VITEK® 2 Gram Negative Trimethoprim/sulfamethoxazole is designed for antimicrobial susceptibility testing of gram-negative organisms 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 Trimethoprim/sulfamethoxazole is a quantitative test. Trimethoprim/sulfamethoxazole 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

Escherichia coli (including susceptible enterotoxigenic strains implicated in traveler's diarrhea)

Klebsiella species Enterobacter species Morganella morganii Proteus vulgaris

Proteus mirabilis Shigella flexneri Shigella sonnei

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 gram-negative 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% 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 an analysis of the provided text regarding the VITEK® 2 Gram Negative Trimethoprim/sulfamethoxazole device, focusing on acceptance criteria and study details:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by the FDA Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems; Guidance for Industry and FDA, Issued Feb. 5, 2003. The specific metric mentioned for performance is overall Category Agreement.

Acceptance Criteria (from FDA Guidance)	Reported Device Performance
Acceptable performance as defined in the FDA Guidance Document for AST Systems	100% Overall Category Agreement

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

Sample Size for Test Set: The document mentions "fresh and stock clinical isolates and stock challenge strains" for the external evaluation, but it does not specify the exact number (sample size) of isolates used in this test set.
Data Provenance: The external evaluation was conducted. The country of origin is not explicitly stated, but it's likely primarily US-based given the FDA regulatory context. The isolates included "fresh and stock clinical isolates and stock challenge strains," indicating a mix of retrospective (stock isolates) and prospective (fresh clinical isolates) data.

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

The document does not specify the number or qualifications of experts used to establish the ground truth. However, for antimicrobial susceptibility testing, the "gold standard" or reference method (CLSI broth microdilution) inherently involves expert-defined protocols and interpretation.

4. Adjudication Method for the Test Set

The document does not describe an adjudication method for the test set in the traditional sense of multiple readers reviewing results. The comparison is made directly against the CLSI broth microdilution reference method.

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

Was it done? No, an MRMC comparative effectiveness study was not conducted. This type of study is typically for evaluating human reader performance with and without AI assistance in diagnostic imaging, which is not applicable to an automated antimicrobial susceptibility test system.
Effect size: Not applicable, as no such study was performed.

6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance

Was it done? Yes, the performance described for the VITEK® 2 Gram Negative Trimethoprim/sulfamethoxazole is a standalone (algorithm only) performance. The device determines the MIC value and interpretive category automatically after incubation. The comparison is against the reference method, showing the device's inherent accuracy.

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, providing quantitative Minimum Inhibitory Concentration (MIC) values.

8. Sample Size for the Training Set

The document does not explicitly mention a separate "training set" sample size or details about the development process that would typically involve a training phase for a machine learning model. For AST devices like VITEK, the "training" analogous to model development often involves extensive internal testing and refinement against reference methods during product development, prior to the external validation described. The current submission focuses on the validation of the finalized device.

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

Since a distinct "training set" with established ground truth is not explicitly described, the method for establishing its ground truth is not provided. However, based on the nature of these devices, the development process would involve comparing device results against the CLSI broth microdilution reference method for a vast number of isolates during the initial design and optimization phases.

Summary

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K073406

Image /page/0/Picture/1 description: The image shows the logo for bioMérieux. The logo features a stylized image of a cell or sphere with radiating lines, bisected by a curved line. Below the image is the company name, "BIOMÉRIEUX," in a sans-serif font.

510(k) SUMMARY

JAN 2 3 2008

VITEK® 2 Gram Negative Trimethoprim/sulfamethoxazole

510(k) Submission Information:

	Submitter's Name:	bioMérieux, Inc.
	Address:	595 Anglum RoadHazelwood, MO 63042
	Contact Person:	Nancy WeaverAssociate Director, Regulatory Affairs
	Phone Number:	314-731-8695
	Fax Number:	314-731-8689
	Date of Preparation:	November 29, 2007
B.	Device Name:
	Formal/Trade Name:	VITEK® 2 Gram NegativeTrimethoprim/sulfamethoxazole( $≤$ 1/19 - $≥$ 16/304 µg/ml)
	Classification Name:	Fully Automated Short-Term Incubation CycleAntimicrobial Susceptibility Device, 21 CFR 866.164
	Common Name:	VITEK 2 AST-GN SXT
C.	Predicate Device:
		VITEK 2 Gram Negative Ertapenem (K041982).

D. 510(k) Summary:

VITEK® 2 Gram Negative Trimethoprim/sulfamethoxazole is designed for antimicrobial susceptibility testing of Escherichia coli, Klebsiella sp., Enterobacter sp., Morganella morganii, Proteus mirabilis, Proteus vulgaris, Shigella flexneri and Shigella sonnei. VITEK 2 Gram Negative Trimethoprim/Sulfamethoxazole 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 antimicrobial presented in VITEK 2 AST Cards is in concentrations equivalent by efficacy to standard method concentrations in mog/ml. 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 800/638-4835 Fax: 314/731-Phone: 314/731-8500 8700

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VITEK 2 Gram Negative Trimethoprim/sulfamethoxazole 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 Trimethoprim/sulfamethoxazole. 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 Trimethoprim/sulfamethoxazole 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 Trimethoprim/sulfamethoxazole demonstrated acceptable performance of 100% 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 earlier guidance document is cited.

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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 consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES U.S.A." arranged around the perimeter. Inside the circle is a stylized symbol that resembles an abstract caduceus or a representation of human figures. The symbol is composed of three curved lines that converge at the bottom, creating a sense of movement or flow.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JAN 23 2008

Ms. Nancy Weaver Associate Director, Regulatory Affairs bioMérieux, Inc. 595 Anglum Road Hazelwood, MO 63042

K073406 Re: Trade/Device Name: VITEK 2® Gram Negative Trimethoprim/sulfamethoxazole (≤ 1/19 – 16/304 µg/ml) Regulation Number: 21 CFR 866.1645 Regulation Name: Fully Automated Short-Term Incubation Cycle Antimicrobial Susceptibility Device Regulatory Class: Class II Product Code: LON Dated: November 29, 2007 Received: December 4, 2007

Dear Ms. Weaver:

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 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); 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 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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Indication for Use

510(k) Number (if known): k07 3406

Device Name: VITEK® 2 Gram Negative Trimethoprim/sulfamethoxazole (< 1/19 - > 16/304 ug/ml)

Indication For Use:

Active in vitro and in clinical infections

Escherichia coli (including susceptible enterotoxigenic strains implicated in traveler's diarrhea)

Klebsiella species Enterobacter species Morganella morganii Proteus vulgaris

Proteus mirabilis Shigella flexneri Shigella sonnei

Prescription Use _ X (21 CFR Part 801 Subpart D) Over the Counter Use (21 CFR Part 801 Subpart C)

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

And/Or

Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OVD)

.
Judith McRobb

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K073406

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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.”