VITEK® 2 Gram Negative Cefotaxime 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 is a quantitative test. Cefotaxime 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 clinical infections: Acinetobacter spp. Citrobacter spp. Enterobacter spp. Escherichia.coli Klebsiella spp. (including Klebsiella pneumoniae) Morganella morganii Proteus mirabilis Proteus vulgaris Providencia rettgeri Providencia stuartii Serratia marcescens

In vitro data available but clinical significance is unknown: Providencia spp. Salmonella spp. (including Salmonella typhi)

The VITEK® 2 Antimicrobial Susceptibility Test (AST) is intended to be used with the VITEK® 2 System for the automated quantitative or qualitative susceptibility testing of isolated colonies for the most clinically significant aerobic gram-negative bacilli, Staphylococcus spp., Enterococcus 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

Here's a breakdown of the acceptance criteria and study information for the VITEK® 2 AST Gram Negative Cefotaxime device, based on the provided text:

Acceptance Criteria and Device Performance

Acceptance Criteria	Reported Device Performance (%)
Overall Essential Agreement	97.5
Overall Category Agreement	97.8

Study Information

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

Test Set Size: Not explicitly stated as a single number. The study utilized "fresh and stock clinical isolates, as well as a set of challenge strains."
Data Provenance: The text does not specify the country of origin. It indicates the data is from an "external evaluation" and involved "clinical isolates," suggesting retrospective or prospective clinical samples were used, but the exact nature (retrospective/prospective) is not explicitly detailed for the clinical isolates.

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

Number of Experts: This information is not provided in the text.
Qualifications: This information is not provided in the text.

4. Adjudication method for the test set:

Adjudication Method: This information is not provided in the text. The ground truth was established by comparing the device's performance against the CLSI broth microdilution reference method, which is a standardized laboratory method, not typically involving expert adjudication in the same way an image interpretation study would.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and if so, what was the effect size of how much human readers improve with AI vs without AI assistance:

MRMC Study: No, an MRMC comparative effectiveness study was not performed. This device is an automated antimicrobial susceptibility testing system, not an AI-assisted diagnostic tool for human readers.

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

Standalone Performance: Yes, the study evaluated the standalone performance of the VITEK® 2 AST-GN Cefotaxime system. The system automatically performs the test, monitors growth, and generates a report with MIC values and interpretive categories. The reported Essential Agreement and Category Agreement are measures of this standalone performance compared to the reference method.

7. The type of ground truth used:

Ground Truth: The ground truth was established using the CLSI broth microdilution reference method, incubated at 16-20 hours, as defined in the FDA Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems. This is a recognized standard laboratory method for determining antimicrobial susceptibility.

8. The sample size for the training set:

Training Set Size: This information is not provided. The VITEK® 2 system is a diagnostic device that performs susceptibility testing, not typically a machine learning model that undergoes a training phase in the conventional sense with a distinct "training set" of patient data. The development of such a system would involve extensive method development and validation using various strains, but this is different from a machine learning training set.

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

Training Set Ground Truth: As above, a traditional "training set" with ground truth in the context of machine learning is not applicable here. The fundamental principles and performance of the VITEK® 2 system were established against the CLSI broth microdilution reference method during its development and validation.

Summary

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

February 16, 2017

BIOMERIEUX, INC. KAREN RUSSELL STAFF REGULATORY AFFAIRS SPECIALIST 595 ANGLUM ROAD HAZELWOOD MO 63042

Re: K161437

Trade/Device Name: VITEK®2 AST Gram Negative Cefotaxime (≤0.25 ->64 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, LTT, LTW Dated: December 30, 2016 Received: January 3, 2017

Dear Ms. Russell:

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.

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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/ResourcesforYou/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,

Ribhi Shawar -A

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

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Indications for Use

510(k) Number (if known) K161437

Device Name

VITEK® 2 AST Gram Negative Cefotaxime (<0.25 =>64 µg/mL)

Indications for Use (Describe)

In vitro data available but clinical significance is unknown: Providencia spp. Salmonella spp. (including Salmonella typhi)

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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VITEK® 2 AST-GN Cefotaxime: Section 028. 510(k) Summary

A. 510(k) Submission Information:

Submitter's Name:	bioMérieux, Inc.
Address:	595 Anglum RoadHazelwood, MO 63042
Contact Person:	Karen RussellStaff Regulatory Affairs Specialist
Phone Number:Fax Number:	314-731-8639314-731-8689
Date of Preparation:	May 23, 2016
B. Device Name:	Formal/Trade Name: VITEK® 2 Gram Negative Cefotaxime(≤0.25 – ≥64 µg/mL)
Classification Name:	21 CFR 866.1645Fully Automated Short-Term Incubation Cycle AntimicrobialSusceptibility System
Product Code:	LON
Common Name:	VITEK® 2 AST-GN Cefotaxime

C. Predicate Device: VITEK® 2 AST-GN Ertapenem (K152075)

D. 510(k) Summary:

VITEK® 2 Gram Negative Cefotaxime 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 Cefotaxime is a quantitative test. Cefotaxime 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 Acinetobacter spp. Citrobacter spp. Enterobacter spp. Escherichia.coli

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Klebsiella spp. (including Klebsiella pneumoniae) Morganella morganii Proteus mirabilis Proteus vulgaris Providencia rettgeri Providencia stuartii Serratia marcescens

In vitro data available but clinical significance is unknown Providencia spp. Salmonella spp. (including Salmonella typhi)

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 Cefotaxime 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 Cefotaxime.

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VITEK® 2 AST-GN Cefotaxime Traditional 510(k) Submission

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 Cefotaxime 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 Cefotaxime demonstrated acceptable performance of 97.5% overall Essential Agreement and 97.8% overall category agreement with the reference method. A limitation will be taken for P. vulgaris and Shigella spp. 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.”