(174 days)
Not Found
Yes
The summary explicitly mentions "machine vision tracking of vertebral anatomy," which is a strong indicator of AI/ML being used for image analysis and tracking.
No
Explanation: A therapeutic device is one that treats or prevents a disease or condition. This device is described as providing image guidance to assist in endovascular procedures, which classifies it as a diagnostic or guidance tool, not a therapeutic one.
No
Explanation: The device is described as providing "image guidance by overlaying preoperative 3D vessel anatomy... onto live fluoroscopic images in order to assist in the positioning of guidewires, catheters and other endovascular devices." It is "intended to assist fluoroscopy-guided endovascular procedures" and is not intended for diagnostic purposes. Its function is to assist in surgical procedures, not to diagnose medical conditions.
Yes
The device description explicitly states "Cydar EV is a software only medical device." While it has hardware requirements and interacts with hardware (client machines, video framegrabber, X-ray machine), the device itself, as marketed and described, is the software running on the cloud servers.
Based on the provided information, Cydar EV is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Cydar EV's Function: Cydar EV is an image guidance system. It uses pre-existing medical images (CT scans) and live imaging (fluoroscopy) to assist medical professionals during surgical procedures. It does not analyze biological specimens.
- Intended Use: The intended use clearly states it's for "image guidance by overlaying preoperative 3D vessel anatomy... onto live fluoroscopic images in order to assist in the positioning of guidewires, catheters and other endovascular devices." This is a procedural assistance tool, not a diagnostic test performed on a specimen.
Therefore, Cydar EV falls under the category of a medical device used for image guidance during surgical procedures, not an In Vitro Diagnostic device.
No
The letter does not mention that the FDA has reviewed and approved or cleared a PCCP for this specific device.
Intended Use / Indications for Use
Cydar EV provides image guidance by overlaying preoperative 3D vessel anatomy, from a previously acquired contrast-enhanced, diagnostic CT scan, onto live fluoroscopic images in order to assist in the positioning of guidewires, catheters and other endovascular devices.
Cydar EV is intended to assist fluoroscopy-guided endovascular procedures in the lower thorax, abdomen and pelvis. Suitable procedures include (but are not limited to) endovascular aortic aneurysm repair (AAA and mid-distal TAA), angioplasty, stenting and embolization in the common iliac, proximal external iliac and proximal internal iliac arteries and corresponding veins.
Cydar EV is not intended for use in the X-ray guided procedures in the liver, kidneys or pelvic organs.
Product codes
OWB
Device Description
Cydar EV is a Software-as-a-Service product and consists only of the software running on Cydar's cloud servers. Cydar EV provides augmented reality enhanced X-ray fluoroscopy images for use during X-ray guided surgery.
Cydar EV is a software only medical device. It defines minimum requirements to the hardware it runs on. Access to Cydar EV will be effected by a secure connection over either private networks or the public Internet.
The cloud communication, storage and processing solution is operated and maintained by specially trained Cydar Ltd staff and is based on the Ubuntu Linux operating system (versions 12.4 and 14.4). The client machines are based on Microsoft Windows 8.1, running the Google Chrome web-browser (version 47) and equipped with a video framegrabber (Foresight AccuStream Express HD+). The client machine captures a live fluoroscopy video feed from the X-rays machine's external (secondary) video port using HDMI, DVI, S-video, or analogue format. Any platform, which complies with the specified minimum hardware and software requirements and with successful system self-test and validation activities can be supported.
The Cydar EV will be marketed as a software only solution for the end-user (with recommended hardware requirements). Any special needs such as integration in a specific environment and updates / upgrades will be covered by individual service contract and fulfilled by specially trained service technicians.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
contrast-enhanced, diagnostic CT scan, live fluoroscopic images
Anatomical Site
lower thorax, abdomen and pelvis, common iliac, proximal external iliac and proximal internal iliac arteries and corresponding veins. Not intended for use in the liver, kidneys or pelvic organs.
