The VITEK® 2 Compact System is intended to be used with VITEK® 2 AST Cards for the automated quantitative or qualitative susceptibility testing of isolated colonies for most clinically significant aerobic gram-negative bacilli, Staphylococcus spp., Enterococcus spp., Streptococcus agalactiae and S. pneumoniae. It is intended for use as a laboratory aid in the determination of in vitro susceptibility to antimicrobial agents.

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 AST card. The cards are filled with a vacuum filling process, sealed and placed into the reader/incubator. The VITEK 2 Compact monitors growth based on attenuation of light measured by an optical scanner 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 Our pleation of the interpretive category result for each antibiotic contained on the VITEK 2 AST Card.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the VITEK® 2 Compact, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Stated or Implied)	Reported Device Performance (VITEK® 2 Compact compared to VITEK® 2 System)
Challenge Testing Performance	99.4% agreement with the VITEK® 2 System.
Reproducibility (Essential Agreement comparing median MIC values)	100% essential agreement.
Precision (Essential agreement comparing individual results to instrument median)	97.79% essential agreement.
Quality Control (New range for quality control)	99.04% in range.
Substantial Equivalence with Predicate	The device "demonstrated substantially equivalent performance when compared to the VITEK® 2 System" and a "substantial equivalence determination" was issued by the FDA. This implies that the performance metrics met the criteria for substantial equivalence to the predicate.

2. Sample Size and Data Provenance

Test Set Sample Size: Not explicitly stated as a number. The text mentions "External evaluations were conducted with a test set of challenge, reproducibility and quality control for both gram-negative and gram-positive organisms."
Data Provenance: Not explicitly stated (e.g., country of origin). The study was described as "External evaluations," suggesting it was conducted outside of bioMérieux's direct control. The filing is with the US FDA, so it's likely relevant to the US regulatory context.
Retrospective/Prospective: Not explicitly stated. The nature of the "challenge, reproducibility and quality control" testing suggests it was prospective, conducted specifically to evaluate the new device.

3. Number of Experts and Qualifications for Ground Truth

Not explicitly stated. The ground truth for comparative performance in this context is the results obtained from the predicate device, the VITEK® 2 System. There is no mention of human experts establishing ground truth for individual cases outside of the predicate device's output.

4. Adjudication Method for the Test Set

Not applicable in the human expert sense. The "ground truth" for comparison was the performance of the predicate VITEK® 2 System itself. The performance data presented (e.g., % agreement) directly compares the new device's output to the predicate's output.

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

No. This is not a study involving human readers or interpretation of medical images or other data where AI would assist human readers. It's an automated antimicrobial susceptibility testing device, comparing its automated results to those of a predicate automated device.

6. Standalone Performance

Yes. The study evaluates the performance of the VITEK® 2 Compact device on its own, comparing its output directly to the predicate device. This is by nature a standalone performance assessment. The device generates "the MIC value and the interpretive category result for each antibiotic."

7. Type of Ground Truth Used

The ground truth used for comparison was the results obtained from the predicate device (VITEK® 2 System). The text states: "The VITEK® 2 Compact demonstrated substantially equivalent performance when compared to the VITEK® 2 System."

8. Sample Size for the Training Set

Not applicable/not provided. This device is not described as using machine learning or needing a "training set" in the conventional AI sense. It's an automated system based on established microbiological principles (attenuation of light over time to determine growth and MIC).

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

Not applicable. As noted above, this device does not appear to utilize a training set in the AI machine learning context. Its operation is based on an optical scanner monitoring growth and calculating values, essentially mimicking the doubling dilution technique.

Summary

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FEB 7 2005

Image /page/0/Picture/1 description: The image shows the logo for bioMérieux. The logo consists of the word "BIOMÉRIEUX" in a stylized font, with a graphic above it. The graphic appears to be a stylized representation of a cell or sphere with a line extending from the top and bottom.

1050002

510(k) SUMMARY

VITEK® 2 Compact

510(k) Submission Information:

Submitter's Name:	bioMérieux, Inc.
Address:	595 Anglum RoadHazelwood, MO 63042
Contact Person:	Nancy WeaverStaff Regulatory Affairs Specialist
Phone Number:	314-731-8695
Fax Number:	314-731-8689
Date of Preparation:	December 30, 2004
B. Device Name:
Formal/Trade Name:	VITEK® 2 Compact
Classification Name:	Fully Automated Short-Term Incubation CycleAntimicrobial Susceptibility Device,21 CFR 866.1645
Common Name:	VITEK 2 Compact System
C. Predicate Device:	VITEK® 2 System (N50510/S082)

D. 510(k) Summary:

VITEK® 2 Compact System is intended to be used with VITEK® 2 AST Cards for the automated quantitative or qualitative susceptibility testing of isolated colonies for most clinically significant aerobic gram-negative bacilli, Staphylococcus spp., Enterococcus spp., Streptococcus agalactiae and S. pneumoniae. It is intended for use as a laboratory aid in the determination of in vitro susceptibility to antimicrobial agents. Antimicrobials presented in VITEK 2 AST Cards are 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.

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 AST card. The cards are filled with a vacuum filling process, sealed and placed into the reader/incubator. The VITEK 2 Compact monitors growth based on attenuation of light measured by an optical scanner over a defined period of time (up to 18 hours). At the

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completion of the incubation cycle, a report is generated that contains the MC value Our pleation of the interpretive category result for each antibiotic contained on the VITEK 2 AST Card.

The VITEK 2 Compact demonstrated substantially equivalent performance when He VITEK 2 System. The Premarket Notification (510[k]) presents data in support of VITEK 2 Compact System. External evaluations were conducted with at six in support of VTER 2 Tompatic of challenge, reproducibility and quality control for both gram-negative and gram-positive organisms. The VITEK 2 Compact control for both grain negative and of 99.4% for challenge testing when compared to the VITEK 2. Reproducibility was 100% essential agreement when comparing median virent z. Noproducilling the VITEK 2 System. Precision dilution differences comparing individual results to the instrument median demonstrated 97.79% essential companing increation to the new in range for quality control was 99.04%.

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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 - USA" around the perimeter. Inside the circle is a stylized image of an eagle with three lines representing its wings.

FEB 1 7 2005

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Nancy Weaver Staff Regulatory Affairs Specialist BioMérieux, Inc. 595 Anglum Road Hazelwood, MO 63042-2320

K050002 Re: Trade/Device Name: VITEK® 2 Compact 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: December 30, 2004 Received: January 3, 2005

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) This letter witi anow you to ogin manical equivalence of your device of your device to a legally premarket notification: "The sults in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific information about the application of labeling requirements to your device, If you desire specific into this in advertising of your device, please contact the Office of In of questions on the prome Evaluation and Safety at (240)276-0484. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Tou may obtain other general information on your responsibilities under the Act from the Tou may obtain of Scherers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html

Sincerely yours,

Sales, a Form

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): K050002

VITEK® 2 Compact Device Name:

Indications For Use:

The VITEK® 2 Compact is intended to be used for the automated quantitative or qualitative susceptibility testing of isolated colonies for most clinically significant aerobic gram-negative bacilli, Staphylococcus spp., Enterococcus spp., Streptococus agalactiae and S. pneumoniae.

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)

Hoeym Wht
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Office of In Vitro Diagnostic Device Evaluation and Safety

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VITEK® 2 Compact 510(k) Volume 1: p. 9

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.”