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 Description

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).

AI/ML Overview

The provided text is a 510(k) Summary for the medical device EndoNaut. It details the device, its intended use, and a comparison to a predicate device to establish substantial equivalence. However, it does not contain information about a specific study proving the device meets acceptance criteria related to its performance in terms of AI model accuracy, such as sensitivity, specificity, or reader study outcomes.

The document primarily focuses on demonstrating that the new version of EndoNaut (Subject Device) has similar intended use, functionalities, and safety/effectiveness profiles as its previously cleared predicate device (Predicate Device [K212383](https://510k.innolitics.com/search/K212383)), despite some architectural changes (e.g., from standalone software to a server/client model). It emphasizes design verification and validation activities rather than clinical performance studies for AI accuracy.

Here's a breakdown of why the requested information cannot be fully extracted and what can be inferred:

Unable to provide a table of acceptance criteria and reported device performance related to AI model accuracy. The document states:

"The subject of this premarket submission did not require clinical studies to support equivalence." (Page 17)
It mentions "Verification and validation activities have demonstrated that the EndoNaut (Server) software variant performs equally as the EndoNaut (Standalone) predicate software by providing reliable results, without functional regression and moreover, offers robust safety/security mechanisms." (Page 18)
It refers to "Features which call machine-learning algorithms: Registration 3D/2D Motion detection Contrast injection detection" (Page 6). It states that "[t]he algorithms have not been changed. Only the way they are implemented is different... These implementation changes do not change the purpose of the algorithms (they do what they did before)." (Page 6)

This implies that the "performance" validated was primarily related to the continued functionality and safety of the existing algorithms within the new architecture, rather than a re-evaluation of their diagnostic accuracy or impact on human performance in a clinical setting. Thus, there are no specific accuracy metrics (e.g., sensitivity, specificity, AUC) or reader study results reported for the device in this document.

Based on the provided text, the following information is either explicitly stated, can be inferred, or is explicitly absent:

A table of acceptance criteria and the reported device performance:
- Acceptance Criteria for AI Performance (e.g., sensitivity, specificity): Not provided in the document. The submission focuses on substantial equivalence to a predicate device and verification of existing algorithms within a new architecture, rather than establishing new performance benchmarks for AI accuracy.
- Reported Device Performance: No quantitative performance metrics (e.g., sensitivity, specificity, accuracy, AUC) related to the AI algorithms' diagnostic capabilities are reported. The performance discussion centers on "functional regression" checks and demonstrating "reliable results" and "robust safety/security mechanisms" for the software change (Page 18).
Sample size used for the test set and the data provenance: Not specified in the context of AI performance evaluation. The document mentions "Simulated use testing (Validation)" (Page 18) but does not detail the dataset used, its size, or provenance.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not specified. As no clinical studies or specific accuracy evaluations are detailed, the ground truth establishment for such performance metrics is not discussed.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not specified.
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 done/reported. The document explicitly states: "The subject of this premarket submission did not require clinical studies to support equivalence." (Page 17).
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not explicitly detailed with performance metrics. The document confirms the presence of machine learning algorithms for "Registration 3D/2D, Motion detection, Contrast injection detection" and states that "The algorithms have not been changed. Only the way they are implemented is different... These implementation changes do not change the purpose of the algorithms (they do what they did before)." (Page 6). This suggests that the algorithms themselves were part of the predicate device and their function was maintained, but a formal standalone performance study for this specific submission is not presented. The verification activities might have included internal functional testing of these algorithms.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not specified regarding the AI features. For the general functionality, the "ground truth" would be the expected behavior and output based on design specifications and the predicate device's performance.
The sample size for the training set: Not specified. The document states that the machine learning algorithms "have not been changed" from the predicate device (Page 6), implying that any training would have occurred for the predicate device, but details are not provided here.
How the ground truth for the training set was established: Not specified.

