Foresight Intracardiac Echocardiology (ICE) System
Device Facts
| Record ID | K162789 |
|---|---|
| Device Name | Foresight Intracardiac Echocardiology (ICE) System |
| Applicant | Conavi Medical, Inc. |
| Product Code | DQO · Cardiovascular |
| Decision Date | Mar 28, 2017 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 870.1200 |
| Device Class | Class 2 |
Indications for Use
The Foresight Intracardiac Echocardiography (ICE) System is indicated for intraluminal ultrasound visualization of cardiac and great vessel anatomy and physiology as well as visualization of other aevices in the heart and great vessels of patients.
Device Story
Foresight ICE System provides real-time, minimally-invasive ultrasound guidance for intracardiac procedures (e.g., atrial ablation, transseptal punctures). System consists of a 10.3F single-use sterile catheter and a cart-based console with Acquisition and Display Module (ADM) and Patient Interface Module (PIM). Catheter features a mechanically rotated single ultrasound imaging element with a pivot mechanism for side and forward viewing. Console includes dual monitors, touchscreen/mouse/keyboard inputs, and DICOM storage. Physician operates catheter via deflection/rotation; technician manages console software. System produces 2D images, post-processed 3D renderings, and ECG-gated 3D images to reduce motion artifacts. Provides visualization of cardiovascular structures (vena cava, aorta, atria, ventricles, valves) and flow velocities via Color/PW Doppler. Used in EP labs to improve procedure safety, expediency, and patient tolerance by providing spatial orientation of devices and identifying complications like pericardial effusions.
Clinical Evidence
No clinical testing included. Substantial equivalence based on non-clinical data: bench-top evaluations, animal testing, packaging validation, biological safety, electrical safety, and acoustic output testing (per IEC 60601-2-37 and NEMA UD-2).
Technological Characteristics
10.3F single-use catheter; PEBAX 5533 atraumatic tip; mechanically rotated single-element transducer (9MHz center frequency). Imaging modes: B-Mode, M-Mode, Pulsed Wave Doppler, Color Doppler. Console: mobile cart, DICOM/native storage, IEC 60601-1 compliant. Sterilization: Ethylene Oxide (ISO 11135-1).
Indications for Use
Indicated for intraluminal ultrasound visualization of cardiac and great vessel anatomy, physiology, and other devices in the heart and great vessels of adult patients.
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
- Conavi Medical (Formerly Colibri Technologies) ICE system (K151126)
- Acuson Corp. AcuNav™ Diagnostic Ultrasound Catheter (K992631)
Submission Summary (Full Text)
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March 28, 2017
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Conavi Medical Inc. Sam Mostafavi Director of Quality & Regulatory Affairs 293 Lesmill Road Ontario, CANADA M3B 2V1
Re: K162789
Trade/Device Name: Foresight Intracardiac Echocardiographic (ICE) System Regulation Number: 21 CFR 870.1200 Regulation Name: Diagnostic Intravascular Catheter Regulatory Class: Class II Product Code: DQO, ITX Dated: December 15, 2016 Received: December 19, 2016
Dear Sam Mostafavi:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices. good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely.
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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### Indications for Use
510(k) Number (if known) K162789
#### Device Name
Foresight Intracardiac Echocardiography (ICE) System
Indications for Use (Describe)
The Foresight Intracardiac Echocardiography (ICE) System is indicated for intraluminal ultrasound visualization of cardiac and great vessel anatomy and physiology as well as visualization of other aevices in the heart and great vessels of patients.
| Type of Use (Select one or both, as applicable) | |
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# 510(k) Summary
This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
#### 510(k) Number: K162789
#### Applicant Information:
| Date Prepared: | February 17, 2017 |
|-------------------|--------------------------------|
| Name: | Conavi Medical Inc. |
| Address: | 293 Lesmill Road |
| | North York, ON, Canada M3B 2V1 |
| Contact Person: | Sam Mostafavi |
| | Sam@Conavi.com |
| Mobile Number: | 650-670-6972 |
| Office Number: | (416) 483-0100 |
| Facsimile Number: | (416) 483-0101 |
#### Device Information:
| Trade/Proprietary Name: | Intracardiac Echocardiography (ICE) System |
|-------------------------|-----------------------------------------------------------------------------------------------------------------------|
| Common Name: | Foresight Intracardiac Echocardiography (ICE) System |
| Classification Name(s): | Diagnostic Intravascular Catheters, 21 CFR 870.1200 (DQO)<br>Diagnostic Ultrasonic Transducers, 21 CFR 892.1570 (ITX) |
| Class: | Class II |
| Panel: | Division of Cardiovascular Devices |
#### Predicate Device:
- Conavi Medical (Formerly Colibri Technologies) ICE system K151126 ■ Acuson Corp. AcuNav™ Diagnostic Ultrasound Catheter K992631
#### Device Description
The Foresight ICE System is intended to be used for real-time, 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, and intra-procedure complications including pericardial effusions. 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.
