(182 days)
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.
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.
This appears to be a 510(k) Pre-market Notification document for the VERAFEYE System. It describes the device's intended use and compares it to predicate devices to establish substantial equivalence, rather than detailing a study used to prove the device meets specific acceptance criteria in the context of an AI/ML study.
Therefore, the requested information points (1-9) which are typically associated with performance evaluations of AI/ML devices, are not directly addressed in this document. The document focuses on regulatory comparison and safety/effectiveness based on non-clinical data and equivalence to existing devices.
Specifically:
- Acceptance Criteria and Reported Device Performance: This document doesn't provide a table of acceptance criteria for AI performance or reported device performance in that context. It focuses on functional and technological comparisons with predicate devices.
- Sample Size and Data Provenance (Test Set): Not applicable as this is not an AI/ML performance study.
- Number of Experts and Qualifications (Ground Truth): Not applicable.
- Adjudication Method: Not applicable.
- Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not applicable. The document states, "No clinical testing is included in the submission. Determination of substantial equivalence is based on an assessment of non-clinical data."
- Standalone Performance Study (Algorithm Only): Not applicable.
- Type of Ground Truth Used: Not applicable.
- Sample Size for Training Set: Not applicable.
- How Ground Truth for Training Set was Established: Not applicable.
The document primarily makes a case for substantial equivalence based on technical characteristics, intended use, and non-clinical performance data, rather than reporting on an AI/ML specific performance study. It lists various safety and performance standards (e.g., UL 60601-1, IEC 60601-2-37, ISO 10993-1) that the device was tested against to demonstrate safety and effectiveness for regulatory clearance.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo in blue. Underneath the FDA logo is the word "ADMINISTRATION" also in blue.
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.
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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
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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
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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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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
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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 VolumeIntracardiacEchocardiography (ICE)Catheter - # K212959 | |||
| Classification: | Class II | Class II | Same as predicate | |
| Regulation: | 21 CFR 870.1200 | 21 CFR 870.1200 | Same as predicate | |
| RegulationName: | Diagnostic IntravascularCatheter | Diagnostic IntravascularCatheter | Same as predicate | |
| Product Code: | OBJ | OBJ | Same as predicate | |
| Catheter Type: | IntracardiacEchocardiography | IntracardiacEchocardiography | Same as predicate | |
| Intended use: | The VERAFEYE ImagingCatheter is intended forintracardiac and intra-luminalvisualization of cardiac andgreat vessel anatomy andphysiology as well asvisualization of other devicesin the heart of adult patients.The catheter is intended forimaging guidance only, not | The catheter is intended forintracardiac and intra-luminal visualization ofcardiac and great vesselanatomy andphysiology as well asvisualization of other devicesin the heart of adult andpediatric patients.The catheter is intended for | Same as predicate | |
| treatment delivery, duringcardiac interventionalpercutaneous procedures. | imaging guidance only, nottreatment delivery, duringcardiac interventionalpercutaneous procedures. | |||
| Imaging energy: | Ultrasound | Ultrasound | Same as predicate | |
| Acoustic Array: | 64 channel (segmentedaperture) | 192 channel (segmentedaperture) | Same as predicate | |
| Insertable OuterDiameter: | 11 French (3.7mm) | 12.5 French (4.2 mm) | Same as predicate | |
| InsertableLength: | - Total Insertable length:95cm- Distal Tip: 51mm | - Total Insertable Length: 90cm- Distal Tip: 30.5mm (1.20")- Strain Relief:39.4mm(1.55") | Same as predicate | |
| Patient ContactMaterial(Catheter Body): | Nylon (ML21)Pebax 35 & Pebax 55Polymethyl Pentene (TPX)Silicone (grade 4035) | Pebax seriesComply with ISO 10993-1 | Same as predicate | |
| Medical Device 1 | Luma Vision Subject Device: | Predicate Device: | Comparison | |
| VERAFEYE Imaging Catheter | ACUSON AcuNav VolumeIntracardiacEchocardiography (ICE)Catheter - # K212959 | |||
