(209 days)
Turnpike catheters: The Turnpike catheters are intended to access discrete regions of the coronary and/or peripheral vasculature. They may be used to facilitate placement and exchange of guidewires and to subselectively infuse/ deliver diagnostic and therapeutic agents, and to assist in crossing de novo coronary chronic total occlusions (CTO).
GuideLiner V3 catheter: GuideLiner catheters are intended to be used in conjunction with guide catheters to access discrete regions of the coronary and/or peripheral vasculature. to facilitate placement of interventional devices, and to assist in crossing de novo coronary chronic total occlusions (CTO).
TrapLiner catheter: The TrapLiner catheter is intended for use in conjunction with guide catheters to access discrete regions of the coronary and/or peripheral vasculature, to facilitate placement of interventional devices, to facilitate the exchange of an interventional device while maintaining the position of a guidewire within the vasculature, and to assist in crossing de novo coronary chronic total occlusions (CTO).
Turnpike catheters: The Turnpike catheters are single lumen catheters designed for use in the coronary and peripheral vasculature. The catheter shaft is constructed of two polymer layers that encapsulate a braid and a duallayer coil. The distal 60 cm of the Turnpike catheters are hydrophilic coated, and all models are compatible with 0.014" guidewires and 5F guide catheters. The turnpike catheters are available in four configurations: Turnpike, Turnpike Spiral, Turnpike Gold, and Turnpike LP.
GuideLiner V3 catheters: The GuideLiner V3 catheter is a rapid-exchange guide extension catheter designed for use in the coronary and peripheral vasculature. It is available in five sizes - 5F, 5.5F, 6F, 7F, and 8F. All sizes of the GuideLiner V3 catheter have a 150 cm working length, consisting of a 125 cm long stainless steel pushwire shaft followed distally by a 25 cm long full-round, silicone-wiped guide extension segment. The distal 17 cm of the 125 cm pushwire shaft is covered with a semicircular shaped polymer that meets the proximal end of the full-round guide extension segment.
TrapLiner catheters: The TrapLiner catheter is a rapid-exchange guide extension catheter with a trapping balloon on the distal end of the pushrod. The stainless steel hypotube pushrod is covered on the distal end by a semi-circular polymer ('half-pipe') and transitions to a hydrophilic coated full-round polymer guide extension section. There are two radiopaque marker bands on the guide extension segment, one on the distal tip and one on the collar. The Nylon trapping balloon (3.1 mm diameter) is located proximal to the half-pipe and has a single radiopaque gold marker under the proximal end of the balloon is reflowed, and an adhesive is applied on each end. The TrapLiner catheter has an over-molded Nylon hub on the proximal end to facilitate balloon inflation.
The provided text does not contain information about acceptance criteria or a study designed to prove a device meets acceptance criteria in the context of an AI/ML device. The document is an FDA 510(k) premarket notification for various catheters (Turnpike, GuideLiner V3, TrapLiner) and details their indications for use, technological characteristics, and a clinical study conducted to evaluate their safety and effectiveness for assisting in crossing de novo coronary chronic total occlusions (CTO).
The clinical study described is a prospective, multi-center, single-arm study of 150 subjects. It evaluates the safety and effectiveness of the catheters and specialized guidewires in patients undergoing CTO-PCI, not an AI device. The primary endpoint was "procedure success through discharge or 24 hours post-procedure, whichever came first," with specific components for angiographic visualization of guidewire placement and absence of in-hospital MACE.
Therefore, I cannot provide a table of acceptance criteria and reported device performance, or details about sample size for a test set, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, ground truth type, or training set information as requested, because this information is not present in the provided text for an AI/ML device.
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).