Circa Scientific, Inc. · Class II · Cleared May 1, 2025
| K-number | K251007 |
| Device name | CrossWise RF Transseptal Access System (Models: CW-1085S, CW-1085A, CW-1012W, CW-1012C, CW-1085C, CW-1085V, CW-1013F) |
| Applicant | Circa Scientific, Inc. |
| Product code | DXF |
| Device class | Class II |
| Decision date | May 1, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 870.5175 |
The CrossWise RF Transseptal Access System is a catheter device used to create an atrial septal defect in the heart by delivering monopolar radiofrequency energy. It can also infuse heparinized saline and contrast media solutions. The device is inserted over a guidewire and is compatible with multiple commercially available introducer sheaths.
The subject device adds three new model variants (CW-1085C, CW-1085V, CW-1013F) with the same cannula, shaft, and distal tip design as the predicate. The only modification is minor dimensional changes to the proximal luer hub on the dilator component to accommodate compatibility with CardioCurve, Vizigo, and Faradrive introducer sheaths instead of just Agilis, Swartz, Watchman, and FlexCath.
ISO 10993-1:2018 (biological evaluation), ISO 15223-1:2021 (device symbols and labeling), ISO 20417:2021 (manufacturer information), ISO 11070-1:2014 (sterile intravascular introducers), and ISO 80369-7:2021 (small-bore connectors for healthcare applications).
The device is substantially equivalent because the material composition, extruded shaft, distal tip design, energy delivery mechanism (monopolar RF), and all key components remain identical to the predicate K241414. The only changes are minor proximal luer hub dimensional modifications needed to connect with three additional commercial sheaths, which do not raise new safety or effectiveness questions since the actual dilator extrusion performing the procedure is unchanged. Bench testing confirmed compatibility without affecting device performance.
View the full FDA submission: accessdata.fda.gov