Sorin B-CARE5 for Stockert S5 System

• • Terminated Z-2074-2010 FDA Unclassified (pre-2012) ·initiated 18 Jun 2010

  Although accessories were designed for use with two models, the HLM C5 and the HLM S5, the submission that included references to the Mast Roller Pump, B-Care5, and the Electrical Venous Line Occluder accessories covered the new HLM S5 system. The three accessories were not cleared for use with the HLM C5.

Full name

Sorin B-CARE5 for the Stockert S5 System

510(k) Number

K092463 ↗

FDA Product Code

DTQ

Device Class

Class II

Regulation

21 CFR Part 870.4220

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Modification to Stockert S5 System

  Class II

  FDA 510(k) K062396 Active Cleared 28 Sep 2006

• Modification to: Stockert S5 System

  Class II

  FDA 510(k) K071318 Active Cleared 6 Jul 2007

• Sorin C5 System; 85/C5 Mast Roller Pump System 150(1X Rp 150 and Control Panel with Connecting Cables); S5/C5 Mast Rolle

  Class II

  FDA 510(k) K103762 Active Cleared 20 Jan 2011

• Air Purge Control System for S5 System Model 23-45-05

  Class II

  FDA 510(k) K091007 Active Cleared 2 Jul 2009

• Xtra

  Class II

  FDA 510(k) K131553 Active Cleared 21 Mar 2014

• Sorin Connect

  Class II

  FDA 510(k) K170460 Active Cleared 8 Jun 2017

See all devices from Sorin Group Deutschland GmbH →

• What types of open-heart surgeries is the Sorin B-Care5 designed to support during cardiopulmonary bypass procedures?

  The Sorin B-Care5 for the Stockert S5 System is specifically designed to provide controlled oxygenation, ventilation, and circulation support during open-heart surgeries. It integrates with the Stockert S5 platform to ensure precise hemodynamic management and patient safety, making it suitable for procedures requiring cardiopulmonary bypass, such as coronary artery bypass grafting (CABG), valve replacements, or other complex cardiac interventions.

• Is the Sorin B-Care5 intended for reuse in clinical settings, or is it meant to be used only once?

  The Sorin B-Care5 is explicitly designed for single-use in clinical settings. This design choice helps maintain sterility and performance consistency, as outlined in the manufacturer’s instructions for proper handling and storage.

• How should the Sorin B-Care5 be stored to ensure it remains sterile and functional?

  The device is supplied sterile, so storage must follow the manufacturer’s guidelines to preserve sterility and performance. This typically includes keeping it in its original packaging, in a clean, dry environment, and away from direct sunlight or extreme temperatures until ready for use.

• What regulatory pathway was followed for FDA clearance of the Sorin B-Care5, and what does this mean for its use?

  The Sorin B-Care5 received FDA 510(k) clearance (K092463) under the traditional review pathway, with a decision of *Substantially Equivalent* to a predicate device. This means it was evaluated by the FDA’s Cardiovascular (CV) advisory committee and determined to have the same intended use and technological characteristics as a previously cleared device, ensuring compliance with Class II medical device regulations (870.4220).

• Are there multiple models or configurations available for the Sorin B-Care5, or is it a single unified system?

  The Sorin B-Care5 is designed as a console component specifically integrated with the Stockert S5 system, rather than a standalone device. While it may include various compatible configurations or accessories (as referenced by the multiple registration numbers), the core device itself is a unified console for cardiopulmonary bypass procedures, tailored to work seamlessly with the Stockert S5 platform.