(249 days)
Not Found
No
The summary describes a standard ultrasound imaging catheter and its performance testing, with no mention of AI or ML capabilities.
No.
Explanation: The device is explicitly stated to be "for imaging guidance only, not treatment delivery". Its purpose is diagnostic visualization, not therapeutic intervention.
Yes
The "Intended Use / Indications for Use" section states: "The NuVision ICE Catheter™ is intended for intracardiac and intra-luminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart of adult and pediativ patients." Additionally, the "Device Description" explicitly calls it a "diagnostic ultrasound imaging catheter".
No
The device description clearly outlines a physical catheter with an ultrasound transducer, electrical connectors, and mechanical components for rotation and deflection. It is a hardware device that connects to an ultrasound console.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples such as blood, urine, or tissue that have been taken from the human body to detect diseases or other conditions. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The NuVision ICE Catheter is a diagnostic ultrasound imaging catheter. Its purpose is to visualize internal anatomy (cardiac and great vessels) and other devices within the body in real-time. It does not analyze samples taken from the body.
- Intended Use: The intended use clearly states "intracardiac and intra-luminal visualization" and "imaging guidance only, not treatment delivery". This describes an in-vivo (within the living organism) diagnostic imaging procedure, not an in-vitro test.
The device is a medical device used for diagnostic imaging in vivo, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The NuVision ICE Catheter™ is intended for intracardiac and intra-luminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart of adult and pediativ patients. The catheter is intended for imaging guidance only, not treatment delivery, during cardiac interventional percutaneous procedures.
Product codes
OBJ
Device Description
The NuVision ICE Catheter is a diagnostic ultrasound imaging catheter designed for intracardiac use. The catheter can be advanced, retracted and rotated within the anatomy. The catheter is comprised of a 10 Fr outer shaft capable of being rotated and deflected, which houses an ultrasound transducer. The outer shaft rotation is driven directly from a probe knob on the handle, while a deflection knob on the handle drives the deflection by controlling a deflectable inner shaft situated within the outer shaft.
The imaging ultrasound transducer is a 2D piezo-electric array capable of real-time 3D imaging. The imaging field emanates perpendicular to the axis of one side of the imaging tip, also referred to as a probe. The tip movement, in combination with deflection of the distal catheter, provide the user with the ability to adjust the orientation of the imaging tip to visualize the target anatomy.
An electrical connector proximal to the handle allows connection to the NuVision Connector Cable which also connects to an ultrasound cardiac imaging console. Printed circuit boards within the catheter system's electrical connectors help with signal distribution and conditioning. The NuVision ICE Catheter System relies on power from the ultrasound cardiac imaging console to function.
The NuVision ICE Catheter is used with a compatible ultrasound cardiac imaging system with software cleared for market in accordance with 21 CFR 807.81(a)(3).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Intracardiac and intra-luminal visualization of cardiac and great vessel anatomy.
Indicated Patient Age Range
adult and pediatric patients.
Intended User / Care Setting
Not Found
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
Non-clinical data includes bench-top evaluations, animal testing, packaging validation, biological safety, electrical safety, acoustic output testing, and animal testing.
The NuVision ICE Catheter was developed per the Guidance for Industry and FDA Staff, Marketing Clearance of Diagnostic Ultrasound Systems and Transducers (2019). Nonclinical data includes bench-top performance evaluations, packaging validation, biological safety, electromagnetic compatibility, and acoustic output testing. The devices used for testing were manufactured in accordance with the design specifications and approved manufacturing documentation.
The catheter dimensional characteristics were evaluated to verify conformance to design specifications and EN ISO 10555-1:2013: Sterile, single-use intravascular catheters - Part 1: General requirements. The physical integrity, functionality, and overall performance of the catheter were evaluated including:
- a) Visual and Dimensional Characteristics
- b) Simulated Use
- · Package opening and transfer to sterile field
- · Sterile sleeve loading
- c) Catheter Functional Performance
- · Reach
- · Deflection
- · Rotation
- · Radiopacity
- d) Electro-Acoustic Performance
- e) Durability
- · Multiple insertions
- · Rotation Cycling
- · Deflection Cycling
- · Tip Kinking and buckling
- · Leakage
- · Particulate generation
- · Tensile strength
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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).
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
March 5, 2021
NuVera Medical, Inc. Robert Nardelli Vice President, RA/QA 140 Knowles Dr. Los Gatos, California 95032
Re: K201775
Trade/Device Name: NuVision ICE Catheter Regulation Number: 21 CFR 870.1200 Regulation Name: Diagnostic Intravascular Catheter Regulatory Class: Class II Product Code: OBJ Dated: March 2, 2021 Received: March 3, 2021
Dear Robert Nardelli:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Jessica Paulsen Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K201775
Device Name NuVision ICE Catheter
Indications for Use (Describe)
The NuVision ICE Catheter™ is intended for intracardiac and intra-luminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart of adult and pediativ patients. The catheter is intended for imaging guidance only, not treatment delivery, during cardiac interventional percutaneous procedures.
