(45 days)
This submission is for the addition of Tigeycline to the Etest® product range for MIC delemination across a concentration range of 0.016-256 ug/mL. In vitro susceptibility testing of Tigecycline is indicated for Gram positive and Gram negative aerobic bacteria such as Enterobacteriaceae, Pseudomonas, Staphylococcus and Entercococus species and S. pneumoniae and anaerobic bacteria.
Etest® is a quantitative technique for the determination of antimicrobial susceptibility of microorganisms as tested on agar using overnight incubation. The system comprises a predefined antibiotic gradient which is used to determine the Minimum Inhibitory Concentration (MIC) in ug/mL of antimicrobial agents against microorganisms. Etest® can be used to test non-fastidious Gram negative and Gram positive aerobic bacteria such as Enterobacteriaceae, Pseudomonas, Staphylococcus and Entercococus species and fastidious bacteria, such as S. pneumoniae, Haemophilus Species, N. gonorrhoeae, and anaerobes.
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Here's an analysis of the provided text to extract information about the Etest® Antimicrobial Susceptibility Test – Tigecycline, focusing on acceptance criteria and study details:
1. A table of acceptance criteria and the reported device performance
The provided text does not explicitly state specific quantitative acceptance criteria or the reported device performance in a clear, tabulated format. It is a 510(k) clearance letter, which confirms substantial equivalence to a predicate device rather than presenting detailed study results and acceptance criteria directly.
Typically, such studies would compare the Etest® results to a reference method (e.g., broth microdilution) and report metrics like Categorical Agreement (CA), Essential Agreement (EA), statistical correlation (e.g., R-squared), or percentages of minor, major, and very major errors. These quantitative measures would be compared against predefined acceptance criteria (e.g., CA ≥ 90%, Major Error < 3%).
However, based on the nature of antimicrobial susceptibility testing device clearances, the general expectation is that the device demonstrates performance comparable to the reference method.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify the sample size used for the test set or the data provenance (country of origin, retrospective/prospective). This information would typically be found in the detailed study report submitted as part of the 510(k) application, which is not included here.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
The document does not provide information on the number or qualifications of experts used to establish ground truth. For antimicrobial susceptibility testing, the "ground truth" is typically established by a recognized reference method (e.g., broth microdilution or agar dilution) performed by trained laboratory personnel, rather than expert clinicians/radiologists.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
The document does not detail any adjudication method used for the test set. Adjudication is less common in direct comparison studies for quantitative results like MICs, where a reference method provides a definitive value.
5. 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 MRMC comparative effectiveness study was done. This device is an antimicrobial susceptibility test, which quantifies the Minimum Inhibitory Concentration (MIC) of an antibiotic for a microorganism. It is not an AI-powered diagnostic imaging device that requires human interpretation and thus, MRMC studies and "human readers improving with AI" are not relevant to this type of device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This device, the Etest®, is a physical strip with a predefined antibiotic gradient. While its reading involves visual interpretation of the ellipse of inhibition, it is not an "algorithm only without human-in-the-loop performance" in the context of modern AI. The reading of the MIC from the Etest strip is typically performed visually by a trained human. The "performance" being assessed is the accuracy of the Etest method itself when read by a human, compared to a reference method.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For antimicrobial susceptibility testing, the "ground truth" is established by a reference culture-based method, typically broth microdilution or agar dilution. These methods are standardized by organizations like the Clinical and Laboratory Standards Institute (CLSI) and are considered the gold standard for determining MIC values. The Etest's performance is compared against these reference methods.
8. The sample size for the training set
The document does not provide information on the sample size for the training set. For Etest®, "training set" doesn't apply in the same way as for machine learning models. Instead, the device's design and initial validation would have been based on extensive historical data and development work, but specific "training set" sizes are not relevant in this context.
9. How the ground truth for the training set was established
As with the "training set" concept being largely irrelevant for this type of device, the "ground truth for the training set" is also not discussed. The development and validation of the Etest® method itself relied on established microbiological principles and comparisons to standard reference methods over time.
Summary of Missing Information:
It's crucial to understand that a 510(k) clearance letter like this is an outcome document confirming substantial equivalence. It does not typically contain the detailed technical data, study protocols, or results that were submitted in the full 510(k) application. To get the specific quantitative data for acceptance criteria, sample sizes, and detailed methodology, one would need to review the full 510(k) submission, which is often not publicly available in its entirety.
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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS) of the United States of America. The logo features a stylized eagle with three swooping lines representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
OCT 1 3 2005
Ms. Anne Bolmström President and CEO AB Biodisk Dalvägen 10 S-169 56 Solna Sweden
K052366 Re:
K052300
Trade/Device Name: Etest® Antimicrobial Susceptibility Test – Tigecycline MIC at 0.016-256 Regulation Number: 21 CFR 866.1640 Regulation Name: Antimicrobial Susceptibility Test Powder Regulatory Class: Class II Product Code: JWY Dated: August 24, 2005 Received: August 29, 2005
Dear Ms. Bolmström:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave teviewed your becamed the device is substantially equivalent (for the indications ferenced above und have actes negally marketed predicate devices marketed in interstate 10 use stated in the encreativent of the enactment date of the Medical Device Amendments, or to commence provision to May 20, 1978, the excordance with the provisions of the Federal Food, Drug, devices mat have been receasined in quire approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The r out may, therefore, mainer of the Act include requirements for annual registration, listing of general condors provisions of wactice, 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 your device is elaborized (ove a controls. Existing major regulations affecting your device it may be subject to such additions (CFR), Parts 800 to 895. In addition, FDA can be found in fire announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean r lease of advised that I Drivers and evice complies with other requirements of the Act mall i DA has made a determinations administered by other Federal agencies. You must of any I edital statutes and regainents ancluding, but not limited to: registration and listing (21 Comply with an the Free Feep Parts 801 and 809); and good manufacturing practice CI It I art 807), labeling 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 (240)276-0484. 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/industry/support/index.html
Sincerely yours,
Sale, a For
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: K052366
Device Name: Etest® Antimicrobial Susceptibility Test – Tigecycline MIC at 0.016-256 ug/mL.
Indications For Use: This submission is for the addition of Tigeycline to the Etest® Indications For Use. This Submission is for the addition with Gram positive and product range for MIC delemination across of For 200 pg.m. In S. pneumoniae and anaerobic bacteria.
Etest® is a quantitative technique for the determination of antimicrobial susceptibility of Efest® is a quantitative technique for the acterials aerobic bacteria such as both non-fastidious Gran negative and Olain poccus and Entercococus species and
Enterobacteriaceae, Pseudomonas, Staphylococcus and Entercococus species and Enterobacteriatede, I Scadomondo, S. J. gonorrhoeae, S. pneumoniae, fastidious bacteria, such as anaerooss, The system comprises a predefined antibiotic Streptococcus, Haemophilus Species: The Uyeton Institution (MIC) in
gradient which is used to determine the Minimum Instagramiams on tested on agar gradient which is used to determine the Miniman 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)
Salazar
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) Kos 2366
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§ 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).