Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes standard ultrasound imaging and processing techniques (2D, 3D rendering, Doppler) and does not mention any AI or ML capabilities.

Therapeutic

No
The device is used for visualization and guidance during intracardiac procedures, not to treat or cure a disease.

Diagnostic

Yes

The device is indicated for "intraluminal ultrasound visualization of cardiac and great vessel anatomy and physiology" and to "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." This visualization and information gathering for anatomical, physiological, and complication assessment are characteristic of diagnostic functions.

SaMD (Software as a Medical Device)

No

The device description explicitly states it is comprised of a catheter and a cart-based console, which are hardware components. While it includes software for image display and manipulation, it is not solely software.

IVD (In Vitro Diagnostic)

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to provide information about a person's health.
Device Function: The Foresight Intracardiac Echocardiography (ICE) System is an imaging device that uses ultrasound to visualize structures inside the body (intracardiac and intraluminal). It does not analyze samples taken from the body.
Intended Use: The intended use clearly states "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." This is a diagnostic imaging function performed directly on the patient, not on a sample.

The device is a diagnostic imaging system used for real-time visualization during procedures, which falls under the category of medical devices, but not specifically In Vitro Diagnostics.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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.

Product codes

DQO, ITX

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.

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.

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Ultrasound

Anatomical Site

Cardiac and great vessel anatomy

Indicated Patient Age Range

Adults

Intended User / Care Setting

Physicians trained in cardiac catheterization in combination with fluoroscopic imaging and cardiac monitoring equipment with resuscitation equipment readily available.

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Non-clinical data includes bench-top evaluations, animal testing, packaging validation, biological safety, electrical safety, acoustic output testing, and animal testing.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K151126, K992631

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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).

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other, with flowing lines suggesting movement or connection.

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.

1

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

2

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)
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.

