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 growing aerobic 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 ceftazidime/avibactam at concentrations of 0.25/4 to 64/4 ug/mL to the test panel.

The gram-negative organisms which may be used for ceftazidime/avibactam susceptibility testing in this panel are:

Citrobacter freundii complex, Citrobacter koseri, Enterobacter cloacae, Escherichia coli, Klebsiella oxytoca. Klebsiella pneumoniae, Morganii, Proteus mirabilis. Pseudomonas aeruginosa. Providencia rettgeri, Providencia stuartii, and Serratia marcescens

Device Description

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

This document describes the validation of Beckman Coulter's MicroScan Dried Gram-Negative MIC/Combo Panels with Ceftazidime/Avibactam for determining antimicrobial susceptibility.

Here's a breakdown of the acceptance criteria and study details based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document uses "Essential Agreement" as the primary performance metric. While specific numerical acceptance criteria (e.g., "must be at least X%") are not explicitly stated as a separate line item, the reported values are presented as demonstrating "acceptable performance" compared to an FDA guidance document.

Acceptance Criteria (Implied)	Reported Device Performance
Overall Essential Agreement (Enterobacteriaceae) required to be acceptable per FDA guidance	95%
Overall Essential Agreement (Pseudomonas aeruginosa) required to be acceptable per FDA guidance	96.3%
Reproducibility and Precision with different inoculum methods (Turbidity or Prompt™) and instruments (autoSCAN-4 or WalkAway)	Acceptable
Quality Control testing	Acceptable

Note: The document states the performance was compared with CLSI frozen Reference Panel, as defined in an FDA guidance document. This implies the acceptable thresholds are those outlined in that guidance, though they are not explicitly listed in this summary.

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

Sample Size (Test Set): Not explicitly stated with a single numerical value. The "external evaluations" were conducted with "fresh and stock Efficacy isolates and stock Challenge strains." However, the number of these isolates is not provided in this summary.
Data Provenance: Not explicitly stated. The document refers to "external evaluations," but does not specify the country of origin of the data or whether the study was retrospective or prospective. Given the context of a 510(k) submission, it's highly likely to be prospective clinical and/or simulated data, but this is not confirmed.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not provided in the document. The ground truth is established by a "CLSI frozen Reference panel," which is a laboratory standard rather than human expert consensus.

4. Adjudication Method for the Test Set

This information is not applicable as the ground truth is established by a "CLSI frozen Reference panel" and not through human experts requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

A multi-reader multi-case (MRMC) comparative effectiveness study was not conducted. This is a study for an in vitro diagnostic device, not an imaging device requiring human reader interpretation. The device is designed to determine antimicrobial susceptibility, which is a direct measurement against a reference, not an interpretation task where human readers would improve with AI assistance.

6. Standalone Performance

Yes, standalone performance was done. The study directly compares the MicroScan Dried Gram-Negative MIC/Combo Panels' performance against a CLSI frozen Reference panel. This is effectively the algorithm/device's performance without human-in-the-loop assistance for the susceptibility reading itself, although humans operate the device and interpret the results against clinical breakpoints. The "Essential Agreement" values represent this standalone performance. The document states panels are "read either visually or with MicroScan instrumentation," indicating the device itself generates the MIC values.

7. Type of Ground Truth Used

The ground truth used was a CLSI frozen Reference Panel. This is a laboratory standard for antimicrobial susceptibility testing, considered the definitive method against which new methods are compared.

8. Sample Size for the Training Set

The document does not mention a training set or its sample size. This type of device (an antimicrobial susceptibility test panel) is not typically "trained" like a machine learning algorithm for image analysis. Instead, its performance is validated through comparison to a well-established reference method, ensuring it consistently and accurately measures antimicrobial susceptibility.

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

As there is no mention of a training set, this information is not applicable.

Summary

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December 15, 2017

Beckman Coulter, Inc. Teresa Wong Senior Regulatory Analyst 1584 Enterprise Blvd. West Sacramento, California 95691

Re: K172337

Trade/Device Name: MicroScan Dried Gram Negative MIC/Combo Panels with Ceftazidime/Avibactam (0.25/4 - 64/4 ug/mL) Regulation Number: 21 CFR 866.1640 Regulation Name: Antimicrobial susceptibility test powder Regulatory Class: Class II Product Codes: LTT. JWY. LRG. LTW Dated: August 1, 2017 Received: August 2, 2017

Dear Teresa Wong:

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

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Part 820); 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 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

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Indications for Use

510(k) Number (if known) K172337

Device Name

MicroScan Dried Gram-Negative MIC/Combo Panels with Ceftazidime/Avibactam (0.25/4 - 64/4 µg/mL)

Indications for Use (Describe)

This particular submission is for the antimicrobial ceftazidime/avibactam at concentrations of 0.25/4 to 64/4 ug/mL to the test panel.

The gram-negative organisms which may be used for ceftazidime/avibactam susceptibility testing in this panel are:

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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510(k) Summarv

510(k) Submission Information:

Device Manufacturer:	Beckman Coulter
Contact name:	Teresa Wong, Senior Analyst Regulatory Affairs
Phone:	916-374-2432
Fax:	916-374-2119
Date prepared:	October 27, 2017
Product Name:	Microdilution Minimum Inhibitory Concentration (MIC) Panels
Trade Name:	MicroScan Dried Gram-Negative MIC/Combo Panels with Ceftazidime/Avibactam(0.25/4 – 64/4 µg/mL)
Intended Use:	To determine antimicrobial agent susceptibility
Classification:	Class II
Product Code:	LTT
510(k) Notification:	New antimicrobial agent - Ceftazidime/Avibactam
Predicate device:	MicroScan Dried Gram-Negative MIC/Combo Panels - Imipenem (K162740)

510(k) Summary:

The proposed MicroScan Dried Gram-Negative MIC/Combo Panel demonstrated substantially equivalent performance when compared with an 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 ceftazidime/avibactam.

The external evaluations were conducted with fresh 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 95% for Enterobacteriaceae and 96.3% for Pseudomonas aeruginosa when using our most common inoculum and read method for ceftazidime/avibactam when compared with the frozen Reference panel.

Inoculum and instrument reproducibility testing demonstrated acceptable reproducibility and precision with ceftazidime/avibactam, 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 ceftazidime/avibactam.

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

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).