ETEST TELAVANCIN IN 0.002-32 UG/ML AND 0.016-256 UG/ML by BIOMERIEUX SA

This submission is for Etest® Telavancin for MIC determinations across 0.002-32 µg/mL and 0.016-256 µg/mL with Staphylococcus aureus (including methicillin-resistant isolates), Enterococcus faecalis (vancomycin-susceptible isolates only), Streptococcus agalactiae and Streptococcus anginosus group.

Etest® is a quantitative technique for determination of antimicrobial susceptibility of both non-fastidious Gram negative and Gram positive aerobic bacteria such as Enterobacterias, 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 using overnight incubation.

Device Description

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 using overnight incubation.

AI/ML Overview

Here's an analysis of the acceptance criteria and study details based on the provided document. Unfortunately, the provided document is a 510(k) clearance letter and an "Indications For Use" statement. It does not contain the detailed study information required to fully answer all parts of your request, such as specific acceptance criteria thresholds, reported performance metrics, sample sizes for test and training sets, details on expert ground truth, or MRMC studies.

Therefore, I will extract what is available and note where information is missing.

Extracted Information:

The document describes the clearance of "Etest® Telavancin for Antimicrobial Susceptibility Testing." The device determines the Minimum Inhibitory Concentration (MIC) for Telavancin against specific bacteria.

Acceptance Criteria and Study Overview

Due to the nature of the provided document (510(k) clearance letter), specific numerical acceptance criteria (e.g., % agreement with a predicate device) and detailed study results are not present. However, the clearance implies that the device met the FDA's requirements for substantial equivalence to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied by 510(k) Clearance Process):
For an Antimicrobial Susceptibility Test (AST) device seeking 510(k) clearance, the primary acceptance criteria revolve around substantial equivalence to a legally marketed predicate device. This typically involves demonstrating acceptable agreement (e.g., Categorical Agreement (CA), Essential Agreement (EA)) between the new device and the predicate device, or a reference method, for MIC determination.

Reported Device Performance:

Device Name: Etest® Telavancin - Antimicrobial Susceptibility Test
MIC Range: 0.002-32 µg/mL and 0.016-256 µg/mL
Tested Organisms:
- Staphylococcus aureus (including methicillin-resistant isolates)
- Enterococcus faecalis (vancomycin-susceptible isolates only)
- Streptococcus agalactiae
- Streptococcus anginosus group

Specific numerical performance data (e.g., % Categorical Agreement, % Essential Agreement, resolution of discordant results) are NOT provided in this document.

2. Sample Size for the Test Set and Data Provenance

Sample Size: NOT PROVIDED in this document.
Data Provenance: NOT PROVIDED in this document (e.g., country of origin, retrospective/prospective). Studies for AST devices typically involve testing a diverse collection of bacterial isolates, usually prospectively collected or from well-characterized strain collections.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Number of Experts: NOT PROVIDED in this document.
Qualifications of Experts: NOT PROVIDED in this document. For AST devices, ground truth (reference method results) is typically established by trained microbiologists following standardized laboratory procedures.

4. Adjudication Method for the Test Set

Adjudication Method: NOT PROVIDED in this document. For AST, adjudication methods aren't typically described as 2+1/3+1 in the same way as imaging studies. Discordant results (e.g., between the test device and the reference method) would usually be retested or investigated by a senior microbiologist to determine the definitive result.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

MRMC Study: NOT APPLICABLE/NOT DONE. MRMC studies are primarily for devices that assist human readers in interpreting clinical images (e.g., AI for radiology). This device is an in vitro diagnostic for antimicrobial susceptibility testing, which provides a direct MIC output, not an interpretation assistance for a human reader of complex data.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

Standalone Performance: YES, inherently. The Etest® Telavancin system is a standalone diagnostic test. It functions by itself to determine the MIC. The performance described (though not explicitly detailed in this document) would be its standalone accuracy compared to a reference method. It's not an AI algorithm, but a phenotypic assay.

7. The Type of Ground Truth Used

Ground Truth Type: For antimicrobial susceptibility testing, the ground truth is typically established by a reference phenotypic method, such as broth microdilution or agar dilution, performed according to CLSI (Clinical and Laboratory Standards Institute) guidelines. This is considered the "gold standard" for MIC determination.

8. The Sample Size for the Training Set

Training Set Sample Size: NOT APPLICABLE/NOT PROVIDED. Etest® is a phenotypic method, not a machine learning or AI algorithm that requires a "training set" in the conventional sense. Its performance relies on the biochemical interactions on the strip and agar, rather than a learned model from data.

9. How the Ground Truth for the Training Set Was Established

Ground Truth for Training Set: NOT APPLICABLE. As noted above, this device does not use a training set in the machine learning sense.

Summary

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized symbol resembling a caduceus, featuring a staff with a single snake winding around it, topped with a three-pronged design.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993

bioMérieux c/o Asa Karlsson Regulatory Affairs Manager 5 rue des Aqueducs Craponne, France 69290

16 2011 MAY

Re: K102535

Trade/Device Name: Etest® Telavancin for Antimicrobial Susceptibility Testing Regulation Number: 21 CFR 866.1640 Regulation Name: Antimicrobial Susceptibility Test (AST) Powder Regulatory Class: Class II Product Code: JWY Dated: April 13, 2011 Received: April 19, 2011

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.

If your device is classified (see above) into class II (Special Controls), 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket

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Page 2 - Asa Karlsson

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 Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

fayazadym

Sally A. Hojvat, M.Sc., 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

K 102538 510(k) Number (if known):

Device Name: Etest® Telavancin - Antimicrobial Susceptibility: Test - MC at 0.002-32 µg/mL and 0.016-256 ug/mL.

Indications For Use: This submission is for Etest® Telavancin for MIC determinations across 0.002-32 µg/mL and 0.016-256 µg/mL with Staphylooous aureus (including methicillin-resistant isolates), Entervoous faecalis (vancomycin-susceptible isolates only), Streptocous agalactive and Streptorous anginous group.

Etest® is a quantitative technique for determination of antimicrobial susceptibility of both non-fastidious Gram negative and Gram positive aerobic bacteria such as Enterbaturias, Staphylovaus and Entervoors species and fastidious bacteria, such as anaerobes, N. gonorrhoeae, S. pneumoniae, Streptorouxu 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 using overnight incubation.

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)

Sae atter
Division Sign-Off

Office of In Vitro Diag

Device Evaluation and S

510(k) K 102535

Regulation Number and Section

§ 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).