VITEK® 2 GN Imipenem is designed for antimicrobial susceptibility testing of Gram-negative bacilli. VITEK 2 GN Imipenem is a quantitative test intended for use with the VITEK 2 and VITEK 2 Compact Systems using VITEK 2 Systems 5.02 Software as a laboratory aid in the determination of in vitro susceptibility to antimicrobial agents. Imipenem has been shown to be active both in vitro and in clinical infections against most strains of the following microorganisms according to the FDA label for the antimicrobial.

Active in vitro and in clinical infections:

Acinetobacter spp.
Citrobacter spp.
Enterobacter aerogenes
Escherichia coli
Klebsiella spp.
Morganella morganii
Proteus vulgaris
Providencia rettgeri
Pseudomonas aeruginosa
Serratia marcescens

Active in vitro but clinical significance unknown: Providencia stuartii

The VITEK® 2 Antimicrobial Susceptibility Test (AST) is intended to be used with the VITEK® 2 System for the automated quantitative or qualitative susceptibility testing of isolated colonies for the most clinically significant aerobic gram-negative bacilli, Staphylococcus spp., Enterococcus spp., Streptococcus agalactiae, S. pneumoniae and clinically significant yeast. The VITEK 2 Systems (PC) 5.02 Software is intended for use with VITEK 2 and VITEK 2 Compact Systems.

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 - 0 .50% 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 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 a breakdown of the acceptance criteria and study information for the VITEK® 2 Gram Negative Imipenem & VITEK 2 Systems (PC) 5.02 Software, based on the provided text:

Acceptance Criteria and Device Performance

Acceptance Criteria Category	Acceptance Criteria (Target)	Reported Device Performance
Overall Essential Agreement	Not explicitly stated as a numerical target in the text. However, "acceptable performance" is mentioned when compared to the CLSI reference method.	95.7%
Overall Category Agreement	Not explicitly stated as a numerical target in the text. However, "acceptable performance" is mentioned when compared to the CLSI reference method.	94.8%
Reproducibility	Acceptable results	Acceptable results
Quality Control	Acceptable results	Acceptable results

Note: The document states that the performance was "substantially equivalent" to the CLSI broth microdilution reference method, as defined in the FDA Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems; Guidance for Industry and FDA, Issued August 28, 2009. This guidance likely contains the specific numerical acceptance criteria that "acceptable performance" refers to, though they are not detailed in this excerpt.

Study Information

Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated as a total number. The study utilized "fresh clinical isolates and stock challenge strains."
- Data Provenance: The study was an "external evaluation." No specific country of origin is mentioned, but "clinical isolates" imply real-world patient samples, and "stock challenge strains" are laboratory-maintained reference strains. The study type is prospective for the fresh clinical isolates and likely retrospective for the stock challenge strains.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Adjudication Method: Not specified. The comparison was made against the "CLSI broth microdilution reference method," which is a standardized laboratory procedure, not typically requiring expert adjudication in the same way imaging studies might.
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:
- MRMC Study: No, this was not a multi-reader multi-case comparative effectiveness study. This device is an automated antimicrobial susceptibility test system, not an AI-powered diagnostic tool requiring human interpretation. The comparison is between the automated system and a laboratory reference method.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Standalone Performance: Yes, the described study evaluates the "VITEK 2 Gram Negative Imipenem" device's performance directly against the CLSI reference method. The VITEK 2 Systems (PC) 5.02 software is an integral part of the automated system, operating without direct human intervention in the interpretation of results during the test cycle.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Type of Ground Truth: The ground truth was established by the CLSI broth microdilution reference method. This is a laboratory-standardized methodology for determining minimum inhibitory concentrations (MICs) of antimicrobials against bacteria.
The sample size for the training set:
- Training Set Sample Size: Not specified. The document focuses on the evaluation of the device rather than its development or training.
How the ground truth for the training set was established:
- Training Set Ground Truth: Not specified, as training set information is not provided.

