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

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 (20-24 hours for Streptococi and 16-20 hours for Staphylococci and Enterococci). 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

The provided text describes the VITEK® 2 AST-Gram Positive Dalbavancin (≤0.015 - ≥1 µg/mL) device, which is an antimicrobial susceptibility testing system.

Here's the breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance:

The primary performance metric provided is "Overall Performance (with the reference method)" which is broken down into Essential Agreement (EA), Category Agreement (CA), and specific types of errors (VME, ME, mE).

Metric	Acceptance Criteria (Implied by FDA Guidance)	Reported Device Performance
Essential Agreement (EA)	Not explicitly stated, but typically ≥ 90%	98.1%
Category Agreement (CA)	Not explicitly stated, but typically ≥ 90%	100.0%
Very Major Error (VME)	Not explicitly stated, but typically ≤ 1.5%	0.0%
Major Error (ME)	Not explicitly stated, but typically ≤ 3.0%	0.0%
Minor Error (mE)	Not explicitly stated, but typically ≤ 10%	N/A (listed as "N/A" for CA)

Note: The acceptance criteria for EA, CA, VME, ME, and mE are inferred based on general FDA guidance for AST systems, as the specific numerical targets for acceptability are not directly stated in this document. The table in the document only provides values for %EA and %CA, and then VME, ME, mE which appear to apply to %CA. It's unclear if there are separate VME, ME, and mE targets for %EA based on the table's structure.

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

Test Set Sample Size: Not explicitly stated as a single number. The study involved "fresh and stock clinical isolates, as well as a set of challenge strains." Without a total count, the exact sample size for the test set is unknown.
Data Provenance: The document does not specify the country of origin of the data. It states the evaluations were "external." The isolates were "fresh and stock clinical isolates, as well as a set of challenge strains," indicating a mix of real-world and curated samples. It is a prospective study as it was "designed to confirm the acceptability."

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts:

Number of Experts: Not applicable. The ground truth was established by a reference method, not by human experts.

4. Adjudication Method for the Test Set:

Adjudication Method: Not applicable. The ground truth was established by the CLSI broth microdilution reference method, which is a standardized laboratory procedure, not an expert-based adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:

MRMC Study: No, an MRMC comparative effectiveness study was not done. This device is an automated antimicrobial susceptibility testing system, so human reader performance with or without AI assistance is not relevant.

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

Standalone Performance: Yes, the study assesses the standalone performance of the VITEK® 2 AST-Gram Positive Dalbavancin system (algorithm only), comparing its results directly to the CLSI broth microdilution reference method.

7. The Type of Ground Truth Used:

Ground Truth Type: The ground truth was established using the CLSI broth microdilution reference method. This is considered a standardized, objective laboratory method.

8. The Sample Size for the Training Set:

Training Set Sample Size: Not specified. The document describes an "external evaluation" for performance testing but does not provide details about a separate training set size or how the model was initially developed/trained.

9. How the Ground Truth for the Training Set was Established:

Training Set Ground Truth: Not specified. Since a training set size is not provided, the method for establishing its ground truth is also not mentioned.

Summary

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June 6, 2019

bioMerieux, Inc. Cherece Jones Staff Regulatory Affairs Specialist 595 Anglum Road Hazelwood, Missouri 63042

Re: K190616

Trade/Device Name: VITEK 2 AST-Gram Positive Dalbavancin (≤0.015 - ≥1 µg/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: March 8, 2019 Received: March 11, 2019

Dear Cherece 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. 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

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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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-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 OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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510(k) SUMMARY

VITEK® 2 AST-Gram Positive Dalbavancin (≤0.015 - ≥1 µg/mL)

510(k) Submission Information:

Submitter's Name:	bioMérieux, Inc.
Address:	595 Anglum RoadHazelwood, MO 63042
Contact Person:	Cherece L. JonesStaff Regulatory Affairs Specialist
Phone Number:	314 -731-8684
Fax Number:	314-731-8689
Date of Preparation:	March 8, 2019
B. Device Name:
Formal/Trade Name:	VITEK® 2 AST-Gram Positive Dalbavancin (≤0.015 - ≥1 µg/mL)
Classification Name:	21 CFR 866.1645Fully Automated Short-Term Incubation CycleAntimicrobial Susceptibility SystemProduct Code: LONSubsequent Product Codes: LTT LTW
Common Name:	VITEK® 2 AST-GP Dalbavancin (≤0.015 - ≥1 µg/mL)
C. Predicate Device:	VITEK® 2 AST-GP Ceftaroline (≤0.06 – ≥4 µg/mL)(K141149)

D. 510(k) Summary:

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Active both in vitro and in clinical infections

Staphylococcus aureus (including methicillin-resistant isolates) Enterococcus faecalis (vancomycin-susceptible isolates only) Streptococcus agalactiae

The VITEK® 2 Gram-positive Susceptibility Card is intended for use with the VITEK® 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of Staphylococcus spp., Enterococcus spp., and S. agalactiae to antimicrobial agents when used as instructed.

The antimicrobial presented in VITEK® 2 AST-GP 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.

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 (20-24 hours for Streptococi and 16-20 hours for Staphylococci and Enterococci). 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.

VITEK® 2 AST-GP Dalbayancin 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-GP Dalbavancin. 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-GP Dalbayancin by comparing its performance with the CLSI broth microdilution reference method incubated at 20-24 hours for Streptococci and 16-20 hours for Staphylococci and Enterococci. The data is representative of performance on both the VITEK® 2 Compact instrument platforms.

The VITEK® 2 AST-GP Dalbavancin demonstrated acceptable performance as presented in Table 1 below:

Overall Performance(with the referencemethod)	%EA	VME	ME	mE	%CA	VME	ME	mE
98.1	N/A	N/A	N/A	100.0	0.0	0.0	N/A

Table 1: VITEK® 2 AST-GP Dalbavancin Performance

Reproducibility and Quality 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.”