Summary based on the document:

This 510(k) submission for EndoNaut (K222070) is primarily concerned with demonstrating substantial equivalence to a previously cleared predicate device (EndoNaut K212383) following changes in software architecture and minor hardware updates. It relies on:

Design verification and validation (V&V) activities: These include risk assessments, usability reviews, requirement reviews, design reviews, clinical evaluation report reviews, testing on unit level, integration testing, interoperability testing, performance testing, safety testing, and simulated use testing (Page 18).
No new clinical studies: The submission explicitly states that clinical studies were not required to support equivalence (Page 17).
Consistency of AI algorithms: The document clarifies that the underlying machine learning algorithms for features like 3D/2D registration, motion detection, and contrast injection detection have not been changed but their implementation differs due to the new software architecture. The validation activities focused on ensuring these algorithms perform "equally as the EndoNaut (Standalone) predicate software" (Page 18) without "functional regression" and maintaining safety and security.

Therefore, the document does not provide the detailed acceptance criteria or performance study results typically associated with AI model accuracy (e.g., sensitivity, specificity, reader studies) for a new AI function or a significant modification that would necessitate re-evaluation of diagnostic performance. Instead, it attests to the maintained functionality and safety of existing features within an updated system.

Summary

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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

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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

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Indications for Use

510(k) Number (if known) K222070

Device Name EndoNaut

Indications for Use (Describe)

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)
Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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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 SAS74F, rue de Paris35000 RennesFrance
Contact Person:	Mrs Audrey Gallois, QA & RA LeaderPhone: +33 6 86 95 44 39E-mail: audrey.gallois@therenva.com
Establishment Registration Nº:	3011240766
Date prepared:	25/10/2022

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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.

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 Software3. EndoNaut Server Main Display SW

3. Predicate device and accessories

Predicate medicaldevice name	Manufacturer	510K number
EndoNaut	Therenva	K212383

Predicate accessory name	Manufacturer	510K number
EndoNaut workstationModel: TS1CA2DS1-2	Therenva	referred to in K212383 510(k)submission
EndoSize	Therenva	K160376also referred to in K212383510(k) submission
EndoNaut Server MainDisplay SW	Therenva	No prior 510(k) clearance

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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 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.

5. Indications for use

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.

