VITEK® 2 Gram Negative Gentamicin is designed for antimicrobial susceptibility testing of Gram negative bacilli and is 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 Gram Negative Gentamicin is a quantitative test. Gentamicin 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 Klebsiella species Proteus species Serratia species 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, Staphylococus 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

The provided text describes the performance of the VITEK® 2 AST-GN Gentamicin device for antimicrobial susceptibility testing. Here's a breakdown of the acceptance criteria and the study that proves the device meets them:

Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Metric)	Reported Device Performance (%)
Overall Essential Agreement (EA)	99.4%
Overall Category Agreement (CA)	98.6%

Study Details

Sample Size Used for the Test Set and Data Provenance:
- The document states that an "external evaluation was conducted with fresh and stock clinical isolates, as well as a set of challenge strains." However, specific sample sizes for these test sets are not provided in the document.
- The data provenance regarding the country of origin or whether it was retrospective or prospective is not explicitly stated. It can be inferred that it involved clinical isolates, suggesting real-world samples, but the collection method (retrospective/prospective) is not detailed.
Number of Experts Used to Establish Ground Truth and Qualifications:
- This information is not provided in the document, as the ground truth was established by a reference method rather than human experts interpreting results.
Adjudication Method for the Test Set:
- Adjudication methods (e.g., 2+1, 3+1) are not applicable here because the ground truth was established by a quantitative reference method (CLSI broth microdilution) rather than expert consensus requiring reconciliation.
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, an MRMC study was not done. This type of study is typically performed for imaging devices where human readers interpret medical images. The VITEK® 2 is an automated antimicrobial susceptibility testing system, so its performance is compared directly to a reference laboratory method, not to human interpretation of images. Therefore, improvement of human readers with AI assistance is not applicable.
Standalone Performance:
- Yes, a standalone performance evaluation was done. The described study focuses on the device's performance (VITEK® 2 AST-GN Gentamicin) compared to the CLSI broth microdilution reference method, which represents the algorithm's performance without specific human-in-the-loop assistance in the interpretation of the susceptibility results, beyond standard laboratory handling. The VITEK® 2 is an automated system that generates a report with MIC values and interpretive categories.
Type of Ground Truth Used:
- The ground truth used was the CLSI broth microdilution reference method, specifically incubated at 16-20 hours. This is a laboratory standard for determining minimum inhibitory concentrations (MICs) of antimicrobials.
Sample Size for the Training Set:
- The document does not provide the sample size for any training set. This is because the VITEK® 2 system, as described, is likely based on established microbiological principles and a defined algorithm for growth detection and MIC calculation, rather than a machine learning model that requires explicit training data in the context of typical AI/ML studies. The evaluation described is for validation of the device's performance against a reference method.
How the Ground Truth for the Training Set Was Established:
- As there's no mention of a traditional "training set" in the context of a machine learning model, this question is not fully applicable. The core methodology of the VITEK® 2 system (miniaturized versions of the doubling dilution technique) is based on the established science of antimicrobial susceptibility testing, with the CLSI broth microdilution method serving as the gold standard for validating its output.

Summary

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with flowing lines representing hair or movement.

March 13, 2017

Public Health Service

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

BIOMERIEUX, INC MS. CHERECE JONES STAFF REGULATORY AFFAIRS SPECIALIST 595 ANGLUM RD. HAZELWOOD MO 63042

Re: K163563

Trade/Device Name: VITEK® 2 AST-GN Gentamicin (≤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: December 16, 2016

Received: December 19, 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 (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.

{1}------------------------------------------------

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,

Steven R. Gitterman -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

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K163563

Device Name VITEK® 2 AST-GN Gentamicin (≤ 1 ->16 ug/mL)

Indications for Use (Describe)

Active in vitro and in clinical infections Citrobacter species Enterobacter species Escherichia coli Klebsiella species Proteus species Serratia species 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, Staphylococus spp., Enterococcus spp., Streptococcus spp. and clinically significant yeast.

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

Image /page/3/Picture/0 description: The image shows the logo for bioMérieux. The logo consists of the company name in a sans-serif font, with a stylized graphic above it. The graphic features a sphere with curved lines on the left side, and a curved line extending from the top to the bottom of the sphere.

510(k) SUMMARY

VITEK® 2 AST-GN Gentamicin

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:	December 16, 2016
Device Name:
Formal/Trade Name:	VITEK® 2 AST-GN Gentamicin (≤ 1 - ≥ 16 µg/mL)
Classification Name:	21 CFR 866.1645Fully Automated Short-Term Incubation CycleAntimicrobial Susceptibility SystemProduct Code: LON
Common Name:	VITEK® 2 AST-GN Gentamicin
Predicate Device:	VITEK® 2 GN Doxycycline (K121546)

D. 510(k) Summary:

VITEK® 2 Gram Negative Gentamicin 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 Gram Negative Gentamicin is a quantitative test. Gentamicin 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

{4}------------------------------------------------

Escherichia coli Klebsiella species Proteus species Serratia species 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.

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 Gentamicin 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 Gentamicin. 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 Gentamicin 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 Gentamicin demonstrated acceptable performance of 99.4% overall Essential Agreement and 98.6% 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.”