Foresight Intracardiac Echocardiography (ICE) System

{0}------------------------------------------------ Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 December 18, 2015 Colibri Technologies Inc. Sam Mostafavi Director, Quality And Regulatory 293 Lesmill Road North York, ON, M3B 2V1 Canada Re: K151126 Trade/Device Name: Foresight Intracardiac Echocardiography (ICE) System Regulation Number: 21 CFR 870.1200 Regulation Name: Diagnostic Intravascular Catheter Regulatory Class: Class II Product Code: DQO, ITX Dated: November 10, 2015 Received: November 17, 2015 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 {1}------------------------------------------------ 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. 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 yours, Mitchell Stein for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ #### Indications for Use 510(k) Number (if known) K151126 Device Name Foresight Intracardiac Echocardiography (ICE) System Indications for Use (Describe) The Foresight ICE System is indicated for intracardiac and intraluminal ultrasound visualization of cardiac and great vessel anatomy as well as visualization of other devices in the heart and great vessels of patients. The Foresight ICE System is intended to be used by physicians trained in cardiac catheterization with fluoroscopic imaging and cardiac monitoring equipment with resuscitation equipment readily available. 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) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below. {3}------------------------------------------------ # 510(K) SUMMARY ### 510(k) Number: K151126 #### Applicant Information: Colibri Technologies Inc. 293 Lesmill Road North York, ON, M3B 2V1 #### Contact Person: Sam Mostafavi Director of Quality and Regulatory Affairs Sam.Mostafavi@Colibritech.com 650-670-6972 Date Prepared: November 10, 2015 #### Device Information: | Name of device: | Intracardiac Echocardiography (ICE) System | |-------------------------|-----------------------------------------------------------------------------------------------------------------------| | Trade/Proprietary 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) | | Classification: | Class II | #### Predicate Device: - K980851 Boston Scientific Galaxy™ Intravascular Ultrasound Imaging System #### Device Description The Foresight ICE System is an imaging system intended for intracardiac and intraluminal ultrasound visualization of cardiac and greater vessel anatomy. The Foresight ICE System is comprised of a 10.3F sterile, single-use catheter intended to operate with Patient Interface Module (PIM) and the Hummingbird Console. The Foresight ICE Catheter uses a mechanically scanned single element imaging transducer that allows for both 2D imaging, similar to an existing rotational ICE Catheter, as well as 3D imaging. The Foresight ICE Catheter is designed to provide ultrasound images of cardiovascular anatomy. It is a mechanically scanning catheter with a single imaging transducer that rotates within the distal end of a deflectable sheath. The distal tip of the sheath is shaped as a dome and made of an acoustically transmissive material (that is also visually transparent). The distal 10 cm of the catheter can be deflected in a single {4}------------------------------------------------ direction by extending the deflection controller on the handle near the proximal end of the catheter. The Hummingbird Console is a cart based console that connects to the PIM. It is used to generate and transmit ultrasound imaging energy to activate an ultrasound transducer located at the distal tip of the Foresight ICE Catheter, and then acquire received ultrasound imaging data from the catheter. It then processes imaging data and displays it to the users. It consists of two displays - one for a technician or nurse and one for the physician. It also provides user interfaces for user input. The PIM serves as the interface between the single-use catheter and the Hummingbird Console. It acts as a relay for electrical ultrasound signals between the Hummingbird Console and catheter. It contains a motor and associated drive system to rotate the transducer imaging assembly of the catheter. #### Indications for Use The Foresight ICE System is indicated for intracardiac and intraluminal ultrasound visualization of cardiac and great vessel anatomy as well as visualization of other devices in the heart and great vessels of patients. The Foresight ICE System is intended to be used by physicians trained in cardiac catheterization in combination with fluoroscopic imaging and cardiac monitoring equipment with resuscitation equipment readily available. #### Comparison of Technological Characteristics with Predicate Device: Tables below provide a comparison between Colibri Foresight ICE system and Boston Scientific Galaxy™ Intravascular Ultrasound Imaging System, K980851 predicate device: | Component | Sonicath Ultra<br>9MHZ (K980851) | Colibri ICE System | Comment | |---------------|---------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Catheter type | Intracardiac<br>Echocardiography | Intracardiac<br>Echocardiography | Same as Sonicath Ultra<br>9MHZ (predicate) | | Intended use | The UltralCE<br>Rounded Tip<br>Catheter is indicated<br>for enhanced<br>ultrasonic<br>visualization of<br>intracardiac<br>structures. | The Foresight ICE System is<br>indicated for intracardiac and<br>intraluminal ultrasound<br>visualization of cardiac and<br>great vessel anatomy as well<br>as visualization of other<br>devices in the heart and great<br>vessels of patients.