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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 SoftwareName	EndoNaut(Predicate Device)K212383	EndoNaut(Subject Device)	Comparable Properties anSubstantialEquivalence Discussion
System Trade (and Com-mon) Name	EndoNaut System	EndoNaut System	IdenticalTwo new system configura-tions have been added (MHSand FHS). The tests carriedout and the risk analyses didnot reveal any particular riskand validated the safety andperformance of the systems.
Medical Device SoftwareTrade Name	EndoNaut	EndoNaut SW	SimilarBecause a new variant of En-doNaut Software is intro-duced, we introduce a newnaming convention to avoidconfusion between Endo-Naut (Standalone) SW andEndoNaut (Server) SW.The naming convention isdetailed 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 changeSee below "Workstationcart"
Accessory 2	EndoSize Software(K160376)	EndoSize Software(K160376)	IdenticalTherefore, substantiallyequivalent.
Accessory 3	EndoNaut WorkstationMain Display	EndoNaut Server Main Dis-play	New
Identification and traceabil-ity (UDI)	EndoNaut (system):3760262480046	EndoNaut (system) (Variant1 = EndoNaut SW + Endo-Naut Workstation):3760262480046	SimilarNo risk related to identifica-tion between EndoNautmedical 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 Systembecause different UDI-DIsare allocated.
		EndoNaut System FHS:3760262480077
		EndoNaut (Standalone)SW:
Medical Device SoftwareName	EndoNaut(Predicate Device)K212383	EndoNaut(Subject Device)	Comparable Properties anSubstantialEquivalence Discussion
	EndoNaut WorkstationTS1CA2DS1-2:3760262480039	3760262480022EndoNaut (Server) SW:3760262480053EndoNaut WorkstationTS1CA2DS1-2:3760262480039EndoNaut Server Main Dis-play SW: 3760262480091	New UDI-DI allocated toEndoNaut SW medical de-vice software variant, Endo-Naut Server and its new ac-cessory EndoNaut ServerMain DisplaySee also "Labelling" here af-ter.
Software versioning	2-level versioningVersion x.y	3-level versioningVersion x.y.z	SimilarAdoption of a more tradi-tional versioning systemmore commonly applied bysoftware publishers to Endo-Naut (Server) SW and Endo-Naut Server Main DisplaySW.This change did not raise anyparticular risk nor questionsof safety and effectiveness.
Product Code	OWB	OWB (Primary productcode), LLZ (Secondaryproduct code)	SimilarOWB is used as Primaryproduct code in reference toour original predicates but inno case does EndoNaut pro-duce x-rays. LLZ productcode is much more relevant.
Regulation Number	892.1650	892.1650892.2050	SimilarSecondary code added.
Regulation Names	Interventional FluoroscopicX-Ray System	Interventional FluoroscopicX-Ray SystemMedical Image Managementand Processing System	SimilarRegulation name of second-ary code added which ismore adequate for our ad-vanced medical imaging de-vice.
Software Safety class (62304)	B	B	IdenticalTherefore,substantiallyequivalent.
Level of concern	Moderate	Moderate	IdenticalTherefore,substantiallyequivalent.
Intended use	EndoNaut provides imageguidance by overlaying pre-operative 3D vessel anatomyonto live fluoroscopic im-ages in order to assist in the	EndoNaut is an image fusionsoftware solution and com-puterized navigational sys-tem intended to assist X-rayfluoroscopy guided	SimilarMinor rewording of the In-tended Use has been made tofacilitate the understandingby the users and recipients of
Medical Device SoftwareName	EndoNaut(Predicate Device)K212383	EndoNaut(Subject Device)	Comparable Properties anSubstantialEquivalence Discussion
	positioning of the guide-wires, catheters and otherendovascular devices.	procedures in the positioningof surgical instruments andendovascular devices.	the information but also tomake the "imaging inputdata" consistent with the "in-dications for use".The general purpose of thedevice and its function re-main unchanged. The minorrewording of the IntendedUse does not raise differentquestions of safety and ef-fectiveness.
Indications for use	EndoNaut is indicated forthe treatment of patients withendovascular diseases andwho needs for example(without this list being re-strictive):endovascular aortic an-eurysm repair (AAAand TAA), angioplasty, stenting, embolization in iliac ar-teries and correspond-ing veins. EndoNaut is indicated forendovascular procedures inthe thorax, abdomen, pelvisand lower limbs.	EndoNaut is an image fusionsoftware solution and com-puterized navigational sys-tem intended to assist X-rayfluoroscopy-guided proce-dures in the positioning ofsurgical instruments andendovascular devices.EndoNaut is indicated foruse 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, orperipheral artery diseasetreatment.The information provided bythe software or system is inno way intended to substitutefor, in whole or in part, thesurgeon's judgment andanalysis of the patient's con-dition.It is mandatory to check thereal-time anatomy with asuitable imaging technique,such as a contrast-enhancedangiography, before deploy-ing any invasive medical de-vice.	SimilarWithout being a X-ray de-vice itself, as a matter ofprinciple, EndoNaut workswith fluoroscopic images toproduce image fusion. Theclear reference to X-rayguided procedures aims atproviding more transpar-ency.Conditions and anatomicallocations are the same, justwritten in a slightly differentway.
