Cydar EV (Series B) and Cydar EV Maps

K212442 · Cydar , Ltd. · OWB · Dec 3, 2021 · Radiology

Device Facts

Record IDK212442
Device NameCydar EV (Series B) and Cydar EV Maps
ApplicantCydar , Ltd.
Product CodeOWB · Radiology
Decision DateDec 3, 2021
DecisionSESE
Submission TypeTraditional
Regulation21 CFR 892.1650
Device ClassClass 2
AttributesSoftware as a Medical Device

Intended Use

Cydar EV provides tools to: Import and visualise CT data Segment and annotate vascular anatomy from CT data Place and edit virtual guidewires and measure lengths on them Make measurements of anatomical structures on planar sections of the CT data Produce an operative plan from measurements and segmentation of preoperative vessel anatomy Overlay planning information such as preoperative vessel anatomy onto live fluoroscopic images, aligned based on the position of anatomical features present in both Non-rigidly transform the visualisation of anatomy when intra-operative vessel deformation is observed Post-operatively review data relating to procedures where the system was used

Device Story

Cydar EV is a cloud-based SaaS platform for endovascular surgery planning and intra-operative guidance. It imports patient CT data to allow clinicians to segment vascular anatomy, perform measurements, and create a 3D 'Pre-operative Map'. During surgery, the system overlays this map onto live fluoroscopic X-ray images, using anatomical features for alignment. Clinicians can non-rigidly transform the map to account for intra-operative vessel deformation. The system is operated by vascular surgeons, interventional radiologists, and specialist nurses in the OR or office. It provides visual guidance to assist in device positioning; it does not control surgical instruments or life-sustaining equipment. The output is interpreted by the clinician, who must verify real-time anatomy via contrast angiography before device deployment. Benefits include improved visualization and planning for complex endovascular procedures.

Clinical Evidence

Bench testing only. Software verification and validation were conducted to confirm performance, functionality, and reliability, specifically for the new measurement and annotation features. The device passed all pre-determined pass/fail criteria.

Technological Characteristics

Software-as-a-Service (SaaS) platform hosted on cloud servers. Operates via standard web browser on a client PC (Cydar Appliance). Complies with DICOM (NEMA PS 3.1-3.20) standards. Adheres to IEC 62304 (software lifecycle), IEC 62366 (usability), and ISO 14971 (risk management). No patient contact; no hardware control.

Indications for Use

Indicated for patients undergoing fluoroscopic X-ray guided endovascular surgery in the chest, abdomen, and pelvis who have had a pre-operative CT scan. Not recommended for patients under 18 due to unknown performance in immature vertebral anatomy.

Regulatory Classification

Identification

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

Special Controls

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

Predicate Devices

Related Devices

Submission Summary (Full Text)

