(59 days)
The VITEK® Gram Negative Gatifloxacin is designed for antimicrobial susceptibility testing of Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Acinetobacter lwoffii, Citrobacter koseri, Citrobacter freundii, Enterobacter aerogenes, Enterobacter cloacae, Klebsiella oxytoca, Morganella morganii and Proteus vulgaris. It is intended for use with the VITEK® System as a laboratory aid in the determination of in vitro susceptibility to antimicrobial agents.
The VITEK GNS Cards are essentially miniaturized versions of the doubling dilution technique for determining the minimum inhibitory concentration (MIC) my 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 automatically fills, seals and places the card into the incubator/reader. The VITEK monitors the growth of each well in the card over a defined period of time (up to 15 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.
Here's a breakdown of the acceptance criteria and the study that demonstrates the VITEK® Gram Negative Gatifloxacin device meets those criteria, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Substantial equivalence to the NCCLS reference agar dilution method. | Demonstrated substantial equivalent performance. |
| Acceptable overall Essential Agreement when compared to the agar dilution reference method. | 97.9% overall Essential Agreement. |
| Acceptable Reproducibility. | Demonstrated acceptable results. |
| Acceptable Quality Control. | Demonstrated acceptable results. |
| (General requirement: Device performs as intended for susceptibility testing of specified organisms to Gatifloxacin) | Designed for AST of specific Gram-negative organisms. Intended for use with VITEK® System. |
Important Note: The document implies the acceptance criteria through its comparison to the "NCCLS reference agar dilution method" and references the "Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems; Guidance for Industry and FDA, February 5, 2003." While specific numerical thresholds for "acceptable" reproducibility and quality control are not explicitly stated, the FDA's acceptance of the 97.9% Essential Agreement implies this met their requirements.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document mentions an "external evaluation... with fresh and stock clinical isolates and stock challenge strains." It does not provide a specific number for the sample size (i.e., the number of isolates or tests performed).
- Data Provenance: The data provenance is not explicitly stated in terms of country of origin. The study was an "external evaluation." It utilized both "fresh and stock clinical isolates" (implying retrospective clinical data or recently collected clinical data) and "stock challenge strains" (implying laboratory-controlled prospective data).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. The ground truth was established by the "NCCLS reference agar dilution method," which is a laboratory standard rather than expert consensus on individual cases.
4. Adjudication Method for the Test Set
This information is not applicable as the ground truth was established by a laboratory reference method (NCCLS agar dilution), not by human expert interpretation requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a multi-reader multi-case comparative effectiveness study was not done. This device is an automated antimicrobial susceptibility testing system, and the study compares its performance against a reference laboratory method, not against human readers.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Yes, a standalone study was performed. The VITEK® system is a "Fully Automated Short-Term Incubation Cycle Antimicrobial Susceptibility Device." The study compared the VITEK® Gram Negative Gatifloxacin's performance directly against the NCCLS reference agar dilution method. The description of the VITEK® operation ("automatically fills, seals and places the card into the incubator/reader. The VITEK monitors the growth... a report is generated") indicates it operates without human intervention in the interpretive phase.
7. The Type of Ground Truth Used
The ground truth used was the NCCLS reference agar dilution method. This is a laboratory-based, established standard methodology for determining minimum inhibitory concentrations (MICs) of antimicrobials.
8. The Sample Size for the Training Set
The document does not provide information regarding a "training set" or its sample size. The VITEK® system is presented as a device that performs a test, rather than an algorithm that learns from a training set in the typical machine learning sense. The development of the VITEK® system itself would have involved extensive R&D and calibration, but the specific term "training set" for this submission is not used.
9. How the Ground Truth for the Training Set Was Established
As no training set is explicitly mentioned in the context of this 510(k) submission, the method for establishing its ground truth is not provided.
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OCT 3 1 2003
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510(k) SUMMARY
VITEK® Gram Negative Gatifloxacin
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: | August 29, 2003 |
| B. Device Name: | |
| Formal/Trade Name: | VITEK® Gram Negative Gatifloxacin (1.5 - 10 µg/ml) |
| Classification Name: | Fully Automated Short-Term Incubation CycleAntimicrobial Susceptibility Device, 21 CFR 866.1645 |
| Common Name: | VITEK GNS Gatifloxacin |
| C. Predicate Device: | VITEK® Gram Negative Susceptibility Card -Cefpodoxime (N50510/S073) |
D. 510(k) Summary:
B
C
VITEK® Gram Negative Gatifloxacin is designed for antimicrobial susceptibility testing of Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis. Acinetobacter Iwoffii, Citrobacter koseri, Citrobacter freundii, Enterobacter aerogenes, Enterobacter cloacae, Klebsiella oxytoca, Morganella morganii and Proteus vulgaris. It is intended for use with the VITEK® System as a laboratory aid in the determination of in vitro susceptibility to antimicrobial agents. The antimicrobial presented in VITEK GNS Card is in concentrations equivalent by efficacy to standard method concentrations in mcg/ml. The VITEK GNS Cards are essentially miniaturized versions of the doubling dilution technique for determining the minimum inhibitory concentration (MIC) my 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 automatically fills, seals and places the card into the incubator/reader. The VITEK monitors the growth of each well in the card over a defined period of time (up to 15 hours). At the
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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 Gram Negative Gatifloxacin demonstrated substantially equivalent performance when compared with the NCCLS reference agar dilution method, as defined in the Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems; Guidance for Industry and FDA, February 5, 2003.
The Premarket Notification (510[k]) presents data in support of VITEK Gram Negative Gatifloxacin.
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 Gram Negative Gatifloxacin by comparing its performance with the NCCLS agar dilution reference method. VITEK Gram Negative Gatifloxacin demonstrated acceptable performance of 97.9% overall Essential Agreement when compared to the agar dilution reference method. 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 U.S. Department of Health and Human Services. The seal features a stylized eagle with three lines representing its body and wings. The eagle is oriented towards the upper right of the image. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.
Public Health Service
OCT 3 1 2003
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Nancy Weaver Staff Regulatory Affairs Specialist BioMerieux, Inc. 595 Anglum Road Hazelwood, MO 63042-2320
Re: K032711
Trade/Device Name: VITEK® Gram Negative Gatifloxacin (1.5-10 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: August 29, 2003 Received: September 2, 2003
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. Iisting 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 (301) 594-3084. 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,
Steven Sutman
Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement
KD32711 510(k) Number (if known): _
Device Name: VITEK® Gram Negative Gatifloxacin (1.5 - 10 µg/ml)
Indications for Use:
The VITEK® Gram Negative Gatifloxacin is designed for antimicrobial susceptibility testing of Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Acinetobacter lwoffii, Citrobacter koseri, Citrobacter freundii, Enterobacter aerogenes, Enterobacter cloacae, Klebsiella oxytoca, Morganella morganii and Proteus vulgaris. It is intended for use with the VITEK® System as a laboratory aid in the determination of in vitro susceptibility to antimicrobial agents.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Freddie tur Poole
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K032711
- For Prescription Use Only
§ 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.”