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.

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 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.

AI/ML Overview

This 510(k) summary focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed clinical study with specific acceptance criteria and performance metrics for the new device. Therefore, much of the requested information about acceptance criteria, study design, and performance outcomes is not explicitly available in this document.

However, I can extract information related to the device's technical characteristics and the types of testing performed to support its safety and efficacy.

Here's a breakdown of the available information:

1. Table of acceptance criteria and the reported device performance:

The document does not provide a formal table of "acceptance criteria" and "reported device performance" in the typical sense of a clinical study evaluating diagnostic accuracy or clinical outcomes. Instead, it presents a comparison of the new device's technical specifications with those of the predicate device to demonstrate substantial equivalence.

Key comparisons highlighting "performance" relative to the predicate (implicitly, the acceptance is that the new device is "similar to" or "does not adversely affect" the predicate's performance):

Feature	Predicate Device (Sonicath Ultra 9MHZ; K980851)	Colibri ICE System	Comment (Implied Acceptance/Performance)
Catheter Type	Intracardiac Echocardiography	Intracardiac Echocardiography	Same as predicate.
Intended Use	Enhanced ultrasonic visualization of intracardiac structures.	Intracardiac and intraluminal ultrasound visualization of cardiac and great vessel anatomy as well as visualization of other devices in the heart and great vessels. Used by physicians trained in cardiac catheterization in combination with fluoroscopic imaging and cardiac monitoring equipment.	Similar to predicate. Broader wording related to "great vessel anatomy" and "other devices." Stated to be "more similar to that of the AcuNav Diagnostic Ultrasound Catheter (K992631), which itself refers to the same predicate device (K980851)." Implied acceptance: functional equivalence for visualization tasks.
Outside Diameter	9F	10.3F	Similar to predicate. Justification provided for safety despite larger size (fits commercially available 10F introducer sheath, similar to AcuNav K992631, and adult vascular anatomy is large enough). Implied acceptance: "Safety and effectiveness is not affected."
Imaging Energy	Ultrasound	Ultrasound	Same as predicate.
Catheter Configuration	Single ultrasound imaging element, mechanically rotated.	Single ultrasound imaging element, mechanically rotated.	Same as predicate.
Imaging Frequency	9MHz	9MHz	Same as predicate.
Longitudinal distance from distal tip to imaging transducer	Approximately 4-11 mm	Approximately 1-2 mm	Similar to predicate. Implied acceptance: "The reduced distance does not adversely affect the safety and efficacy of the imaging modality." Further stated: "lessens the uncertainty about when the catheter tip will come into contact with tissue as compared to the predicate device" (an improvement).
Acoustic Output (Max pressure)	3.258 MPa	1.61 MPa	Similar to predicate. Implied acceptance: "The reduced acoustic output reduces risk of tissue bioeffects."
Acoustic Output (MI)	1.275	0.57	Similar to predicate. Implied acceptance: "The reduced acoustic output reduces risk of tissue bioeffects."
Acoustic Output (PRF)	7.68 KHz	5.0 KHz	Similar to predicate. Implied acceptance: "The reduced acoustic duty cycle reduces risk of tissue bioeffects."
Acoustic Testing	As per NEMA UD-2, Rev 1 1993	As per IEC 60601-2-37:2007 and equivalent analysis to NEMA UD-2 performance.	Similar to predicate. Implied acceptance: meets current relevant standards.
Sterilization	ISO 11737 (Gamma Irradiation)	ISO 11737 (Ethylene Oxide)	Similar to predicate (different method, but both are validated).
Imaging Modes	B-mode (2D)	B-mode (2D) and 3D Display	Same B-mode (2D) functionality as predicate. The 3D mode is an additional capability; justified as not hindering efficacy and not adding safety risks, as "3D images are generated without movement of the catheter" and "type and intensity of energy deposited...is the same or less." Implied acceptance: 3D is a supplemental feature that does not compromise substantial equivalence.
Biocompatibility	ISO 10993, Externally Communicating Device, Circulating Blood category.	ISO 10993, Externally Communicating Device, Circulating Blood category.	Same as predicate (meeting the same standard).
Measurements	Depth markers, depth measurements, in plane distance and area measurements.	Depth markers, in plane depth distance measurements.	Similar to predicate. Note specifies: "worst case uncertainty of any depth measurement is +/- 1.2mm." (This is a specific performance metric for depth measurement accuracy, implying it's within an acceptable range).
Catheter Tip Directionality	Requires separate multipurpose EP long sheath or guiding catheter for improved directionality.	Integrates a tip deflection mechanism using a deflection handle and pullwire to provide integrated control of catheter tip direction.	Similar to predicate. (This indicates an improvement in usability/control compared to the predicate, but is considered substantially equivalent in function).