<br>The Foresight ICE System is<br>intended to be used by<br>physicians trained in cardiac<br>catheterization in combination<br>with fluoroscopic imaging and<br>cardiac monitoring equipment<br>with resuscitation equipment<br>readily available. | Similar to Sonicath Ultra<br>9MHZ (predicate).<br>The indication for use<br>for the Colibri ICE<br>system is more similar<br>to that of the AcuNav<br>Diagnostic Ultrasound<br>Catheter (K992631),<br>which itself refers to the<br>same predicate device<br>(K980851). | ### Catheter comparison Table {5}------------------------------------------------ | Outside<br>Diameter | 9F | 10.3 F | Similar to Sonicath Ultra<br>9 MHZ (predicate). | |-----------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | Fits inside the<br>recommended<br>Convoy Introducer<br>sheath (with an ID of<br>8.5F) | Fits inside a commercially<br>available 10 F introducer<br>sheath. | Safety and<br>effectiveness is not<br>affected (footnote)1. | | | | | The 10F AcuNav<br>Diagnostic Ultrasound<br>Catheter (K992631),<br>which itself refers to the<br>same predicate device<br>(K980851), fits inside a<br>commercially available<br>10F introducer sheath. | | | | | The UltraICE (Formerly<br>Sonicath Ultra 9MHz)<br>IFU states "The<br>UltraICE Catheter is<br>introduced through a<br>standard 9F (3mm) /<br>10F (3.3mm) venous or<br>arterial access system." | | | Imaging energy | Ultrasound | Ultrasound | | Catheter<br>configuration | Single ultrasound<br>imaging element,<br>mechanically rotated. | Single ultrasound imaging<br>element, mechanically rotated. | Same as Sonicath Ultra<br>9MHZ (predicate). | | Ultrasound<br>imaging<br>frequency | 9MHz | 9MHz | Same as Sonicath Ultra<br>9MHZ (predicate). | | Distal end<br>configuration | Rotating imaging<br>core with acoustic<br>window, with soft<br>atraumatic tip<br>(LDPE). The<br>ultrasound imaging<br>transducer has<br>a fixed orientation<br>relative to the<br>longitudinal axis of<br>the catheter. | Rotating imaging core with<br>acoustic window, with soft<br>atraumatic tip (PEBAX<br>5533). The ultrasound<br>imaging transducer is<br>mounted on a pivot<br>mechanism that allows the<br>transducer to controllably<br>change is orientation<br>relative to the longitudinal<br>axis of the catheter. | Similar to Sonicath Ultra<br>9MHZ (predicate). | | Longitudinal<br>distance from<br>distal tip of<br>catheter to<br>imaging<br>transducer. | Varies -<br>approximately 4-11<br>mm depending on<br>orientation. | Approximately 1-2 mm. | Similar to Sonicath Ultra<br>9MHZ (predicate).<br>The reduced distance<br>does not adversely<br>affect the safety and<br>efficacy of the imaging<br>modality.<br>During imaging, the<br>reduced longitudinal<br>distance between the<br>transducer and distal tip<br>of the catheter means<br>that the imaged tissue<br>is in closer proximity to<br>the catheter tip and<br>therefore lessens the<br>uncertainty about when<br>the catheter tip will<br>come into contact with<br>tissue as compared to<br>the predicate device. | | Proximal end<br>configuration | Single connector,<br>mechanical snap<br>into motor drive unit. | Single connector, mechanical<br>snap into motor drive unit<br>(referred to as PIM). | Same as Sonicath Ultra<br>9MHZ (predicate). | | Acoustic output | Max pressure:<br>3.258 MPa | 1.61 MPa | Similar to Sonicath Ultra<br>9MHZ (predicate).<br>The reduced acoustic<br>output reduces risk of<br>tissue bioeffects. | | | MI: 1.275 | 0.57 | Similar to Sonicath Ultra<br>9MHZ (predicate).<br>The reduced acoustic<br>output reduces risk of<br>tissue bioeffects. | | | | | Note: worst case<br>acoustic output<br>parameters occur for a<br>transducer that is fully<br>forward viewing within<br>the ICE catheter and<br>therefore the<br>autoscanning mode is<br>equivalent to the non-<br>scanning mode under<br>the condition where the<br>steady state motor<br>speed is at maximum. | | | PRF: 7.68 KHz | PRF: 5.0 KHz | Similar to Sonicath Ultra<br>9MHZ (predicate). The<br>reduced acoustic duty<br>cycle reduces risk of<br>tissue bioeffects. | | Acoustic testing | As per NEMA UD-2,<br>Rev 1 1993 | As per IEC 60601-2-<br>37:2007 and equivalent<br>analysis to NEMA UD-2<br>performance. | Similar to Sonicath Ultra<br>9MHZ (predicate). | | Sterilization | ISO 11737 (Gamma<br>Irradiation) | ISO 11737 (Ethylene<br>Oxide). | Similar to Sonicath Ultra<br>9MHZ (predicate). | | Imaging modes | B-mode | B-mode | Same as Sonicath Ultra<br>9MHZ (predicate). | | | 2D Display:<br>Transducer limited to<br>a fixed orientation<br>~10 degrees from<br>the full side-viewing<br>position | 2D Display:<br>Transducer oriented in a<br>predetermined position that<br>can be set within a range of<br>~10 degrees from the full<br>side-viewing position to ~10<br>degrees from the full forward<br>looking position. | Similar to Sonicath Ultra<br>9MHZ (predicate). | | | 3D Display:<br>N/A | 3D Display:<br>Transducer can be scanned<br>from a start angle to a stop<br>angle within the range of ~10<br>degrees from the full side-<br>viewing position to ~10<br>degrees from the full forward<br>looking position. | Similar to Sonicath Ultra<br>9MHZ (predicate).<br>Maximum acoustic<br>output in 3D mode is<br>the same as for B-mode<br>imaging. | | Biocompatibility | ISO 10993,<br>Externally<br>Communicating<br>Device, Circulating<br>Blood category. | ISO 10993, Externally<br>Communicating Device,<br>Circulating Blood category. | Same as Sonicath Ultra<br>9MHZ (predicate). | | Insertable length | 110cm;<br>approximately<br>90 cm usable. | 94 cm | Similar to Sonicath Ultra<br>9MHZ (predicate).<br>Since predicate does<br>not have handle /<br>proximal extension,<br>approximately<br>20cm or more are<br>required to extend from<br>MDU to entry site. | | Catheter<br>construction | Biocompatible<br>Thermopolymer over<br>braided core. | Biocompatible Thermopolymer<br>over braided core. | Same as Sonicath Ultra<br>9MHZ (predicate). | | Re-usability | Single use | Single use | Same as Sonicath Ultra<br>9MHZ (predicate). | | Preparation | Flush with sterile<br>water through distal<br>tip with needle. | Flush with sterile water<br>through luer connector at<br>proximal end. | Similar to Sonicath Ultra<br>9MHZ (predicate);<br>Improved usability,<br>reduced risk. | | Directionality of<br>catheter tip | Instructions for use<br>of the UltralCE<br>catheter recommend<br>the use of a separate<br>multipurpose EP<br>long sheath or<br>guiding catheter to<br>improve the<br>directionality of the<br>catheter tip. | Integrates a tip deflection<br>mechanism using a deflection<br>handle and pullwire to<br>provide integrated control of<br>catheter tip direction. | Similar to Sonicath Ultra<br>9MHZ (predicate). | ¹ a) Bleeding risk: Manual pressure is the default technique for vascular closure of 9-11F puncture sites for venous access. Catheter sizes larger than 10F are used routinely in clinical practice for venous access, (for example: Niagara Catheter 13.5F) is used for temporary dialysis lines. b) Fit within the anatomy The adult cardiovascular anatomy in which the Foresight catheter and UltralCE catheter would be introduced is quite large relative to the size of the catheters themselves. The common femoral vein diameter was assessed in an article by Fronek et al (Journal of vascular surgery May 2001, Volume 33, lssue 5, Pages 1050–1056) and states that for men and women the values are 12.9 mm +/- 1.81mm and 11.2 mm +/- 1.89mm respectively. {6}------------------------------------------------ {7}------------------------------------------------ {8}------------------------------------------------ {9}------------------------------------------------ ## Console Comparison Table | Component | Sonicath Ultra<br>9MHZ (K980851) | Colibri ICE System | Comment | |--------------------------------------------------------|-----------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------| | Configuration | Mobile cart with<br>braking system. | Mobile cart with braking<br>system. | Same as Sonicath Ultra<br>9MHZ (predicate). | | Input | Keyboard, trackball<br>and custom interface<br>buttons. | Touchscreen, touchpad,<br>and keyboard. | Similar to Sonicath Ultra<br>9MHZ (predicate). | | Display | Dedicated image<br>display monitor | Dedicated image display<br>monitor, images also<br>displayed on Touchscreen. | Same as Sonicath Ultra<br>9MHZ (predicate). | | Data storage | DICOM | DICOM and native format. | Same as Sonicath Ultra<br>9MHZ (predicate). | | Interface with<br>external systems | Interface to PACS | Interface to PACS | Same as Sonicath Ultra<br>9MHZ (predicate). | | Footprint (centre to<br>centre distance of<br>casters) | 580 x 610mm | 502 x 502mm | Similar to Sonicath Ultra<br>9MHZ (predicate). | | Peripherals | DVD-ROM, Printer,<br>VHS | DVD-ROM, Printer, USB | Similar to Sonicath Ultra<br>9MHZ (predicate). | | Electrical safety | IEC 60601-1 2nd<br>edition | IEC 60601-1 3rd edition | Similar to Sonicath Ultra<br>9MHZ (predicate). | | Sterile barrier<br>interface | Motor Drive Unit<br>encapsulated in<br>single use disposable<br>sterile bag. | Motor Drive Unit (referred to<br>as Patient Interface<br>Module) encapsulated in<br>single use disposable<br>sterile bag. | Same as Sonicath Ultra<br>9MHZ (predicate). | | Measurements | Depth markers,<br>depth<br>measurements, in<br>plane