(175 days)
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 devices in the heart and great vessels of patients.
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. 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.
The provided document is a 510(k) premarket notification for a medical device (Foresight Intracardiac Echocardiography (ICE) System). It focuses on demonstrating substantial equivalence to predicate devices, rather than establishing acceptance criteria and proving performance against them in the way modern AI/ML device submissions might.
Therefore, many of the requested details, such as specific acceptance criteria for algorithm performance, performance metrics, sample sizes for test sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, and training set details, are not present in this document.
The document primarily relies on non-clinical data (bench-top evaluations, animal testing, biological safety, electrical safety, acoustic output testing, packaging validation, and compliance with various IEC/ISO standards) to demonstrate substantial equivalence to previously cleared ICE systems. It explicitly states: "No clinical testing is included in the submission. Determination of substantial equivalence Performance is based on an assessment of non-clinical data."
However, I can extract and infer some information based on the type of submission and the data that is provided.
Acceptance Criteria and Study for Foresight Intracardiac Echocardiography (ICE) System
Based on the provided 510(k) summary (K162789), the device is a diagnostic ultrasound system (ICE) intended for visualization of cardiac and great vessel anatomy. The "acceptance criteria" in this context are not quantitative performance metrics for an AI algorithm, but rather the demonstration of substantial equivalence to predicate devices through engineering and non-clinical testing. The study supporting this is a series of non-clinical tests and comparisons.
1. Table of Acceptance Criteria and Reported Device Performance
As this is a 510(k) for an ultrasound imaging system without specific AI algorithms requiring performance metrics like sensitivity/specificity for disease detection, the "acceptance criteria" are related to product specifications, safety, and functionality, demonstrating equivalence to the predicate.
| Acceptance Criterion (Implicit) | Reported Device Performance/Comparison (Indirectly 'Meets') |
|---|---|
| Intended Use Equivalence | The Foresight ICE System's intended use (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) is deemed similar to the predicate AcuNav™ (K992631) and identical to previous Colibri ICE System (K151126). |
| Functional & Technological Equivalence (Catheter) | Ultrasound Imaging Frequency: 9MHz (matches K151126, within 4-10 MHz range of K992631).Catheter Type: Intracardiac Echocardiography (matches predicates).Outside Diameter: 10.3F (similar to 10F of K992631, matches K151126).Imaging Modes: B-Mode, M-Mode, Pulsed Wave Doppler, Color Doppler (expanded vs. K151126, similar to K992631).Acoustic Output (Max Pressure): 2.55MPa (higher than K151126's 1.61 MPa, but "below reporting limits and well below diagnostic limits"). |
| Functional & Technological Equivalence (Console) | Configuration: Mobile cart with braking system (same as predicate K151126).Input: Touchscreen, touchpad, keyboard (same as predicate K151126).Display: Dedicated image display + touchscreen (same as predicate K151126).Data Storage: DICOM and native format (same as predicate K151126). |
| Biocompatibility | Complies with ISO 10993-7:2008 for Ethylene Oxide Sterilization residuals and ISO 10993-10:2010 for irritation/skin sensitization. Reported as "Same as predicate devices" in type of testing. |
| Sterilization | Complies with ISO 11135-1:2014, ISO 11138:2006-1, AAMI/ANSI/ISO 11737-1 (Ethylene Oxide). Reported as "Same as predicate devices" in type given that predicates comply with ISO 11737. |
| Electrical Safety / EMC | Complies with IEC 60601-1 (general safety), IEC 60601-1-2 (EMC), IEC 60601-2-37 (specific to ultrasound, but listed as EMC standard - likely a typo and means the specific standard for diagnostic ultrasound). |
| Usability | Complies with IEC 60601-1-6 (Usability). |
| Animal Testing (for safety/functionality, not performance) | Performed (mentioned in Non-clinical performance data) as part of safety and functionality verification. |
| Bench-top Evaluations (for safety/functionality) | Performed (mentioned in Non-clinical performance data) to verify performance characteristics. |
2. Sample Size for Test Set and Data Provenance:
- Test Set Sample Size: Not applicable in the context of typical AI/ML validation with a "test set" of patient data. The "test set" here refers to physical devices undergoing various engineering and safety tests. The document does not specify the number of devices or components tested, but implies standard engineering testing practices.
