ABBOTT MEDICAL · Class II · Cleared May 20, 2025
| K-number | K251231 |
| Device name | ViewFlex X ICE Catheter, Sensor Enabled |
| Applicant | ABBOTT MEDICAL |
| Product code | OBJ |
| Device class | Class II |
| Decision date | May 20, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 870.1200 |
The ViewFlex™ X ICE Catheter, Sensor Enabled™ is a sterile, single-use intracardiac ultrasound catheter designed for visualizing cardiac anatomy, physiology, and device placement in adult and adolescent patients. It features a 9 French shaft with a 64-element ultrasound transducer at the tip and, when used with compatible mapping systems, provides 3-D location and orientation information.
The device is a 9 French ICE catheter with a 90 cm useable length, identical to the predicate in working length and shaft size. Key modification from the predicate is the addition of magnetic sensors within the flexible tip to accommodate 3-D location sensing capability, along with component changes to improve manufacturability and material stability.
Biocompatibility testing was conducted per ISO 10993 voluntary consensus standards for an external communicating medical device with limited (≤24 hour) circulating blood contact. Bench design verification testing included dimensional, visual, mechanical integrity, simulated use, electrical, packaging, and shelf-life testing.
The device has identical indications for use, intended use, and principles of operation as the predicate ViewFlex™ Xtra ICE Catheter (K223077). Although magnetic sensors were added to the flexible tip, the fundamental design, catheter dimensions, working length, French size, and interface compatibility remain unchanged. Bench testing and biocompatibility data demonstrate the device performs at least as safely and effectively as the predicate despite the component modifications.
View the full FDA submission: accessdata.fda.gov