VITEK® 2 Gram Negative Levofloxacin is designed for antimicrobial susceptibility testing of Enterobacter cloacae, Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Pseudomonas aeruginosa, Serratia marcescens, Acinetobacter baumannii, Acinetobacter Iwoffi, Citrobacter koseri, Citrobacter freundii, Enterobacter aerogenes, Enterobacter sakazakii, Klebsiella oxytoca, Morganella morganii, Pantoea agglomerans, Proteus vulgaris, Providencia rettgeri, Providencia stuartii, Pseudomonas fluorescens. VITEK 2 Gram Negative Levofloxacin is a quantitative test. It 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.

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 gramnegative bacilli, Staphylococcus spp., Enterococcus spp., Streptococcus agalactiae, and S. pneumoniae.

Device Description

The antimicrobial presented in VITEK 2 AST Cards is in concentrations equivalent by efficacy to standard method concentrations in mog/m!. 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% 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 MC 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 the study details for the VITEK® 2 Gram Negative Levofloxacin device, based on the provided document:

Acceptance Criteria and Device Performance

1. Table of Acceptance Criteria and Reported Device Performance

Metric	Acceptance Criteria (Defined by FDA Guidance Document)	Reported Device Performance (VITEK® 2 Gram Negative Levofloxacin)
Overall Category Agreement	"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 Feb. 5, 2003."	95.8%
Reproducibility	Acceptable results (implied by the FDA guidance)	Acceptable results
Quality Control	Acceptable results (implied by the FDA guidance)	Acceptable results

Note: The specific numerical thresholds for "acceptable results" for reproducibility and quality control are not provided in this summary but are implicit in the cited FDA guidance document. The overall category agreement of 95.8% is explicitly stated as acceptable performance.

Study Details

2. Sample size used for the test set and the data provenance

Test Set Sample Size: Not explicitly stated as a single number. The study utilized "fresh and stock clinical isolates and stock challenge strains."
Data Provenance: Not explicitly stated (e.g., specific countries). The term "external evaluation" suggests data collected outside of the device manufacturer's core development environment, likely from multiple clinical sites. The data is retrospective and/or prospective, as it includes "fresh and stock clinical isolates" (fresh would be prospective, stock would be retrospective).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided in the given document. The ground truth was established by the CLSI broth microdilution reference method, which is a standardized laboratory procedure, not typically an assessment by human experts in the sense of clinical interpretation.

4. Adjudication method for the test set

Not applicable / None. The ground truth was established by the CLSI broth microdilution reference method, which is a direct measurement, not an adjudicated human interpretation.

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. The VITEK® 2 system is an automated device for antimicrobial susceptibility testing. It's not an AI system designed to assist human readers in interpreting images or clinical data. Its "performance" is compared to a reference method, not to human interpretation.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Yes. The study evaluated the VITEK® 2 Gram Negative Levofloxacin system (which includes the instrument and the AST cards) against the CLSI broth microdilution reference method. This is a standalone performance assessment of the automated system. The VITEK 2 automatically fills, seals, incubates, and reads the cards to generate results.

7. The type of ground truth used

CLSI broth microdilution reference method. This is a recognized standard laboratory method for determining minimum inhibitory concentrations (MICs) of antimicrobial agents.

8. The sample size for the training set

Not explicitly stated. The document describes a verification study (external evaluation) and doesn't explicitly detail a separate "training set" within the context of model development, which is typical for machine learning models. For a device like VITEK 2, the "training" data would likely refer to the extensive development and internal validation data used to optimize the algorithms for growth detection and MIC determination, which is not detailed here.

9. How the ground truth for the training set was established

Not explicitly stated. Similar to point 8, the document doesn't detail how ground truth was established for an explicit "training set." However, it's reasonable to infer that during internal development and optimization, the CLSI broth microdilution reference method (or similar gold standard methods) would have been used to establish ground truth for any data used to refine the device's algorithms.

Summary

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K072038

Image /page/0/Picture/1 description: The image shows the logo for bioMérieux. The logo consists of the company name in a stylized font, with a graphic above it. The graphic is a black circle with lines emanating from it, and a curved line extending above and below the circle.

510(k) SUMMARY

: 1 : 1 : 10 :

VITEK® 2 Gram Negative Levofloxacin

510(k) Submission Information:

Submitter's Name:	bioMérieux, Inc.
Address:	595 Anglum RoadHazelwood, MO 63042
Contact Person:	Jolyn TeniladoSenior Regulatory Affairs Specialist
Phone Number:	314-731-8386
Fax Number:	314-731-8689
Date of Preparation:	July 20, 2007
B. Device Name:
Formal/Trade Name:	VITEK® 2 Gram Negative Levofloxacin (≤ 0.12 - ≥ 8µg/ml)
Classification Name:	Fully Automated Short-Term Incubation CycleAntimicrobial Susceptibility Device, 21 CFR 866.1645
Common Name:	VITEK 2 AST-GN Levofloxacin
C. Predicate Device:D. 510(k) Summary:	VITEK 2 Gram Negative Ertapenem (K041982).

VITEK® 2 Gram Negative Levofloxacin is designed for antimicrobial susceptibility testing of Enterpbacter cloacae, Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Pseudomonas aeruginosa. Serratia marcescens. Acinetobacter baumannii, Acinetobacter twoffi, Citrobacter koseri, Čitrobacter freundii, Enterobacter aerogenes, Enterobacter sakazakii, Klebsiella oxytoca, Morqanella morqanii, Pantoea agglomerans, Proteus vulgaris, Providencia rettgeri, Providencia stuartii. Pseudomonas fluorescens. It 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. The antimicrobial presented in VITEK 2 AST Cards is in concentrations equivalent by efficacy to standard method concentrations in mog/m!. 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.

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VITEK 2 Gram Negative Levofloxacin 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 Feb. 5, 2003 .*

The Premarket Notification (510[k]) presents data in support of VITEK 2 Gram Negative Levofloxacin. An external evaluation was conducted with fresh and stock clinical isolates and stock challenge strains. The external evaluations were designed to confirm the acceptability of VITEK 2 Gram Negative Levofloxacin 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 Negative Levofloxacin demonstrated acceptable performance of 95,8% overall Category Agreement. Reproducibility and Quality Control demonstrated acceptable results.

*Note: This device clinical trial was initiated prior to the March 5, 2007 issuance of the revised guidance, which is why the older guidance document is cited.

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

SEP 1 2 2007

Ms. Joyln Tenllado Senior Regulatory Affairs Specialist bioMérieux, Inc. 595 Anglum Road Hazelwood, MO 63042

K072038 Re: Trade/Device Name: VITEK® 2 Gram Negative Levofloxacin (≤0.12 - ≥8μg/ml) Regulation Number: 21 CFR 866.1645 Regulation Name: Fully Automated Short-Term Incubation Cycle Antimicrobial Susceptibility Devices Regulatory Class: Class II Product Code: LON Dated: July 20, 2007 Received: July 25, 2007

Dear Ms. Tenllando:

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 or clossified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that clannt 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 publiah 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 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 et freth 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 yours,

Sally attaym

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

K072038 510(k) Number (if known):_

Device Name: VITEK® 2 Gram Negative Levofloxacin (≤ 0.12 – ≥ 8 µg/ml)

Indications For Use:

Prescription Use X (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)

Rourrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) vision Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

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510(k)_14072038

p. 10

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.”