(76 days)
The IBI Inquiry™ ClearICE™ Intracardiac Echocardiography Catheter is intended for intra-cardiac and intra-luminal visualization of cardiac anatomy and physiology as well as visualization of other devices in the heart.
The IBI Inquiry™ ClearICE™ Intracardiac Echocardiography Catheter is comprised of a single-use, disposable ultrasonic phased-array imaging transducer. A Inquiry ClearICE catheter is steerable: catheter, 9 Fr (2.97 mm) in diameter, 90 cm to 110 cm insertable length and available in various curve configuration. The distal portion of the catheter can be deflected in four directions in two orthogonal planes: left-right (in a plane perpendicular to imaging plane) and anterior-posterior (in a plane coincident with the image plane). Bi-directional steering controlled by push/pull handle mechanism and quad-directional steering controlled by a push/pull mechanism and rotating knob. The non-sterile, reusable GE Connector Cable is use to connect IBI InquiryTM ClearICE™ Intracardiac Echocardiography Catheter to the GE Vivid i Ultrasound system. The IBI Inquiry™ ClearICE™ Intracardiac Echocardiography Catheter is used with commercially available GE Connector Cable and Vivid- i Diagnostic Ultrasound System. The IBI Inquiry™ ClearICE™ Intracardiac Echocardiography Catheter is comprised of three major components: (1) the catheter itself; (2) the steering mechanism; and (3) the reusable GE Connector Cable & GE Vivi i Ultrasound System.
This looks like a 510(k) premarket notification for a medical device called the IBI Inquiry™ ClearICE™ Intracardiac Echocardiography Catheter. This document asserts substantial equivalence to previously cleared predicate devices, rather than presenting a de novo study to establish new acceptance criteria or device performance.
Therefore, the document does not contain the information required to answer your prompt. Specifically, it does not include:
- A table of acceptance criteria and reported device performance.
- Sample sizes for test sets, data provenance, number of experts for ground truth, or adjudication methods for test sets.
- Information on Multi-Reader Multi-Case (MRMC) comparative effectiveness studies.
- Information on standalone algorithm performance studies.
- The type of ground truth used in any performance studies.
- Sample size for training sets or how ground truth was established for training sets.
Instead, the submission focuses on demonstrating that the IBI Inquiry™ ClearICE™ catheter is "substantially equivalent" in its technologies and functionality to existing, legally marketed ACUSON AcuNav ultrasound catheters. Substantial equivalence means that the device is as safe and effective as a legally marketed predicate device. This typically involves comparing design, materials, performance specifications, and indications for use against the predicate, rather than conducting new clinical trials to establish de novo performance criteria.
The document lists the following predicate devices:
- #K042593 (January 5, 2005) cleared as ACUSON AcuNav 8Fr Ultrasound Catheter.
- #K033650 (February 24, 2004) cleared as ACUSON AcuNav 90/10 Diagnostic Ultrasound Catheter.
- #K992632 (November 8, 2001) cleared as ACUSON AcuNav Diagnostic Ultrasound Catheter.
The submission confirms that "The IBI Inquiry™ ClearICE Intracardiac Echocardiography Catheter designed and validated in compliance with the following standards," and then lists several ISO, IEC, BS EN, and AAMI standards, along with FDA regulations and guidance documents. Compliance with these standards and regulations is part of the process of demonstrating substantial equivalence for safety and performance, but it does not involve the kind of specific performance study details you requested for AI/algorithm-driven devices.
§ 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).