(47 days)
The VITEK® Gram Positive Susceptibility Test is intended to be used with the VITEK® 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, and S. pneumoniae. VITEK® Gram Positive Ertapenem is designed for antimicrobial susceptibility testing of Staphylococcus aureus and Streptococcus agalactiae. 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 GPS Cards are essentially miniaturized versions of the doubling dilution technique for determining the minimum inhibitory concentration (MIC) microdilution methodology. After the card is inoculated with a standardized organism suspension, it is placed in the Reader/Incubator of the VITEK System. Organism growth inside the card is optically monitored throughout the 6-15 hour incubation cycle. MIC results are automatically calculated once a predetermined growth threshold is reached, and a report is generated that contains the MIC result and the interpretive category result.
Here's an analysis of the provided text regarding the VITEK® Gram Positive Ertapenem device's acceptance criteria and study details:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria (Stated) | Reported Device Performance |
|---|---|---|
| Overall Category Agreement | Not explicitly stated | 99.3% Overall Category Agreement |
| Reproducibility | Not explicitly stated | Acceptable results |
| Quality Control | Not explicitly stated | Acceptable results |
Note: The document references the "FDA Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems; Guidance for Industry and FDA. Issued Feb. 5, 2003" for defining substantial equivalence, which would contain the specific acceptance criteria for AST systems. However, these specific numerical criteria are not enumerated within the provided text.
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the numerical sample size used for the test set. It mentions:
- Test Set Description: "external evaluations were designed to confirm the VITEK Gram Positive Ertapenem by comparing its performance with the NCCLS agar dilution reference method."
- Data Provenance: The external evaluations were conducted with "fresh and stock clinical isolates and stock challenge strains." This implies the data is likely a mix of retrospective (stock clinical isolates) and potentially prospective (fresh clinical isolates) data. The country of origin is not specified but is implicitly within the scope of FDA approval requirements, suggesting data from the US or international data meeting US standards.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
The document does not mention the use of experts to establish the ground truth for the test set. Instead, it states that the device's performance was compared to the "NCCLS reference agar dilution method," which is a laboratory-based, objective reference standard for antimicrobial susceptibility testing.
4. Adjudication Method for the Test Set
No adjudication method is mentioned as the ground truth was established by the "NCCLS reference agar dilution method," not human interpretation requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is an automated antimicrobial susceptibility test system, not an imaging or diagnostic device that typically involves human readers. The comparison is between the automated system and a reference lab method.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, this was a standalone performance study. The VITEK® Gram Positive Ertapenem system is an automated device designed to calculate MIC results and interpretive categories without human intervention once the card is inoculated and placed in the system. Its performance was directly compared to the NCCLS reference method.
7. The Type of Ground Truth Used
The type of ground truth used was the NCCLS reference agar dilution method. This is an established microbiological laboratory gold standard for determining antimicrobial susceptibility, providing objective minimum inhibitory concentration (MIC) values.
8. The Sample Size for the Training Set
The document does not explicitly state the sample size used for any 'training set.' For a device like VITEK, which measures growth patterns against known antibiotic concentrations, the "training" (calibration and validation) would typically involve extensive testing against known strains and reference methods during its development. The provided text only describes the clinical evaluation or test set performance.
9. How the Ground Truth for the Training Set Was Established
Since no specific "training set" is mentioned, the method for establishing its ground truth is also not detailed. However, based on the nature of antimicrobial susceptibility testing, any developmental or 'training' data would have had its ground truth established using standard reference methods like the NCCLS agar dilution method or similar, highly controlled laboratory techniques to ensure accurate MIC determination for algorithm development and calibration.
{0}------------------------------------------------
Image /page/0/Picture/2 description: The image shows the logo for bioMérieux. The logo consists of a stylized globe with vertical lines on the left half and a solid black right half. Below the globe is the company name, "BIOMÉRIEUX", in a simple sans-serif font.
510(k) SUMMARY
VITEK® Gram Positive Ertapenem
510(k) Submission Information:
| Submitter's Name: | bioMérieux, Inc. |
|---|---|
| Address: | 595 Anglum RoadHazelwood, MO 63042 |
| Contact Person: | Jolyn TenlladoRegulatory Affairs Specialist |
| Phone Number: | 314-731-8386 |
| Fax Number: | 314-731-8689 |
| Date of Preparation: | October 22, 2004 |
| B. Device Name: | |
| Formal/Trade Name: | VITEK® Gram Positive Ertapenem (≤0.5 - ≥32µg/ml) |
| Classification Name: | Fully Automated Short-Term Incubation CycleAntimicrobial Susceptibility Device,21 CFR 866.1645 |
| Common Name: | VITEK GPS Ertapenem |
| C. Predicate Device: | VITEK Gram Positive Susceptibility (GPS) Card forGatifloxacin (N50510/S143) |
D. 510(k) Summary:
VITEK® Gram Positive Ertapenem is designed for antimicrobial susceptibility testing of Staphyloccocus aureus and Steptococcus agalactiae. 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 GPS Cards is in concentrations equivalent by efficacy to standard method concentrations in mcg/ml. The VITEK GPS Cards are essentially miniaturized versions of the doubling dilution technique for determining the minimum inhibitory concentration (MIC) microdilution methodology.
After the card is inoculated with a standardized organism suspension, it is placed in the Reader/Incubator of the VITEK System. Organism growth inside the card is optically monitored throughout the 6-15 hour incubation cycle. MIC results are automatically
p. 53
{1}------------------------------------------------
calculated once a predetermined growth threshold is reached, and a report is generated that contains the MIC result and the interpretive category result.
VITEK Gram Positive Ertapenem demonstrated substantially equivalent performance when compared with the NCCLS reference agar dilution method, as defined in the FDA 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 Gram Positive The Fromanet Notineation (oroly) Pras conducted with fresh and stock clinical isolates and stock challenge strains. The external evaluations were designed to confirm the and otook chairenge birain Positive Ertapenem by comparing its performance with the NCCLS agar dilution reference method. VITEK Gram Positive Ertapenem demonstrated acceptable performance of 99.3% overall Category Agreement when compared to the agar dilution reference method. Reproducibility and Quality Control demonstrated acceptable results.
{2}------------------------------------------------
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" around the perimeter. Inside the circle is an abstract image of a human figure with an eagle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
DEC 1 3 2004
Ms. Jolyn Tenllado Regulatory Affairs Specialist BioMérieux, Inc. 595 Anglum Road Hazelwood, MO 63042-2320
K042963 Re:
Trade/Device Name: VITEK® Gram Positive Ertapenem (≤0.5 - ≥32 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: October 22, 2004 Received: October 27, 2004
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).
{3}------------------------------------------------
Page 2
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). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Sagaxtys
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
{4}------------------------------------------------
Indications for Use
510(k) Number (if known): K042963
Device Name: VITEK® Gram Positive Ertapenem (≤0.5 – ≥32 µg/ml)
Indications For Use:
The VITEK® Gram Positive Susceptibility Test is intended to be used with the VITEK® 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, and S. pneumoniae. VITEK® Gram Positive Ertapenem is designed for antimicrobial susceptibility testing of Staphylococcus aureus and Streptococcus agalactiae. It is intended for use with the VITEK System as a laboratory aid in the determination of in vitro susceptibility to antimicrobial agents.
Prescription Use X (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)
Ludlow h. Locke
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Salay
510(k) K04 2963
Page 1 of 1
p. 10
§ 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.”