Medical Device SoftwareName	EndoNaut(Predicate Device)K212383	EndoNaut(Subject Device)	Comparable Properties anSubstantialEquivalence Discussion
Labelling	1 label in the "about" sectionfor the Medical Device Soft-ware with the Trade Name"EndoNaut Software".+1 label on the workstationwith the Trade Name "Endo-Naut" (for the whole Sys-tem) and Workstation modelNumber = TS1CA2DS1-2 +unique Serial (production)Number (for the whole Sys-tem)	For EndoNaut System:1 label in the "about" sectionfor the Medical Device Soft-ware with the Trade Name"EndoNaut Software".+1 label on the workstationwith the Trade Name "Endo-Naut" (for the whole Sys-tem) and Workstation modelNumber = TS1CA2DS1-2 +unique Serial (production)Number (for the whole Sys-tem)For EndoNaut Server:1 label in the "about" sectionfor the Medical Device Soft-ware server with the TradeName "EndoNaut Server".	Identical (EndoNaut Soft-ware and EndoNaut Work-station)NewThe label on the new Soft-ware variant follows thesame rule as for EndoNautSoftware.As EndoNaut Server has nouser interface, if it is inte-grated into a System, it willkeep its own labelling andthe labelling of the Systemwill be indicated on anothercomponent of the System (aclient for example). This willbe done under the responsi-bility of the integrator.
Directions for use(UserGuide(s))	1 User Guide for EndoNautSoftware1 User Guide for EndoNautWorkstation +1 addendum for informingabout the conditions govern-ing the marketing of Endo-Naut.	For EndoNaut System:1 User Guide for EndoNautSoftware1 User Guide for EndoNautWorkstation +1 addendum for informingabout the conditions govern-ing the marketing of Endo-Naut System.For EndoNaut Systemcomposed of EndoNaut(Server) SW:Integration manual, Com-munication Protocol andDeveloper Documentation.	Slight changes to EndoNautStandalone SW IFU onlyfollowing minor SW release.No change to EndoNautWorkstation IFU.NewEndoNaut Server will beprovided with an integrationmanual and CommunicationProtocol.EndoNaut Server Main Dis-play SW will be providedwith an integration manualand Developer Documenta-tion.
Input data	DICOM ImagesEndoNaut archive producedwith Therenva EndoSizePlanning Software.C-Arm video stream	DICOM ImagesEndoNaut archive producedwith Therenva EndoSizePlanning Software.C-Arm video stream	SimilarNo new input data. No newfeatures.Only the minimum hardwareand software requirementsdiffer slightly due to the
Medical Device SoftwareName	EndoNaut(Predicate Device)K212383	EndoNaut(Subject Device)	Comparable Properties anSubstantialEquivalence Discussion
	Minimum HW and SW re-quirementsClinical and performance re-quirements (display of fu-sion data, measurements,motion detection, data re-fresh, interoperability)	Minimum HW and SW re-quirementsClinical and performance re-quirements (display of fu-sion data, measurements,motion detection, data re-fresh, interoperability)	different deployment config-urations.The hardware compatibilityevaluation was carried outduring the design validationof EndoNaut. The require-ments for hardware werealso assessed during the clin-ical protocol by collectingdata on hardware used by thesurgeon during the study.The difference did not raiseany risk nor safety or perfor-mance concerns.
Output data	Verified and validated fea-tures (Image visualization,measurements, fusion, regis-tration, motion detection,contrast detection)Code and technical docu-mentation	Verified and validated fea-tures (Image visualization,measurements, fusion, regis-tration, motion detection,contrast detection)	SimilarV&V's activities demon-strate an equivalent level ofperformance of the Endo-Naut. For its server version,due to the different architec-ture, in some cases (recali-bration in particular) weeven note a gain in terms ofexecution speed. No unac-ceptable risk for the securityof users, patients or IT hasbeen identified. No changeswere made to productionmethods, code review andassociated documentation.The outputs produced arecompliant with the standards.
Medical Device SoftwareName	EndoNaut(Predicate Device)K212383	EndoNaut(Subject Device)	Comparable Properties anSubstantialEquivalence Discussion
Machine-Learning algo-rithms	The algorithms are carriedby the EndoNaut softwareonly.Features which call ma-chine-learning algorithms:Registration 3D/2D Motion detection Contrast injectiondetection	The algorithms are carriedby the EndoNaut (standaloneand server) software only.Features which call ma-chine-learning algorithms:Registration 3D/2D Motion detection Contrast injectiondetection	SimilarThe algorithms have notbeen changed. Only the waythey are implemented is dif-ferent between the EndoNautStandalone Software and theEndoNaut Server Software(different architectures).These implementationchanges do not change thepurpose of the algorithms(they do what they did be-fore). The validation carriedout raised no additionalquestions for safety and ef-fectiveness.
