susceptibility test powder is a device that consists of an antimicrobial drug powder packaged in vials in specified amounts and intended for use in clinical laboratories for determining in vitro susceptibility of bacterial pathogens to these therapeutic agents. Test results are used to determine the antimicrobial agent of choice in the treatment of bacterial diseases.(b)
Classification. Class II (performance standards).