(29 days)
Yes
The document explicitly mentions an "AI module" and describes its function in semi-automatic registration.
No.
The device is an imaging solution for intraoperative navigation and guidance during endovascular procedures, not a device that directly treats the disease itself.
No
The device is an imaging solution for intraoperative navigation and guidance during endovascular procedures, not for diagnosis. Its purpose is to assist in positioning surgical tools by combining pre-operative scans and intra-operative imagery.
No
The device description explicitly mentions the "EndoNaut Workstation accessory" and describes testing performed on this workstation, indicating it includes hardware components beyond just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use clearly describes a device used for intraoperative navigation and guidance during endovascular procedures. This involves assisting with the positioning of medical devices within the body, which is a clinical procedure, not a diagnostic test performed on samples outside the body.
- Device Description: The description reinforces that EndoNaut is an "imaging solution for intraoperative navigation and guidance tool." It combines imaging data to help with device placement during surgery.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis. The focus is entirely on image-guided intervention.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. EndoNaut's function falls squarely within the realm of surgical guidance and navigation, not in vitro diagnostic testing.
No
The provided input does not explicitly state that the FDA has reviewed and approved or cleared a PCCP for this specific device. The text "Control Plan Authorized (PCCP) and relevant text Not Found" further confirms the absence of such information.
Intended Use / Indications for Use
EndoNaut is indicated for the treatment of patients with endovascular diseases and who needs, such as but not limited to the following examples:
- · endovascular aortic aneurysm repair (AAA and TAA),
- · angioplasty,
- · stenting.
- · embolization in iliac arteries and corresponding veins.
EndoNaut is indicated for endovascular procedures in the thorax, abdomen, pelvis and lower limbs.
Product codes
OWB
Device Description
EndoNaut system is an imaging solution for intraoperative navigation and guidance tool for endovascular procedures (aorto-iliac and peripheral).
EndoNaut provides localization assistance by combining 3D preoperative scans and 2D intra-operative fluoroscopy imagery to help position guides, catheters and other vascular devices.
EndoNaut Software is interoperable with EndoSize which is a standalone Software designed and developed by Therenva to enable case planning strategy and device (endoprosthesis) selection before 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 intended to be used for pre-operational planning and sizing. 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
fluoroscopy, angiography, CT scan
Anatomical Site
thorax, abdomen, pelvis and lower limbs
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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 predicate device (K171829) 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 Reviews
- Testing on unit level (Module verification)
- . Integration testing (EndoNaut Software embedded on the EndoNaut Workstation accessory and tests on several operating systems)
- Interoperability testing (with EndoSize Software) ●
- 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 as it its predicate TS1CA2DS1-1 by the COFRAC accredited testing laboratory. These tests showed that the EndoNaut Workstation TS1CA2DS1-2 meets the design specification and performed as intended.
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
August 31, 2021
Image /page/0/Picture/1 description: The image contains two logos. The logo on the left is the Department of Health & Human Services - USA logo. The logo on the right is the FDA U.S. Food & Drug Administration logo. The FDA logo is in blue.
Therenva SAS % Cemil Göksu CEO 74F rue de Paris Rennes, 35000 FRANCE
Re: K212383
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 Dated: July 12, 2021 Received: August 2, 2021
Dear Cemil Göksu:
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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
1
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 (QS)
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 medical devices and radiation-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,
Image /page/1/Picture/6 description: The image shows a digital signature. The signature is from Laurel M. Burk -S. The document was signed on August 31, 2021 at 10:53:59 -04'00'.
Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K212383
Device Name EndoNaut
Indications for Use (Describe)
EndoNaut is indicated for the treatment of patients with endovascular diseases and who needs, such as but not limited to the following examples:
- · endovascular aortic aneurysm repair (AAA and TAA),
- · angioplasty,
- · stenting.
- · embolization in iliac arteries and corresponding veins.
EndoNaut is indicated for endovascular procedures in the thorax, abdomen, pelvis and lower limbs.
Type of Use (Select one or both, as applicable)X 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 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 teal-colored shape that resembles a sail or a stylized leaf, partially enclosed by a gray circle. The company name "Therenva" is written in gray, with the tagline "Share medical innovation" in a smaller font below the name.
