VITEK® 2 Gram Positive Moxifloxacin for Streptococcus pneumoniae is designed for antimicrobial susceptibility testing of Streptococcus pneumoniae. 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) my 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 VITEK® 2 Gram Positive Moxifloxacin for Streptococcus pneumoniae device, focusing on acceptance criteria and supporting study details:

1. Table of Acceptance Criteria and Reported Device Performance:

The document refers to "acceptable performance" as defined in the Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems; guidance for Industry and FDA. Issued February 5, 2003. While the specific numerical acceptance criteria from this guidance document are not explicitly detailed in the provided text, the device's performance against these unstated criteria is reported.

Acceptance Criterion (from referenced guidance)	Reported Device Performance
Overall Essential Agreement (EA)	99.6%
Reproducibility	Acceptable
Quality Control	Acceptable

Note: The exact numerical thresholds for "Acceptable" for Reproducibility and Quality Control are not specified in the provided text but would be defined in the referenced FDA guidance document.

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

Sample Size for Test Set: Not explicitly stated in terms of a specific number of isolates. The document mentions "fresh and stock clinical isolates and stock challenge strains" were used in the external evaluation.
Data Provenance: Not explicitly stated (e.g., country of origin). The study involved "external evaluations," implying multiple locations, but specific geographic details are absent. The isolates were a mix of "fresh and stock clinical isolates" (implying retrospective and potentially prospective clinical samples) and "stock challenge strains."

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

Number of Experts: Not specified.
Qualifications of Experts: Not specified. The ground truth was established by the NCCLS reference microbroth dilution method. While this method is performed by laboratory personnel, the document does not specify if "experts" (e.g., microbiologists with specific experience) formally established or adjudicated the ground truth results, beyond adhering to the standard method.

4. Adjudication Method for the Test Set:

Adjudication Method: Not explicitly described. The primary method for establishing ground truth was the NCCLS reference microbroth dilution method. This method inherently provides a reference result, and the document does not mention a separate adjudication process for reconciling differing interpretations between multiple readers or methods.

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

No, an MRMC comparative effectiveness study was not explicitly described. The study focused on comparing the VITEK® 2 system's performance against a reference method (NCCLS microbroth dilution), not on the improvement of human readers with AI assistance.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

Yes, a standalone performance evaluation was done. The VITEK® 2 system is an automated device ("algorithm only" in the sense that it automatically processes and interprets results without direct human intervention in the interpretation of that specific test). Its performance was compared directly to the NCCLS reference method. The "report is generated that contains the MIC value along with the interpretive category result for each antibiotic contained on the card," indicating an automated output.

7. The Type of Ground Truth Used:

Type of Ground Truth: The ground truth was established using the NCCLS reference microbroth dilution method. This is considered a gold standard in vitro laboratory method for antimicrobial susceptibility testing.

8. The Sample Size for the Training Set:

Sample Size for Training Set: Not explicitly stated. The document describes an "external evaluation" for confirming acceptability, but it does not detail a separate training phase or the size of a training dataset. Given this is a 510(k) for an AST device, the "training" (development and refinement) of the AST algorithm would likely have involved extensive historical data and might not be documented as a distinct "training set" in the same way an AI/ML model for image interpretation would be.

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

How Ground Truth for Training Set Was Established: Not explicitly stated. If there was an internal training or development phase, it's highly probable that the ground truth for that phase would also have been established using the NCCLS reference microbroth dilution method, as it is the accepted standard. However, the document does not provide details on this.

Summary

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510(k) SUMMARY

VITEK® 2 Gram Positive Moxifloxacin for Streptococcus pneumoniae

A. Submitter Information:

Submitter's Name:	bioMérieux, Inc.
Address:	595 Anglum RoadHazelwood, MO 63042
Contact Person:	Nancy Weaver, Staff RegulatoryAffairs Specialist
Phone Number:	314-731-8695
Fax Number:	314-731-8689
Date of Preparation:	June 6, 2003
B. Device Name:
Formal/Trade Name:	VITEK® 2 Gram Positive Moxifloxacin forStreptococcus pneumoniae
Classification Name:	Fully Automated Short-Term Incubation CycleAntimicrobial Susceptibility Device,21 CFR 866.1645
Common Name:	VITEK 2 AST-GP Moxifloxacin for Streptococcuspneumoniae
C. Predicate Device:	VITEK® 2 Streptococcus pneumoniaeSusceptibility Test for Ceftriaxone (N50510/S135)

D. 510(k) Summary:

VITEK 2 Gram Positive Moxifloxacin for Streptococcus pneumoniae is designed for antimicrobial susceptibility testing of Streptococcus pneumoniae. 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) my 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

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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.

VITEK 2 Gram Positive Moxifloxacin for Streptococcus pneumoniae demonstrated substantially equivalent performance when compared with the NCCLS reference microbroth dilution method, as defined in the Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems; guidance for Industry and FDA. Issued February 5, 2003.

The Premarket Notification (510[k]) presents data in support of VITEK 2 Gram Positive Moxifloxacin for Streptococcus pneumoniae.

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 Positive Moxifloxacin for Streptococcus pneumoniae by companing its performance with the NCCLS microbroth dilution reference method. VITEK 2 Gram Positive Moxifloxacin for Streptococcus pneumoniae demonstrated acceptable performance of 99.6% overall Essential Agreement when compared to the microbroth 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 shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features a staff with a snake winding around it, and three horizontal bars above it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the caduceus symbol.

Public Health Service

AUG 1 3 2003

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

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

K031865 Re: Trade/Device Name: VITEK® 2 Gram Positive Moxifloxacin for Streptococcus pneumoniae (0.25-2 mcg/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: June 6, 2003 Received: June 18, 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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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 Putman

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

510(k) Number (if known):

Device Name: VITEK® 2 Gram Positive Moxifloxacin for Streptococcus pneumoniae, 0.25 - 2 mcg/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)

Neesa 8/12/03
Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

✓
Perscription use -
(Per 21 CFR 801.109)

KO3186 2 510(k)_

Over the - Counter un

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.”