(24 days)
VITEK® 2 Gram Positive Vancomycin is designed for antimicrobial susceptibility testing of Enterococcus species, Staphylococcus species and Streptococcus agalactiae. VITEK 2 Gram Positive Vancomycin is a quantitative test. 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 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 gramnegative bacilli, Staphylococcus spp., Enterococcus spp., Streptococcus agalactiae, and S. pneumoniae.
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.
The following information describes the acceptance criteria and study proving the device meets those criteria:
1. Acceptance Criteria and Reported Device Performance:
| Criteria | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Overall Category Agreement | Not explicitly stated (implied acceptable performance) | 99.6% |
| Reproducibility | Not explicitly stated (implied acceptable results) | Acceptable results |
| Quality Control | Not explicitly stated (implied acceptable results) | Acceptable results |
2. Sample Size and Data Provenance:
- Test Set Sample Size: Not explicitly stated, but the study involved "fresh and stock clinical isolates and stock challenge strains."
- Data Provenance: Not explicitly stated, but the isolates appear to be clinical, meaning they likely originated from various clinical settings. Given the submitter's location (Hazelwood, MO, USA), it's highly probable the data is primarily from the USA. The study design as described ("external evaluation") suggests the data was collected for the purpose of validating the device, indicating a prospective or at least a controlled retrospective design.
3. Number of Experts and Qualifications:
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified. The reference method used was the CLSI broth microdilution, which is a standardized laboratory method, not typically adjudicated by clinical experts in the same way imaging studies might be. The "experts" would likely be trained microbiologists performing and interpreting the reference method.
4. Adjudication Method for the Test Set:
- Adjudication Method: Not applicable in the traditional sense. The comparison was against the CLSI broth microdilution reference method, which is a standardized, objective laboratory assay. Any discrepancies between the VITEK 2 device and the reference method would be analyzed, but there isn't a "human adjudication" process as seen in imaging studies.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- MRMC Study: No, an MRMC comparative effectiveness study was not conducted as this device is an automated antimicrobial susceptibility test system, not an imaging analysis tool requiring human interpretation/reading. Therefore, there's no "human readers get better with AI assistance" effect size to report.
6. Standalone Performance:
- Standalone Performance: Yes, the study evaluated the "standalone" performance of the VITEK® 2 Gram Positive Vancomycin device by comparing its results directly with the CLSI broth microdilution reference method. The device's ability to determine MIC values and interpretive categories was assessed independently of human intervention during the test itself.
7. Type of Ground Truth Used:
- Ground Truth Type: Expert consensus on the CLSI broth microdilution reference method. The "gold standard" for determining antimicrobial susceptibility in this context is the Clinical and Laboratory Standards Institute (CLSI) broth microdilution reference method.
8. Sample Size for the Training Set:
- Training Set Sample Size: Not specified in the provided summary. The summary focuses on the external evaluation/test set.
9. How the Ground Truth for the Training Set Was Established:
- Training Set Ground Truth Establishment: Not specified in the provided summary. However, for AST devices, training data ground truth would typically be established using a similar, if not identical, reference method as the test set (i.e., CLSI broth microdilution) to ensure consistency and accuracy in developing the device's algorithms.
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510(k) SUMMARY
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VITEK® 2 Gram Positive Vancomycin
510(k) Submission Information:
| Submitter's Name: | bioMérieux, Inc. |
|---|---|
| Address: | 595 Anglum RoadHazelwood, MO 63042 |
| Contact Person: | Jolyn TenlladoSenior Regulatory Affairs Specialist |
| Phone Number. | 314-731-8386 |
| Fax Number: | 314-731-8689 |
| Date of Preparation: | September 17, 2007 |
| Device Name: | |
| Formal/Trade Name: | VITEK® 2 Gram Positive Vancomycin (≤ 0.5 - ≥ 32µg/ml) |
| Classification Name: | Fully Automated Short-Term Incubation CycleAntimicrobial Susceptibility Device, 21 CFR 866.1645 |
| Common Name: | VITEK 2 AST-GP Vancomycin |
| Predicate Device: | VITEK 2 Gram Positive Daptomycin (K050075). |
D. 510(k) Summary:
B.
C.
VITEK® 2 Gram Positive Vancomycin is designed for antimicrobial susceptibility testing of Enterococcus species. Staphylococus species and Streptococcus agalactiae. 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/mi. 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 Vancomvcin demonstrated substantially equivalent performance when compared with the CLSI broth microdilution reference method, as defined in the FDA Class II
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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 Vancyomycin. 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 Vancomycin by comparing its performance with the CLSI broth microdifution reference method. The data is representative of performance on both the VITEK 2 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 Vancomvoin demonstrated acceptable performance of 99.6% overall Category Agreement. Reproducibility and Quality Control demonstrated acceptable results.
*Note: This device clinical trial was initiated prior to the March 5, 2007 issuance of the revised quidance, which is why the older guidance document is cited.
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Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Jolyn Tenllado Senior Regulatory Affairs Specialist bioMérieux 595 Anglum Road Hazelwood, MO 63042
OCT 1 5 2007
Re: K072668
Trade/Device Name: VITEK® 2 Gram Positive Vancomycin (≤ 0.5 - ≥ 32 µg/ml) Regulation Number: 21 CFR & 866.1645 Regulation Name: Antimicrobial Susceptibility Test System – Short Incubation Regulatory Class: II Product Code: LON Dated: September 17, 2007 Received: September 21, 2007
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 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" (21CFR 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,
a A
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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Indications for Use
510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________
Device Name: VITEK® 2 Gram Positive Vancomycin (≤ 0.5 - ≥ 32 µg/ml)
Indications For Use:
VITEK® 2 Gram Positive Vancomycin is designed for antimicrobial susceptibility testing of Enterococcus species, Staphylococcus species and Streptococcus agalactiae. VITEK 2 Gram Positive Vancomycin is a quantitative test. 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 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 gramnegative bacilli, Staphylococcus spp., Enterococcus spp., Streptococcus agalactiae, and S. pneumoniae.
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)
Fuddie lu. Poole
Page 1 of 1
Asion Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K072668
§ 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.”