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

VITEK® 2 Gram Positive Amoxicillin 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.

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 incubatorireader. 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 study details for the VITEK® 2 Gram Positive Amoxicillin for Streptococcus pneumoniae:

Acceptance Criteria and Device Performance

Acceptance Criteria Category	Acceptance Criteria (Target)	Reported Device Performance	Comments
Overall Category Agreement	Acceptable performance as defined by FDA Class II Special Controls Guidance Document	97.0%	The document states "acceptable performance" without a specific numerical threshold for "acceptable" within the text provided. However, the 97.0% achieved performance is stated to be "acceptable."
Reproducibility	Acceptable results	Acceptable results	Achieved
Quality Control	Acceptable results	Acceptable results	Achieved

Note: The FDA Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems; Guidance for Industry and FDA, Issued Feb. 5, 2003, would contain the specific numerical acceptance criteria for Category Agreement, Essential Agreement, and potentially other metrics, which are not detailed in this 510(k) summary directly. The summary only states that performance was "acceptable" as defined by this guidance.

Study Details

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Test Set Sample Size: The document mentions "fresh and stock clinical isolates and stock challenge strains." It does not provide a specific numerical sample size for the test set.
Data Provenance: Not explicitly stated (e.g., country of origin). The study involved "external evaluation," which implies real-world clinical isolates. It is a prospective comparison against a reference method.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided in the document. For antimicrobial susceptibility testing, the "ground truth" is typically established by a reference method, not by human expert interpretation of raw data.

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

This information is not applicable in the context of AST device validation as described. Adjudication methods like "2+1" or "3+1" are typical for image-based diagnostic studies requiring radiologists or pathologists to resolve discrepancies. For AST, the device's results are directly compared to the reference method (CLSI broth microdilution); discrepancies are analyzed, but not resolved by expert adjudication in the same way.

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 MRMC comparative effectiveness study was not done. This type of study applies to diagnostic devices that involve human interpretation, often assisted by AI. The VITEK® 2 system is an automated device designed to determine antimicrobial susceptibility, not to assist human readers in interpreting images or other complex data.

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

Yes, this was a standalone (algorithm only) performance study. The VITEK 2 system automatically processes the antimicrobial medium, monitors growth, and generates results (MIC value and interpretive category). The comparison is between the automated VITEK 2 system and the CLSI broth microdilution reference method. There is no human-in-the-loop performance component being evaluated here.

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

Reference Method: The ground truth was established by the CLSI broth microdilution reference method. This is a standardized, laboratory-based method for determining minimum inhibitory concentrations (MICs) of antimicrobial agents.

8. The sample size for the training set

The document does not specify a separate "training set" or its sample size. For in vitro diagnostic devices like AST systems, the development often involves internal testing and refinement, but explicit separate "training" and "test" sets in the machine learning sense are not typically detailed in 510(k) summaries unless a de novo algorithm is being validated. The submission focuses on the external validation of the finalized device.

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

Not applicable/details not provided, as a distinct "training set" and its ground truth establishment are not discussed in the provided text. The device's underlying principles are based on established microbiological methods (miniaturized doubling dilution) rather than a machine learning model trained on a specific dataset.

Summary

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K063597

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JAN 1 9 2007

510(k) SUMMARY

VITEK® 2 Gram Positive Amoxicillin for Streptococcus pneumoniae

510(k) Submission Information:

Submitter's Name:	bioMérieux, Inc.
Address:	595 Anglum RoadHazelwood, MO 63042
Contact Person:	Jolyn TenlladoSenior Regulatory Affairs Specialist
Phone Number:	314-731-8386
Fax Number:	314-731-8689
Date of Preparation:	November 29, 2006
B. Device Name:
Formal/Trade Name:	VITEK® 2 Gram Positive Amoxicillin for Streptococcuspneumoniae
Classification Name:	Fully Automated Short-Term Incubation CycleAntimicrobial Susceptibility Device, 21 CFR 866.1645
Common Name:	VITEK 2 AST-GP Amoxicillin for Streptococcuspneumoniae
C. Predicate Device:	VITEK 2 Gram Positive Telithromycin for Streptococcuspneumoniae (K053186).

D. 510(k) Summary:

VITEK 2 Gram Positive Amoxicillin 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 Amoxicillin 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 Amoxicillin for Streptococcus pneumoniae by comparing its performance with the CLSI broth microditution 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 Positive Amoxicillin for Streptococcus pneumoniae demonstrated acceptable performance of 97.0% overall Category Agreement. Reproducibility and Quality Control demonstrated acceptable results.

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Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Jolyn Tenllado Senior Regulatory Affairs Specialist bioMérieux, Inc. 595 Anglum Road Hazelwood, MO 63042-2320

JAN 1 9 2007

Re: K063597 Trade/Device Name: VITEK® 2 Gram Positive Amoxicillin for Streptococcus pneumoniae (< 0.06 -> 8 µg/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 29, 2006 Received: December 4, 2006

Dear Ms. Tenllado:

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)276-0450. 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,

Sally anton

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): K063597

Device Name: VITEK® 2 Gram Positive Amoxicillin for Streptococcus pneumoniae (< 0.06 - > 8 µg/ml)

Indications For Use:

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)

Freddie W. Poole

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

p. 10

K06 3597

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.”