(30 days)
These devices are to be used by a trained physician only. Cannulae are used to cannulate vessels, perfuse vessels or organs, and/or connect with accessory extracorporeal equipment. The cannula introducer is intended to facilitate proper insertion and placement of the appropriately-sized cannula within the vessel for cardiopulmonary bypass. The Bio-Medicus™ cannulae (18-cm [7.09-in] tip length models) may be used in either the femoral position as an arterial delivery cannula or in the jugular position as a venous return cannula. This product is intended for use up to 6 hours.
This kit is a combination of the following two sets of devices:
- Bio-Medicus Adult Cannula and Introducer, cleared on November 18, 2014 (K142673)
- Bio-Medicus Insertion Kit, cleared on April 9, 2015 (K150567)
The Bio-Medicus Adult Cannula and Introducer is designed to cannulate vessels, perfuse vessels or organs, and/or connect with accessory extracorporeal equipment and is designed for periods of up to six hours of use.
The Bio-Medicus cannula (18 cm [7.09 in] tip length models) may be used in either the femoral position as an arterial delivery cannula or in the jugular position as a venous return cannula.
Bio-Medicus™ Insertion Kits contains the necessary components to achieve insertion of a Bio-Medicus™ cannula and introducer. The included items are: a Seldinger needle, a guidewire, a scalpel blade, stepped dilators, and a catheter tip syringe.
This is a 510(k) premarket notification for a medical device, not an AI/ML powered device. Therefore, the information regarding acceptance criteria and study details for AI/ML performance is not applicable. The provided document concerns a traditional medical device (Bio-Medicus™ Adult Cannula Kit) and focuses on demonstrating substantial equivalence to predicate devices based on design, materials, intended use, and manufacturing processes, rather than AI model performance metrics.
§ 870.4210 Cardiopulmonary bypass vascular catheter, cannula, or tubing.
(a)
Identification. A cardiopulmonary bypass vascular catheter, cannula, or tubing is a device used in cardiopulmonary surgery to cannulate the vessels, perfuse the coronary arteries, and to interconnect the catheters and cannulas with an oxygenator. The device includes accessory bypass equipment.(b)
Classification. Class II (performance standards).