{0}------------------------------------------------ December 3, 2021 Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the seal of the Department of Health & Human Services. To the right of the seal is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font below. Cydar Ltd. % Vanisha Mistry Head of Compliance Bulbeck Mill. Mill Lane Barrington, Cambs CB22 7QY UNITED KINGDOM Re: K212442 Trade/Device Name: Cydar EV Series B, Cydar EV Maps Regulation Number: 21 CFR 892.1650 Regulation Name: Image-Intensified Fluoroscopic X-Ray System Regulatory Class: Class II Product Code: OWB Dated: November 3, 2021 Received: November 5, 2021 Dear Vanisha Mistry: 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, , for 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) K212442 Device Name Cydar EV Series B, Cydar EV Maps #### Indications for Use (Describe) Cydar EV provides tools to: - Import and visualise CT data - · Segment and annotate vascular anatomy from CT data - · Place and edit virtual guidewires and measure lengths on them - Make measurements of anatomical structures on planar sections of the CT data - · Produce an operative plan from measurements and segmentative vessel anatomy · Overlay planning information such as preoperative vessel anatomy onto live fluoroscopic images, aligned based on the position of anatomical features present in both - · Non-rigidly transform the visualisation of anatomy when intra-operative vessel deformation is observed - · Post-operatively review data relating to procedures where the system was used Cydar EV is intended to assist fluoroscopic X-ray guided endovascular procedures in the chest, abdomen, and pelvis by presenting the operative plan in the context of intraoperative fluoroscopy. Cydar EV is intended to be used for patients undergoing a fluoroscopic X-ray guided endovascular surgery in the chest abdomen and pelvis, and who have had a pre-operative CT-scan. The performance of the Cydar EV software in the presence of immature vertebral anatomy is unknown. The Instructions for Use explicitly state this uncertainty and that the software is therefore not recommended for use in patients under the age of 18. IMPORTANT: Pre-Operative Maps show static anatomy derived from the pre-operative CT. Real-time anatomy moves with the cardiorespiratory cycle; progressive disease may cause the anatomy to change over time; and stiff wires, stents or other surgical instruments, may straighten and displace blood vessels from the pre-operative position It is therefore mandatory to check the real-time anatomy with a suitable imaging technique, such as contrast angiography, before deploying any invasive medical device. 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) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ Image /page/3/Picture/1 description: The image shows the logo for "Cydar Medical". The logo consists of a green target symbol on the left, followed by the text "Cydar Medical" in a dark blue sans-serif font. The target symbol is a circle with a crosshair inside. # Cydar Ltd 510(k) Submission: Cydar EV Series B # Section 5: 510(k) Summary Wed Nov 3 (git: 2 a 6 2 7 2 a) # Contents - · S05.1 Section 5: 510(k) Summary - Submitter Details · S05.1.1 - · S05.1.2 Device Name - · S05.1.3 Predicate Device Identification - · S05.1.4 Device Description - · S05.1.5 Statement of Intended Use - Indications for Use · S05.1.5.1 - · S05.1.5.2 Differences from Predicate Device - · S05.1.6 Predicate Device Comparison - · S05.1.7 Technological Characteristics - · S05.1.8 Performance Data - · S05.1.9 Benefit- Risk Conclusion # S05.1 Section 5: 510(k) Summary ## S05.1.1 Submitter Details | Business Name | Cydar Ltd | |---------------|----------------------------------------------------------------| | Address | Bulbeck Mill<br>Barrington<br>Cambridgeshire<br>CB22 7QY<br>UK | Contact person: {4}------------------------------------------------ | Name | Rob Hague | |--------------|-----------------------| | Position | CTO | | Phone number | +44 1223 778 020 | | Email | rob.hague@cydar.co.uk | #### US Agent: | Contact Name | Michael van der Woude | |---------------|------------------------------------------------------------------------------| | Business Name | Emergo Global Representation LLC | | Address | 2500 Bee Cave Road<br>Bldg 1, Suite 300<br>Austin, TX 78746<br>United States | | Phone | 512 327-9997 | | Fax | 512 327-9998 | | Email | USAgent@UL.com | This summary was prepared on 2021-11-03. ## S05.1.2 Device Name The device is know as Cydar EV. It is an an evolution of a previous device of the same name, which is the subject of 510(k) K160088. To distinguish the two devices, the older device is referred to as Cydar EV Series A, and the device that is the subject of this application Cydar EV Series B. Unless otherwise stated, Cydar EV in this application refers to the subject device, Cydar EV Series B. Both devices are referred to as Cydar EV Maps in all literature supplied to the user, with a version number to distinguish