(30 days)
The Nanostim™ Introducer Kit is intended to provide a conduit into the venous system for insertion of diagnostic and other interventional devices.
The St Jude Medical Nanostim Introducer Kit is designed to perform as a quiding sheath for introduction of diagnostic and interventional devices. The Nanostim™ Introducer Kit is comprised of an introducer sheath and a dilator. The Introducer Kit is compatible with 0.035" and 0.038" guidewires and is available in 18F and one length of 30 cm.
The introducer is fitted with a hemostasis valve to minimize air introduction during insertion and/or exchange, and a sideport with a three-way stopcock. The introducer features a radiopaque tip marker incorporated within the sheath material to identify the location of the distal tip of the sheath. Design modifications were made to the current design to improve the manufacturability and to increase the product shelf life. The changes made to the Nanostim Introducer Kit do not affect the intended use of the device or alter the fundamental scientific technology of the device.
The provided text is a 510(k) summary for the Nanostim Introducer Kit, which is a medical device. This document focuses on demonstrating substantial equivalence to a predicate device, rather than proving a device meets specific clinical performance criteria for accuracy or diagnostic efficacy in the way an AI or diagnostic imaging device would.
Therefore, many of the requested categories for AI/diagnostic studies (e.g., sample size of test set, ground truth experts, MRMC studies, standalone performance) are not applicable here. This document primarily describes engineering verification and biocompatibility testing.
Here's the information extracted from the document that is relevant to acceptance criteria and device performance:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Performed | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Visual test | Not explicitly stated (implied to meet visual standards) | All pre-determined acceptance criteria were met. |
| Dimensional measurement test | Not explicitly stated (implied to meet specifications) | All pre-determined acceptance criteria were met. |
| Tensile Strength | Not explicitly stated (implied to meet specifications) | All pre-determined acceptance criteria were met. |
| Torsional Strength | Not explicitly stated (implied to meet specifications) | All pre-determined acceptance criteria were met. |
| Liquid Leak | Not explicitly stated (implied to prevent leaks) | All pre-determined acceptance criteria were met. |
| Simulated Use | Not explicitly stated (implied to function as intended) | All pre-determined acceptance criteria were met. |
| Biocompatibility: Cytotoxicity | In accordance with ISO 10993-1:2009 for an external communicating device with limited exposure ( |
§ 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).