(37 days)
VITEK 2® Gram Positive Moxifloxacin is designed for antimicrobial susceptibility testing of Staphylococcus aureus (methicillin-susceptible strains only). It is intended for use with the VITEK 2® System as a laboratory aid in the determination of in vitro susceptibility to antimicrobial agents.
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 automatically fills, seals and places the card into the incubator/reader. 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.
Here's a summary of the acceptance criteria and study details for the VITEK® 2 Gram Positive Moxifloxacin, based on the provided text:
1. Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (from FDA Draft Guidance) | Reported Device Performance (VITEK® 2 Gram Positive Moxifloxacin) |
|---|---|
| Sufficient Essential Agreement with reference method | 99.2% overall Essential Agreement |
2. Sample Size Used for the Test Set and Data Provenance:
The document mentions "fresh and stock clinical isolates and stock challenge strains". It does not explicitly state the exact sample size for the test set.
- Data Provenance: Not explicitly stated, though the mention of "external evaluation" suggests multiple sites, potentially within the USA, given the FDA submission. The letter from the FDA does state "Over the country USA" likely referring to the manufacturer's location, rather than data provenance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
The ground truth was established using the NCCLS reference agar dilution method. This is a standardized laboratory method for determining antimicrobial susceptibility, not directly an expert consensus in the typical sense (e.g., a panel of radiologists). While laboratories performing this method require trained personnel, the document does not specify the number of individuals or their specific qualifications beyond adherence to the NCCLS standard.
4. Adjudication Method for the Test Set:
Not applicable. The comparison was made against a standardized laboratory reference method (NCCLS agar dilution), not human expert interpretations requiring adjudication.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study:
No, an MRMC study was not performed. This device is an automated antimicrobial susceptibility testing system, not an imaging or diagnostic AI requiring human-in-the-loop performance evaluation.
6. Standalone Performance:
Yes, a standalone performance study was done. The VITEK® 2 Gram Positive Moxifloxacin was compared directly against the NCCLS reference agar dilution method to determine its "Essential Agreement."
7. Type of Ground Truth Used:
The ground truth used was the NCCLS reference agar dilution method. This is a validated laboratory method considered the gold standard for determining minimum inhibitory concentration (MIC) and susceptibility in microbiology.
8. Sample Size for the Training Set:
The document does not explicitly mention a separate "training set" or its size. The described validation study details an "external evaluation" that tested the VITEK® 2 system. For such automated systems, "training" might refer to the development and calibration of the algorithm itself using internal data, which would likely have preceded this external validation study.
9. How the Ground Truth for the Training Set Was Established:
As no explicit training set is detailed, the method for establishing its ground truth is not provided. If the device's algorithms were developed internally, it's highly probable they were trained against similar reference methods (like agar dilution) to establish accurate MIC readings and interpretive categories.
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SEP 1 0 2003
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510(k) SUMMARY
VITEK® 2 Gram Positive Moxifloxacin
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 18, 2003 |
| B. Device Name: | |
| Formal/Trade Name: | VITEK® 2 Gram Positive Moxifloxacin |
| Classification Name: | Fully Automated Short-Term Incubation CycleAntimicrobial Susceptibility Device,21 CFR 866.1645 |
| Common Name: | VITEK 2 AST-GP Moxifloxacin |
| C. Predicate Device: | VITEK 2 Gram Positive AST Panel forSparfloxacin (N50510/S141) |
D. 510(k) Summary:
VITEK® 2 Gram Positive Moxifloxacin is designed for antimicrobial susceptibility testing of Staphylococcus aureus (methicillin-susceptible strains only). It is intended for use with the VITEK® 2 System 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 automatically fills, seals and places the card into the incubator/reader. The VITEK 2 monitors the growth of each well in the card over a defined period of time (up
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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 Moxifloxacin demonstrated substantially equivalent performance when compared with the NCCLS reference agar dilution method, as defined in the FDA DRAFT document "Guidance on Review Criteria for Assessment of Antimicrobial susceptibility Devices", dated March 8, 2000 and 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 Moxifloxacin.
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 Moxifloxacin by comparing its performance with the NCCLS agar dilution reference method. VITEK 2 Gram Positive Moxifloxacin demonstrated acceptable performance of 99.2% 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
Public Health Service
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SEP 1 0 2003
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
Re: K032399
Trade/Device Name: VITEK 2% Gram Positive Moxifloxacin (0.25-8 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 29, 2003 Received: August 4, 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, 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 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
510(k) Number (if known): K032399
Device Name: VITEK 2® Gram Positive Moxifloxacin (0.25 - 8 µg/ml)
Indications for Use:
VITEK 2® Gram Positive Moxifloxacin is designed for antimicrobial susceptibility testing of Staphylococcus aureus (methicillin-susceptible strains only). It is intended for use with the VITEK 2® System as a laboratory aid in the determination of in vitro susceptibility to antimicrobial agents.
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Concurrence of CDRH, Office of Device Evaluation (ODE)
Division Sign-Off the text in the image is
Office of In Vitro Diagnostic Device Evaluation and Safety
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Perscription Use
Over the country USA
§ 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.”