VITEK® 2 Gram Positive Telithromycin for Streptococcus pneumoniae is designed for antimicrobial susceptibility testing of Streptococcus pneumoniae. VITEK 2 Gram Positive Telithromycin for Streptococcus pneumoniae is a qualitative 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 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

The provided text describes the acceptance criteria and study for the VITEK® 2 Gram Positive Telithromycin for Streptococcus pneumoniae device. This device is an automated antimicrobial susceptibility test system.

Here's a breakdown of the requested information:

1. A table of acceptance criteria and the reported device performance

Metric	Acceptance Criteria	Reported Device Performance
Overall Category Agreement	"Acceptable performance" (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). While a specific percentage for acceptance isn't explicitly stated as a numerical threshold, the guidance document would outline typical benchmarks for AST systems.	99.5%
Reproducibility	Acceptable results	Acceptable
Quality Control	Acceptable results	Acceptable

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

Sample Size for Test Set: The document mentions "fresh and stock clinical isolates and stock challenge strains." It does not provide a specific number for the sample size of the test set used in the external evaluation.
Data Provenance: The data was generated through an "external evaluation." The country of origin is not explicitly stated, but bioMérieux, Inc. is based in Hazelwood, MO, USA, and the submission is to the FDA, suggesting the study was likely conducted, or at least overseen, within the US context. The use of "clinical isolates" implies retrospective data, while "stock challenge strains" are laboratory-maintained and can be used prospectively. The exact mix is not detailed.

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

The document does not specify the number or qualifications of experts used to establish the ground truth.

4. Adjudication method for the test set

The document does not describe any specific adjudication method.

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 done. This device is an automated in vitro diagnostic system for antimicrobial susceptibility testing, not a device intended to assist human readers in image interpretation or diagnosis. Therefore, its performance is compared to a reference method, not against human readers.

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

Yes, a standalone performance evaluation was done. The VITEK® 2 system is a "Fully Automated Short-Term Incubation Cycle Antimicrobial Susceptibility Device." The study compared the device's performance directly against the CLSI broth microdilution reference method. The VITEK 2 automatically fills, seals, incubates, and reads the cards, generating results without human interpretation of raw growth data.

7. The type of ground truth used

The ground truth used was the CLSI broth microdilution reference method. This is a laboratory-standardized method for determining the minimum inhibitory concentration (MIC) of antibiotics.

8. The sample size for the training set

The document does not provide information about a separate training set or its sample size. The focus is on the performance evaluation of the device as a whole. While such systems are developed using data, the submission predominantly details the validation study for regulatory approval.

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

The document does not provide information on how the ground truth for a training set was established, as it does not explicitly describe a "training set" in the context of this regulatory submission.

Summary

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K 053/86

510(k) SUMMARY

VITEK® 2 Gram Positive Telithromycin for Streptococcus pneumoniae

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:	November 10, 2005
B. Device Name:
Formal/Trade Name:	VITEK® 2 Gram Positive Telithromycin for Streptococcuspneumoniae
Classification Name:	Fully Automated Short-Term Incubation CycleAntimicrobial Susceptibility Device, 21 CFR 866.1645
Common Name:	VITEK 2 AST-GP Telithromycin for Streptococcuspneumoniae
C. Predicate Device:	VITEK 2 Gram Positive Moxifloxacin for Streptococcuspneumoniae (K031865).

VITEK® 2 Gram Positive Telithromycin for Streptococcus pneumoniae is designed for antimicrobial susceptibility testing of Streptococcus pneumoniae. 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 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.

VITEK 2 Gram Positive Telithromycin for Streptococcus pneumoniae demonstrated substantially equivalent performance when compared with the CLSI broth microdilution reference method, as

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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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 Positive Telithromycin for Streptococcus pneumoniae. 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 Positive Telithromycin for Streptococcus pneumoniae by comparing its performance with the CLSI microbroth dilution reference method. The data is representative of performance on both the VITEK 2 System 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 Telithromycin for Streptococcus pneumoniae demonstrated acceptable performance of 99.5% overall Category Agreement. Reproducibility and Quality Control demonstrated acceptable results.

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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 stylized eagle with three stripes extending from its wing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

DEC 1 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

Re: K053186 Trade/Device Name: VITEK 2® Gram Positive Telithromycin for Streptococcus pneumoniae (<0.25 - >4 ug/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: November 10, 2005 Received: November 14, 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) 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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240)276-0484. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html

Sincerely yours,

Sales, a ton

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): K053186

Device Name: VITEK® 2 Gram Positive Telithromycin for Streptococcus pneumoniae (< 0.25 - > 4 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)

Freddie A. Cook

Vision Sign-Off

Office of In Vitze Diagnostic Device Evaluation and Salety

510(k) K053181

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.”