Proxima submits 510(k) documentation for EvoEndo gastroscope
Proxima CRO, a company guiding emerging medical device and pharmaceutical companies from the earliest stages of product development through commercialisation, has successfully authored and submitted a 510(k) for the EvoEndo Model LE Single-Use Gastroscope, a device that is indicated for both paediatric and adult patients five years and older.
The submission was supported through grant funding by Southwest National Pediatric Device Innovation Consortium (SWPDC.org), of which EvoEndo is a portfolio company and Proxima CRO is a service partner.
Isabella Schmitt, RAC, director of regulatory affairs at Proxima CRO, said: “510(k) clearance is a significant achievement in the path to commercialization, signifying that the product is a safe, effective, and legally marketed device. We’re excited to see a trans-nasal endoscope specifically designed with the comfort of the paediatric patient in mind. There are always specific challenges when bringing paediatric products to market, so finding and working with innovators who see the products through to commercialisation is always exciting. We are happy to have worked with both EvoEndo and SWPDC on getting this much needed product to market.”
Areas of compliance required for a medical device 510(k) submission include: 1) labelling, claims, and intended use of products; 2) product development and manufacturing operations; 3) product safety & effectiveness; and 4) product registration, records, customer complaints, and adverse reactions.
Heather Underwood, CEO, EvoEndo, said: “This is an exceptional accomplishment for our team. “The FDA 510(k) clearance validates our commitment to offer a safer, faster, and more affordable alternative to sedated endoscopy for both paediatric and adult patients, and supports the broader adoption of safer, unsedated procedures throughout the U.S.”
EvoEndo’s Single-Use Endoscopy System eliminates the need for general anaesthesia, or conscious sedation, during routine upper endoscopic procedures. The 510(k) was granted on February 14, 2022.
Chester J. Koh, MD, executive director and contact principal investigator of SWPDC, said: “We like nothing more than seeing our investments and assistance help improve the lives of paediatric patients, families, and providers. This is why we exist. To bring products like this to market to make healthcare better, safer, more effective, and more accessible to children around the world.”
As a multi-institutional consortium that includes Texas Children’s Hospital and Baylor College of Medicine, Texas A&M University, Rice University, University of Houston, Fannin Innovation Studio, and other partners, SWPDC is a “free and no-strings-attached” virtual accelerator that supports paediatric device innovators throughout the paediatric device life cycle by providing device seed funding, consulting, design and engineering assistance, potential clinical collaborators, and connections to local programs and resources.