(61 days)
The Sensititre 18 hour MIC or Breakpoint Susceptibility system is an in vitro diagnostic product for clinical susceptibility testing of gram negative and gram positive organisms. This 510(k) is for the addition of Cefdinir in the dilution range of 0.06 - 64 ug/ml to the Sensititre 18 - 24 hour MIC panel for testing non-fastidious gram negative isolates. There are no approved primary "Indications for Use" and the clinical significance of Cefdinir is unknown when evaluating Enterobacteriaceae or any other non-fastidious gram negative rods. In vitro data, without clinical correlation is provided for Citrobacter diversus, Escherichia coli, Klebsiella pneumoniae, and Proteus mirabilis. Cefdinir is inactive against Pseudomonas and Enterobacter species.
Susceptibility Test Panel
This document is a 510(k) clearance letter for a medical device and thus does not contain the detailed study information typically found in a clinical trial report or a scientific publication. Therefore, I cannot provide a complete answer to all parts of your request based solely on the provided text.
However, I can extract information related to the device, its intended use, and the type of information that was likely considered for its clearance.
Device Name: Sensititre 18-24 Hour Susceptibility Plates (specifically, the addition of Cefdinir to the Sensititre 18-24 hour MIC panel).
Regulatory Class: II
Product Code: JWY
Here's a breakdown of what can and cannot be answered based on the provided text:
1. A table of acceptance criteria and the reported device performance
- Cannot be fully provided as typical performance metrics (e.g., sensitivity, specificity, accuracy) are not included in this document.
- The acceptance criteria for substantial equivalence are generally that the device is as safe and effective as a legally marketed predicate device.
- The document states that the FDA "determined the device is substantially equivalent... to legally marketed predicate devices." This is the core finding, implying the performance met the FDA's criteria for equivalence based on the submitted data.
- The "reported device performance" is summarized as the ability of the Sensititre 18-24 hour MIC panel to test for Cefdinir susceptibility in specific non-fastidious gram-negative isolates (Citrobacter diversus, Escherichia coli, Klebsiella pneumoniae, and Proteus mirabilis) in a dilution range of 0.06 - 64 ug/ml.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not explicitly stated in the provided text. The letter mentions "In vitro data" was provided. Details about the sample size (number of isolates tested), country of origin, or study design (retrospective/prospective) are not present.
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 explicitly stated in the provided text. For susceptibility testing, ground truth is typically established by a reference method (e.g., agar dilution or broth microdilution following CLSI guidelines), not by human expert consensus in the way it might be for image interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable and not stated. Adjudication methods like 2+1 or 3+1 are typically used in studies involving human interpretation where consensus among experts is needed. For an in vitro diagnostic device measuring antimicrobial susceptibility, the ground truth is usually an objective measurement from a reference method.
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
- Not applicable. This device is an in vitro diagnostic (IVD) for antimicrobial susceptibility testing, which is a laboratory assay. It does not involve "human readers" interpreting images or other complex data that would necessitate an MRMC study or AI assistance in the way described.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable in the AI sense. The Sensititre system is a standalone automated/semi-automated system for determining Minimum Inhibitory Concentration (MIC). Its performance is evaluated independently of human interpretation of complex patterns, but a laboratory technologist would still perform the test and interpret the numerical MIC results against breakpoints. So, while it's an "algorithm only" in the sense it provides a direct result, it's not "AI" in the modern sense of machine learning for complex pattern recognition. The "standalone performance" would refer to its accuracy compared to a reference method, which is implied by the substantial equivalence determination.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For antimicrobial susceptibility testing, the ground truth is typically established by a reference method, such as the Clinical and Laboratory Standards Institute (CLSI) recommended broth microdilution or agar dilution methods. The device's results (MIC values) would have been compared to these reference method results for accuracy.
8. The sample size for the training set
- Not explicitly stated in the provided text. This is not typically disclosed in a 510(k) clearance letter. For an IVD like this, there isn't a "training set" in the machine learning sense. Instead, there are validation studies performed with a sufficient number of bacterial isolates to demonstrate the device's accuracy and reproducibility.
9. How the ground truth for the training set was established
- Not applicable for a "training set" in the AI sense. As mentioned above, ground truth for such IVDs is established by comparing results to a recognized reference method for antimicrobial susceptibility testing (e.g., CLSI guidelines).
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Food and Drug Administration 2098 Gaither Road Rockville MD 20850
FEB 1 6 1999
Cynthia C. Knapp Director Lab Services AccuMed International, Inc. 29299 Clemens Road, Suite 1-K Westlake, OH 44145
Re: K984489 Trade Name: Sensititre 18-24 Hour Susceptibility Plates Regulatory Class: II Product Code: JWY Dated: December 15, 1998 Received: December 17, 1998
Dear Ms. Knapp:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770)488-7655.
This letter will allow you to begin marketing your device as described in your 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 advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll free number (800) 638-2041 or at (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html"
Sincerely yours,
Steven Sutman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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10(k) Number (if known): K984489
Device Name: Susceptibility Test Panel
Indications For Use:
The Sensititre 18 hour MIC or Breakpoint Susceptibility system is an in vitro diagnostic product for clinical susceptibility testing of gram negative and gram positive organisms.
This 510(k) is for the addition of Cefdinir in the dilution range of 0.06 - 64 ug/ml to the Sensititre 18 - 24 hour MIC panel for testing non-fastidious gram negative isolates. There are no approved primary "Indications for Use" and the clinical significance of Cefdinir is unknown when evaluating Enterobacteriaceae or any other non-fastidious gram negative rods. In vitro data, without clinical correlation is provided for Citrobacter diversus, Escherichia coli, Klebsiella pneumoniae, and Proteus mirabilis. Cefdinir is inactive against Pseudomonas and Enterobacter species.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH. Office of Device Evaluation (ODE)
Woody Dubose
Division of Clinical Laboratory Devices 510(k) Number_K 98 44 89
Prescription Use Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96) .
§ 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).