(24 days)
The Prelude® 7F Short Sheath Introducer is intended to provide access and facilitate the percutaneous introduction of various devices into veins and/or arteries while maintaining hemostasis for a variety of diagnostic and therapeutic procedures. This device can also provide access to a native or synthetic graft used for hemodialysis. The side port of the sheath allows adequate flow to perform temporary hemodialysis. The device is not indicated for long term vascular or hemodialysis access.
The Prelude® 7F Short Sheath Introducer consists of a sheath introducer with integral hemostasis valve and side port extension tubing extending from the sheath hub. A detachable 3-way stopcock is connected to the side port extension tubing. A compatible vessel dilator is provided with the introducer. The device is available in 7F size with a sheath tubing length of 11cm. The French size designates the size of the catheter the sheath will accept. The 11cm effective length of the sheath introducer refers to the usable length of the sheath. The French size and wire tip size are printed on the dilator hub indicating the size of the catheter and guide wire that the sheath will accept.
The provided document describes the Prelude® 7F Short Sheath Introducer and its premarket notification (510(k)). The core of this submission is to demonstrate substantial equivalence to a predicate device, not necessarily to independently prove specific clinical performance criteria of a novel AI-powered diagnostic device. Therefore, many of the requested points related to AI performance, ground truth, and expert studies are not applicable to this type of medical device submission.
Here's an analysis based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (from International Standard ISO 11070:1998) | Reported Device Performance |
|---|---|
| Dimensional verification | Met pre-determined acceptance criteria |
| Force at break - junction between sheath introducer and sheath hub | Met pre-determined acceptance criteria |
| Surface imperfections | Met pre-determined acceptance criteria |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated. The document mentions "significant testing was successfully completed" but doesn't provide specific sample sizes for each test.
- Data Provenance: Not applicable in the context of device performance testing. The tests are laboratory-based and conducted on the manufactured device itself, not necessarily using patient data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Not applicable. This device is a physical medical instrument, and its performance is evaluated through engineering and material testing, not through expert-reviewed clinical "ground truth" derived from patient data.
4. Adjudication Method for the Test Set
- Not applicable. Performance testing for this type of device typically involves objective measurements against established engineering specifications and international standards, rather than expert adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, an MRMC study was not done. This type of study is relevant for diagnostic devices (especially those involving image interpretation by human readers) to assess reader performance with and without AI assistance. The Prelude® 7F Short Sheath Introducer is an interventional device, not an AI diagnostic tool.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- No, a standalone study was not done. This is not an AI algorithm. Its performance is evaluated based on its physical properties and mechanical integrity.
7. Type of Ground Truth Used
- The "ground truth" for this device's performance testing is defined by the technical specifications and criteria outlined in the ISO 11070:1998 standard ("Sterile, single-use intravascular catheter introducers") and the internal risk analysis. This involves objective measurements of physical properties (dimensions, force at break, surface imperfections) against predefined acceptable ranges.
8. Sample Size for the Training Set
- Not applicable. This device does not involve a training set as it's not an AI/machine learning model.
9. How the Ground Truth for the Training Set Was Established
- Not applicable, as there is no training set for this device.
§ 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).