- Data Provenance: The data comes from non-clinical testing conducted by Conavi Medical Inc. (Canada-based). It is not patient data (retrospective or prospective), but rather lab, benchtop, and animal model data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts:
- Not applicable. This submission does not involve an AI algorithm where human experts establish ground truth from patient data. The "ground truth" for the device's functionality is established by engineering specifications, relevant IEC/ISO standards, and the performance of predicate devices.
4. Adjudication Method for the Test Set:
- Not applicable. There is no "adjudication" in the sense of resolving discrepancies in expert labeling of medical images. Testing involves objective measurements against engineering specifications and safety standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
- No. The document explicitly states: "No clinical testing is included in the submission." Therefore, no MRMC study was conducted comparing human readers with and without AI assistance, as there is no AI component being evaluated for diagnostic assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is an imaging system, not a standalone algorithm. Its performance is inherent to its ability to generate images, which are then interpreted by a human user.
7. The Type of Ground Truth Used:
- The "ground truth" is established by engineering specifications, international safety and performance standards (IEC, ISO, NEMA), and the established performance characteristics of the predicate devices. For example, the "ground truth" for acoustic output is derived from regulatory limits and safe operation ranges for diagnostic ultrasound. "Animal testing" contributes to safety and functional verification, but not to establishing a diagnostic "ground truth" on patient cases.
8. The Sample Size for the Training Set:
- Not applicable. This device does not use machine learning algorithms that require a "training set" of data.
9. How the Ground Truth for the Training Set was Established:
- Not applicable. See point 8.
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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.
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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely.
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K162789
Device Name
Foresight Intracardiac Echocardiography (ICE) System
Indications for Use (Describe)
The Foresight Intracardiac Echocardiography (ICE) System is indicated for intraluminal ultrasound visualization of cardiac and great vessel anatomy and physiology as well as visualization of other aevices in the heart and great vessels of patients.
| Type of Use (Select one or both, as applicable) | |
|---|---|
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510(k) Summary
This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
510(k) Number: K162789
Applicant Information:
| Date Prepared: | February 17, 2017 |
|---|---|
| Name: | Conavi Medical Inc. |
| Address: | 293 Lesmill Road |
| North York, ON, Canada M3B 2V1 | |
| Contact Person: | Sam Mostafavi |
| Sam@Conavi.com | |
| Mobile Number: | 650-670-6972 |
| Office Number: | (416) 483-0100 |
| Facsimile Number: | (416) 483-0101 |
Device Information:
| Trade/Proprietary Name: | Intracardiac Echocardiography (ICE) System |
|---|---|
| Common Name: | Foresight Intracardiac Echocardiography (ICE) System |
| Classification Name(s): | Diagnostic Intravascular Catheters, 21 CFR 870.1200 (DQO)Diagnostic Ultrasonic Transducers, 21 CFR 892.1570 (ITX) |
| Class: | Class II |
| Panel: | Division of Cardiovascular Devices |
Predicate Device:
- Conavi Medical (Formerly Colibri Technologies) ICE system K151126 ■ Acuson Corp. AcuNav™ Diagnostic Ultrasound Catheter K992631
Device Description
The Foresight ICE System is intended to be used for real-time, minimally-invasive guidance of several different intracardiac procedures including, but not limited to, atrial ablation procedures and transseptal punctures. The system will provide image information of cardiovascular anatomic features, spatial relationships of other devices within the heart and great vessels, physiological information of cardiovascular structures and features, and intra-procedure complications including pericardial effusions. In doing so we expect to provide an imaging system capable of improving the safety, expediency, cost-effectiveness and patient tolerance of the aforementioned procedures compared to the same procedures using the existing technologies and methodologies.