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):

This document does not describe any clinical test sets, sample sizes, or data provenance (country, retrospective/prospective) for evaluating device performance in humans or animals. The testing described focuses on bench and laboratory testing against international standards for safety and technical performance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):

Not applicable. No clinical test set or ground truth establishment by experts is mentioned in this submission.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

Not applicable. No clinical test set or adjudication method is mentioned.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. This device is an imaging system, not an AI-powered diagnostic tool, and no MRMC study or AI assistance is mentioned.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. This is not an AI algorithm. It's a medical device for imaging.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

For the technical performance evaluation described (e.g., acoustic output, electrical safety, biocompatibility, sterilization), the "ground truth" is adherence to established international standards (e.g., IEC, ISO, NEMA) and engineering specifications, verified through laboratory testing. There is no mention of clinical ground truth (pathology, expert consensus, outcomes data).

8. The sample size for the training set:

Not applicable. This device does not involve a "training set" in the context of machine learning or AI.

9. How the ground truth for the training set was established:

Not applicable.

Summary of the Study that Proves the Device Meets Acceptance Criteria (based on the provided text):

The "study" or rather, the evidence provided to demonstrate that the device meets its (largely implied) acceptance criteria for substantial equivalence to the predicate, consists of a comprehensive battery of bench and laboratory verification and validation testing.

This testing was conducted in compliance with a list of relevant international standards to demonstrate:

Biological Safety: ISO 10993-1 (biocompatibility)
Electrical Safety and Performance: IEC 60601-1 (3rd edition), IEC 60601-1-2 (EMC), IEC 60601-2-18 (endoscopic equipment), IEC 60601-2-37 (ultrasound medical diagnostic and monitoring equipment).
Sterilization: ISO 11135 (Ethylene Oxide sterilization validation for medical devices).
Usability: IEC 60601-1-6.
Acoustic Output: Tested per IEC 60601-2-37:2007 (and deemed analytically equivalent to NEMA UD-2 performance). The device was shown to have reduced acoustic output (Max Pressure, MI, PRF) compared to the predicate, which is presented as a safety improvement ("reduces risk of tissue bioeffects").
Functional Equivalence: Technical specifications of the catheter and console (e.g., imaging frequency, imaging modes - B-mode), physical dimensions, and operational characteristics were compared directly to the predicate. Differences (like the 10.3F OD, improved tip directionality, and 3D imaging capability) were justified as either similar enough not to raise new safety/efficacy concerns or as enhancements that do not hinder the primary function of the device compared to the predicate. The "worst case uncertainty of any depth measurement is +/- 1.2mm" is a specific performance result mentioned for the device's measurement capability.

The conclusion is that based on the Intended Use, Indications for Use, product technical information, performance evaluation (through standards compliance and direct comparison), and standards compliance, the Colibri Foresight ICE System has shown to be substantially equivalent to the cited predicate device (Boston Scientific Galaxy™ Intravascular Ultrasound Imaging System, K980851). No human clinical trials were described to prove this equivalence.

Summary

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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

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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

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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 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)

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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)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 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.

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direction by extending the deflection controller on the handle near the proximal end of the catheter.

