(182 days)
No
The summary describes a standard ultrasound imaging system and catheter with 2D and 3D imaging capabilities. There is no mention of AI, ML, or any features that would suggest the use of such technologies for image processing, analysis, or other functions. The performance studies are limited to bench, laboratory, and electrical safety tests, with no mention of studies related to algorithmic performance.
No.
The device is intended for imaging and visualization purposes, explicitly stating it is "for imaging guidance only, not treatment delivery." This indicates a diagnostic or guidance function rather than a therapeutic one.
Yes
The VERAFEYE Imaging System is explicitly stated as being intended "to evaluate the presence or absence of pathology" and provides information that "may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes." This directly indicates its role in diagnosis.
No
The device description explicitly states the system is comprised of a catheter and an ultrasound imaging system with a console and computer screen, indicating significant hardware components beyond just software.
Based on the provided information, the VERAFEYE Imaging Catheter and VERAFEYE Imaging System are not In Vitro Diagnostic (IVD) devices.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- VERAFEYE's Function: The VERAFEYE system uses ultrasound to create images of internal anatomy (heart, vessels, etc.) within the patient's body. It is used for visualization and imaging guidance during procedures, not for analyzing samples taken from the body.
The intended use and device description clearly indicate that this is an in vivo imaging system, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
VERAFEYE Imaging Catheter
The VERAFEYE Imaging Catheter is intended for intra-luminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart of adult patients.
The catheter is intended for imaging guidance only, not treatment delivery, during cardiac interventional percutaneous procedures.
VERAFEYE Imaging System
The VERAFEYE Imaging System is intended for cardiac applications. The system transmits ultrasound energy into adult patients creating 2D (B-mode), & 3D images of the heart, cardiac valves, great vessels, and surrounding anatomical structures to evaluate the presence or absence of pathology.
The system also provides the ability to indicate scale with respect to anatomical structures, which provides information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes.
The system utilizes catheters which are intended for intra-cardiac and intraluminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart of adult patients is intended for imaging guidance only, not treatment delivery, during cardiac interventional percutaneous procedures.
Product codes
OBJ, IYO
Device Description
The VERAFEYE System is intended to be used for live, minimally-invasive guidance of several different intracardiac procedures including, but not limited to, atrial ablation procedures and transseptal punctures. The system will provide image information of cardiovascular anatomic features, spatial relationships of other devices within the heart and great vessels, physiological information of cardiovascular structures and features. In doing so we expect to provide an imaging system capable of improving the safety, expediency, cost-effectiveness and patient tolerance of the aforementioned procedures compared to the same procedures using the existing technologies and methodologies.
The system will be comprised of a catheter and an ultrasound imaging system with a console and computer screen.
The VERAFEYE Imaging System includes the System Console (SC) for image display and manipulation as well as the Catheter Interface Unit (CIU) which the catheter connects to. The SC will have two monitors to allow for ease of image view and review for both the technician and physician user.
The technician user will be able to control the system software via a graphical user interface using multiple methods of input including a mouse and keyboard. Caster wheels on the SC will allow easy movement of the system throughout the cardiac interventional lab which can have a small footprint as well as small obstacles to cross.
The catheter will be a 11Fr single use, sterile device, which will be able to perform intracardiac and intraluminal ultrasound imaging of adults. The catheter will be capable of live 2D side viewing imaging, as well as live 3D rendered images. The imaging system will be able to resolve and measure features such as the inferior and superior vena cava, ascending and descending aorta, left and right atria, left and right ventric valve, mitral valve and tricuspid valve.
The physician user will have easy steering maneuverability of the catheter via deflection and rotation, facilitating control over the position of the transducer to allow for multiple angles of images.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Cardiac, heart, cardiac valves, great vessels, surrounding anatomical structures
Indicated Patient Age Range
adult patients
Intended User / Care Setting
clinician, physician, technician user. Cardiac interventional lab.
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)
No clinical testing is included in the submission. Determination of substantial equivalence is based on an assessment of non-clinical data.
