(121 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the description of the device and its functionality does not mention any AI or ML components. The core function is image fusion and manual adjustment of the fused image.
No.
The device assists in surgical planning and guidance by displaying pre-operative anatomy superimposed on fluoroscopy; it does not directly treat or diagnose a disease or condition.
No
The device is intended to assist fluoroscopic X-ray guided endovascular procedures by presenting the operative plan in the context of intraoperative fluoroscopy. It creates a "Pre-operative Map" from a patient's CT scan and superimposes it on real-time fluoroscopy images for surgical guidance. It does not provide a diagnosis or identify a disease or condition; rather, it aids in the execution of a medical procedure.
Yes
The device description explicitly states that Cydar EV is a "Software-as-a-Service product and consists only of the software running on Cydar's cloud servers." While it interacts with external hardware like the Cydar Appliance (an off-the-shelf video frame grabber) and standard monitors, these are described as not being medical devices themselves and are outside the scope of the 510(k) submission. The core medical device functionality resides solely in the software.
Based on the provided information, Cydar EV is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that Cydar EV is intended to assist fluoroscopic X-ray guided endovascular procedures by presenting the operative plan in the context of intraoperative fluoroscopy. This is a surgical planning and guidance tool, not a device used to examine specimens derived from the human body for the purpose of providing information for the diagnosis, prevention, or treatment of disease.
- Device Description: The device description details software that processes medical images (CT and fluoroscopy) to create and display an operative plan and superimpose it on live imaging. It does not involve the analysis of biological samples.
- Input Imaging Modality: The inputs are imaging modalities (CT, fluoroscopy, angiography), not biological specimens.
- Anatomical Site: The anatomical sites mentioned are parts of the body (chest, abdomen, pelvis, heart and vessels), not biological samples.
IVD devices are specifically designed to perform tests on samples such as blood, urine, tissue, etc., to provide diagnostic information. Cydar EV's function is to aid in surgical procedures by providing visual guidance based on pre-operative and intra-operative imaging.
N/A
Intended Use / Indications for 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 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.
Product codes (comma separated list FDA assigned to the subject device)
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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT data
fluoroscopic images
Anatomical Site
chest, abdomen, and pelvis
Indicated Patient Age Range
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.
Intended User / Care Setting
The target clinical users for the Cydar EV Series B device are experienced medical practitioners specialising in endovascular surgery (such as vascular surgeons and interventional radiologists) radiographers, and specialist nurses. Other users of the planning functions may include medical device company representatives and product specialists.
Operating room, office (during planning)
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)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
December 3, 2021
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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)
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3
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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 |
| Barrington | |
| Cambridgeshire | |
| CB22 7QY | |
| UK |
Contact person:
4
| Name | Rob Hague |
|---|---|
| Position | CTO |
| Phone number | +44 1223 778 020 |
| rob.hague@cydar.co.uk |
US Agent:
| Contact Name | Michael van der Woude |
|---|---|
| Business Name | Emergo Global Representation LLC |
| Address | 2500 Bee Cave Road |
| Bldg 1, Suite 300 | |
| Austin, TX 78746 | |
| United States | |
| Phone | 512 327-9997 |
| Fax | 512 327-9998 |
| 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
Criteria | Cydar EV Series B
Cydar Medical Ltd
Device under
assessment | Cydar EV Series A
Cydar Medical Ltd
Primary Equivalent Device
K160088 | EndoSize
Therenva
Secondary Equivalent
Device
K141475 | Identified differences or
conclusion of no difference |
|----------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1. Technical Characteristics | | | | |
| Assessment
Criteria | Cydar EV Series B
Cydar Medical Ltd
Device under
assessment | Cydar EV Series A
Cydar Medical Ltd
Primary Equivalent Device
K160088 | EndoSize
Therenva
Secondary Equivalent
Device
K141475 | Identified differences or
conclusion of no difference |
| 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 | Cydar EV is intended to
display combined live 2D X-
ray fluoroscopy and 3D
anatomy for image guidance
during surgery.
Features of the device
include:
Import and visualise CT scan
data.
Segment and annotate
vascular anatomy from CT
data.
Produce an operative plan
Overlay planning
information such
as preoperative vessel
anatomy onto live
fluoroscopic images, aligned
based on the position of
anatomical features present
in the fluoroscopic images.
