VITEK® 2 AST-Gram Negative Tobramycin 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 Tobramycin is a qualitative test. Tobramycin 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: Citrobacter spp. Enterobacter spp. Escherichia coli Klebsiella spp. Morganella morganii Pseudomonas aeruginosa Proteus mirabilis Proteus vulgaris Providencia spp. Serratia spp.

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, Staphylococus spp., Enterococcus spp., Streptococcus spp. and clinically significant yeast.

Device Description

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.

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

The document describes the VITEK® 2 AST-Gram Negative Tobramycin device, an automated antimicrobial susceptibility testing system.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the "acceptable performance" thresholds mentioned in the document, which align with FDA guidance for AST systems.

Performance Metric	Acceptance Criteria (Implied by context of FDA Guidance)	Reported Device Performance (VITEK® 2 AST-GN Tobramycin)
Overall Essential Agreement	Not explicitly stated but generally high (e.g., >90%)	98.5%
Overall Category Agreement	Not explicitly stated but generally high (e.g., >90%)	96.9%
Reproducibility	"Acceptable results" (specific % not given)	"Acceptable results"
Quality Control	"Acceptable results" (specific % not given)	"Acceptable results"

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

Sample Size: Not explicitly stated as a single number. The study used "fresh and stock clinical isolates, as well as a set of challenge strains." The exact number of isolates for each category is not specified.
Data Provenance: Not explicitly stated (e.g., country of origin, specific hospitals). The data is from an "external evaluation." It is implicitly prospective or a mix of retrospective (stock isolates) and prospective (fresh clinical isolates).

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

Not applicable. The ground truth for antimicrobial susceptibility testing is established by a reference laboratory method (CLSI broth microdilution), not by human experts interpreting images or clinical data.

4. Adjudication Method for the Test Set

Not applicable. The ground truth is determined by a standardized reference methodology (CLSI broth microdilution), so there is no need for expert adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. This is an in vitro diagnostic device for antimicrobial susceptibility testing, not a device that involves human readers interpreting cases (e.g., radiology images). Therefore, an MRMC study comparing human reader performance with and without AI assistance is not relevant.

6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance)

Yes, a standalone performance study was done. The VITEK® 2 AST-GN Tobramycin device's performance (Essential Agreement and Category Agreement) was compared directly against the CLSI broth microdilution reference method. This is a measure of the device's algorithmic performance without human interpretation or intervention beyond sample preparation and loading.

7. Type of Ground Truth Used

The ground truth used was the CLSI broth microdilution reference method, which is a laboratory standard for determining minimum inhibitory concentrations (MICs) of antimicrobial agents.

8. Sample Size for the Training Set

Not explicitly stated. The document refers to "external evaluation" and "challenge strains" for the test set. It does not provide information specifically about a training set. For an AST system, "training" often refers to the development and optimization of the interpretive algorithms, which may involve internal strain collections and development data, but this information is not detailed in the provided text.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as details about a separate "training set" and its ground truth establishment are not provided in the document. The ground truth for the overall device's development and validation would consistently rely on established reference methods like CLSI broth microdilution.

Summary

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

February 1, 2017

BIOMÉRIEUX, INC MARY BETH ANHEUSER STAFF REGULATORY AFFAIRS SPECIALIST 595 ANGLUM ROAD HAZELWOOD MO 63042

Re: K163083

Trade/Device Name: VITEK® 2 AST-Gram Negative Tobramycin (≤ 1 -> 16 µg/mL) Regulation Number: 21 CFR 866.1645 Regulation Name: Fully automated short-term incubation cycle antimicrobial susceptibility system Regulatory Class: II Product Code: LON, LTW, LTT Dated: October 27, 2016

Received: November 3, 2016

Dear Ms. Anheuser:

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 (OS) 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/ResourcesforYou/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 -A

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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K163083

Device Name

VITEK® 2 AST-Gram Negative Tobramycin (≤ 1 - ≥ 16 µg/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-GN Tobramycin

510(k) Submission Information:

Submitter's Name:	bioMérieux, Inc.
Address:	595 Anglum RoadHazelwood, MO 63042
Contact Person:	Mary Beth AnheuserStaff Regulatory Affairs Specialist
Phone Number:	314-731-8518
Fax Number:	314-731-8689
Date of Preparation:	October 27, 2016
B. Device Name:
Formal/Trade Name:	VITEK® 2 AST- GN Tobramycin (≤ 1 - ≥ 16µg/mL)
Classification Name:	21 CFR 866.1645Fully Automated Short-Term Incubation CycleAntimicrobial Susceptibility SystemProduct Code LON
Common Name:	VITEK® 2 AST-GN Tobramycin
C. Predicate Device:	VITEK® 2 GN Piperacillin/tazobactam (K113200)

D. 510(k) Summary:

VITEK® 2 AST-Gram Negative Tobramycin 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 Tobramycin is a qualitative test. Tobramycin 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 Citrobacter species Enterobacter species Escherichia coli

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Klebsiella species Morganella morganii Pseudomonas aeruginosa Proteus mirabilis Proteus vulgaris Providencia species Serratia species

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.

VITEK® 2 AST-GN Tobramycin 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 Tobramycin. 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 Tobramycin by comparing its performance with the CLSI broth microdilution reference method incubated at 16-20 hrs. The data is representative of performance on both the VITEK® 2 and VITEK® 2 Compact instrument platforms. VITEK® 2 AST-GN Tobramycin demonstrated acceptable performance of 98.5% overall Essential Agreement and 96.9% overall Category Agreement with the reference method. 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.”