(276 days)
The BASHIR™ Endovascular Catheter and BASHIR™ S-B Endovascular Catheter are mechanical thrombolysis catheters indicated for the:
- · Controlled and selective infusion of physician-specified fluids, including thrombolytics, into the pulmonary arteries for treatment of pulmonary embolism.
- · Infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature, enabling the restoration of blood flow in patients with venous thrombus.
The BASHIR™ Endovascular Catheter is a device intended for mechanical thrombolysis via expanding the distal infusion basket, allowing localized infusion of physician-specified fluids, including thrombolytics, into the peripheral or pulmonary vasculature. The distal infusion segment of the device is 12.50 cm (4.94 in.) long and consists of an expandable basket with a nitinol core surrounded by mini-infusion catheters, each with multiple infusion holes (hereafter referred to as the "infusion basket"). The infusion basket is expanded and closed using the red actuator located on the handle at the proximal end of the device. The BASHIR™ S-B Endovascular Catheter is a second model intended for smaller anatomies, with an infusion basket that is 10.0 cm (3.94 in.). The devices are otherwise the same.
The physician-specified fluid is then delivered via the basket infusion line located on the handle. Pulse sprays are followed by infusion through laser-drilled holes in the infusion limbs of the basket after placement in the peripheral vasculature or in the pulmonary artery. After the completion of fluid delivery, the infusion limbs are collapsed to a straight position and then the catheter is retracted into the sheath and removed from the patient.
The BASHIR™ Endovascular Catheter and BASHIR™ S-B Endovascular catheters are composed of common biocompatible materials used in vascular catheters are mechanical and contain no electrical components and require no capital equipment.
I am sorry, but the provided text is a 510(k) premarket notification for a medical device (Bashir Endovascular Catheter) submitted to the FDA. It details information about the device, its intended use, comparison to predicate devices, and various performance tests (biocompatibility, sterility, bench testing, animal testing, and clinical testing).
However, this document does not contain information about an AI/ML powered device, specifically:
- Acceptance criteria and reported device performance for an AI/ML model
- Sample sizes for test sets and data provenance for an AI/ML model
- Number and qualifications of experts for ground truth establishment for an AI/ML model
- Adjudication methods for an AI/ML model
- Multi-reader multi-case (MRMC) comparative effectiveness studies for an AI/ML model
- Standalone performance of an AI/ML algorithm
- Type of ground truth used for an AI/ML model
- Sample size for the training set of an AI/ML model
- How ground truth for the training set was established for an AI/ML model
Therefore, I cannot fulfill your request based on the provided text as it does not describe an AI-powered device or its associated study results.
§ 870.5150 Embolectomy catheter.
(a)
Identification. An embolectomy catheter is a balloon-tipped catheter that is used to remove thromboemboli, i.e., blood clots which have migrated in blood vessels from one site in the vascular tree to another.(b)
Classification. Class II (performance standards).