Non-rigidly transform the
visualisation of anatomy
when intra-operative vessel
deformation is observed. | EndoSize is a software
solution that is intended
to provide Physicians and
Clinical Specialists with
additional information to
assist them in reading and
interpreting DICOM CT
scan images of structures
of the heart and vessels.
EndoSize enables the user
to visualize and measure
(diameters, lengths,
volumes, angles)
structures of the heart
and vessels. | Conclusion: Cydar EV Series B
is similar intended use to the
primary predicate device
differing only in additional
features; placement and
editing virtual guidewires,
measurement of lengths and
measurement of anatomical
structures on planar sections
of CT data is similar to the
secondary predicate device.
Measurement accuracy
verification testing and
summative user study is
performed as part of the
design and development
process |
| Assessment
Criteria | Cydar EV Series B
Cydar Medical Ltd
Device under
assessment | Cydar EV Series A
Cydar Medical Ltd
Primary Equivalent Device
K160088 | EndoSize
Therenva
Secondary Equivalent
Device
K141475 | Identified differences or
conclusion of no difference |
| Indications for
use | 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. | Cydar EV provides image
guidance by overlaying
preoperative 3D vessel
anatomy from a previously
acquired contrast-
enhanced, diagnostic CT
scan onto live X-ray
fluoroscopy images in order
to assist in the positioning of
guidewires, catheters and
other endovascular devices.
Cydar EV is intended to
assist X-ray fluoroscopy-
guided endovascular
procedures in the lower
thorax, abdomen and pelvis.
Suitable procedures include
endovascular aortic
aneurysm repair,
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 X-ray guided
procedures in the liver,
kidneys or pelvic organs. | Therenva Endosize
enables visualization and
measurement of
structures of the heart
and vessels for pre-
operational planning and
sizing for cardiovascular
interventions and surgery
General functionalities
are provided such as:
• Segmentation of
cardiovascular
structures
• Automatic and manual
centreline detection
• Visualisation of CT scan
images in every planes,
2D review, 3D
reconstruction, Volume
Rendering, MPR,
Stretched CMPR
• Measurement and
annotation tools
• Reporting tools | Conclusion: Changes in
wording clarifying target
anatomy between Cydar EV
Series B and primary predicate
|
| Assessment
Criteria | Cydar EV Series B
Cydar Medical Ltd
Device under
assessment | Cydar EV Series A
Cydar Medical Ltd
Primary Equivalent Device
K160088 | EndoSize
Therenva
Secondary Equivalent
Device
K141475 | Identified differences or
conclusion of no difference |
| Classification
Product code /
regulation | OWB; Interventional
Fluoroscopic X-Ray
System: Regulation:
892.1660 | OWB; Interventional
Fluoroscopic X-Ray System
Regulation Regulation:
892.1660 | LLZ ; System image
processing radiology
Regulation: 892.2050 | OWB sufficiently covers the
intended use of Cydar EV. |
| Construction | Software product | Software product | Software Product | No difference |
| Performance | Preoperative planning:
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; Visualise the
segmented vascular
anatomy, annotations +/-
measurements together
(the 'Operative Plan')
Intra-operative (Fusion
imaging functions):
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-operative (Review
functions): Post-
operatively review data
relating to procedures
where the system was
used | Preoperative planning:
Import and visualise CT
data; Segment and annotate
vascular anatomy from CT
data; Visualise the
segmented vascular
anatomy, annotations +/-
measurements together (the
'Operative Plan')
Intra-operative (Fusion
imaging functions: 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-operative (Review
functions): Post-operatively
review data relating to
procedures where the
system was used | Preoperative planning:
Visualisation, annotations
and measurement
performed by clinicians
intended to provide
referring physicians with
clinically relevant
information for diagnosis,
surgery, and treatment
planning. | Conclusion: Difference
between Cydar EV Series B and
primary predicate are features;
place and edit virtual
guidewires and measure
lengths on them and make
measurements of anatomical
structures on planar sections
of the CT data
EndoSize is indicated for
preoperative planning only
Measurement accuracy
verification testing and
summative user study is
performed as part of the
design and development
process |
| Assessment
Criteria | Cydar EV Series B
Cydar Medical Ltd
Device under
assessment | Cydar EV Series A
Cydar Medical Ltd
Primary Equivalent Device
K160088 | EndoSize
Therenva
Secondary Equivalent
Device
K141475 | Identified differences or
conclusion of no difference |
| Design | Cydar EV Series B device is
a software only medical
device that runs on a
standard computer that
meets the minimum
requirements. It can use
local DICOM files or
distant PACS server. The
device does not contact
the patient, nor does it
control any life sustaining
devices. The information
and measurements
displayed, exported or
printed are validated and
interpreted by Physicians.
