VITEK® 2 Gram Negative Ciprofloxacin 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 Ciprofloxacin is a quantitative test. Ciprofloxacin 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 Citrobacter freundii Citrobacter koseri (diversus) Enterobacter cloacae Escherichia coli Klebsiella pneumonia Morganella morganii Proteus mirabilis Proteus vulgaris Providencia rettgeri Providencia stuartii Pseudomonas aeruginosa Salmonella typhi Serratia marcescens Shigella sonnei

In vitro data available but clinical significance is unknown Enterobacter aerogenes Klebsiella oxytoca Salmonella enteritidis

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, 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

Here's a breakdown of the acceptance criteria and the study details for the VITEK® 2 AST-GN Ciprofloxacin device, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly derived from the statement, "VITEK® 2 AST-GN Ciprofloxacin 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 document does not explicitly state numerical acceptance criteria, but rather reports the device's performance against the reference method.

Performance Metric	Acceptance Criteria (Implied by FDA Guidance)	Reported Device Performance
Overall Essential Agreement	Substantially Equivalent (as per FDA Guidance)	97.1%
Overall Category Agreement	Substantially Equivalent (as per FDA Guidance)	97.1%
Reproducibility	Acceptable (as per FDA Guidance)	Acceptable Results
Quality Control	Acceptable (as per FDA Guidance)	Acceptable Results

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

The document states: "An external evaluation was conducted with fresh and stock clinical isolates, as well as a set of challenge strains." However, it does not provide the specific sample size (number of isolates) for the test set. The data provenance is described as "clinical isolates," implying a retrospective nature, and "challenge strains," which are laboratory-derived. The country of origin for the data is not specified.

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

The document does not provide information on the number of experts used or their qualifications to establish the ground truth.

4. Adjudication Method for the Test Set

The document does not specify an adjudication method.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study, nor does it discuss any effect size of AI assistance on human readers. This device is an automated antimicrobial susceptibility system, not a human-interpreted diagnostic imaging tool.

6. Standalone Performance

Yes, a standalone performance study was done. The "external evaluation" comparing the VITEK® 2 AST-GN Ciprofloxacin to the CLSI broth microdilution reference method represents the standalone performance of the algorithm/device. The VITEK® 2 system is described as automated.

7. Type of Ground Truth Used

The ground truth used was the CLSI broth microdilution reference method. This is considered a gold standard for determining Minimum Inhibitory Concentrations (MICs) of antimicrobial agents.

8. Sample Size for the Training Set

The document does not provide a sample size for a training set. Automated AST systems typically rely on pre-established algorithms derived from extensive microbiology knowledge and data, rather than a distinct "training set" in the machine learning sense described here. The study focuses on validation against a reference method.

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

Since there is no explicitly mentioned "training set" in the context of machine learning, the document does not describe how ground truth for a training set was established. The "ground truth" referenced for the performance evaluation is the CLSI broth microdilution reference method.

Summary

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

June 21, 2017

BIOMERIEUX, INC CHERECE JONES STAFF REGULATORY AFFAIRS SPECIALIST 595 ANGLUM RD. HAZELWOOD MO 63042

Re: K162737

Trade/Device Name: VITEK 2 AST-GN Ciprofloxacin (< 0.06 ->4 ug/ml) Regulation Number: 21 CFR 866.1645 Regulation Name: Fully automated short-term incubation cycle antimicrobial susceptibility system Regulatory Class: II

Product Code: LON Dated: May 17, 2017 Received: May 18, 2017

Dear Ms. Jones:

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/Resourcesfor You/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 -S For

Uwe Scherf, M.Sc., PhD. 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) K162737

Device Name

VITEK® 2 AST-GN Ciprofloxacin (≤ 0.06 ->4 µg/mL)

Indications for Use (Describe)

In vitro data available but clinical significance is unknown Enterobacter aerogenes Klebsiella oxytoca Salmonella enteritidis

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

VITEK® 2 AST-GN Ciprofloxacin

510(k) Submission Information:

Submitter's Name:	bioMérieux, Inc.
Address:	595 Anglum RoadHazelwood, MO 63042
Contact Person:	Cherece L. JonesStaff Regulatory Affairs Specialist
Phone Number:	314 -731-8684
Fax Number:	314-731-8689
Date of Preparation:	September 29, 2016
Device Name:
Formal/Trade Name:	VITEK® 2 AST-GN Ciprofloxacin (≤ 0.06 – > 4ug/mL)
Classification Name:	21 CFR 866.1645Fully Automated Short-Term Incubation CycleAntimicrobial Susceptibility SystemProduct Code: LON
Common Name:	VITEK® 2 AST-GN Ciprofloxacin
Predicate Device:	VITEK® 2 GN Doxycycline (K121546)

D. 510(k) Summary:

VITEK® 2 Gram Negative Ciprofloxacin 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 Ciprofloxacin is a quantitative test. Ciprofloxacin 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 Citrobacter freundii

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Citrobacter koseri (diversus) Enterobacter cloacae Escherichia coli Klebsiella pneumonia Morganella morganii Proteus mirabilis Proteus vulgaris Providencia rettgeri Providencia stuartii Pseudomonas aeruginosa Salmonella typhi Serratia marcescens Shigella sonnei

In vitro data available but clinical significance is unknown Enterobacter aerogenes Klebsiella oxytoca Salmonella enteritidis

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 Ciprofloxacin 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).

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The Premarket Notification (510[k]) presents data in support of VITEK® 2 AST-GN Ciprofloxacin. 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 Ciprofloxacin 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 Ciprofloxacin demonstrated acceptable performance of 97.1% overall Essential Agreement and 97.1% overall Category Agreement with the reference method. 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.”