4

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
(K992631)	Colibri ICE System
(K151126)	Comments
Classification	Class II	Class II, 21 CFR §§ 1200 and
892.1570	Class II, 21 CFR §§ 1200	Same as predicate
devices
Regulation Name	Diagnostic Intravascular Catheter	Diagnostic Intravascular Catheter	Diagnostic Intravascular Catheter	Same as predicate
devices
Product code	DQO, ITX	DQO, ITX	DQO, ITX	Same as predicate
devices
Catheter type	Intracardiac Echocardiography	Intracardiac Echocardiography	Intracardiac Echocardiography	Same as predicate
devices
Clinical
performance data	No clinical testing is included in
the submission. Determination of
substantial equivalence
Performance is based on an
assessment of non-clinical data.	Human clinical testing is mentioned
in the substantial Equivalency
discussion, but the study protocol is
unknown.	No clinical testing was included in
the submission. Determination of
substantial equivalence
Performance was based on an
assessment of non-clinical data.	Same as predicate
device K151126
Non clinical
performance data	Non-clinical data includes bench-
top evaluations, animal testing,
packaging validation, biological
safety, electrical safety, acoustic
output testing, and animal testing.	Non-clinical testing includes
performance testing, animal testing,
human testing, biocompatibility and
non-pyrogenic.	Non-clinical data includes bench-
top evaluations, animal testing,
packaging validation, biological
safety, electrical safety, acoustic
output testing, and animal testing.	Similar to
predicate devices
Intended 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.	For use directly within the vascular
and/or the right heart for
intravascular or intracardiac
ultrasound imaging. The device is
specifically indicated for use in
visualization of vascular anatomy,
cardiac and great vessel anatomy
and physiology, or other devices in
the heart, as well as measurement of
blood flow. ventricle The company
anticipates that the device will be
used for a variety of intravascular
and intracardiac imaging
applications, consistent with its
intended use, including vascular
stent placement, monitoring left
ventricular function post-surgery;
identifying congenital abnormalities
before therapeutic procedures;
visualizing the relative orientation of
diagnostic and therapeutic catheters;
and visualizing procedures such as
transseptal insertion of other
catheters, valvuloplasties, balloon
septostomies, septal defect closures,
and pacemaker or defibrillator lead
insertion or extraction.	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.	Similar to AcuNav
Diagnostic
Ultrasound
Catheter
(K992631)
Principals of
operation	Generation of structural and
physiological images /
representations / measurements of
cardiovascular anatomy using
pulse-echo ultrasound systems.	Generation of structural and
physiological images /
representations / measurements of
cardiovascular anatomy using pulse-
echo ultrasound systems.	Generation of structural images /
representations / measurements of
cardiovascular anatomy using
pulse-echo ultrasound systems.	Same as predicate
devices
Outside Diameter
	10.3 F
Fits inside a commercially
available 10 F introducer sheath.	10F	10.3 F
Fits inside a commercially
available 10 F introducer sheath.	Similar to the 10F
AcuNav
Diagnostic
Ultrasound
Catheter
(K992631), which
itself refers to the
same predicate
device (K980851),
fits inside a
commercially
available 10F
introducer sheath.
Imaging energy	Ultrasound	Ultrasound	Ultrasound	Same as predicate
devices
Catheter
configuration	Single ultrasound imaging
element, mechanically rotated.	64 Element phased array ultrasound.	Single ultrasound imaging
element, mechanically rotated.	Same as predicate
devices
Ultrasound imaging
frequency	9MHz (Center Frequency)	4-10 MHz	9MHz	Same as predicate
device K151126
Distal end
configuration	Rotating imaging core with
acoustic window, with soft
atraumatic tip (PEBAX 5533).
The ultrasound imaging transducer
is mounted on a pivot mechanism
that allows the transducer to
controllably change is orientation
relative to the longitudinal axis of
the catheter.	Static imaging core with rigid
phased-array at distal tip.	Rotating imaging core with
acoustic window, with soft
atraumatic tip (PEBAX 5533).
The ultrasound imaging transducer
is mounted on a pivot mechanism
that allows the transducer to
controllably change is orientation
relative to the longitudinal axis of
the catheter.	Same as predicate
device K151126
Proximal end
configuration	Single connector, mechanical snap
into motor drive unit (referred to
as PIM).	Single connector, mechanical snap
into SwiftLink adapter	Single connector, mechanical snap
into motor drive unit (referred to
as PIM).	Same as predicate
device K151126
Acoustic output	Max Pressure: 2.55MPa	Not available	Max Pressure: 1.61 MPa	The increase in
max pressure and
MI is due to the
new modes.
However, even in
the new modes,
acoustic output is
below reporting
limits and well
below diagnostic
limits and does
not raise new risk
	MI: 0.93	Not available	MI: 0.57	The increase in
max pressure and
MI is due to the
new modes.
However, even in
the new modes,
acoustic output is
below reporting
limits and well
below diagnostic
limits and does
not raise new risk
Acoustic testing	As per IEC 60601-2-37:2007 and
equivalent analysis to NEMA UD-
2 performance	As per NEMA UD-2, Rev 1 1993	As per IEC 60601-2-37:2007 and
equivalent analysis to NEMA UD-
2 performance	Same as predicate
device K151126
Sterilization	ISO 11135-1:2014
ISO 11138:2006-1
AAMI/ANSI/ ISO 11737-1
(Ethylene Oxide)	ISO 11737 (Ethylene Oxide)	ISO 11737 (Ethylene Oxide)	Same as predicate
devices
Imaging Modes	B-Mode
M-Mode
Pulsed Wave Doppler
Color Doppler	B-Mode
M-Mode
Continuous Wave Doppler
Pulsed Wave Doppler
Color Doppler
Power Doppler	B-mode	Similar to
predicate devices
2D Imaging
Configuration	Single element scanning 360
degrees around the catheter.
Transducer oriented in a
predetermined position that can be
set within a range of ~10 degrees
from the full side-viewing position
to ~10 degrees from the full
forward looking position.	Phased array limited to ~90 degree
sector emanating from the side of
the catheter.	Single element scanning 360
degrees around the catheter.
Transducer oriented in a
predetermined position that can be
set within a range of ~10 degrees
from the full side-viewing position
to ~10 degrees from the full
forward looking position.	Same as predicate
device K151126
3D Imaging
Configuration	Transducer can be scanned from a
start angle to a stop angle within
the range of ~10 degrees from the
full side-viewing position to ~10
degrees from the full forward
looking position.	N/A	Transducer can be scanned from a
start angle to a stop angle within
the range of ~10 degrees from the
full side-viewing position to ~10
degrees from the full forward
looking position.	Same as predicate
device K151126
Biocompatibility	ISO 10993-7:2008, Externally
Communicating Device,
Circulating Blood category	ISO 10993, Externally
Communicating Device, Circulating
Blood category.	ISO 10993, Externally
Communicating Device,
Circulating Blood category	Same as predicate
devices
Insertable length	94 cm	90cm	94 cm	Similar to
predicate devices
Catheter
construction	Biocompatible Thermopolymer
over braided core	Biocompatible Thermopolymer over
braided core.	Biocompatible Thermopolymer
over braided core	Same as predicate
derives
Re-usability	Single use	Single use	Single use	Same as predicate
derives
Preparation	Flush with sterile water through
luer connector at proximal end	No preparation required.	Flush with sterile water through
luer connector at proximal end	Same as predicate
device K151126
Directionality of
catheter tip	Integrates a tip deflection
mechanism using a deflection
handle and pullwire to provide
integrated control of catheter tip
direction.	Integrates a tip deflection
mechanism using a deflection
handle and pullwires to provide
integrated control of catheter tip
direction.	Integrates a tip deflection
mechanism using a deflection
handle and pullwire to provide
integrated control of catheter tip
direction.	Same as predicate
devices

