(249 days)
The NuVision 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 of adult and pediativ patients. The catheter is intended for imaging guidance only, not treatment delivery, during cardiac interventional percutaneous procedures.
The NuVision ICE Catheter is a diagnostic ultrasound imaging catheter designed for intracardiac use. The catheter can be advanced, retracted and rotated within the anatomy. The catheter is comprised of a 10 Fr outer shaft capable of being rotated and deflected, which houses an ultrasound transducer. The outer shaft rotation is driven directly from a probe knob on the handle, while a deflection knob on the handle drives the deflection by controlling a deflectable inner shaft situated within the outer shaft.
The imaging ultrasound transducer is a 2D piezo-electric array capable of real-time 3D imaging. The imaging field emanates perpendicular to the axis of one side of the imaging tip, also referred to as a probe. The tip movement, in combination with deflection of the distal catheter, provide the user with the ability to adjust the orientation of the imaging tip to visualize the target anatomy.
An electrical connector proximal to the handle allows connection to the NuVision Connector Cable which also connects to an ultrasound cardiac imaging console. Printed circuit boards within the catheter system's electrical connectors help with signal distribution and conditioning. The NuVision ICE Catheter System relies on power from the ultrasound cardiac imaging console to function.
The NuVision ICE Catheter is used with a compatible ultrasound cardiac imaging system with software cleared for market in accordance with 21 CFR 807.81(a)(3).
This FDA 510(k) summary for the NuVision ICE Catheter describes extensive non-clinical testing to demonstrate substantial equivalence to a predicate device. However, it explicitly states that no clinical performance data was included in the submission. Therefore, the device's performance in terms of clinical accuracy or diagnostic capability is not evaluated in this document through human reader studies or comparison to clinical ground truth.
Here's an analysis of the provided information concerning acceptance criteria and studies:
1. Table of Acceptance Criteria and Reported Device Performance
Because this submission relies on non-clinical testing for substantial equivalence, the "acceptance criteria" are primarily engineering and safety specifications, and "device performance" refers to its ability to meet those non-clinical specifications.
| Acceptance Criteria (Category) | Specific Test/Standard | Reported Device Performance |
|---|---|---|
| Dimensional and Performance | Conformance to EN ISO 10555-1:2013 | Evaluated for conformance to design specifications |
| Visual and Dimensional Characteristics | Evaluated (Implied conformance) | |
| Simulated Use (Package opening, sterile field transfer, sleeve loading) | Evaluated (Implied functionality as intended) | |
| Catheter Functional Performance (Reach, Deflection, Rotation, Radiopacity) | Evaluated (Implied functionality as intended) | |
| Electro-Acoustic Performance | Evaluated (Implied functionality as intended) | |
| Durability (Multiple insertions, Rotation/Deflection Cycling, Tip Kinking/Buckling, Leakage, Particulate generation, Tensile strength) | Evaluated (Implied durability and integrity) | |
| Sterilization and Shelf Life | ISO 11135-1:2014 (SAL of 10^-6^) | Sterilized via Ethylene Oxide, cycle validated to SAL 10^-6^ |
| Packaging performance (ISO 11607-1, ISO 11607-2) | Evaluated for integrity through product lifecycle | |
| Biocompatibility | EN ISO 10993 series standards (Externally Communicating Device, Circulating Blood category) | Evaluated for biocompatibility |
| Electromagnetic Compatibility & Electrical Safety | FDA Guidance for Diagnostic Ultrasound Systems, EN 60601-2-37, IEC 60601-1, IEC 60601-2-37, IEC 60601-1-2 (4th Edition) | Evaluated for compliance to relevant standards and guidance |
| Temperature Sensor Functionality | Probe never reaches temperature limit of 43°C | Thermistor incorporated, ultrasound system adjusts power to assure limit is not reached |
2. Sample size used for the test set and the data provenance
- Test Set Sample Size: Not explicitly stated in terms of a specific number of devices. The document mentions "Product samples" were subjected to testing. This typically refers to a statistically significant number of units from production lots as required by quality systems for verification and validation, but the exact number isn't provided here.
- Data Provenance: The data is from non-clinical bench-top evaluations, animal testing, packaging validation, biological safety, electrical safety, and acoustic output testing conducted by the manufacturer, NuVera Medical, Inc. Animal testing is mentioned across multiple instances (page 5, 9). The document does not provide details on the number or type of animals used, nor their country of origin.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Ground Truth Experts: Not applicable in the context of this submission. Since no clinical performance data was provided, no human experts (e.g., radiologists, cardiologists) were used to establish ground truth for a clinical test set. The validation relies on expert engineering and quality assurance personnel performing and verifying non-clinical tests according to established standards.
4. Adjudication method for the test set
- Adjudication Method: Not applicable. There was no clinical test set requiring expert adjudication of results.
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
- MRMC Study: No. This submission does not involve AI or a comparative effectiveness study with human readers. The device is an Intracardiac Echocardiography (ICE) Catheter, a hardware device for imaging, not an AI-powered diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not applicable. The device is a hardware imaging catheter, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Type of Ground Truth: For the non-clinical tests, the "ground truth" refers to the established engineering specifications, performance standards (e.g., ISO, IEC, NEMA), and direct measurements/observations during bench testing and animal studies. For example, for durability, the "ground truth" would be the device enduring a certain number of cycles without failure, as per its design specifications. For biocompatibility, it's compliance with ISO 10993 standards.
8. The sample size for the training set
- Training Set Sample Size: Not applicable. This is a hardware device submission, not a machine learning algorithm.
9. How the ground truth for the training set was established
- Training Set Ground Truth Establishment: Not applicable.
§ 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).