(103 days)
Yes
The summary explicitly mentions "Machine-Learning algorithms" and "AI features".
No
The device is an image fusion software solution and computerized navigational system that assists in positioning surgical instruments and endovascular devices. Its intended use is to guide procedures, not to directly treat or provide therapy to patients.
No
EndoNaut is described as 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. Its purpose is to guide rather than diagnose.
No
The device description explicitly states that EndoNaut consists of a "software part" and a "hardware part" and that the software is "supported by hardware and software accessories." This indicates it is not solely software.
Based on the provided information, no, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that EndoNaut is an image fusion software and navigational system intended to assist X-ray fluoroscopy-guided procedures in the positioning of surgical instruments and endovascular devices. It is used during a procedure to guide the physician.
- IVD Definition: An In Vitro Diagnostic device is defined as a medical device intended to be used in vitro for the examination of specimens, including blood and tissue samples, derived from the human body, solely or principally for the purpose of providing information concerning a physiological or pathological state, or concerning a congenital abnormality, or to determine the safety and compatibility of transfused blood, or to monitor therapeutic measures.
- EndoNaut's Function: EndoNaut does not examine specimens from the human body in vitro. It processes and displays medical images (DICOM and C-Arm video) to provide real-time guidance during a surgical procedure.
While EndoNaut is a medical device and utilizes image processing and AI, its function is to aid in surgical navigation and instrument positioning in vivo, not to perform diagnostic tests on samples in vitro.
No
The provided text does not contain any explicit statement that the FDA has reviewed and approved or cleared a Predetermined Change Control Plan (PCCP) for this specific device. The section for "Control Plan Authorized (PCCP) and relevant text" states "Not Found".
Intended Use / 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.
Product codes
OWB, LLZ
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).
Mentions image processing
Yes
Mentions AI, DNN, or ML
Yes
Input Imaging Modality
DICOM Images, C-Arm video stream, Intra-operative fluoroscopy or angiography, pre-operative CT scan image, pre-operative 3D scanner volume reconstruction (if any in case of PAD procedures).
Anatomical Site
Chest, abdomen, pelvis, neck and lower limbs
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Physicians in a clinical setting (implied by "fluoroscopy X-ray guided procedures" and "operating procedure").
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The subject of this premarket submission did not require clinical studies to support equivalence.
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.
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
- 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
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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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.
- 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") |
- EndoSize Software
- 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
data on hardware used by the
surgeon during the study.
The difference did not raise
any 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) | Similar
V&V's activities demon-
strate an equivalent level of
performance of the Endo-
Naut. For its server version,
due to the different architec-
ture, in some cases (recali-
bration in particular) we
even note a gain in terms of
execution speed. No unac-
ceptable risk for the security
of users, patients or IT has
been identified. No changes
were made to production
methods, code review and
associated documentation.
The outputs produced are
compliant with the standards. |
| Medical Device Software
Name | EndoNaut
(Predicate Device)
K212383 | EndoNaut
(Subject Device) | Comparable Properties an
Substantial
Equivalence Discussion |
| Machine-Learning algo-
rithms | The algorithms are carried
by the EndoNaut software
only.
Features which call ma-
chine-learning algorithms:
Registration 3D/2D Motion detection Contrast injection
detection | The algorithms are carried
by the EndoNaut (standalone
and server) software only.
Features which call ma-
chine-learning algorithms:
Registration 3D/2D Motion detection Contrast injection
detection | Similar
The algorithms have not
been changed. Only the way
they are implemented is dif-
ferent between the EndoNaut
Standalone Software and the
EndoNaut Server Software
(different architectures).
These implementation
changes do not change the
purpose of the algorithms
(they do what they did be-
fore). The validation carried
out raised no additional
questions for safety and ef-
fectiveness. |
| Hardware compatibility | EndoNaut Software is the
class 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 device
software. | EndoNaut system consists of
a software part that car-
ries the medical features
and technologies that
are controlled and a hardware part that en-
ables the medical device
to be used in accordance
with its intended pur-
pose. The hardware part
can be: the EndoNaut
Workstation or a computer meeting
the minimum Hard-
ware and Software
requirements for
EndoNaut
standalone SW or
EndoNaut Server.
