(84 days)
ETEST® is a quantitative technique for determination of antimicrobial susceptibility of non-fasticious Gram-negative and Gram-positive aerobic bacteria such as Enterobacteriaceae, Pseudomonas, Staphylococcus, and fastidious bacteria, such as anaerobes, N. gonorrhoeae, S. pneumoniae, Streptococcus and Haemophilus species. The system comprises a predefined antibiotic gradient which is used to determine the Minimum Inhibitory Concentration (MIC), in ug/mL, of different antimicrobial agents against microorganisms as tested on agar media using overnight incubation.
Telavancin has been shown to be active against the Gram positive aerobic microorganisms listed below, according to the FDA label for this antimicrobial agent.
Active both in vitro and in clinical infections: Staphylococcus aureus (including methicillin resistant isolates) Enterococcus faecalis (vancomycin susceptible isolates only)
ETEST® is a thin, inert and non-porous plastic strip carrying on one side (A) the MIC reading scale in ug/mL, and on the other side (B) a predefined antibiotic gradient.
When the strip is applied to an inoculated agar surface, the preformed antibiotic gradient immediately transfers into the agar matrix, then forming a stable, continuous and exponential gradient of antibiotic concentrations directly underneath the strip. Bacterial growth becomes visible during incubation, and a symmetrical inhibition ellipse centered along the strip appears. The MIC value is read from the scale in terms of ug/mL at complete inhibition of bacterial growth, where the pointed end of the ellipse intersects the strip.
Here's an analysis of the acceptance criteria and study detailed in the provided document for the ETEST® Telavancin device:
Acceptance Criteria and Device Performance
| Criteria | Reported Device Performance (%) |
|---|---|
| Staphylococcus aureus | |
| Essential Agreement (EA) | 98.4 |
| Category Agreement (CA) | 97.9 |
| Enterococcus faecalis | |
| Essential Agreement (EA) | 91.6 |
| Category Agreement (CA) | 97.6 |
Study Information:
-
Sample sizes used for the test set and the data provenance:
The document does not specify the exact sample sizes for Staphylococcus aureus or Enterococcus faecalis isolates used in the test set. It mentions "External evaluations were conducted with fresh and stock clinical isolates, as well as a set of challenge strains." The provenance of the data (country of origin) is not explicitly stated. The nature of the data (retrospective or prospective) is also not explicitly detailed, but the use of "fresh and stock clinical isolates" suggests a mix, potentially with retrospective elements for the stock isolates and prospective elements for the fresh isolates. -
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided in the document. The ground truth was established by comparing the device's performance to the CLSI M07-A10 January 2015 broth microdilution reference method, which is a standardized laboratory procedure, not typically relying on individual expert judgment for ground truth determination. -
Adjudication method for the test set:
This is not applicable as the ground truth was established by a standardized reference method (CLSI broth microdilution) rather than human adjudication. -
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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The ETEST® Telavancin is an antimicrobial susceptibility test system, not an AI-assisted diagnostic tool for human readers. Its performance is evaluated against a reference laboratory method. -
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Yes, a standalone performance evaluation was done. The ETEST® Telavancin device's performance was compared directly to the CLSI M07-A10 broth microdilution reference method, without human-in-the-loop assistance influencing the ETEST® results. The ETEST® strip itself is read visually by a laboratory technician to determine the MIC value, which is part of its intended "standalone" use. -
The type of ground truth used:
The ground truth used was a reference laboratory method: the CLSI M07-A10 January 2015 broth microdilution method. This method is considered the gold standard for antimicrobial susceptibility testing. -
The sample size for the training set:
The document does not provide information regarding a separate "training set" or its sample size. For medical devices like AST systems, the development often involves an iterative process of design and internal testing, but the document focuses on the validation against established reference methods, which is typically done on a distinct "test set." -
How the ground truth for the training set was established:
Since no information on a specific "training set" and its sample size is provided, the method for establishing its ground truth is also not described.
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July 3, 2018
bioMérieux SA Asa Karlsson Sr. Regulatory Affairs Manager 376 Chemin de l'Orme Marcy L'Etoile, 69280 Fr
Re: K180936
Trade/Device Name: ETEST Telavancin (TLA) (0.002-32 ug/mL) Regulation Number: 21 CFR 866.1640 Regulation Name: Antimicrobial susceptibility test powder Regulatory Class: Class II Product Code: JWY Dated: April 9, 2018 Received: April 10, 2018
Dear Ms. Karlsson:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Ribhi Shawar -S
For
Uwe Scherf, M.Sc., Ph.D. Director Division of Microbiology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K180936
Device Name ETEST® Telavancin (TLA) (0.002 - 32 ug/mL)
Indications for Use (Describe)
ETEST® is a quantitative technique for determination of antimicrobial susceptibility of non-fasticious Gram-negative and Gram-positive aerobic bacteria such as Enterobacteriaceae, Pseudomonas, Staphylococcus, and fastidious bacteria, such as anaerobes, N. gonorrhoeae, S. pneumoniae, Streptococcus and Haemophilus species. The system comprises a predefined antibiotic gradient which is used to determine the Minimum Inhibitory Concentration (MIC), in ug/mL, of different antimicrobial agents against microorganisms as tested on agar media using overnight incubation.
