Pavmed Inc. (NSDQ:PAVM) plans to drop the 510(k) application for its PortIO intraosseous infusion system and instead pursue a de novo pathway for its device, according to a document the company filed with the SEC yesterday.
The move is based on a recommendation from the FDA, the company said.
The company’s 510(k) relied upon substantial equivalence to a previously-approved predicate device with an indication for use for up to 24 hours. Pavmed met with the FDA in July this year to discuss the issue of substantial equivalence, the company said.
The FDA gave Pavmed feedback at that meeting and the company narrowed the indications for its PortIO system and included a needle in the system’s kit.
But the FDA has told Pavmed that PortIO is not substaintially equivalent to the proposed predicate, despite these changes, and has instead encouraged the company to pursue a de novo classification.
The New York-based company said it plans to follow a de novo pathway for PortIO under a broader indication, for up to seven days. Pavmed also reported that it hopes to land a pre-submission meeting with the FDA.