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The system will be comprised of catheter and a cart based console. The console includes the Acquisition and Display Module (ADM) for image display and manipulation as well as the Patient Interface Module (PIM) which the catheter connects to. The ADM 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 an easy to use interface using multiple methods of input including a mouse, keyboard and/or a touch screen. Casters on the ADM will allow easy movement of the system throughout an EP Lab which can have a small footprint as well as small obstacles to cross.
The catheter will be a 10.3F single use, sterile device, which will be able to perform intracardiac and intraluminal ultrasound imaging of adults. The catheter will be capable of real-time 2D side and forward viewing imaging with the ability to produce rapidly post processed 3D rendered images as well as ECG gated 3D images to reduce motion artifacts. 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 ventricle, fossa ovalis, aortic valve, mitral valve and tricuspid valves. It will display / measure flow velocities using Color and PW Doppler. The physician user will have easy steering maneuverability of the catheter via deflection and rotation, as well as having control over the position of the transducer to allow for multiple angles of images.
#### Indications for Use
The Foresight ICE System is indicated for intracardiac and intraluminal ultrasound visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart and great vessels of patients.
#### Functional and Technological Comparison
Tables 1 below include functional and technological comparison between the updated Conavi Foresight ICE catheter and market cleared Acuson Corp. AcuNav™ Diagnostic Ultrasound Catheter (K992631).
Tables 2 include functional and technological comparison between the updated Conavi Medical Foresight ICE system and the market cleared Foresight ICE System (K151126).
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Table-1: Catheter substantial equivalency comparison
| Component | Subject Device | Predicate Devices | | |
|-----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Conavi ICE System | Acuson Corporation AcuNavTM<br>(K992631) | Colibri ICE System<br>(K151126) | Comments |
| Classification | Class II | Class II, 21 CFR §§ 1200 and<br>892.1570 | Class II, 21 CFR §§ 1200 | Same as predicate<br>devices |
| Regulation Name | Diagnostic Intravascular Catheter | Diagnostic Intravascular Catheter | Diagnostic Intravascular Catheter | Same as predicate<br>devices |
| Product code | DQO, ITX | DQO, ITX | DQO, ITX | Same as predicate<br>devices |
| Catheter type | Intracardiac Echocardiography | Intracardiac Echocardiography | Intracardiac Echocardiography | Same as predicate<br>devices |
| Clinical<br>performance data | No clinical testing is included in<br>the submission. Determination of<br>substantial equivalence<br>Performance is based on an<br>assessment of non-clinical data. | Human clinical testing is mentioned<br>in the substantial Equivalency<br>discussion, but the study protocol is<br>unknown. | No clinical testing was included in<br>the submission. Determination of<br>substantial equivalence<br>Performance was based on an<br>assessment of non-clinical data. | Same as predicate<br>device K151126 |
| Non clinical<br>performance data | Non-clinical data includes bench-<br>top evaluations, animal testing,<br>packaging validation, biological<br>safety, electrical safety, acoustic<br>output testing, and animal testing. | Non-clinical testing includes<br>performance testing, animal testing,<br>human testing, biocompatibility and<br>non-pyrogenic. | Non-clinical data includes bench-<br>top evaluations, animal testing,<br>packaging validation, biological<br>safety, electrical safety, acoustic<br>output testing, and animal testing. | Similar to<br>predicate devices |
| Intended use | The Foresight ICE System is<br>indicated for intracardiac and<br>intraluminal ultrasound<br>visualization of cardiac and great<br>vessel anatomy and physiology as<br>well as visualization of other<br>devices in the heart and great<br>vessels of patients. | For use directly within the vascular<br>and/or the right heart for<br>intravascular or intracardiac<br>ultrasound imaging. The device is<br>specifically indicated for use in<br>visualization of vascular anatomy,<br>cardiac and great vessel anatomy<br>and physiology, or other devices in<br>the heart, as well as measurement of<br>blood flow. ventricle The company<br>anticipates that the device will be<br>used for a variety of intravascular<br>and intracardiac imaging<br>applications, consistent with its<br>intended use, including vascular<br>stent placement, monitoring left<br>ventricular function post-surgery;<br>identifying congenital abnormalities<br>before therapeutic procedures;<br>visualizing the relative orientation of<br>diagnostic and therapeutic catheters;<br>and visualizing procedures such as<br>transseptal insertion of other<br>catheters, valvuloplasties, balloon<br>septostomies, septal defect closures,<br>and pacemaker or defibrillator lead<br>insertion or extraction. | The Foresight ICE System is<br>indicated for intracardiac and<br>intraluminal ultrasound<br>visualization of cardiac and great<br>vessel anatomy as well as<br>visualization of other devices in<br>the heart and great vessels of<br>patients.