VITEK® 2 Gram Positive Erythromycin for Streptococcus pneumoniae is designed for antimicrobial susceptibility testing of Streptococcus pneumoniae. VITEK 2 Gram Positive Erythromycin 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 bacilii, 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 acceptance criteria and study for the VITEK® 2 Gram Positive Erythromycin for Streptococcus pneumoniae device:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria Category	Acceptance Criteria (Implicit from FDA Guidance)	Reported Device Performance
Overall Category Agreement	Not explicitly stated, but typically ≥ 90% for AST systems.	98.9%
Reproducibility	Acceptable results (implicit standard)	Acceptable results
Quality Control	Acceptable results (implicit standard)	Acceptable results

Note: The document refers to "FDA Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems; Guidance for Industry and FDA, Issued Feb. 5, 2003" for defining acceptable performance. While specific numeric acceptance criteria for Category Agreement are not explicitly written in this extract, generally, for AST systems, a high percentage (e.g., >90%) of Category Agreement is expected for FDA clearance. The document states that the device "demonstrated substantially equivalent performance when compared with the CLSI broth microdilution reference method," indicating it met the implicit standards of this guidance.

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

Sample Size: Not explicitly stated as a single number. The study used "fresh and stock clinical isolates and stock challenge strains." This suggests a diverse set of samples, but the total number is not provided.
Data Provenance: The isolates included "fresh and stock clinical isolates" (implying real-world patient samples) and "stock challenge strains" (likely reference strains from culture collections). The country of origin is not specified, but bioMérieux is a multinational company with operations in the US. The study involved an "external evaluation," which could imply multi-center data collection or independent testing. It is a prospective evaluation comparing the device against a reference method.

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

The ground truth was established by the CLSI broth microdilution reference method. This is an objective laboratory method, not a subjective expert consensus. Therefore, the concept of "number of experts" or their qualifications for establishing ground truth as typically applied to image-based AI studies is not directly applicable here. The performance of the CLSI method itself is dependent on trained laboratory technicians adhering to standardized protocols.

4. Adjudication Method for the Test Set:

None in the traditional sense. The comparison was directly between the VITEK 2 device's results (MIC values and interpretive categories) and the results from the CLSI broth microdilution reference method. Discrepancies would be analyzed against the standard, rather than adjudicated by human experts.

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. This is a study for an automated antimicrobial susceptibility testing (AST) device, which does not involve human "readers" in the diagnostic interpretation loop in the same way an image analysis AI would. The device automates a laboratory test. Its performance is compared to a reference laboratory method, not to human interpretation of data before and after AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

Yes. This study is a standalone performance evaluation of the VITEK 2 system. The VITEK 2 monitors growth and generates MIC values and interpretive categories autonomously. The study confirms its performance in this standalone capacity against the CLSI reference method.

7. The Type of Ground Truth Used:

Objective Reference Method: The ground truth was established by the CLSI broth microdilution reference method. This is considered the gold standard for antimicrobial susceptibility testing.

8. The Sample Size for the Training Set:

Not applicable / Not explicitly stated. This document describes a PMA/510(k) submission for a device, which historically did not involve "training sets" in the context of machine learning (AI) development. The VITEK 2 system operates based on established microbiological principles (growth detection) and pre-determined thresholds, rather than being "trained" on a large dataset in the AI sense. While there's an inherent development process that refines the algorithms, the document doesn't refer to a distinct "training set" like an AI model would have.

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

Not applicable. As mentioned above, the concept of a "training set" with ground truth in the AI context isn't directly applicable here. The system's underlying science is based on established microbiological principles, and its performance parameters are likely derived from extensive R&D and validation studies, not from a singular "training set" with independently established ground truth in the AI machine learning paradigm.

Summary

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Image /page/0/Picture/0 description: The image shows the logo for bioMerieux. The logo consists of a black circle with a textured pattern inside, positioned above the company name "BIOMERIEUX" in a stylized font. A thin, curved line bisects the circle and extends downwards between the letters of the company name.

Ka63492

GEC & 1 2006

510(k) SUMMARY

VITEK® 2 Gram Positive Erythromycin 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 16, 2006
Device Name:	.
Formal/Trade Name:	VITEK® 2 Gram Positive Erythromycin for Streptococcuspneumoniae
Classification Name:	Fully Automated Short-Term Incubation CycleAntimicrobial Susceptibility Device, 21 CFR 866.1645
Common Name:	VITEK 2 AST-GP Erythromycin for Streptococcuspneumoniae
Predicate Device:	VITEK 2 Gram Positive Telithromycin for Streptococcuspneumoniae (K053186).

D. 510(k) Summary:

в.

VITEK® 2 Gram Positive Erythromycin 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 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.

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

bioMérieux, Inc.

Fax: 314/731-595 Anglum Road, Hazelwood, Missouri 63042-2320, USA Phone: 314/731-8500 800/638-4835 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 Erythromycin 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 Erythromycin for Streptococcus pneumoniae by companing 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 Positive Ervithromycin for Streptococcus pneumoniae demonstrated acceptable performance of 98.9% overall Category Agreement. Reproducibility and Quality Control demonstrated acceptable results.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. In the center of the seal is an eagle with its wings spread.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

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

DEC 2 1 2006

Re: K063492

Trade/Device Name: VITEK®2 Gram Positive Erythromycin for Streptococcus pneumoniae (≤0.25 - ≥1 µg/mL) Regulation Number: 21 CFR 866.1645 Regulation Name: Short-Term Antimicrobial Susceptibility Test System Regulatory Class: Class II Product Code: LON Dated: November 16, 2006 Received: November 17, 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). 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

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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 attorn

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): K0b 3492

Device Name: VITEK® 2 Gram Positive Erythromycin for Streptococcus pneumoniae (< 0.25 - > 1 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 Peale
Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

K063492

p. 10

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.”