Type of Use (Select one or both, as applicable)
| ☑ Production Use (Part 21 CFR 601 Subpart E) | ☐ Same-Site Control Use (21 CFR 601 Subpart E) |
|---|---|
| ------------------------------------------------------------------------------------ | ------------------------------------------------ |
Prescription Use (Part 21 CFR 801 Subpart D)
__ Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/0 description: The image shows the logo for NuVera Medical. The logo consists of a stylized, geometric shape in orange and yellow, resembling folded paper or ribbons. To the right of the shape is the text "NuVera" in a clean, sans-serif font, with "MEDICAL" in a smaller font size directly below it. The overall design is modern and professional.
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: | K201775 |
|---|---|
| Date Prepared: | June 26, 2020 |
| Applicant Information: | NuVera Medical, Inc |
| 140 Knowles Drive | |
| Los Gatos, CA 95032 | |
| Registration Number: 3016516752 | |
| Contact Person: | Robert Nardelli robert@nuveramedical.com |
| Office Number: | 408-560-2500 |
| Device Information: | |
| Trade/Proprietary Name: | NuVision ICE Catheter |
| Common Name: | Intracardiac Echocardiography (ICE) Catheter |
| Classification Name(s): | Diagnostic Intravascular Catheters, 21 CFR 870.1200 (OBJ) |
Class: Class II
Panel: Division of Cardiovascular Devices
AcuNav™ Diagnostic Ultrasound Catheter (K071234) Predicate Device:
Device Description
The NuVision ICE Catheter is a diagnostic ultrasound imaging catheter designed for intracardiac use. The catheter can be advanced, retracted and rotated within the anatomy. The catheter is comprised of a 10 Fr outer shaft capable of being rotated and deflected, which houses an ultrasound transducer. The outer shaft rotation is driven directly from a probe knob on the handle, while a deflection knob on the handle drives the deflection by controlling a deflectable inner shaft situated within the outer shaft.
The imaging ultrasound transducer is a 2D piezo-electric array capable of real-time 3D imaging. The imaging field emanates perpendicular to the axis of one side of the imaging tip, also referred to as a probe. The tip movement, in combination with deflection of the distal catheter, provide the user with the ability to adjust the orientation of the imaging tip to visualize the target anatomy.
4
Image /page/4/Picture/0 description: The image contains the logo for NuVera Medical. The logo consists of a geometric shape in orange and yellow, resembling folded paper. To the right of the shape is the company name, "NuVera," in a simple, sans-serif font. Below "NuVera" is the word "MEDICAL" in a smaller font size.
NuVision™ ICE Catheter
An electrical connector proximal to the handle allows connection to the NuVision Connector Cable which also connects to an ultrasound cardiac imaging console. Printed circuit boards within the catheter system's electrical connectors help with signal distribution and conditioning. The NuVision ICE Catheter System relies on power from the ultrasound cardiac imaging console to function.
The NuVision ICE Catheter is used with a compatible ultrasound cardiac imaging system with software cleared for market in accordance with 21 CFR 807.81(a)(3).
Indications for Use
The NuVision ICE Catheter is intended for intracardiac and intra-luminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart of adult and pediatric patients. The catheter is intended for imaging guidance only, not treatment delivery, during cardiac interventional percutaneous procedures.
Functional and Technological Comparison
The table below includes a functional and technological comparison between the NuVision ICE Catheter and the market-cleared Siemens AcuNav™ Diagnostic Ultrasound Catheter (K071234).
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Image /page/5/Picture/0 description: The image contains the logo for Nuvera Medical. The logo consists of a stylized, geometric shape in orange and yellow, resembling folded paper or a ribbon. To the right of the geometric shape, the word "NUVERA" is written in a bold, sans-serif font, with the word "MEDICAL" appearing below it in a smaller font size.
