(131 days)
For use directly within the vasculature and/or the right heart for intravascular or intracardiac ultrasound imaging. The device is specifically indicated for use in visualization of vascular anatomy, cardiac and great vessel anatomy and physiology, or other devices in the heart, as well as measurement of blood flow. The company anticipates that the device will be used for a variety of intravascular and intracardiac imaging applications, consistent with its intended use, including vascular stent placement, monitoring left ventricular function post-surgery; identifying congenital abnormalities before therapeutic procedures; visualizing the relative orientation of diagnostic and therapeutic catheters; and visualizing procedures such as transseptal insertions of other catheters, valvuloplasties, balloon septostomies, septal defect closures, and pacemaker or defibrillator lead insertion or extraction.
The AcuNav™ Diagnostic Ultrasound Catheter is intended for intra-cardiac and intra-luminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart. The AcuNav™ is intended for use in right heart only.
The AcuNav is an ultrasound-tipped catheter device which is used directly within the vasculature and/or the right heart for intravascular or intracardiac ultrasound imaging. The AcuNav incorporates a single-use, disposable ultrasonic phased-array imaging transducer, which must be used in conjunction with an Acuson ultrasound imaging platform to generate the acoustic waves and process the information for display to the physician. The catheter is 10 French in diameter and 90 cm in insertable length. The distal portion of the catheter can be deflected in four directions in two orthogonal planes: left-right (in a plane perpendicular to the image plane) and anterior-posterior (in a plane coincident with the image plane). The distal end of the catheter contains the transducer, which is oriented to provide a two-dimensional (90 degree vector) image in a plane parallel to the axis of the catheter. The transducer offers all imaging modes at frequencies between 4.0 and 10.0 MHz.
This 510(k) summary for the AcuNav™ Diagnostic Ultrasound Catheter does not contain specific acceptance criteria or an explicit study that proves the device meets such criteria in a quantitative manner. The document focuses on establishing substantial equivalence to predicate devices rather than providing detailed performance metrics against predefined acceptance criteria.
However, based on the provided text, we can infer the overarching "acceptance criterion" to be Substantial Equivalence to the identified predicate devices, meaning the device performs equivalently in terms of safety and effectiveness. The study supporting this is described as performance testing, animal testing, and human clinical testing.
Below is an attempt to structure the information, acknowledging the limitations of the provided text in terms of detailed, quantitative acceptance criteria and study specifics.
Acceptance Criteria and Device Performance
The core acceptance criterion for this 510(k) submission is the demonstration of substantial equivalence to predicate devices. This implies that the device's technological characteristics and performance do not raise new questions of safety or effectiveness. The reported "performance" is implicitly deemed equivalent to the predicate devices through the testing conducted.
| Acceptance Criterion (Inferred from 510(k) process) | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate Devices | Confirmed by performance testing, animal testing, and human clinical testing. The device has the same intended use and very similar principles of operation and technological characteristics as the predicate devices. Minor technological differences (acoustic parameters, transducer configuration, imaging format, steering mechanism, materials, sterilization methods) do not raise new questions of safety or effectiveness. |
| Biocompatibility | Demonstrated to be biocompatible. |
| Non-pyrogenicity | Demonstrated to be non-pyrogenic. |
Study Information
Due to the nature of a 510(k) summary, detailed study parameters are not typically included. The document refers generally to "performance testing, animal testing, and human clinical testing" to support substantial equivalence. Specifics on each of these are absent.
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Sample size used for the test set and the data provenance: Not specified in the provided text. The document mentions "human clinical testing" but does not provide details on the number of subjects or the geographical origin of the data (e.g., country of origin, retrospective or prospective nature).
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not specified in the provided text.
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Adjudication method for the test set: Not specified in the provided text.
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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-powered diagnostic tool. The concept of "human readers improve with AI vs without AI assistance" does not apply to this type of medical device submission.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This device is an ultrasound catheter requiring human operation and interpretation; it is not an algorithm-only standalone diagnostic tool.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not explicitly stated. For "human clinical testing," the ground truth would typically come from a combination of clinical assessments, other imaging modalities, and potentially pathology or procedural outcomes, but this is not detailed. For "performance testing" and "animal testing," the ground truth would be based on controlled experimental conditions and established biological models.
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The sample size for the training set: Not applicable. This device is an ultrasound catheter, not a machine learning or AI model that requires a "training set" in the conventional sense.
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How the ground truth for the training set was established: Not applicable, as it's not an AI/ML device.
§ 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).