Non-clinical performance data included:
- UL 60601-1, Safety Requirements for Medical Equipment
- IEC 60601-2-37 Diagnostic Ultrasound Safety Standards
- AIUM/NEMA UD-3, Standard for Real Time Display of Thermal and Mechanical
- Acoustic Output Indices on Diagnostic Ultrasound Equipment
- AIUM/NEMA UD-2, Acoustic Output Measurement Standard for Diagnostic Ultrasound
- Safety and EMC Requirements for Medical Equipment o EN/IEC 60601-1 EN/IEC 60601-1-2
- ISO 10993-1, Biocompatibility
- ISO 11135, Sterilization of health-care products- Ethylene oxide
- ISO 11607-1 and ISO 11607-2, Packaging for terminally sterilized medical devices
- IEC 62304:2006
- IEC 62366:2014
- IEC 62359:2010
After analyzing the results of the bench, laboratory and electrical safety tests it can be concluded that the VERAFEYE Imaging Catheter and the predicate device (K212959) are substantially equivalent. After analyzing the results of the bench, laboratory and electrical safety tests, it can be concluded that the VERAFEYE Imaging System and the predicate device (K211726) are substantially equivalent.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.1200 Diagnostic intravascular catheter.
(a)
Identification. An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.(b)
Classification. Class II (performance standards).
0
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March 24, 2025
Luma Vision Limited Marta Walker Quality Assurance & Regulatory Affairs Director Block C, Parkview House Beech Hill Office Campus, Beech Hill Road Dublin, D04 K5D0 Ireland
Re: K242893
Trade/Device Name: VERAFEYE System: VERAFEYE Imaging Catheter & VERAFEYE Imaging System Regulation Number: 21 CFR 892.1200 Regulation Name: Diagnostic intravascular catheter Regulatory Class: Class II Product Code: OBJ, IYO Dated: September 10, 2024 Received: September 23, 2024
Dear Marta Walker:
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 (the 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 available 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.
1
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (OS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatory
2
assistance/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,
Aneesh S. Deoras -S
Aneesh Deoras Assistant Director Division of Cardiac Electrophysiology, Diagnostics, and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K242893
Device Name
VERAFEYE System VERAFEYE Imaging Catheter & VERAFEYE Imaging System
Indications for Use (Describe)
VERAFEYE Imaging Catheter
The VERAFEYE Imaging Catheter is intended for intra-luminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart of adult patients.
The catheter is intended for imaging guidance only, not treatment delivery, during cardiac interventional percutaneous procedures.
VERAFEYE Imaging System
The VERAFEYE Imaging System is intended for cardiac applications. The system transmits ultrasound energy into adult patients creating 2D (B-mode), & 3D images of the heart, cardiac valves, great vessels, and surrounding anatomical structures to evaluate the presence or absence of pathology.
The system also provides the ability to indicate scale with respect to anatomical structures, which provides information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes.
The system utilizes catheters which are intended for intra-cardiac and intraluminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart of adult patients is intended for imaging guidance only, not treatment delivery, during cardiac interventional percutaneous procedures.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☒ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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4
Image /page/4/Picture/0 description: The image shows the logo for Luma Vision. The logo consists of a blue abstract design on the left, followed by the word "LUMA" in large, bold, black letters. Below "LUMA" is the word "VISION" in smaller, black letters. The abstract design appears to be a stylized representation of light or vision, with blue shapes radiating outward from a central point.
