The finished product is a lightweight reusable surgical respirator that helps reduce wearer exposure to airborne particles. It is designed to be sterilized with steam in hospital settings and uses a silicone seal that is detachable and also sterilizable by steam. The respirator has adjustable silicone face straps to allow users with vary face shapes to adjust the fit and maintain the airtight seal.
Moore noted that a typical surgical mask is not N95-rated. Medical N95 respirators need to be fit and validated to confirm that there are no leaks around the edges. He said, “We realized that if we have a frame that is validated, we have the option of putting in other materials that are approved for N95 classification. And in addition, the doctor can take other types of material—for example regular surgical mask material—when needed to create other options. It’s very versatile in how it can be adopted. The intention is to supply filter inserts that can be swapped out in about 15 seconds. When you’re done, you just throw the old one [filter] away.”
Garrett Spurgeon, Director of Product Development for NextStep Arthropedix, explained why they chose titanium. “By using the same material that we use in our highly complex orthopedic implants that contain structures that are very difficult to clean, we knew that we had a material that was lightweight, it could be cleaned and sterilized in almost any hospital setting because it doesn’t necessarily represent a new worst case burden for the hospital to clean it. We have a wealth of data that was part of previous orthopedic device submissions that helps back this up. Titanium was the most efficient and functional choice because we were able to leverage a lot of the data that already exists for our complex orthopedic implants.”
FDA Clearance
Once the team had finalized the respirator, it was time to submit it for expedited FDA 510(k) clearance. Spurgeon spearheaded that task.
Spurgeon told OTW that he had “just answered questions from our FDA reviewer on what we do and how we would expect these devices to be cleaned and sterilized in the hospital. We provided those answers along with the other mechanical test data with the filter material. The FDA is in the process of reviewing it all. Our end goal is to get the device cleared and on the market under emergency use authorization. That process is for Class II medical devices. The FDA is allowing us to enjoy an expedited review period—hopefully within a week or two timeframe instead of the standard 90 days—and then we can get these to our end users who are in desperate need of these devices.”