Hardware compatibility	EndoNaut Software is theclass II medical device Soft-ware which runs on a sepa-rate interventional tools (im-aging) workstation, the so-named EndoNaut Work-station which is the acces-sory of the medical devicesoftware.	EndoNaut system consists ofa software part that car-ries the medical featuresand technologies thatare controlled and a hardware part that en-ables the medical deviceto be used in accordancewith its intended pur-pose. The hardware partcan be: the EndoNautWorkstation or a computer meetingthe minimum Hard-ware and Softwarerequirements forEndoNautstandalone SW orEndoNaut Server.The Hardware partmust be compliantwith the US regula-tions.	SimilarHardware and Software re-quirements have been ad-justed to EndoNaut Serverand are indicated in the Di-rections for use as a prereq-uisite. V&V activities didn'tshow any risk or failure. Noadditional questions raisedfor safety and effectiveness.
Software Operating System	Windows 10 64 bits	Windows 10 64 bits	IdenticalTherefore, substantiallyequivalent.
Software interoperability	EndoNaut requires the use ofEndoSize software(K160376) to prepare patient	EndoNaut is interoperablewith the EndoSize software(K160376) which is de-signed to prepare patient	Similar as regards EndoSizeand New for EndoNaut(Server) SW and EndoNautServer Main Display SW
Medical Device SoftwareName	EndoNaut(Predicate Device)K212383	EndoNaut(Subject Device)	Comparable Properties andSubstantialEquivalence Discussion
	data and perform preopera-tive sizing.Data imported from En-doSize include 3D volume,preoperative images, sizingreport (comments and meas-urements), and snapshotstaken during sizing.	data and perform pre-opera-tive sizing.Data imported from En-doSize include 3D volume,preoperative images, sizingreport (comments and meas-urements), and snapshotstaken during sizing.EndoNaut Server does nothave a user interface. TheUser interface is provided bythe clients.External interface with cli-ents is provided through acommunication protocol.	Some clarifications aremade.Preoperative data is a man-datory input for the use of AIfeatures, but it is not for thePAD features.Preoperative data includepre-op CT images and sizingreport (in case of AI proce-dures). The stent placementstrategy and sizing are usu-ally performed pre-opera-tively via the use of softwaredevices such as EndoSize.Alternatives to EndoSize ex-ist: other sizing or visualiza-tion software. In such cases,the data is then printed onpaper and used in the operat-ing room as is.The communication protocolof EndoNaut (Server) SWdid not raise any risk norsafety or performance con-cerns.
Visualization	Intra-operative fluoroscopyor angiography, pre-opera-tive CT scan image, pre-op-erative 3D scanner volumereconstruction (if any in caseof PAD procedures).For AI procedures:Before and during the inter-vention, the user can accessinformation from pre-opera-tive sizing report such as pre-op CT images, measure-ments, comments, snap-shots and strategy.	Intra-operative fluoroscopyor angiography, pre-opera-tive CT scan image, pre-op-erative 3D scanner volumereconstruction (if any in caseof PAD procedures).For AI procedures:Before and during the inter-vention, the user can accessinformation from pre-opera-tive sizing report such as pre-op CT images, measure-ments, comments, snap-shots and strategy.	Identical
Export	Take and export snapshots.Export panoramas in case ofPAD module.	Take and export snapshots.Export panoramas in case ofPAD module.	IdenticalTherefore, substantially
Medical Device Software Name	EndoNaut (Predicate Device) K212383	EndoNaut (Subject Device)	Comparable Properties an Substantial Equivalence Discussion
3D-2D / 2D-2D Registration	Display 2D-3D fusion: 3D volume pre-op overlay on per-op 2D fluoroscopy. Semi-automatic registration (automatic or manual initialization, automatic computation and manual validation).	Display 2D-3D fusion: 3D volume pre-op overlay on per-op 2D fluoroscopy. Semi-automatic registration (automatic or manual initialization, automatic computation and manual validation).	Identical
	Panorama creation: Acquisition and save of fluoroscopy and angiography stage by stage keeping the same C-Arm orientation.	Panorama creation: Acquisition and save of fluoroscopy and angiography stage by stage keeping the same C-Arm orientation.
	Display 2D-2D fusion: 2D pre-op angiographic overlay on per-op 2D fluoroscopy. Synchronization between current per-op 2D fluoroscopy and 2D fluoroscopy from recorded panorama.	Display 2D-2D fusion: 2D pre-op angiographic overlay on per-op 2D fluoroscopy. Synchronization between current per-op 2D fluoroscopy and 2D fluoroscopy from recorded panorama.
Dynamic update on C-arm / table / patient motion	Automatic motion detection Registration: automatic/manual initialization and manual user validation.	Automatic motion detection Registration: automatic/manual initialization and manual user validation.	Similar Slight change for EndoNaut (Standalone) SW: The registration workflow is modified to be more consistent with clinical expectations. The possibility to start again a registration in automatic mode is offered instead of switching to semi-automatic mode after a first try in automatic mode. The way the automatic mode works and its performance, safety characteristics are unchanged. Without any change being made to the automatic mode (so no impact on safety or performance, risks), users have the possibility to adapt the image received from the CArm to display more bone structures for example. Once he relaunches the registration in automatic mode, it