Luma Vision Limited Block C, Parkview House, Beech Hill Office Campus, Beech Hill Road, Dublin D04 K5D0, Ireland
www.lumavision.com info@lumavision.com
Department of Health and Human Services Center for Devices and Radiological Health Office of Product Evaluation and Quality Office of Cardiovascular Devices
510(k) Summary of Safety and Effectiveness Information as required by section 21 CFR 807.92
Submitter of 510(k):
| Manufacturer Name: | Luma Vision Limited |
|---|---|
| Address: | Block C, Parkview House, |
| Beech Hill Office Campus, | |
| Beech Hill Road, | |
| Dublin D04 K5D0, Ireland | |
| Contact Person | Marta Walker |
| Phone: | 0031680132668 |
| Email: | Marta.walker@lumavison.com |
| Job Title: | Quality Assurance & Regulatory Affairs Director |
510K Bundle Submission of VERAFEYE Imaging Catheter & VERAFEYE Imaging System
22 September 2024
| Device Information: |
|---|
Date Prepared:
| Trade / Proprietary name: | VERAFEYE System |
|---|---|
| Common / Usual name: | VERAFEYE Imaging Catheter & VERAFEYE Imaging System |
| Device: | Catheter, Ultrasound, Intravascular |
| Regulation Description: | Diagnostic Intravascular Catheter |
| Classification: | 21 CFR§870.1200 (OBJ) - Class II |
| Device: | System, Imaging, Pulsed Echo, Ultrasonic |
| Regulation Description: | Ultrasonic Pulsed Echo Imaging System |
| Classification: | 21 CFR§892.1560 (IYO) - Class II |
Panel: Cardiovascular
Predicate & Reference Devices:
Primary Predicate Device: K212959 Trade/Device Name: ACUSON AcuNav Volume Intracardiac Echocardiography (ICE) Catheter Regulation Number: 21 CFR 870.1200 Regulation Name: Diagnostic Intravascular Catheter Regulatory Class: Class II Product Code: OBJ
5
Secondary Predicate Device: K211726
Trade/Device Name: ACUSON SC2000 Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulatory Class: Class II Product Code: OBJ, IYO, IYN, ITX, LLZ
Reference Predicate Devices:
Reference Device: K181042, Ultra ICE Plus – PI 9 MHz Peripheral Imaging Catheter (reference is used to compare to the motor unit only)
Device Description:
The VERAFEYE System is intended to be used for live, minimally-invasive guidance of several different intracardiac procedures including, but not limited to, atrial ablation procedures and transseptal punctures. The system will provide image information of cardiovascular anatomic features, spatial relationships of other devices within the heart and great vessels, physiological information of cardiovascular structures and features. In doing so we expect to provide an imaging system capable of improving the safety, expediency, cost-effectiveness and patient tolerance of the aforementioned procedures compared to the same procedures using the existing technologies and methodologies.
The system will be comprised of a catheter and an ultrasound imaging system with a console and computer screen.
The VERAFEYE Imaging System includes the System Console (SC) for image display and manipulation as well as the Catheter Interface Unit (CIU) which the catheter connects to. The SC will have two monitors to allow for ease of image view and review for both the technician and physician user.
The technician user will be able to control the system software via a graphical user interface using multiple methods of input including a mouse and keyboard. Caster wheels on the SC will allow easy movement of the system throughout the cardiac interventional lab which can have a small footprint as well as small obstacles to cross.
The catheter will be a 11Fr single use, sterile device, which will be able to perform intracardiac and intraluminal ultrasound imaging of adults. The catheter will be capable of live 2D side viewing imaging, as well as live 3D rendered images. The imaging system will be able to resolve and measure features such as the inferior and superior vena cava, ascending and descending aorta, left and right atria, left and right ventric valve, mitral valve and tricuspid valve.
The physician user will have easy steering maneuverability of the catheter via deflection and rotation, facilitating control over the position of the transducer to allow for multiple angles of images.
Intended Use: Cardiac
Indication for Use:
VERAFEYE Imaging Catheter
The VERAFEYE Imaging Catheter is intracardiac and intra-luminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart of adult patients. The catheter is intended for imaging guidance only, not treatment delivery, during cardiac interventional percutaneous procedures.
VERAFEYE Imaging System
The VERAFEYE Imaging System is intended for cardiac applications. The system transmits ultrasound energy into adult patients creating 2D (B-mode), & 3D images of the heart, cardiac valves, great vessels, and surrounding anatomical structures to evaluate the presence or absence of pathology.
