VERAFEYE System VERAFEYE Imaging Catheter & VERAFEYE Imaging System

K242893 · Luma Vision Limited · OBJ · Mar 24, 2025 · Cardiovascular

Device Facts

• Record ID: K242893
• Device Name: VERAFEYE System VERAFEYE Imaging Catheter & VERAFEYE Imaging System
• Applicant: Luma Vision Limited
• Product Code: OBJ · Cardiovascular
• Decision Date: Mar 24, 2025
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1200
• Device Class: Class 2

Intended 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.

Device Story

VERAFEYE System provides live, minimally-invasive ultrasound guidance for intracardiac procedures (e.g., atrial ablation, transseptal punctures). System includes 11Fr single-use sterile imaging catheter, console, and computer screen. Catheter transducer, steered via deflection/rotation, captures 2D (B-mode) and 3D images of heart, valves, and great vessels. Technician operates system via GUI (mouse/keyboard) in cardiac interventional lab; physician maneuvers catheter. System processes ultrasound signals to display anatomical features and spatial relationships of devices. Output provides real-time visualization and scale measurement to assist clinicians in evaluating pathology and guiding procedures. Benefits include improved safety, expediency, and patient tolerance compared to existing methodologies.

Clinical Evidence

No clinical testing included. Substantial equivalence determination based on non-clinical bench, laboratory, and electrical safety data, including compliance with UL 60601-1, IEC 60601-2-37, AIUM/NEMA UD-2/UD-3, and biocompatibility testing per ISO 10993-1.

Technological Characteristics

Ultrasound imaging system with 11Fr catheter. Catheter materials: Nylon (ML21), Pebax 35/55, Polymethyl Pentene (TPX), Silicone (grade 4035). 64-channel segmented aperture transducer. Operating frequency 5.25 MHz. Connectivity: Standalone console with dual monitors. Sterilization: EtO. Software: Windows 10 OS. Compliance: IEC 60601-1, IEC 60601-2-37, IEC 60601-2-18, IEC 62304, IEC 62366.

Indications for Use

Indicated for adult patients requiring intra-cardiac and intra-luminal visualization of cardiac and great vessel anatomy, physiology, and other devices during cardiac interventional percutaneous procedures. Intended for imaging guidance only, not treatment delivery.

Regulatory Classification

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.

Predicate Devices

• ACUSON AcuNav Volume Intracardiac Echocardiography (ICE) Catheter (K212959)
• ACUSON SC2000 Diagnostic Ultrasound System (K211726)

Reference Devices

• Ultra ICE Plus – PI 9 MHz Peripheral Imaging Catheter (K181042)

Submission Summary (Full Text)

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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.

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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 ([e-mail]) or phone [phone] 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) | |
|------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------|
| <div> <span> <span style="font-size:16px">☒</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> <span style="font-size:16px">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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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 [e-mail]