distance and<br>area measurements. | Depth markers, in plane<br>depth distance<br>measurements. | Similar to Sonicath Ultra<br>9MHZ (predicate). | | | | | Note: based on the test<br>results the worst case<br>uncertainty of any depth<br>measurement is +/-<br>1.2mm. | {10}------------------------------------------------ lmpact of 3D imaging capability - The predicate device K980851 (Boston Scientific Galaxy™ Intravascular Ultrasound Imaging System) does not generate 3D reconstructions of anatomy, as it operates with a transducer oriented in a fixed sideviewing position (~10 degrees from the full side-viewing position) while the Colibri Foresight ICE system can vary the transducer orientation from side viewing (~10 degrees from the full side-viewing position) to forward-viewing (~10 degrees from the full forward looking position). In terms of the intended uses, each of the stated uses is discussed separately below: - 1. Therapeutic use: The device does not provide therapy, and thus has no intended therapeutic use. - 2. Diagnostic use: While the device does provide visualization of anatomy, it does not claim to diagnose any particular condition. The visualization can be provided in real-time 2D. The 3D imaging capability augments the visualization by reconstructing 2D information into 3D and does not diagnose any conditions. The device can be used as labelled for diagnostic use without 3D reconstruction. - 3. Prosthetic use: The device is not a prosthetic, and thus has no intended prosthetic use. - 4. Surgical use: The device is not a surgical device, and thus has no intended surgical use. The 3D capability of the Colibri Foresight ICE System does not affect the substantially equivalency for the determination relative to the 2D system because of the following Safety and Efficacy justifications: - 1. Efficacy: Since the Foresight ICE system can achieve approximately the same real-time side viewing angles as the predicate device and can resultantly generate equivalent views, the system is able to provide at least equivalent efficacy in guiding procedures. The ability to tilt the transducer to view at different angles and generate 3D images is supplemental to this B-mode imaging functionality and does not hinder the efficacy. - 2. Safety: The acquisition of 3D imagery does not alter the way in which the catheter interacts with the body relative to the predicate: - a) 3D images are generated without movement of the catheter, by altering the speed of rotation of the imaging assembly inside the sheath - b) The type and intensity of energy deposited to the body is the same or less than the predicate device By design, the worst case maximum temporal in situ intensity, for the Foresight ICE Imaging System, occurs for the situation where the transducer is in the full forward looking position. This condition has been used to define the worst case B-mode acoustic output and is applicable to both 2D and 3D imaging display modalities. Such a situation would indeed occur for a 3D sweep, provided that the user wanted to include the most forward viewing A-line as part of the intended 3D reconstruction. The interpretation of 3D reconstructions do not add risk to the patient as users are instructed that the reconstructions need to be considered in light of motion artifacts that may be present due to cardiac motions. Moreover, no measurements of structures in 3D are permitted, nor are length measurements permitted in the real-time 2D images. {11}------------------------------------------------ # Testing completed: Verification and validation testing was completed in compliance with the following standards: - ISO 10993-1, Biological evaluation of medical devices Part 1: Evaluation and . testing within a risk management process. - IEC 60601-1, 3rd edition, Medical Electrical Equipment Part 1: General . requirements for basic safety and essential performance. - IEC 60601-1-2, Medical Electrical Equipment Part 1-2: General Requirements . for Basic Safety and Essential Performance - Collateral Standard: Electromagnetic Compatibility. - IEC 60601-1-6, Medical Electrical Equipment Part 1-6: General Requirements . for Basic Safety and Essential Performance - Collateral Standard: Usability. - IEC 60601-2-18, Medical Electrical Equipment - Part 2-18: Particular requirements for the basic safety and essential performance of endoscopic equipment. - IEC 60601-2-37, Medical Electrical Equipment Part 1-2: General Requirements . for Basic Safety and Essential Performance - Collateral Standard: Electromagnetic Compatibility. - ISO 11135, Second edition 2014, sterile, single-use intravascular catheters Part . 1: General requirements. ## Conclusion: Based upon the Intended Use, Indications for Use, product technical information, performance evaluation, and standards compliance provided in this premarket notification, the Colibri Foresight ICE System has shown to be substantially equivalent to the cited predicate device.