(234 days)
No
The document describes standard ultrasound imaging technology and processing without mentioning any AI or ML components.
No.
This device is an imaging system designed for visualization, not for providing therapy.
Yes
The device is intended for "intracardiac and intraluminal ultrasound visualization of cardiac and great vessel anatomy," which is a form of medical imaging used to diagnose conditions by visualizing internal structures. One of the provided reference device, K992631, is explicitly mentioned as "AcuNav Diagnostic Ultrasound Catheter".
No
The device description explicitly states that the system is comprised of a catheter, a Patient Interface Module (PIM), and a Hummingbird Console, all of which are hardware components. While the system includes software for processing and displaying imaging data, it is not solely software.
Based on the provided information, the Foresight ICE System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is for intracardiac and intraluminal ultrasound visualization of anatomy and other devices within the body. This is an in vivo (within a living organism) application, not in vitro (outside of the body, typically on biological samples).
- Device Description: The system uses an ultrasound catheter inserted into the body to generate images. This is a direct interaction with the patient's internal anatomy.
- Lack of Sample Analysis: IVD devices typically analyze biological samples (blood, urine, tissue, etc.) to provide diagnostic information. This device is purely for imaging and visualization within the body.
Therefore, the Foresight ICE System is an in vivo imaging device, not an IVD.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
DQO, ITX
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.
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
Not Found
Intended User / Care Setting
physicians trained in cardiac catheterization
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)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
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)
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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) |
| 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
9MHZ (K980851) | Colibri ICE System | Comment |
|---------------|---------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Catheter type | Intracardiac
Echocardiography | Intracardiac
Echocardiography | Same as Sonicath Ultra
9MHZ (predicate) |
| Intended use | The UltralCE
Rounded Tip
Catheter is indicated
for enhanced
ultrasonic
visualization of
intracardiac
structures. | 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 Sonicath Ultra
9MHZ (predicate).
The indication for use
for the Colibri ICE
system is more similar
to that of the AcuNav
Diagnostic Ultrasound
Catheter (K992631),
which itself refers to the
same predicate device
(K980851). |
Catheter comparison Table
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| Outside
Diameter | 9F | 10.3 F | Similar to Sonicath Ultra
9 MHZ (predicate). |
|-----------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Fits inside the
recommended
Convoy Introducer
sheath (with an ID of
8.5F) | Fits inside a commercially
available 10 F introducer
sheath. | Safety and
effectiveness is not
affected (footnote)1. |
| | | | The 10F AcuNav
Diagnostic Ultrasound
Catheter (K992631),
which itself refers to the
same predicate device
(K980851), fits inside a
commercially available
10F introducer sheath. |
| | | | The UltraICE (Formerly
Sonicath Ultra 9MHz)
IFU states "The
UltraICE Catheter is
introduced through a
standard 9F (3mm) /
10F (3.3mm) venous or
arterial access system." |
| | Imaging energy | Ultrasound | Ultrasound |
| Catheter
configuration | Single ultrasound
imaging element,
mechanically rotated. | Single ultrasound imaging
element, mechanically rotated. | Same as Sonicath Ultra
9MHZ (predicate). |
| Ultrasound
imaging
frequency | 9MHz | 9MHz | Same as Sonicath Ultra
9MHZ (predicate). |
| Distal end
configuration | Rotating imaging
core with acoustic
window, with soft
atraumatic tip
(LDPE). The
ultrasound imaging
transducer has
a fixed orientation
relative to the
longitudinal axis of
the catheter. | 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. | Similar to Sonicath Ultra
9MHZ (predicate). |
| Longitudinal
distance from
distal tip of
catheter to
imaging
transducer. | Varies -
approximately 4-11
mm depending on
orientation. | Approximately 1-2 mm. | Similar to Sonicath Ultra
9MHZ (predicate).
The reduced distance
does not adversely
affect the safety and
efficacy of the imaging
modality.
During imaging, the
reduced longitudinal
distance between the
transducer and distal tip
of the catheter means
that the imaged tissue
is in closer proximity to
the catheter tip and
therefore lessens the
uncertainty about when
the catheter tip will
come into contact with
tissue as compared to
the predicate device. |
| Proximal end
configuration | Single connector,
mechanical snap
into motor drive unit. | Single connector, mechanical
snap into motor drive unit
(referred to as PIM). | Same as Sonicath Ultra
9MHZ (predicate). |
| Acoustic output | Max pressure:
3.258 MPa | 1.61 MPa | Similar to Sonicath Ultra
9MHZ (predicate).
The reduced acoustic
output reduces risk of
tissue bioeffects. |
| | MI: 1.275 | 0.57 | Similar to Sonicath Ultra
9MHZ (predicate).
