Who is the manufacturer of EndoNaut?

Therenva Sas filed the 510(k) submission for EndoNaut (K222070).

What is the FDA product code for EndoNaut?

OWB. It is classified under 21 CFR 892.1650 as a Class 2 device in the Radiology panel.

What is the regulatory pathway for EndoNaut?

510(k) clearance (submission type: Traditional).

Does EndoNaut use AI or machine learning?

Yes. EndoNaut (K222070) is flagged as an AI/ML-enabled medical device in the FDA's AI/ML device list.

Who can help prepare an FDA 510(k) submission like EndoNaut?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Can an AI/ML device like EndoNaut get a guaranteed FDA 510(k) clearance?

Yes. Innolitics offers a guaranteed FDA 510(k) clearance engagement for AI/ML Software as a Medical Device — combining engineering and regulatory execution under one agreement with a guaranteed clearance outcome. Eligibility: the device must be an AI/ML Software as a Medical Device (SaMD), and its performance must meet the criteria Innolitics determines during an initial regulatory strategy engagement to be necessary for FDA clearance. See https://innolitics.com/services/end-to-end-samd/ or contact https://innolitics.com/contact.

EndoNaut

K222070 · Therenva Sas · OWB · Oct 25, 2022 · Radiology

Device Facts

Record ID	K222070
Device Name	EndoNaut
Applicant	Therenva Sas
Product Code	OWB · Radiology
Decision Date	Oct 25, 2022
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 892.1650
Device Class	Class 2
Attributes	AI/ML, Software as a Medical Device

Indications for Use

EndoNaut is an image fusion software solution and computerized navigational system intended to assist X-ray fluoroscopy-guided procedures in the positioning of surgical instruments and endovascular devices. EndoNaut is indicated for use by Physicians for patients undergoing a fluoroscopy X-ray guided procedure in the chest, abdomen, pelvis, neck and lower limbs, such as aneurysm repair, artery/vein embolization, or peripheral artery disease treatment. The information provided by the software or system is in no way intended to substitute for, in whole or in part, the surgeon's judgment and analysis of the patient's condition. It is mandatory to check the real-time anatomy with a suitable imaging technique, such as a contrast-enhanced angiography, before deploying any invasive medical device.

Device Story

EndoNaut is a computerized navigation system assisting X-ray fluoroscopy-guided procedures. It takes DICOM images (pre-operative CT) and live C-Arm video streams as input. The system performs 3D-2D image fusion, overlaying pre-operative 3D vessel anatomy onto live fluoroscopic images to guide surgical instruments and endovascular devices. It features automatic motion detection and registration (automatic/manual initialization with manual validation). Used in clinical settings (e.g., OR) by physicians. The system includes a workstation and software (standalone or server-client architecture). Output is visual guidance displayed to the surgeon to assist in positioning devices. It does not substitute for surgeon judgment; real-time anatomy verification via contrast-enhanced angiography is mandatory before device deployment.

Clinical Evidence

No clinical studies were required to support substantial equivalence. Evidence consists of bench testing, including verification and validation of software architecture, interoperability, electrical safety, EMC, and usability. Performance was validated against the predicate device.

Technological Characteristics

Software-based navigation system; runs on Windows 10 64-bit. Hardware includes a fanless 27" LCD Panel PC (1920x1080) and 15.6" touch secondary display. Connectivity via Ethernet/USB. Complies with IEC 60601-1, IEC 60601-1-6, IEC 60601-2, and ISO 14971. Software lifecycle follows IEC 62304 (Class B).

Indications for Use

Indicated for patients undergoing fluoroscopy X-ray guided procedures in the chest, abdomen, pelvis, neck, and lower limbs (e.g., aneurysm repair, embolization, peripheral artery disease treatment). For use by physicians.

