VITEK® 2 Gram Negative Piperacillin/tazobactam is designed for antimicrobial susceptibility testing of gram-negative organisms and is intended for use with the VITEK® 2 Compact Systems as a laboratory aid in the determination of in vitro susceptibility to antimicrobial agents. VITEK 2 Gram Negative Piperacillin/tazobactam is a quantitative test. Piperacillin/ tazobactam has been shown to be active against most strains of the organisms listed below according to the FDA label for the antimicrobial.

Active in vitro and in clinical infections Klebsiella pneumoniae Acinetobacter baumanii Escherichia coli Pseudomonas aeruginosa

Active in vitro but their clinical significance is uknown:

Proteus vulgaris

Providencia rettgeri

Providencia stuartii

Citrobacter koseri Morqanella morganii Proteus mirabilis

Salmonella enterica Serratia marcescens

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 gram-negative bacilli, Staphylococcus spp., Enterococcus spp., Streptococcus agalactiae, and S. pneumoniae.

Device Description

VITEK® 2 Gram Negative Piperacillin/Tazobactam is designed for antimicrobial susceptibility testing of Acinetobacter baumanii, Escherichia coli, Klebsiella pneumoniae, Pseudomonas aeruginosa, Citrobacter koseri, Morganii, Proteus mirabilis, Proteus vulgaris, Providencia rettgeri, Providencia stuartii, Salmonella enterica and Serratia marcescens. 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 mod/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.

AI/ML Overview

Here's an analysis of the acceptance criteria and the study that demonstrates the device meets these criteria, based on the provided text:

Device Name: VITEK® 2 Gram Negative Piperacillin/Tazobactam (≤ 4 - ≥ 128 µg/ml)

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria Category	Acceptance Criteria (Threshold)	Reported Device Performance
Essential Agreement (EA)	Not explicitly stated, but based on the reported performance being "acceptable" in relation to the predicate device, it implies a certain minimum threshold for equivalence. The FDA guidance document Antimicrobial Susceptibility Test (AST) Systems; Guidance for Industry and FDA, Issued Feb. 5, 2003 would specify this; typically >=90%.	96.6%
Category Agreement (CA)	Not explicitly stated, but based on "acceptable performance," similar to EA, it implies a minimum threshold; typically >=90%.	96.6%
Reproducibility	Not explicitly stated, but "acceptable performance" implies a minimum threshold.	100%
Quality Control (QC) Results	"acceptable"	Acceptable

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

Sample Size: Not explicitly stated as a numerical value for the test set. The document mentions "fresh and stock clinical isolates" were used.
Data Provenance: The study was an "external evaluation" designed to confirm performance by comparing it with the CLSI broth microdilution reference method. The text does not specify the country of origin of the data or whether it was retrospective or prospective.

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

Number of Experts: Not mentioned.
Qualifications of Experts: Not mentioned.

4. Adjudication Method for the Test Set:

Not explicitly stated. The ground truth method (CLSI broth microdilution) is a standardized laboratory method, so expert adjudication in the traditional sense (e.g., radiologists reviewing images) is not applicable here.

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, an MRMC comparative effectiveness study was not done. This device is an automated antimicrobial susceptibility test system, not an imaging device requiring human reader interpretation in the context of AI assistance. The performance is assessed against a reference laboratory method.

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

Yes, the core of the study is a standalone performance evaluation. The VITEK® 2 system is an automated device designed to determine antimicrobial susceptibility. Its performance (Essential Agreement, Category Agreement) is directly compared to a reference method (CLSI broth microdilution), which represents its "standalone" diagnostic accuracy without human intervention in the susceptibility determination process itself.

7. The Type of Ground Truth Used:

The ground truth used was the CLSI broth microdilution reference method. This is considered the gold standard for determining minimum inhibitory concentrations (MICs) of antimicrobials.

