VITEK® 2 AST-Gram Negative Minocycline 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 Minocycline is a quantitative test. Minocycline 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: Acinetobacter spp.
Klebsiella (Enterobacter) aerogenes Escherichia coli Klebsiella spp.

The VITEK® 2 Gram-negative Susceptibility Card is intended for use with the VITEK® 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of clinically significant aerobic Gram-negative bacilli to antimicrobial agents when used as instructed.

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

Based on the provided text, here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria (from FDA Guidance Document)	Reported Device Performance (VITEK® 2 AST-GN Minocycline)
Overall Essential Agreement (EA) with CLSI broth microdilution reference method	97.0%
Overall Category Agreement (CA) with CLSI broth microdilution reference method	93.7%
Reproducibility and Quality Control results	Acceptable

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The text states an "external evaluation was conducted with fresh and stock clinical isolates, as well as a set of challenge strains." While it doesn't provide a specific numerical sample size for the test set, it indicates the types of strains used.

The data provenance is not explicitly mentioned regarding the country of origin. However, the use of "fresh and stock clinical isolates" suggests a prospective or a mix of prospective and retrospective collection of clinical samples. "Challenge strains" are typically laboratory-prepared or well-characterized strains used for validation.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This section is not applicable as the device (VITEK® 2 AST-GN Minocycline) is an automated system for antimicrobial susceptibility testing, and the ground truth is established by a reference laboratory method (CLSI broth microdilution), not by human experts interpreting images or assay results in a subjective manner.

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

This section is not applicable. Adjudication methods like 2+1 or 3+1 are typically used when multiple human readers are involved in subjective interpretation, and disagreements need to be resolved. In this case, the reference method (CLSI broth microdilution) provides a quantitative result, and the device's performance is compared directly to it, not through a process of expert adjudication.

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

This section is not applicable. The VITEK® 2 AST-GN Minocycline is an automated antimicrobial susceptibility testing system. It determines susceptibility without human interpretation in the loop in the same way a human reader would. Therefore, a multi-reader, multi-case study comparing human readers with and without AI assistance is not relevant for this type of device.

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

Yes, a standalone performance evaluation was done. The VITEK® 2 AST-GN Minocycline is described as a "Fully Automated Short-Term Incubation Cycle Antimicrobial Susceptibility System." The study explicitly compares its performance (97.0% Essential Agreement, 93.7% Category Agreement) directly against the CLSI broth microdilution reference method. This comparison assesses the algorithm's performance in isolation from human intervention in the interpretation process.

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

The ground truth used was the CLSI broth microdilution reference method, which is a widely accepted laboratory standard for determining minimum inhibitory concentrations (MICs) of antimicrobials. This is a quantitative, laboratory-based measurement.

8. The sample size for the training set

The text does not explicitly state the sample size for the training set. It only mentions the "external evaluation" for performance testing. Typically, information about training sets for medical devices, particularly those with complex algorithms, is detailed more extensively in the full submission, but it's not present in this summary.

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

The text does not explicitly state how the ground truth for the training set was established. Assuming a similar methodology to the test set, it would likely involve the CLSI broth microdilution reference method. However, without specific information, this remains an assumption. The summary focuses on the validation study's ground truth.

Summary

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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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Image /page/1/Picture/0 description: The image shows the logo for bioMérieux. The logo is a circle with a blue top half and a gradient green bottom half. The word "BIOMÉRIEUX" is written in white, sans-serif font in the center of the blue portion of the circle.

510(k) SUMMARY

VITEK® 2 AST-GN Minocycline

510(k) Submission Information:

Submitter's Name:	bioMérieux, Inc.
Address:	595 Anglum RoadHazelwood, MO 63042
Contact Person:	Craig BuehlerSr. Regulatory Affairs Specialist
Phone Number:	314-731-8358
Fax Number:	314-731-8689
Date of Preparation:	December 19, 2018
Formal/Trade Name:	VITEK® 2 AST- GN Minocycline (≤ 0.5 – ≥ 32µg/mL)
Classification Name:	21 CFR 866.1645Fully Automated Short-Term Incubation CycleAntimicrobial Susceptibility SystemProduct Code LON
Common Name:	VITEK® 2 AST-GN Minocycline
Predicate Device:	VITEK® 2 AST-GN Amikacin (K172731)

D. 510(k) Summary:

Active in vitro and in clinical infections: Acinetobacter spp.

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Klebsiella (Enterobacter) aerogenes Escherichia coli Klebsiella spp.

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 Minocycline 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 Minocycline. 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 Minocycline by comparing its performance with the CLSI broth microdilution reference method incubated at 16-20 hours (20-24 hours for Acinetobacter species). The data is representative of performance on both the VITEK® 2 and VITEK® 2 Compact instrument platforms. VITEK® 2 AST-GN Minocycline demonstrated acceptable performance of 97.0% overall Essential Agreement and 93.7% overall Category Agreement with the reference method. Reproducibility and Quality Control demonstrated acceptable results.

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March 7, 2019

bioMérieux, Inc. Craig Buehler Sr. Regulatory Affairs Specialist 595 Anglum Road Hazelwood, Missouri 63042

Re: K183551

Trade/Device Name: VITEK 2 AST-Gram Negative Minocycline (< 0.5 -> 32 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 19, 2018 Received: December 20, 2018

Dear Craig Buehler:

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, 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

§ 866.1645 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.”