Regulatory Classification

Identification

An image-intensified fluoroscopic x-ray system is a device intended to visualize anatomical structures by converting a pattern of x-radiation into a visible image through electronic amplification. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

Special Controls

*Classification.* Class II (special controls). An anthrogram tray or radiology dental tray intended for use with an image-intensified fluoroscopic x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9. In addition, when intended as an accessory to the device described in paragraph (a) of this section, the fluoroscopic compression device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.

Predicate Devices

EndoNaut (K212383)

Reference Devices

EndoSize (K160376)

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. October 25, 2022 Therenva SAS % Cemil Goksu CEO 74F rue de Paris Rennes, 35000 FRANCE Re: K222070 Trade/Device Name: EndoNaut Regulation Number: 21 CFR 892.1650 Regulation Name: Image-Intensified Fluoroscopic X-Ray System Regulatory Class: Class II Product Code: OWB, LLZ Dated: September 23, 2022 Received: September 23, 2022 Dear Cemil Goksu: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's {1}------------------------------------------------ requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, Laurel Burk, Ph.D. Assistant Director Diagnostic X-Ray Systems Team DHT8B: Division of Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ #### Indications for Use 510(k) Number (if known) K222070 Device Name EndoNaut #### Indications for Use (Describe) EndoNaut is an image fusion software solution and computerized navigational system intended to assist X-ray fluoroscopy-guided procedures in the positioning of surgical instruments and endovascular devices. EndoNaut is indicated for use by Physicians for patients undergoing a fluoroscopy X-ray guided procedure in the chest, abdomen, pelvis, neck and lower limbs, such as aneurysm repair, artery/vein embolization, or peripheral artery disease treatment. The information provided by the software or system is in no way intended to substitute for, in whole or in part, the surgeon's judgment and analysis of the patient's condition. It is mandatory to check the real-time anatomy with a suitable imaging technique, such as a contrast-enhanced angiography, before deploying any invasive medical device. | Type of Use (Select one or both, as applicable) | | |-----------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------| | <div> Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> Over-The-Counter Use (21 CFR 801 Subpart C) </div> | #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ Image /page/3/Picture/1 description: The image shows the logo for Therenva. The logo consists of a teal sail-like shape that is connected to a gray circle. To the right of the logo is the word "Therenva" in gray, and below that is the phrase "Share medical innovation" in a smaller font. # EndoNaut Traditional 510(K) Summary ## 1. Submitter information | Manufacturer Name: | Therenva SAS 74F, rue de Paris 35000 Rennes France | |--------------------------------|-------------------------------------------------------------------------------------------------------| | Contact Person: | Mrs Audrey Gallois, QA & RA Leader Phone: +33 6 86 95 44 39 E-mail: audrey.gallois@therenva.com | | Establishment Registration Nº: | 3011240766 | | Date prepared: | 25/10/2022 | {4}------------------------------------------------ Image /page/4/Picture/1 description: The image shows the logo for Therenva. The logo consists of a teal and gray abstract shape on the left, followed by the word "Therenva" in gray. Below the word "Therenva" is the phrase "Share medical innovation" in a smaller, gray font. The logo is simple and modern, and the colors are calming and professional. 