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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.

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