Telavancin has been shown to be active against the Gram positive aerobic microorganisms listed below, according to the FDA label for this antimicrobial agent.
Active both in vitro and in clinical infections: Staphylococcus aureus (including methicillin resistant isolates) Enterococcus faecalis (vancomycin susceptible isolates only)
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) SUMMARY
ETEST® Telavancin
A. 510(k) Submission Information:
| Submitter's Name: | bioMerieux SA |
|---|---|
| Address: | 376 Chemin de l'Orme69280 Marcy-l'Etoile, FRANCE |
| Contact Person: | Asa KarlssonSr. Regulatory Affairs Manager |
| Phone Number: | +33 (0)6 48 61 68 49 |
| Date of Preparation: | July 2, 2018 |
B. Device Name:
| Formal/Trade Name: | ETEST® Telavancin (TLA) (0.002 - 32 ug/mL) |
|---|---|
| Classification Name: | 21 CFR 866.1640Manual Antimicrobial Susceptibility Test SystemsProduct Code: JWY |
| Common Name(s): | ETEST® Telavancin; ETEST® TLA |
| C. Predicate Device: | ETEST® Ceftaroline (CPT) (0.002-32 µg/mL)(K151873) |
D. Device Description:
ETEST® is a thin, inert and non-porous plastic strip carrying on one side (A) the MIC reading scale in ug/mL, and on the other side (B) a predefined antibiotic gradient.
When the strip is applied to an inoculated agar surface, the preformed antibiotic gradient immediately transfers into the agar matrix, then forming a stable, continuous and exponential gradient of antibiotic concentrations directly underneath the strip. Bacterial growth becomes visible during incubation, and a symmetrical inhibition ellipse centered along the strip appears. The MIC value is read from the scale in terms of ug/mL at complete inhibition of bacterial growth, where the pointed end of the ellipse intersects the strip.
E. Intended Use:
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ETEST® is a quantitative technique for determination of antimicrobial susceptibility of nonfastidious Gram-negative and Gram-positive aerobic bacteria such as Enterobacteriaceae, Pseudomonas, Staphylococcus, and Enterococcus species and fastidious bacteria, such as anaerobes, N. gonorrhoeae, S. pneumoniae, Streptococcus and Haemophilus species. The system comprises a predefined antibiotic gradient which is used to determine the Minimum Inhibitory Concentration (MIC), in ug/mL, of different antimicrobial agents against microorganisms as tested on agar media using overnight incubation.
Telavancin has been shown to be active against the Gram positive aerobic microorganisms listed below, according to the FDA label for this antimicrobial agent.
Active both in vitro and in clinical infections:
Staphylococcus aureus (including methicillin resistant isolates) Enterococcus faecalis (vancomycin susceptible isolates only)
F. Performance Overview
ETEST® Telavancin demonstrated substantially equivalent performance when compared with the CLSI M07-A10 January 2015 broth microdilution reference method, following rules as defined in the FDA Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems; Guidance for Industry and FDA, issued on August 28, 2009 and following specifications as defined in CLSI M100-S27 January 2017.
This Premarket Notification (510[k]) presents data in support of ETEST® Telavancin for Gram positive aerobic bacteria: Staphylococcus aureus and Enterococcus faecalis. External evaluations were conducted with fresh and stock clinical isolates, as well as a set of challenge strains. The external evaluations were designed to establish the performance of ETEST® Telavancin by comparing with the CLSI broth microdilution reference method.
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ETEST® Telavancin demonstrated acceptable performance as presented in Table 1 below: Table 1: Performance Characteristics for ETEST® Telavancin
| % Essential Agreement | % Category Agreement | |
|---|---|---|
| (EA) | (CA) | |
| Staphylococcus aureus(including methicillin resistantisolates) | 98.4 | 97.9 |
| Enterococcus faecalis(vancomycin susceptibleisolates only) | 91.6 | 97.6 |
Reproducibility and Quality Control demonstrated acceptable results.
G. Conclusion:
The performance data presented in this submission support a substantial equivalence decision. ETEST® Telavancin (0.002-32 µg/mL) is substantially equivalent to ETEST® Ceftaroline (0.002-32 µg/mL) (K151873).
§ 866.1640 Antimicrobial susceptibility test powder.
(a)
Identification. An antimicrobial susceptibility test powder is a device that consists of an antimicrobial drug powder packaged in vials in specified amounts and intended for use in clinical laboratories for determining in vitro susceptibility of bacterial pathogens to these therapeutic agents. Test results are used to determine the antimicrobial agent of choice in the treatment of bacterial diseases.(b)
Classification. Class II (performance standards).