Section 5 - EndoNaut Special 510(K) Summary
This Special 510(k) summary is submitted in accordance with the requirements of 21 CFR Part 807.92.
Therenva SAS hereby submits this Special 510(k) to provide a notification submission for a modified device EndoNaut and evidence of substantial equivalence to to the Predicate Medical Device EndoNaut (K171829).
The accessories are also subject to this Special 510(k).
1. Submitter information
| Manufacturer Name: | Therenva SAS
74F, rue de Paris
35000 Rennes
France |
|--------------------------------|-------------------------------------------------------------------------------------------------------|
| Contact Person: | Mrs Audrey Gallois, OA & RA Leader
Phone: +33 6 86 95 44 39
E-mail: audrey.gallois@therenva.com |
| Establishment Registration Nº: | 3011240766 |
| Date prepared: | 12-Jul-21 |
2. Device Identification
| Trade Name: | EndoNaut |
|---|---|
| Regulation Name: | Interventional Fluoroscopic X-ray System |
| Regulatory Class: | Class II |
| Product Code: | OWB |
| Classification Regulation: | 21 CFR 892.1650 |
| Classification Panel: | Radiology |
| Accessories: | 1. Separate interventional tools workstation |
| 2. EndoSize Software |
4
Image /page/4/Picture/1 description: The image shows the logo for Therenva. The logo consists of a stylized teal-colored shape resembling a leaf or wing, connected to a gray circle. To the right of the circle is the word "Therenva" in gray, block letters. Below "Therenva" is the tagline "Share medical innovation" in a smaller, lighter gray font.
3. Predicate device and accessories
- Predicate Medical Device Software: EndoNaut (K171829) ●
- Predicate Accessories:
4. Description of the device
EndoNaut system is an imaging solution for intraoperative navigation and guidance tool for endovascular procedures (aorto-iliac and peripheral).
EndoNaut provides localization assistance by combining 3D preoperative scans and 2D intra-operative fluoroscopy imagery to help position guides, catheters and other vascular devices.
EndoNaut Software is interoperable with EndoSize which is a standalone Software designed and developed by Therenva to enable case planning strategy and device (endoprosthesis) selection before 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 intended to be used for pre-operational planning and sizing. EndoSize is medical device software which obtained a substantial equivalence determination and FDA clearance through the CDRH premarket notification process (510(K)) (NºK160376).
5
Image /page/5/Picture/1 description: The image is a logo for Therenva, a company that shares medical innovation. The logo features a stylized symbol on the left, consisting of a teal crescent shape intersecting with a gray circle. To the right of the symbol is the company name, "Therenva," in gray, block letters. Below the name is the tagline, "Share medical innovation," in a smaller, lighter gray font.
5. Comparison to the cleared (legacy) device and substantial equivalent discussion
| Medical Device Software Name | EndoNaut
(Predicate Device)
K171829 | EndoNaut
(Subject Device) | Comparable Properties an
Substantial
Equivalence Discussion |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Medical Device Software
Trade Name | EndoNaut | EndoNaut | Identical |
| Accessory 1 | Separate interventional tools
workstation | EndoNaut Workstation | Different.
Designation adjustment
only.
We have reclarified the qual-
ification of hardware versus
software. By definition,
here, the hardware (Endo-
Naut Workstation) is an ac-
cessory to the software med-
ical device. To better differ-
entiate what is applicable to
one and the other, we have
identified the software by
"EndoNaut Software" and
the hardware by "EndoNaut
Workstation". The Endo-
Naut Workstation alone is
not subject to any regulatory
submission. It is integrated
with the System submitted
for FDA approval under the
name, EndoNaut. |
| Accessory 1 Ref. | TS1CA2DS1-1 | TS1CA2DS1-2 | Different
Change of the Panel PC, the
Control Panel model and Ca-
blings.