Indicated Patient Age Range
18 or older
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)
Non-Clinical Performance Data:
Non-clinical performance testing was performed to demonstrate safety and effectiveness and compliance with:
- IEC 62304:2015 Medical device software – Software life cycle processes
- IEC 62366-1:2015 Medical devices – Application of usability engineering to medical devices
- ISO 14971:2007 Medical devices – Application of risk management to medical devices
- NEMA PS 3.1-3.20 Digital Imaging and Communications in Medicine (DICOM) Set (2011)
- Guidance for Industry and FDA Staff – Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (issued May 11, 2005).
Software verification testing included:
- registration accuracy calculated from images of the vertebral anatomy as documented in Varnavas A, Carrell T, Penney G. "Fully automated 2D—3D registration and verification" Medical Image Analysis 26 (2015):1 08–119, and
- overlay alignment accuracy in the web browser display, and
- information security, and
- responsiveness of overlays to changes in the fluoroscopy imagery.
Software validation testing included:
- the intended use and commercial claims, and usability testing with representative clinical users ● considering:
- o ease of use,
- o visibility and legibility of displays and overlays
- usability testing with system operators and IT staff,
- testing of the vessel segmentation tool,
- system availability and up-time.
Clinical Performance Data:
Study type: Multi-centre observational study.
Clinical Endpoints: Primary endpoints were the accuracy, robustness, usability, procedure time, radiation exposure, and iodinated contrast volume.
Subject Inclusion/Exclusion: Patients who were willing and able to give informed consent, aged 18 or older, scheduled to undergo an X-ray guided intervention in an anatomic zone covered by the technology, had a pre-operative CT scan, and able and willing to comply with the study requirements.
Study Monitoring: Cloud monitoring and data collection performed by Cydar Ltd.
Key results: The clinical endpoint and user feedback data supported the hypothesis of clinical effectiveness. Results of the clinical investigation support the indications for use of the Cydar EV to provide image guidance by overlaying preoperative (diagnostic) 3D vessel anatomy onto live fluoroscopic images in order to assist in the positioning of guidewires, catheters and other endovascular devices by achieving accurate, robust, and usable image guidance. Clinical study conclusion confirms that the device is safe and effective as used according to the instructions for use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized graphic of three human profiles facing right, stacked on top of each other. The profiles are rendered in a dark color, possibly black or a dark shade of gray. The graphic is encircled by text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 7, 2016
Cydar Ltd. % Mr. Richard Vincins Vice President, OA/RA Emergo Global Consulting, LLC 816 Congress Avenue, Suite 1400 AUSTIN TX 78701
Re: K160088
Trade/Device Name: Cydar EV Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: II Product Code: OWB Dated: May 24, 2016 Received: June 1, 2016
Dear Mr. Vincins:
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. 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 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Robert Ochs
Robert Ochs. Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K160088
్రి
Device Name Cydar EV
Indications for Use (Describe)
Cydar EV provides image guidance by overlaying preoperative 3D vessel anatomy, from a previously acquired contrastenhanced, diagnostic CT scan, onto live fluoroscopic images in order to assist in the positioning of guidewires, catheters and other endovascular devices.
Cydar EV is intended to assist fluoroscopy-guided endovascular procedures in the lower thorax, abdomen and pelvis. Suitable procedures include (but are not limited to) endovascular aortic aneurysm repair (AAA and mid-distal TAA), angioplasty, stenting and embolization in the common iliac, proximal external iliac and proximal internal iliac arteries and corresponding veins.
Cydar EV is not intended for use in the X-ray guided procedures in the liver, kidneys or pelvic organs.
| 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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the
time to review instructions, search existing data sources, gather and maintain the data needed and complete
and review the collection of information. Send comments regarding this burden estimate or any other aspect
of this information collection, including suggestions for reducing this burden, to:
| Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff |
|---|
| PRAStaff@fda.hhs.gov |
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of
information unless it displays a currently valid OMB number."
