Mindray Announces FDA 510(k) Clearance of Its A5 Anesthesia System

MAHWAH, N.J., Feb 24, 2011 /PRNewswire-Asia-FirstCall/ -- Mindray Medical International Limited (NYSE: MR), a leading developer, manufacturer and marketer of medical devices worldwide, today announced that its A5 Anesthesia System has received 510(k) clearance from the U.S. Food and Drug Administration (FDA). The A5 anesthesia device, part of the all new A Series portfolio, is an anesthesia delivery platform that will complement Mindray's broad range of existing ultrasound and patient monitoring systems.

A5 Straight

The A5's intuitive user interface and ergonomic design simplify workflows. Meanwhile, its 15" touch screen enables clinicians to quickly and easily select ventilation settings, so less time is spent maneuvering and more time is devoted to patient care. The ample work surface, central brake and integrated cable sweeps enhance effectiveness and device mobility.

A5 is the first and only anesthesia machine that conforms to the IHE (Integrating the Healthcare Enterprise) Patient Care Domain (PCD) profile. At no additional charge, every A5 provides data output in the industry standard HL7 protocol. HL7, with the IHE PCD profile, is recognized among anesthesia information management systems (AIMS) and electronic medical records (EMR) systems as the demonstrated industry standard for unambiguous interoperability.

The A5 provides a range of advanced ventilation modes enabling effective care across different patient acuity types. Integrated spirometry offers additional information which enhances careful decision making.

The unique, auxiliary O2/Air Blender reduces the risk of surgical fires by controlling the oxygen concentration under the drape, near the patient's head and chest.

"The A5 Anesthesia System is simple to use and well designed with the most intuitive user interface in the business," said Thomas Barford, Vice President of Anesthesia Systems at Mindray North America. "We are confident that the A5 will be very competitive and well-received in the marketplace."

"The A5 is the first of our new series of anesthesia machines that bring advanced design features to the Mindray portfolio. By creating a highly differentiated product that includes more standard ventilation features, we are significantly expanding our ability to serve the US hospital market," said David Gibson, President, Mindray North America.

About Mindray

We are a leading developer, manufacturer and marketer of medical devices worldwide. We maintain global headquarters in Shenzhen, China, U.S. headquarters in Mahwah, New Jersey and multiple sales offices in major international markets. From our main manufacturing and engineering base in China and through our worldwide distribution network, we are able to supply internationally a broad range of products across three primary business segments, comprised of patient monitoring and life support products, in-vitro diagnostic products and medical imaging systems. For more information, please visit http://www.mindray.com.

Press Release A5 510(k) Clearance part number 0002-08-1394