a specific release of the software. At the time Cydar EV Series B is placed on the market, the next version number will be assigned to the first release of that device. | Type of 510(k) Submission | Traditional | |---------------------------|---------------------------------------------------------------| | Trade or Proprietary Name | Cydar EV Also referred to as Cydar EV Series B, Cydar EV Maps | | Common or Usual Name | Interventional Fluoroscopic X-Ray System | | Regulation Number | 21 CFR 892.1650 | | Product Code | OWB, Interventional Fluoroscopic X-Ray System | | Class of Device | Class II | | Panel | Radiology | | Multiple Devices | None. | {5}------------------------------------------------ ## S05.1.3 Predicate Device Identification All aspects of Cydar EV's functionality are substantially equivalent to one or both legally marketed predicate devices listed below. | Device | Manufacturer | 510(k) | Scope | |------------------------------|--------------|---------|-----------------------------------------------------------| | Cydar EV (primary predicate) | Cydar Ltd | K160088 | CT import, intra-operative overlay, post-operative review | | Endosize | Therenva SAS | K141475 | Measurements and segmentation on CT scans | ## S05.1.4 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 enables expert clinical users to build an operative plan, called a Pre-operative Map, which consists of 3D blood vessel anatomy from the patient's CT scan. measurements, and other annotations deemed relevant by the clinical user. During surgery, Cydar EV's fusion imaging superimposes the Pre-operative Map on a duplicated display of the X-ray fluoroscopy. The clinical users can interact and non-rigidly transform a copy of the Map, called the Adjusted Map, when they see that the real-time anatomy has deformed. After surgery, clinical users can review data about the case via the web interface. No specific accessories are required for the use of Cydar EV. The software is provided as a service and accessed via standard web browser. For intra-operative fusion imaging use, the browser is run on a client PC device called the Cydar Appliance. The Cydar Appliance is an off-the-shelf video frame grabber and is not in itself a medical device nor considered in the scope of this 510(k) submission. The Windows image on the PC (ie Cydar Appliance) is controlled by Cydar and not configurable by the end-user. The Cydar Appliance may display its output on one or more external monitors via standard video connections e.g DVI or HDMI (in addition to any built-in display). A particular installation of the PC (ie Cydar Appliance) may provide a touchscreen and/ or peripheral devices such as mice, trackpads, keyboards, and handheld remote control to operate the user interface of the Cydar EV service. The software implementing the upload of CT scans in DICOM format ('Cydar Gateway ') is a medical image communications device and is therefore also not considered in the scope of this 510(k) submission. #### S05.1.5 Statement of Intended Use Cydar EV provides tools to: - Import and visualise CT data - Segment and annotate vascular anatomy from CT data - Place and edit virtual guidewires and measure lengths on them - Make measurements of anatomical structures on planar sections of the CT data - · Produce an operative plan from measurements and segmentation of preoperative vessel anatomy - Overlay planning information such as preoperative vessel anatomy onto live fluoroscopic images, aligned based on the position of anatomical features present in both - Non-rigidly transform the visualisation of anatomy when intra-operative vessel deformation is observed - Post-operatively review data relating to procedures where the system was used #### S05.1.5.1 Indications for Use {6}------------------------------------------------ Cydar EV is intended to assist fluoroscopic X-ray guided endovascular procedures in the chest, abdomen, and pelvis by presenting the operative plan in the context of intraoperative fluoroscopy. Cydar EV is intended to be used for patients undergoing a fluoroscopic X-ray guided endovascular surgery in the chest abdomen and pelvis, and who have had a pre-operative CT-scan. The performance of the Cydar EV software in the presence of immature vertebral anatomy is unknown. The Instructions for Use explicitly state this uncertainty and that the software not recommended for use in patients under the age of 18. IMPORTANT: Pre-Operative Maps show static anatomy derived from the pre-operative CT. Real-time anatomy moves with the cardiorespiratory cycle; progressive disease may cause the anatomy to change over time; and stiff wires, stents or other surgical instruments, may straighten and displace blood vessels from the preoperative position It is therefore mandatory to check the real-time anatomy with a suitable imaging technique, such as contrast angiography, before deploying any invasive medical device. #### S05.1.5.2 Differences from Predicate Device The Indications for Use for Cydar EV