(212 days)
The GrebSet micro-introducer kit is intended to facilitate the percutaneous placement of guidewires in the vascular system and for delivery of contrast media to vascular sites.
The GrebSet micro-introducer kit is designed to gain access and deliver contrast media to selected vascular sites. The GrebSet catheter is compatible with ≤0.038"/.965mm guidewires. Each GrebSet kit consists of the following components:
- Access needle (21G echogenic percutaneous entry needle OR 20G echogenic Trocar . needle)
- 0.018" guidewire .
- Dilator .
- Catheter with radiopaque marker band located on distal tip ●
The provided text does not describe a study involving an AI-powered device or software. Instead, it is a 510(k) summary for a physical medical device, the "GrebSet micro-introducer kit," which is a diagnostic intravascular catheter.
Therefore, the specific information requested about acceptance criteria, study design, expert involvement, and AI performance metrics cannot be extracted from this document, as it pertains to the approval of a traditional hardware medical device through substantial equivalence to predicate devices, rather than an AI-driven one.
The "Summary of Non-Clinical Testing" section describes bench tests performed to ensure the device performs as intended, but these are engineering performance tests, not clinical studies for AI. The document explicitly states: "No clinical evaluations of this product have been conducted."
Therefore, I cannot populate the table or answer the questions with the information provided in the input.
§ 870.1200 Diagnostic intravascular catheter.
(a)
Identification. An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.(b)
Classification. Class II (performance standards).