Due to these changes, the
Product number
"TS1CA2DS1-2" has been
changed. New testings have
been performed. |
| Accessory 2 | EndoSize Software
(K160376) | EndoSize Software
(K160376) | Identical
EndoSize Software is an ac-
cessory that is intended to
supplement the performance
of EndoNaut. |
| Identification and traceability | Name: EndoNaut
No UDI | Trade name: EndoNaut
Common name: EndoNaut
System
UDI-DI: 3760262480046 | Different
No risk related to idenfica-
tion between older and
newer EndoNaut device.
EndoNaut is now referring to
the EndoNaut System while
the EndoNaut Software is
named EndoNaut Software |
| Medical Device Software | EndoNaut | EndoNaut | Comparable Properties an |
| Name | (Predicate Device) | (Subject Device) | Substantial |
| | K171829 | | Equivalence Discussion |
| | | | No unit of the predicate device was sold in the USA. |
| Manufacturer | Therenva SAS | Therenva SAS | Identical |
| Product Code | OWB | OWB | Identical |
| Regulation Number | 892.1650 | 892.1650 | Identical |
| Regulation Name | Interventional Fluoroscopic
X-Ray System | Interventional Fluoroscopic
X-Ray System | Identical |
| Software Safety class (62304) | B | B | Identical |
| Level of concern | Moderate | Moderate | Identical |
| Intended use | Intended use and indications
for use were mixed.
See below Indications for
use. | EndoNaut provides image
guidance by overlaying pre-
operative 3D vessel anatomy
onto live fluoroscopic im-
ages in order to assist in the
positioning of the guide-
wires, catheters and other
endovascular devices. | Different
A distinction between "In-
tended use" and "indications
for use" has been made based
on the recommendations of
the FDA Guidance " The
510(k) Program: Evaluating
Substantial Equivalence in
Premarket
Notifications
[510(k)]" (section IV, D, 1). |
| Indications for use | EndoNaut provides image
guidance by overlaying pre-
operative 3D vessel anatomy
onto live fluoroscopic im-
ages in order to assist in the
positioning of the guide-
wires, catheters and other
endovascular devices.
EndoNaut is intended to as-
sist endovascular procedures
in the thorax, abdomen,
neck, pelvis and lower limbs.
Suitable procedures include
(but not limited to) endovas-
cular aortic aneurysm repair
(AAA and TAA), angio-
plasty, stenting and emboli-
zation in iliac arteries and
corresponding veins.
EndoNaut is not intended for
use in the X-ray guided pro-
cedures in the liver, kidneys
or pelvic organs. | 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 corresponding
veins.EndoNaut is indicated for
endovascular procedures in
the thorax, abdomen, pelvis
and lower limbs. | Different
A distinction between "In-
tended use" and "indications
for use" has been made based
on the recommendations of
the FDA Guidance " The
510(k) Program: Evaluating
Substantial Equivalence in
Premarket
Notifications
[510(k)]" (section IV, D, 1). |
| Medical Device Software
Name | EndoNaut
(Predicate Device)
K171829 | EndoNaut
(Subject Device) | Comparable Properties and
Substantial
Equivalence Discussion |
| Labelling | 1 label in the "about" section
for the Medical Device Soft-
ware with the Trade Name
"EndoNaut"
+
1 label for the Separate inter-
ventional tools workstation
with the Trade Name "Endo-
Naut" and Product Number
= TS1CA2DS1-1 + unique
Serial (production) Number | 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) | Different
Each component of the En-
doNaut System has its
proper labelling.
Complete review of Label-
ling design. Use of symbols
of ISO 15223-1.
Addition of UDI.
Identical
The system has a unique
identifier (S/N). |
| Directions for use (User
Guide(s)) | 1 User guide for EndoNaut | 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. | Different
The directions for use have
been enhanced to clearly dis-
tinguish the instructions spe-
cific to the medical device
Software, "EndoNaut SW"
from the instructions specific
to the EndoNaut Work-
station, accessory to Endo-
Naut SW. |
| Hardware compatibility | Software only product; runs
on a separate interventional
tools (imaging) workstation. | 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. | Different
EndoNaut (legacy device)
was intended to be sold with
and installed on the separate
interventional tools work-
station (ref: TS1CA2DS1-1)
or installed on any hardware
meeting the minimum re-
quirements.