The system also provides the ability to indicate scale with respect to anatomical structures, which provides information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes.
The system utilizes catheters which are intended for intraluminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart of adult patients. The catheter is intended for imaging guidance only, not treatment delivery, during cardiac interventional percutaneous procedures.
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Functional and Technological Comparison:
Tables 1 below include functional and technological comparison between the VERAFEYE Imaging Catheter and market cleared ACUSON AcuNav Volume Intracardiac Echocardiography (ICE) Catheter, K212959
Tables 2 include functional and technological comparison between the VERAFEYE Imaging System and market cleared ACUSON SC2000 Diagnostic Ultrasound System, K211726
Table 1. Predicate device 1: Medical Device 1: VERAFEYE Imaging Catheter
| Medical Device 1 | Luma Vision Subject Device: | Predicate Device: | Comparison | |
|---|---|---|---|---|
| VERAFEYE Imaging Catheter | ACUSON AcuNav Volume | |||
| Intracardiac | ||||
| Echocardiography (ICE) | ||||
| Catheter - # K212959 | ||||
| Classification: | Class II | Class II | Same as predicate | |
| Regulation: | 21 CFR 870.1200 | 21 CFR 870.1200 | Same as predicate | |
| Regulation | ||||
| Name: | Diagnostic Intravascular | |||
| Catheter | Diagnostic Intravascular | |||
| Catheter | Same as predicate | |||
| Product Code: | OBJ | OBJ | Same as predicate | |
| Catheter Type: | Intracardiac | |||
| Echocardiography | Intracardiac | |||
| Echocardiography | Same as predicate | |||
| Intended use: | The VERAFEYE Imaging | |||
| Catheter is intended for | ||||
| intracardiac and intra-luminal | ||||
| visualization of cardiac and | ||||
| great vessel anatomy and | ||||
| physiology as well as | ||||
| visualization of other devices | ||||
| in the heart of adult patients. | ||||
| The catheter is intended for | ||||
| imaging guidance only, not | The catheter is intended for | |||
| intracardiac and intra- | ||||
| luminal visualization of | ||||
| cardiac and great vessel | ||||
| anatomy and | ||||
| physiology as well as | ||||
| visualization of other devices | ||||
| in the heart of adult and | ||||
| pediatric patients. | ||||
| The catheter is intended for | Same as predicate | |||
| treatment delivery, during | ||||
| cardiac interventional | ||||
| percutaneous procedures. | imaging guidance only, not | |||
| treatment delivery, during | ||||
| cardiac interventional | ||||
| percutaneous procedures. | ||||
| Imaging energy: | Ultrasound | Ultrasound | Same as predicate | |
| Acoustic Array: | 64 channel (segmented | |||
| aperture) | 192 channel (segmented | |||
| aperture) | Same as predicate | |||
| Insertable Outer | ||||
| Diameter: | 11 French (3.7mm) | 12.5 French (4.2 mm) | Same as predicate | |
| Insertable | ||||
| Length: | - Total Insertable length: | |||
| 95cm |
- Distal Tip: 51mm | - Total Insertable Length: 90
cm - Distal Tip: 30.5mm (1.20")
- Strain Relief:
39.4mm(1.55") | Same as predicate | |
| Patient Contact
Material
(Catheter Body): | Nylon (ML21)
Pebax 35 & Pebax 55
Polymethyl Pentene (TPX)
Silicone (grade 4035) | Pebax series
Comply with ISO 10993-1 | Same as predicate | |
| Medical Device 1 | Luma Vision Subject Device: | Predicate Device: | Comparison | |
| | VERAFEYE Imaging Catheter | ACUSON AcuNav Volume
Intracardiac
Echocardiography (ICE)
Catheter - # K212959 | | |
| Minimum
Introducer
Sheath
Requirement: | 12 French or greater | 13 French | Same as predicate | |
| Packaging: | PETG thermoformed tray
Nylon/Tyvek Pouch | Tyvek/Polyester Pouch &
Solid Unbleached
Sulfate Box and Insert | Same as predicate | |
| Sterilization
method: | EtO sterilization | EtO sterilization | Same as predicate | |
| Single-use: | Yes | Yes | Same as predicate | |
| Shelf Life: | 6 months | 1 year | Same as predicate | |
| Compatible with
previously
cleared
ultrasound
systems: | N/A - no previous cleared
device
It is compatible with the
system in this bundle
submission (medical device 2) | Yes | Same as predicate | |
| Clinical
Performance
Data: | No clinical testing is included
in the submission.
