Medline ReNewal Reprocessed Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound Catheter (8F, 8FG, 10F, 10FG)
Surgical Instrument Service and Savings Inc.The Medline ReNewal Reprocessed Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound Catheters are reprocessed ultrasound catheters used in cardiac electrophysiology procedures. They provide real-time 2D ultrasound imaging and 3D location sensing inside the heart and great vessels to help clinicians visualize anatomy and other procedural devices during interventions.
Intended Use
The Medline ReNewal Reprocessed Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound Catheters 8F, 8FG, 10F, 10FG are indicated for intra-cardiac and intra-luminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart. When used with compatible CARTO 3 EP Navigation Systems, the SOUNDSTAR eco Catheter provides location information.
Technology
The catheter consists of a CARTO connector, SwiftLink (ultrasound) connector, handle and shaft. It includes a 64-element ultrasound transducer for 2D imaging and a 3D location sensor, providing location information to compatible CARTO 3 Electrophysiology Navigation Systems. Deflection and tension knobs allow articulation of the distal tip and control image plane orientation with four-directional deflection.
Performance
The device underwent non-clinical functional performance testing including simulated use, visual inspection, mechanical tests, ultrasound transducer testing, dimensional analysis, localization, device functionality, electrical safety, cleaning validation, biocompatibility, sterilization validation, packaging and shelf-life tests. These demonstrated substantial equivalence to predicate devices.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
2/25/2025
3 months - 2
FDA Approval
6/5/2025
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