The reduced acoustic
output reduces risk of
tissue bioeffects. |
| | | | Note: worst case
acoustic output
parameters occur for a
transducer that is fully
forward viewing within
the ICE catheter and
therefore the
autoscanning mode is
equivalent to the non-
scanning mode under
the condition where the
steady state motor
speed is at maximum. |
| | PRF: 7.68 KHz | PRF: 5.0 KHz | Similar to Sonicath Ultra
9MHZ (predicate). 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 Sonicath Ultra
9MHZ (predicate). |
| Sterilization | ISO 11737 (Gamma
Irradiation) | ISO 11737 (Ethylene
Oxide). | Similar to Sonicath Ultra
9MHZ (predicate). |
| Imaging modes | B-mode | B-mode | Same as Sonicath Ultra
9MHZ (predicate). |
| | 2D Display:
Transducer limited to
a fixed orientation
~10 degrees from
the full side-viewing
position | 2D Display:
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. | Similar to Sonicath Ultra
9MHZ (predicate). |
| | 3D Display:
N/A | 3D Display:
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. | Similar to Sonicath Ultra
9MHZ (predicate).
Maximum acoustic
output in 3D mode is
the same as for B-mode
imaging. |
| Biocompatibility | ISO 10993,
Externally
Communicating
Device, Circulating
Blood category. | ISO 10993, Externally
Communicating Device,
Circulating Blood category. | Same as Sonicath Ultra
9MHZ (predicate). |
| Insertable length | 110cm;
approximately
90 cm usable. | 94 cm | Similar to Sonicath Ultra
9MHZ (predicate).
Since predicate does
not have handle /
proximal extension,
approximately
20cm or more are
required to extend from
MDU to entry site. |
| Catheter
construction | Biocompatible
Thermopolymer over
braided core. | Biocompatible Thermopolymer
over braided core. | Same as Sonicath Ultra
9MHZ (predicate). |
| Re-usability | Single use | Single use | Same as Sonicath Ultra
9MHZ (predicate). |
| Preparation | Flush with sterile
water through distal
tip with needle. | Flush with sterile water
through luer connector at
proximal end. | Similar to Sonicath Ultra
9MHZ (predicate);
Improved usability,
reduced risk. |
| Directionality of
catheter tip | Instructions for use
of the UltralCE
catheter recommend
the use of a separate
multipurpose EP
long sheath or
guiding catheter to
improve the
directionality of the
catheter tip. | Integrates a tip deflection
mechanism using a deflection
handle and pullwire to
provide integrated control of
catheter tip direction. | Similar to Sonicath Ultra
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.
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7
8
9
Console Comparison Table
| Component | Sonicath Ultra
9MHZ (K980851) | Colibri ICE System | Comment |
|--------------------------------------------------------|-----------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------|
| Configuration | Mobile cart with
braking system. | Mobile cart with braking
system. | Same as Sonicath Ultra
9MHZ (predicate). |
| Input | Keyboard, trackball
and custom interface
buttons. | Touchscreen, touchpad,
and keyboard. | Similar to Sonicath Ultra
9MHZ (predicate). |
| Display | Dedicated image
display monitor | Dedicated image display
monitor, images also
displayed on Touchscreen. | Same as Sonicath Ultra
9MHZ (predicate). |
| Data storage | DICOM | DICOM and native format. | Same as Sonicath Ultra
9MHZ (predicate). |
| Interface with
external systems | Interface to PACS | Interface to PACS | Same as Sonicath Ultra
9MHZ (predicate). |
| Footprint (centre to
centre distance of
casters) | 580 x 610mm | 502 x 502mm | Similar to Sonicath Ultra
9MHZ (predicate). |
| Peripherals | DVD-ROM, Printer,
VHS | DVD-ROM, Printer, USB | Similar to Sonicath Ultra
9MHZ (predicate). |
| Electrical safety | IEC 60601-1 2nd
edition | IEC 60601-1 3rd edition | Similar to Sonicath Ultra
9MHZ (predicate). |
| Sterile barrier
interface | Motor Drive Unit
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 Sonicath Ultra
9MHZ (predicate). |
| Measurements | Depth markers,
depth
measurements, in
plane distance and
area measurements. | Depth markers, in plane
depth distance
measurements. | Similar to Sonicath Ultra
9MHZ (predicate). |
| | | | Note: based on the test
results the worst case
uncertainty of any depth
measurement is +/-
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:
-
- Therapeutic use: The device does not provide therapy, and thus has no intended therapeutic use.
-
- 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.
-
- Prosthetic use: The device is not a prosthetic, and thus has no intended prosthetic use.
-
- 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:
-
- 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.
-
- 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.