VITEK 2 Streptococcus Meropenem is designed for antimicrobial susceptibility testing of Streptococcus species 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 Streptococcus Meropenem is a quantitative test. Meropenem 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 Streptococcus pneumoniae (penicillin-susceptible strains) Streptococcus agalactiae Streptococcus pyogenes

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.

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-ST Meropenem device, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criterion	Reported Device Performance
Overall Essential Agreement	98.6%
Overall Category Agreement	96.6%
Reproducibility	Acceptable results
Quality Control	Acceptable results

Note: The specific numerical acceptance criteria (e.g., minimum percentage for essential and category agreement) are not explicitly stated in the provided text. However, "substantially equivalent performance" is mentioned, and the reported results are described as demonstrating "acceptable performance" compared to the CLSI broth microdilution reference method, which serves as the benchmark.

2. Sample Size and Data Provenance for the Test Set

Sample Size: Not explicitly stated as a numerical value for the entire test set. The text mentions "fresh and stock clinical isolates, as well as a set of challenge strains." This suggests a varied and potentially large sample, but a concrete number is not provided.
Data Provenance: Not explicitly stated (e.g., country of origin). The isolates are described as "fresh and stock clinical isolates," implying they were derived from actual patient samples, and "challenge strains." The study was an "external evaluation," which typically means it was conducted independently or at multiple sites. It does not specify if the data was retrospective or prospective, but given the nature of AST, it's likely a mix, with clinical isolates being pre-existing (retrospective) and challenge strains potentially being specifically prepared for the study.

3. Number of Experts and Qualifications for Establishing Ground Truth (Test Set)

This information is not provided in the text. Antimicrobial Susceptibility Testing (AST) systems typically establish ground truth by comparing to a gold standard method (like CLSI broth microdilution), not usually through expert consensus on individual interpretative calls.

4. Adjudication Method (Test Set)

This information is not provided and is generally not applicable to AST systems where the ground truth is established by a reference laboratory method rather than human interpretation requiring adjudication.

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

This was not done. MRMC studies are relevant for medical imaging devices where human readers interpret images and their performance is compared with and without AI assistance. This device is an automated antimicrobial susceptibility testing system, not an imaging device.

6. Standalone Performance Study

Yes, a standalone study was done. The VITEK® 2 AST-ST Meropenem device's performance was compared directly to the CLSI broth microdilution reference method. The reported Essential Agreement (98.6%) and Category Agreement (96.6%) reflect the algorithm's (device's) performance without human-in-the-loop modifications to its results. The device "automatically fills, seals and places the card into the incubator/reader" and "monitors the growth of each well... At the completion of the incubation cycle, a report is generated that contains the MIC value along with the interpretive category result." This describes an automated, standalone process.

7. Type of Ground Truth Used

The ground truth used was the CLSI broth microdilution reference method. This is considered the gold standard for antimicrobial susceptibility testing.

8. Sample Size for the Training Set

The document does not provide specific details about a 'training set' sample size. While the initial development of such a system would involve extensive data for model building, the K132507 submission focuses on the validation study comparing the finalized device to the reference method.

9. How Ground Truth for the Training Set Was Established

The document does not provide this information. Similar to point 8, the focus is on the validation study. However, for AST systems, ground truth for training data would also typically be established using a recognized reference method like CLSI broth microdilution.

Summary

{0}------------------------------------------------

K132507

Image /page/0/Picture/1 description: The image shows a logo with the text "BIOMERIEUX" written in a stylized font. Above the text is a circular symbol divided into two halves, with the left half shaded with vertical lines and the right half solid black. A thin, curved line extends vertically through the center of the circle, adding a dynamic element to the logo.

510(k) SUMMARY

Address:

VITEK® 2 AST-ST Meropenem

510(k) Submission Information:

Submitter's Name:

bioMérieux, Inc.

595 Anglum Road Hazelwood, MO 63042

Nathan Hardesty

Staff Regulatory Affairs Specialist

VITEK® 2 AST-ST Meropenem

Contact Person:

Phone Number:

Fax Number:

314 -731-8666 314-731-8689

August 9, 2013

B. Device Name:

Formal/Trade Name:

Date of Preparation:

Classification Name:

21 CFR 866.1645 Fully Automated Short-Term Incubation Cycle Antimicrobial Susceptibility System Product Code LON

NOV 1 5 2013

Common Name:

C. Predicate Device:

VITEK 2 AST-ST Ceftriaxone (K122359)

D. 510(k) Summary:

VITEK® 2 Streptococcus Meropenem is designed for antimicrobial susceptibility testing of Streptoccus species 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 Streptococcus Meropenem is a quantitative test. Meropenem 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 Streptococcus pneumoniae (penicillin-susceptible strains) Streptococcus agalactiae Streptococcus pyogenes

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.

bioMérieux, Inc.

595 Anglum Road, Hazelwood, Missouri 63042-2320, USA Phone: 314/731-8500 800/638-4835 Fax: 314/731-8700 http://www.biomerieux-usa.com

{1}------------------------------------------------

The antimicrobial presented in VITEK 2 AST-ST 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-ST Meropeners 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-ST Meropenem. 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-ST Meropenem by comparing its performance with the CLSI broth microdilution reference method incubated at 20 - 24 hrs. The data is representative of performance on both the VITEK® 2 and VITEK® 2 Compact instrument platforms. VITEK 2 AST-ST Meropenem demonstrated acceptable performance of 98.6% overall essential Agreement and 96.6% overall category agreement with the reference method. Reproducibility and Quality Control demonstrated acceptable results.

{2}------------------------------------------------

Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular in shape, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized emblem that resembles an abstract caduceus or a symbol of health and medicine. The emblem consists of three curved lines that converge at the bottom, creating a sense of movement or flow.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

November 15, 2013

bioMerieux, Inc. c/o Mr. Nathan Hardesty Staff Regulatory Affairs Specialist 595 Anglum Road Hazelwood, MO 63042

Re: K132507

Trade/Device Name: VITEK® 2 AST-ST Meropenem (<0.06 - >4ug/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: August 27, 2013 Received: August 28, 2013

Dear Mr. Hardesty:

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

{3}------------------------------------------------

Page 2 - Mr. Hardesty

CFR Part 807); labeling (21 CFR Part 801); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree 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" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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.

Sincerely vours.

Sally AFB/Wat -S

Sally A. Hojvat, M.Sc., Ph.D. Director Division of Microbiology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

Indications for Use

510(k) Number (if known): K132507

Device Name: VITEK® 2 AST-ST Meropenem ( ≤ 0.06 - ≥ 4 µg/mL )

Indications For Use:

Active in vitro and in clinical infections Streptococcus pneumoniae (penicillin-susceptible strains) Streptococcus agalactiae Streptococcus pyogenes

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of Center for Devices and Radiological Health (CDRH)

Ribhi Shawar -S 2013.11.12 16:59:21 -05'00'

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.”