(447 days)
The ShoocinTM Introducer Kits are intended for use to facilitate the introduction of guide wires, catheters and other accessory medical devices through the skin into a vein or artery and minimize blood loss associated with such introduction.
The ShoocinTM Introducer Kit consists of a puncture needle, a guide wire with a guide wire collimator, a sheath introducer, and a dilator. The puncture needle incorporates a lumen, which provides a conduit for the insertion of the guide wire into the vascular system. The flexible stainless steel guide wire is utilized as a guiding mechanism for the insertion of the introduction sheath into the vascular system. The guide wire contains a wire collimator, which assists in funneling the wire through the lumen of the puncture needle and contains marking that are visible under fluoroscopy, which can determine in length of the guide wire within the vascular system. The sheath introducer provides a conduit for introducing other interventional devices, including guide wires and interventional catheters, into the vascular system. The main components of this assembly are a non-hydrophilic coated sheath introducer, hemostasis valve housing, and a side port with tubing connected to a 3-way stopcock/valve. The dilator is used to provide support and stability to the sheath introducer during deployment into the vascular system. The proximal end of the dilator includes a luer port and has a tapered, atraumatic distal tip. Both the sheath and dilator contain bismuth, making these devices visible under fluoroscopy.
The provided text describes a medical device, the Shoocin™ Introducer Kit, and its substantial equivalence to a predicate device (Pinnacle Precision Access System). The acceptance criteria and the study proving the device meets them are primarily focused on biocompatibility and performance testing, rather than an AI/ML-based diagnostic or prognostic device study.
Here's an analysis of the provided information, structured according to your request, with an emphasis on what is and is not present in the document.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are generally implied to be meeting the standards of the predicate device and relevant ISO standards. The document explicitly lists performance tests and biocompatibility tests from ISO standards as criteria. The reported performance is that the device "successfully passed all" these tests.
| Acceptance Criteria (Test/Standard) | Reported Device Performance (Shoocin™ Introducer Kit) |
|---|---|
| **Biocompatibility (ISO 10993-1, External Communicating Device, Limited Duration |
§ 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).