VITEK® 2 Gram Positive Daptomycin 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 Daptomycin is a quantitative test. Daptomycin has been shown to be active against the microorganisms listed below according to the FDA label for the antimicrobial.

Active in vitro and in clinical infections:

Enterococcus faecalis (vancomycin-susceptible strains only) Staphylococcus aureus (including methicillin-resistant strains)

The VITEK® 2 Antimicrobial Susceptibility Test (AST) is intended to be used with the VITEK® 2 and VITEK® 2 Compact Systems for the automated quantitative or qualitative susceptibility testing of isolated colonies for the most clinically significant aerobic gramneqative bacilli, Staphylococcus spp., Enterococcus spp., Streptococcus agalactiae, and S. pneumoniae.

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 bacterial 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 System 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 antibiotic contained on the card.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study details for the VITEK® 2 Gram Positive Daptomycin device, based on the provided 510(k) summary:

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated as numerical targets in the provided text. However, the study aims to demonstrate "substantially equivalent performance" to 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 March 5, 2007.

The reported performance directly addresses the "Category Agreement" as a key metric for demonstrating substantial equivalence.

Performance Metric	Acceptance Criteria (Implicit)	Reported Device Performance
Overall Category Agreement	Substantially equivalent to CLSI broth microdilution reference method (as per FDA guidance)	98.4%
Reproducibility	Acceptable results (as defined by FDA guidance for AST systems)	Acceptable results
Quality Control	Acceptable results (as defined by FDA guidance for AST systems)	Acceptable results

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

Sample Size for Test Set: The exact numerical sample size for "fresh clinical isolates" and "stock challenge strains" is not provided. It is stated as "an external evaluation was conducted with fresh clinical isolates and stock challenge strains."
Data Provenance: The data is described as an "external evaluation" using "fresh clinical isolates and stock challenge strains." This suggests a prospective collection of isolates, though the specific country of origin is not mentioned. Given bioMérieux's location in Missouri, USA, it's highly probable the isolates were collected in the United States.

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

This information is not provided in the summary. For Antimicrobial Susceptibility Test (AST) systems, the "ground truth" is typically established by a recognized reference method (like CLSI broth microdilution), rather than human experts adjudicating results. The CLSI method itself has established protocols for accuracy and reliability.

4. Adjudication Method for the Test Set

This information is not applicable/provided in the context of an AST device where the ground truth is established by a reference method (CLSI broth microdilution), rather than human consensus.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

This is not applicable to this device. The VITEK® 2 system is an automated AST system that provides quantitative and interpretive results. It is not an AI-assisted diagnostic tool that human readers would interpret. Therefore, an MRMC study assessing human reader improvement with AI assistance is not relevant.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, this was a standalone performance study. The VITEK® 2 system is automated and its performance was directly compared to the CLSI broth microdilution reference method without human intervention during the test result generation by the VITEK® 2 system. The reported "98.4% overall Category Agreement" reflects the standalone performance of the device.

7. The Type of Ground Truth Used

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

8. The Sample Size for the Training Set

This information is not provided in the summary. The VITEK® 2 system is a well-established automated diagnostic platform, and its underlying methodology for determining MICs is based on miniaturized doubling dilution techniques rather than machine learning models that require explicit "training sets" in the conventional sense. The "training" for such systems involves extensive development and validation against reference methods to ensure accuracy across a wide range of microorganisms and antimicrobial concentrations.

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

This information is not provided and is likely not applicable in the typical sense of machine learning training. The VITEK 2 system's operational principles are based on established microbiological methods (doubling dilution technique), not on a "training set" that requires external ground truth establishment. The development process for such a system would involve rigorous optimization and internal validation against the CLSI reference method to ensure its algorithms accurately determine MICs.

Summary

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K091126

JUN 18 2009

510(k) SUMMARY

VITEK® 2 Gram Positive Daptomycin

510(k) Submission Information:

Submitter's Name:	bioMérieux, Inc.
Address:	595 Anglum RoadHazelwood, MO 63042
Contact Person:	Jolyn TenlladoAssociate Staff Regulatory Affairs Specialist
Phone Number:	314-731-8386
Fax Number:	314-731-8689
Date of Preparation:	April 17, 2009
B. Device Name:
Formal/Trade Name:	VITEK® 2 Gram Positive Daptomycin (≤ 0.12 - ≥ 8 µg/ml)
Classification Name:	Fully Automated Short-Term Incubation CycleAntimicrobial Susceptibility Device, 21 CFR 866.1645
Common Name:	VITEK 2 AST-GP Daptomycin
C. Predicate Device:	VITEK 2 Gram Positive Vancomycin (K072668)

BIGMÉ

RIE U X

D. 510(k) Summary:

VITEK® 2 Gram Positive Daptomycin 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 Daptomycin is a quantitative test. Daptomycin has been shown to be active against the microorganisms listed below according to the FDA label for the antimicrobial.

Active in vitro and in clinical infections:

Enterococcus faecalis (vancomycin-susceptible strains only) Staphylococcus aureus (including methicillin-resistant strains)

The antimicrobial presented in VITEK 2 AST Cards is in concentrations equivalent by efficacy to standard method concentrations in mooml. The VITEK 2 AST Cards are essentially miniaturized versions of the doubling dilution technique for determining the minimum inhibitory concentration (MIC) microdilution methodology.

bioMérieux, Inc.

595 Anglum Road, Hazelwood, Missouri 63042-2320, USA Phone: 314/731-8500 800/638-4835 Fax: 314/731-8700

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generated that contains the MIC value along with the interpretive category result for each antibiotic contained on the card.

VITEK 2 Gram Positive Daptomycin 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 March 5, 2007.

The Premarket Notification (510[k]) presents data in support of VITEK 2 Gram Positive Daptomycin. An external evaluation was conducted with fresh clinical isolates and stock challenge strains. The external evaluations were designed to confirm the acceptability of VITEK 2 Gram Positive Daptomycin by comparing its performance with the CLSI broth microdilution reference method. The data is representative of performance on both the VITEK 2 and VITEK 2 Compact instrument platforms, as evidenced in the AST equivalency study presented in the VITEK 2 Compact 510(k), K050002. VITEK 2 Gram Positive Daptomycin demonstrated acceptable performance of 98,4% overall Category Agreement. Reproducibility and Quality Control demonstrated acceptable results.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes representing the three levels of government: federal, state, and local. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.

Public Health Service

JUN 18 2009 Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Jolyn Tenllado Associate Staff Regulatory Affairs Specialist bioMérieux 595 Anglum Road Hazelwood, MO 63042

Re: K091126

Trade/Device Name: VITEK® 2 Gram Positive Daptomycin (≤ 0.12 -> 8 µg/ml) Regulation Number: 21 CFR 866.1645 Regulation Name: Short-Term Antimicrobial Susceptibility Test System Regulatory Class: Class II Product Code: LON Dated: April 17, 2009 Received: April 20, 2009

Dear Ms Tenllado:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 deternination 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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at 240-276-0450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

Sally attagin

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

Enclosure

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Indications for Use

510(k) Number (if known): K091126

Device Name: VITEK® 2 Gram Positive Daptomycin (≤ 0.12 - > 8 µg/ml)

Indications For Use:

Active in vitro and in clinical infections:

Enterococcus faecalis (vancomycin-susceptible strains only) Staphylococcus aureus (including methicillin-resistant strains)

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 CDRH, Office of In Vitro Diagnostic Devices (OIVD)

foe alton

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(K) K071126

Page 1 of 1

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.”