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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 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 Change Being Effected is the addition of a clarification instruction for the use of the introducer in the catheter device User Manual and Directions for Use.

This document describes the regulatory submission for the Siemens ACUSON AcuNav Volume Intracardiac Echocardiography Catheter. The submission is for a modification to an already cleared device (K173618), specifically adding a clarification instruction in the user manual regarding the use of an introducer.

1. Table of Acceptance Criteria and Reported Device Performance

Since this submission is for a labeling change to an already cleared device, and states that the device itself is unchanged, the "acceptance criteria" here refer to the demonstration of continued compliance with safety standards and the non-introduction of new safety or effectiveness concerns due to the labeling change. There are no new performance metrics reported for the device itself in this submission.

2. Sample size used for the test set and the data provenance

No new test set data was generated or used for this specific submission because the device itself is unchanged, and the submission is for a labeling modification. The substantial equivalence is based on the predicate device, K173618.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. No new test set data requiring expert review was generated for this submission.

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

Not applicable. No new test set data requiring adjudication was generated for this submission.

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 ultrasound catheter, not an AI-assisted diagnostic tool.

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

Not applicable. This device is an ultrasound catheter, not an algorithm, and does not operate in a standalone algorithmic fashion.

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

Not applicable to this submission, as it focuses on demonstrating continued safety and equivalence for a labeling change rather than new clinical performance data. The original predicate device's substantial equivalence would have been based on clinical experience and performance data typical for diagnostic intravascular catheters, but this detail is not provided in this document.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device.

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

Not applicable. This is not an AI/machine learning device.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The study proving the device meets the (continued) acceptance criteria is primarily non-clinical testing and a comparative analysis against the predicate device (K173618).

• Rationale for the study: The submission states that "The catheter device remains unchanged from previously cleared submission for the predicate device, AcuNav Volume ICE Catheter (K173618). The Change Being Effected is the addition of a warning to clarify the proper use of the introducer used with the catheter device and does not introduce new safety and effectiveness concerns."
• Nature of the study: The "study" involves demonstrating that the modified device (with the labeling clarification) maintains substantial equivalence to the predicate device. This is achieved by:
  • Verification of Unchanged Device Characteristics: Confirming that the device's technology, patient contact materials, and principles of operation are identical to the predicate.
  • Compliance with Safety Standards: The document lists adherence to numerous voluntary standards for acoustic output, biocompatibility, cleaning/disinfection (implicitly maintained), thermal, electrical, electromagnetic, and mechanical safety, as well as sterilization and packaging. These standards were presumably met by the predicate device and the unchanged hardware.
  • Evaluation of the Labeling Change Impact: A critical aspect is the assessment that the addition of the clarification instruction in the user manual "does not impact the substantial equivalence of the catheter device as currently cleared under K173618" and "does not introduce new safety and effectiveness concerns." This is a regulatory determination based on reviewing the proposed labeling change.
• Conclusion: "Because the AcuNav Volume 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." This statement directly indicates that the "study" for this submission focuses on non-clinical aspects and the lack of change in the device itself, making new clinical performance data unnecessary for proving continued acceptance.

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The VeriSight VeriSight Pro ICE 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. The catheter is intended for imaging guidance only, not treatment delivery, during cardiac interventional percutaneous procedures.

The Intracardiac Echocardiography (ICE) System comprises of the VeriSight Pro ICE Catheters, the ICE PIM, and the EPIQ Diagnostic Ultrasound System (cleared under K202216).

The VeriSight/VeriSight Pro Intracardiac Echocardiography (ICE) catheters are sterile, disposable, and for single use only. The catheter's distal end has an ultrasound transducer providing 2D and/or 3D imaging capabilities. A handle, located at the proximal end of the catheter, has two steering wheels that can be manually operated to control four-way articulation of the distal segment in anterior, posterior, left and right directions. The catheter has a 9 French (F) shaft and a usable length of 90 cm.

The VeriSight and VeriSight Pro ICE Catheters are identical in all regards (material, processing, assembly and packaging). The VeriSight ICE catheter provides 2D ultrasound imaging capabilities. The VeriSight Pro ICE catheter provides 2D and/or 3D ultrasound imaging capabilities, depending on the model and configuration of the EPIQ ultrasound system it connects to. The catheters are compatible with ancillary equipment such as sheaths and introducers. The catheters are sterilized via Ethylene Oxide.

The catheters connect to the Philips EPIQ Diagnostic Ultrasound System via a patient interface module (PIM); the connection between the catheter and the PIM is located outside the sterile field. The catheters will not operate if connected to any other imaging system. These catheters are for exclusive use with Philips EPIQ 7C, CVx, and CVxi series of ultrasound systems, cleared under K202216.

The provided document, a 510(k) Summary for the Philips VeriSight Intracardiac Echocardiography (ICE) Catheter, indicates that clinical data was not required to establish substantial equivalence for this device. Therefore, there is no study detailing acceptance criteria or device performance in a clinical setting for this submission.

The manufacturer states: "The VeriSight/VeriSight Pro ICE catheters use the same scientific technology, operating principles and shares similar indications for use as the predicate device. Therefore, clinical data is not required to establish substantial equivalence." (Page 8).

Instead, the submission relies on the substantial equivalence to a predicate device (Siemens AcuNav Diagnostic Ultrasound Catheter 8F, 10F, cleared under K170263) and extensive non-clinical performance testing to demonstrate safety and effectiveness.

Here's a breakdown of the non-clinical testing performed:

1. Table of Acceptance Criteria and Reported Device Performance:

Since a clinical study was not conducted to establish performance metrics like sensitivity, specificity, or accuracy against an established ground truth, there is no direct table of acceptance criteria and reported device performance in the context of clinical outcomes. The "performance" in this context refers to the successful completion of engineering design verification and validation tests.

2. Sample Size Used for the Test Set and Data Provenance:

Not applicable, as no clinical test set was used for the purpose of demonstrating device performance against clinical acceptance criteria. The testing listed above refers to engineering and bench testing, for which specific sample sizes are not detailed in this summary but are generally conducted on a representative number of devices.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

Not applicable, as no ground truth was established by experts in a clinical context for this submission. The "ground truth" for the non-clinical tests would have been the established engineering specifications and regulatory standards.

4. Adjudication Method for the Test Set:

Not applicable, as no clinical test set requiring adjudication was used.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:

No, an MRMC comparative effectiveness study was not done. The submission explicitly states that clinical data was not required.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

Not applicable. The device is a physical intracardiac echocardiography catheter, not an AI algorithm. Its function is to provide imaging capabilities for human interpretation.

7. The Type of Ground Truth Used:

For the non-clinical performance testing, the "ground truth" was defined by:

• Engineering design specifications and performance requirements for the device.
• Established national and international voluntary standards for medical devices, electrical safety, electromagnetic compatibility (EMC), and diagnostic ultrasound safety (e.g., EN/IEC 60601-1, EN/IEC 60601-1-2, EN/IEC 60601-2-37, IEC 62359).
• Results from preclinical animal testing for safety and function.

8. The Sample Size for the Training Set:

Not applicable, as this device does not involve a machine learning or AI algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established:

Not applicable, as there is no training set for this device.

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