Determination of substantial
equivalence is based on an
assessment of non-clinical
data. | No clinical testing is included
in the submission.
Determination of substantial
equivalence is based on an
assessment of non-clinical
data. | Same as predicate | |
| Non-clinical
performance
data: | - UL 60601-1, Safety
Requirements for Medical
Equipment - IEC 60601-2-37 Diagnostic
Ultrasound Safety
Standards - AIUM/NEMA UD-3,
Standard for Real Time
Display of Thermal and
Mechanical - Acoustic Output
Indices on Diagnostic
Ultrasound
Equipment - AIUM/NEMA UD-2,
Acoustic Output
Measurement
Standard for
Diagnostic
Ultrasound - Safety and EMC
Requirements for Medical | - UL 60601-1, Safety
Requirements for
Medical Equipment - IEC 60601-2-37
Diagnostic Ultrasound
Safety Standards - AIUM/NEMA UD-3,
Standard for Real Time
Display of Thermal and
Mechanical - Acoustic Output
Indices on
Diagnostic
Ultrasound
Equipment - AIUM/NEMA UD-
2, Acoustic Output
Measurement
Standard for
Diagnostic
Ultrasound | Same as predicate | |
| Medical Device 1 | Luma Vision Subject Device: | Predicate Device: | Comparison | |
| | VERAFEYE Imaging Catheter | ACUSON AcuNav Volume
Intracardiac
Echocardiography (ICE)
Catheter - # K212959 | | |
| | | Safety and EMC
Requirements for
Medical Equipment o EN/IEC 60601-1 EN/IEC
60601-1-2 | | |
| | Equipment o EN/IEC
60601-1 EN/IEC 60601-1-2
ISO 10993-1,
Biocompatibility
ISO 11135, Sterilization of
health-care products-
Ethylene oxide
ISO 11607-1 and ISO 11607-2,
Packaging for terminally
sterilized medical devices | ISO 10993-1,
Biocompatibility
ISO 11135, Sterilization of
health-care products-
Ethylene oxide
ISO 11607-1 and ISO 11607-
2, Packaging for terminally
sterilized medical devices | | |
| Principles of operation: | The VERAFEYE Imaging
Catheter provides
functionality to inspect and
visualize intracardiac as well
as intraluminal structures and
patient physiology. The
device uses ultrasound as the
physical imaging modality,
where the transducer is
integrated within a catheter
and steered intra-luminally to
a target structure that will be
examined by the user. The
catheter is delivered via
minimally invasive access and
enables anatomical
visualization to doctors
during intraluminal and
intracardiac procedures in
real time through a software
application. | The ACUSON AcuNav
Volume Intracardiac
Echocardiography (ICE)
Catheter is a 12.5F
catheter with 90 cm of
usable length and four-way
steering that provides real-
time three-dimensional
ultrasound images of
anatomical structures and
devices, in addition to
conventional real-time two-
dimensional images. | Same as predicate | |
| | Population: | Adult | Adult and pediatric
population | Same as predicate |
7
8
Intended Use Comparison for VERAFEYE Imaging System: Same as the predicate
Intended Use – VERAFEYE Imaging System
9
The VERAFEYE Imaging System is intended for cardiac applications. The system transmits ultrasound energy into adult patients creating 2D (B-mode), & 3D images of the heart, cardiac valves, great vessels, and surrounding anatomical structures to evaluate the presence or absence of pathology.
The system also provides the ability to indicate scale with respect to anatomical structures, which provides information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes.
