Summit Medical Gets New 510(K) Clearances for Sterilization of its InstruSafe Trays

As technology advances, so does the complexity of medical devices, increasing the difficulty associated with sterilization procedures.

Summit Medical Inc. recently obtained U.S. Food and Drug Administration 510(k) for two new sterilization cycles on the firm’s InstruSafe instrument protection trays. The newest 510(k) clearances are for Sterrad 100NX Express Cycle, which the company says enables fast turnaround for products such as endoscopes used for robotic surgery, and a product called the 4 Minute Steam Cycle for use with popular rigid containers. Company officials claim that Summit is “one of only a handful” of tray manufacturers to receive express cycle clearance.

Company officials said they will pursue additional 510(k) clearances throughout 2015 for sterilization cycles on the InstruSafe instrument protection trays.

“Validation testing is a high priority,” said Marcus Super, director of InstruSafe sales and marketing. “Our staff, including myself, has worked in sterile processing and the operating room in multiple capacities. This shared experience provides a sincere obligation to provide a product that is safe to use, offers our customers an array of sterilization cycles for reprocessing, and gives them an unmatched level of protection for their instrumentation,”

“510(k) clearances continue to be a primary focus of our company with the InstruSafe brand,” said Kevin McIntosh, president of Summit Medical.

With the addition of two recent clearances, Summit Medical has authorized use of its InstruSafe instrument protection trays for the following cycles:
• 4 Minute Steam Sterilization Cycle
• 8 Minute Steam Sterilization Cycle
• Ethylene Oxide
• Sterrad 100S
• Sterrad 100NX Standard Cycle
• Sterrad 100NX Express Cycle
• 4 Minute Steam Cycle for use with popular rigid containers

Summit Medical is a St. Paul, Minn.–based medical device manufacturer that makes instrument protection trays, as well as ear, nose and throat products such as ventilation tubes, myringotomy blades and nasal splints along with many other surgical and non-surgical products.