The Hardware part
must be compliant
with the US regula-
tions. | Similar
Hardware and Software re-
quirements have been ad-
justed to EndoNaut Server
and are indicated in the Di-
rections for use as a prereq-
uisite. V&V activities didn't
show any risk or failure. No
additional questions raised
for safety and effectiveness. |
| Software Operating System | Windows 10 64 bits | Windows 10 64 bits | Identical
Therefore, substantially
equivalent. |
| Software interoperability | EndoNaut requires the use of
EndoSize software
(K160376) to prepare patient | EndoNaut is interoperable
with the EndoSize software
(K160376) which is de-
signed to prepare patient | Similar as regards EndoSize
and New for EndoNaut
(Server) SW and EndoNaut
Server Main Display SW |
| Medical Device Software
Name | EndoNaut
(Predicate Device)
K212383 | EndoNaut
(Subject Device) | Comparable Properties and
Substantial
Equivalence Discussion |
| | data and perform preopera-
tive sizing.
Data imported from En-
doSize include 3D volume,
preoperative images, sizing
report (comments and meas-
urements), and snapshots
taken during sizing. | data and perform pre-opera-
tive sizing.
Data imported from En-
doSize include 3D volume,
preoperative images, sizing
report (comments and meas-
urements), and snapshots
taken during sizing.
EndoNaut Server does not
have a user interface. The
User interface is provided by
the clients.
External interface with cli-
ents is provided through a
communication protocol. | Some clarifications are
made.
Preoperative data is a man-
datory input for the use of AI
features, but it is not for the
PAD features.
Preoperative data include
pre-op CT images and sizing
report (in case of AI proce-
dures). The stent placement
strategy and sizing are usu-
ally performed pre-opera-
tively via the use of software
devices such as EndoSize.
Alternatives to EndoSize ex-
ist: other sizing or visualiza-
tion software. In such cases,
the data is then printed on
paper and used in the operat-
ing room as is.
The communication protocol
of EndoNaut (Server) SW
did not raise any risk nor
safety or performance con-
cerns. |
| Visualization | Intra-operative fluoroscopy
or angiography, pre-opera-
tive CT scan image, pre-op-
erative 3D scanner volume
reconstruction (if any in case
of PAD procedures).
For AI procedures:
Before and during the inter-
vention, the user can access
information from pre-opera-
tive sizing report such as pre-
op CT images, measure-
ments, comments, snap-
shots and strategy. | Intra-operative fluoroscopy
or angiography, pre-opera-
tive CT scan image, pre-op-
erative 3D scanner volume
reconstruction (if any in case
of PAD procedures).
For AI procedures:
Before and during the inter-
vention, the user can access
information 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 of
PAD module. | Take and export snapshots.
Export panoramas in case of
PAD module. | Identical
Therefore, 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 Software
Name | EndoNaut
(Predicate Device)
K212383 | EndoNaut
(Subject Device) | Comparable Properties an
Substantial
Equivalence Discussion |
| | | | may get better results at the
end of the registration pro-
cess. |
| | | | For EndoNaut (Server) SW:
These features have been
transferred in the new soft-
ware architecture.
Final validation is always re-
quired. It is implemented at
the integrator's discretion via
the SYNC_CT_ACCEPT
command. |
| | | | New risks due to the new
software architecture have
been addressed. New clinical
data were not necessary.
V&V activities were per-
formed and successful. No
additional questions raised
for safety and effectiveness. |
| Patient contacting | No | No | Identical |
| Energy emitted or absorbed | No | No | Identical |
| Workstation main display &
computer | Panel PC ACL OR-PC 27LP
Rated AC 100-240V, 1.5-0.6
A ~47 – 63 Hz
Monitor size: 27" LCD
Brightness: 300 cd/m2
Resolution: 1920 x 1080
Cooling Fanless (no mainte-
nance) | Panel PC ACL OR-PC 27LP
Rated AC 100-240V, 1.5-0.6
A ~47 – 63 Hz
Monitor size: 27" LCD
Brightness: 300 cd/m2
Resolution: 1920 x 1080
Cooling Fanless (no mainte-
nance) | Identical |
| Workstation secondary dis-
play (touch screen) | One Touch monitor ELO
model 1502L,
rated AC 100-240 V
Input frequency: 50-60 Hz
Monitor size: 15.6" LCD
Native resolution:
Full HD : 1920 x 1080 ;
HD (WXGA) : 1366 x 768
Brightness:
Touch Pro 270 nits
Touch technology: PCAP | One Touch monitor ELO
model 1502L or 1519LM
rated AC 100-240 V
Input frequency: 50-60 Hz
Monitor size: 15.6" LCD
Native resolution:
Full HD : 1920 x 1080
(1502L);
HD (WXGA) : 1366 x 768
(1502L, 1519 LM)
Brightness:
Touch Pro 270 nits | Similar
Similar for ELO Touch
1502L, one reference added
(1519LM) which offers very
similar performance.
