The VITEK 2 Gram Negative Moxifloxacin is designed for antimicrobial susceptibility testing of Klebsiella pneumoniae, Citrobacter freundii, Enterobacter cloacae, Escherichia coli, Klebsiella oxytoca and Proteus mirabilis. 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 an analysis of the provided text regarding the acceptance criteria and study for the VITEK® 2 Gram Negative Moxifloxacin device:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance	Metric
Acceptable Performance	98.7% overall Essential Agreement	Essential Agreement (EA)

Notes:

The document explicitly states 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" defined the criteria. However, the exact numerical thresholds for "acceptable performance" (e.g., minimum percentage for Essential Agreement) are not directly stated in this extract, only that 98.7% demonstrated acceptable performance. We infer from the statement that the 98.7% EA met the pre-defined acceptance criteria.

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

Sample Size: Not explicitly stated as a total number. The study mentions "fresh and stock clinical isolates and stock challenge strains" and that an "external evaluation was conducted."
Data Provenance: Not explicitly stated (e.g., country of origin, specific institutions). The phrasing "external evaluation" suggests data was collected outside of bioMérieux's internal labs. The data was a mix of "fresh and stock clinical isolates" (implying retrospective and potentially prospective clinical samples, or at least isolates derived from them) and "stock challenge strains" (likely standardized, well-characterized strains used for validation).

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

This information is not provided in the given text.

4. Adjudication Method for the Test Set

This information is not provided in the given text.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of Human Readers Improve With AI vs. Without AI Assistance

No, this was not an MRMC study. The VITEK® 2 system is an automated device for antimicrobial susceptibility testing (AST), not an AI-assisted diagnostic imaging system where human readers interpret results. The comparison was between the automated device and a reference laboratory method (NCCLS agar dilution).

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

Yes, this was a standalone study. The VITEK 2 device's performance was directly compared against the NCCLS reference method. The VITEK 2 system operates "automatically fills, seals and places the card into the incubator/reader" and "monitors the growth of each well... At the completion of the incubation cycle, a report is generated that contains the MIC value along with the interpretive category result." This describes an automated process without human interpretation as part of the primary device function being tested for performance.

7. The Type of Ground Truth Used

Reference Method (NCCLS agar dilution method). The study explicitly states the VITEK 2 Gram Negative Moxifloxacin's performance was compared "with the NCCLS reference agar dilution method." This method is considered the gold standard for determining minimum inhibitory concentrations (MICs) of antimicrobials.

8. The Sample Size for the Training Set

Not Applicable / Not Provided. The document describes a performance validation study against a reference method, not the development or training of a machine learning algorithm. While the device certainly has algorithms embedded, the text focuses on its clinical performance evaluation rather than its initial algorithmic training.

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

Not Applicable / Not Provided. As this was not an AI/ML training study in the typical sense of needing a "training set," this information is not relevant or stated in the provided text.

Summary

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

K032861

NOV 1 2 2003

Image /page/0/Picture/2 description: The image shows the logo for bioMerieux. The logo consists of the company name "bioMerieux" in a stylized font, with a vertical line running through the middle of the text. Above the text is a circular graphic with a textured pattern on the left side and a solid black fill on the right.

510(k) SUMMARY

VITEK® 2 Gram Negative Moxifloxacin

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 8, 2003
B. Device Name:
	Formal/Trade Name:	VITEK® 2 Gram Negative Moxifloxacin (0.25 - 4.0µg/ml)
	Classification Name:	Fully Automated Short-Term Incubation CycleAntimicrobial Susceptibility Device,21 CFR 866.1645
	Common Name:	VITEK 2 AST-GN Moxifloxacin
	C. Predicate Device:	VITEK 2 Gram Negative Susceptibility Test forCefpodoxime (N50510/S120)

D. 510(k) Summary:

VITEK® 2 Gram Negative Moxifloxacin is designed for antimicrobial susceptibility testing of, Klebsiella pneumoniae, Citrobacter freundii, Enterobacter cloacae, Escherichia coli Klebsiella oxytoca and Proteus mirabilis. 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 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 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

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

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 Negative Moxifloxacin 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 Moxifloxacin. 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 Moxifloxacin by comparing its performance with the NCCLS agar dilution reference method. VITEK 2 Gram Negative Moxifloxacin demonstrated acceptable performance of 98.7% overall Essential Agreement when compared to the agar dilution reference method. Reproducibility and Quality Control demonstrated acceptable results.

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

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" written around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

NOV 1 2 2003

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

Re: K032861

Trade/Device Name: VITEK 2® Gram Negative Moxifloxacin (0.25-4 ug/ml) Regulation Number: 21 CFR 866.1645 Regulation Name: Fully Automated Short-Term Incubation Cycle Antimicrobial Susceptibility Devices Regulatory Class: Class II Product Code: LON Dated: September 8, 2003 Received: September 12, 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).

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

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). Other general information on your responsibilities under the Act may be obtained 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

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

Indications for Use Statement

510(k) Number (if known): K032861

Device Name: VITEK 2° Gram Negative Moxifloxacin (0.25 - 4 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)

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K032861

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.”