<br>The Foresight ICE System is<br>intended to be used by physicians<br>trained in cardiac catheterization<br>in combination with fluoroscopic<br>imaging and cardiac monitoring<br>equipment with resuscitation<br>equipment readily available. | Similar to AcuNav<br>Diagnostic<br>Ultrasound<br>Catheter<br>(K992631) |
| Principals of<br>operation | Generation of structural and<br>physiological images /<br>representations / measurements of<br>cardiovascular anatomy using<br>pulse-echo ultrasound systems. | Generation of structural and<br>physiological images /<br>representations / measurements of<br>cardiovascular anatomy using pulse-<br>echo ultrasound systems. | Generation of structural images /<br>representations / measurements of<br>cardiovascular anatomy using<br>pulse-echo ultrasound systems. | Same as predicate<br>devices |
| Outside Diameter | | | | |
| | 10.3 F<br>Fits inside a commercially<br>available 10 F introducer sheath. | 10F | 10.3 F<br>Fits inside a commercially<br>available 10 F introducer sheath. | Similar to the 10F<br><i>AcuNav</i><br>Diagnostic<br>Ultrasound<br>Catheter<br>(K992631), which<br>itself refers to the<br>same predicate<br>device (K980851),<br>fits inside a<br>commercially<br>available 10F<br>introducer sheath. |
| Imaging energy | Ultrasound | Ultrasound | Ultrasound | Same as predicate<br>devices |
| Catheter<br>configuration | Single ultrasound imaging<br>element, mechanically rotated. | 64 Element phased array ultrasound. | Single ultrasound imaging<br>element, mechanically rotated. | Same as predicate<br>devices |
| Ultrasound imaging<br>frequency | 9MHz (Center Frequency) | 4-10 MHz | 9MHz | Same as predicate<br>device K151126 |
| Distal end<br>configuration | Rotating imaging core with<br>acoustic window, with soft<br>atraumatic tip (PEBAX 5533).<br>The ultrasound imaging transducer<br>is mounted on a pivot mechanism<br>that allows the transducer to<br>controllably change is orientation<br>relative to the longitudinal axis of<br>the catheter. | Static imaging core with rigid<br>phased-array at distal tip. | Rotating imaging core with<br>acoustic window, with soft<br>atraumatic tip (PEBAX 5533).<br>The ultrasound imaging transducer<br>is mounted on a pivot mechanism<br>that allows the transducer to<br>controllably change is orientation<br>relative to the longitudinal axis of<br>the catheter. | Same as predicate<br>device K151126 |
| Proximal end<br>configuration | Single connector, mechanical snap<br>into motor drive unit (referred to<br>as PIM). | Single connector, mechanical snap<br>into SwiftLink adapter | Single connector, mechanical snap<br>into motor drive unit (referred to<br>as PIM). | Same as predicate<br>device K151126 |
| Acoustic output | Max Pressure: 2.55MPa | Not available | Max Pressure: 1.61 MPa | The increase in<br>max pressure and<br>MI is due to the<br>new modes.<br>However, even in<br>the new modes,<br>acoustic output is<br>below reporting<br>limits and well<br>below diagnostic<br>limits and does<br>not raise new risk |
| | MI: 0.93 | Not available | MI: 0.57 | The increase in<br>max pressure and<br>MI is due to the<br>new modes.<br>However, even in<br>the new modes,<br>acoustic output is<br>below reporting<br>limits and well<br>below diagnostic<br>limits and does<br>not raise new risk |
| Acoustic testing | As per IEC 60601-2-37:2007 and<br>equivalent analysis to NEMA UD-<br>2 performance | As per NEMA UD-2, Rev 1 1993 | As per IEC 60601-2-37:2007 and<br>equivalent analysis to NEMA UD-<br>2 performance | Same as predicate<br>device K151126 |
| Sterilization | ISO 11135-1:2014<br>ISO 11138:2006-1<br>AAMI/ANSI/ ISO 11737-1<br>(Ethylene Oxide) | ISO 11737 (Ethylene Oxide) | ISO 11737 (Ethylene Oxide) | Same as predicate<br>devices |
| Imaging Modes | B-Mode<br>M-Mode<br>Pulsed Wave Doppler<br>Color Doppler | B-Mode<br>M-Mode<br>Continuous Wave Doppler<br>Pulsed Wave Doppler<br>Color Doppler<br>Power Doppler | B-mode | Similar to<br>predicate devices |