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The system will be comprised of catheter and a cart based console. The console includes the Acquisition and Display Module (ADM) for image display and manipulation as well as the Patient Interface Module (PIM) which the catheter connects to. The ADM will have two monitors to allow for ease of image view and review for both the technician and physician user. The technician user will be able to control the system software via an easy to use interface using multiple methods of input including a mouse, keyboard and/or a touch screen. Casters on the ADM will allow easy movement of the system throughout an EP Lab which can have a small footprint as well as small obstacles to cross.
The catheter will be a 10.3F single use, sterile device, which will be able to perform intracardiac and intraluminal ultrasound imaging of adults. The catheter will be capable of real-time 2D side and forward viewing imaging with the ability to produce rapidly post processed 3D rendered images as well as ECG gated 3D images to reduce motion artifacts. The imaging system will be able to resolve and measure features such as the inferior and superior vena cava, ascending and descending aorta, left and right atria, left and right ventricle, fossa ovalis, aortic valve, mitral valve and tricuspid valves. It will display / measure flow velocities using Color and PW Doppler. The physician user will have easy steering maneuverability of the catheter via deflection and rotation, as well as having control over the position of the transducer to allow for multiple angles of images.
Indications for Use
The Foresight ICE System is indicated for intracardiac and intraluminal ultrasound visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart and great vessels of patients.
Functional and Technological Comparison
Tables 1 below include functional and technological comparison between the updated Conavi Foresight ICE catheter and market cleared Acuson Corp. AcuNav™ Diagnostic Ultrasound Catheter (K992631).
Tables 2 include functional and technological comparison between the updated Conavi Medical Foresight ICE system and the market cleared Foresight ICE System (K151126).
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Table-1: Catheter substantial equivalency comparison
| Component | Subject Device | Predicate Devices | ||
|---|---|---|---|---|
| Conavi ICE System | Acuson Corporation AcuNavTM(K992631) | Colibri ICE System(K151126) | Comments | |
| Classification | Class II | Class II, 21 CFR §§ 1200 and892.1570 | Class II, 21 CFR §§ 1200 | Same as predicatedevices |
| Regulation Name | Diagnostic Intravascular Catheter | Diagnostic Intravascular Catheter | Diagnostic Intravascular Catheter | Same as predicatedevices |
| Product code | DQO, ITX | DQO, ITX | DQO, ITX | Same as predicatedevices |
| Catheter type | Intracardiac Echocardiography | Intracardiac Echocardiography | Intracardiac Echocardiography | Same as predicatedevices |
| Clinicalperformance data | No clinical testing is included inthe submission. Determination ofsubstantial equivalencePerformance is based on anassessment of non-clinical data. | Human clinical testing is mentionedin the substantial Equivalencydiscussion, but the study protocol isunknown. | No clinical testing was included inthe submission. Determination ofsubstantial equivalencePerformance was based on anassessment of non-clinical data. | Same as predicatedevice K151126 |
| Non clinicalperformance data | Non-clinical data includes bench-top evaluations, animal testing,packaging validation, biologicalsafety, electrical safety, acousticoutput testing, and animal testing. | Non-clinical testing includesperformance testing, animal testing,human testing, biocompatibility andnon-pyrogenic. | Non-clinical data includes bench-top evaluations, animal testing,packaging validation, biologicalsafety, electrical safety, acousticoutput testing, and animal testing. | Similar topredicate devices |
