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.

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.

AI/ML Overview

Unfortunately, the provided text does not contain the specific details about acceptance criteria, reported device performance, or the study design (sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, standalone performance) for the Cydar EV Series B and Cydar EV Maps device.

The document is a 510(k) summary for FDA clearance, which focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed report of performance studies. It mentions that "Software verification and validation were conducted to establish the performance, functionality and reliability characteristics of this device, with particular focus on the modified features. The device has passed all of the tests based on pre-determined Pass/Fail criteria." However, it does not elaborate on what those criteria were, what the results were, or the specifics of the studies performed.

Here's a breakdown of what is and isn't present:

What is available in the text:

Device Name: Cydar EV Series B, Cydar EV Maps
Intended Use: Assisting fluoroscopic X-ray guided endovascular procedures in the chest, abdomen, and pelvis by presenting the operative plan in the context of intraoperative fluoroscopy.
Specific features mentioned: Import/visualize CT data, segment/annotate vascular anatomy, place/edit virtual guidewires and measure lengths, make measurements of anatomical structures on planar sections of CT data, produce operative plan, overlay planning information onto live fluoroscopic images, non-rigidly transform visualization of anatomy when intra-operative vessel deformation is observed, post-operatively review data.
Claim of verification and validation: "Software verification and validation were conducted to establish the performance, functionality and reliability characteristics of this device, with particular focus on the modified features. The device has passed all of the tests based on pre-determined Pass/Fail criteria."
Nature of the device: Software-as-a-Service product, software only medical device.
Target users: Experienced medical practitioners specializing in endovascular surgery (vascular surgeons, interventional radiologists), radiographers, specialist nurses.
Ground truth mentions (general): "The information and measurements displayed, exported or printed are validated and interpreted by Physicians." and "Measurement accuracy verification testing and summative user study is performed as part of the design and development process."

What is NOT available in the text regarding acceptance criteria and performance study details:

A table of acceptance criteria and the reported device performance: The document states that "The device has passed all of the tests beased on pre-determined Pass/Fail criteria" but does not list these criteria or the specific performance metrics achieved.
Sample sized used for the test set and the data provenance: No information on the number of cases or patients used for testing, nor where the data originated (country, retrospective/prospective).
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: While it mentions "trained clinical specialists" and "Physicians" interpreting information, it doesn't specify how many were involved in establishing ground truth for testing, or their exact qualifications.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not mentioned.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not mentioned. The document describes the device as intended to "assist" procedures but doesn't quantify this assistance with comparative effectiveness metrics.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: The document emphasizes user interpretation ("dependant on the interpretation of trained clinical specialists") and "measurement accuracy verification testing," but doesn't explicitly state if standalone algorithm performance was assessed separate from human-in-the-loop. Given it's an "assistive" device, human interaction is inherent to its intended use.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): While "Physicians" validate and interpret, the specific method for establishing "ground truth" (e.g., whether it was expert consensus alone, or validated against pathology or surgical outcomes) is not detailed.
The sample size for the training set: No information is provided regarding the training data for any underlying algorithms.
How the ground truth for the training set was established: No information is provided regarding the training data.

To obtain this level of detail, one would typically need to refer to detailed study reports, peer-reviewed publications, or the full 510(k) submission, portions of which are often confidential. This summary document provides a high-level overview for regulatory clearance.

Summary

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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

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

, 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

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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.

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)

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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)

· 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 MillBarringtonCambridgeshireCB22 7QYUK

Contact person:

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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 RoadBldg 1, Suite 300Austin, TX 78746United 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.

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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

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

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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.

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.

