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.

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).

AI/ML Overview

This FDA 510(k) summary for the NuVision ICE Catheter describes extensive non-clinical testing to demonstrate substantial equivalence to a predicate device. However, it explicitly states that no clinical performance data was included in the submission. Therefore, the device's performance in terms of clinical accuracy or diagnostic capability is not evaluated in this document through human reader studies or comparison to clinical ground truth.

Here's an analysis of the provided information concerning acceptance criteria and studies:

1. Table of Acceptance Criteria and Reported Device Performance

Because this submission relies on non-clinical testing for substantial equivalence, the "acceptance criteria" are primarily engineering and safety specifications, and "device performance" refers to its ability to meet those non-clinical specifications.

Acceptance Criteria (Category)	Specific Test/Standard	Reported Device Performance
Dimensional and Performance	Conformance to EN ISO 10555-1:2013	Evaluated for conformance to design specifications
	Visual and Dimensional Characteristics	Evaluated (Implied conformance)
	Simulated Use (Package opening, sterile field transfer, sleeve loading)	Evaluated (Implied functionality as intended)
	Catheter Functional Performance (Reach, Deflection, Rotation, Radiopacity)	Evaluated (Implied functionality as intended)
	Electro-Acoustic Performance	Evaluated (Implied functionality as intended)
	Durability (Multiple insertions, Rotation/Deflection Cycling, Tip Kinking/Buckling, Leakage, Particulate generation, Tensile strength)	Evaluated (Implied durability and integrity)
Sterilization and Shelf Life	ISO 11135-1:2014 (SAL of 10^-6^)	Sterilized via Ethylene Oxide, cycle validated to SAL 10^-6^
	Packaging performance (ISO 11607-1, ISO 11607-2)	Evaluated for integrity through product lifecycle
Biocompatibility	EN ISO 10993 series standards (Externally Communicating Device, Circulating Blood category)	Evaluated for biocompatibility
Electromagnetic Compatibility & Electrical Safety	FDA Guidance for Diagnostic Ultrasound Systems, EN 60601-2-37, IEC 60601-1, IEC 60601-2-37, IEC 60601-1-2 (4th Edition)	Evaluated for compliance to relevant standards and guidance
Temperature Sensor Functionality	Probe never reaches temperature limit of 43°C	Thermistor incorporated, ultrasound system adjusts power to assure limit is not reached

2. Sample size used for the test set and the data provenance

Test Set Sample Size: Not explicitly stated in terms of a specific number of devices. The document mentions "Product samples" were subjected to testing. This typically refers to a statistically significant number of units from production lots as required by quality systems for verification and validation, but the exact number isn't provided here.
Data Provenance: The data is from non-clinical bench-top evaluations, animal testing, packaging validation, biological safety, electrical safety, and acoustic output testing conducted by the manufacturer, NuVera Medical, Inc. Animal testing is mentioned across multiple instances (page 5, 9). The document does not provide details on the number or type of animals used, nor their country of origin.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Ground Truth Experts: Not applicable in the context of this submission. Since no clinical performance data was provided, no human experts (e.g., radiologists, cardiologists) were used to establish ground truth for a clinical test set. The validation relies on expert engineering and quality assurance personnel performing and verifying non-clinical tests according to established standards.

4. Adjudication method for the test set

Adjudication Method: Not applicable. There was no clinical test set requiring expert adjudication of results.

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

MRMC Study: No. This submission does not involve AI or a comparative effectiveness study with human readers. The device is an Intracardiac Echocardiography (ICE) Catheter, a hardware device for imaging, not an AI-powered diagnostic tool.

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

Standalone Performance: Not applicable. The device is a hardware imaging catheter, not an algorithm.

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

Type of Ground Truth: For the non-clinical tests, the "ground truth" refers to the established engineering specifications, performance standards (e.g., ISO, IEC, NEMA), and direct measurements/observations during bench testing and animal studies. For example, for durability, the "ground truth" would be the device enduring a certain number of cycles without failure, as per its design specifications. For biocompatibility, it's compliance with ISO 10993 standards.

8. The sample size for the training set

Training Set Sample Size: Not applicable. This is a hardware device submission, not a machine learning algorithm.

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

Training Set Ground Truth Establishment: Not applicable.

