MicroScan Dried Gram-Negative 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-neqative 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 acceptance criteria and study detailed in the provided text:

Acceptance Criteria and Device Performance

1. Table of Acceptance Criteria and Reported Device Performance:

Performance Metric	Acceptance Criteria (Implicit)	Reported Device Performance
Essential Agreement (EA) for Eravacycline	Acceptable Performance (CLSI defined)	96.8%
Inoculum Reproducibility	Acceptable Reproducibility	Acceptable
Instrument Reproducibility	Acceptable Reproducibility	Acceptable
Quality Control (QC) Testing	Acceptable Results	Acceptable

Note: The document states that the device 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." This FDA guidance document would contain the explicit, quantitative acceptance criteria for Essential Agreement, which the 96.8% met.

2. Sample Size Used for the Test Set and Data Provenance:

Sample Size: The exact number of isolates used in the external evaluations is not explicitly stated. However, the text mentions "fresh, recent and stock Efficacy isolates and stock Challenge strains."
Data Provenance: The data was collected from "external evaluations." The country of origin is not specified, nor is whether the data was retrospective or prospective. Given the nature of an antimicrobial susceptibility test, it's highly likely to involve prospective testing of isolates.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:

Number of Experts: This information is not provided in the document for the establishment of the ground truth.
Qualifications of Experts: This information is not provided in the document.

4. Adjudication Method for the Test Set:

The document does not describe an adjudication method for establishing the ground truth. The comparison is made against a "CLSI frozen Reference Panel," which inherently serves as the reference standard. This suggests that the reference panel itself is the gold standard, rather than a process of expert adjudication for each test.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No, an MRMC comparative effectiveness study was not done. The study focuses on the performance of the automated device (MicroScan Dried Gram-Negative MIC/Combo Panels) against a reference standard (CLSI frozen Reference Panel), not on comparing human readers with and without AI assistance. The text explicitly refers to "MicroScan Dried Gram-Negative MIC/Combo Panels" as the "proposed" device, indicating it's an automated system.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

Yes, a standalone study was performed. The study assessed the performance of the "MicroScan Dried Gram-Negative MIC/Combo Panels" in determining Minimum Inhibitory Concentrations (MICs). This panel is an automated device designed to yield results without human intervention in the interpretation of the MICs. The comparison is against a CLSI reference panel, which is the standard for standalone device evaluation.

7. The Type of Ground Truth Used:

CLSI Frozen Reference Panel. The ground truth was established by a "CLSI frozen Reference Panel." The Clinical and Laboratory Standards Institute (CLSI) sets the gold standard for antimicrobial susceptibility testing, and their reference panels are widely accepted as reliable ground truth in this field.

8. The Sample Size for the Training Set:

Not Applicable / Not Provided. The document describes a performance evaluation of a device, not the development or training of an AI algorithm in the traditional sense. Therefore, there is no mention of a "training set" for an AI model. This device is a pre-programmed diagnostic tool, not a machine learning model that requires a training phase.

9. How the Ground Truth for the Training Set Was Established:

Not Applicable / Not Provided. As there is no mention of a training set for an AI algorithm, the method for establishing its ground truth is not relevant to this document.

Summary

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Image /page/0/Picture/0 description: The image shows the logo for Beckman Coulter. The logo consists of a red circular graphic on the left, with two curved white lines inside. To the right of the graphic are the words "BECKMAN" in bold, followed by "COULTER" in a larger, bold font on the line below. The text is black.

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:	January 22, 2019
Product Name:	Microdilution Minimum Inhibitory Concentration (MIC) Panels
Trade Name:	MicroScan Dried Gram-Negative MIC/Combo Panels with Eravacycline (ERV) (0.016-32 µg/mL)
Intended Use:	To determine antimicrobial agent susceptibility
Classification:	Class II
Product Code:	LTT
510(k) Notification:	New antimicrobial agent - Eravacycline
Predicate device:	MicroScan Dried Gram-Negative MIC/Combo Panels Ceftazidime/Avibactam -(K172337)

510(k) Summary:

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 eravacycline.

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 96.8% for eravacycline when compared with the frozen Reference panel.

Inoculum and instrument reproducibility testing demonstrated acceptable reproducibility and precision with eravacycline, 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 eravacycline.

Beckman Coulter, 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

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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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April 18, 2019

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

Re: K190109

Trade/Device Name: MicroScan Dried Gram Negative MIC/Combo Panels with Eravacycline (ERV) (0.016-32 ug/mL) Regulation Number: 21 CFR 866.1640 Regulation Name: Antimicrobial susceptibility test powder Regulatory Class: Class II Product Code: JWY, LTT, LRG, LTW Dated: January 22, 2019 Received: January 23, 2019

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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

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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 (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 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

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).