Indications for Use

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 Ultra9MHZ (K980851)	Colibri ICE System	Comment
Catheter type	IntracardiacEchocardiography	IntracardiacEchocardiography	Same as Sonicath Ultra9MHZ (predicate)
Intended use	The UltralCERounded TipCatheter is indicatedfor enhancedultrasonicvisualization ofintracardiacstructures.	The Foresight ICE System isindicated for intracardiac andintraluminal ultrasoundvisualization of cardiac andgreat vessel anatomy as wellas visualization of otherdevices in the heart and greatvessels of patients.The Foresight ICE System isintended to be used byphysicians trained in cardiaccatheterization in combinationwith fluoroscopic imaging andcardiac monitoring equipmentwith resuscitation equipmentreadily available.	Similar to Sonicath Ultra9MHZ (predicate).The indication for usefor the Colibri ICEsystem is more similarto that of the AcuNavDiagnostic UltrasoundCatheter (K992631),which itself refers to thesame predicate device(K980851).

Catheter comparison Table

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OutsideDiameter	9F	10.3 F	Similar to Sonicath Ultra9 MHZ (predicate).
	Fits inside therecommendedConvoy Introducersheath (with an ID of8.5F)	Fits inside a commerciallyavailable 10 F introducersheath.	Safety andeffectiveness is notaffected (footnote)1.
			The 10F AcuNavDiagnostic UltrasoundCatheter (K992631),which itself refers to thesame predicate device(K980851), fits inside acommercially available10F introducer sheath.
			The UltraICE (FormerlySonicath Ultra 9MHz)IFU states "TheUltraICE Catheter isintroduced through astandard 9F (3mm) /10F (3.3mm) venous orarterial access system."
	Imaging energy	Ultrasound	Ultrasound
Catheterconfiguration	Single ultrasoundimaging element,mechanically rotated.	Single ultrasound imagingelement, mechanically rotated.	Same as Sonicath Ultra9MHZ (predicate).
Ultrasoundimagingfrequency	9MHz	9MHz	Same as Sonicath Ultra9MHZ (predicate).
Distal endconfiguration	Rotating imagingcore with acousticwindow, with softatraumatic tip(LDPE). Theultrasound imagingtransducer hasa fixed orientationrelative to thelongitudinal axis ofthe catheter.	Rotating imaging core withacoustic window, with softatraumatic tip (PEBAX5533). The ultrasoundimaging transducer ismounted on a pivotmechanism that allows thetransducer to controllablychange is orientationrelative to the longitudinalaxis of the catheter.	Similar to Sonicath Ultra9MHZ (predicate).
Longitudinaldistance fromdistal tip ofcatheter toimagingtransducer.	Varies -approximately 4-11mm depending onorientation.	Approximately 1-2 mm.	Similar to Sonicath Ultra9MHZ (predicate).The reduced distancedoes not adverselyaffect the safety andefficacy of the imagingmodality.During imaging, thereduced longitudinaldistance between thetransducer and distal tipof the catheter meansthat the imaged tissueis in closer proximity tothe catheter tip andtherefore lessens theuncertainty about whenthe catheter tip willcome into contact withtissue as compared tothe predicate device.
Proximal endconfiguration	Single connector,mechanical snapinto motor drive unit.	Single connector, mechanicalsnap into motor drive unit(referred to as PIM).	Same as Sonicath Ultra9MHZ (predicate).
Acoustic output	Max pressure:3.258 MPa	1.61 MPa	Similar to Sonicath Ultra9MHZ (predicate).The reduced acousticoutput reduces risk oftissue bioeffects.
	MI: 1.275	0.57	Similar to Sonicath Ultra9MHZ (predicate).The reduced acousticoutput reduces risk oftissue bioeffects.
			Note: worst caseacoustic outputparameters occur for atransducer that is fullyforward viewing withinthe ICE catheter andtherefore theautoscanning mode isequivalent to the non-scanning mode underthe condition where thesteady state motorspeed is at maximum.
	PRF: 7.68 KHz	PRF: 5.0 KHz	Similar to Sonicath Ultra9MHZ (predicate). Thereduced acoustic dutycycle reduces risk oftissue bioeffects.
Acoustic testing	As per NEMA UD-2,Rev 1 1993	As per IEC 60601-2-37:2007 and equivalentanalysis to NEMA UD-2performance.	Similar to Sonicath Ultra9MHZ (predicate).
Sterilization	ISO 11737 (GammaIrradiation)	ISO 11737 (EthyleneOxide).	Similar to Sonicath Ultra9MHZ (predicate).
Imaging modes	B-mode	B-mode	Same as Sonicath Ultra9MHZ (predicate).
	2D Display:Transducer limited toa fixed orientation~10 degrees fromthe full side-viewingposition	2D Display:Transducer oriented in apredetermined position thatcan be set within a range of~10 degrees from the fullside-viewing position to ~10degrees from the full forwardlooking position.	Similar to Sonicath Ultra9MHZ (predicate).
	3D Display:N/A	3D Display:Transducer can be scannedfrom a start angle to a stopangle within the range of ~10degrees from the full side-viewing position to ~10degrees from the full forwardlooking position.	Similar to Sonicath Ultra9MHZ (predicate).Maximum acousticoutput in 3D mode isthe same as for B-modeimaging.
Biocompatibility	ISO 10993,ExternallyCommunicatingDevice, CirculatingBlood category.	ISO 10993, ExternallyCommunicating Device,Circulating Blood category.	Same as Sonicath Ultra9MHZ (predicate).
Insertable length	110cm;approximately90 cm usable.	94 cm	Similar to Sonicath Ultra9MHZ (predicate).Since predicate doesnot have handle /proximal extension,approximately20cm or more arerequired to extend fromMDU to entry site.
Catheterconstruction	BiocompatibleThermopolymer overbraided core.	Biocompatible Thermopolymerover braided core.	Same as Sonicath Ultra9MHZ (predicate).
Re-usability	Single use	Single use	Same as Sonicath Ultra9MHZ (predicate).
Preparation	Flush with sterilewater through distaltip with needle.	Flush with sterile waterthrough luer connector atproximal end.	Similar to Sonicath Ultra9MHZ (predicate);Improved usability,reduced risk.
Directionality ofcatheter tip	Instructions for useof the UltralCEcatheter recommendthe use of a separatemultipurpose EPlong sheath orguiding catheter toimprove thedirectionality of thecatheter tip.	Integrates a tip deflectionmechanism using a deflectionhandle and pullwire toprovide integrated control ofcatheter tip direction.	Similar to Sonicath Ultra9MHZ (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.