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: | [e-mail] |
| 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 Volume<br>Intracardiac<br>Echocardiography (ICE)<br>Catheter - # K212959 | | |
| Classification: | Class II | Class II | Same as predicate | |
| Regulation: | 21 CFR 870.1200 | 21 CFR 870.1200 | Same as predicate | |
| Regulation<br>Name: | Diagnostic Intravascular<br>Catheter | Diagnostic Intravascular<br>Catheter | Same as predicate | |
| Product Code: | OBJ | OBJ | Same as predicate | |
| Catheter Type: | Intracardiac<br>Echocardiography | Intracardiac<br>Echocardiography | Same as predicate | |
| Intended use: | The VERAFEYE Imaging<br>Catheter is intended for<br>intracardiac and intra-luminal<br>visualization of cardiac and<br>great vessel anatomy and<br>physiology as well as<br>visualization of other devices<br>in the heart of adult patients.<br>The catheter is intended for<br>imaging guidance only, not | The catheter is intended for<br>intracardiac and intra-<br>luminal visualization of<br>cardiac and great vessel<br>anatomy and<br>physiology as well as<br>visualization of other devices<br>in the heart of adult and<br>pediatric patients.<br>The catheter is intended for | Same as predicate | |
| | treatment delivery, during<br>cardiac interventional<br>percutaneous procedures. | imaging guidance only, not<br>treatment delivery, during<br>cardiac interventional<br>percutaneous procedures. | | |
| Imaging energy: | Ultrasound | Ultrasound | Same as predicate | |
| Acoustic Array: | 64 channel (segmented<br>aperture) | 192 channel (segmented<br>aperture) | Same as predicate | |
| Insertable Outer<br>Diameter: | 11 French (3.7mm) | 12.5 French (4.2 mm) | Same as predicate | |
| Insertable<br>Length: | - Total Insertable length:<br>95cm<br>- Distal Tip: 51mm | - Total Insertable Length: 90<br>cm<br>- Distal Tip: 30.5mm (1.20")<br>- Strain Relief:<br>39.4mm(1.55") | Same as predicate | |
| Patient Contact<br>Material<br>(Catheter Body): | Nylon (ML21)<br>Pebax 35 & Pebax 55<br>Polymethyl Pentene (TPX)<br>Silicone (grade 4035) | Pebax series<br>Comply with ISO 10993-1 | Same as predicate | |
| Medical Device 1 | Luma Vision Subject Device: | Predicate Device: | Comparison | |
| | VERAFEYE Imaging Catheter | ACUSON AcuNav Volume<br>Intracardiac<br>Echocardiography (ICE)<br>Catheter - # K212959 | | |
| Minimum<br>Introducer<br>Sheath<br>Requirement: | 12 French or greater | 13 French | Same as predicate | |
| Packaging: | PETG thermoformed tray<br>Nylon/Tyvek Pouch | Tyvek/Polyester Pouch &<br>Solid Unbleached<br>Sulfate Box and Insert | Same as predicate | |
| Sterilization<br>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<br>previously<br>cleared<br>ultrasound<br>systems: | N/A - no previous cleared<br>device<br>It is compatible with the<br>system in this bundle<br>submission (medical device 2) | Yes | Same as predicate | |
| Clinical<br>Performance<br>Data: | No clinical testing is included<br>in the submission.<br>Determination of substantial<br>equivalence is based on an<br>assessment of non-clinical<br>data. | No clinical testing is included<br>in the submission.<br>Determination of substantial<br>equivalence is based on an<br>assessment of non-clinical<br>data. | Same as predicate | |
| Non-clinical<br>performance<br>data: | - UL 60601-1, Safety<br>Requirements for Medical<br>Equipment<br>- IEC 60601-2-37 Diagnostic<br>Ultrasound Safety<br>Standards<br>- AIUM/NEMA UD-3,<br>Standard for Real Time<br>Display of Thermal and<br>Mechanical<br>- Acoustic Output<br>Indices on Diagnostic<br>Ultrasound<br>Equipment<br>- AIUM/NEMA UD-2,<br>Acoustic Output<br>Measurement<br>Standard for<br>Diagnostic<br>Ultrasound<br>- Safety and EMC<br>Requirements for Medical | - UL 60601-1, Safety<br>Requirements for<br>Medical Equipment<br>- IEC 60601-2-37<br>Diagnostic Ultrasound<br>Safety Standards<br>- AIUM/NEMA UD-3,<br>Standard for Real Time<br>Display of Thermal and<br>Mechanical<br>- Acoustic Output<br>Indices on<br>Diagnostic<br>Ultrasound<br>Equipment<br>- AIUM/NEMA UD-<br>2, Acoustic Output<br>Measurement<br>Standard for<br>Diagnostic<br>Ultrasound | Same as predicate | |
| Medical Device 1 | Luma Vision Subject Device: | Predicate Device: | Comparison | |
| | VERAFEYE Imaging Catheter | ACUSON AcuNav Volume<br>Intracardiac<br>Echocardiography (ICE)<br>Catheter - # K212959 | | |
| | | Safety and EMC<br>Requirements for<br>Medical Equipment o EN/IEC 60601-1 EN/IEC<br>60601-1-2 | | |
| | Equipment o EN/IEC<br>60601-1 EN/IEC 60601-1-2<br>ISO 10993-1,<br>Biocompatibility<br>ISO 11135, Sterilization of<br>health-care products-<br>Ethylene oxide<br>ISO 11607-1 and ISO 11607-2,<br>Packaging for terminally<br>sterilized medical devices | ISO 10993-1,<br>Biocompatibility<br>ISO 11135, Sterilization of<br>health-care products-<br>Ethylene oxide<br>ISO 11607-1 and ISO 11607-<br>2, Packaging for terminally<br>sterilized medical devices | | |
| Principles of operation: | The VERAFEYE Imaging<br>Catheter provides<br>functionality to inspect and<br>visualize intracardiac as well<br>as intraluminal structures and<br>patient physiology. The<br>device uses ultrasound as the<br>physical imaging modality,<br>where the transducer is<br>integrated within a catheter<br>and steered intra-luminally to<br>a target structure that will be<br>examined by the user. The<br>catheter is delivered via<br>minimally invasive access and<br>enables anatomical<br>visualization to doctors<br>during intraluminal and<br>intracardiac procedures in<br>real time through a software<br>application. | The ACUSON AcuNav<br>Volume Intracardiac<br>Echocardiography (ICE)<br>Catheter is a 12.5F<br>catheter with 90 cm of<br>usable length and four-way<br>steering that provides real-<br>time three-dimensional<br>ultrasound images of<br>anatomical structures and<br>devices, in addition to<br>conventional real-time two-<br>dimensional images. | Same as predicate | |
| | Population: | Adult | Adult and pediatric<br>population | Same as predicate |