| Intended use | The Foresight ICE System isindicated for intracardiac andintraluminal ultrasoundvisualization of cardiac and greatvessel anatomy and physiology aswell as visualization of otherdevices in the heart and greatvessels of patients. | For use directly within the vascularand/or the right heart forintravascular or intracardiacultrasound imaging. The device isspecifically indicated for use invisualization of vascular anatomy,cardiac and great vessel anatomyand physiology, or other devices inthe heart, as well as measurement ofblood flow. ventricle The companyanticipates that the device will beused for a variety of intravascularand intracardiac imagingapplications, consistent with itsintended use, including vascularstent placement, monitoring leftventricular function post-surgery;identifying congenital abnormalitiesbefore therapeutic procedures;visualizing the relative orientation ofdiagnostic and therapeutic catheters;and visualizing procedures such astransseptal insertion of othercatheters, valvuloplasties, balloonseptostomies, septal defect closures,and pacemaker or defibrillator leadinsertion or extraction. | The Foresight ICE System isindicated for intracardiac andintraluminal ultrasoundvisualization of cardiac and greatvessel anatomy as well asvisualization of other devices inthe heart and great vessels ofpatients.The Foresight ICE System isintended to be used by physicianstrained in cardiac catheterizationin combination with fluoroscopicimaging and cardiac monitoringequipment with resuscitationequipment readily available. | Similar to AcuNavDiagnosticUltrasoundCatheter(K992631) |
| Principals ofoperation | Generation of structural andphysiological images /representations / measurements ofcardiovascular anatomy usingpulse-echo ultrasound systems. | Generation of structural andphysiological images /representations / measurements ofcardiovascular anatomy using pulse-echo ultrasound systems. | Generation of structural images /representations / measurements ofcardiovascular anatomy usingpulse-echo ultrasound systems. | Same as predicatedevices |
| Outside Diameter | ||||
| 10.3 FFits inside a commerciallyavailable 10 F introducer sheath. | 10F | 10.3 FFits inside a commerciallyavailable 10 F introducer sheath. | Similar to the 10FAcuNavDiagnosticUltrasoundCatheter(K992631), whichitself refers to thesame predicatedevice (K980851),fits inside acommerciallyavailable 10Fintroducer sheath. | |
| Imaging energy | Ultrasound | Ultrasound | Ultrasound | Same as predicatedevices |
| Catheterconfiguration | Single ultrasound imagingelement, mechanically rotated. | 64 Element phased array ultrasound. | Single ultrasound imagingelement, mechanically rotated. | Same as predicatedevices |
| Ultrasound imagingfrequency | 9MHz (Center Frequency) | 4-10 MHz | 9MHz | Same as predicatedevice K151126 |
| Distal endconfiguration | Rotating imaging core withacoustic window, with softatraumatic tip (PEBAX 5533).The ultrasound imaging transduceris mounted on a pivot mechanismthat allows the transducer tocontrollably change is orientationrelative to the longitudinal axis ofthe catheter. | Static imaging core with rigidphased-array at distal tip. | Rotating imaging core withacoustic window, with softatraumatic tip (PEBAX 5533).The ultrasound imaging transduceris mounted on a pivot mechanismthat allows the transducer tocontrollably change is orientationrelative to the longitudinal axis ofthe catheter. | Same as predicatedevice K151126 |
| Proximal endconfiguration | Single connector, mechanical snapinto motor drive unit (referred toas PIM). | Single connector, mechanical snapinto SwiftLink adapter | Single connector, mechanical snapinto motor drive unit (referred toas PIM). | Same as predicatedevice K151126 |
| Acoustic output | Max Pressure: 2.55MPa | Not available | Max Pressure: 1.61 MPa | The increase inmax pressure andMI is due to thenew modes.However, even inthe new modes,acoustic output isbelow reportinglimits and wellbelow diagnosticlimits and doesnot raise new risk |
| MI: 0.93 | Not available | MI: 0.57 | The increase inmax pressure andMI is due to thenew modes.However, even inthe new modes,acoustic output isbelow reportinglimits and wellbelow diagnosticlimits and doesnot raise new risk | |
| Acoustic testing | As per IEC 60601-2-37:2007 andequivalent analysis to NEMA UD-2 performance | As per NEMA UD-2, Rev 1 1993 | As per IEC 60601-2-37:2007 andequivalent analysis to NEMA UD-2 performance | Same as predicatedevice K151126 |
| Sterilization | ISO 11135-1:2014ISO 11138:2006-1AAMI/ANSI/ ISO 11737-1(Ethylene Oxide) | ISO 11737 (Ethylene Oxide) | ISO 11737 (Ethylene Oxide) | Same as predicatedevices |
| Imaging Modes | B-ModeM-ModePulsed Wave DopplerColor Doppler | B-ModeM-ModeContinuous Wave DopplerPulsed Wave DopplerColor DopplerPower Doppler | B-mode | Similar topredicate devices |