Traditional 510(k) Notification
Table 5-1: Catheter substantial equivalency comparison
| Subject Device | Predicate Device | ||
|---|---|---|---|
| Component | NuVision ICE Catheter | Siemens AcuNav™ (K071234) | Comments |
| Classification | Class II | Class II | Same as predicate device |
| Regulation | 21 CFR 870.1200 | 21 CFR 870.1200 | Same as predicate device |
| Regulation Name | Diagnostic Intravascular Catheter | Diagnostic Intravascular Catheter | Same as predicate device |
| Product code | OBJ | OBJ | Same as predicate device |
| Catheter type | Intracardiac Echocardiography | Intracardiac Echocardiography | Same as predicate device |
| 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. | No clinical testing is referenced in | ||
| the submission. | Same as predicate device | ||
| 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 data includes bench-top | ||
| evaluations, animal testing, packaging | |||
| validation, biological safety, electrical | |||
| safety, acoustic output testing, and animal | |||
| testing. | Same as predicate device | ||
| Intended use | The NuVision ICE Catheter is intended for | ||
| intracardiac and intra-luminal visualization | |||
| of cardiac and great vessel anatomy and | |||
| physiology as well as visualization of other | |||
| devices in the heart of adult and pediatric | |||
| patients. The catheter is intended for | |||
| imaging guidance only, not treatment | |||
| delivery, during cardiac interventional | |||
| percutaneous procedures. | The catheter is intended for intra-cardiac | ||
| and intra-luminal visualization of cardiac | |||
| and great vessel anatomy and physiology | |||
| as well as visualization of other devices in | |||
| the heart of adult and pediatric patients. | |||
| The catheter is intended for imaging | |||
| guidance only, not treatment delivery, | |||
| during cardiac interventional percutaneous | |||
| procedures. | Same as predicate device | ||
| Principles 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. | Same as predicate device | ||
| Outside Diameter | 10F | 10F | Same as predicate device |
| Component | Subject Device | ||
| NuVision ICE Catheter | Predicate Device | ||
| Siemens AcuNav™ (K071234) | Comments | ||
| Imaging energy | Ultrasound | Ultrasound | Same as predicate device |
| Transducer | |||
| configuration | Multi-element 2D phased array-on-ASIC | ||
| ultrasound transducer at distal tip. | Multi-element linear phased array | ||
| ultrasound transducer at distal tip. | Similar to predicate | ||
| device. Basic transducer | |||
| technology is the same. | |||
| The NuVision ICE | |||
| Catheter 2D array | |||
| supports 3D imaging. | |||
| Ultrasound imaging | |||
| frequency | 4-10 MHz | 4-10 MHz | Same as predicate device |
| Proximal end | |||
| configuration | Single connector, mechanical snap into | ||
| NuVision Connector Cable. | Single connector, mechanical snap into | ||
| SwiftLink adapter | Same as predicate device | ||
| Acoustic testing | As per IEC 60601-2-37 and equivalent | ||
| analysis to NEMA UD- 2 performance | As per IEC 60601-2-37 and equivalent | ||
| analysis to NEMA UD- 2 performance | Same as predicate device | ||
| Sterilization | Ethylene Oxide | Ethylene Oxide | Same as predicate device |
| Imaging Modes | B-Mode (2D and 3D) | ||
| M-Mode | |||
| Doppler Pulsed Wave Doppler | |||
| Continuous Wave Doppler | |||
| Color Doppler (2D and 3D) | |||
| Power Doppler | B-Mode (2D only) | ||
| M-Mode | |||
| Doppler Pulsed Wave Doppler | |||
| Continuous Wave Doppler | |||
| Color Doppler (2D only) | |||
| Power Doppler | Same as predicate device | ||
| Similar to predicate | |||
| device. The NuVision ICE | |||
| Catheter 2D array | |||
| supports 3D imaging. | |||
| Imaging | |||
| Configuration | Phased array limited to ~90-degree sector | ||
| emanating from the side of the catheter. | Phased array limited to ~90-degree sector | ||
| emanating from the side of the catheter. | Same as predicate device | ||
| Biocompatibility | ISO 10993, Externally Communicating | ||
| Device, Circulating Blood category | ISO 10993, Externally Communicating | ||
| Device, Circulating Blood category. | Same as predicate device | ||
| Insertable length | 90 cm | 90 cm | Same as predicate device |
| Catheter | |||
| construction | Coaxial shafts of biocompatible | ||
| thermopolymer over braided core | Single shaft of biocompatible | ||
| thermopolymer over braided core | Similar to predicate | ||
| device. The NuVision ICE | |||
| Catheter uses a dual shaft | |||
| design to allow | |||
| independent rotation of | |||
| the catheter tip | |||
| Component | Subject Device | Predicate Device | Comments |
| NuVision ICE Catheter | Siemens AcuNav™ (K071234) | ||
| Re-usability | Single use | Single use | Same as predicate device |
| Preparation | No preparation required. | No preparation required. | Same as predicate device |
| Directionality of | |||
| catheter tip | Integrates a tip deflection mechanism | ||
| using a deflection handle and pull-line to | |||
| provide integrated bidirectional deflection | |||
| of an inner shaft. Catheter tip is rotated | |||
| with outer shaft independent of deflection. | Integrates a tip deflection mechanism | ||
| using a deflection handle and pull-line to | |||
| provide integrated 4-way deflection of | |||
| catheter. | Similar to predicate | ||
| device. Both devices use | |||
| pull-lines to deflect the | |||
| catheter tip. NuVision ICE | |||
| Catheter allows | |||
| independent rotation of | |||
| the catheter tip. | |||
| Temperature | |||
| Sensor | Incorporates a thermistor within the probe | ||
| tip. The ultrasound system reads the | |||
| thermistor and adjusts power to assure the | |||
| probe never reaches temperature limit of | |||
| 43° C. | Ultrasound system energy delivery was | ||
| calibrated to assure probe never reaches | |||
| temperature limit of 43° C. | Similar to predicate | ||
| device. NuVision ICE | |||
| Catheter allows use of | |||
| real-time probe | |||
| temperature feedback to | |||
| make energy adjustments. |
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Image /page/6/Picture/0 description: The image contains the logo for NuVera Medical. The logo consists of a stylized, geometric shape in shades of orange and yellow, resembling folded or layered elements. To the right of the shape, the text "NuVera" is written in a clean, sans-serif font, with the word "MEDICAL" appearing below it in a smaller font size.
