VITEK® 2 AST-Gram Negative Amikacin 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 AST-Gram Negative Amikacin is a quantitative test. Amikacin 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: Pseudomonas species Escherichia coli Proteus mirabilis Klebsiella species Enterobacter species Serratia species Acinetobacter species (excluding A. baumannii Complex)

In vitro data available but clinical significance unknown: Citrobacter freundii

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 acrobic gram-negative bacilli, Staphylococus spp., Enterococcus spp., Streptococcus spp. and clinically significant yeast.

Device Description

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.

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

The provided document is a 510(k) premarket notification for a medical device called "VITEK® 2 AST-GN Amikacin," an antimicrobial susceptibility testing system. While it specifies the device's performance against certain acceptance criteria, it does not describe a study involving human readers or AI assistance in the context of diagnostic imaging. Therefore, I will extract relevant information about the non-AI device's performance and address the provided questions within that scope, noting where the information is not applicable to an AI/human reader study.

Here's a breakdown of the requested information based on the provided document:

Acceptance Criteria and Device Performance (for a non-AI diagnostic device)

Acceptance Criteria	Reported Device Performance
Essential Agreement (EA) with reference method	94.9% overall Essential Agreement with the CLSI broth microdilution reference method.
Category Agreement (CA) with reference method	98.4% overall Category Agreement with the CLSI broth microdilution reference method.
Reproducibility	Acceptable results. (Specific metrics not quantitatively reported in this summary, but stated as acceptable).
Quality Control	Acceptable results. (Specific metrics not quantitatively reported in this summary, but stated as acceptable).

Study Details (for VITEK® 2 AST-GN Amikacin)

Sample sizes used for the test set and the data provenance:
- Test Set Sample Size: The document mentions that an "external evaluation was conducted with fresh and stock clinical isolates, as well as a set of challenge strains." It doesn't provide a specific numerical sample size for the test set, but implies a combination of clinical isolates and challenge strains were used.
- Data Provenance: Not explicitly stated, but "clinical isolates" typically implies patient samples. The document does not specify the country of origin or if the data was retrospective or prospective. It refers to a "Premarket Notification (510[k])" which typically involves prospective studies for new devices, but this is not explicitly stated for the data collection itself.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This is not applicable to the VITEK® 2 AST-GN Amikacin device study as described. The ground truth for antimicrobial susceptibility testing is established via a "CLSI broth microdilution reference method," not through human expert consensus in the way a diagnostic imaging study would be. Therefore, no information is provided on expert numbers or qualifications for ground truth establishment.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. The ground truth is a laboratory reference method, not an adjudicated read from experts.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and what was the effect size of how much human readers improve with AI vs. without AI assistance:
- Not applicable. This study pertains to an automated antimicrobial susceptibility testing system, not an AI-assisted diagnostic imaging system with human readers. No MRMC study was performed, and thus no effect size on human reader improvement with AI assistance is reported.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, this study is essentially a standalone performance evaluation of the VITEK® 2 AST-GN Amikacin system against a reference method. The device itself is an automated system; it's not designed to assist a human in interpreting results but rather to provide the results directly. Its performance (Essential Agreement and Category Agreement) is reported as standalone.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The ground truth used was the CLSI broth microdilution reference method (Clinical and Laboratory Standards Institute). This is considered the gold standard for determining minimum inhibitory concentrations (MICs) of antimicrobials.
The sample size for the training set:
- The document describes a "Premarket Notification (510[k])" and refers to "external evaluation" and "clinical isolates" for the test set. It does not explicitly mention a separate "training set" or its size. In the context of traditional diagnostic devices (not AI/ML, which often have distinct training and testing phases), the "training" might be considered part of the device's development and internal validation, which isn't detailed in this summary.
How the ground truth for the training set was established:
- Not applicable, as a distinct training set with its own ground truth establishment is not described for this type of device and study within the provided summary. The device's underlying methodology (miniaturized doubling dilution) is based on established principles, and validation is done against the CLSI reference method.

Summary

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December 8, 2017

bioMérieux, Inc. Esther Hernandez Regulatory Affairs Specialist 595 Anglum Road Hazelwood, Missouri 63042

Re: K172731

Trade/Device Name: VITEK 2 AST-GN Amikacin (<= 1 ->=64 ug/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, LTW, LTT Dated: September 7, 2017 Received: September 11, 2017

Dear Esther Hernandez:

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 Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR

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Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Ribhi Shawar -S 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) K172731

Device Name VITEK® 2 AST- GN Amikacin (≤1 -> 64 µg/mL)

Indications for Use (Describe)

In vitro data available but clinical significance unknown: Citrobacter freundii

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)

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510(k) SUMMARY

VITEK® 2 AST-GN Amikacin

510(k) Submission Information:

Submitter's Name:	bioMérieux, Inc.
Address:	595 Anglum RoadHazelwood, MO 63042
Contact Person:	Esther HernandezRegulatory Affairs Specialist
Phone Number:	314-731-8841
Fax Number:	314-731-8689
Date of Preparation:	September 7, 2017
1. Device Name:
Formal/Trade Name:	VITEK® 2 AST- GN Amikacin (≤ 1 – > 64 µg/mL)
Classification Name:	21 CFR 866.1645Fully Automated Short-Term Incubation CycleAntimicrobial Susceptibility SystemProduct Code LON
Common Name:	VITEK® 2 AST-GN Amikacin
2. Predicate Device:	VITEK® 2 AST-GN Cefepime (K161227)

D. 510(k) Summary:

VITEK® 2 AST-Gram Negative Amikacin 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 AST-Gram Negative Amikacin is a quantitative test. Amikacin 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: Pseudomonas species Escherichia coli Proteus mirabilis

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Klebsiella species Enterobacter species Serratia species Acinetobacter species (excluding A. baumannii Complex)

In vitro data available but clinical significance unknown: Citrobacter freundii

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.

VITEK® 2 AST-GN Amikacin 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 Amikacin. 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 Amikacin by comparing its performance with the CLSI broth microdilution reference method incubated at 16-20 hours (20-24 hours for Acinetobacter species). The data is representative of performance on both the VITEK® 2 Compact instrument platforms. VITEK® 2 AST-GN Amikacin demonstrated acceptable performance of 94.9% overall Essential Agreement and 98.4% overall Category Agreement with the reference method. Reproducibility and Ouality 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.”