2. Device Identification Therenva SAS 74F rue de Paris 35000 Rennes, France Tel: +33 9 72 52 29 20 | Trade Name: | EndoNaut | |----------------------------|----------------------------------------------------------------------------------------------------------------------------| | Regulation Name: | Interventional Fluoroscopic X-ray System | | Regulatory Class: | Class II | | Product Code: | OWB (Interventional Fluoroscopic X-ray System)(Primary) LLZ (System, Image Processing, Radiological)(Secondary) | | Classification Regulation: | 21 CFR 892.1650 and 21 CFR 892.2050 | | Classification Panel: | Radiology | | Accessories: | 1. Workstation for navigation tools ("EndoNaut Workstation") 2. EndoSize Software 3. EndoNaut Server Main Display SW | #### 3. Predicate device and accessories | Predicate medical device name | Manufacturer | 510K number | |----------------------------------|--------------|-------------| | EndoNaut | Therenva | K212383 | | Predicate accessory name | Manufacturer | 510K number | |--------------------------------------------|--------------|-------------------------------------------------------------| | EndoNaut workstation Model: TS1CA2DS1-2 | Therenva | referred to in K212383 510(k) submission | | EndoSize | Therenva | K160376 also referred to in K212383 510(k) submission | | EndoNaut Server Main Display SW | Therenva | No prior 510(k) clearance | {5}------------------------------------------------ Image /page/5/Picture/1 description: The image shows the logo for Therenva. The logo consists of a teal-colored, curved shape on the left, followed by a gray circle. The word "Therenva" is written in gray, and below it, the phrase "Share medical innovation" is written in a smaller font, also in gray. The logo appears to be for a medical company. ## 4. Description of the device EndoNaut is a computerized navigation system consisting of a software part that carries the medical features and technologies that are controlled and can be installed on a hardware part that enables the medical device to be used in accordance with its intended purpose. EndoNaut is intended to assist X-ray fluoroscopy-guided procedures in the positioning of surgical instruments and endovascular devices. EndoNaut Software parts are supported by hardware and software accessories which enable image display and an interaction with the user. The Software part is interoperable with EndoSize which is a standalone Software designed and developed by Therenva to enable case planning strategy and device (endoprosthesis) selection be-fore endovascular procedure. EndoSize is used by practitioners (in the preparation phase of the operating procedure) or by endoprosthesis manufacturers to visualize vascular structures and/or carry out an extract of the vascular structure from the preoperative CT scan. EndoSize is medical device software which obtained a substantial equivalence determination and FDA clearance through the CDRH premarket notification process (510(K)) (NºK160376). #### 5. Indications for use EndoNaut is an image fusion software solution and computerized navigational system intended to assist X-ray fluoroscopy-guided procedures in the positioning of surgical instruments and endovascular devices. EndoNaut is indicated for use by Physicians for patients undergoing a fluoroscopy X-ray guided procedure in the chest, abdomen, pelvis, neck and lower limbs, such as aneurysm reparr, artery/vein embolization, or peripheral artery disease treatment. The information provided by the software or system is in no way intended to substitute for, in whole or in part, the surgeon's judgment and analysis of the patient's condition. It is mandatory to check the real-time anatomy with a suitable imaging technique, such as a contrastenhanced angiography, before deploying any invasive medical device. {6}------------------------------------------------ Image /page/6/Picture/1 description: The image shows the logo for Therenva. The logo consists of a stylized teal-colored shape that resembles a sail or a leaf, connected to a gray circle. To the right of the logo is the word "Therenva" in gray, with the tagline "Share medical innovation" in a smaller font below it, also in gray. The logo appears to be for a medical company. ### 6. Comparison to the cleared (legacy) device and substantial equivalent discussion | Medical Device Software Name | EndoNaut (Predicate Device) K212383 | EndoNaut (Subject Device) | Comparable Properties an Substantial Equivalence Discussion | |---------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | System Trade (and Com- mon) Name | EndoNaut System | EndoNaut System | Identical Two new system configura- tions have been added (MHS and FHS). The tests carried out and the risk analyses did not reveal any particular risk and validated the safety and performance of the systems. | | Medical Device Software Trade Name | EndoNaut | EndoNaut SW | Similar Because a new variant of En- doNaut