VITEK® 2 Yeast Micafungin is designed for antifungal susceptibility testing of Candida species. VITEK® 2 Yeast Micafungin is a quantitative test intended for use with the VITEK® 2 COMPACT Systems as a laboratory aid in the determination of in vitro susceptibility to antimicrobial agents. VITEK® 2 Yeast Micafungin has been shown to be active against most isolates of the microorganisms listed below, according to the FDA label for this antifungal.

Active in vitro and clinical infections:

Candida albicans
Candida glabrata Candida guilliermondii
Candida krusei
Candida parapsilosis
Candida tropicalis

The VITEK @ 2 Antimicrobial Susceptibility Test (AST) is intended to be used with the VITEK® 2 Systems for the automated quantitative or qualitative susceptibility testing of isolated colonies for the most clinically significant aerobic gram-negative bacilli, Staphylococcus spp., Enterococcus spp., Streptococcus spp., S. pneumoniae, and clinically significant yeast.

Device Description

AI/ML Overview

The provided text describes a Special 510(k) Device Modification for the VITEK 2 AST-YS Micafungin, which involves changing the expected Quality Control (QC) range for the QC organism C. parapsilosis ATCC 22019. It focuses on the regulatory approval process rather than a detailed study comparing device performance against acceptance criteria in a clinical setting for diagnostic accuracy.

Therefore, many of the requested elements for describing "acceptance criteria and the study that proves the device meets the acceptance criteria" in terms of algorithm performance or clinical utility are not applicable or not provided in this document. The focus of this document is a modification to a QC range, which ensures the reliability of the test itself, not its diagnostic accuracy in patients.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Original QC Range)	Reported Device Performance (New QC Range)	Notes
Expected QC range for C. parapsilosis ATCC 22019: 0.5-2 µg/mL	Expected QC range for C. parapsilosis ATCC 22019: 0.25-1 µg/mL	This is a modification to the acceptance criteria (specifically, the QC range) based on a CLSI M23 study. The validation for this new range demonstrated "acceptable performance during risk assessment validation studies." The document does not provide specific performance metrics (e.g., accuracy, sensitivity, specificity, or reproducibility rates) against these ranges.

2. Sample size used for the test set and the data provenance:

Sample size: Not specified. The document mentions a "completed CLSI M23 study" but does not provide details on the number of isolates or replicates used in this study to establish the new QC range.
Data provenance: Not specified (e.g., country of origin, retrospective or prospective).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not Applicable. This document concerns a change in a QC range for an Antimicrobial Susceptibility Test (AST) device, not a diagnostic device where expert ground truth on patient samples would typically be established. The "ground truth" here is the established and validated range for a specific QC organism based on a standardized protocol (CLSI M23).

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not Applicable. Adjudication methods are typically used in clinical studies involving interpretation of images or other subjective data by multiple readers. This document describes a QC range modification for an automated AST device, which relies on objective measurements.

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:

Not Applicable. This is not an AI-assisted diagnostic device, nor does it involve human readers interpreting results in a MRMC study context.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Partially Applicable. The VITEK 2 system is an automated AST device. The "algorithm" here refers to the system's ability to accurately determine susceptibility based on its internal processes and calibrated ranges. The document states that "Validation of the modified QC range and QC performance with the modified range has now been established," implying standalone performance verification for the device with the new QC range. However, no specific performance metrics (e.g., categorical agreement, essential agreement) of this standalone performance are provided in this summary.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

The "ground truth" for establishing the QC range is derived from standardized laboratory testing protocols (CLSI M23) using a reference QC organism (C. parapsilosis ATCC 22019). This involves multiple replications of testing under controlled conditions to determine the consistent susceptibility range of the QC organism to the antimicrobial agent (micafungin).

8. The sample size for the training set:

Not Applicable / Not Provided. This document does not pertain to an algorithm that requires a "training set" in the context of machine learning or AI. The CLSI M23 study would involve a study set to establish the new range, but it's not a "training set" in the computational sense. The size of this study set is not specified.

9. How the ground truth for the training set was established:

Not Applicable / Not Provided. As noted above, there's no "training set" in the computational sense. The "ground truth" for the QC range was established through a "completed CLSI M23 study" which provides a standardized methodology for determining acceptable QC ranges for AST devices.