Series B are similar to those for Cydar EV Series A (identified as the primary predicate device), with the addition of measurement functionality similar to that indicated for Endosize. Where there are differences, the clinical data demonstrates that this does not impact safety or performance. More detail on this correspondence is provided in the next section. ## S05.1.6 Predicate Device Comparison The following table compares the Cydar EV Series B to the predicate devices 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. Conclusion: No difference in intended surgical interventions between these devices. However the intended targeted anatomy is clarified in Cydar EV Series B. See section references)in this summary. | Assessment<br>Criteria | Cydar EV Series B<br>Cydar Medical Ltd<br>Device under<br>assessment | Cydar EV Series A<br>Cydar Medical Ltd<br>Primary Equivalent Device<br>K160088 | EndoSize<br>Therenva<br>Secondary Equivalent<br>Device<br>K141475 | Identified differences or<br>conclusion of no difference | |----------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 1. Technical Characteristics | | | | | | Assessment<br>Criteria | Cydar EV Series B<br>Cydar Medical Ltd<br>Device under<br>assessment | Cydar EV Series A<br>Cydar Medical Ltd<br>Primary Equivalent Device<br>K160088 | EndoSize<br>Therenva<br>Secondary Equivalent<br>Device<br>K141475 | Identified differences or<br>conclusion of no difference | | Intended Use | Cydar EV provides tools<br>to:<br>• Import and visualise CT<br>data<br>• Segment and annotate<br>vascular anatomy from<br>CT data<br>• Place and edit virtual<br>guidewires and<br>measure lengths on<br>them<br>• Make measurements of<br>anatomical structures<br>on planar sections of<br>the CT data<br>• Produce an operative<br>plan from<br>measurements and<br>segmentation of<br>preoperative vessel<br>anatomy<br>• Overlay planning<br>information such as<br>preoperative vessel<br>anatomy onto live<br>fluoroscopic images,<br>aligned based on the<br>position of anatomical<br>features present in both<br>• Non-rigidly transform<br>the visualisation of<br>anatomy when intra-<br>operative vessel<br>deformation is<br>observed<br>• Post-operatively review<br>data relating to<br>procedures where the<br>system was used | Cydar EV is intended to<br>display combined live 2D X-<br>ray fluoroscopy and 3D<br>anatomy for image guidance<br>during surgery.<br>Features of the device<br>include:<br>Import and visualise CT scan<br>data.<br>Segment and annotate<br>vascular anatomy from CT<br>data.<br>Produce an operative plan<br>Overlay planning<br>information such<br>as preoperative vessel<br>anatomy onto live<br>fluoroscopic images, aligned<br>based on the position of<br>anatomical features present<br>in the fluoroscopic images.<br>Non-rigidly transform the<br>visualisation of anatomy<br>when intra-operative vessel<br>deformation is observed. | EndoSize is a software<br>solution that is intended<br>to provide Physicians and<br>Clinical Specialists with<br>additional information to<br>assist them in reading and<br>interpreting DICOM CT<br>scan images of structures<br>of the heart and vessels.<br>EndoSize enables the user<br>to visualize and measure<br>(diameters, lengths,<br>volumes, angles)<br>structures of the heart<br>and vessels. | Conclusion: Cydar EV Series B<br>is similar intended use to the<br>primary predicate device<br>differing only in additional<br>features; placement and<br>editing virtual guidewires,<br>measurement of lengths and<br>measurement of anatomical<br>structures on planar sections<br>of CT data is similar to the<br>secondary predicate device.<br>Measurement accuracy<br>verification testing and<br>summative user study is<br>performed as part of the<br>design and development<br>process | | Assessment<br>Criteria | Cydar EV Series B<br>Cydar Medical Ltd<br>Device under<br>assessment | Cydar EV Series A<br>Cydar Medical Ltd<br>Primary Equivalent Device<br>K160088 | EndoSize<br>Therenva<br>Secondary Equivalent<br>Device<br>K141475 | Identified differences or<br>conclusion of no difference | | Indications for<br>use | Cydar EV is intended to<br>assist fluoroscopic X-ray<br>guided endovascular<br>procedures in the chest,<br>abdomen, and pelvis by<br>presenting the operative<br>plan in the context of<br>intraoperative<br>fluoroscopy.<br>Cydar EV is intended to be<br>used for patients<br>undergoing a fluoroscopic<br>X-ray guided endovascular<br>surgery in the chest<br>abdomen and pelvis, and<br>who have had a pre-<br>operative CT-scan.<br>The performance of the<br>Cydar EV software in the<br>presence of immature<br>vertebral anatomy is<br>unknown. The<br>Instructions for Use<br>explicitly state this<br>uncertainty and that the<br>software is therefore not<br>recommended for use in<br>patients under the age of<br>18.