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.

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

The VITEK® 2 AST Cards are essentially miniaturized versions of the doubling dilution technique for determining the minimum inhibitory concentration (MIC) microdilution methodology.

The isolate to be tested is diluted to a standardized concentration in 0.45 - 0.50% saline before being used to rehydrate the antimicrobial medium within the card. The VITEK® 2 automatically fills, seals and places the card into the incubator/reader. The VITEK® 2 COMPACT has a manual filling and sealing operation. The VITEK® 2 monitors the growth of each well in the card over a defined period of time (up to 18 hours). At the completion of the incubation cycle, a report is generated that contains the MIC value along with the interpretive category result for each antimicrobial contained on the card.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study details for the VITEK® 2 AST-Yeast Micafungin device, based on the provided text:

Acceptance Criteria and Device Performance

Criteria	Acceptance Standard (as per FDA Guidance Document: Antimicrobial Susceptibility Test (AST) Systems)	Reported Device Performance
Overall Essential Agreement (EA)	Not explicitly stated as a numerical threshold in the document, but "acceptable performance" is implied by the reported value.	98.9%
Overall Category Agreement (CA)	Not explicitly stated as a numerical threshold in the document, but "acceptable performance" is implied by the reported value.	96.6%
Reproducibility and Quality Control (QC)	"Acceptable results"	Demonstrated acceptable results

Study Details

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

The document mentions "fresh and stock clinical isolates, as well as a set of challenge strains." However, the exact sample size (number of isolates or cases) used for the test set is not provided in the text.
Data Provenance: The study involved an "external evaluation," implying data was collected from various sources, likely clinical laboratories. The country of origin is not specified, but the review is by the US FDA, suggesting data may be from the US or otherwise internationally relevant for US market approval. The data includes both retrospective (stock clinical isolates) and potentially prospective (fresh clinical isolates) components.

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

Not applicable / Not explicitly stated. The ground truth was established by a reference method (CLSI broth microdilution), not by human expert consensus or interpretation of the device results.

4. Adjudication method for the test set:

Not applicable. Since the ground truth was established by a reference method (CLSI broth microdilution), there was no need for expert adjudication of the ground truth for the test set. The device's results were directly compared to the reference method.

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:

No. This is an Antimicrobial Susceptibility Test (AST) device, an in vitro diagnostic (IVD) intended for automated measurement of MIC values. It is not an AI-assisted diagnostic imaging or interpretation device that would involve human readers or assess improvement with AI assistance.

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

Yes. The VITEK® 2 AST-Yeast Micafungin system is an automated device designed to determine antifungal susceptibility. The study compared its performance directly against a reference method (CLSI broth microdilution), indicating a standalone performance evaluation of the device's algorithm and system.

7. The type of ground truth used:

Reference method: The ground truth was established using the CLSI broth microdilution reference method, which is a widely accepted standard for antimicrobial susceptibility testing.

8. The sample size for the training set:

Not provided. The document describes a performance evaluation of the device but does not detail the development or training of any underlying algorithms. It's possible the device uses pre-calibrated methods rather than a machine learning model that requires a distinct "training set" in the traditional sense, or this information was not deemed necessary for the 510(k) summary.

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

Not applicable / Not provided. As the training set size is not given, the method for establishing its ground truth is also not described. If statistical methods are used for calibration, those would implicitly rely on data for which the ground truth (established by a reference method) is known.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

March 25, 2016

BIOMERIEUX, INC. CHERECE JONES STAFF REGULATORY AFFAIRS SPECILAIST 595 ANGLUM ROAD HAZELWOOD MO 63042

Re: K151923

Trade/Device Name: Vitek 2 AST-Yeast Micafungin (0.06-8 ug/ml) Regulation Number: 21 CFR 866.1640 Regulation Name: Antimicrobial Susceptibility Test Powder Regulatory Class: II Product Code: NGZ, LRG, LTT, LTW Dated: March 7, 2016 Received: March 8, 2016

Dear Ms. Jones:

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 Parts 801 and 809); medical device reporting (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.

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If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

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) K151923

Device Name VITEK® 2 AST-Yeast Micafungin (0.06 - 8 ug/mL)

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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510(k) SUMMARY

VITEK® 2 AST AST-YS Micafungin

A. 510(k) Submission Information:

Submitter's Name:	bioMérieux, Inc.
Address:	595 Anglum RoadHazelwood, MO 63042
Contact Person:	Cherece JonesStaff Regulatory Affairs Specialist
Phone Number:	314-731-8684
Fax Number:	314-731-8689
Date of Preparation:	February 5, 2016
Device Name:
Formal/Trade Name:	VITEK® 2 AST-Yeast Micafungin (0.06 - 8µg/mL)
Classification Name:	21 CFR 866.1640Antimicrobial susceptibility test powderProduct Code NGZ
Common Name:	VITEK® 2 AST-YS Micafungin
Predicate Device:	VITEK® 2 AST-YS Flucytosine (K133952)

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 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

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Candida parapsilosis Candida tropicalis

The VITEK® 2 Antimicrobial Susceptibility Test (AST) is intended to be used with the VITEK® 2 System 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.

The antimicrobial presented in VITEK® 2 AST-YS Cards is in concentrations equivalent by efficacy to standard method concentrations in mcg/ml. The VITEK® 2 AST Cards are essentially miniaturized versions of the doubling dilution technique for determining the minimum inhibitory concentration (MIC) microdilution methodology.

VITEK® 2 AST-YS Micafungin demonstrated substantially equivalent performance when compared with the CLSI broth microdilution reference method, as defined in the FDA Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems; Guidance for Industry and FDA, Issued August 28, 2009.

This 510(k) presents data in support of VITEK® 2 AST-YS Micafungin. An external evaluation was conducted with fresh and stock clinical isolates, as well as a set of challenge strains. The external evaluations were designed to confirm the acceptability of VITEK® 2 AST-YS Micafungin by comparing its performance with the CLSI broth microdilution reference method incubated at 24 hrs. The data is representative of performance on both the VITEK®2 and VITEK® 2 COMPACT instrument platforms. VITEK® 2 AST-YS Micafungin demonstrated acceptable performance of 98.9% for overall Essential Agreement and 96.6% for overall Category Agreement for Candida species. Reproducibility and Quality Control demonstrated acceptable results.

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).