(127 days)
The Sensititre® YeastOne® Susceptibility System is an in vitro diagnostic product for clinical susceptibility testing of Candida spp. This 510(k) is for Micafungin in the dilution range of 0.008 – 16 µg/ml is intended for testing Candida spp. on the Sensititre® YeastOne® Susceptibility system. The approved primary "Indications for Use" and clinical significance of Micafungin is for: Candida albicans Candida glabrata Candida krusei Candida parapsilosis Candida tropicalis
Not Found
The provided text is a 510(k) clearance letter for the Sensititre® YeastOne® Susceptibility System with Micafungin. It does not contain the detailed study information required to answer the specific questions about acceptance criteria, device performance, sample sizes, ground truth establishment, or expert involvement in the way a clinical study report would.
The document states the device's "Indications for Use" and that it is "substantially equivalent" to legally marketed predicate devices, but it does not present the results of a primary study with acceptance criteria and a detailed breakdown of performance metrics. Instead, it refers to general controls provisions of the Act and the device's classification.
Therefore, based solely on the provided text, I cannot provide the requested information for the following reasons:
- Acceptance Criteria and Reported Device Performance: This document does not specify quantitative acceptance criteria for the device's performance (e.g., specific percentages for essential agreement or categorical agreement) nor does it provide a table of reported device performance metrics against such criteria.
- Sample Size and Data Provenance (Test Set): The document does not describe a test set or its sample size.
- Number of Experts and Qualifications (Ground Truth for Test Set): The process of establishing ground truth for a test set is not outlined.
- Adjudication Method: No adjudication method is mentioned as a study is not detailed.
- Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: This is not mentioned as the device is an in vitro diagnostic (IVD) antimicrobial susceptibility test, not an imaging AI device requiring human reader interpretation in the same way.
- Standalone Performance: The document does not present standalone algorithm performance data.
- Type of Ground Truth Used: The method for determining the "true" susceptibility for any study is not described. For antimicrobial susceptibility testing, this would typically involve a reference method, but it is not detailed here.
- Sample Size for Training Set: No training set is mentioned as a study is not detailed.
- How Ground Truth for Training Set was Established: Not applicable as no training set is mentioned.
In summary, the provided document is a regulatory clearance letter, not a study report. It confirms the device's equivalence and indications for use but does not delve into the detailed methodology or results of the performance studies that would have been submitted to the FDA to support the 510(k) application.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
TREK DIAGNOSTIC SYSTEMS CINDY KNAPP DIRECTOR US REGULATORY AND CLINICAL AFFAIRS I THERMO FISHER WAY OAKWOOD VILLAGE OH 44146
January 31, 2014
Re: K133038
Trade/Device Name: Sensititre Yeastone Susceptibility Plates Regulation Number: 21 CFR 866.1640 Regulation Name: Antimicrobial susceptibility test powder Regulatory Class: II Product Code: NGZ Dated: January 02, 2014 Received: January 06, 2014
Dear Mrs. Knapp:
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 Parts 801 and 809); medical device reporting (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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Page 2-Mrs. Knapp
If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact 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/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Uwe Scherf - S for
Sally A. Hojvat, 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): K133038
Device Name: Sensititre® YeastOne® Sysceptibility System with Micafungin (0.008 -16ug/ml) for Candida spp.
Indications for Use: The Sensititre® YeastOne® Susceptibility System is an in vitro diagnostic product for clinical susceptibility testing of Candida spp.
This 510(k) is for Micafungin in the dilution range of 0.008 – 16 µg/ml is intended for testing Candida spp. on the Sensititre® YeastOne® Susceptibility system. The approved primary "Indications for Use" and clinical significance of Micafungin is for:
Candida albicans Candida glabrata Candida krusei Candida parapsilosis Candida tropicalis
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
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Concurrence of Center for Devices and Radiological Health (CDRH)
§ 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).