The VITEK® 2 Gram Positive AST Panel for Streptococcus pneumoniae: Levofloxacin is intended for use with the VITEK® 2 System in clinical laboratories as an in vitro test to determine the susceptibility of Streptococcus pneumoniae to antimicrobial agents. The antimicrobial presented in the VITEK® 2 AST panel is in concentrations equivalent by efficacy to standard method concentrations in mcg/ml.

Device Description

The VITEK 2 Gram Positive AST Panel for Streptococcus pneumoniae: Levofloxacin is intended for use with the VITEK® 2 System in clinical laboratories as an in vitro test to intendou the susceptibility of Streptococcus pneumoniae to antimicrobial agents. The antimicrobial presented in the VITEK® 2 AST panel is in concentrations equivalent by afficacy to standard method concentrations in mcg/ml. The AST panels are essentially miniaturized versions of the doubling dilution technique for determining the minimum inhibitory concentration (MIC) my microdilution methodology.

The VITEK 2 system automatically fills the AST panels with a standardized organism suspension. The organism suspension may either be prepared automatically by the VITEK 2 or prepared manually. The filled AST panels are automatically sealed and loaded into the optical reader/incubator. Temperature is monitored and controlled throughout the incubation cycle. Organism growth in the test panel is continually monitored by the optical system. Optical readings are transformed by the VITEK 2 System into antimicrobial MIC's and category (Sensitive/Intermediate/Resistant) interpretations.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study details for the VITEK® 2 Gram Positive AST Panel for Streptococcus pneumoniae: Levofloxacin, based on the provided text:

Acceptance Criteria and Device Performance

Acceptance Criteria	Reported Device Performance
Acceptable performance when compared with an NCCLS frozen Reference Panel, as defined in the FDA DRAFT document "Guidance on Review Criteria for Assessment of Antimicrobial susceptibility Devices", dated March 8, 2000.	99.8% overall Essential Agreement with automatic dilution when compared to the frozen reference panel.
Acceptable reproducibility (for both automatic and manual dilution methods).	Demonstrated acceptable reproducibility.
Acceptable Quality Control results.	Demonstrated acceptable Quality Control results.

Study Details

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

Test set: The text mentions an "external evaluation ... with fresh and stock clinical isolates and stock challenge strains." However, the exact sample size for these strains is not specified.
Data Provenance: The study involved an "external evaluation," suggesting data was collected from sources outside the direct developer's lab, but specific countries of origin are not mentioned. It involved both "fresh and stock clinical isolates," implying a mix of retrospective (from existing collections) and potentially prospective (newly collected) samples.

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

The ground truth for the test set was established by comparing the VITEK® 2 system's performance to an "NCCLS frozen reference panel." This reference panel itself would have established MICs. The text does not specify the number or qualifications of experts involved in creating or verifying the NCCLS frozen reference panel or its expected results.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

The text does not describe an adjudication method in the traditional sense of multiple human readers or experts resolving discrepancies. The comparison was directly to an "NCCLS frozen reference panel" (and "Expected Result" for challenge strains), which implies a pre-established, authoritative ground truth rather than a process of reaching consensus among experts for each test case.

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:

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted. This device is an automated antimicrobial susceptibility testing system, not an AI-assisted diagnostic tool for human readers. Its performance is evaluated against a reference method.

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

Yes, a standalone performance evaluation was conducted. The VITEK® 2 system is essentially an "algorithm only" device (an automated system) that determines susceptibility without human intervention in the interpretation of the primary optical readings. The study evaluated its performance in this standalone capacity.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

The primary ground truth used was the results from an NCCLS frozen Reference Panel. For "challenge strains," the ground truth was an "Expected Result," which would presumably also be derived from a validated reference method or expert consensus for those specific strains. This is a type of reference standard.

8. The sample size for the training set:

The document does not provide information regarding a distinct "training set" or its sample size. The VITEK® 2 system's underlying algorithms and concentrations would have been developed and validated over time, but the specific 510(k) summary focuses on the clinical validation (test set performance) of this specific panel against a reference method.

