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The Foresight ICE System is indicated for intracardiac and intraluminal ultrasound visualization of cardiac and great vessel anatomy as well as visualization of other devices in the heart and great vessels of patients.

The Foresight ICE System is intended to be used by physicians trained in cardiac catheterization in combination with fluoroscopic imaging and cardiac monitoring equipment with resuscitation equipment readily available.

The Foresight ICE System is an imaging system intended for intracardiac and intraluminal ultrasound visualization of cardiac and greater vessel anatomy. The Foresight ICE System is comprised of a 10.3F sterile, single-use catheter intended to operate with Patient Interface Module (PIM) and the Hummingbird Console.

The Foresight ICE Catheter uses a mechanically scanned single element imaging transducer that allows for both 2D imaging, similar to an existing rotational ICE Catheter, as well as 3D imaging.

The Foresight ICE Catheter is designed to provide ultrasound images of cardiovascular anatomy. It is a mechanically scanning catheter with a single imaging transducer that rotates within the distal end of a deflectable sheath. The distal tip of the sheath is shaped as a dome and made of an acoustically transmissive material (that is also visually transparent). The distal 10 cm of the catheter can be deflected in a single direction by extending the deflection controller on the handle near the proximal end of the catheter.

The Hummingbird Console is a cart based console that connects to the PIM. It is used to generate and transmit ultrasound imaging energy to activate an ultrasound transducer located at the distal tip of the Foresight ICE Catheter, and then acquire received ultrasound imaging data from the catheter. It then processes imaging data and displays it to the users. It consists of two displays - one for a technician or nurse and one for the physician. It also provides user interfaces for user input.

The PIM serves as the interface between the single-use catheter and the Hummingbird Console. It acts as a relay for electrical ultrasound signals between the Hummingbird Console and catheter. It contains a motor and associated drive system to rotate the transducer imaging assembly of the catheter.

This 510(k) summary focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed clinical study with specific acceptance criteria and performance metrics for the new device. Therefore, much of the requested information about acceptance criteria, study design, and performance outcomes is not explicitly available in this document.

However, I can extract information related to the device's technical characteristics and the types of testing performed to support its safety and efficacy.

Here's a breakdown of the available information:

1. Table of acceptance criteria and the reported device performance:

The document does not provide a formal table of "acceptance criteria" and "reported device performance" in the typical sense of a clinical study evaluating diagnostic accuracy or clinical outcomes. Instead, it presents a comparison of the new device's technical specifications with those of the predicate device to demonstrate substantial equivalence.

Key comparisons highlighting "performance" relative to the predicate (implicitly, the acceptance is that the new device is "similar to" or "does not adversely affect" the predicate's performance):

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):

This document does not describe any clinical test sets, sample sizes, or data provenance (country, retrospective/prospective) for evaluating device performance in humans or animals. The testing described focuses on bench and laboratory testing against international standards for safety and technical performance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):

Not applicable. No clinical test set or ground truth establishment by experts is mentioned in this submission.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

Not applicable. No clinical test set or adjudication method is mentioned.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. This device is an imaging system, not an AI-powered diagnostic tool, and no MRMC study or AI assistance is mentioned.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. This is not an AI algorithm. It's a medical device for imaging.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

For the technical performance evaluation described (e.g., acoustic output, electrical safety, biocompatibility, sterilization), the "ground truth" is adherence to established international standards (e.g., IEC, ISO, NEMA) and engineering specifications, verified through laboratory testing. There is no mention of clinical ground truth (pathology, expert consensus, outcomes data).

8. The sample size for the training set:

Not applicable. This device does not involve a "training set" in the context of machine learning or AI.

9. How the ground truth for the training set was established:

Not applicable.

Summary of the Study that Proves the Device Meets Acceptance Criteria (based on the provided text):

The "study" or rather, the evidence provided to demonstrate that the device meets its (largely implied) acceptance criteria for substantial equivalence to the predicate, consists of a comprehensive battery of bench and laboratory verification and validation testing.

This testing was conducted in compliance with a list of relevant international standards to demonstrate:

• Biological Safety: ISO 10993-1 (biocompatibility)
• Electrical Safety and Performance: IEC 60601-1 (3rd edition), IEC 60601-1-2 (EMC), IEC 60601-2-18 (endoscopic equipment), IEC 60601-2-37 (ultrasound medical diagnostic and monitoring equipment).
• Sterilization: ISO 11135 (Ethylene Oxide sterilization validation for medical devices).
• Usability: IEC 60601-1-6.
• Acoustic Output: Tested per IEC 60601-2-37:2007 (and deemed analytically equivalent to NEMA UD-2 performance). The device was shown to have reduced acoustic output (Max Pressure, MI, PRF) compared to the predicate, which is presented as a safety improvement ("reduces risk of tissue bioeffects").
• Functional Equivalence: Technical specifications of the catheter and console (e.g., imaging frequency, imaging modes - B-mode), physical dimensions, and operational characteristics were compared directly to the predicate. Differences (like the 10.3F OD, improved tip directionality, and 3D imaging capability) were justified as either similar enough not to raise new safety/efficacy concerns or as enhancements that do not hinder the primary function of the device compared to the predicate. The "worst case uncertainty of any depth measurement is +/- 1.2mm" is a specific performance result mentioned for the device's measurement capability.

The conclusion is that based on the Intended Use, Indications for Use, product technical information, performance evaluation (through standards compliance and direct comparison), and standards compliance, the Colibri Foresight ICE System has shown to be substantially equivalent to the cited predicate device (Boston Scientific Galaxy™ Intravascular Ultrasound Imaging System, K980851). No human clinical trials were described to prove this equivalence.

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