| MinimumIntroducerSheathRequirement: | 12 French or greater | 13 French | Same as predicate | |
| Packaging: | PETG thermoformed trayNylon/Tyvek Pouch | Tyvek/Polyester Pouch &Solid UnbleachedSulfate Box and Insert | Same as predicate | |
| Sterilizationmethod: | EtO sterilization | EtO sterilization | Same as predicate | |
| Single-use: | Yes | Yes | Same as predicate | |
| Shelf Life: | 6 months | 1 year | Same as predicate | |
| Compatible withpreviouslyclearedultrasoundsystems: | N/A - no previous cleareddeviceIt is compatible with thesystem in this bundlesubmission (medical device 2) | Yes | Same as predicate | |
| ClinicalPerformanceData: | No clinical testing is includedin the submission.Determination of substantialequivalence is based on anassessment of non-clinicaldata. | No clinical testing is includedin the submission.Determination of substantialequivalence is based on anassessment of non-clinicaldata. | Same as predicate | |
| Non-clinicalperformancedata: | - UL 60601-1, SafetyRequirements for MedicalEquipment- IEC 60601-2-37 DiagnosticUltrasound SafetyStandards- AIUM/NEMA UD-3,Standard for Real TimeDisplay of Thermal andMechanical- Acoustic OutputIndices on DiagnosticUltrasoundEquipment- AIUM/NEMA UD-2,Acoustic OutputMeasurementStandard forDiagnosticUltrasound- Safety and EMCRequirements for Medical | - UL 60601-1, SafetyRequirements forMedical Equipment- IEC 60601-2-37Diagnostic UltrasoundSafety Standards- AIUM/NEMA UD-3,Standard for Real TimeDisplay of Thermal andMechanical- Acoustic OutputIndices onDiagnosticUltrasoundEquipment- AIUM/NEMA UD-2, Acoustic OutputMeasurementStandard forDiagnosticUltrasound | Same as predicate | |
| Medical Device 1 | Luma Vision Subject Device: | Predicate Device: | Comparison | |
| VERAFEYE Imaging Catheter | ACUSON AcuNav VolumeIntracardiacEchocardiography (ICE)Catheter - # K212959 | |||
| Safety and EMCRequirements forMedical Equipment o EN/IEC 60601-1 EN/IEC60601-1-2 | ||||
| Equipment o EN/IEC60601-1 EN/IEC 60601-1-2ISO 10993-1,BiocompatibilityISO 11135, Sterilization ofhealth-care products-Ethylene oxideISO 11607-1 and ISO 11607-2,Packaging for terminallysterilized medical devices | ISO 10993-1,BiocompatibilityISO 11135, Sterilization ofhealth-care products-Ethylene oxideISO 11607-1 and ISO 11607-2, Packaging for terminallysterilized medical devices | |||
| Principles of operation: | The VERAFEYE ImagingCatheter providesfunctionality to inspect andvisualize intracardiac as wellas intraluminal structures andpatient physiology. Thedevice uses ultrasound as thephysical imaging modality,where the transducer isintegrated within a catheterand steered intra-luminally toa target structure that will beexamined by the user. Thecatheter is delivered viaminimally invasive access andenables anatomicalvisualization to doctorsduring intraluminal andintracardiac procedures inreal time through a softwareapplication. | The ACUSON AcuNavVolume IntracardiacEchocardiography (ICE)Catheter is a 12.5Fcatheter with 90 cm ofusable length and four-waysteering that provides real-time three-dimensionalultrasound images ofanatomical structures anddevices, in addition toconventional real-time two-dimensional images. | Same as predicate | |
| Population: | Adult | Adult and pediatricpopulation | Same as predicate |
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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 SubjectDevice: | Predicate Device: | |
|---|---|---|---|
| VERAFEYE ImagingSystemv 1.0 | ACUSON SC2000Diagnostic UltrasoundSystem, K211726 | Comparison | |
| Classification: | Class II | Class II | Same aspredicate |
| Regulation: | 21 CFR 892.1560 -IYO | 21 CFR 892.1560 -IYO21 CFR 892.1550-IYN21 CFR 892.1570 -ITX21 CFR 892.1200 -OBJ21 CFR 892.2050-LLZ | Same aspredicate |
| Regulation Name: | IYO - Ultrasonicpulsed echo imagingsystem. | IYO- Ultrasonic pulsedecho imaging system.LLZ- Medical imagemanagement andprocessing system.Others | Same aspredicate |
| Product Code: | IYO | IYO, IYN, ITX, OBJ,LLZ | Same aspredicate |
| Indication for Use-Device: | Cardiac - IntracardiacEchocardiography | CardiacOthers (Fetal,Abdominal, Pediatric,Small Organ,Peripheral vessel,Musculo-skeletal(Conventional) | Same aspredicate |
| Table 2: Predicate Device: Medical Device 2: VERAFEYE Imaging System | ||
|---|---|---|
| -- | -- | ---------------------------------------------------------------------- |
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| Medical Device 2 | Luma Vision SubjectDevice: | Predicate Device: | Comparison |
|---|---|---|---|
| VERAFEYE ImagingSystemv 1.0 | ACUSON SC2000Diagnostic UltrasoundSystem, K211726 | ||
| Operating Frequency: | 5.25 MHz | Musculo-skeletal(Superficial)Between 1.7 MHz &10MHz | Same aspredicate |
