(27 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 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 two-dimensional images. Modifications include the clarification to the indications for use statement and the update of labeling. There are no new indications for use in this modification.
This document is a 510(k) premarket notification for the ACUSON AcuNav Volume Intracardiac Echocardiography Catheter. It seeks to establish substantial equivalence to a previously cleared device (K163478).
Based on the provided text, there are no acceptance criteria, device performance results, or a study explicitly proving the device meets these criteria in the typical sense of a clinical or analytical performance study with specific metrics. The submission focuses on substantial equivalence based on technological characteristics and a clarification of the Indications for Use.
Here's an breakdown of the requested information based on the document:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated as performance metrics like sensitivity, specificity, accuracy, or similar quantitative measures for an AI/device algorithm. Instead, the "acceptance criteria" for this submission appear to be demonstrating substantial equivalence to the predicate device. This is primarily established by showing the new device has the same intended use, technological characteristics, and safety profile as the predicate.
- Reported Device Performance: No specific quantitative performance metrics (e.g., sensitivity, specificity) are reported. The document states that the device has been evaluated for acoustic output, biocompatibility, cleaning and disinfection effectiveness, thermal, electromagnetic, and mechanical safety, and found to conform with applicable medical device safety standards.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable/Not provided. This submission does not describe a clinical test set with human or animal subjects that would require a sample size for performance evaluation. The evaluation is based on non-clinical testing for safety and technological equivalence.
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/Not provided. Since no clinical performance study with a test set is described, there's no mention of experts establishing ground truth for such a set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not provided. No clinical test set requiring adjudication is described.
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
- No. This submission is for an intracardiac echocardiography catheter, which is a diagnostic imaging device, not an AI algorithm intended to assist human readers or perform automated interpretations. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant to this device and was not performed.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- No. This device is not an algorithm that operates in a standalone manner. It is a physical catheter that provides imaging guidance to a clinician.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable/Not provided in the context of a performance study. For the safety and performance evaluations mentioned (acoustic output, biocompatibility, etc.), the "ground truth" would be established by compliance with recognized standards and verified through established testing methodologies.
8. The sample size for the training set
- Not applicable/Not provided. This device does not employ machine learning or AI that would require a training set.
9. How the ground truth for the training set was established
- Not applicable/Not provided. No training set is described.
Summary of the Study:
The submission for the ACUSON AcuNav Volume Intracardiac Echocardiography Catheter relies on demonstrating substantial equivalence to a predicate device (ACUSON AcuNav Volume ICE Catheter, K163478). The key arguments for substantial equivalence are:
- Same Intended Use: The indications for use are the same as the predicate, with only a clarification in wording for this submission. The catheter is for intracardiac and intra-luminal visualization of cardiac and great vessel anatomy and physiology, and visualization of other devices, for imaging guidance during cardiac interventional percutaneous procedures in adult and pediatric patients.
- Same Technological Characteristics: The device shares the same technology, patient contact materials, and principles as the predicate device. It is a 12.5F catheter with 90 cm usable length and four-way steering, providing real-time 3D and 2D ultrasound images.
- Non-Clinical Testing: The device underwent non-clinical testing to ensure safety and compliance with various standards, including:
- Acoustic output (AIUM/NEMA UD-3, UD-2)
- Biocompatibility (ISO 10993-1)
- Cleaning and disinfection effectiveness
- Thermal, electromagnetic, and mechanical safety (UL 60601-1, IEC 60601-2-37, EN/IEC 60601-1, EN/IEC 60601-1-2)
The submission explicitly states: "Because the ACUSON 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 indicates that no new clinical study was performed or required for this 510(k) submission.
§ 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).