Medical Device SoftwareName	EndoNaut(Predicate Device)K212383	EndoNaut(Subject Device)	Comparable Properties anSubstantialEquivalence Discussion
			may get better results at theend of the registration pro-cess.
			For EndoNaut (Server) SW:These features have beentransferred in the new soft-ware architecture.Final validation is always re-quired. It is implemented atthe integrator's discretion viathe SYNC_CT_ACCEPTcommand.
			New risks due to the newsoftware architecture havebeen addressed. New clinicaldata were not necessary.V&V activities were per-formed and successful. Noadditional questions raisedfor safety and effectiveness.
Patient contacting	No	No	Identical
Energy emitted or absorbed	No	No	Identical
Workstation main display &computer	Panel PC ACL OR-PC 27LPRated AC 100-240V, 1.5-0.6A ~47 – 63 HzMonitor size: 27" LCDBrightness: 300 cd/m2Resolution: 1920 x 1080Cooling Fanless (no mainte-nance)	Panel PC ACL OR-PC 27LPRated AC 100-240V, 1.5-0.6A ~47 – 63 HzMonitor size: 27" LCDBrightness: 300 cd/m2Resolution: 1920 x 1080Cooling Fanless (no mainte-nance)	Identical
Workstation secondary dis-play (touch screen)	One Touch monitor ELOmodel 1502L,rated AC 100-240 VInput frequency: 50-60 HzMonitor size: 15.6" LCDNative resolution:Full HD : 1920 x 1080 ;HD (WXGA) : 1366 x 768Brightness:Touch Pro 270 nitsTouch technology: PCAP	One Touch monitor ELOmodel 1502L or 1519LMrated AC 100-240 VInput frequency: 50-60 HzMonitor size: 15.6" LCDNative resolution:Full HD : 1920 x 1080(1502L);HD (WXGA) : 1366 x 768(1502L, 1519 LM)Brightness:Touch Pro 270 nits	SimilarSimilar for ELO Touch1502L, one reference added(1519LM) which offers verysimilar performance.The brightness offered bythe ELO 1519LM ap-proaches the full HD ELO1502L.The slight differences be-tween the two models do not
Medical Device SoftwareName	EndoNaut(Predicate Device)K212383	EndoNaut(Subject Device)	Comparable Properties anSubstantialEquivalence Discussion
		1519LM: 225 nitsTouch technology: PCAP	raise risk, safety nor perfor-mance concerns.
Workstation cart	One mobile frame holderITD, including one isolatingtransformer, rated AC 115V/ 230V 50/60Hz 1240VA	One mobile frame holderITD, including one isolatingtransformer, rated AC 115V/ 230V 50/60Hz 1240VA.	Minor changeChange of pro-cart Basicframe: column raised by 16cm for better visibility. Nochange of pro-cart supplier.No change of materials. In-stability hazards have beenevaluated and tested.No confusion possible be-tween the old mobile frameholder and the new mobileframe holder because theyare different part reference.No overbalance or hazardsthat could jeopardize thesafety of the users and bene-ficiaries and call into ques-tion the performanceof the medical device couldbe observed.
Workstation dimensions	Height: 1740 mmWidth (footprint): 661 (640)mmDepth (footprint): 950 (660)mmWeight: 70 kg	Height: 1850 mmWidth (footprint): 661 (640)mmDepth (footprint): 950 (660)mmWeight: 72 kg	SimilarMinor dimensional andweight changes do not resultin additional risks.
Workstation Connectors	Digital video input: DVI-Dor DVI-I*Video output: HDMINetwork: 10/100/1000 MbpsEthernet (RJ45)USB interface USB 3.0(x2)	Digital video input: DVI-Dor DVI-I*Video output: HDMINetwork: 10/100/1000 MbpsEthernet (RJ45)USB interface USB 3.0(x2)	Identical
Workstation Power supply	Input voltage:100 - 230 VAC / 50 - 60 Hz	Input voltage:100 - 230 VAC / 50 - 60 Hz	Identical
Workstation cablings	Connection BoxFront cable RJ45DVI front cableUSB 3.0 front cable1m (x2)Power supplies	Connection BoxFront cable RJ45DVI front cableUSB 3.0 front cable1m (x2)Power supplies	Identical
Medical Device SoftwareName	EndoNaut(Predicate Device)K212383	EndoNaut(Subject Device)	Comparable Properties anSubstantialEquivalence Discussion
	Power supply extension IECC7-C14	Power supply extension IECC7-C14
	Power supply extension jack2.5mm 3m	Power supply extension jack2.5mm 3m
	IEC extension cable 1m(red)	IEC extension cable 1m(red)
	IEC extension cable 0.5m(blue)	IEC extension cable 0.5m(blue)
	External power supply XPPOWER (for ELO TOUCH1502L)	External power supply XPPOWER (for ELO TOUCH1502L)
	External power supplyBICKER (for ACL ORPC-27LP) BET-1012M	External power supplyBICKER (for ACL ORPC-27LP) BET-1012M
	Video cabling: DVI 5mOther cables:	Video cabling: DVI 5mOther cables:
	HDMI cable 1.5m	HDMI cable 1.5m
	HDMI/DP adapterUSB 3.0 A/B 1m	HDMI/DP adapterUSB 3.0 A/B 1m
	USB 2.0 2m	USB 2.0 2m
	Equipotential 1.5m	Equipotential 1.5m
IEC 62304	Applied	Applied	Identical
IEC 62366	Applied	Applied	Identical
ISO 14971	Applied	Applied	Identical
DICOM Standard parts 1-20	Applied	Applied	Identical
Conformity to IEC 60601-1of EndoNaut workstation	YesFor CENELEC countries	YesFor CENELEC countries	IdenticalIEC 60601-1 is not a FDArecognized standard versionbut is applied and included inV&V protocol and results.
Conformity to ANSI AAMIES60601-1:2005/(R)2012andA1:2012,C1:2009/(R)2012 andA2:2010/(R)2012 (Consolidated Text) of EndoNautworkstation	Yes	Yes	Identical
Conformity to IEC 60601-2of the separate Workstationfor navigation tools	Yes	Yes	IdenticalIEC 60601-2 FDA recog-nized standard version is ap-plied and included in V&Vprotocol and results.
Conformity to IEC 60601-1-6 of EndoNaut workstation	Yes	Yes	IdenticalIEC 60601-1-6 FDA recog-nized standard version is ap-plied and included in V&Vprotocol and results.