Software is intro- duced, we introduce a new naming convention to avoid confusion between Endo- Naut (Standalone) SW and EndoNaut (Server) SW. The naming convention is detailed in Section 6 (Endo- Naut System Device De- scription). No risk related to identifica- tion between the two soft- ware variants. | | Manufacturer | Therenva SAS | Therenva SAS | Identical | | Accessory 1 | EndoNaut Workstation | EndoNaut Workstation | Minor change See below "Workstation cart" | | Accessory 2 | EndoSize Software (K160376) | EndoSize Software (K160376) | Identical Therefore, substantially equivalent. | | Accessory 3 | EndoNaut Workstation Main Display | EndoNaut Server Main Dis- play | New | | Identification and traceabil- ity (UDI) | EndoNaut (system): 3760262480046 | EndoNaut (system) (Variant 1 = EndoNaut SW + Endo- Naut Workstation): 3760262480046 | Similar No risk related to identifica- tion between EndoNaut medical device software/sys- tem because different UDI- DIs are allocated. | | | EndoNaut SW (Standalone): 3760262480022 | EndoNaut System MHS: 3760262480084 | No risk related to identifica- tion of EndoNaut System because different UDI-DIs are allocated. | | | | EndoNaut System FHS: 3760262480077 | | | | | EndoNaut (Standalone)SW: | | | Medical Device Software Name | EndoNaut (Predicate Device) K212383 | EndoNaut (Subject Device) | Comparable Properties an Substantial Equivalence Discussion | | | EndoNaut Workstation TS1CA2DS1-2: 3760262480039 | 3760262480022 EndoNaut (Server) SW: 3760262480053 EndoNaut Workstation TS1CA2DS1-2: 3760262480039 EndoNaut Server Main Dis- play SW: 3760262480091 | New UDI-DI allocated to EndoNaut SW medical de- vice software variant, Endo- Naut Server and its new ac- cessory EndoNaut Server Main Display See also "Labelling" here af- ter. | | Software versioning | 2-level versioning Version x.y | 3-level versioning Version x.y.z | Similar Adoption of a more tradi- tional versioning system more commonly applied by software publishers to Endo- Naut (Server) SW and Endo- Naut Server Main Display SW. This change did not raise any particular risk nor questions of safety and effectiveness. | | Product Code | OWB | OWB (Primary product code), LLZ (Secondary product code) | Similar OWB is used as Primary product code in reference to our original predicates but in no case does EndoNaut pro- duce x-rays. LLZ product code is much more relevant. | | Regulation Number | 892.1650 | 892.1650 892.2050 | Similar Secondary code added. | | Regulation Names | Interventional Fluoroscopic X-Ray System | Interventional Fluoroscopic X-Ray System Medical Image Management and Processing System | Similar Regulation name of second- ary code added which is more adequate for our ad- vanced medical imaging de- vice. | | Software Safety class (62304) | B | B | Identical Therefore, substantially equivalent. | | Level of concern | Moderate | Moderate | Identical Therefore, substantially equivalent. | | Intended use | EndoNaut provides image guidance by overlaying pre- operative 3D vessel anatomy onto live fluoroscopic im- ages in order to assist in the | EndoNaut is an image fusion software solution and com- puterized navigational sys- tem intended to assist X-ray fluoroscopy guided | Similar Minor rewording of the In- tended Use has been made to facilitate the understanding by the users and recipients of | | Medical Device Software Name | EndoNaut (Predicate Device) K212383 | EndoNaut (Subject Device) | Comparable Properties an Substantial Equivalence Discussion | | | positioning of the guide- wires, catheters and other endovascular devices. | procedures in the positioning of surgical instruments and endovascular devices. | the information but also to make the "imaging input data" consistent with the "in- dications for use". The general purpose of the device and its function re- main unchanged. The minor rewording of the Intended Use does not raise different questions of safety and ef- fectiveness. | | Indications for use | EndoNaut is indicated for the treatment of patients with endovascular diseases and who needs for example (without this list being re- strictive): endovascular aortic an- eurysm repair (AAA and TAA), angioplasty, stenting, embolization in iliac ar- teries and correspond- ing veins. EndoNaut is indicated for endovascular procedures in the thorax, abdomen, pelvis and lower limbs. | EndoNaut is an image fusion software solution and