VITEK 2® Gram Positive Linezolid 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

The VITEK 2® Gram Positive Linezolid for Streptococcus pneumoniae device is designed for antimicrobial susceptibility testing of Streptococcus pneumoniae. It is intended for use with the VITEK 2® System as a laboratory aid in determining in vitro susceptibility to antimicrobial agents.

1. A table of acceptance criteria and the reported device performance

The acceptance criteria for this device are not explicitly quantified in the provided text in terms of specific percentages for Category Agreement, Essential Agreement, or Minor/Major/Very Major errors. However, the FDA's "Guidance on Review Criteria for Assessment of Antimicrobial susceptibility Devices" (March 8, 2000) and "Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems" (Feb 5, 2003) would have defined these criteria.

Based on the study results, the device demonstrated acceptable performance:

Performance Metric	Acceptance Criteria (Implicit from FDA Guidance)	Reported Device Performance (VITEK 2® Gram Positive Linezolid for Streptococcus pneumoniae)
Overall Category Agreement	High percentage (e.g., >90-95% is typical)	100.0%
Reproducibility	Acceptable results	Acceptable results
Quality Control	Acceptable results	Acceptable results

2. Sample size used for the test set and the data provenance

Sample Size for Test Set: The document mentions "fresh and stock clinical isolates and stock challenge strains" for the external evaluation. However, the specific number of isolates used in the test set is not provided in the given text.
Data Provenance: The data was obtained from an "external evaluation." The country of origin of the data is not specified, but given the submitter's address (Hazelwood, MO, USA) and the FDA approval process, it is highly likely tests were conducted or overseen within the USA. The data appears to be prospective as it's an evaluation conducted for regulatory submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

The ground truth was established using the NCCLS reference microbroth dilution method. This is a standardized laboratory method, not reliant on individual expert interpretation in the same way as, for example, a radiologist reading an image. Therefore, there were no human experts (like radiologists) establishing the ground truth; instead, it was a standardized biochemical assay result.

4. Adjudication method for the test set

The ground truth was established by the NCCLS reference microbroth dilution method. This method inherently provides a definitive result, so there was no adjudication method (e.g., 2+1, 3+1) needed among human experts, as the reference method served as the objective gold standard.

5. 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, a multi-reader multi-case (MRMC) comparative effectiveness study involving human readers and AI assistance was not done. This device is an automated in vitro diagnostic device for antimicrobial susceptibility testing, not an imaging or interpretive AI system intended to assist human readers. It directly generates an MIC value and interpretive category.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Yes, this was a standalone performance study. The VITEK 2® system, on its own (algorithm and instrument), generated the susceptibility results which were then directly compared against the NCCLS reference method. There is no human-in-the-loop for the interpretation step of the VITEK 2 system's output that is described.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The type of ground truth used was the NCCLS reference microbroth dilution method. This is a standardized laboratory reference method for determining Minimum Inhibitory Concentrations (MICs).

8. The sample size for the training set

The document does not specify a separate "training set" or its sample size. The description focuses on an "external evaluation" as a test set. For an in vitro diagnostic device like this, the "training" (development and refinement) of the system likely involved internal testing and optimization by the manufacturer, but these details are not provided in the 510(k) summary.

9. How the ground truth for the training set was established

Since a "training set" is not explicitly mentioned or detailed, the method for establishing its ground truth is not provided. If an internal training set was used during development, it would also likely have been established using a similar reference method to the NCCLS microbroth dilution method for consistency and accuracy.

Summary

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K0314/10

510(k) SUMMARY

VITEK 2® Gram Positive Linezolid for Streptococcus pneumoniae

510(k) Submission Information:

Submitter's Name:	bioMérieux, Inc.
Address:	595 Anglum RoadHazelwood, MO 63042
Contact Person:	Nancy Weaver, Staff Regulatory Specialist
Phone Number:	314-731-8695
Fax Number:	314-731-8689
Date of Preparation:	April 25, 2003
B. Device Name:
Formal/Trade Name:	VITEK 2® Gram Positive Linezolid forStreptococcus pneumoniae
Classification Name:	Fully Automated Short-Term Incubation CycleAntimicrobial Susceptibility Device,21 CFR 866.1645
Common Name:	VITEK 2 AST-GP Linezolid for Streptococcuspneumoniae
C. Predicate Device:	VITEK 2® Streptococcus pneumoniaeSusceptibility Test for Ceftriaxone (N50510/S135)

D. 510(k) Summary:

The VITEK 2® Gram Positive Linezolid 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 monitors the growth of each well in the card over a defined period of time (up to 18 hours).

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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 Linezolid for Streptococcus pneumoniae demonstrated substantially equivalent performance when compared with the NCCLS reference microbroth 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 Positive Linezolid 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 Linezolid for Streptococcus pneumoniae by comparing its performance with the NCCLS microbroth dilution reference method. VITEK 2 Gram Positive Linezolid for Streptococcus pneumoniae demonstrated acceptable performance of 100.0% overall Category 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

Public Health Service

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JUL 1 0 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

Re: K031410 Trade/Device Name: VITEK 2® Gram Positive Linezolid (1 ug/ml) for Streptococcus pneumoniae 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: April 25, 2003 Received: May 13, 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. Iisting 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): K034110

Device Name: VITEK 2® Gram Positive Linezolid (1ug/ml) for Streptococcus pneumoniae

Indications for Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Freddie L. Poole
Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) KO3 1410

for Prescription Use only

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.”