Summary

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510(k) SUMMARY

VITEK® 2 Gram Negative Imipenem & VITEK 2 Systems (PC) 5.02 Software

510(k) Submission Information:

Submitter's Name:	bioMérieux, Inc.
Address:	595 Anglum RoadHazelwood, MO 63042
Contact Person:	Jolyn TenlladoSenior Manager, Regulatory Affairs
Phone Number:	314-731-8386
Fax Number:	314-731-8689
Date of Preparation:	December 22, 2010
B. Device Name:
Formal/Trade Name:	VITEK® 2 Gram Negative Imipenem ( $\leq$ 0.25 - $\geq$ 16 µg/ml)
Classification Name:	Fully Automated Short-Term Incubation Cycle AntimicrobialSusceptibility Device, 21 CFR 866.1645
Common Name:	VITEK 2 AST-GN Imipenem
C. Predicate Device:	VITEK 2 Gram Negative Meropenem K091899

D. 510(k) Summary:

VITEK® 2 Gram Negative Imipenem is designed for antimicrobial susceptibility testing of Gram negative microorganisms and is intended for use with the VITEK 2 and VITEK 2 Compact Systems using VITEK 2 Systems (PC) 5.02 software as a laboratory aid in the determination of in vitro susceptibility to antimicrobial agents. VITEK 2 Gram Neqative Imipenem is a quantitative test. Imipenem has been shown to be active against the microorganisms listed below according to the FDA label for the antimicrobial.

Active in vitro and in clinical infections:

Acinetobacter spp.	Morganella morganii
Citrobacter spp.	Proteus vulgaris
Enterobacter aerogenes	Providencia rettgeri
Escherichia coli	Pseudomonas aeruginosa
Klebsiella spp.	Serratia marcescens

Active in vitro but clinical significance unknown: Providencia stuartii

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.

bioMérieux, Inc.

595 Anglum Road, Hazelwood, Missouri 63042-2320, USA Phone: 314/731-8500 800/6. 8700

http://www.biomerieux-usa.com

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any 1. 1

The bacterial isolate to be tested is diluted to a standardized concentration in 0.45 - 0 .50% 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 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 Negative Imipenem demonstrated substantially equivalent performance when compared with the CLSI broth microdilution reference method, as defined in the FDA Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems; Guidance for Industry and FDA, Issued August 28, 2009.

The Premarket Notification [510(k)] presents data in support of VITEK 2 Gram Negative Imipenem. An external evaluation was conducted with fresh clinical isolates and stock challenge strains. The external evaluations were designed to confirm the acceptability of VITEK 2 Gram Negative Imipenem by comparing its performance with the CLSI broth microdilution reference method. The data is representative of performance on both the VITEK 2 Compact instrument platforms. VITEK 2 Gram Negative Imipenem using VITEK 2 Systems 5.02 software demonstrated acceptable performance of 95.7% overall Essential Agreement and 94.8% overall Category Agreement. Reproducibility and Quality Control demonstrated acceptable results using both the VITEK 2 and VITEK 2 Compact instrument systems.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the top half of the circle. In the center of the seal is a stylized image of an eagle.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993

bioMérieux, Inc. c/o Jolyn Tenllado Director, Regulatory Affairs 595 Anglum Rd. Hazelwood, Missouri 63042

OCT 1 4 2011

Re: K103752

Trade/Device Name: VITEK® 2 Gram Negative Imipenem (<=0.25 - >=16 µg/mL) with VITEK 2 Systems (PC) 5.02 Software Regulation Number: 21 CFR§ 866.1645 Regulation Name: Short-Term Antimicrobial Susceptibility Test System Regulatory Class: Class II Product Code: LON Dated: October 10, 2011 Received: October 11, 2011

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 class II (Special Controls), 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter

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Page 2 – Jolyn Tenllado

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 Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office

of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Villy a. Htton

Sally A. Hoivat, 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): K103752

Device Name: VITEK® 2 Gram Negative Imipenem (<=0.25 ->=16 µg/mL) with VITEK 2 Systems (PC) 5.02 Software

Indications For Use:

Active in vitro and in clinical infections:

Acinetobacter spp.	Morganella morganii
Citrobacter spp.	Proteus vulgaris
Enterobacter aerogenes	Providencia rettgeri
Escherichia coli	Pseudomonas aeruginosa
Klebsiella spp.	Serratia marcescens

Active in vitro but clinical significance unknown: Providencia stuartii

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 M. Poole
Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) ki63752

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.”