The system utilizes catheters which are intended for intra-cardiac and intraluminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart of adult patients. The catheter is intended for imaging guidance only, not treatment delivery, during cardiac interventional percutaneous procedures.
Intended Use of Predicate Device:
Note: in yellow the parts of the Intended Use of the indication for use Cardia. The one used for the Intended Use of VERAFEYE Imaging System
The SC2000 ultrasound imaging system is intended for the following applications: Cardiac, Neo-natal and Fetal Cardiac, Pediatric, Transesophageal, Adult Cephalic, Peripheral Vessel, Abdominal, Intraoperative Abdominal, Musculo-skeletal Conventional, and Musculo-skeletal Superficial applications. The system also provides the ability to (indicate scale with respect to) measure anatomical structures and calculation packages that provide information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes. The typical examinations performed using the SC2000 Ultrasound System are: Cardiac Imaging Applications and Analysis
The system transmits ultrasound energy into adult, pediatric, neonatal, and fetal cardiac patients creating 2D (B), & 3D, MMode (M), Color Doppler (CD), Color Power Doppler (CPD), Pulsed Wave (PW) Doppler, and Continuous Wave Doppler (CWD) to obtain images and blood flow velocity of the heart, cardiac valves, great vessels, and surrounding anatomical structures to evaluate the presence or absence of pathology. The system may be used to acquire patient electrocardiogram for synchronizing the diastolic and systolic capture of ultrasound images.
The system also supports catheters which are intended for intra-cardiac and intraluminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart of adult and pediatric patients. The catheter is intended for imaging guidance only, not treatment delivery, during cardiac interventional percutaneous procedures. The system has Cardiac Measurements and Calculation Packages that provide information that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes. Vascular Imaqinq Applications and Analysis
The system transmits ultrasound energy into various parts of the body of adult patients creating 2D (B), Color Doppler
(CD), Color Power Doppler (CPD), Pulsed Wave Doppler (PWD), and Continuous Wave Doppler (CWD) to obtain images and blood flow velocity of the carotid arteries or juggler veins in the neck; superficial and deep veins and arteries in the arms and legs and abdomen; and surrounding anatomical structures to evaluate the presence or absence of pathology. The system may be used to acquire patient electrocardiogram for synchronizing the diastolic and systolic capture of ultrasound images. The system has Vascular Measurements and Calculation Packages that provide information that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes. Superficial Imaging Applications
The system transmits ultrasound energy into various parts of the body of adult patients creating 2D (B), Color Doppler The system transmits ultrasound energy into various parts of the body of adult patients creating 2D (B), Color Doppler
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(CD), Color Power Doppler (CPD), Pulsed Wave Doppler (PWD), and Continuous Wave Doppler (CWD) to obtain images and blood flow velocity of conventional or superficial musculoskeletal structures and surrounding anatomical structures to evaluate the presence of pathology. The system may be used to acquire patient electrocardiogram for synchronizing the diastolic and systolic capture of ultrasound images.
Intraoperative Imaging Applications
The system transmits ultrasound energy into various parts of the body of adult patients creating 2D (B). Color Doppler
(CD), Color Power Doppler (CPD), and Pulsed Wave Doppler (PWD) to obtain images and blood flow velocity that provide guidance during intraoperative procedures.
Transcranial Imaging Applications
The system transmits ultrasound energy into the cranium of adult patients creating 2D (B), Color Doppler (CD), Color Power Doppler (CPD), Pulsed Wave Doppler (PWD), and Continuous Wave Doppler (CWD) to obtain images and blood flow velocity of the brain and surrounding anatomical structures to evaluate the presence or absence of pathology. The system provides Measurement Packages that provide information that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes.
| Medical Device 2 | Luma Vision Subject
Device: | Predicate Device: | |
|--------------------------------|----------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------|----------------------|
| | VERAFEYE Imaging
System
v 1.0 | ACUSON SC2000
Diagnostic Ultrasound
System, K211726 | Comparison |
| Classification: | Class II | Class II | Same as
predicate |
| Regulation: | 21 CFR 892.1560 -
IYO | 21 CFR 892.1560 -
IYO
21 CFR 892.1550-
IYN
21 CFR 892.1570 -
ITX
21 CFR 892.1200 -
OBJ
21 CFR 892.2050-
LLZ | Same as
predicate |
| Regulation Name: | IYO - Ultrasonic
pulsed echo imaging
system. | IYO- Ultrasonic pulsed
echo imaging system.