In summary, this regulatory submission focuses on a modification to an existing device's quality control parameters, rather than a de novo clinical validation study of a diagnostic device's accuracy. The "study" mentioned is a "CLSI M23 study" that established a new expected QC range for a specific organism.

Summary

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June 20, 2018

bioMerieux, Inc. Jolyn Tenllado Regulatory Affairs Expert 595 Anglum Rd. Hazelwood, Missouri 63042

Re: K181368

Trade/Device Name: VITEK 2 AST-YS Micafungin (≤0.06 - ≥8 µg/mL) Regulation Number: 21 CFR 866.1640 Regulation Name: Antimicrobial susceptibility test powder Regulatory Class: Class II Product Code: NGZ, LRG, LTT, LTW Dated: May 22, 2018 Received: May 23, 2018

Dear Jolyn Tenllado:

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 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) K181368

Device Name

VITEK® 2 AST-YS Micafungin (≤0.06 ->8 ug/mL)

Indications for Use (Describe)

Active in vitro and clinical infections:

Candida albicans
Candida glabrata Candida guilliermondii
Candida krusei
Candida parapsilosis
Candida tropicalis

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) SUMMARY

VITEK 2 AST-YS Micafungin Special 510(k): Device Modification

510(k) Submission Information:

Submitter's Name:	bioMérieux, Inc.
Address:	595 Anglum RoadHazelwood, MO 63042
Contact Person:	Jolyn TenlladoRA Expert, Global Regulatory Affairs Microbiology
Phone Number:	314-731-8386
Fax Number:	314-731-8689
Date of Preparation:	May 22, 2018
B. Device Name:
Formal/Trade Name:	VITEK 2 AST-Yeast Micafungin (≤0.06 – ≥8 µg/mL)
Classification Name:	Fully Automated Short-Term Incubation CycleAntimicrobial Susceptibility Device, 21 CFR 866.1645
Common Name:	VITEK 2 AST-YS Micafungin
C. Predicate Device:	VITEK 2 AST-YS Micafungin (K151923)

D. 510(k) Summary:

VITEK® 2 Yeast Micafungin is designed for antifungal susceptibility testing of Candida species. VITEK® 2 Yeast Micafungin is a quantitative test intended for use with the VITEK® 2 and VITEK® 2 COMPACT Systems as a laboratory aid in the determination of in vitro susceptibility to antimicrobial aqents. VITEK® 2 Yeast Micafungin has been shown to be active against most isolates of the microorganisms listed below, according to the FDA label for this antifungal.

Active in vitro and clinical infections: Candida albicans Candida qlabrata Candida quilliermondii Candida krusei Candida parapsilosis Candida tropicalis

The VITEK® 2 Antimicrobial Susceptibility Test (AST) is intended to be used with the VITEK® 2 Systems for the automated quantitative susceptibility testing of isolated colonies for the most clinically significant aerobic gram-negative bacilli, Staphylococcus spp., Enterococcus spp., Streptococcus spp., S. pneumoniae, and clinically significant yeast.

bioMérieux, Inc.

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The intended use of the VITEK 2 AST-YS Micafungin, as described in its labeling (package insert), has not changed as a result of this modification to change the expected QC range for QC organism C. parapsilosis ATCC 22019 from 0.5-2 µg/mL to 0.25-1 µg/mL based on a completed CLSI M23 study to establish the new QC range. This modification does not affect the fundamental scientific technology of this device. The device design was not altered in any way.

The VITEK 2 AST-YS Micafungin modified device, to change the QC organism C. parapsilosis ATCC 22019 expected QC range from 0.5-2 µg/mL to 0.25-1 µg/mL, demonstrated acceptable performance during risk assessment validation studies. Validation of the modified QC range and QC performance with the modified range has now been established. This Special 510(k) Device Modification presents data in support of the VITEK AST-YS Micafungin QC organism expected range change, and corresponding labeling changes, allowing a substantial equivalence decision when compared with the VITEK 2 AST-YS Micafungin unmodified device cleared under K151923.

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).