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Image /page/7/Picture/1 description: The image is a logo for a company called "Therenva". The logo consists of a stylized image of a circle with a teal-colored shape inside of it, followed by the company name in gray text. Below the company name is the tagline "Share medical innovation" in a smaller font, also in gray.

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Image /page/8/Picture/1 description: The image shows the logo for Therenva. The logo consists of a teal abstract shape and a gray circle 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.

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Image /page/9/Picture/1 description: The image shows the logo for Therenva. The logo consists of a teal abstract shape and a gray circle 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.

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Image /page/10/Picture/1 description: The image shows the logo for Therenva. The logo consists of a teal and gray circular design on the left, followed by the word "Therenva" in gray, and the words "Share medical innovation" in a smaller gray font below the word "Therenva". The circular design appears to be a stylized representation of a medical device or technology.

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Image /page/11/Picture/1 description: The image shows the logo for Therenva. The logo consists of a teal and gray circular design on the left, followed by the word "Therenva" in gray, and the words "Share medical innovation" in a smaller gray font below the word "Therenva". The circular design appears to be a stylized letter "T".

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Image /page/12/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, lighter gray font. The abstract shape on the left appears to be a stylized representation of a leaf or wing, with a gray circle behind it.

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Image /page/13/Picture/1 description: The image shows the logo for Therenva. The logo consists of a teal abstract shape on the left, resembling a sail or a stylized 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 size below it.

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Image /page/14/Picture/1 description: The image shows the logo for Therenva. The logo consists of a teal-colored abstract shape on the left, resembling a stylized leaf or wing, connected to a gray circle. To the right of the circle is the word "Therenva" in gray, with the tagline "Share medical innovation" in a smaller font size underneath.

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Image /page/15/Picture/1 description: The image is a logo for Therenva, a company that shares medical innovation. The logo features a stylized teal and gray symbol to the left of the company name, which is written in gray. Below the company name is the tagline "Share medical innovation" in a smaller, lighter gray font.