The conditions for installing
the software on the work-
station are identical.
Only the model number of
the workstation has changed
(ref: TS1CA2DS1-2). |
| Software Operating System | Win Pro 7 SP1x64
Win Pro 10 64bits | Win Pro 10 64bits | Different
Support for Windows 7
ended on January 14, 2020. |
| Medical Device Software
Name | EndoNaut
(Predicate Device)
K171829 | EndoNaut
(Subject Device) | Comparable Properties an
Substantial
Equivalence Discussion |
| Software interoperability | EndoNaut software requires
the use of EndoSize software
(K160376) to prepare patient
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. | EndoNaut requires the use of
EndoSize
software
(K160376) to prepare patient
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. | Similar
Some clarifications are
made.
Preoperative data is a man-
datory input for the use of AI
module, but it is not for the
PAD module.
Preoperative data include
pre-op CT images and sizing
report (in case of AI module
use).
The stent placement strategy
and sizing are usually per-
formed pre-operatively 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. |
| Data management | The user can import and
manage patient data within
the software. Patient data in-
clude pre-op CT images and
sizing report. | The user can import and
manage patient data within
the software. Patient data in-
clude pre-op CT images and
sizing report. | Similar
EndoNaut Software now en-
ables import and export of
data with a PACS. |
| 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 module).
AI module only:
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 module).
AI module only:
Before and during the inter-
vention, the user can access
information from pre-opera-
tive sizing report such as pre-
op CT images, measurements,
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 |
| Medical Device Software
Name | EndoNaut
(Predicate Device)
K171829 | EndoNaut
(Subject Device) | Comparable Properties an
Substantial
Equivalence Discussion |
| 3D-2D / 2D-2D Registration | AI module:
Display 2D-3D fusion: 3D
volume pre-op overlay on
per-op 2D fluoroscopy.
Semi-automatic registration
(automatic or manual initial-
ization, automatic computa-
tion and manual validation). | AI module:
Display 2D-3D fusion: 3D
volume pre-op overlay on
per-op 2D fluoroscopy.
Semi-automatic registration
(automatic or manual initial-
ization, automatic computa-
tion and manual validation). | Identical |
| | Lower limbs module:
Panorama creation: Acquisi-
tion 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 fluoros-
copy and 2D fluoroscopy
from recorded panorama. | PAD (lower limbs) module:
Panorama creation: Acquisi-
tion 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 fluoros-
copy and 2D fluoroscopy
from recorded panorama. | |
| Dynamic update on C-arm /
table / patient motion | Automatic motion
detection; registration is
updated manually. | Automatic motion detection
Registration: auto-
matic/manual initialization
and manual user validation. | Different
Improvement of semi-auto-
matic registration (already
existing requirement). The
change does not significantly
affect the use of the device.
No new risks or possible er-
rors were detected or identi-
fied. New clinical data were
not necessary. V&V activi-
ties were performed and suc-
cessful. No additional ques-
tions raised for safety and ef-
fectiveness. |
| Tools | AI module:
Draw markers on intra-oper-
ative images, locate/track
points between per-op and
pre-op images, and take
measurements on pre-op CT
scan images and fusion
view.
Lower limbs module:
Draw lesions markers on
panorama (stenosis and | AI module:
Draw markers on intra-oper-
ative images, locate/track
points between per-op and
pre-op images, and take
measurements on pre-op CT
scan images and fusion
view.
PAD (lower limbs) module:
Draw lesions markers on
panorama (stenosis and | Identical |
| Medical Device Software
Name | EndoNaut
(Predicate Device)
K171829 | EndoNaut
(Subject Device) | Comparable Properties an
Substantial
Equivalence Discussion |
| | thrombosis), calibrate the
length of previous marked
lesions due to inserted mate-
rial, draw markers, create a
control panorama. | thrombosis), calibrate the
length of previous marked
lesions due to inserted mate-
rial, draw markers, create a
control panorama. | |
| Patient contacting | No | No | Identical |
| Energy emitted or absorbed | No | No | Identical |
| Workstation main display &
computer | Panel PC Baaske, model e-
medic Silence TP 4
Rated AC 100-240V, 2.3-
0.8A 50-60Hz | Panel PC ACL OR-PC
27LP
Rated AC 100-240V, 1.5-0.6
A ~47 – 63 Hz | Different
No new risks or possible er-
rors were detected or identi-
fied. V&V activities were
performed and successful.
