FDA Clears I.C. Medical's Advanced Surgical Smoke Evacuation System

The U.S. Food and Drug Administration (USFDA) has granted Phoenix-based I.C. Medical Company 510(k) clearance to market the Crystal Vision 450D in the United States on October 30, 2017.

 

The Crystal Vision 450D is an "intelligent" surgical smoke evacuation device, with sophisticated features and enhanced functionality. It employs a unique design that pulls air through a narrow opening at very high speeds causing air to spin and form a powerful air vortex around the ESU blade. Smoke particles expelled from the surgical site are captured in the air barrier created by the vortex before they escape. Thus, instead of trying to catch and pull back particles that are traveling away from the smoke nozzle, the Crystal Vision's design enables surgeons to create an invisible barrier through which smoke particles cannot escape into the operating room.

 

The CV 450D has a built-in valve that allows for hands-free smoke evacuation. ULPA filtration and sensors detect when the filter is full and alert surgical staff with an audible and visible indicator. If the filter is not changed in a timely manner, the machine stops to prevent smoke particles from escaping into the OR.

 

Other advanced/improved features of the CV 450D make the device more convenient, ergonomic and easier to handle in the OR. These include:

 

- The ULPA filter is recessed into the machine and the charcoal output filter is partially recessed- giving the device a sleek, modern, ergonomic profile;

 

- The front panel of machine is angled 30 degrees for easy viewing by surgical staff from low levels- such as the bottom of an ESU cart;

 

- The digital numerical readout is larger and can be seen from a distance;

 

- Push button settings with precise flow setting in open procedure or laparoscopic mode

 

Unique among smoke evacuators, the Crystal Vision 450D can operate in either open or laparoscopic mode with just the push of a button. In "lap" mode, the CV removes smoke gently and efficiently while maintaining the pneumoperitinium. Pneumoperitoneal pressure is continuously monitored and the Crystal Vision automatically activates to reduce abdominal pressure to a safe level. If intra-abdominal pressure reaches 27mmHg, the unit automatically alarms. If intra-abdominal pressure reaches 30 mmHg, it automatically activates, reducing pressure in the abdomen to a safe level, thus protecting the patient from run-away insufflation and embolism.

 

The CV's unique low flow range is easily adjusted to match the in-flow rate of the insufflator, helping to regulate pneumoperitoneal pressure. The evacuator pump stops automatically if the tissue is accidentally suctioned.

 

At the end of a procedure, surgical staff can use the manual button on the CV smoke evacuator to deflate the patient's abdomen. By removing CO2 gas in this way, the patient's body does not have to absorb excess gas residue. This reduces, and, in some cases, eliminates the painful joint aches that result from pushing on the abdomen to remove gas. It also speeds up post-op recovery time.

 

Another "smart" feature of the Crystal Vision is the "No Patient" indicator for laparoscopic procedures. If there is no pressure or zero atmospheric pressure at the input for the ULPA Filter with Fluid trap, the unit will indicate this with a "No Patient" audible and visual indicator. If the intra-abdominal tubing gets kinked for instance, the unit will display "No Patient" audible and visible indicator.

 

"The Crystal Vision 450D is revolutionary in terms of capture effectiveness, ease of use and field clarity," said Ioan Cosmescu, inventor, and co-founder of I.C. Medical. "It will materially improve health and safety in the surgical theater for both patients and clinical staff, while also improving clinical outcomes by improving visibility and reducing plume pollution in the operating room."

 

The Crystal Vision 450D is CE marked and approved for use in Japan, Canada, New Zealand, and Australia.