8. The Sample Size for the Training Set:

The document does not provide information regarding a separate training set. The VITEK 2 system's underlying algorithm for determining MICs and interpretive categories would have been developed and validated previously, and this submission focuses on the performance of a specific antimicrobial-device combination (Piperacillin/Tazobactam on the VITEK 2 AST-GN card) against a reference method. It's possible the "training" (development) of the MIC interpretation algorithms for the VITEK 2 system happened prior to this specific submission, and this study is a validation for a new antimicrobial.

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

Since no specific training set for this particular antimicrobial validation is mentioned, the method for establishing its ground truth is also not specified. However, for the underlying VITEK 2 system's development, it would have involved extensive testing against reference methods like CLSI broth microdilution.

Summary

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K080107

.. ( )

510(k) SUMMARY

VITEK® 2 Gram Negative Piperacillin/Tazobactam

510(k) Submission Information:

Submitter's Name:	bioMérieux, Inc.
Address:	595 Anglum RoadHazelwood, MO 63042
Contact Person:	Nancy WeaverAssociate Director, Regulatory Affairs
Phone Number:	314-731-8695
Fax Number:	314-731-8689
Date of Preparation:	January 11, 2008
Device Name:
Formal/Trade Name:	VITEK® 2 Gram Negative Piperacillin/Tazobactam(≤ 4 - ≥ 128 µg/ml)
Classification Name:	Fully Automated Short-Term Incubation Cycle AntimicrobialSusceptibility Device, 21 CFR 866.1645
Common Name:	VITEK 2 AST-GN Piperacillin/Tazobactam
Predicate Device:	VITEK 2 Gram Negative Levofloxacin (K072038).

D. 510(k) Summary:

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VITEK 2 Gram Negative Piperacillin/Tazobactam demonstrated substantially equivalent VTFEN Z Grant Negalife I speracilling reference method, as defined in the penomanoo when somple 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 Negative The Tremans. Notinodion (orlogy) provinced with fresh and stock clinical r liperaoliin Fuzubuotam - xn external evaluations were designed to confirm the lished stool onalience or and setive Piperacillin/Tazobactam by comparing its performance with the CLSI broth microdilution reference method. The data is representative of performance on with the SEOF broth misroaliation rolonat instrument platforms, as evidenced in the AST equivalency study presented in the VITEK 2 Compact 510(k), K050002. VITEK 2 Gram Negative oqundler your claus procession demonstrated acceptable performance of 96.6% Essential Agreement, 96.6% Category Agreement and 100% reproducibility. Quality Control results were acceptable.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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 forming its body and wing. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.

Public Health Service

FFB 28 200

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Nancy Weaver Associate Director Regulatory Affairs bioMérieux 595 Anglum Road Hazelwood, MO 63042

K080107 Re:

Trade/Device Name: VITEK® 2 Gram Negative Piperacillin/tazobactam (≤ 4 - ≥ 128 ug/ml) Regulation Number: 21 CFR § 866.1645 Regulation Name: Antimicrobial Susceptibility Test System -- Short Incubation Regulatory Class: II Product Code: LON Dated: January 11, 2008 Received: January 15, 2008

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 advice for your device on our labeling regulation (21 CFR Part 801), 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" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Sally attayna

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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Indication for Use

510(k) Number (if known): | (ひ80/07

Device Name: VITEK® 2 Gram Negative Piperacillin/tazobactam (≤ 4 - ≥ 128 µg/ml)

Indication For Use:

Active in vitro and in clinical infections Klebsiella pneumoniae Acinetobacter baumanii Escherichia coli Pseudomonas aeruginosa

Active in vitro but their clinical significance is uknown:

Proteus vulgaris

Providencia rettgeri

Providencia stuartii

Citrobacter koseri Morqanella morganii Proteus mirabilis

Salmonella enterica Serratia marcescens

Prescription Use X (21 CFR Part 801 Subpart D) And/Or

Over the Counter Use (21 CFR Part 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)

Fueddie Lu. Root

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K08 0107

Page 1 of 1

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.”