| 2D Imaging<br>Configuration | Single element scanning 360<br>degrees around the catheter.<br>Transducer oriented in a<br>predetermined position that can be<br>set within a range of ~10 degrees<br>from the full side-viewing position<br>to ~10 degrees from the full<br>forward looking position. | Phased array limited to ~90 degree<br>sector emanating from the side of<br>the catheter. | Single element scanning 360<br>degrees around the catheter.<br>Transducer oriented in a<br>predetermined position that can be<br>set within a range of ~10 degrees<br>from the full side-viewing position<br>to ~10 degrees from the full<br>forward looking position. | Same as predicate<br>device K151126 |
| 3D Imaging<br>Configuration | Transducer can be scanned from a<br>start angle to a stop angle within<br>the range of ~10 degrees from the<br>full side-viewing position to ~10<br>degrees from the full forward<br>looking position. | N/A | Transducer can be scanned from a<br>start angle to a stop angle within<br>the range of ~10 degrees from the<br>full side-viewing position to ~10<br>degrees from the full forward<br>looking position. | Same as predicate<br>device K151126 |
| Biocompatibility | ISO 10993-7:2008, Externally<br>Communicating Device,<br>Circulating Blood category | ISO 10993, Externally<br>Communicating Device, Circulating<br>Blood category. | ISO 10993, Externally<br>Communicating Device,<br>Circulating Blood category | Same as predicate<br>devices |
| Insertable length | 94 cm | 90cm | 94 cm | Similar to<br>predicate devices |
| Catheter<br>construction | Biocompatible Thermopolymer<br>over braided core | Biocompatible Thermopolymer over<br>braided core. | Biocompatible Thermopolymer<br>over braided core | Same as predicate<br>derives |
| Re-usability | Single use | Single use | Single use | Same as predicate<br>derives |
| Preparation | Flush with sterile water through<br>luer connector at proximal end | No preparation required. | Flush with sterile water through<br>luer connector at proximal end | Same as predicate<br>device K151126 |
| Directionality of<br>catheter tip | Integrates a tip deflection<br>mechanism using a deflection<br>handle and pullwire to provide<br>integrated control of catheter tip<br>direction. | Integrates a tip deflection<br>mechanism using a deflection<br>handle and pullwires to provide<br>integrated control of catheter tip<br>direction. | Integrates a tip deflection<br>mechanism using a deflection<br>handle and pullwire to provide<br>integrated control of catheter tip<br>direction. | Same as predicate<br>devices |
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# Foresight ICE System
510(k) Notification
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#### Foresight ICE System 510(k) Notification
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#### Table-2: Console Comparison Table
| Component | Subject Device:<br>Conavi ICE System | Predicate Device:<br>Colibri ICE System (K151126) | Comment |
|-----------------------------------------------------|--------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------|--------------------------|
| Configuration | Mobile cart with braking system | Mobile cart with braking system | Same as predicate device |
| Input | Touchscreen, touchpad, and keyboard | Touchscreen, touchpad, and keyboard | Same as predicate device |
| Display | Dedicated image display monitor, images<br>also displayed on Touchscreen | Dedicated image display monitor, images also<br>displayed on Touchscreen | Same as predicate device |
| Data storage | DICOM and native format | DICOM and native format | Same as predicate device |
| Footprint (centre to centre<br>distance of casters) | 502 x 502mm | 502 x 502mm | Same as predicate device |
| Electrical safety | IEC 60601-1 3rd edition | IEC 60601-1 3rd edition | Same as predicate device |
| Sterile barrier interface | Motor Drive Unit (referred to as Patient<br>Interface Module) encapsulated in single<br>use disposable sterile bag | Motor Drive Unit (referred to as Patient<br>Interface Module) encapsulated in single use<br>disposable sterile bag | Same as predicate device |
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Foresight ICE System System: Transducer: Foresight ICE Catheter
Intended Use: Visualization of human anatomy by means of ultrasound imaging:
| Clinical Application | | Mode of Operation | | | | | | |
|-----------------------------|---------------------------------|-------------------|---|-----|-----|------------------|-----------------------|---------------------|
| General<br>(Track 1 Only) | Specific<br>(Tracks 1 & 3) | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Specify) | Other*<br>(Specify) |
| Ophthalmic | Ophthalmic | | | | | | | |
| Fetal<br>Imaging<br>& Other | Fetal | | | | | | | |
| | Abdominal | | | | | | | |
| | Intra-operative (Specify) | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | | | | | | | |
| | Small Organ (Specify) | | | | | | | |
| | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal…
