(59 days)
The AcuNav Volume is intended for imaging guidance, not treatment delivery, of cardiac interventional percutaneous procedures; intraluminal visualization of great vessel anatomy and physiology; intracardiac visualization of cardiac anatomy, physiology, and devices within the heart of an adult or a pediatric patient.
The ACUSON AcuNav Volume ICE Catheter is a 12.5F catheter with 90 cm of usable length and four-way steering that provides real-time three-dimensional ultrasound images of anatomical structures and devices, in addition to conventional real-time twodimensional images.
The provided document is a 510(k) premarket notification for the ACUSON AcuNav Volume Intracardiac Echocardiography Catheter. This document asserts the substantial equivalence of the new device to a predicate device (ACUSON AcuNav V diagnostic ultrasound catheter, K081808) rather than presenting a performance study with acceptance criteria for a novel AI/software-as-a-medical-device (SaMD) product.
Therefore, the document does not contain the information requested regarding acceptance criteria and the study that proves the device meets the acceptance criteria for an AI/SaMD product. Specifically, it lacks:
- A table of acceptance criteria and reported device performance (for an AI/SaMD).
- Sample sizes used for a test set or data provenance related to AI performance.
- Number of experts, qualifications, or adjudication methods for ground truth establishment.
- Information on Multi-Reader Multi-Case (MRMC) comparative effectiveness studies.
- Stand-alone algorithm performance data.
- The type of ground truth used for AI-specific evaluation.
- Sample size for a training set or how its ground truth was established.
Instead, the document focuses on:
- Substantial Equivalence: The primary assertion is that the ACUSON AcuNav Volume is substantially equivalent to an existing device (the ACUSON AcuNav V).
- Nonclinical Testing: Design verification testing, safety, and electromagnetic compliance testing were performed. The device was evaluated for acoustic output, biocompatibility, cleaning/disinfection, thermal, electromagnetic, and mechanical safety, conforming to applicable medical device safety standards (e.g., UL 60601-1, IEC 60601-2-37, ISO 10993-1).
- Lack of Clinical Data Requirement: The document explicitly states: "Because the AcuNav Volume 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." This means no clinical study was conducted to demonstrate device performance in a clinical setting against specific acceptance criteria.
- Similarities and Differences Table: A table is provided comparing the new device (AcuNav Volume) and the predicate device (AcuNav V) on features like indications for use, patient contact materials, tip dimensions, distal shaft dimensions, electrical connector, and packaging.
In summary, this document is a regulatory submission for a physical medical device, demonstrating substantial equivalence to a predicate, not a performance study for an AI/SaMD product. Therefore, it does not provide the information requested in the prompt, which is tailored for AI/SaMD performance evaluation studies.
§ 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).