6

Foresight ICE System

510(k) Notification

7

Foresight ICE System 510(k) Notification

8

9

10

11

Table-2: Console Comparison Table

| Component | Subject Device:
Conavi ICE System | Predicate Device:
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
also displayed on Touchscreen | Dedicated image display monitor, images also
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
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
Interface Module) encapsulated in single
use disposable sterile bag | Motor Drive Unit (referred to as Patient
Interface Module) encapsulated in single use
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
(Track 1 Only)	Specific
(Tracks 1 & 3)	B	M	PWD	CWD	Color
Doppler	Combined
(Specify)	Other*
(Specify)
Ophthalmic	Ophthalmic
Fetal
Imaging
& Other	Fetal
	Abdominal
	Intra-operative (Specify)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric
	Small Organ (Specify)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal (Conventional)
	Musculo-skeletal (Superficial)

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	Intravascular
	Other (Specify)
Cardiac	Cardiac Adult	P	N	N	N
	Cardiac Pediatric
	Intravascular (Cardiac)	P	N	N	N
	Trans-esoph. (Cardiac)
	Intra-cardiac	P	N	N	N
	Other (Specify)
Peripheral Vessel	Peripheral vessel
	Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix

Examples of other modes of operation may include: A-mode, Amplitude Doppler, 3-D Imaging, Tissue Motion Doppler, and Color Velocity Imaging.

For evidence of compliance of the system to guidance provided in Guidance for Industry and FDA Staff - Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers, please refer to EXT-019. A copy is provided in Appendix 24.8.

14

Testing completed:

Verification and validation testing is completed in compliance with the following standards:

IEC 60601-1: 2005, + CORR. 1:2006 + CORR. 2:2007 + A1:2012, Medical Electrical Equipment 1. - Part 1: General requirements for basic safety and essential performance.
1. IEC 60601-1-2:2007, Medical Electrical Equipment Part 1-2: General Requirements for Basic Safety and Essential Performance - Collateral Standard: Electromagnetic Compatibility.
1. IEC 60601-1-6:2013. Medical Electrical Equipment Part 1-6: General Requirements for Basic Safety and Essential Performance - Collateral Standard: Usability.
1. IEC 60601-2-18:2009 in conjunction with IEC 60601-1:2005, Medical Electrical Equipment -Part 2-18: Particular requirements for the basic safety and essential performance of endoscopic equipment.
1. IEC 60601-2-37:2007, Medical Electrical Equipment Part 1-2: General Requirements for Basic Safety and Essential Performance - Collateral Standard: Electromagnetic Compatibility.
ISO 10993-2:2006, Biological evaluation of medical devices Part 2: Animal welfare 6. requirements.
1. AAMI/ANSI/ISO 10993-7:2008(R) 2012, Biological evaluation of medical devices Part 7: Ethylene Oxide Sterilization residuals.
1. ISO 10993-10:2010, Biological evaluation of medical devices Part 10: Tests for irritation and skin sensitization.
1. ISO 11135-1:2014, Sterilization of health-care products. Ethylene oxide Requirements for the development, validation and routine control of sterilization process for medical devices.

Conclusion:

Conavi Foresight ICE System and predicate devices have nearly identical intended use and very similar principles of operational and technological characteristics. The subject device (Conavi Foresight ICE System) and predicate devices are all intended for use in intravascular and/or intracardiac imaging, and the minor technological differences do not raise any new safety and effectiveness risk or concerns. After analyzing the results of bench test. laboratory test, electrical safety test, and animal test, it is the conclusion of Conavi Medical that Conavi Foresight ICE System is safe and as effective for the intended use, is as safe and effective as the predicate devices, and is substantially equivalent to the cited predicate devices.