(30 days)
The Biosense Webster SOUNDSTAR® eco Diagnostic Ultrasound Catheter and related accessory devices 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.
The modified SOUNDSTAR eco 8F and SOUNDSTAR eco 8F G Catheters are both 90 cm long and 8F in diameter. They are IntraCardiac Echo (ICE) Catheters with acoustic array and magnetic location sensor equivalent to the currently cleared SQUNDSTAR eco 10F and SOUNDSTAR eco 10FG Catheters. The magnetic location sensor (providing location information to the CARTO 3 EP Navigation System Version 2.3 and 3.2) and an ultrasound transducer (acquiring real time ultrasound images) are embedded in the catheter tip.
The modified SOUNDSTAR eco 8F and SOUNDSTAR eco 8F G Catheters have a bifurcated 'tail' originating from the catheter handle which is identical to the bifurcated tail of the predicate device; the SOUNDSTAR eco 10F. One leg terminates in the SOUNDSTAR Flex Tab connector, which connects via the appropriate SWIFTLINK cable, to the appropriate Ultrasound system. Specifically, for the SOUNDSTAR eco Catheter 8F. the SWIFTLINK cable connects to the Acuson Cypress™, the Acuson Sequoia™ or the Acuson X300™ and Acuson SC2000™ Ultrasound systems. For the SOUNDSTAR eco 8F G Catheter, the SWIFTLINK cable connects to Vivid i and Vivid q Ultrasound systems.
Both versions of SOUNDSTAR eco 8F and SOUNDSTAR eco 8F G Catheters are based on the existing SOUNDSTAR eco 10F and SOUNDSTAR eco 10FG catheters and have the same intended use and clinical applications. The predicate and modified catheters share the majority of components and manufacturing process as explained previously.
The modified SOUNDSTAR eco 8F and SOUNDSTAR eco 8F G Catheters, when connected to the corresponding Ultrasound Systems, will provide real-time integration of ultrasound images with CARTO 3 Version 2.3 and Version 3.2 electromagnetic acquired maps.
The provided text describes modifications to an existing medical device, the SOUNDSTAR® eco Diagnostic Ultrasound Catheter, and does not contain information about explicit acceptance criteria or a study proving the device meets specific performance metrics in the context of an AI-powered system or a diagnostic accuracy study. The document is a 510(k) summary for a Special 510(k) submission, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting new clinical performance data for a novel device or AI algorithm.
Therefore, the following information cannot be extracted from the provided text: acceptance criteria table, reported device performance, sample size for test set, data provenance, number of experts for ground truth, expert qualifications, adjudication method, MRMC study details, standalone performance, type of ground truth for test set, training set sample size, or training set ground truth establishment.
The document primarily details mechanical and sensor design changes to existing catheters (from 10F to 8F diameter, and a change in magnetic sensor design to allow compatibility with the Stereotaxis Niobe® environment) and reaffirms the device's intended use and substantial equivalence to previously cleared devices. The "Summary of Nonclinical Tests" section mentions "Design Verification Testing" and "Safety and Electromagnetic Compliance testing" were performed to support the changes. However, it does not specify performance aspects like sensitivity, specificity, or accuracy that would be relevant to the questions asked about AI device performance.
§ 870.1200 Diagnostic intravascular catheter.
(a)
Identification. An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.(b)
Classification. Class II (performance standards).