(232 days)
The EMBOL-X Introducer Sheath is indicated for use in procedures requiring the introduction of EMBOL-X Intra-Aortic Filters.
Edwards Lifesciences' EMBOL-X Introducer Sheath is a sterile, non-pyrogenic, singleuse introducer made of flexible and non-flexible polymeric materials. It consists of a single lumen housing and a removable, snap-lock obturator.
The housing has a flexible suture flange for attachment to the vessel and orientation markings on the shaft and suture flange to assist in the placement of the EMBOL-X Introducer Sheath. Inside the housing is an internal valve to prevent backbleeding.
The device also has additional suture loops on the proximal end of the Introducer housing and a design that allows air to vent from the Introducer during insertion.
Here's a breakdown of the acceptance criteria and study information based on the provided text, focusing on the lack of information for a device like an introducer sheath:
Important Note: The provided document describes a medical device (introducer sheath), not an AI or software-based diagnostic tool. Therefore, many of the requested categories like "multi-reader multi-case study," "standalone algorithm performance," "sample size for training set," and "ground truth for training set" are not applicable or not present in this type of submission. Medical devices like this are typically evaluated based on engineering performance, biocompatibility, and manufacturing quality to demonstrate substantial equivalence to a predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Tests Performed | Reported Performance |
|---|---|---|
| Biocompatibility | Cytotoxicity | Met acceptance criteria. |
| Haemocompatibility | Met acceptance criteria. | |
| Irritation/Intracutaneous Toxicity | Met acceptance criteria. | |
| Sensitization | Met acceptance criteria. | |
| Systemic Toxicity | Met acceptance criteria. | |
| Pyrogenicity | Met acceptance criteria. | |
| Genotoxicity | Met acceptance criteria. | |
| Thrombogenicity | Met acceptance criteria. | |
| Sterility | Sterility Testing | Met acceptance criteria. |
| Performance Testing / Shelf Life | Tensile | Met acceptance criteria. |
| Leak | Met acceptance criteria. | |
| Vent | Met acceptance criteria. | |
| Latch Compression | Met acceptance criteria. | |
| Flange Flex | Met acceptance criteria. | |
| Insertion, Removal, and Retention Force | Met acceptance criteria. | |
| Functional/Compatibility | Functional/Compatibility testing with associated devices | Met acceptance criteria. |
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: The document does not specify the sample sizes used for each functional and safety test (e.g., how many sheaths were tested for tensile strength or leak). It only states that "All data met acceptance criteria."
- Data Provenance: Not specified. This type of submission for a physical medical device typically does not detail data provenance in the same way an AI/software device would. The tests are likely conducted in a controlled lab environment.
- Retrospective/Prospective: Not applicable in the context of this device's testing. These are laboratory-based engineering and biological tests, not clinical data collection.
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: For a physical medical device like an introducer sheath, "ground truth" as it relates to expert consensus on diagnostic images or clinical outcomes is not relevant. The "ground truth" comes from objective measurements against engineering specifications and validated biological testing methodologies. The document does not mention the use of external experts for establishing this kind of ground truth. Internal quality control and R&D personnel are typically responsible for these measurements.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable: Adjudication methods like 2+1 or 3+1 are used for resolving disagreements among multiple human readers in clinical studies or image interpretation. These are not relevant for the functional and safety testing of a physical medical device.
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 a physical medical instrument (introducer sheath), not an AI or software-based diagnostic tool. Therefore, MRMC studies and AI assistance are irrelevant to its evaluation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable: This device is a physical medical instrument, not an algorithm or software.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Technical Specifications / Biocompatibility Standards: The "ground truth" for this device comes from established engineering specifications (e.g., tensile strength, leak rate limits) and widely accepted biocompatibility standards (e.g., ISO 10993 series). The device is tested against these predefined, objective criteria.
8. The sample size for the training set
- Not Applicable: This device is a physical medical instrument and does not involve AI or machine learning, which would require a training set.
9. How the ground truth for the training set was established
- Not Applicable: This device is a physical medical instrument and does not involve AI or machine learning training data.
§ 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).