(28 days)
The 15F iSLEEVE Introducer Set is intended to facilitate femoral access to the vascular system for introduction and removal of the LOTUS Edge Valve System and ancillary devices. The iSLEEVE Introducer Set is suitable for use in vessels ≥ 5.9 mm.
The iSLEEVE Introducer Set is a sterile, single-use introducer catheter that provides percutaneous access to the femoral artery for introduction and removal of compatible transcatheter heart valve systems and ancillary devices into the vascular system. The iSLEEVE Introducer Set is composed of a dilator and an introducer sheath with a threeway stopcock.
The distal end of the introducer sheath is passively expandable which allows for transient sheath expansion when the compatible valve system is introduced through it. Once expanded, this region of the introducer sheath is radially compliant, which allows it to expand and collapse as needed during device delivery and removal. This reduces the time the access vessel is expanded. A hydrophilic coating is applied to the entire iSLEEVE introducer sheath which increases the lubricity to aid in delivery when activated.
The provided text is a 510(k) summary for the Boston Scientific iSLEEVE Introducer Set. It focuses on demonstrating substantial equivalence to a predicate device for regulatory clearance. Since this is a medical device, the acceptance criteria and study that proves the device meets the acceptance criteria are based on non-clinical performance (bench testing), as explicitly stated in the document.
The document does not describe:
- A table of acceptance criteria and reported device performance with specific numerical values beyond meeting general criteria for physical integrity, functionality, and performance.
- Sample sizes used for a "test set" in the context of an AI/human reader study.
- Data provenance, number of experts, adjudication methods, or MRMC studies, as these relate to AI/image-based diagnostic devices, not a catheter introducer.
- Standalone algorithm performance or details about training sets for an AI.
- Types of ground truth in a clinical sense (e.g., pathology), as the device's performance is assessed through bench tests.
Based on the provided text, here is the information that can be extracted, and where applicable, why certain information (relevant to an AI or diagnostic device) is not available:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not provide a quantitative table of acceptance criteria with specific numerical performance values. Instead, it broadly states the categories of performance assessed through bench testing.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Physical Integrity | Demonstrated through bench testing. |
| Functionality | Demonstrated through bench testing. |
| Performance | Demonstrated through bench testing. |
| Dimensional Requirements | Met through bench testing. |
| Visibility under Fluoroscopy | Met through bench testing. |
| Interface with Compatible Devices | Met through bench testing. |
| Enhance advancement and withdrawal of LOTUS Edge Valve System | Modified distal tip designed to achieve this, confirmed through bench testing. |
2. Sample Sizes Used for the Test Set and Data Provenance
- Sample Size: Not specified in terms of a "test set" as would be relevant for an AI or diagnostic study. Performance was evaluated via bench testing, which typically involves a specified number of physical units, but this specific number is not provided in this 510(k) summary.
- Data Provenance: Not applicable in the context of clinical data for a "test set" as this is bench testing of a physical device.
3. Number of Experts Used to Establish Ground Truth and Qualifications
- Not applicable. Ground truth for a physical catheter introducer is established by engineering specifications, material properties, and physical testing protocols, not by expert clinical review of images or data.
4. Adjudication Method for the Test Set
- Not applicable, as this refers to a process for resolving discrepancies in expert labeling or diagnoses for clinical data, which is not relevant for bench testing of this device.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- No, an MRMC study was not done. The document explicitly states: "Performance testing from clinical studies is not required to demonstrate substantial equivalence of the iSLEEVE Introducer Set." MRMC studies are typically performed for diagnostic devices (e.g., AI in radiology) to assess changes in human reader performance with and without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a physical catheter introducer, not an algorithm. Standalone performance refers to the performance of an AI algorithm on its own, which is irrelevant here.
7. The Type of Ground Truth Used
- Engineering Specifications and Benchmarking: The ground truth for this device's performance is established by pre-defined engineering specifications, functional requirements, and comparison to the performance of the predicate device (K191871) under controlled bench test conditions. For example, "dimensional requirements" means the device must meet specific size tolerances, which is a quantitative ground truth. "Visibility under fluoroscopy" would be assessed against a defined standard or observation.
8. The Sample Size for the Training Set
- Not applicable. The concept of a "training set" applies to machine learning algorithms. This document describes a physical medical device submitted for 510(k) clearance based on substantial equivalence to a predicate, primarily through non-clinical bench testing.
9. How the Ground Truth for the Training Set was Established
- Not applicable. As there is no training set for an algorithm, there is no "ground truth" to establish for it in this context. The "ground truth" for the device's design and manufacturing is based on established engineering principles, material science, and regulatory standards for medical devices.
§ 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).