(34 days)
INTENDED USE:
The iSLEEVE Introducer Set is intended to facilitate femoral access to the vascular system.
INDICATIONS FOR USE:
The 14F iSLEEVE Introducer Set is intended to facilitate femoral access to the vascular svstem for introduction and removal of the ACURATE TF Valve Svstem and ancillary devices. The iSLEEVE Introducer Set is suitable for use in vessels ≥ 5.5 mm diameter.
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.
A product mandrel and flushing tube are also supplied with the iSLEEVE Introducer Set.
This document is a 510(k) Pre-Market Notification from the FDA regarding the "iSLEEVE™ Introducer Set". It's a regulatory clearance document, not a study report detailing acceptance criteria for an AI/ML device. Therefore, the requested information about acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, and MRMC studies is not applicable to this document. The document describes a medical device (catheter introducer), not an AI system.
However, I can extract the information that is present about the device's technical specifications and the testing performed, acknowledging that it's "non-clinical performance data" for a physical device, not an AI model.
Here's an analysis based on the provided text, explicitly stating where the requested AI/ML-related details are not available or not applicable:
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Table of Acceptance Criteria and Reported Device Performance:
Acceptance Criteria (General) Reported Device Performance (General) Physical integrity Bench testing was performed to evaluate physical integrity, functionality, and performance. Functionality Bench testing was performed to evaluate physical integrity, functionality, and performance. The distal end of the introducer sheath is passively expandable, radially compliant, expands and collapses as needed, and has a hydrophilic coating to increase lubricity. Performance Bench testing was performed to evaluate physical integrity, functionality, and performance. Performance criteria includes dimensional requirements, visibility under fluoroscopy, and interface with compatible devices. The proposed 14F iSLEEVE Introducer Set has a modified distal tip design to enhance robustness and ease of vessel insertion compared to the predicate. Usability (ease of use) The modified distal tip design enhances robustness and ease of vessel insertion. Compatibility (interface with other devices) Evaluated interface with compatible devices. Intended to facilitate introduction and removal of the ACURATE TF Valve System and ancillary devices. Radiographic visibility Evaluated visibility under fluoroscopy. Dimensional requirements Evaluated dimensional requirements. Suitable for use in vessels ≥ 5.5 mm diameter. Substantial Equivalence to Predicate K180785 The device incorporates substantially equivalent design, packaging, fundamental technology, manufacturing processes, sterilization process and intended use as the predicate. Based on indications for use, technological characteristics, and performance testing, the iSLEEVE Introducer Set is considered substantially equivalent to the iSLEEVE Introducer Set, K180785. The 14F iSLEEVE Introducer Set has a modified distal tip design compared to the predicate. -
Sample size used for the test set and the data provenance:
- Sample Size: Not specified for any specific test. The document generally refers to "bench testing."
- Data Provenance: The testing appears to be "non-clinical performance bench testing" conducted by Boston Scientific Corporation. This is likely internal testing, not patient data (retrospective or prospective). Country of origin is not specified, but the applicant (Boston Scientific) is based in the USA.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- N/A. This is a physical medical device, not an AI/ML system requiring expert-established ground truth from medical images or data. The "ground truth" for a physical device would typically be its adherence to engineering specifications and performance standards established through bench testing.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- N/A. Not applicable to a physical medical device's bench testing.
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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:
- N/A. This device is a catheter introducer, not an AI imaging or diagnostic tool. No MRMC study was conducted or is relevant.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- N/A. This is a physical device, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For a physical device, the "ground truth" for performance would be its adherence to established engineering specifications and performance standards as measured by various bench tests (e.g., dimensional accuracy, material properties, functional movements, compatibility with other devices). No medical "ground truth" types like pathology or expert consensus on clinical findings are applicable here.
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The sample size for the training set:
- N/A. This is a physical medical device, not an AI/ML system that uses training data.
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How the ground truth for the training set was established:
- N/A. 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).