Rachel Klemovitch, Assistant Editor04.09.24
Peleton Surgical has received FDA clearance (K240071) to market its single-use surgical power driver. This solution aims to improve patient safety and costs that are associated with re-usable surgical drivers as well as ease workflows for surgeons and staff.
This is the first-ever FDA clearance given to a single-use surgical power driver. The FDA created a new product category for the evaluation and clearance of this device.
Peleton’s single-use power driver offers great precision and ergonomics. It is launched with a patented solution for charging the driver through the sterile barrier of the packaging. Surgery centers can get the drivers and accessories delivered fully charged, sterile, and ready to use in operating rooms.
Peleton Surgical wanted the FDA to thoroughly review the functional and safety data associated with the use of a surgical power driver, to create standards in an area where improper cleaning and frequent battery charges can result in patient risk and operational inefficiencies. Peleton went through very extensive testing before FDA clearance involving the surgical driver, its attachments, and its accessories, all from leading surgical power driver manufacturers.
“We listened to surgeons, nurses, and administrators when designing our breakthrough single-use surgical power driver and attachments. The integrated battery pack solves a lot of practical challenges for OR staff and actually helps reduce cost per use,” said Peleton Surgical director and CEO, Andy Bala. “At the same time, we were able to address nurse, surgeon, and SPD concerns about patient safety related to the reprocessing of reusable drivers and their attachments.”
This is the first-ever FDA clearance given to a single-use surgical power driver. The FDA created a new product category for the evaluation and clearance of this device.
Peleton’s single-use power driver offers great precision and ergonomics. It is launched with a patented solution for charging the driver through the sterile barrier of the packaging. Surgery centers can get the drivers and accessories delivered fully charged, sterile, and ready to use in operating rooms.
Peleton Surgical wanted the FDA to thoroughly review the functional and safety data associated with the use of a surgical power driver, to create standards in an area where improper cleaning and frequent battery charges can result in patient risk and operational inefficiencies. Peleton went through very extensive testing before FDA clearance involving the surgical driver, its attachments, and its accessories, all from leading surgical power driver manufacturers.
“We listened to surgeons, nurses, and administrators when designing our breakthrough single-use surgical power driver and attachments. The integrated battery pack solves a lot of practical challenges for OR staff and actually helps reduce cost per use,” said Peleton Surgical director and CEO, Andy Bala. “At the same time, we were able to address nurse, surgeon, and SPD concerns about patient safety related to the reprocessing of reusable drivers and their attachments.”