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 determination of the susceptibility of most clinically significant aerobic gram-positive cocci including Staphylococcus spp., Enterococcus spp., Streptococcus agalactiae, and S. pneumoniae.

VITEK 2 Gram Positive Ertapenem 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.

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

VITEK® 2 Gram Positive Ertapenem for Streptococcus pneumoniae Acceptance Criteria Study Summary

This document summarizes the acceptance criteria and the study proving the device meets these criteria for the VITEK® 2 Gram Positive Ertapenem for Streptococcus pneumoniae.

1. Table of Acceptance Criteria and Reported Device Performance

Performance Measure	Acceptance Criteria (Implicit)	Reported Device Performance
Overall Category Agreement	Substantial Equivalence to CLSI (NCCLS) reference method (typically ≥90%)	94.9%
Reproducibility	Acceptable (Specific % not given, but implied by "demonstrated acceptable results")	Acceptable Results
Quality Control	Acceptable (Specific % not given, but implied by "demonstrated acceptable results")	Acceptable Results

Note: The FDA Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems; Guidance for Industry and FDA, Issued Feb. 5, 2003, typically sets benchmarks for category agreement in AST devices for substantial equivalence.

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

Test Set Sample Size: Not explicitly stated as a single number. The study utilized "fresh and stock clinical isolates and stock challenge strains."
Data Provenance: The external evaluation was designed to confirm acceptability, suggesting data was collected specifically for this submission. The origin of the clinical isolates (e.g., country) is not specified. The study is prospective in the sense that it was conducted to compare the VITEK 2 device against a reference method.

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

Number of Experts: Not applicable. The ground truth was established by a reference laboratory method, not by expert interpretation.
Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable. The "CLSI (NCCLS) microbroth dilution reference method" was used as the gold standard for ground truth. This method itself establishes results, rather than requiring expert adjudication of interpretations.

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

MRMC Study Done? No. This device is an automated antimicrobial susceptibility test system. Its performance is compared against a reference laboratory method, not against human readers. Therefore, an MRMC study and analysis of human reader improvement with AI assistance is not relevant or presented.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Standalone Study Done? Yes. The study evaluated the VITEK® 2 system's performance (which is an automated algorithm) directly against the CLSI (NCCLS) reference method. This is effectively a standalone performance evaluation of the device.

7. Type of Ground Truth Used

Type of Ground Truth: The ground truth was established by the CLSI (NCCLS) microbroth dilution reference method. This is a recognized laboratory standard for determining minimum inhibitory concentrations (MICs) of antimicrobials.

8. Sample Size for the Training Set

Training Set Sample Size: Not explicitly mentioned. For AST devices, the "training" (or development) process involves establishing the algorithms and interpretive criteria for the VITEK 2 system based on extensive historical data and correlation studies between growth patterns and known MICs. The specific dataset used for this initial development is not detailed in this submission. The external evaluation uses "fresh and stock clinical isolates and stock challenge strains" which serve as a validation set.

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

Ground Truth for Training Set: The submission does not detail the specific ground truth establishment for a "training set." However, it can be inferred that the VITEK 2 system's underlying algorithms and interpretive rules would have been developed and validated against a large body of data where MICs were determined by established reference methods (like CLSI microbroth dilution) for various microorganisms and antimicrobials. This iterative process allows the system to learn and correlate growth patterns detected by the VITEK 2 with known antimicrobial susceptibility results from reference methods.

Summary

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Image of BIOMERIEUX logo

BIOMÉRIEUX

K051849

510(k) SUMMARY

AUG 1 6 2005

VITEK® 2 Gram Positive Ertapenem 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:	July 6, 2005
B. Device Name:
	Formal/Trade Name:	VITEK® 2 Gram Positive Ertapenem for Streptococcuspneumoniae
	Classification Name:	Fully Automated Short-Term Incubation CycleAntimicrobial Susceptibility Device, 21 CFR 866.1645
	Common Name:	VITEK 2 AST-GP ETP
	C. Predicate Device:	VITEK 2 Gram Positive Moxifloxacin for Streptococcuspneumoniae (K031865).

D. 510(k) Summary:

VITEK® 2 Gram Positive Ertapenem 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 Ertapenem for Streptocccus pneumoniae demonstrated substantially equivalent performance when compared with the CLSI (NCCLS) reference agar dilution method, 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.

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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The Premarket Notification (510[k]) presents data in support of VITEK 2 Gram Positive Ertapenem 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 Ertapenem for Streptococcus pneumoniae by comparing its performance with the CLSI (NCCLS) 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 Ertapenem for Streptococcus pneumoniae demonstrated acceptable performance of 94.9% overall Category Agreement. Reproducibility and Quality Control demonstrated acceptable results.

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AUG 1 6 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

K051849 Re: Trade/Device Name: VITEK 20 Gram Positive Ertapenem for Streptococcus pneumoniae (≤0.5 - ≥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: July 6, 2005 Received: July 7, 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 (OS) 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,

Sale, a For

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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510(k) Number (if known): K051849

Device Name: VITEK® 2 Gram Positive Ertapenem for Streptococcus pneumoniae (< 0.5 - > 8 µg/ml)

Indications For Use:

. .

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 viren = and virier = oompact lonies for the most clinically significant aerobic gramsusceptiblicy toculing of hocaccus spp., Enterococcus spp., Streptococcus agalactiae, and S. pneumoniae.

O: phounder. vilier 2 Gram . Streptococcus pneumoniae. VITEK 2 Gram anniniorobial odoopilland use with the VITEK 2 and VITEK 2 Compact Systems as a laboratory aid in the determination of in vitro susceptibility to antimicrobial agents.

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)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

p. 10

KO 51849 510(k) _______________________________________________________________________________________________________________________________________________________________________

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.”