VITEK® 2 Gram Positive Ceftaroline is designed for antimicrobial susceptibility testing of Gram positive microorganisms 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 Positive Ceftaroline is a quantitative test. Ceftaroline 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 Staphylococcus aureus (including methicillin-susceptible and -resistant isolates) 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., 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 the study details for the VITEK® 2 AST-GP Ceftaroline device, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Metric)	Target	Reported Device Performance
Overall Essential Agreement (EA)	≥ 90% (Implicit based on standard AST system guidance)	97.9%
Overall Category Agreement (CA)	≥ 90% (Implicit based on standard AST system guidance)	99.2%
Reproducibility	Acceptable	Acceptable Results
Quality Control	Acceptable	Acceptable Results

Note: The specific numerical targets for Essential Agreement and Category Agreement are not explicitly stated in the document, but for antimicrobial susceptibility testing (AST) systems, FDA guidance typically expects performance well above 90% for these metrics to demonstrate substantial equivalence.

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

Sample Size: Not explicitly stated in terms of an exact number of isolates. The document mentions "fresh and stock clinical isolates, as well as a set of challenge strains." This implies a diverse and representative set of strains, but the specific count is missing.
Data Provenance: Not explicitly stated. The study was an "external evaluation," which generally means it was conducted independently of the device developer. The geographic origin (e.g., country) is not specified, nor is whether the clinical isolates were retrospective or prospectively collected.

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

Number of Experts: Not applicable. The ground truth was established by a reference method, not by human experts.
Qualifications of Experts: N/A

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable. The comparison was made against a single, established reference method (CLSI broth microdilution); therefore, no adjudication among multiple expert readers was necessary.

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

Was it done?: No. This type of study is typically performed for imaging or diagnostic devices where human readers interpret results. The VITEK® 2 system is an automated AST system that provides quantitative and interpretive results directly.
Effect Size of human reader improvement: N/A

6. Standalone Performance Study (Algorithm only without human-in-the-loop performance)

Was it done?: Yes. The study directly compared the VITEK® 2 AST-GP Ceftaroline's performance to the CLSI broth microdilution reference method. The VITEK® 2 system operates autonomously to determine MIC values and interpretive categories, so this constitutes a standalone performance evaluation.

7. Type of Ground Truth Used

Type of Ground Truth: The ground truth was established by the CLSI broth microdilution reference method, incubated at 16-20 hours. This is the gold standard for antimicrobial susceptibility testing.

8. Sample Size for the Training Set

Sample Size for Training Set: Not explicitly stated. The document focuses on the external evaluation for efficacy, which is analogous to a test set. Information regarding a separate training set used during the development of the VITEK® 2 AST-GP Ceftaroline algorithm is not provided in this summary.

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

How Ground Truth for Training Set Was Established: Not explicitly stated. Given that no separate training set details are provided, it's presumed that the development of the VITEK® 2 algorithm would have involved extensive in-house testing and calibration against reference methods, similar to how the final evaluation was conducted. However, the exact process and ground truth source for training (if applicable in a traditional machine learning sense, which may not be directly applicable to this type of device development) are not detailed here.

Summary

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K/41149

Image /page/0/Picture/1 description: The image shows the logo for bioMerieux. The logo consists of the word "BIOMERIEUX" in a stylized font, with a circular symbol above it. The circle is divided in half, with the left half filled with horizontal lines and the right half solid black. A curved line runs vertically through the center of the circle and the text.

JUN 20 2014 VITEK® 2 AST-GP Ceftaroline

Traditional 510(k) Submission

510(k) SUMMARY

VITEK® 2 AST-GP Ceftaroline

510(k) Submission Information:

Submitter's Name: Address:

bioMérieux, Inc.

Charlene Ferrand Regulatory Affairs Officer

314 -731-8630

314-731-8689

21 CFR 866.1645

Product Code LON

595 Anglum Road Hazelwood, MO 63042

Contact Person:

Phone Number:

Fax Number:

Date of Preparation:

April 8th, 2014

VITEK® 2 AST-GP Ceftaroline

Antimicrobial Susceptibility System

VITEK® 2 AST-GP Ceftaroline

B. Device Name:

Formal/Trade Name:

Classification Name:

Common Name:

VITEK® 2 AST-GP Clindamycin (K122547)

Fully Automated Short-Term Incubation Cycle

D. 510(k) Summary:

C. Predicate Device:

Active in vitro and in clinical infections

Staphylococcus aureus (including methicillin-susceptible and -resistant isolates)

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 microorganisms, Staphylococcus spo., Enterococcus spo., Streptococcus spp. and clinically significant yeast.

The antimicrobial presented in VITEK 2 AST-GP Cards is in concentrations equivalent by efficacy to standard method concentrations in mcg/ml. The VITEK® 2 AST Cards are essentially miniaturized

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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.

VITEK 2 AST-GP Ceftaroline 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-GP Ceftaroline. An external evaluation was conducted with fresh and stock clinical isolates, as well as a set of challenge The external evaluations were designed to confirm the acceptability of VITEK® 2 AST-GP strains. Ceftaroline 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-GP Ceftaroline demonstrated acceptable performance of 97.9% overall essential Agreement and 99.2% overall category agreement with the reference method. Reproducibility and Quality Control demonstrated acceptable results.

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Image /page/2/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" in bold, uppercase letters. The text is horizontally oriented and appears to be a header or title. The font is a sans-serif typeface, and the overall impression is one of official documentation or signage.

Public Health Service

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

BIOMERIEUX, INC. CHARLENE FERRAND 595 ANGLUM RD. HAZELWOOD MO 63042-2320

June 20, 2014

Re: K141149

Trade/Device Name: VITEK® 2 AST-GP Ceftaroline (<0.06- ≥4μg/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 7, 2014 Received: May 8, 2014

Dear Ms. Ferrand:

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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) 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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Page 2-Ms. Ferrand

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.

Uwe Scherf -S for

Sally Hojvat, 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known) K141149

Device Name

VITEK® 2 AST-GP Ceftaroline ( < 0.06 - ≥4 µg/mL)

Indications for Use (Describe)

Active in vitro and in clinical infections

Staphylococcus aureus (including methicillin-susceptible and -resistant isolates)

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 arrobic gram-negative bacilli, Staphylococcus spp., Enterococcus spp., and clinically significant yeast.

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

Ribhi Shawar -S 2014.06.20 11:01:26 -04'00'

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

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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.”