FDA grants 510(k) clearance to Summit Medical for additional sterilisation cycles

21 July 2014 (Last Updated July 21st, 2014 18:30)

The US Food and Drug Administration (FDA) has granted 510(k) clearance to Summit Medical for sterilisation methods on its Instru-Safe instrument protection trays.

The US Food and Drug Administration (FDA) has granted 510(k) clearance to Summit Medical for sterilisation methods on its Instru-Safe instrument protection trays.

Currently, the Instru-Safe instrument protection trays are approved for the four-minute steam sterilisation cycle, eight-minute steam sterilisation cycle, ethylene oxide, Sterrad 100S and Sterrad 100 NX standard cycle.

The company said that the validations serve as a safeguard, to ensure the product will not inhibit sterility of surgical instrumentation.

Approval of more sterilisation cycles provides additional options for hospitals and health care centres.

"We have gone through rigorous validation testing and multiple 510(k) submissions."

Summit Medical executive vice president and COO Kevin McIntosh said: "Instru-Safe trays continue to be an industry leader for organizing and protecting surgical instrumentation.

"As part of our efforts to continually improve our unique product and differentiate ourselves in the market, we have gone through rigorous validation testing and multiple 510(k) submissions.

"We do this to ensure customer confidence in our instrument protection products and to demonstrate our commitment to the sterile processing community."

The instrument protection trays are used to organise and protect other medical devices that are sterilised by a healthcare provider.

In order to customise trays to meet the preferences of the surgical teams who use them on a daily basis, the company's team of product developers, engineers and field representatives around the country work closely with hospitals and facilities, according to Summit.

As well as instrument protection trays, the company also manufactures ENT products such as ventilation tubes, myringotomy blades and nasal splints, along with many other surgical and non-surgical products.

The company also markets proprietary products including the EarPopper Ear Pressure Relief Device, Dizzy FIX BPPV Training Device, and Silverstein MicroWick Drug Delivery System.