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Image /page/16/Picture/1 description: The image is a logo for a company called "Therenva". The logo consists of a circular graphic to the left of the company name. The graphic is a circle with a teal, sail-shaped object inside of it. Below the company name is the tagline "Share medical innovation".

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Image /page/17/Picture/1 description: The image shows the logo for Therenva, a company that shares medical innovation. The logo features a gray circle with a teal, sail-shaped design extending from the bottom left. The company name, "Therenva," is written in gray, block letters to the right of the circle. Below the name, the tagline "Share medical innovation" is written in a smaller, lighter gray font.

7. Summary of the technical characteristics

EndoNaut (Subject Device) has similar intended use, intended users, indications for use, anatomical location, limitations, patient population, environment of use than the predicate device, EndoNaut (Legacy Device).

EndoNaut workstation TS1CA2DS1-2 has similar material and technical characteristics (design, power, principle of operation) than the predicate accessory, the separate intervention tools workstation TS1CA2DS1-2.

The change of EndoNaut software architecture (monolithic architecture to a server/client architecture) did not fundamentally change the intended use nor the functionalities offered by EndoNaut.

However, Therenva performed a full battery of design, requirement and unit tests and positioned itself in a comprehensive initial review of the risks associated with this change.

The differences between the new modified devices (systems and accessories to their predicates do not raise any question with respect to the safety and effectiveness of the subject device and accessory.

8. Summary of Clinical Performance Data

The subject of this premarket submission did not require clinical studies to support equivalence.

9. Performance Data

EndoNaut does not produce x-rays. EndoNaut may interact with fluoroscopic imaging systems only to retrieve a live video stream using a passive connection or communication protocol, i.e. without returning any data to this system.

Then, EndoNaut does not need to be conform to applicable Performance Standards for Ionizing Radiation Emitting Products [21 CFR Subchapter J, Federal Diagnostic X-ray Equipment Standard].

The device is designed and manufactured under the Quality System Regulations as outlined in 21 CFR § 820 and ISO 13485 Standards.

The predicate device (K212383) and the new modified subject device and their respective accessories, the separate interventional tools workstation and EndoSize Software, have been subject to the same Therenva quality assurance system during their design and development:

. Risk assessment
Usability File Reviews
Requirement Reviews ●
. Design Reviews
Clinical Evaluation Report Reviews

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Image /page/18/Picture/1 description: The image is a logo for a company called "Therenva". The logo consists of a stylized symbol on the left and the company name on the right. The symbol is a combination of a circle and a teal-colored shape that resembles a leaf or wing. Below the company name is the tagline "Share medical innovation" in a smaller font.

Directions for use or Integration manuals Reviews ●
Testing on unit level (Module verification) ●
Integration testings
Interoperability testings
. Performance testing (Verification)
Safety testing (Verification)
Simulated use testing (Validation) .

The same design verification testing including electrical safety, EMC, functional and mechanical testing's were carried out on the new EndoNaut Workstation TS1CA2DS1-2 by the COFRAC accredited testing laboratory. These tests showed that the EndoNaut Workstation TS1CA2DS1-2 meets the design specification and performed as intended.

Verification and validation activities have demonstrated that the EndoNaut (Server) software variant performs equally as the EndoNaut (Standalone) predicate software by providing reliable results, without functional regression and moreover, offers robust safety/security mechanisms.

The devices also demonstrated compliance with the same following standards:

ISO 14971 medical devices Application of risk management to medical devices ●
IEC 62304 medical devices Software Software life-cycle processes .

Specific to EndoNaut Workstation:

IEC 60601-1 - Medical electrical equipment - Electrical safety
ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 . (Consolidated Text)
IEC 60601-2 Medical electrical equipment EMC disturbances ●
IEC 60601-1-6 Medical electrical equipment Usability ●

10. Statement of substantial equivalence

Based on the information supplied in this Traditional 510(k), Therenva SAS concludes that the EndoNaut (Subject device) is substantially equivalent to the predicate device and accessories with regard to its features, clinical applications and use.

The devices are safe and effective and do not introduce unacceptable risks for the patients nor the users when used as intended and documented by Therenva.

Regulation Number and Section

§ 892.1650 Image-intensified fluoroscopic x-ray system.

(a)
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.(b)
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.