(89 days)
The Sensititre 18 - 24 hour MIC or Breakpoint Susceptibility System is an in vitro diagnostic product for clinical susceptibility testing of non fastidious isolates. This 5 IV(k) is for the newly approved Breakpoints for Telavancin, utilizing the 0.002% Polysorbate 80 for the reference method in the dilution range of 0.0005-2ug/ml to the Sensititee 18 - 24 hour MCC panel for terfeirences of on positive isolates. The approved primary "Indications for Use" and clinical significance for non-fastidious Gram positive isolates; Staphylococcus aureus (including methicillin-resistant isolates) Enterococcus faecalis
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The provided FDA 510(k) clearance letter does not contain the detailed study information required to answer your request in full. It primarily focuses on the regulatory aspects of the device's clearance. However, I can extract the acceptance criteria and a general overview of what the study was for from the document.
Here's an analysis of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The document states: "This 510(k) is for the newly approved Breakpoints for Telavancin, utilizing the 0.002% Polysorbate 80 for the reference method in the dilution range of 0.0005-2ug/ml to the Sensititre 18 - 24 hour MCC panel for terfeirences of on positive isolates."
This phrasing indicates that the acceptance criteria are tied to the concept of "newly approved Breakpoints for Telavancin." The study would have aimed to demonstrate that the Sensititre system's results align with these established breakpoints. The specific quantitative acceptance criteria (e.g., Categorical Agreement, Essential Agreement percentages) and the reported device performance (actual values achieved) are not detailed within this document. These would typically be found in the full 510(k) submission or associated clinical study reports, which are not provided here.
However, based on typical Antimicrobial Susceptibility Test (AST) device submissions, the acceptance criteria would generally revolve around:
- Essential Agreement (EA): The percentage of isolates for which the MIC (Minimum Inhibitory Concentration) value obtained by the test device is within plus or minus one doubling dilution of the reference method MIC.
- Categorical Agreement (CA): The percentage of isolates for which the interpretive category (Susceptible, Intermediate, or Resistant) obtained by the test device agrees with the interpretive category of the reference method.
- Major Errors (ME): Instances where the test device classifies an isolate as Susceptible when the reference method classifies it as Resistant.
- Very Major Errors (VME): Instances where the test device classifies an isolate as Resistant when the reference method classifies it as Susceptible.
- Minor Errors (mE): Instances where the test device classifies an isolate as Intermediate when the reference method classifies it as Susceptible or Resistant, or vice versa.
Without the actual study report, I cannot provide numerical values for the reported device performance against specific acceptance criteria.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify the sample size (number of isolates) used in the test set.
- Data Provenance: The document does not specify the country of origin of the data or whether the study was retrospective or prospective. Typically, clinical studies for AST devices involve prospective collection of isolates from various clinical sites.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- This information is not provided in the document. For AST devices, the "ground truth" is typically established by a recognized reference method performed by trained microbiologists, rather than a panel of "experts" in the way it might be for image-based diagnostic AI.
4. Adjudication Method for the Test Set
- This information is not provided in the document. For AST devices, the reference method's result is generally considered the "gold standard," and complex adjudication methods like 2+1 or 3+1 are not typically used to establish ground truth for MIC values.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- An MRMC study is not applicable to this type of device. The Sensititre system is an automated or semi-automated system that provides an MIC value and interpretive category, not an image-based diagnostic that requires human interpretation. Therefore, a study comparing Human Readers with and without AI assistance is not relevant here.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- The Sensititre system itself is the "standalone" device in this context. The study evaluates the performance of the system (including its reagents and methodology) against a recognized reference method. It's not an "algorithm only" in the sense of an AI model, but rather a complete diagnostic test system. The clearance is based on its standalone performance relative to the reference method.
7. The Type of Ground Truth Used
- The ground truth used is implicitly stated as the "reference method in the dilution range of 0.0005-2ug/ml". For AST devices, this typically refers to a standardized broth microdilution method (e.g., CLSI broth microdilution reference method) for determining the MIC.
8. The Sample Size for the Training Set
- This information is not applicable/not provided in the context of this device. The Sensititre system is not an AI/ML device that requires a "training set" in the conventional sense. Its performance is based on its established methodology and reagents, which are validated during manufacturing and clinical studies.
9. How the Ground Truth for the Training Set was Established
- This information is not applicable/not provided as there is no "training set" for this type of device.
In summary, the provided document offers limited details regarding the specifics of the performance study. It broadly indicates that the device was evaluated against reference methods to support the "newly approved Breakpoints for Telavancin." Comprehensive details on sample sizes, specific performance metrics (EA, CA, ME, VME), and the exact study methodology would be found in the complete 510(k) submission, which is not included here.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 16, 2014
THERMOFISHER SCIENTIFIC CYNTHIA KNAPP DIRECTOR OF CLINICAL OPERATIONS I THERMO FISHER WAY OAK WOOD VILLAGE OH 44146
Re: K141000
Trade/Device Name: The Sensititre 18-24 hour MIC Susceptibility System Susceptibility Test Plate with Telavancin (0.0005-2ug/mL) Regulation Number: 21 CFR 866.1640 Regulation Name: Antimicrobial susceptibility test powder Requlatory Class: II Product Code: JWY, LRG, LTT, LTW Dated: July 2. 2014 Received: July 3. 2014
Dear Ms. 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 mav. 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 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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If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education 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" (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 Industry and Consumer Education 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,
Sally A Hojvat -S
Sally A. Hojvat, M.Sc., PhD. Director Division of Microbiology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K141000
Device Name
The Sensititre® 18 - 24 hour MIC Susceptibility System Susceptibility Test Plate with Telavancin (0.0005-20g/ml)
Indications for Use (Describe)
The Sensititre 18 - 24 hour MIC or Breakpoint Susceptibility System is an in vitro diagnostic product for clinical susceptibility testing of non fastidious isolates.
This 5 IV(k) is for the newly approved Breakpoints for Telavancin, utilizing the 0.002% Polysorbate 80 for the reference method in the dilution range of 0.0005-2ug/ml to the Sensititee 18 - 24 hour MCC panel for terfeirences of on positive isolates.
The approved primary "Indications for Use" and clinical significance for non-fastidious Gram positive isolates;
Staphylococcus aureus (including methicillin-resistant isolates) Enterococcus faecalis
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
L Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Ribhi Shawar -S 2014.07.14 15:55:23 -04
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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).