AssessmentCriteria	Cydar EV Series BCydar Medical LtdDevice underassessment	Cydar EV Series ACydar Medical LtdPrimary Equivalent DeviceK160088	EndoSizeTherenvaSecondary EquivalentDeviceK141475	Identified differences orconclusion of no difference
1. Technical Characteristics
AssessmentCriteria	Cydar EV Series BCydar Medical LtdDevice underassessment	Cydar EV Series ACydar Medical LtdPrimary Equivalent DeviceK160088	EndoSizeTherenvaSecondary EquivalentDeviceK141475	Identified differences orconclusion of no difference
Intended Use	Cydar EV provides toolsto:• Import and visualise CTdata• Segment and annotatevascular anatomy fromCT data• Place and edit virtualguidewires andmeasure lengths onthem• Make measurements ofanatomical structureson planar sections ofthe CT data• Produce an operativeplan frommeasurements andsegmentation ofpreoperative vesselanatomy• Overlay planninginformation such aspreoperative vesselanatomy onto livefluoroscopic images,aligned based on theposition of anatomicalfeatures present in both• Non-rigidly transformthe visualisation ofanatomy when intra-operative vesseldeformation isobserved• Post-operatively reviewdata relating toprocedures where thesystem was used	Cydar EV is intended todisplay combined live 2D X-ray fluoroscopy and 3Danatomy for image guidanceduring surgery.Features of the deviceinclude:Import and visualise CT scandata.Segment and annotatevascular anatomy from CTdata.Produce an operative planOverlay planninginformation suchas preoperative vesselanatomy onto livefluoroscopic images, alignedbased on the position ofanatomical features presentin the fluoroscopic images.Non-rigidly transform thevisualisation of anatomywhen intra-operative vesseldeformation is observed.	EndoSize is a softwaresolution that is intendedto provide Physicians andClinical Specialists withadditional information toassist them in reading andinterpreting DICOM CTscan images of structuresof the heart and vessels.EndoSize enables the userto visualize and measure(diameters, lengths,volumes, angles)structures of the heartand vessels.	Conclusion: Cydar EV Series Bis similar intended use to theprimary predicate devicediffering only in additionalfeatures; placement andediting virtual guidewires,measurement of lengths andmeasurement of anatomicalstructures on planar sectionsof CT data is similar to thesecondary predicate device.Measurement accuracyverification testing andsummative user study isperformed as part of thedesign and developmentprocess
AssessmentCriteria	Cydar EV Series BCydar Medical LtdDevice underassessment	Cydar EV Series ACydar Medical LtdPrimary Equivalent DeviceK160088	EndoSizeTherenvaSecondary EquivalentDeviceK141475	Identified differences orconclusion of no difference
Indications foruse	Cydar EV is intended toassist fluoroscopic X-rayguided endovascularprocedures in the chest,abdomen, and pelvis bypresenting the operativeplan in the context ofintraoperativefluoroscopy.Cydar EV is intended to beused for patientsundergoing a fluoroscopicX-ray guided endovascularsurgery in the chestabdomen and pelvis, andwho have had a pre-operative CT-scan.The performance of theCydar EV software in thepresence of immaturevertebral anatomy isunknown. TheInstructions for Useexplicitly state thisuncertainty and that thesoftware is therefore notrecommended for use inpatients under the age of18.IMPORTANT: Pre-Operative Maps showstatic anatomy derivedfrom the pre-operativeCT. Real-time anatomymoves with thecardiorespiratory cycle;progressive disease maycause the anatomy tochange over time; and stiffwires, stents or othersurgical instruments, maystraighten and displaceblood vessels from thepre-operative positionIt is thereforemandatory to check thereal-time anatomy witha suitable imagingtechnique, such ascontrast angiography,before deploying anyinvasive medical device.	Cydar EV provides imageguidance by overlayingpreoperative 3D vesselanatomy from a previouslyacquired contrast-enhanced, diagnostic CTscan onto live X-rayfluoroscopy images in orderto assist in the positioning ofguidewires, catheters andother endovascular devices.Cydar EV is intended toassist X-ray fluoroscopy-guided endovascularprocedures in the lowerthorax, abdomen and pelvis.Suitable procedures includeendovascular aorticaneurysm repair,angioplasty, stenting andembolization in thecommon iliac, proximalexternal iliac and proximalinternal iliac arteries andcorresponding veins.Cydar EV is not intended foruse in X-ray guidedprocedures in the liver,kidneys or pelvic organs.	Therenva Endosizeenables visualization andmeasurement ofstructures of the heartand vessels for pre-operational planning andsizing for cardiovascularinterventions and surgeryGeneral functionalitiesare provided such as:• Segmentation ofcardiovascularstructures• Automatic and manualcentreline detection• Visualisation of CT scanimages in every planes,2D review, 3Dreconstruction, VolumeRendering, MPR,Stretched CMPR• Measurement andannotation tools• Reporting tools	Conclusion: Changes inwording clarifying targetanatomy between Cydar EVSeries B and primary predicate
AssessmentCriteria	Cydar EV Series BCydar Medical LtdDevice underassessment	Cydar EV Series ACydar Medical LtdPrimary Equivalent DeviceK160088	EndoSizeTherenvaSecondary EquivalentDeviceK141475	Identified differences orconclusion of no difference
ClassificationProduct code /regulation	OWB; InterventionalFluoroscopic X-RaySystem: Regulation:892.1660	OWB; InterventionalFluoroscopic X-Ray SystemRegulation Regulation:892.1660	LLZ ; System imageprocessing radiologyRegulation: 892.2050	OWB sufficiently covers theintended use of Cydar EV.
Construction	Software product	Software product	Software Product	No difference
