Grand Rapids, Mich. (PRWEB) March 22, 2012
Pressure Point Inc., a medical device developer focused on non-pharmacological products to alleviate the effects of nausea and vomiting, has achieved 510(k) premarket notification clearance from the US Food and Drug Administration for its Pressure Right® single-use, disposable device designed to decrease the incidence of post-operative nausea and vomiting (PONV).
Applied to patients’ wrists before induction of anesthesia, Pressure Right utilizes a cost-effective pressure technology, to complement the use of routine antiemetic drugs to mitigate negative effects of nausea and vomiting commonly associated with surgery and anesthesia. Manufacturing of the Pressure Right device is handled through a partnership with Laminin Medical Products based in Grand Rapids, Mich.
Joseph DiLustro, chairman and CEO of Pressure Point, explains that his firm’s FDA 510(k) effort took several months. In order to address technology and performance issues raised by the FDA, the firm sought third-party support from medical device regulatory consulting firm from Emergo Group, adds DiLustro.
“We chose professional representation because it was in our best interest to do so considering that the 510(k) process is very complex,” DiLustro says. “Pressure Right® had to prove substantial equivalence to predicate devices based on strong clinical support, and because Pressure Right® uses different design features, we were required to perform very stringent performance testing for our indication for use. We needed a strong regulatory organization to advise us from conception through the 510(k) submission process.”
According to Julie Powell, vice president of quality assurance consulting at Emergo Group, the consultancy assisted Pressure Point in defining testing requirements, vendor evaluation and setting engineering testing parameters. Emergo Group also assisted with the FDA 510(k) submission phase of Pressure Point’s premarket notification effort.
“Medical device companies such as Pressure Point with innovative products often face especially complex FDA 510(k) clearance efforts,” Powell explains. “Substantial equivalence issues are not as clear-cut, and additional testing requirements can take up substantial time and resources. Pressure Point was able to leverage our regulatory expertise to achieve 510(k) clearance in a timely, cost-effective manner.”
About Pressure Point
Our primary mission is to protect patients and reduce risk against emetic symptoms. As an adjunctive therapy, Pressure Right® has clinically proven to provide increased efficacy in the management of nausea and vomiting post-operatively. Pressure Point is a provider of non-pharmacological medical device applications for antiemetic management use. Further information at http://www.pressurerightstrip.com
About Emergo Group
Emergo Group is a global medical device regulatory consulting firm providing a wide range of services for medical device registration, QMS compliance, clinical trial management, in-country representation, reimbursement and distributor search consulting. Learn more at http://www.emergogroup.com
Pressure Point Inc.