(29 days)
The catheter is intended for intracardiac and intra-luminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart of adult and pediatric patients. The catheter is intended for imaging guidance only, not treatment delivery, during cardiac interventional percutaneous procedures.
The ACUSON AcuNav Volume Intracardiac Echocardiography (ICE) Catheter is a 12.5F catheter with 90 cm of usable length and four-way steering that provides real-time threedimensional ultrasound images of anatomical structures and devices, in addition to conventional real-time two-dimensional images.
This document is a 510(k) Premarket Notification from Siemens Medical Solutions USA, Inc. for their ACUSON AcuNav Volume Intracardiac Echocardiography (ICE) Catheter. The FDA has reviewed the submission and determined that the device is substantially equivalent to a legally marketed predicate device (K203726, also an ACUSON AcuNav Volume Intracardiac Echocardiography Catheter).
However, the provided text does not contain information about acceptance criteria or a study that proves the device meets specific performance acceptance criteria related to an AI/ML algorithm.
Instead, this submission is for a medical device (an ultrasound catheter) that:
- Provides real-time three-dimensional ultrasound images.
- Is intended for intracardiac and intra-luminal visualization of cardiac and great vessel anatomy and physiology, as well as other devices in the heart, for adult and pediatric patients.
- Is intended for imaging guidance only, not treatment delivery, during cardiac interventional percutaneous procedures.
The 510(k) summary explicitly states: "Because the ACUSON AcuNav Volume Intracardiac Echocardiography (ICE) catheter in this submission uses the same technology, patient contact materials and principles as the predicate device, clinical data is not required to establish substantial equivalence."
Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving the device meets those criteria, as the document states such a study was not required or provided for this specific 510(k) submission. The FDA clearance is based on substantial equivalence to a predicate device, and compliance with general medical device safety and quality standards (e.g., UL, IEC, ISO standards for safety, EMC, biocompatibility, sterilization, and packaging).
In summary, there is no discussion of an AI/ML component, clinical performance study, or specific acceptance criteria for performance metrics (like sensitivity, specificity, AUC, etc.) in the provided text.
§ 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).