(114 days)
The Tigereye System is intended to facilitate the intraluminal placement of conventional guidewires beyond stenotic lesions (including sub and chronic total occlusions) in the peripheral vasculature prior to further percutaneous intervention using OCT-assisted orientation and imaging. The system is an adjunct to fluoroscopy by providing images of vessel lumen and wall structures. The Tigereye system is contraindicated for use in the iliac, coronary, cerebral, renal or carotid vasculature.
The Tigereye System combines the use of Avinger's optical coherence tomography (OCT) technology with peripheral vascular chronic total occlusion (CTO) crossing capabilities. The Tigereye System consists of the Tigereye CTO-crossing catheter, a Lightbox Sled with integrated umbilical (referred to as "Sled"), and the Lightbox HS Imaging Console (referred to as "Lightbox"). The Tigereye CTO-crossing catheter is a coaxial 5 French device with a working length of 140 cm. It is comprised of two components-an outer support catheter and an inner assembly or drive shaft. It is provided sterile and is a single-use device compatible with 5 Fr vascular sheaths. The Tigereye CTO-crossing head incorporates an optical fiber that allows real-time diagnosis of vessel condition and morphology as well as OCT-guided CTO crossing during the procedure with its connection to an optical Sled and Lightbox. The software of the Lightbox has been updated to version 4.6.0, which builds on version 4.4.0 that was reviewed and cleared under K182341.
The provided text does not describe a study involving an AI/Machine Learning device. Instead, it is a 510(k) summary for the Tigereye CTO-Crossing Catheter, a medical device used for crossing chronic total occlusions in peripheral vasculature. The device utilizes Optical Coherence Tomography (OCT) for imaging and orientation, but this is a physical imaging technology, not an AI/ML algorithm.
Therefore, many of the requested elements, such as acceptance criteria for AI performance (e.g., sensitivity, specificity), ground truth establishment for AI models, sample sizes for training/test sets for AI, MRMC studies, or standalone algorithm performance, are not applicable to this submission.
The document focuses on demonstrating substantial equivalence to a predicate device (Ocelot PIXL CTO-Crossing Catheter) and a reference device (Pantheris SV Catheter) through:
- Comparison of Technological Characteristics: Highlighting similarities in intended use, imaging modality (OCT), safety standards, materials, and operational characteristics.
- Performance Data: This section details engineering and biocompatibility tests, not clinical or AI performance. These include:
- Biocompatibility testing (cytotoxicity, sensitization, hemocompatibility, etc.)
- Electrical safety and electromagnetic compatibility (EMC)
- Software verification and validation (for the Lightbox component, which houses the control software, not an AI for image analysis)
- Mechanical testing (e.g., catheter length, flow rate, tip rotation, force to cross occlusion, torque, tensile strength).
The conclusion states that the data "raises no new questions of safety and effectiveness and that the Tigereye catheter is substantially equivalent to the predicate device."
In summary, based on the provided text, it's impossible to fill out the requested table or answer most of the questions, as they pertain to the evaluation of an AI/Machine Learning device, which the Tigereye CTO-Crossing Catheter is not.
§ 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).