Performance	Preoperative planning:Import and visualise CTdata; Segment andannotate vascularanatomy from CT data;Place and edit virtualguidewires and measurelengths on them; Makemeasurements ofanatomical structures onplanar sections of the CTdata; Visualise thesegmented vascularanatomy, annotations +/-measurements together(the 'Operative Plan')Intra-operative (Fusionimaging functions):Overlay planninginformation such aspreoperative vesselanatomy onto livefluoroscopic images,aligned based on theposition of anatomicalfeatures present in both;Non-rigidly transform thevisualisation of anatomywhen intra-operativevessel deformation isobservedPost-operative (Reviewfunctions): Post-operatively review datarelating to procedureswhere the system wasused	Preoperative planning:Import and visualise CTdata; Segment and annotatevascular anatomy from CTdata; Visualise thesegmented vascularanatomy, annotations +/-measurements together (the'Operative Plan')Intra-operative (Fusionimaging functions: Overlayplanning information suchas preoperative vesselanatomy onto livefluoroscopic images, alignedbased on the position ofanatomical features presentin both; Non-rigidlytransform the visualisationof anatomy when intra-operative vesseldeformation is observedPost-operative (Reviewfunctions): Post-operativelyreview data relating toprocedures where thesystem was used	Preoperative planning:Visualisation, annotationsand measurementperformed by cliniciansintended to providereferring physicians withclinically relevantinformation for diagnosis,surgery, and treatmentplanning.	Conclusion: Differencebetween Cydar EV Series B andprimary predicate are features;place and edit virtualguidewires and measurelengths on them and makemeasurements of anatomicalstructures on planar sectionsof the CT dataEndoSize is indicated forpreoperative planning onlyMeasurement accuracyverification testing andsummative user study isperformed as part of thedesign and developmentprocess
AssessmentCriteria	Cydar EV Series BCydar Medical LtdDevice underassessment	Cydar EV Series ACydar Medical LtdPrimary Equivalent DeviceK160088	EndoSizeTherenvaSecondary EquivalentDeviceK141475	Identified differences orconclusion of no difference
Design	Cydar EV Series B device isa software only medicaldevice that runs on astandard computer thatmeets the minimumrequirements. It can uselocal DICOM files ordistant PACS server. Thedevice does not contactthe patient, nor does itcontrol any life sustainingdevices. The informationand measurementsdisplayed, exported orprinted are validated andinterpreted by Physicians.EV Maps complies withthe DICOM voluntarystandards (ACR/NEMADigital Imaging andCommunication inMedicine).	Cydar EV is a software onlymedical device that runs ona standard computer thatmeets the minimumrequirements. It can uselocal DICOM files or distantPACS server. The devicedoes not contact thepatient, nor does it controlany life sustaining devices.The information andmeasurements displayed,exported or printed arevalidated and interpreted byPhysicians.EV complies with the DICOMvoluntary standards (ACR/NEMA Digital Imaging andCommunication inMedicine).	EndoSize is a software-only device that runs on astandard computer thatmeets the minimumrequirements. It can uselocal DICOM files ordistant PACS server. Thedevice does not contactthe patient, nor does itcontrol any life sustainingdevices. The informationand measurementsdisplayed, exported orprinted are validated andinterpreted by Physicians.EndoSize complies withthe DICOM voluntarystandards (ACR/NEMADigital Imaging andCommunication inMedicine)	Conclusion: No difference todesign between Cydar EVSeries B and primarypredicate, this includes nodifference to algorithm ordevelopment process.
2. Clinical Characteristics
Same clinicalcondition orpurpose,includingsimilarseverity andstage ofdisease	Cydar EV is intended onlyto be used for patientsundergoing a fluoroscopicX-ray guided endovascularsurgery in the chest,abdomen, and pelvis, andwho have had a pre-operative CT-scan.The clinical proceduresindicated for the Cydar EVdevices are the same. Forthese procedures aclinical specialist willdetermine the stage ofdisease is advanced andrequires intervention.Cydar EV devices are usedfor guidance during theprocedure.	Cydar EV (Series A) isintended to assistfluoroscopy-guidedendovascular procedures inthe lower thorax, abdomenand pelvis. Suitableprocedures include (but arenot limited to) endovascularaortic aneurysm repair, (AAAand mid-distal TAA),stenting, and embolisationin the common iliac,proximal external iliac andproximal internal iliacarteries and theircorresponding veins. CydarEV (Series A) is not intendedfor use in X-ray guidedprocedures in the liver,kidneys or pelvis organs.	Intended for patients whorequire cardiovascularinterventions, EVAR,TEVAR, TAVI andPeripheral
AnatomicalSite	Device is used indicatedfor fluoroscopic X-rayguided endovascularprocedures in the chest,abdomen, and pelvis	Device is used indicated forfluoroscopic X-ray guidedendovascular procedures inthe lower thorax,abdomen, and pelvis	Device is used indicatedfor heart and vessels	No significant difference. Theanatomy is clarified in thisdocument (add Sectionreferences).
AssessmentCriteria	Cydar EV Series BCydar Medical LtdDevice underassessment	Cydar EV Series ACydar Medical LtdPrimary Equivalent DeviceK160088	EndoSizeTherenvaSecondary EquivalentDeviceK141475	Identified differences orconclusion of no difference
User Profile	The target clinical usersfor the Cydar EV Series Bdevice are experiencedmedical practitionersspecialising inendovascular surgery(such as vascularsurgeons andinterventionalradiologists)radiographers, andspecialist nurses. Otherusers of the planningfunctions may includemedical device companyrepresentatives andproduct specialists.	The target clinical users forthe Cydar EV Series A deviceare experienced medicalpractitioners specialising inendovascular surgery (suchas vascular surgeons andinterventional radiologists)radiographers, andspecialist nurses.	Physicians and clinicalspecialists, users involvedin preoperative planning	No difference in targeted users
PatientContact	No patient contact	No patient contact	No patient contact	No difference
ClinicalEnvironment	Operating room, office(during planning)	Operating room, office(during procedure planning)	Office (during procedureplanning)	Conclusion: No significantdifference. Cydar EV Series Band secondary predicate differslightly in intended clinicalenvironment as the predicateis not intended for intra-operative use.
3. Non-clinical performance data
Standards	IEC 62304IEC 62366ISO 14971	IEC 62304IEC 62366ISO 14971	IEC 62304ISO 14971	Equivalent standards applied
NEMA PS 3.1-3.20 DICOM	Applied	Applied	Applied	Conclusion: No difference