EV Maps complies with
the DICOM voluntary
standards (ACR/NEMA
Digital Imaging and
Communication in
Medicine). | Cydar EV is a software only
medical device that runs on
a standard computer that
meets the minimum
requirements. It can use
local DICOM files or distant
PACS server. The device
does not contact the
patient, nor does it control
any life sustaining devices.
The information and
measurements displayed,
exported or printed are
validated and interpreted by
Physicians.
EV complies with the DICOM
voluntary standards (ACR/
NEMA Digital Imaging and
Communication in
Medicine). | EndoSize is a software-
only device that runs on a
standard computer that
meets the minimum
requirements. It can use
local DICOM files or
distant PACS server. The
device does not contact
the patient, nor does it
control any life sustaining
devices. The information
and measurements
displayed, exported or
printed are validated and
interpreted by Physicians.
EndoSize complies with
the DICOM voluntary
standards (ACR/NEMA
Digital Imaging and
Communication in
Medicine) | Conclusion: No difference to
design between Cydar EV
Series B and primary
predicate, this includes no
difference to algorithm or
development process. |
| 2. Clinical Characteristics | | | | |
| Same clinical
condition or
purpose,
including
similar
severity and
stage of
disease | Cydar EV is intended only
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 clinical procedures
indicated for the Cydar EV
devices are the same. For
these procedures a
clinical specialist will
determine the stage of
disease is advanced and
requires intervention.
Cydar EV devices are used
for guidance during the
procedure. | Cydar EV (Series A) 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),
stenting, and embolisation
in the common iliac,
proximal external iliac and
proximal internal iliac
arteries and their
corresponding veins. Cydar
EV (Series A) is not intended
for use in X-ray guided
procedures in the liver,
kidneys or pelvis organs. | Intended for patients who
require cardiovascular
interventions, EVAR,
TEVAR, TAVI and
Peripheral | |
| Anatomical
Site | Device is used indicated
for fluoroscopic X-ray
guided endovascular
procedures in the chest,
abdomen, and pelvis | Device is used indicated for
fluoroscopic X-ray guided
endovascular procedures in
the lower thorax,
abdomen, and pelvis | Device is used indicated
for heart and vessels | No significant difference. The
anatomy is clarified in this
document (add Section
references). |
| Assessment
Criteria | Cydar EV Series B
Cydar Medical Ltd
Device under
assessment | Cydar EV Series A
Cydar Medical Ltd
Primary Equivalent Device
K160088 | EndoSize
Therenva
Secondary Equivalent
Device
K141475 | Identified differences or
conclusion of no difference |
| User Profile | The target clinical users
for the Cydar EV Series B
device are experienced
medical practitioners
specialising in
endovascular surgery
(such as vascular
surgeons and
interventional
radiologists)
radiographers, and
specialist nurses. Other
users of the planning
functions may include
medical device company
representatives and
product specialists. | The target clinical users for
the Cydar EV Series A device
are experienced medical
practitioners specialising in
endovascular surgery (such
as vascular surgeons and
interventional radiologists)
radiographers, and
specialist nurses. | Physicians and clinical
specialists, users involved
in preoperative planning | No difference in targeted users |
| Patient
Contact | No patient contact | No patient contact | No patient contact | No difference |
| Clinical
Environment | Operating room, office
(during planning) | Operating room, office
(during procedure planning) | Office (during procedure
planning) | Conclusion: No significant
difference. Cydar EV Series B
and secondary predicate differ
slightly in intended clinical
environment as the predicate
is not intended for intra-
operative use. |
| 3. Non-clinical performance data | | | | |
| Standards | IEC 62304
IEC 62366
ISO 14971 | IEC 62304
IEC 62366
ISO 14971 | IEC 62304
ISO 14971 | Equivalent standards applied |
| NEMA PS 3.1-
3.20 DICOM | Applied | Applied | Applied | Conclusion: No difference |
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8
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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.