The brightness offered by
the ELO 1519LM ap-
proaches the full HD ELO
1502L.
The slight differences be-
tween the two models do not |
| Medical Device Software
Name | EndoNaut
(Predicate Device)
K212383 | EndoNaut
(Subject Device) | Comparable Properties an
Substantial
Equivalence Discussion |
| | | 1519LM: 225 nits
Touch technology: PCAP | raise risk, safety nor perfor-
mance concerns. |
| Workstation cart | One mobile frame holder
ITD, including one isolating
transformer, rated AC 115V
/ 230V 50/60Hz 1240VA | One mobile frame holder
ITD, including one isolating
transformer, rated AC 115V
/ 230V 50/60Hz 1240VA. | Minor change
Change of pro-cart Basic
frame: column raised by 16
cm for better visibility. No
change of pro-cart supplier.
No change of materials. In-
stability hazards have been
evaluated and tested.
No confusion possible be-
tween the old mobile frame
holder and the new mobile
frame holder because they
are different part reference.
No overbalance or hazards
that could jeopardize the
safety of the users and bene-
ficiaries and call into ques-
tion the performance
of the medical device could
be observed. |
| Workstation dimensions | Height: 1740 mm
Width (footprint): 661 (640)
mm
Depth (footprint): 950 (660)
mm
Weight: 70 kg | Height: 1850 mm
Width (footprint): 661 (640)
mm
Depth (footprint): 950 (660)
mm
Weight: 72 kg | Similar
Minor dimensional and
weight changes do not result
in additional risks. |
| Workstation Connectors | Digital video input: DVI-D
or DVI-I*
Video output: HDMI
Network: 10/100/1000 Mbps
Ethernet (RJ45)
USB interface USB 3.0
(x2) | Digital video input: DVI-D
or DVI-I*
Video output: HDMI
Network: 10/100/1000 Mbps
Ethernet (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 Box
Front cable RJ45
DVI front cable
USB 3.0 front cable
1m (x2)
Power supplies | Connection Box
Front cable RJ45
DVI front cable
USB 3.0 front cable
1m (x2)
Power supplies | Identical |
| Medical Device Software
Name | EndoNaut
(Predicate Device)
K212383 | EndoNaut
(Subject Device) | Comparable Properties an
Substantial
Equivalence Discussion |
| | Power supply extension IEC
C7-C14 | Power supply extension IEC
C7-C14 | |
| | Power supply extension jack
2.5mm 3m | Power supply extension jack
2.5mm 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 XP
POWER (for ELO TOUCH
1502L) | External power supply XP
POWER (for ELO TOUCH
1502L) | |
| | External power supply
BICKER (for ACL ORPC-
27LP) BET-1012M | External power supply
BICKER (for ACL ORPC-
27LP) BET-1012M | |
| | Video cabling: DVI 5m
Other cables: | Video cabling: DVI 5m
Other cables: | |
| | HDMI cable 1.5m | HDMI cable 1.5m | |
| | HDMI/DP adapter
USB 3.0 A/B 1m | HDMI/DP adapter
USB 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 60601-1
of EndoNaut workstation | Yes
For CENELEC countries | Yes
For CENELEC countries | Identical
IEC 60601-1 is not a FDA
recognized standard version
but is applied and included in
V&V protocol and results. |
| Conformity to ANSI AAMI
ES60601-1:2005/(R)2012
and
A1:2012,
C1:2009/(R)2012 and
A2:2010/(R)2012 (Consolidated Text) of EndoNaut
workstation | Yes | Yes | Identical |
| Conformity to IEC 60601-2
of the separate Workstation
for navigation tools | Yes | Yes | Identical
IEC 60601-2 FDA recog-
nized standard version is ap-
plied and included in V&V
protocol and results. |
| Conformity to IEC 60601-1-
6 of EndoNaut workstation | Yes | Yes | Identical
IEC 60601-1-6 FDA recog-
nized standard version is ap-
plied and included in V&V
protocol and results. |
7
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.
8
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.
9
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.
10
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.
11
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".
12
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.
13
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.
14
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.
15
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.
16
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".
17
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
18
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.