K190378

The Story behind the Spirotome Endo

Based on approvals in 2006 (K060384) and 2008 (K080095), the Spirotome was commercialized in the US for several indications.  However, European legislation (CE certification) approved the Spirotome for all soft tissues of the human body.  The Spirotome Endo was released for commercialization in 2012 and several, mainly European researchers, such as Prof. Gordts, Prof. Campo and Dr. ter Brugge, published about efficacy and safety. And in 2012 both the American Society for Reproductive Medicine (ASRM) and the European Society of Human Reproduction and Embryology (ESHRE) issued guidelines wherein the Spirotome Endo was advocated for applications in the internal female reproductive organs.  The Spirotome indeed is unique in this application.  Gynecologists were interested in the Spirotome because of histological and molecular biology of the uterine wall.  But the question raised if previous 510(k) applications covered these new ones for the US.  Asked about this, the FDA said no! The applications in the internal female reproductive organs cause new safety issues that were not covered by the former approvals. New safety and efficacy data could be submitted.  A thorough but transparent review process resulted in approval of the Spirotome Endo on May 24, 2019.  The Spirotome Endo is a family of large core soft tissue biopsy medical devices to be used in humans to take out adequate samples of tissue.  The Spirotome Endo is intended to provide soft tissue for histological and biomolecular detection and confirmation of imaged abnormalities of the internal female reproductive organs such as the uterus, ovaries, and retroperitoneal lymph nodes. The Spirotome Endo is available for the US through Blue Endo.