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.

AI/ML Overview

Here's an analysis of the provided text, focusing on the acceptance criteria and study data for the Beckman Coulter MicroScan Dried Gram Negative MIC/Combo Panels with Meropenem/Vaborbactam:

The document describes the Beckman Coulter MicroScan Dried Gram Negative MIC/Combo Panels with Meropenem/Vaborbactam (0.03/8-64/8µg/mL), a device intended for determining antimicrobial agent susceptibility. The device is classified as Class II and operates by rehydrating dried antimicrobial agent dilutions with a standardized suspension of the organism, incubating for 16-20 hours, and then reading the minimum inhibitory concentration (MIC).

Acceptance Criteria and Reported Device Performance

The core acceptance criterion for the device's performance is "Essential Agreement" when compared to a CLSI frozen Reference Panel. While a specific numerical target for Essential Agreement is not explicitly stated as an "acceptance criterion" in a table format, the document clearly states that the device "demonstrated substantially equivalent performance" and "acceptable performance with an overall Essential Agreement of 98.3%." This implies that the observed 98.3% Essential Agreement met the internal or regulatory threshold for acceptability.

Acceptance Criteria	Reported Device Performance (Meropenem/Vaborbactam)
Essential Agreement	98.3%

Note: The document also mentions "acceptable reproducibility and precision" for inoculum and instrument testing (using Turbidity or Prompt® inoculum methods and autoSCAN-4 or WalkAway systems), and "acceptable results" for Quality Control testing for meropenem/vaborbactam. While these are important aspects of device performance, the primary comparative performance metric explicitly stated against a reference panel is Essential Agreement.

Study Details

Sample size used for the test set and the data provenance:
- Test Set Description: The external evaluations were conducted with "fresh, recent and stock Efficacy isolates and stock Challenge strains."
- Sample Size: The exact sample size for the test set (number of isolates or strains) is not explicitly stated in the provided text.
- Data Provenance: The document does not specify the country of origin of the data. The data appears to be prospective in the sense that the evaluations were designed to confirm acceptability of the proposed panel, rather than analyzing existing archived data.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided in the text. The ground truth is established by a "CLSI frozen Reference panel," which implies a standardized laboratory method, not expert interpretation.
Adjudication method for the test set:
- This information is not applicable/provided. The method relies on a single, standardized reference panel (CLSI frozen Reference Panel) for comparison, not a multi-reader adjudication process.
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:
- No, an MRMC comparative effectiveness study was not done. This device is an Antimicrobial Susceptibility Test (AST) system, which determines the MIC of an antibiotic against bacteria, not an AI-powered diagnostic imaging or interpretation tool for human readers. Therefore, the concept of human readers improving with or without AI assistance does not apply.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- This device essentially functions as a standalone algorithm/system in its primary determination of MICs. While human operators are involved in setting up the test and reading the results (or loading into an automated reader), the "performance" described (Essential Agreement) is that of the device itself in comparison to a reference standard, not a human-in-the-loop scenario. There's no AI component mentioned as an 'algorithm'.
The type of ground truth used:
- The ground truth used for comparison is a CLSI frozen Reference Panel. This represents a standardized, established laboratory method for determining antimicrobial susceptibility, considered the gold standard for comparison in AST device evaluations.
The sample size for the training set:
- This information is not provided in the text. The concept of a "training set" typically applies to machine learning or AI models. This document describes a traditional in-vitro diagnostic device, and while there would have been internal development data, it's not described in terms of "training sets" as it would be for an AI device.
How the ground truth for the training set was established:
- This information is not provided and is likely not applicable in the context of this type of device and its evaluation as described. The ground truth for comparative evaluation was the CLSI frozen Reference Panel.

Summary

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Indications for Use

510(k) Number (if known)

Device Name

Indications for Use (Describe)

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)

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February 12, 2019

Beckman Coulter, Inc. Elaine Duncan Senior Analyst Regulatory Affairs 1584 Enterprise Blvd. West Sacramento, California 95691

Re: K183127

Trade/Device Name: MicroScan Dried Gram Negative MIC/Combo Panels with Meropenem/Vaborbactam (0.03/8-64/8μg/mL) Regulation Number: 21 CFR 866.1640 Regulation Name: Antimicrobial susceptibility test powder Regulatory Class: Class II Product Code: LTT, JWY, LRG, LTW Dated: November 12, 2018 Received: November 13, 2018

Dear Elaine Duncan:

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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's

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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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-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.

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

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510(k) Summarv

510(k) Submission Information:

Device Manufacturer:	Beckman Coulter
Contact name:	Elaine Duncan, Senior Analyst Regulatory Affairs
Phone:	916-374-3279
Fax:	916-374-2480
Date prepared:	November 02, 2018
Product Name:	Microdilution Minimum Inhibitory Concentration (MIC) Panels
Trade Name:	MicroScan Dried Gram-Negative MIC/Combo Panels with Meropenem/Vaborbactam(0.03/8-64/8 µg/mL)
Intended Use:	To determine antimicrobial agent susceptibility
Classification:	Class II
Product Code:	LTT
510(k) Notification:	New antimicrobial agent – Meropenem/Vaborbactam
Predicate device:	MicroScan Dried Gram-Negative MIC/Combo Panels Ceftazidime/Avibactam –(K172337)

510(k) Summary:

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 meropenem/vaborbactam.

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 98.3% for meropenem/vaborbactam when compared with the frozen Reference panel.

Inoculum and instrument reproducibility testing demonstrated acceptable reproducibility and precision with meropenem/vaborbactam, 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 meropenem/vaborbactam.

Beckman Coutter, the stylized logo, and the Beckman Coulter product and service marks or registered trademarks of Beckman Coulter, Inc. in the United States and other countries,

is a registered trademark of 3M Company, St. Paul, MN USA

Regulation Number and Section

§ 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).