Traditional 510(k) Notification
NuVision™ ICE Catheter
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Image /page/7/Picture/0 description: The image contains the logo for Nuvera Medical. The logo consists of an abstract geometric shape in orange and yellow, followed by the company name "Nuvera" in a simple, sans-serif font. Below "Nuvera" is the word "Medical" in a smaller font size.
Traditional 510(k) Notification
NuVision™ ICE Catheter
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Image /page/8/Picture/1 description: The image shows the logo for Nuvera Medical. The logo consists of a geometric shape on the left and the company name on the right. The geometric shape is made up of two overlapping shapes, one orange and one yellow. The company name is written in black, with "Nuvera" on top and "Medical" below.
Testing completed:
The NuVision ICE Catheter was developed per the Guidance for Industry and FDA Staff, Marketing Clearance of Diagnostic Ultrasound Systems and Transducers (2019). Nonclinical data includes bench-top performance evaluations, packaging validation, biological safety, electromagnetic compatibility, and acoustic output testing. The devices used for testing were manufactured in accordance with the design specifications and approved manufacturing documentation.
Dimensional and Performance
The catheter dimensional characteristics were evaluated to verify conformance to design specifications and EN ISO 10555-1:2013: Sterile, single-use intravascular catheters - Part 1: General requirements. The physical integrity, functionality, and overall performance of the catheter were evaluated including:
- a) Visual and Dimensional Characteristics
- b) Simulated Use
- · Package opening and transfer to sterile field
- · Sterile sleeve loading
- c) Catheter Functional Performance
- · Reach
- · Deflection
- · Rotation
- · Radiopacity
- d) Electro-Acoustic Performance
- e) Durability
- · Multiple insertions
- · Rotation Cycling
- · Deflection Cycling
- · Tip Kinking and buckling
- · Leakage
- · Particulate generation
- · Tensile strength
Sterilization and Shelf Life
The NuVision ICE Catheter is sterilized via Ethylene Oxide gas using a cycle validated per ISO 11135-1:2014 to a Sterility Assurance Level (SAL) of 10°. Product samples were subjected to sterilization processing, distribution conditioning, and aging and then tested for compliance to the product specification. Packaging performance was evaluated to demonstrate that the packaging system preserves its integrity and that of the device through the lifecycle of the product in accordance with ISO 11607-1 and ISO 11607-2 and its applicable referenced standards.
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Image /page/9/Picture/0 description: The image contains the logo for NuVera Medical. The logo consists of an abstract geometric shape in orange and yellow on the left, followed by the text "NuVera" in a simple, sans-serif font. Below "NuVera" is the word "MEDICAL" in a smaller font size.
Biocompatibility
The NuVision ICE Catheter is made from materials that are used in commercially available medical devices, and commonly used in intravascular devices. The sterilized catheter was evaluated for biocompatibility in accordance with the EN ISO 10993 series standards.
Electromagnetic Compatibility and Electrical Safety
Acoustic Output was evaluated in accordance with FDA Guidance. Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers (June 2019) and EN 60601-2-37:2008: Medical electrical equipment — Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment (IEC 60601-2-37:2015).
Electrical and thermal safety testing was conducted in accordance with EN 60601-1:2006/ IEC 60601-1:2005/A1:2012: Medical electrical equipment — Part 1: General requirements for basic safety and essential performance and IEC 60601-2-37 Edition 2.1 2015: Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment.
Electromagnetic compatibility testing was evaluated, demonstrating compliance to IEC 60601-1-2 (4th Edition).
Conclusion:
The NuVision ICE Catheter and the predicate device have nearly identical intended use and very similar principles of operational and technological characteristics. The subject device and predicate device are both 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 tests, laboratory tests, electrical safety tests, and animal tests, it can be concluded that the NuVision ICE Catheter is safe and effective for the intended use, is as safe and effective as the predicate device, and is substantially equivalent to the cited predicate device.