<br>IMPORTANT: Pre-<br>Operative Maps show<br>static anatomy derived<br>from the pre-operative<br>CT. Real-time anatomy<br>moves with the<br>cardiorespiratory cycle;<br>progressive disease may<br>cause the anatomy to<br>change over time; and stiff<br>wires, stents or other<br>surgical instruments, may<br>straighten and displace<br>blood vessels from the<br>pre-operative position<br>It is therefore<br>mandatory to check the<br>real-time anatomy with<br>a suitable imaging<br>technique, such as<br>contrast angiography,<br>before deploying any<br>invasive medical device. | Cydar EV provides image<br>guidance by overlaying<br>preoperative 3D vessel<br>anatomy from a previously<br>acquired contrast-<br>enhanced, diagnostic CT<br>scan onto live X-ray<br>fluoroscopy images in order<br>to assist in the positioning of<br>guidewires, catheters and<br>other endovascular devices.<br>Cydar EV is intended to<br>assist X-ray fluoroscopy-<br>guided endovascular<br>procedures in the lower<br>thorax, abdomen and pelvis.<br>Suitable procedures include<br>endovascular aortic<br>aneurysm repair,<br>angioplasty, stenting and<br>embolization in the<br>common iliac, proximal<br>external iliac and proximal<br>internal iliac arteries and<br>corresponding veins.<br>Cydar EV is not intended for<br>use in X-ray guided<br>procedures in the liver,<br>kidneys or pelvic organs. | Therenva Endosize<br>enables visualization and<br>measurement of<br>structures of the heart<br>and vessels for pre-<br>operational planning and<br>sizing for cardiovascular<br>interventions and surgery<br>General functionalities<br>are provided such as:<br>• Segmentation of<br>cardiovascular<br>structures<br>• Automatic and manual<br>centreline detection<br>• Visualisation of CT scan<br>images in every planes,<br>2D review, 3D<br>reconstruction, Volume<br>Rendering, MPR,<br>Stretched CMPR<br>• Measurement and<br>annotation tools<br>• Reporting tools | Conclusion: Changes in<br>wording clarifying target<br>anatomy between Cydar EV<br>Series B and primary predicate<br> | | Assessment<br>Criteria | Cydar EV Series B<br>Cydar Medical Ltd<br>Device under<br>assessment | Cydar EV Series A<br>Cydar Medical Ltd<br>Primary Equivalent Device<br>K160088 | EndoSize<br>Therenva<br>Secondary Equivalent<br>Device<br>K141475 | Identified differences or<br>conclusion of no difference | | Classification<br>Product code /<br>regulation | OWB; Interventional<br>Fluoroscopic X-Ray<br>System: Regulation:<br>892.1660 | OWB; Interventional<br>Fluoroscopic X-Ray System<br>Regulation Regulation:<br>892.1660 | LLZ ; System image<br>processing radiology<br>Regulation: 892.2050 | OWB sufficiently covers the<br>intended use of Cydar EV. | | Construction | Software product | Software product | Software Product | No difference | | Performance | Preoperative planning:<br>Import and visualise CT<br>data; Segment and<br>annotate vascular<br>anatomy from CT data;<br>Place and edit virtual<br>guidewires and measure<br>lengths on them; Make<br>measurements of<br>anatomical structures on<br>planar sections of the CT<br>data; Visualise the<br>segmented vascular<br>anatomy, annotations +/-<br>measurements together<br>(the 'Operative Plan')<br>Intra-operative (Fusion<br>imaging functions):<br>Overlay planning<br>information such as<br>preoperative vessel<br>anatomy onto live<br>fluoroscopic images,<br>aligned based on the<br>position of anatomical<br>features present in both;<br>Non-rigidly transform the<br>visualisation of anatomy<br>when intra-operative<br>vessel deformation is<br>observed<br>Post-operative (Review<br>functions): Post-<br>operatively review data<br>relating to procedures<br>where the system was<br>used | Preoperative planning:<br>Import and visualise CT<br>data; Segment and annotate<br>vascular anatomy from CT<br>data; Visualise the<br>segmented vascular<br>anatomy, annotations +/-<br>measurements together (the<br>'Operative Plan')<br>Intra-operative (Fusion<br>imaging functions: Overlay<br>planning information such<br>as preoperative vessel<br>anatomy onto live<br>fluoroscopic images, aligned<br>based on the position of<br>anatomical features present<br>in both; Non-rigidly<br>transform the visualisation<br>of anatomy when intra-<br>operative vessel<br>deformation is observed<br>Post-operative (Review<br>functions): Post-operatively<br>review data relating to<br>procedures where the<br>system was used | Preoperative planning:<br>Visualisation, annotations<br>and measurement<br>performed by clinicians<br>intended to provide<br>referring physicians with<br>clinically relevant<br>information for diagnosis,<br>surgery, and treatment<br>planning. | Conclusion: Difference<br>between Cydar EV Series B and<br>primary predicate are features;<br>place and edit virtual<br>guidewires and measure<br>lengths on them and make<br>measurements of anatomical<br>structures on planar sections<br>of the CT data<br>EndoSize is indicated for<br>preoperative planning only<br>Measurement accuracy<br>verification testing and<br>summative user study is<br>performed as part of the<br>design and development<br>process | | Assessment<br>Criteria | Cydar EV Series B<br>Cydar Medical Ltd<br>Device under<br>assessment | Cydar EV Series A<br>Cydar Medical Ltd<br>Primary Equivalent Device<br>K160088 | EndoSize<br>Therenva<br>Secondary Equivalent<br>Device<br>K141475 | Identified differences or<br>conclusion of no difference | | Design | Cydar EV Series B device is<br>a software only medical<br>device that runs on a<br>standard computer that<br>meets the minimum<br>requirements. It can use<br>local DICOM files or<br>distant PACS server. The<br>device does not contact<br>the patient, nor does it<br>control any life sustaining<br>devices. The information<br>and measurements<br>displayed, exported or<br>printed are validated and<br>interpreted by Physicians.