3
Section 5 – 510(k) Summary
Device Name: Cydar EV
K160088
1. 1. Submission Sponsor
Cydar Ltd
Bulbeck Mill
Mill Lane
Barrington
Cambridgeshire
CB22 7QY
UK
Phone number: +44 1223 778 020
Contact: John Clarke
Title: CTO
2. Submission Correspondent
Emergo Global Consulting, LLC
816 Congress Avenue
Suite 1400
Austin, TX 78701
USA
Office Phone: +1 512 327 9997
Contact: Richard A. VINCINS, CQA, CBA, RAC(EU,US)
Title: Vice President, QA/RA
Email: project.management@emergogroup.com
4
3. Date Prepared
24 May 2016
4. Device Identification
| Trade/Proprietary Name: | Cydar EV |
|---|---|
| Common/Usual Name: | Interventional Fluoroscopic X-Ray System |
| Classification Name: | Interventional Fluoroscopic X-Ray System |
| Regulation Number: | 892.1650 |
| Product Code: | OWB, Interventional Fluoroscopic X-Ray System |
| Device Class: | Class II |
| Classification Panel: | Radiology |
5. Legally Marketed Predicate Device
K151598 - VesselNavigator - Philips Medical Systems Nederland B.V.
6. Device Description
Cydar EV is a Software-as-a-Service product and consists only of the software running on Cydar's cloud servers. Cydar EV provides augmented reality enhanced X-ray fluoroscopy images for use during X-ray guided surgery.
Cydar EV is a software only medical device. It defines minimum requirements to the hardware it runs on. Access to Cydar EV will be effected by a secure connection over either private networks or the public Internet.
The cloud communication, storage and processing solution is operated and maintained by specially trained Cydar Ltd staff and is based on the Ubuntu Linux operating system (versions 12.4 and 14.4). The client machines are based on Microsoft Windows 8.1, running the Google Chrome web-browser (version 47) and equipped with a video framegrabber (Foresight AccuStream Express HD+). The client machine captures a live fluoroscopy video feed from the X-rays machine's external (secondary) video port using HDMI, DVI, S-video, or analogue format. Any platform, which complies with the specified minimum hardware and software requirements and with successful system self-test and validation activities can be supported.
The Cydar EV will be marketed as a software only solution for the end-user (with recommended hardware requirements). Any special needs such as integration in a specific environment and updates / upgrades will be covered by individual service contract and fulfilled by specially trained service technicians.
5
7. Indication for Use Statement
Cydar EV provides image guidance by overlaying preoperative 3D vessel anatomy, from a previously acquired contrast-enhanced, diagnostic CT scan, onto live fluoroscopic images in order to assist in the positioning of guidewires, catheters and other endovascular devices.
Cydar EV is intended to assist fluoroscopy-guided endovascular procedures in the lower thorax, abdomen and pelvis. Suitable procedures include (but are not limited to) endovascular aortic aneurysm repair (AAA and mid-distal TAA), angioplasty, stenting and embolization in the common iliac, proximal external iliac and proximal internal iliac arteries and corresponding veins.
Cydar EV is not intended for use in the X-ray guided procedures in the liver, kidneys or pelvic organs.
8. Substantial Equivalence Discussion
The following table compares the Cydar EV to the predicate device with respect to indications for use, principles of operation, technological characteristics, materials, and performance testing. The comparison of the devices provides more detailed information regarding the basis for the determination of substantial equivalence. The subject device does not raise any new issues of safety or effectiveness based on the similarities to the predicate device.
| Manufacturer | Cydar Ltd | Philips Medical Systems
Nederland B.V. | Significant
Differences |
|--------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade Name | Cydar EV
(Subject device) | VesselNavigator
(Predicate device) | N/A |
| 510(k)
Number | K160088 | K151598 | N/A |
| Product Code | OWB | OWB / LLZ | Similar; the Product
Code LLZ is not
considered as
product is not a
PACS system |
| Regulation
Number | 892.1650 | 892.1650 / 892.2050 | Similar; the
regulation number
892.2050 is not
considered as
product is not a
PACS system |
| Regulation
Name | Interventional Fluoroscopic X-
Ray System | Interventional Fluoroscopic X-Ray
System / Picture Archiving and | Similar; the
regulation number |
| Manufacturer | Cydar Ltd | Philips Medical Systems
Nederland B.V. | Significant
Differences |
| Trade Name | Cydar EV
(Subject device) | VesselNavigator
(Predicate device) | |
| | | Communications System | 892.2050, PACS, is
not considered as
product is not a
PACS system |
| Intended use | Display of combined live 2D X-ray fluoroscopy and 3D anatomy for image guidance during surgery. | Display of combined live 2D X-ray fluoroscopy and 3D anatomy for image guidance during surgery. | Identical |
| 3D imaging | Pre-operative | Pre-operative | Identical |
| X-ray fluoroscopy | Live | Live | Identical |
| Indications for Use | Cydar EV provides image guidance by overlaying preoperative 3D vessel anatomy, from a previously acquired contrast-enhanced, diagnostic CT scan, onto live fluoroscopic images in order to assist in the positioning of guidewires, catheters and other endovascular devices.
