VITEK® 2 AST-Gram Negative Delafloxacin is designed for antimicrobial susceptibility testing of Gram Negative bacilli and is 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 AST-Gram Negative Delafloxacin is a quantitative test. Delafloxacin has been shown to be active against most strains of the microorganisms listed below, according to the FDA label for this antimicrobial.

Active in vitro and in clinical infections: Enterobacter cloacae Escherichia coli Klebsiella pneumoniae Pseudomonas aeruginosa

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. 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

This document describes the validation of the VITEK® 2 AST-GN Delafloxacin system for antimicrobial susceptibility testing.

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Acceptance Criteria and Device Performance

Metric	Acceptance Criteria (from FDA Class II Special Controls Guidance Document)	Reported Device Performance
Overall Essential Agreement	Not explicitly stated as a percentage, but implied acceptable.	98.0%
Overall Category Agreement	Not explicitly stated as a percentage, but implied acceptable.	95.9%
Reproducibility	Acceptable	Demonstrated Acceptable
Quality Control	Acceptable	Demonstrated Acceptable

Note: The document refers to the FDA Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems (Issued August 28, 2009) as defining the essential and category agreement requirements, but the specific percentage thresholds are not included in this extract. The reported performance is stated as "demonstrated acceptable performance" against this guidance.

Study Design and Data Details

Sample Size used for the Test Set and the Data Provenance:
- Test Set Sample Size: Not explicitly stated as a numerical value, but the evaluation included "fresh and stock clinical isolates, as well as a set of challenge strains."
- Data Provenance: Not specified regarding country of origin. The study was an "external evaluation," and it included "fresh and stock clinical isolates." This suggests the data is likely retrospective (stock clinical isolates) and potentially prospective (fresh clinical isolates) if collected specifically for this study. The document does not specify if the data was from a single geographical region or multiple.
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 document. The ground truth was established by comparison to a reference method, not by expert consensus on individual cases.
Adjudication Method for the Test Set:
- None in the context of human expert adjudication. The "adjudication" was inherently built into the comparison with the CLSI broth microdilution reference method. Discrepancies would be analyzed against this gold standard.
If a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done:
- No, this was not an MRMC study. This device is an automated antimicrobial susceptibility testing system, not an AI-assisted diagnostic tool for human readers. Therefore, the concept of human readers improving with AI assistance does not apply.
If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, in essence. The study evaluated the VITEK® 2 AST-GN Delafloxacin system's performance (which is an automated system/algorithm) against a reference laboratory method (CLSI broth microdilution). The performance metrics (Essential Agreement, Category Agreement) directly reflect the device's accuracy in determining MIC values and interpretive categories. Human intervention is limited to sample preparation and loading, not interpretation of raw data for diagnosis.
The Type of Ground Truth Used:
- The ground truth was established using the CLSI broth microdilution reference method, incubated at 16-20 hours. This is a well-established and accepted reference standard in microbiology for determining minimum inhibitory concentrations (MICs) of antimicrobials.
The Sample Size for the Training Set:
- This information is not provided in the document. The VITEK® 2 system is a mature technology, and its underlying AST methodology likely has a long history of development and "training" on vast amounts of microbial data to establish its algorithms for growth detection and MIC determination. This specific submission focuses on the validation of Delafloxacin on this existing platform, implying the core AST algorithm was already established.
How the Ground Truth for the Training Set was established:
- This information is not provided in the document. Similar to point 7, the "training" of the VITEK® 2 system's core AST methodology would have involved extensive historical data and comparisons to reference methods like CLSI broth microdilution to develop its algorithms.

Summary

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March 12, 2019

bioMerieux, Inc. Esther Hernandez Regulatory Affairs Specialist 595 Anglum Road Hazlewood, Missouri 63042

Re: K183524

Trade/Device Name: VITEK2 AST-Gram Negative Delafloxacin (≤0.06 - ≥4 ug/mL) Regulation Number: 21 CFR 866.1645 Regulation Name: Fully automated short-term incubation cycle antimicrobial susceptibility system Regulatory Class: Class II Product Code: LON, LTW, LTT Dated: December 18, 2018 Received: December 19, 2018

Dear Ms. Hernandez:

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 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR

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for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 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,

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)

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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VITEK® 2 AST-GN Delafloxacin Traditional 510(k) Submission

510(k) SUMMARY

VITEK® 2 AST-GN Delafloxacin

510(k) Submission Information:

Submitter's Name:	bioMérieux, Inc.
Address:	595 Anglum RoadHazelwood, MO 63042
Contact Person:	Esther HernandezRegulatory Affairs Specialist
Phone Number:	314 -731-8841
Fax Number:	314-731-8689
Date of Preparation:	December 19, 2018
B. Device Name:
Formal/Trade Name:	VITEK® 2 AST- GN Delafloxacin (≤ 0.06 – ≥ 4ug/mL)
Classification Name:	21 CFR 866.1645Fully Automated Short-Term Incubation CycleAntimicrobial Susceptibility SystemProduct Code LON
Common Name:	VITEK® 2 AST-GN Delafloxacin
C. Predicate Device:	VITEK® 2 AST-GN Amikacin (K172731)

D. 510(k) Summary:

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VITEK® 2 AST-GN Delafloxacin Traditional 510(k) Submission

Active in vitro and in clinical infections: Enterobacter cloacae Escherichia coli Klebsiella pneumoniae Pseudomonas aeruginosa

The antimicrobial presented in VITEK® 2 AST-GN 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-GN Delafloxacin 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).

The Premarket Notification (510[k]) presents data in support of VITEK® 2 AST-GN Delafloxacin. 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-GN Delafloxacin by comparing its performance with the CLSI broth microdilution reference method incubated at 16-20 hours. The data is representative of performance on both the VITEK® 2 and VITEK® 2 Compact instrument platforms. VITEK® 2 AST-GN Delafloxacin demonstrated acceptable performance of 98.0% overall Essential Agreement and 95.9% overall Category Agreement with the reference method. Reproducibility and Ouality Control demonstrated acceptable results.

Regulation Number and Section

§ 866.1645 Fully automated short-term incubation cycle antimicrobial susceptibility system.

(a)
Identification. A fully automated short-term incubation cycle antimicrobial susceptibility system is a device that incorporates concentrations of antimicrobial agents into a system for the purpose of determining in vitro susceptibility of bacterial pathogens isolated from clinical specimens. Test results obtained from short-term (less than 16 hours) incubation are used to determine the antimicrobial agent of choice to treat bacterial diseases.(b)
Classification. Class II (special controls). The special control for this device is FDA's guidance document entitled “Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems; Guidance for Industry and FDA.”