LLZ- Medical image
management and
processing system.
Others | Same as
predicate |
| Product Code: | IYO | IYO, IYN, ITX, OBJ,
LLZ | Same as
predicate |
| Indication for Use-
Device: | Cardiac - Intracardiac
Echocardiography | Cardiac
Others (Fetal,
Abdominal, Pediatric,
Small Organ,
Peripheral vessel,
Musculo-skeletal
(Conventional) | Same as
predicate |
| Table 2: Predicate Device: Medical Device 2: VERAFEYE Imaging System | ||
|---|---|---|
| -- | -- | ---------------------------------------------------------------------- |
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| Medical Device 2 | Luma Vision Subject
Device: | Predicate Device: | Comparison |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------|
| | VERAFEYE Imaging
System
v 1.0 | ACUSON SC2000
Diagnostic Ultrasound
System, K211726 | |
| Operating Frequency: | 5.25 MHz | Musculo-skeletal
(Superficial)
Between 1.7 MHz &
10MHz | Same as
predicate |
| Modes: | 2D (B-mode) and 3D | B
M
PWD (Pulse Wave
Doppler)
CWD (Continuous
Wave Doppler)
PW DTI (Doppler
Tissue Image)
Color Doppler
Color Power Doppler
(CPD)
Combined (BMDC) | Same as
predicate |
| Transducers/catheters: | VERAEYE ICE
Catheter VF-VIC-001 | ACUSON AcuNav
Volume Intracardiac
Echocardiography
Catheter | Same as
predicate |
| System Features | | | |
| Patient Registration
Fields: | Yes | yes | Same as
predicate |
| Change/Edit Patient
Information Active Exam: | Yes | yes | Same as
predicate |
| Volume ICE Package: | Yes (VERAFEYE ICE
Catheter VF-VIC-001) | Yes - Acunav Volume
Intracardiac
Echocardiography
Catheter | Same as
predicate |
| Support for AcuNav
Volume ICE Catheter
connected by SwiftLink
Cable: | Yes, Supports
VERAFEYE ICE
catheter | yes | Same as
predicate |
| 2D ICE Package: | Yes (2D B-mode
imaging) | yes | Same as
predicate |
| True Volume Imaging
Support, AcuNav Volume
ICE Catheter: | Yes: volumetric
imaging with
VERAFEYE ICE
catheter | yes | Same as
predicate |
| Cardiac Measurements
and Calculations: | Yes: Length & area | yes | Same as
predicate |
| Edit patient data on
active exam: | Yes | yes | Same as
predicate |
| Zoom & Pan: | Yes | yes | Same as
predicate |
| Circle Tool: | Yes | yes | Same as
predicate |
| MS Windows 10 OS: | Yes | Windows 10 plus
updates | Same as
predicate |
| Medical Device 2 | Luma Vision Subject
Device: | Predicate Device: | |
| | VERAFEYE Imaging
System
v 1.0 | ACUSON SC2000
Diagnostic Ultrasound
System, K211726 | Comparison |
| Cybersecurity Features: | Yes | yes | Same as
predicate |
| Security - User Accounts
User Accounts \local
user
Authentication: | Yes | yes | Same as
predicate |
| Table side Remote
Control: | The VERAFEYE
ultrasound imaging
system will provide
control options through
mouse and keyboard | Yes, Joy-stick | Same as
predicate |
| Service Save logs: | Yes | yes | Same as
predicate |
| Security Hot-fix
Installation: | Yes: Through USB
drive | install a hotfix update
via RUH
(remote update
handling) or USB
drive | Same as
predicate |
| Study Back-up and
Restore: | Yes | yes | Same as
predicate |
| Monitor: | Yes | Yes | Same as
predicate |
| Output Display Standard
(Track 3): | Yes | Yes | Same as
predicate |
| Patient Contact
Materials: | Yes | Tested to ISO 10993-1 | Same as
predicate |
| UL 60601-1 Certified:
AAMI / ANSI ES60601-1:2005/(R)2012 and
A1:2012, C1:2009/(R)2012 and
