VITEK® 2 Gram Negative Gatifloxacin is designed for antimicrobial susceptibility testing of Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Acinetobacter lwoffii, Citrobacter koseri, C. freundii, Enterobacter aerogenes, E. cloacae, Klebsiella oxytoca, Morganella morganii, and Proteus vulgaris. It is intended for use with the VITEK® 2 System as a laboratory aid in the determination of in vitro susceptibility to antimicrobial agents.

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 bacterial isolate to be tested is diluted to a standardized concentration in 0.45% 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 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 antibiotic contained on the card.

AI/ML Overview

Here's a summary of the acceptance criteria and study details for the VITEK® 2 Gram Negative Gatifloxacin, based on the provided document:

Acceptance Criteria and Device Performance

Acceptance Criteria	Reported Device Performance
Overall Essential Agreement (compared to NCCLS reference agar dilution method)	99.7%
Reproducibility	Acceptable results (specific percentage not given)
Quality Control	Acceptable results (specific percentage not given)

Note: The document only explicitly states the acceptance criterion for "Overall Essential Agreement" as acceptable performance. The criteria for reproducibility and quality control are not quantified but stated as "acceptable results."

Study Information

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

Sample Size: Not explicitly stated as a single number. The study utilized "fresh and stock clinical isolates and stock challenge strains."
Data Provenance: Not specified, but generally, clinical isolates would be prospective or retrospective, and stock challenge strains are typically laboratory-maintained. The country of origin is not mentioned.

2. 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 method (NCCLS reference agar dilution method) is a standardized laboratory procedure, not typically established by human experts in the same way an image interpretation might be.

3. Adjudication Method for the Test Set:

This information is not applicable/provided. The NCCLS agar dilution method is a distinct scientific procedure, not subject to human adjudication in the typical sense.

4. 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:

No, an MRMC comparative effectiveness study was not done. This device is an automated antimicrobial susceptibility testing system, not an AI system designed to assist human readers in interpretation.

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

Yes, a standalone performance study was done. The VITEK® 2 system is fully automated and designed to provide results without human intervention beyond sample preparation and loading. The study compares its automated performance to the reference method.

6. The Type of Ground Truth Used:

NCCLS reference agar dilution method. This is a recognized standard laboratory method for determining minimum inhibitory concentrations (MICs) of antimicrobial agents.

7. The Sample Size for the Training Set:

This information is not provided and is likely not applicable in the context of this device. The VITEK® 2 system relies on established biochemical and growth principles for detection, not on a machine learning model that requires a "training set" in the traditional sense. The "training" would be tied to the development and validation of the card's antimicrobial concentrations and the system's growth monitoring algorithms.

8. How the Ground Truth for the Training Set Was Established:

This information is not provided and is likely not applicable for the reasons stated above for sample size. The ground truth for the underlying principles of the VITEK® 2 system would be based on fundamental microbiology and pharmacology, and the design of the miniaturized doubling dilution methodology.

Summary

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K032788

NOV = 4 2003

Image /page/0/Picture/2 description: The image shows the logo for bioMerieux. The logo consists of a stylized image of a cell or sphere that is half black and half white with lines. Below the image is the company name, "BIOMERIEUX" in a stylized font.

510(k) SUMMARY

VITEK® 2 Gram Negative Gatifloxacin

510(k) Submission Information:

Submitter's Name:	bioMérieux, Inc.
Address:	595 Anglum RoadHazelwood, MO 63042
Contact Person:	Nancy WeaverStaff Regulatory Affairs Specialist
Phone Number:	314-731-8695
Fax Number:	314-731-8689
Date of Preparation:	September 3, 2003
B. Device Name:
Formal/Trade Name:	VITEK® 2 Gram Negative Gatifloxacin
Classification Name:	Fully Automated Short-Term Incubation CycleAntimicrobial Susceptibility Device,21 CFR 866.1645
Common Name:	VITEK 2 AST-GN Gatifloxacin
C. Predicate Device:	VITEK 2 Gram Negative Susceptibility Test forCefpodoxime (N50510/S120)

D. 510(k) Summary:

VITEK® 2 Gram Negative Gatifloxacin is designed for antimicrobial susceptibility testing of Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Acinetobacter Iwoffii, Citrobacter koseri, C. freundii, Enterobacter aerogenes, E. cloacae, Klebsiella oxytoca, Morganella morganii, and Proteus vulgaris. It is intended for use with the VITEK® 2 System as a laboratory aid in the determination of in vitro susceptibility to antimicrobial agents. The antimicrobial presented in VITEK 2 AST Cards is in concentrations equivalent by efficacy to standard method concentrations in mca/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 bacterial isolate to be tested is diluted to a standardized concentration in 0.45% 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 monitors the growth of each well in the card over a defined period of time (up

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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 antibiotic contained on the card.

VITEK 2 Gram Neqative Gatifloxacin demonstrated substantially equivalent performance when compared with the NCCLS reference agar dilution method, as defined in the FDA DRAFT document "Guidance on Review Criteria for Assessment of Antimicrobial susceptibility Devices", dated March 8, 2000 and Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems; Guidance for Industry and FDA. Issued Feb. 5, 2003.

The Premarket Notification (510[k]) presents data in support of VITEK 2 Gram Negative Gatifloxacin. An external evaluation was conducted with fresh and stock clinical isolates and stock challenge strains. The external evaluations were designed to confirm the acceptability of VITEK 2 Gram Negative Gatifloxacin by comparing its performance with the NCCLS agar dilution reference method. VITEK 2 Gram Negative Gatifloxacin demonstrated acceptable performance of 99.7% overall Essential Agreement when compared to the agar dilution reference method. Reproducibility and Quality Control demonstrated acceptable results.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized image of an eagle with three lines extending from its head.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

NOV - 4 2003

Ms. Nancy Weaver Staff Regulatory Affairs Specialist Biomerieux, Inc 595 Anglum Road Hazelwood, MO 63042-2320

Re: K032788 Trade/Device Name: VITEK® 2 Gram Negative Gatifloxacin (1-8 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 Dated: September 3, 2003 Received: September 8, 2003

Dear Ms. Weaver:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21. Code of Federal Regulations (CFR), Parts 800 to 895. 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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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Page 2 -

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Steven Sutman

Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Indications for Use Statement

KO32788 510(k) Number (if known):

Device Name: VITEK® 2 Gram Negative Gatifloxacin (1 - 8 µg/ml)

Indications for Use:

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Fea Ott
Division Sign-Off
11/4/03

Office of In Vitro Diagnostic Device Evaluation and Safety

prescription use only.

K632788 510(k).

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.”