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Console Comparison Table

Component	Sonicath Ultra9MHZ (K980851)	Colibri ICE System	Comment
Configuration	Mobile cart withbraking system.	Mobile cart with brakingsystem.	Same as Sonicath Ultra9MHZ (predicate).
Input	Keyboard, trackballand custom interfacebuttons.	Touchscreen, touchpad,and keyboard.	Similar to Sonicath Ultra9MHZ (predicate).
Display	Dedicated imagedisplay monitor	Dedicated image displaymonitor, images alsodisplayed on Touchscreen.	Same as Sonicath Ultra9MHZ (predicate).
Data storage	DICOM	DICOM and native format.	Same as Sonicath Ultra9MHZ (predicate).
Interface withexternal systems	Interface to PACS	Interface to PACS	Same as Sonicath Ultra9MHZ (predicate).
Footprint (centre tocentre distance ofcasters)	580 x 610mm	502 x 502mm	Similar to Sonicath Ultra9MHZ (predicate).
Peripherals	DVD-ROM, Printer,VHS	DVD-ROM, Printer, USB	Similar to Sonicath Ultra9MHZ (predicate).
Electrical safety	IEC 60601-1 2ndedition	IEC 60601-1 3rd edition	Similar to Sonicath Ultra9MHZ (predicate).
Sterile barrierinterface	Motor Drive Unitencapsulated insingle use disposablesterile bag.	Motor Drive Unit (referred toas Patient InterfaceModule) encapsulated insingle use disposablesterile bag.	Same as Sonicath Ultra9MHZ (predicate).
Measurements	Depth markers,depthmeasurements, inplane distance andarea measurements.	Depth markers, in planedepth distancemeasurements.	Similar to Sonicath Ultra9MHZ (predicate).
			Note: based on the testresults the worst caseuncertainty of any depthmeasurement is +/-1.2mm.

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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.
1. 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.
1. Prosthetic use: The device is not a prosthetic, and thus has no intended prosthetic use.
1. 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.
1. 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.

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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.

Regulation Number and Section

§ 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).