(138 days)
The Super Sheath Introducer Sheath is indicated for use in the introduction of diagnostic and interventional devices inserted into the human vasculature of adult and pediatric patients of all ages.
The Super Sheath Introducer Sheath (hereinafter referred to as the "Subject Device") is used to introduce diagnostic or interventional devices into a blood vessel. The Subject Device is available in two products: one consisting of a Sheath and Dilator (Super Sheath Introducer Sheath without Guidewire), and the other consisting of a Sheath, Dilator, and Guidewire (Super Sheath Introducer Sheath with Guidewire), similar to the Predicate Device K121504. These devices are provided sterile and intended for single use, and the shelf-life is three years.
The main component of the Sheath consists of a Sheath hub, a Sheath shaft connected to the Sheath hub, and a three-way stopcock valve connected to the hub with a side port tube. The Sheath shaft is 3.3 French size and available in 5cm and 7cm lengths. The Sheath hub contains a hemostatic valve and has a suture wing. The shape and dimensions of the three-way stopcock luer connector are modified to comply with the new applicable standard ISO 80369-7:2021.
The Dilator has an open, tapered plastic tube for Guidewire insertion. The Dilator tube is press-fit into the inner hub with a bushing. The length of the Dilator tube corresponds to the length of the Sheath shaft, which is longer and available in 10.5 cm and 12.5 cm.
The 0.018" Guidewire is the smallest size Guidewire and a 40 cm long, thin, flexible wire with a inserter attached to the tip. This Guidewire is a legally marketed product which is cleared by the Food and Drug Administration (K021990).
The upper cap and suture wing of the Sheath hub, and the Dilator hub are colored purple. The Dilator tube and the inserter are colored blue. And the unvented cap of the three-way stopcock is pink.
This document is a 510(k) premarket notification for a medical device called the "Super Sheath Introducer Sheath". This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving a device meets specific acceptance criteria through a clinical study or performance data like an AI/ML diagnostic device would.
Therefore, the provided text does not contain the information requested regarding acceptance criteria and a study to prove a device meets those criteria for an AI/ML-based device. The original request is formulated for a performance study of a diagnostic device (likely AI-powered), which requires metrics like sensitivity, specificity, or AUC, and details on clinical validation with ground truth.
The document describes a physical medical device (an introducer sheath), and its substantial equivalence is proven through:
- Bench Testing: Mechanical and physical properties (tensile strength, kink resistance, connection strength, pressure tests, lubricity, radiopacity, corrosion resistance).
- Biocompatibility Testing: Cytotoxicity, intracutaneous reactivity, sensitization, acute systemic toxicity, hemocompatibility, pyrogen test, LAL test.
- Comparison of Technological Characteristics: To a predicate device (K121504) across features like French sizes, indications for use, regulation numbers, components, sterilizations, and dimensional comparisons.
In summary, the provided document does not allow for a response to the specific questions regarding acceptance criteria and performance study details for an AI/ML 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).