A2:2010/(R)2012, Medical electrical
equipment - Part 1: General requirements for
basic safety and essential performance
IEC 60601-1, Medical Electrical Equipment -
Part 1: General Requirements For Basic
Safety
And Essential Performance (IEC 60601-
1:2005, MOD)
· IEC 60601-1-2: 2007(Third Edition), Medical
electrical equipment - Part 1-2: General
requirements for basic safety and essential
performance - Collateral standard:
Electromagnetic compatibility - Requirements
and tests
· IEC 60601-2-37:2007+A1:2015, Medical
electrical equipment - Part 2-37: Particular
requirements for the basic safety and essential
performance of ultrasound medical
diagnostic and monitoring equipment
· IEC 60601-2-18:2009, Medical electrical
equipment - Part 2: Particular requirements
for the safety of endoscopic equipment | Yes | Yes | Same as
predicate |
| Medical Device 2 | Luma Vision Subject
Device: | Predicate Device: | |
| | VERAFEYE Imaging
System
v 1.0 | ACUSON SC2000
Diagnostic Ultrasound
System, K211726 | Comparison |
| Additional non-clinical
performance data
IEC 62304:2006
IEC 62366:2014
AIUM/NEMA UD-3:2004,
Standard for Real Time
Display of Thermal and
Mechanical Acoustic
Output Indices on Diagnostic
Ultrasound Equipment
• AIUM/NEMA UD-2:2004,
Acoustic Output Measurement
Standard for Diagnostic
Ultrasound Equipment
IEC 62359:2010, Ultrasonics –
Field characterization - Test
Methods for the
determination of thermal and
mechanical indices related to
medical diagnostic
ultrasonic fields | yes | yes | Same as
predicate |
| Motor Unit: | Motor Unit –
VERAFEYE system | REFERENCE DEVICE –
Motor unit –
Ultra ICE Plus - PI 9 MHz
Peripheral Imaging
Catheter (K181042) | |
| | Function: Rotates the inner
part of the catheter
NOTE: The motor unit, is
equivalent of the motor unit
of the Ultra ICE Plus catheter
(# K181042) – we can take
this part of that product as a
reference device, as although
it has a different intended use
(for the entire Ultra ICE
catheter than VERAFEYE, the
“motor unit” part of the Ultra
ICE catheter is equivalent
operational principle (rotates)
to the VERAFEYE motor unit
as their intended use is to
rotate the catheter and to | Function: Rotates the
inner part of the
catheter
The reference device
is the Motor unit of
Ultra ICE catheter
(K181042) | Same as
reference device |
12
13
Conclusion:
The VERAFEYE Imaging Catheter and the VERAFEYE Imaging System and predicate devices have identical intended use, principles of operation and technological characteristics.
After analyzing the results of the bench, laboratory and electrical safety tests it can be concluded that the VERAFEYE Imaging Catheter and the predicate device (K212959) are substantially equivalent. After analyzing the results of the bench, laboratory and electrical safety tests, it can be
14
concluded that the VERAFEYE Imaging System and the predicate device (K211726) are substantially equivalent.
The subject devices (VERAFEYE Imaging Catheter and the VERAFEYE Imaging System) and predicate devices are all intended for use in intravascular and/or intracardiac imaging. The results of the relevant performance data and compatibility testing support a determination that the proposed subject devices do not raise new questions of safety or effectiveness and is substantially equivalent to the predicate devices.