<br>EV Maps complies with<br>the DICOM voluntary<br>standards (ACR/NEMA<br>Digital Imaging and<br>Communication in<br>Medicine). | Cydar EV is a software only<br>medical device that runs on<br>a standard computer that<br>meets the minimum<br>requirements. It can use<br>local DICOM files or distant<br>PACS server. The device<br>does not contact the<br>patient, nor does it control<br>any life sustaining devices.<br>The information and<br>measurements displayed,<br>exported or printed are<br>validated and interpreted by<br>Physicians.<br>EV complies with the DICOM<br>voluntary standards (ACR/<br>NEMA Digital Imaging and<br>Communication in<br>Medicine). | EndoSize is a software-<br>only device that runs on a<br>standard computer that<br>meets the minimum<br>requirements. It can use<br>local DICOM files or<br>distant PACS server. The<br>device does not contact<br>the patient, nor does it<br>control any life sustaining<br>devices. The information<br>and measurements<br>displayed, exported or<br>printed are validated and<br>interpreted by Physicians.<br>EndoSize complies with<br>the DICOM voluntary<br>standards (ACR/NEMA<br>Digital Imaging and<br>Communication in<br>Medicine) | Conclusion: No difference to<br>design between Cydar EV<br>Series B and primary<br>predicate, this includes no<br>difference to algorithm or<br>development process. | | 2. Clinical Characteristics | | | | | | Same clinical<br>condition or<br>purpose,<br>including<br>similar<br>severity and<br>stage of<br>disease | Cydar EV is intended only<br>to be used for patients<br>undergoing a fluoroscopic<br>X-ray guided endovascular<br>surgery in the chest,<br>abdomen, and pelvis, and<br>who have had a pre-<br>operative CT-scan.<br>The clinical procedures<br>indicated for the Cydar EV<br>devices are the same. For<br>these procedures a<br>clinical specialist will<br>determine the stage of<br>disease is advanced and<br>requires intervention.<br>Cydar EV devices are used<br>for guidance during the<br>procedure. | Cydar EV (Series A) is<br>intended to assist<br>fluoroscopy-guided<br>endovascular procedures in<br>the lower thorax, abdomen<br>and pelvis. Suitable<br>procedures include (but are<br>not limited to) endovascular<br>aortic aneurysm repair, (AAA<br>and mid-distal TAA),<br>stenting, and embolisation<br>in the common iliac,<br>proximal external iliac and<br>proximal internal iliac<br>arteries and their<br>corresponding veins. Cydar<br>EV (Series A) is not intended<br>for use in X-ray guided<br>procedures in the liver,<br>kidneys or pelvis organs. | Intended for patients who<br>require cardiovascular<br>interventions, EVAR,<br>TEVAR, TAVI and<br>Peripheral | | | Anatomical<br>Site | Device is used indicated<br>for fluoroscopic X-ray<br>guided endovascular<br>procedures in the chest,<br>abdomen, and pelvis | Device is used indicated for<br>fluoroscopic X-ray guided<br>endovascular procedures in<br>the lower thorax,<br>abdomen, and pelvis | Device is used indicated<br>for heart and vessels | No significant difference. The<br>anatomy is clarified in this<br>document (add Section<br>references). | | Assessment<br>Criteria | Cydar EV Series B<br>Cydar Medical Ltd<br>Device under<br>assessment | Cydar EV Series A<br>Cydar Medical Ltd<br>Primary Equivalent Device<br>K160088 | EndoSize<br>Therenva<br>Secondary Equivalent<br>Device<br>K141475 | Identified differences or<br>conclusion of no difference | | User Profile | The target clinical users<br>for the Cydar EV Series B<br>device are experienced<br>medical practitioners<br>specialising in<br>endovascular surgery<br>(such as vascular<br>surgeons and<br>interventional<br>radiologists)<br>radiographers, and<br>specialist nurses. Other<br>users of the planning<br>functions may include<br>medical device company<br>representatives and<br>product specialists. | The target clinical users for<br>the Cydar EV Series A device<br>are experienced medical<br>practitioners specialising in<br>endovascular surgery (such<br>as vascular surgeons and<br>interventional radiologists)<br>radiographers, and<br>specialist nurses. | Physicians and clinical<br>specialists, users involved<br>in preoperative planning | No difference in targeted users | | Patient<br>Contact | No patient contact | No patient contact | No patient contact | No difference | | Clinical<br>Environment | Operating room, office<br>(during planning)…
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