EndoNaut
by Therenva Sas France 510(k)
510(k) K212383
Product code OWB
Overview
The EndoNaut is an Interventional Fluoroscopic X-Ray System designed for intraoperative navigation in endovascular procedures. It integrates AI-based image fusion technology to enhance real-time visualization of anatomical structures, improving precision during interventions.
This system is used in radiology settings for minimally invasive endovascular surgeries, supporting vascular surgeons and interventional cardiologists. Supplied as a reusable medical device, it requires appropriate sterilization and maintenance protocols. The EndoNaut holds FDA 510K clearance under classification II and regulatory number 892.1650, with multiple registration numbers listed under the OWB product code.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK212383 | Date31 Aug 2021 | StatusActive |
Coverage
- Active
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- OWB
- Device Class
- Class II
- Regulation
- 21 CFR Part 892.1650
- Advisory Committee
- Radiology
- FDA Decision
- SESE Substantially Equivalent
Other devices from Therenva Sas
Questions
What types of procedures is the EndoNaut designed to assist with during surgery?
The EndoNaut is specifically designed for intraoperative navigation in endovascular procedures, such as minimally invasive surgeries involving blood vessels. Its AI-based image fusion technology enhances real-time visualization of anatomical structures, which is particularly useful for vascular surgeons and interventional cardiologists performing complex interventions like stent placements, vascular repairs, or aneurysm treatments.
Is the EndoNaut a single-use or reusable device, and what maintenance is required?
The EndoNaut is a reusable medical device, meaning it is intended for repeated use in clinical settings. Since it is reusable, it must undergo appropriate sterilization and maintenance protocols to ensure safety and functionality between procedures. The manufacturer, Therenva SAS, would provide guidelines for cleaning, disinfection, and upkeep.
How is the EndoNaut regulated in the U.S., and what does its classification mean for clinicians?
The EndoNaut holds FDA 510K clearance under classification II, which means it is deemed substantially equivalent to a legally marketed device already on the market. This classification indicates it has undergone rigorous review by the FDA’s Radiology Advisory Committee (RA) to ensure safety and effectiveness for its intended use in intraoperative fluoroscopic imaging. Clinicians can rely on this clearance as evidence of regulatory scrutiny.
Are there different models or sizes available for the EndoNaut, and if so, how would I determine the right fit for my procedures?
The provided data does not specify distinct models or sizes for the EndoNaut, as it is described as a single interventional fluoroscopic system. However, its AI-based image fusion technology is likely designed to adapt to various endovascular procedures, offering flexibility for different anatomical challenges. For specific configuration needs, consulting the manufacturer’s technical documentation or a sales representative would be advisable to ensure compatibility with your clinical workflow.
What settings or environments is the EndoNaut intended for, and does it require specialized infrastructure?
The EndoNaut is designed for use in radiology settings, specifically within operating rooms or interventional suites where fluoroscopic imaging is standard. Since it is an interventional fluoroscopic X-ray system, it requires integration with existing imaging infrastructure, such as C-arm systems, and may need compatible software or hardware for AI-based image fusion. Clinicians should confirm compatibility with their facility’s existing equipment before implementation.
Properties & raw data
Show properties, registry sources and raw records
Sources (1)
- FDA 510(k) K212383