No additional questions
raised for safety and effec-
tiveness. |
| | Monitor size: 24" LCD
Brigthness: 250 cd/ m2 typi-
cal
Resolution: 1920 x 1080
Cooling Fanless (no mainte-
nance) | Monitor size: 27" LCD
Brightness: 300 cd/m2
Resolution: 1920 x 1080
Cooling Fanless (no mainte-
nance) | |
| Workstation secondary dis-
play (touch screen) | One Touch monitor ELO,
model 1519LM,
rated AC 100-240V 1.2-
0.63A 60/50Hz
Monitor size: 15.6" LCD
Resolution: 1366 x 768
Brightness: 225 cd/m2
Touch technology: PCAP | One Touch monitor ELO
model 1502L,
rated AC 100-240 V
Input frequency: 50-60 Hz
Monitor size: 15.6" LCD
Resolution: 1920 x 1080
Brightness: 270 cd/m2
Touch technology: PCAP | Similar
New monitor provides
more effective visual image
resolution.
No new risks or possible er-
rors were detected or identi-
fied. |
| 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. | Identical |
| Workstation dimensions | Height: 1742 mm
Width (footprint): 661 (640)
mm
Depth (footprint): 950 (660)
mm
Weight: 71 kg | Height: 1740 mm
Width (footprint): 661 (640)
mm
Depth (footprint): 950 (660)
mm
Weight: 70 kg | Similar
Minor dimensional and
weight changes do not result
in additional risks. |
| Connectors | Digital video input: DVI-D
or DVI-I*
Analog video input: BNC
Video output: DisplayPort
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) | Similar
Simply a new more common
video interface is now used. |
| Medical Device Software
Name | EndoNaut
(Predicate Device)
K171829 | EndoNaut
(Subject Device) | Comparable Properties an
Substantial
Equivalence Discussion |
| 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
BNC front cable
USB 3.0 front cable 1m
(x2)
Power supplies
Power supply extension jack
2.5mm 3m IEC extension
cable 1m (red)
IEC extension cable 0.5m
(blue)
External power sup-
ply ELO TOUCH
1519LM
External power sup-
ply Baaske
Video cabling: DVI 5m
Other cables:
DisplayPort DVI ca-
ble 1.5m
USB 3.0 A/B 1m
USB 2.0 2m | Connection Box
Front cable RJ45
DVI front cable
USB 3.0 front cable
1m (x2)
Power supplies
Power supply extension IEC
C7-C14
Power supply extension jack
2.5mm 3m
IEC extension cable 1m
(red)
IEC extension cable 0.5m
(blue)
External power supply XP
POWER (for ELO TOUCH
1502L)
External power supply
BICKER (for ACL ORPC-
27LP) BET-1012M
Video cabling: DVI 5m
Other cables:
HDMI cable 1.5m
HDMI/DP adapter
USB 3.0 A/B 1m
USB 2.0 2m
Equipotential 1,5m | Different
No new risks or possible er-
rors were detected or identi-
fied. V&V activities were
performed and successful.