| 2D ImagingConfiguration | Single element scanning 360degrees around the catheter.Transducer oriented in apredetermined position that can beset within a range of ~10 degreesfrom the full side-viewing positionto ~10 degrees from the fullforward looking position. | Phased array limited to ~90 degreesector emanating from the side ofthe catheter. | Single element scanning 360degrees around the catheter.Transducer oriented in apredetermined position that can beset within a range of ~10 degreesfrom the full side-viewing positionto ~10 degrees from the fullforward looking position. | Same as predicatedevice K151126 |
| 3D ImagingConfiguration | Transducer can be scanned from astart angle to a stop angle withinthe range of ~10 degrees from thefull side-viewing position to ~10degrees from the full forwardlooking position. | N/A | Transducer can be scanned from astart angle to a stop angle withinthe range of ~10 degrees from thefull side-viewing position to ~10degrees from the full forwardlooking position. | Same as predicatedevice K151126 |
| Biocompatibility | ISO 10993-7:2008, ExternallyCommunicating Device,Circulating Blood category | ISO 10993, ExternallyCommunicating Device, CirculatingBlood category. | ISO 10993, ExternallyCommunicating Device,Circulating Blood category | Same as predicatedevices |
| Insertable length | 94 cm | 90cm | 94 cm | Similar topredicate devices |
| Catheterconstruction | Biocompatible Thermopolymerover braided core | Biocompatible Thermopolymer overbraided core. | Biocompatible Thermopolymerover braided core | Same as predicatederives |
| Re-usability | Single use | Single use | Single use | Same as predicatederives |
| Preparation | Flush with sterile water throughluer connector at proximal end | No preparation required. | Flush with sterile water throughluer connector at proximal end | Same as predicatedevice K151126 |
| Directionality ofcatheter tip | Integrates a tip deflectionmechanism using a deflectionhandle and pullwire to provideintegrated control of catheter tipdirection. | Integrates a tip deflectionmechanism using a deflectionhandle and pullwires to provideintegrated control of catheter tipdirection. | Integrates a tip deflectionmechanism using a deflectionhandle and pullwire to provideintegrated control of catheter tipdirection. | Same as predicatedevices |
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Foresight ICE System
510(k) Notification
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Foresight ICE System 510(k) Notification
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Table-2: Console Comparison Table
| Component | Subject Device: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, imagesalso displayed on Touchscreen | Dedicated image display monitor, images alsodisplayed on Touchscreen | Same as predicate device |
| Data storage | DICOM and native format | DICOM and native format | Same as predicate device |
| Footprint (centre to centredistance 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 PatientInterface Module) encapsulated in singleuse disposable sterile bag | Motor Drive Unit (referred to as PatientInterface Module) encapsulated in single usedisposable 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 | ColorDoppler | Combined(Specify) | Other*(Specify) |
| Ophthalmic | Ophthalmic | |||||||
| FetalImaging& 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.
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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.
-
- IEC 60601-1-2:2007, Medical Electrical Equipment Part 1-2: General Requirements for Basic Safety and Essential Performance - Collateral Standard: Electromagnetic Compatibility.
-
- IEC 60601-1-6:2013. Medical Electrical Equipment Part 1-6: General Requirements for Basic Safety and Essential Performance - Collateral Standard: Usability.
-
- 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.
-
- 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.
-
- AAMI/ANSI/ISO 10993-7:2008(R) 2012, Biological evaluation of medical devices Part 7: Ethylene Oxide Sterilization residuals.
-
- ISO 10993-10:2010, Biological evaluation of medical devices Part 10: Tests for irritation and skin sensitization.
-
- 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.
§ 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).