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

As no training set is explicitly described, there is no information on how its ground truth would have been established. Any underlying development work for the VITEK® 2 system's broader technology would likely have involved extensive testing against reference methods (like microdilution or agar dilution) to establish accurate MICs and interpretive categories.

Summary

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KO20871

MAR 2 9 2002

510(k) SUMMARY

VITEK® 2 Gram Positive AST Panel for Streptococcus pneumoniae: Levofloxacin

510(k) Submission Information:

Submitter's Name:	bioMérieux, Inc.
Address:	595 Anglum RoadHazelwood, MO 63042
Contact Person:	Nancy Weaver, Staff Regulatory/ClinicalAffairs Specialist
Phone Number:	314-731-8695
Fax Number:	314-731-8689
Date of Preparation:	November 19, 2001
B. Device Name:	VITEK 2 Gram Positive AST Panel forStreptococcus pneumoniae: Levofloxacin
Trade Name:	VITEK® 2 Levofloxacin
Common Name:	Levofloxacin (LEV)
Classification Name:	Fully Automated Short-Term Incubation CycleAntimicrobial Susceptibility Device,21 CFR 866.1645
C. Predicate Device:	VITEK ® 2 Gram Positive AST Panel forStreptococcus pneumoniae:Trimethoprim/Sulfamethoxazole (N50510/S139)

D. 510(k) Summary:

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510(k) Summary (continued)

System into antimicrobial MIC's and category (Sensitive/Intermediate/Resistant) interpretations.

The VITEK 2 Gram Positive AST Panel for Streptococcus pneumoniae: Levofloxacin demonstrated substantially equivalent performance when compared with an NCCLS frozen Reference Panel, as defined in the FDA DRAFT document ""Guidance on Review Criteria for Assessment of Antimicrobial susceptibility Devices", dated March 8, 2000. The Premarket Notification (510[k]) presents data in support of the VITEK 2 Gram Positive AST Panel for Streptococcus pneumoniae: 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 the VITEK 2 AST Panel by comparing its performance with an NCCLS frozen reference panel. Challenge strains were compared to an "Expected Result". The VITEK 2 Gram Positive AST Panel for Streptococcus pneumoniae: Levofloxacin demonstrated acceptable performance of 99.8% overall Essential Agreement with automatic dilution when compared to the frozen reference panel.

Reproducibility testing demonstrated acceptable reproducibility with both automatic and manual dilution methods.

Quality Control demonstrated acceptable results for VITEK 2 Gram Positive AST Panel for Streptococcus pneumoniae: Levofloxacin.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three wavy lines extending from its body. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Nancy Weaver Staff Regulatory/Clinical Affairs Specialist bioMerieux, Inc. 595 Anglum Road, Hazelwood, Missouri 63042-2320

MAR 2 9 2002

Re: K020871

Trade/Device Name: VITEK® 2 Gram Positive Antimicrobial Susceptibility Test Panel for Streptococcus pneumoniae: Levofloxacin 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: November 19, 2001 Received: December 28, 2001

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

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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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, 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/dsma/dsmamain.html

Sincerely yours,

Steven Butman

Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use Statement

510(k) Number (if known): _ K 02087/

Device Name: VITEK® 2 Gram Positive AST Panel for Streptococcus pneumoniae: Levofloxacin

Indications for Use:

The VITEK® 2 Gram Positive AST Panel for Streptococcus pneumoniae: The VITERS E Granded for use with the VITEK® 2 System in clinical Levonoxacin is intended for abo flet mine the susceptibility of Streptococcus laboratories as an in throughts. The antimicrobial panel presented in phoumations as as T card is in concentrations equivalent by efficacy to standard method concentrations in mcg/ml.

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

PRESCRIPTION USE X

Concurrence of CDRH, Office of Device Evaluation (ODE)

Woodyk Dubrez

Division of Clinical Laboratory Devices 510(k) Number_

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.”