Cobe Revolution

• • Terminated Z-0192-2010 FDA Unclassified (pre-2012) ·initiated 25 Sep 2009

  A weakness in the plastic packaging tray could cause the tray to crack; compromising product sterility.

510(k) Number

K011835 ↗

FDA Product Code

KFM

Device Class

Class II

Regulation

21 CFR Part 870.4360

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

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  Class II

  FDA 510(k) K991986 Active Cleared 9 Sep 1999

• Heat Exchanger Modification for Duo and Optima

  Class II

  FDA 510(k) K944267 Active Cleared 28 Apr 1995

• Cobe Patient Monitoring Products

  Class II

  FDA 510(k) K921343 Active Cleared 5 Jan 1993

• Cobe Sampling Site

  Class II

  FDA 510(k) K922484 Active Cleared 3 Dec 1992

• Cobe Cms-Fs Membrane Oxygenator

  Class II

  FDA 510(k) K926467 Active Cleared 9 Nov 1993

• Cobe Smarxt Optima Xp Surface Modified Hollow Fiber Membrane Oxygenator

  Class II

  FDA 510(k) K000255 Active Cleared 25 Apr 2000

See all devices from Cobe Cardiovascular, Inc. →

• What types of surgical procedures is the Cobe Revolution intended for, and why is its centrifugal design considered beneficial?

  The Cobe Revolution is specifically designed for cardiopulmonary bypass procedures during open-heart surgery. Its centrifugal design enables continuous, pulsatile-free blood flow, which helps reduce hemolysis (destruction of red blood cells) and minimizes shear stress on blood components, contributing to better hemodynamic stability during critical interventions.

• Is the Cobe Revolution meant for reuse, or is it intended for single-use only? How does this affect its use in a surgical setting?

  The Cobe Revolution is intended for single-use only in controlled surgical environments. This design ensures sterility and reduces the risk of contamination or device degradation between uses, which is critical in high-stakes procedures like cardiopulmonary bypass where reliability and patient safety are paramount.

• How many model variants of the Cobe Revolution are available, and what does this mean for clinical flexibility?

  Multiple model variants of the Cobe Revolution are registered, as indicated by the diverse FEI numbers (e.g., 3030125051, 1000138054, etc.). This variety allows clinicians to select a specific model based on procedural requirements, patient size, or institutional preferences, ensuring compatibility with different surgical setups and patient needs.

• What storage and handling precautions must be followed to maintain the device’s sterility and functionality?

  The Cobe Revolution must be stored and handled according to the manufacturer’s guidelines to preserve sterility and functionality. Since it is single-use and packaged sterilely, proper storage conditions (e.g., temperature, humidity, and protection from physical damage) are essential to prevent contamination or degradation before use in surgery.

• What regulatory pathway was followed for the Cobe Revolution’s approval, and what does this mean for its clinical use?

  The Cobe Revolution received FDA 510(k) clearance (K011835) under an abbreviated review process, classified as substantially equivalent to a predicate device. This means it was determined to have the same intended use and technological characteristics as a previously approved device, ensuring its safety and effectiveness for cardiopulmonary bypass procedures while streamlining its regulatory approval.