(17 days)
The Edwards Introducer Sheath is designed to facilitate the entry of interventional devices into the human vascular system.
The subject device is comprised of an introducer and introducer sheath. The introducer has a tapered soft/flexible tip and is inserted into the introducer sheath, then inserted into the vessel over a guidewire as an assembly. At the proximal end of the sheath the body tubing is connected to a head assembly. The head assembly consists of a housing that contains three hemostasis valves to minimize blood loss. A side port extension with a three-way stopcock allows for the introduction of anticoagulant, as needed. Once the Introducer/Sheath Assembly has been placed within the vessel, the introducer is removed and the sheath is left in place. The sheath provides and maintains a pathway for the introduction of interventional devices.
The provided document is a 510(k) summary for the Edwards Introducer Sheath, detailing its comparison to predicate devices and results of non-clinical testing. It explicitly states that "All testing demonstrated that the subject device met its acceptance criteria." However, it does not provide a table of specific acceptance criteria values or the reported device performance values for each criterion. It also does not include information about clinical studies in the context of device performance metrics against acceptance criteria.
Therefore, much of the requested information cannot be extracted from this document alone.
Here's what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Bond Tensile Strength | Met acceptance criteria |
| Free Passage of a Guidewire | Met acceptance criteria |
| Kink Resistance (Introducer) | Met acceptance criteria |
| Kink Resistance (Sheath) | Met acceptance criteria |
| Flow Rate | Met acceptance criteria |
Note: The document states, "All testing demonstrated that the subject device met its acceptance criteria." However, it does not provide the specific numerical values for the acceptance criteria (e.g., minimum tensile strength in Newtons) nor the measured performance values of the device for each test. It only confirms that the device passed these tests.
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified for the non-clinical tests.
- Data Provenance: The tests conducted were "In vitro performance testing." No country of origin is mentioned for the testing data itself, but the submitter is based in Irvine, CA, USA. The document refers to the system being "CE marked and commercially available in the European Union" for clinical usage, but this is not tied to the "test set" for performance criteria.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This information is not applicable as the described tests are non-clinical, in vitro performance tests (e.g., bond tensile strength, kink resistance), not clinical studies involving "ground truth" established by experts.
4. Adjudication method for the test set
- This information is not applicable for the same reason 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
- This information is not applicable. The device is an Introducer Sheath, a physical medical device, not an AI or imaging diagnostic tool. Therefore, MRMC studies and AI-assisted human reader improvement are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This information is not applicable as the device is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- This information is not applicable. The "ground truth" for the non-clinical performance tests is based on engineering specifications and physical measurements, rather than clinical 'ground truth' types.
8. The sample size for the training set
- This information is not applicable. There is no mention of a "training set" as this is a physical medical device, not a machine learning model.
9. How the ground truth for the training set was established
- This information is not applicable for the same reason as point 8.
§ 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).