(87 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 510(k) is for Ceftazidime/Avibactam the dilution range of 0.015/4-32/4 ug/ml for testing non-fastidious gram negative organisms on the Sensititre 18 - 24 hour MIC panel. The approved primary "Indications for Use" and clinical significance for non-fastidious Gram negative isolates: Enterobacter cloacae Escherichia coli Klebsiella oxytoca Klebsiella pneumoniae Proteus mirabilis Citrobacter freundii Citrobacter koseri Enterobacter aerogenes Proteus spp. Pseudomonas aeruginosa
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This document describes the FDA clearance (K152774) for the Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Ceftazidime/Avibactam. The information provided is primarily regulatory in nature and does not contain details about specific acceptance criteria or a study proving the device meets those criteria in the format requested.
The document states that the device is "substantially equivalent" to legally marketed predicate devices. This equivalence determination process often involves demonstrating that the new device performs as well as, or comparably to, the predicate device. However, the specifics of these performance studies (like acceptance criteria, sample sizes, ground truth establishment, etc.) are not present within this document.
Therefore, I cannot populate the table or answer most of the questions based solely on the provided text.
Here's what information I can infer or state about the absence of information:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in document | Not specified in document |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample size: Not specified.
- Data provenance: Not specified.
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)
- Not specified.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not specified.
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
- This device is an in vitro diagnostic product for antimicrobial susceptibility testing, not an AI-assisted diagnostic tool that involves "human readers" in the context of imaging or similar interpretation. Therefore, an MRMC study for AI assistance would not be applicable. The document does not mention any studies of this nature.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This device is a standalone susceptibility testing system. Its performance is evaluated on its own ability to determine antimicrobial susceptibility. The specifics of this evaluation are not detailed in this document.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For antimicrobial susceptibility testing, the "ground truth" typically involves reference microbiology methods (e.g., broth microdilution or agar dilution performed according to CLSI standards) to determine the true Minimum Inhibitory Concentration (MIC) or susceptibility category. This document does not explicitly state the ground truth method used, but it's universally implied in such device clearances.
8. The sample size for the training set
- Not specified. This clearance is for a medical device that likely follows established chemical/biological principles, rather than a machine learning model that requires a "training set" in the common AI sense. If there are internal 'training' or optimization phases for the system's readings, those details are not provided.
9. How the ground truth for the training set was established
- Not applicable in the AI sense. If any internal optimization or calibration used "ground truth," it would be established via reference microbiology methods, but these details are not provided.
Summary of available information:
The document is a clearance letter from the FDA stating that the Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Ceftazidime/Avibactam is substantially equivalent to predicate devices for specific non-fastidious gram-negative organisms. It lists the device name, regulation number, regulatory class, and product codes, along with its intended use as an in vitro diagnostic product for clinical susceptibility testing. However, the detailed acceptance criteria and supporting study data requested are not included in this regulatory clearance letter. Such information would typically be found in the 510(k) submission itself, which is not provided here.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 21, 2015
THERMO FISHER SCIENTIFIC CYNTHIA KNAPP DIRECTOR OF CLINICAL OPERATIONS 1 THERMO FISHER WAY OAKWOOD VILLAGE OH 44014-6
Re: K152774
Trade/Device Name: The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Ceftazidime/Avibactam in the dilution range of 0.015/4 - 32/4 ug/mL Regulation Number: 21 CFR 866.1640 Regulation Name: Antimicrobial susceptibility test powder Regulatory Class: II Product Code: JWY, LRG, LTT Dated: September 24, 2015 Received: September 25, 2015
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 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
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electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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/Resourcesfor You/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,
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) K152774
Device Name
The Sensitite 18 - 24 hour MIC or Breakpoint Sysceptibility System with Ceftazidime/Avibactam in the dilution range of 0.015/4-32/4 µg/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 510(k) is for Ceftazidime/Avibactam the dilution range of 0.015/4-32/4 ug/ml for testing non-fastidious gram negative organisms on the Sensititre 18 - 24 hour MIC panel.
The approved primary "Indications for Use" and clinical significance for non-fastidious Gram negative isolates:
- Enterobacter cloacae Escherichia coli Klebsiella oxytoca Klebsiella pneumoniae Proteus mirabilis Citrobacter freundii Citrobacter koseri Enterobacter aerogenes Proteus spp. Pseudomonas aeruginosa
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☒ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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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).