Cydar EV is intended to assist fluoroscopy-guided endovascular procedures in the lower thorax, abdomen and pelvis. Suitable procedures include (but are not limited to) endovascular aortic aneurysm repair (AAA and mid-distal TAA), angioplasty, stenting and embolization in the common iliac, proximal external iliac and proximal internal iliac arteries and corresponding | VesselNavigator provides image guidance by superimposing live fluoroscopic images on a 3D volume of the vessel anatomy to assist in catheter maneuvering and device placement.
VesselNavigator is intended to assist in the treatment of endovascular diseases during procedures such as (but not limited to) AAA, TAA, carotid stenting, iliac interventions. | Similar; indications for both devices emphasize image guidance for fluoroscopy-guided endovascular procedures |
| Manufacturer | Cydar Ltd | Philips Medical Systems
Nederland B.V. | Significant
Differences |
| Trade Name | Cydar EV
(Subject device)
veins.
Cydar EV is not intended for
use in the X-ray guided
procedures in the liver,
kidneys or pelvic organs. | VesselNavigator
(Predicate device) | |
| Construction | Software product | Software product | Identical |
| Host
computer | Separate interventional tools
workstation | Separate interventional tools
workstation | Identical |
| Registration
Overview | 2D-3D registration is achieved
by machine vision tracking of
vertebral anatomy | 2D-3D registration is achieved by
manual initialization and/or
correction followed by dead
reckoning based on
electromechanical tracking of
table and C-arm | Different; the
predicate and
subject devices use
different methods
to perform the
underlying 2D-3D
image registrations
though viewing of
the image overlay
functionality is
then performed the
same with no
additional
questions raised for
safety or efficacy |
| Registration
target | Vertebral anatomy | X-ray C-arm and operating table | Different; targets
reflect different
registration
methods with the
image overlay
functionality being
the same with no
additional
questions raised for
safety or efficacy |
| Patient
contacting | No | No | Identical |
| Manufacturer | Cydar Ltd | Philips Medical Systems
Nederland B.V. | Significant
Differences |
| Trade Name | Cydar EV
(Subject device) | VesselNavigator
(Predicate device) | |
| Energy
emitted or
absorbed | No | No | Identical |
| Dynamic
update on C-
arm / table
motion | Automatic | Automatic | Identical |
| Dynamic
update on
patient
motion | Automatic | Semi-automatic based on
movement of the gantry | Similar; automatic
response to patient
motion allows
registration to
continuously occur
with no additional
questions raised for
safety or efficacy |
| Anatomical
Location | Vascular anatomy of the
chest, abdomen and pelvis. | All vascular anatomy except
coronaries and intracranial
vessels | Similar; the subject
device is restricted
to anatomy
considered
immobile with
respect to the
vertebral column
with no additional
questions raised for
safety or efficacy |
| Ability to
store
roadmaps | Yes | Yes | Identical |
| Ability to
store
snapshots | Yes | Yes | Identical |
| Non-clinical performance data | | | |
| IEC 62304 | Applied | Applied | Identical |
| IEC 62366 | Applied | Applied | Identical |
| Manufacturer | Cydar Ltd | Philips Medical Systems
Nederland B.V. | Significant
Differences |
| Trade Name | Cydar EV
(Subject device) | VesselNavigator
(Predicate device) | |
| ISO 14971 | Applied | Applied | Identical |
| NEMA PS 3.1-
3.20
DICOM | Applied | Applied | Identical |
Table 5A – Comparison of Characteristics
6
7
8
9
9. Non-Clinical Performance Data
As part of demonstrating the safety and effectiveness of Cydar EV and in showing substantial equivalence to the predicate device that is the subject of this 510(k) submission, Cydar Ltd completed a number of non-clinical performance tests. The Cydar EV meets all the requirements for overall design confirming that the design output meets the design inputs and specifications for the device.