No additional questions
raised for safety and effec-
tiveness. |
| IEC 62304 | Applied | Applied | Identical |
| IEC 62366 | Applied | Applied | Identical |
| ISO 14971 | Applied | Applied | Identical |
| DICOM Standard parts 1-20 | Applied | Applied | Similar
A newer DICOM Conform-
ance Statement has been
written for EndoNaut Sys-
tem Software and is pro-
vided in Appendix 2. |
| Conformity to IEC 60601-1
of the separate interventional
tools 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. |
| Medical Device Software
Name | EndoNaut
(Predicate Device)
K171829 | EndoNaut
(Subject Device) | Comparable Properties an
Substantial
Equivalence Discussion |
| Conformity to ANSI AAMI
ES60601-1:2005/(R)2012
and
A1:2012,
C1:2009/(R)2012
and
A2:2010/(R)2012 (Consoli-
dated Text) of the separate
interventional tools work-
station | No | Yes | Different
US deviations to IEC 60601-
1 are taken into account for
the new model of separate
interventional tools work-
station (TS1CA2DS1-2). |
| Conformity to IEC 60601-2
of the separate interventional
tools workstation | 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 the separate interven-
tional tools workstation | Yes | Yes | Identical
IEC 60601-1-6 FDA recog-
nized standard version is ap-
plied and included in V&V
protocol and results. |
6
Image /page/6/Picture/1 description: The image is a logo for a company called "Therenva". The logo consists of a stylized teal and gray icon on the left, followed by the company name in gray, and the tagline "Share medical innovation" in a smaller font below the name. The icon appears to be a combination of a curved teal shape and a gray circle.
7
Image /page/7/Picture/1 description: The image shows the logo for Therenva. The logo consists of a teal-colored, curved shape that resembles a leaf or wing, partially overlapping a gray circle. To the right of the graphic is the word "Therenva" in gray, block letters. Below "Therenva" is the tagline "Share medical innovation" in a smaller, lighter gray font.
8
Image /page/8/Picture/1 description: The image shows the logo for Therenva, a company that shares medical innovation. The logo consists of a stylized symbol on the left, resembling a teal sail or leaf intersecting with a gray circle. To the right of the symbol is the company name, "Therenva," in gray, block letters. Below the name, in a smaller font, is the tagline "Share medical innovation".
9
Image /page/9/Picture/1 description: The image shows the logo for Therenva, a company that shares medical innovations. The logo consists of a teal abstract shape and a gray circle on the left, followed by the company name "Therenva" in gray, and the tagline "Share medical innovation" in a smaller font size below the name. The logo is clean and modern, with a focus on innovation and medical technology.
10
Image /page/10/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 sail or a wing. The company name is written in gray, with the tagline "Share medical innovation" below it in a smaller font.
11
Image /page/11/Picture/1 description: The image is a logo for Therenva, a company that shares medical innovation. The logo consists of a teal-colored abstract shape that resembles a sail or a leaf, next to a gray circle. To the right of the circle is the company name, "Therenva," in gray, with the tagline "Share medical innovation" in a smaller font below.
12
Image /page/12/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, lighter gray font.
13
Image /page/13/Picture/1 description: The image shows the logo for Therenva. The logo consists of a teal abstract shape that looks like a sail, a gray circle, and the word "Therenva" in gray. Below the word "Therenva" is the phrase "Share medical innovation" in a smaller, lighter gray font.
6. Summary of the technical characteristics
EndoNaut (Subject Device) has identical intended users, indications for use, anatomical location, limitations, patient population, environment of use than the predicate device, EndoNaut (Legacy Device).
EndoNaut (Subject Device) has similar HW and SW compatibilities, principle of operation and technical characteristics as the predicate device, EndoNaut.
EndoNaut workstation TS1CA2DS1-2 has similar material characteristics (design, power, principle of operation) than the predicate accessory, the separate intervention tools workstation TS1CA2DS1-1.
The differences between the new modified device and accessories to their predicates do not raise any question with respect to the safety and effectiveness of the subject device and accessory.
7. Performance Data
The predicate device (K171829) 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 Reviews
- Testing on unit level (Module verification)
- . Integration testing (EndoNaut Software embedded on the EndoNaut Workstation accessory and tests on several operating systems)
- Interoperability testing (with EndoSize Software) ●
- 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 as it its predicate TS1CA2DS1-1 by the COFRAC accredited testing laboratory. These tests showed that the EndoNaut Workstation TS1CA2DS1-2 meets the design specification and performed as intended.
14
Image /page/14/Picture/1 description: The image is a 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.
They 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
- . IEC 62366 - medical devices - Application of usability engineering to medical devices
Specific to the 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 ●
8. Statement of substantial equivalence
Based on the information supplied in this Special 510(k), Therenva SAS concludes that the EndoNaut (Subject device) and accessories
-
are substantially equivalent to the predicate devices and accessories .
and -
are safe and effective. ●