| Modes: | 2D (B-mode) and 3D | BMPWD (Pulse WaveDoppler)CWD (ContinuousWave Doppler)PW DTI (DopplerTissue Image)Color DopplerColor Power Doppler(CPD)Combined (BMDC) | Same aspredicate |
| Transducers/catheters: | VERAEYE ICECatheter VF-VIC-001 | ACUSON AcuNavVolume IntracardiacEchocardiographyCatheter | Same aspredicate |
| System Features | |||
| Patient RegistrationFields: | Yes | yes | Same aspredicate |
| Change/Edit PatientInformation Active Exam: | Yes | yes | Same aspredicate |
| Volume ICE Package: | Yes (VERAFEYE ICECatheter VF-VIC-001) | Yes - Acunav VolumeIntracardiacEchocardiographyCatheter | Same aspredicate |
| Support for AcuNavVolume ICE Catheterconnected by SwiftLinkCable: | Yes, SupportsVERAFEYE ICEcatheter | yes | Same aspredicate |
| 2D ICE Package: | Yes (2D B-modeimaging) | yes | Same aspredicate |
| True Volume ImagingSupport, AcuNav VolumeICE Catheter: | Yes: volumetricimaging withVERAFEYE ICEcatheter | yes | Same aspredicate |
| Cardiac Measurementsand Calculations: | Yes: Length & area | yes | Same aspredicate |
| Edit patient data onactive exam: | Yes | yes | Same aspredicate |
| Zoom & Pan: | Yes | yes | Same aspredicate |
| Circle Tool: | Yes | yes | Same aspredicate |
| MS Windows 10 OS: | Yes | Windows 10 plusupdates | Same aspredicate |
| Medical Device 2 | Luma Vision SubjectDevice: | Predicate Device: | |
| VERAFEYE ImagingSystemv 1.0 | ACUSON SC2000Diagnostic UltrasoundSystem, K211726 | Comparison | |
| Cybersecurity Features: | Yes | yes | Same aspredicate |
| Security - User AccountsUser Accounts \localuserAuthentication: | Yes | yes | Same aspredicate |
| Table side RemoteControl: | The VERAFEYEultrasound imagingsystem will providecontrol options throughmouse and keyboard | Yes, Joy-stick | Same aspredicate |
| Service Save logs: | Yes | yes | Same aspredicate |
| Security Hot-fixInstallation: | Yes: Through USBdrive | install a hotfix updatevia RUH(remote updatehandling) or USBdrive | Same aspredicate |
| Study Back-up andRestore: | Yes | yes | Same aspredicate |
| Monitor: | Yes | Yes | Same aspredicate |
| Output Display Standard(Track 3): | Yes | Yes | Same aspredicate |
| Patient ContactMaterials: | Yes | Tested to ISO 10993-1 | Same aspredicate |
| UL 60601-1 Certified:AAMI / ANSI ES60601-1:2005/(R)2012 andA1:2012, C1:2009/(R)2012 andA2:2010/(R)2012, Medical electricalequipment - Part 1: General requirements forbasic safety and essential performanceIEC 60601-1, Medical Electrical Equipment -Part 1: General Requirements For BasicSafetyAnd Essential Performance (IEC 60601-1:2005, MOD)· IEC 60601-1-2: 2007(Third Edition), Medicalelectrical equipment - Part 1-2: Generalrequirements for basic safety and essentialperformance - Collateral standard:Electromagnetic compatibility - Requirementsand tests· IEC 60601-2-37:2007+A1:2015, Medicalelectrical equipment - Part 2-37: Particularrequirements for the basic safety and essentialperformance of ultrasound medicaldiagnostic and monitoring equipment· IEC 60601-2-18:2009, Medical electricalequipment - Part 2: Particular requirementsfor the safety of endoscopic equipment | Yes | Yes | Same aspredicate |
| Medical Device 2 | Luma Vision SubjectDevice: | Predicate Device: | |
| VERAFEYE ImagingSystemv 1.0 | ACUSON SC2000Diagnostic UltrasoundSystem, K211726 | Comparison | |
| Additional non-clinicalperformance dataIEC 62304:2006IEC 62366:2014AIUM/NEMA UD-3:2004,Standard for Real TimeDisplay of Thermal andMechanical AcousticOutput Indices on DiagnosticUltrasound Equipment• AIUM/NEMA UD-2:2004,Acoustic Output MeasurementStandard for DiagnosticUltrasound EquipmentIEC 62359:2010, Ultrasonics –Field characterization - TestMethods for thedetermination of thermal andmechanical indices related tomedical diagnosticultrasonic fields | yes | yes | Same aspredicate |
| Motor Unit: | Motor Unit –VERAFEYE system | REFERENCE DEVICE –Motor unit –Ultra ICE Plus - PI 9 MHzPeripheral ImagingCatheter (K181042) | |
| Function: Rotates the innerpart of the catheterNOTE: The motor unit, isequivalent of the motor unitof the Ultra ICE Plus catheter(# K181042) – we can takethis part of that product as areference device, as althoughit has a different intended use(for the entire Ultra ICEcatheter than VERAFEYE, the“motor unit” part of the UltraICE catheter is equivalentoperational principle (rotates)to the VERAFEYE motor unitas their intended use is torotate the catheter and to | Function: Rotates theinner part of thecatheterThe reference deviceis the Motor unit ofUltra ICE catheter(K181042) | Same asreference device |
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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
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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.
§ 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).