Non-clinical performance testing has been performed on Cydar EV and demonstrates compliance with the following International and FDA-recognized consensus standards and FDA guidance document:
- IEC 62304:2015 Medical device software – Software life cycle processes
- IEC 62366-1:2015 Medical devices – Application of usability engineering to medical devices
- ISO 14971:2007 Medical devices – Application of risk management to medical devices
- NEMA PS 3.1-3.20 Digital Imaging and Communications in Medicine (DICOM) Set (2011)
- . Guidance for Industry and FDA Staff – Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (issued May 11, 2005).
Software verification testing has been performed in accordance with the software verification plan to cover the system requirements at system/integration and unit levels as documented in this submission as well as the identified hazard mitigations. Software verification included:
- registration accuracy calculated from images of the vertebral anatomy as documented in Varnavas A, Carrell T, Penney G. "Fully automated 2D—3D registration and verification" Medical Image Analysis 26 (2015):1 08–119, and
- overlay alignment accuracy in the web browser display, and
- information security, and
- . responsiveness of overlays to changes in the fluoroscopy imagery.
Software validation testing has been performed in accordance with the software validation plan and included:
10
- the intended use and commercial claims, and usability testing with representative clinical users ● considering:
- o ease of use,
- o visibility and legibility of displays and overlays
- . usability testing with system operators and IT staff,
- testing of the vessel segmentation tool,
- system availability and up-time.
All of these tests were used to support substantial equivalence of the subject device.
The test results in this 510(k) premarket notification demonstrate that Cydar EV:
- . complies with the aforementioned international and FDA-recognized consensus standards and FDA guidance document, and
- . meets the acceptance criteria and is adequate for its intended use.
Therefore, Cydar EV is substantially equivalent to the currently marketed predicate device VesselNavigator in terms of safety and effectiveness.
10. Clinical Performance Data
A clinical investigation was conducted to evaluate safety and efficacy of the Cydar EV to provide image guidance by overlaying preoperative (diagnostic) 3D vessel anatomy onto live fluoroscopic images in order to assist in the positioning of guidewires, catheters and other endovascular devices. Cydar EV is intended to assist fluoroscopy-guided endovascular procedures in the chest, abdomen and pelvis. Suitable procedures include (but are not limited to) endovascular aortic aneurysm repair (TAA and AAA), iliac (arterial and venous) angioplasty, stenting and embolisations. The design was a multi-centre observational study examining safety, performance, usability, and clinical effect. The overall design of the clinical study is shown as follows:
- . Clinical Endpoints: Primary endpoints were the accuracy, robustness, usability, procedure time, radiation exposure, and iodinated contrast volume
- Subject Inclusion/Exclusion: The trial participants were patients who:
- O were willing and able to give informed consent, and
- were aged 18 or older, and O
- were scheduled to undergo an X-ray guided intervention in an anatomic zone covered O by the technology, and
- had had a pre-operative CT scan, and O
- O were able and willing to comply with the study requirements.
- Study Monitoring: Cloud monitoring and data collection was performed by Cydar Ltd
11
The clinical endpoint and user feedback data supported the hypothesis of clinical effectiveness. Results of the clinical investigation support the indications for use of the Cydar EV to provide image guidance by overlaying preoperative (diagnostic) 3D vessel anatomy onto live fluoroscopic images in order to assist in the positioning of guidewires, catheters and other endovascular devices by achieving accurate, robust, and usable image guidance. Clinical study conclusion confirms that the device is safe and effective as used according to the instructions for use.
11. Statement of Substantial Equivalence
The Cydar EV, as designed and manufactured, is determined to be substantially equivalent to the referenced predicate device.