com- puterized navigational sys- tem intended to assist X-ray fluoroscopy-guided proce- dures in the positioning of surgical instruments and endovascular devices. EndoNaut is indicated for use by Physicians for pa- tients undergoing a fluoros- copy X-ray guided proce- dure in the chest, abdomen, pelvis, neck and lower limbs, such as aneurysm repair, ar- tery/vein embolization, or peripheral artery disease treatment. The information provided by the software or system is in no way intended to substitute for, in whole or in part, the surgeon's judgment and analysis of the patient's con- dition. It is mandatory to check the real-time anatomy with a suitable imaging technique, such as a contrast-enhanced angiography, before deploy- ing any invasive medical de- vice. | Similar Without being a X-ray de- vice itself, as a matter of principle, EndoNaut works with fluoroscopic images to produce image fusion. The clear reference to X-ray guided procedures aims at providing more transpar- ency. Conditions and anatomical locations are the same, just written in a slightly different way. | | Medical Device Software Name | EndoNaut (Predicate Device) K212383 | EndoNaut (Subject Device) | Comparable Properties an Substantial Equivalence Discussion | | Labelling | 1 label in the "about" section for the Medical Device Soft- ware with the Trade Name "EndoNaut Software". + 1 label on the workstation with the Trade Name "Endo- Naut" (for the whole Sys- tem) and Workstation model Number = TS1CA2DS1-2 + unique Serial (production) Number (for the whole Sys- tem) | For EndoNaut System: 1 label in the "about" section for the Medical Device Soft- ware with the Trade Name "EndoNaut Software". + 1 label on the workstation with the Trade Name "Endo- Naut" (for the whole Sys- tem) and Workstation model Number = TS1CA2DS1-2 + unique Serial (production) Number (for the whole Sys- tem) For EndoNaut Server: 1 label in the "about" section for the Medical Device Soft- ware server with the Trade Name "EndoNaut Server". | Identical (EndoNaut Soft- ware and EndoNaut Work- station) New The label on the new Soft- ware variant follows the same rule as for EndoNaut Software. As EndoNaut Server has no user interface, if it is inte- grated into a System, it willkeep its own labelling and the labelling of the System will be indicated on another component of the System (a client for example). This will be done under the responsi- bility of the integrator. | | Directions for use (User Guide(s)) | 1 User Guide for EndoNaut Software 1 User Guide for EndoNaut Workstation + 1 addendum for informing about the conditions govern- ing the marketing of Endo- Naut. | For EndoNaut System: 1 User Guide for EndoNaut Software 1 User Guide for EndoNaut Workstation + 1 addendum for informing about the conditions govern- ing the marketing of Endo- Naut System. For EndoNaut System composed of EndoNaut (Server) SW: Integration manual, Com- munication Protocol and Developer Documentation. | Slight changes to EndoNaut Standalone SW IFU only following minor SW release. No change to EndoNaut Workstation IFU. New EndoNaut Server will be provided with an integration manual and Communication Protocol. EndoNaut Server Main Dis- play SW will be provided with an integration manual and Developer Documenta- tion. | | Input data | DICOM Images EndoNaut archive produced with Therenva EndoSize Planning Software. C-Arm video stream | DICOM Images EndoNaut archive produced with Therenva EndoSize Planning Software. C-Arm video stream | Similar No new input data. No new features. Only the minimum hardware and software requirements differ slightly due to the | | Medical Device Software Name | EndoNaut (Predicate Device) K212383 | EndoNaut (Subject Device) | Comparable Properties an Substantial Equivalence Discussion | | | Minimum HW and SW re- quirements Clinical and performance re- quirements (display of fu- sion data, measurements, motion detection, data re- fresh, interoperability) | Minimum HW and SW re- quirements Clinical and performance re- quirements (display of fu- sion data, measurements, motion detection, data re- fresh, interoperability) | different deployment config- urations. The hardware compatibility evaluation was carried out during the design validation of EndoNaut. The require- ments for hardware were also assessed during the clin- ical protocol by collecting d…

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