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# Intended Use Comparison for VERAFEYE Imaging System: Same as the predicate

## Intended Use – VERAFEYE Imaging System

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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<br>Device: | Predicate Device: | |
|--------------------------------|----------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------|----------------------|
| | VERAFEYE Imaging<br>System<br>v 1.0 | ACUSON SC2000<br>Diagnostic Ultrasound<br>System, K211726 | Comparison |
| Classification: | Class II | Class II | Same as<br>predicate |
| Regulation: | 21 CFR 892.1560 -<br>IYO | 21 CFR 892.1560 -<br>IYO<br>21 CFR 892.1550-<br>IYN<br>21 CFR 892.1570 -<br>ITX<br>21 CFR 892.1200 -<br>OBJ<br>21 CFR 892.2050-<br>LLZ | Same as<br>predicate |
| Regulation Name: | IYO - Ultrasonic<br>pulsed echo imaging<br>system. | IYO- Ultrasonic pulsed<br>echo imaging system.<br>LLZ- Medical image<br>management and<br>processing system.<br>Others | Same as<br>predicate |
| Product Code: | IYO | IYO, IYN, ITX, OBJ,<br>LLZ | Same as<br>predicate |
| Indication for Use-<br>Device: | Cardiac - Intracardiac<br>Echocardiography | Cardiac<br>Others (Fetal,<br>Abdominal, Pediatric,<br>Small Organ,<br>Peripheral vessel,<br>Musculo-skeletal<br>(Conventional) | Same as<br>predicate |

| | | Table 2: Predicate Device: Medical Device 2: VERAFEYE Imaging System |
|--|--|----------------------------------------------------------------------|
|--|--|----------------------------------------------------------------------|

{11}------------------------------------------------

| Medical Device 2 | Luma Vision Subject<br>Device: | Predicate Device: | Comparison |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------|
| | VERAFEYE Imaging<br>System<br>v 1.0 | ACUSON SC2000<br>Diagnostic Ultrasound<br>System, K211726 | |
| Operating Frequency: | 5.25 MHz | Musculo-skeletal<br>(Superficial)<br>Between 1.7 MHz &<br>10MHz | Same as<br>predicate |
| Modes: | 2D (B-mode) and 3D | B<br>M<br>PWD (Pulse Wave<br>Doppler)<br>CWD (Continuous<br>Wave Doppler)<br>PW DTI (Doppler<br>Tissue Image)<br>Color Doppler<br>Color Power Doppler<br>(CPD)<br>Combined (BMDC) | Same as<br>predicate |
| Transducers/catheters: | VERAEYE ICE<br>Catheter VF-VIC-001 | ACUSON AcuNav<br>Volume Intracardiac<br>Echocardiography<br>Catheter | Same as<br>predicate |
| System Features | | | |
| Patient Registration<br>Fields: | Yes | yes | Same as<br>predicate |
| Change/Edit Patient<br>Information Active Exam: | Yes | yes | Same as<br>predicate |
| Volume ICE Package: | Yes (VERAFEYE ICE<br>Catheter VF-VIC-001) | Yes - Acunav Volume<br>Intracardiac<br>Echocardiography<br>Catheter | Same as<br>predicate |
| Support for AcuNav<br>Volume ICE Catheter<br>connected by SwiftLink<br>Cable: | Yes, Supports<br>VERAFEYE ICE<br>catheter | yes | Same as<br>predicate |
| 2D ICE Package:…