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The changes in wording of the Indications for Use statement from Cydar EV Series A (predicate) to B (device under review) are for the purposes of simplicity and clarity and do not convey any change in the clinical use, accuracy, reliability, safety, or performance. The change in wording from 'lower thorax' to 'chest' is for consistency in conveying the intended clinical use, as opposed to mode of action. The update in wording to remove statements pertaining to use in solid organs is clarified by the restriction to use in endovascular surgery. Cydar EV Series B described in this 510(k) has similar intended use as Cydar EV Series A, differing only in the additional features; Placement and editing virtual guidewires and measurement of lengths and measurement of anatomical structures on planar sections of CT data. The second predicate device; Endosize does include these features and is intended for preoperative planning only.

The subject device has undergone verification and validation activities to ensuring function and performance is as well as the predicate device and the additional features provide accurate and reliable outputs. The results support that the subject is substantially equivalent to the predicate devices.

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S05.1.7 Technological Characteristics

Cydar EV, the subject device, is a software medical device, it does not contact the patient, nor does it control any life sustaining device. The use of this software in pre-operative planning, intra-operative mapping and postoperative follow-up is dependant on the interpretation of trained clinical specialists.

S05.1.8 Performance Data

Software verification and validation were conducted to establish the performance, functionality and reliability characteristics of this device, with particular focus on the modified features. The device has passed all of the tests beased on pre-determined Pass/Fail criteria.

S05.1.9 Benefit- Risk Conclusion

The device under review is substantially equivalent in the areas of general function, application, technical characteristics and use. The intended use differs only in additional features; Placement and editing virtual guidewires and measurement of lengths and measurement of anatomical structures on planar sections of CT data. The device does not introduce a fundamentally new scientific technology and has undergone bench testing to verify accuracy and user validation. Therefore, we conclude the benefits of Cydar EV when used according to the indications for use outweighs risks identified.

Regulation Number and Section

§ 892.1650 Image-intensified fluoroscopic x-ray system.

(a)
Identification. An image-intensified fluoroscopic x-ray system is a device intended to visualize anatomical structures by converting a pattern of x-radiation into a visible image through electronic amplification. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). An anthrogram tray or radiology dental tray intended for use with an image-intensified fluoroscopic x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9. In addition, when intended as an accessory to the device described in paragraph (a) of this section, the fluoroscopic compression device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.

Indications for Use

Indications for Use (Describe)

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Cydar Ltd 510(k) Submission: Cydar EV Series B

Section 5: 510(k) Summary

Contents

S05.1 Section 5: 510(k) Summary

S05.1.1 Submitter Details

US Agent:

S05.1.2 Device Name

S05.1.3 Predicate Device Identification

S05.1.4 Device Description

S05.1.5 Statement of Intended Use

S05.1.5.1 Indications for Use

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

§ 892.1650 Image-intensified fluoroscopic x-ray system.