(179 days)
Intended for use in facilitating the percutaneous introduction of catheters, interventional devices, and temporary pacing leads into the vasculature (including the radial artery).
The Emcee™ Introducer Set is comprised of a percutaneous introducer sheath and dilator. The set may also contain a guidewire and/or an obturator. The Emcee™ Introducer Sheath is comprised of an insert molded hemostatic sheath hub and cap design which encapsulates a hemostatic gasket system. The hub also incorporates a sideport extension line with an attached stopcock. The tubing portion of the sheath is percutaneously introduced into the patient's vasculature. The sideport extension is used for purposes of blood access maintenance and fluid administration. Subsequent to the physician gaining access to the patient's vasculature, a guidewire is inserted into the blood vessel. The Sheath/Dilator combination may be backloaded over the Guidewire to direct the device into the lumen of the vessel. Once the Sheath/Dilator assembly is in place, the dilator and Mini Guidewire (if used) are removed. The Emcee™ Dilator is a tapered plastic tube with an integral luer hub which is inserted into the Emcee™ Introducer Sheath. The Dilator is longer than the Sheath and with its tapered distal tip, serves to facilitate and support the entry of the Sheath into the patient's vasculature. Once the Emcee™ Introducer Sheath is in place, the Dilator is removed. The Emcee™ Introducer Set will be offered with dilators to accommodate the following guidewire diameters: .018", .025", .032", .035", and .038". Other sizes of dilators will also be provided to address physician preferences. The Emcee™ Obturator is a plastic tube with an integral luer hub which is inserted into the Emcee™ Introducer Sheath. The Obturator is approximately the same length as the Sheath and is intended to support the tubing portion of the Sheath while the device remains In Vivo. Components of the Emcee™ Introducer Set have a lubricious coating for a smooth entrance and removal from the vasculature.
The provided document is a 510(k) summary for the Emcee™ Introducer Set, a medical device. It describes the device, its intended use, and states that performance testing was done, but it does not provide specific acceptance criteria or the detailed results of a study that proves the device meets those criteria.
Instead, it states: "The new Emcee™ Introducer Set has been subjected to non-clinical performance testing to provide data supporting its safety and effectiveness for its intended uses." It also mentions "Biocompatibility testing having its basis in International Standards Organization (ISO) 10993-1 (1992)E..." and concludes the device "is considered to be biocompatible."
Therefore, based only on the provided text, I cannot fill in most of the requested information. The document focuses on regulatory approval (510(k) process) based on substantial equivalence to predicate devices, rather than detailed performance study results against predefined acceptance criteria.
However, I can extract the following:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in the document. | The document states the device "has been subjected to non-clinical performance testing to provide data supporting its safety and effectiveness for its intended uses." This implies performance was deemed acceptable for regulatory purposes, but no specific metrics or thresholds are provided. |
| Biocompatibility conforming to ISO 10993-1 (1992)E | "The Emcee™ Introducer Set is considered to be biocompatible." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample size for test set: Not specified.
- Data provenance: Not specified (implied to be from non-clinical testing, likely in a lab setting).
- Retrospective or prospective: 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 applicable/Not specified. This information would typically be relevant for studies involving subjective human assessment (e.g., image interpretation), which is not the nature of the described "non-clinical performance testing" for an introducer set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not specified, for the same reasons as point 3.
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. This is a physical medical device (catheter introducer), not an AI/imaging diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This is a physical medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For biocompatibility, the ground truth was "International Standards Organization (ISO) 10993-1 (1992)E "Biological Evaluation of Medical Devices - Part 1: Guidance on Selection of Tests"."
- For other "non-clinical performance testing," the specific ground truth is not detailed but would likely involve established engineering standards, material science properties, and functional benchmarks relevant to introducer sheaths (e.g., insertion force, hemostasis, flow rates, structural integrity).
8. The sample size for the training set
- Not applicable. As a physical device undergoing non-clinical testing, there isn't a "training set" in the machine learning sense.
9. How the ground truth for the training set was established
- Not applicable.
§ 870.1340 Catheter introducer.
(a)
Identification. A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.(b)
Classification. Class II (performance standards).