Summary

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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

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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

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Indications for Use

510(k) Number (if known) K201775

Device Name NuVision ICE Catheter

Indications for Use (Describe)

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)
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Prescription Use (Part 21 CFR 801 Subpart D)

__ Over-The-Counter Use (21 CFR 801 Subpart C)

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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:	K201775
Date Prepared:	June 26, 2020
Applicant Information:	NuVera Medical, Inc140 Knowles DriveLos Gatos, CA 95032Registration 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

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NuVision™ ICE Catheter

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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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
Clinicalperformance data	No clinical testing is included inthe submission. Determination ofsubstantial equivalence performance isbased on an assessment of non-clinicaldata.	No clinical testing is referenced inthe submission.	Same as predicate device
Non-clinicalperformance data	Non-clinical data includes bench-topevaluations, animal testing, packagingvalidation, biological safety, electricalsafety, acoustic output testing, and animaltesting.	Non-clinical data includes bench-topevaluations, animal testing, packagingvalidation, biological safety, electricalsafety, acoustic output testing, and animaltesting.	Same as predicate device
Intended use	The NuVision ICE Catheter is intended forintracardiac and intra-luminal visualizationof cardiac and great vessel anatomy andphysiology as well as visualization of otherdevices in the heart of adult and pediatricpatients. The catheter is intended forimaging guidance only, not treatmentdelivery, during cardiac interventionalpercutaneous procedures.	The catheter is intended for intra-cardiacand intra-luminal visualization of cardiacand great vessel anatomy and physiologyas well as visualization of other devices inthe heart of adult and pediatric patients.The catheter is intended for imagingguidance only, not treatment delivery,during cardiac interventional percutaneousprocedures.	Same as predicate device
Principles ofoperation	Generation of structural and physiologicalimages / representations / measurementsof cardiovascular anatomy using pulse-echo ultrasound systems.	Generation of structural and physiologicalimages / representations / measurementsof cardiovascular anatomy using pulse-echo ultrasound systems.	Same as predicate device
Outside Diameter	10F	10F	Same as predicate device
Component	Subject DeviceNuVision ICE Catheter	Predicate DeviceSiemens AcuNav™ (K071234)	Comments
Imaging energy	Ultrasound	Ultrasound	Same as predicate device
Transducerconfiguration	Multi-element 2D phased array-on-ASICultrasound transducer at distal tip.	Multi-element linear phased arrayultrasound transducer at distal tip.	Similar to predicatedevice. Basic transducertechnology is the same.The NuVision ICECatheter 2D arraysupports 3D imaging.
Ultrasound imagingfrequency	4-10 MHz	4-10 MHz	Same as predicate device
Proximal endconfiguration	Single connector, mechanical snap intoNuVision Connector Cable.	Single connector, mechanical snap intoSwiftLink adapter	Same as predicate device
Acoustic testing	As per IEC 60601-2-37 and equivalentanalysis to NEMA UD- 2 performance	As per IEC 60601-2-37 and equivalentanalysis 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-ModeDoppler Pulsed Wave DopplerContinuous Wave DopplerColor Doppler (2D and 3D)Power Doppler	B-Mode (2D only)M-ModeDoppler Pulsed Wave DopplerContinuous Wave DopplerColor Doppler (2D only)Power Doppler	Same as predicate deviceSimilar to predicatedevice. The NuVision ICECatheter 2D arraysupports 3D imaging.
ImagingConfiguration	Phased array limited to ~90-degree sectoremanating from the side of the catheter.	Phased array limited to ~90-degree sectoremanating from the side of the catheter.	Same as predicate device
Biocompatibility	ISO 10993, Externally CommunicatingDevice, Circulating Blood category	ISO 10993, Externally CommunicatingDevice, Circulating Blood category.	Same as predicate device
Insertable length	90 cm	90 cm	Same as predicate device
Catheterconstruction	Coaxial shafts of biocompatiblethermopolymer over braided core	Single shaft of biocompatiblethermopolymer over braided core	Similar to predicatedevice. The NuVision ICECatheter uses a dual shaftdesign to allowindependent rotation ofthe 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 ofcatheter tip	Integrates a tip deflection mechanismusing a deflection handle and pull-line toprovide integrated bidirectional deflectionof an inner shaft. Catheter tip is rotatedwith outer shaft independent of deflection.	Integrates a tip deflection mechanismusing a deflection handle and pull-line toprovide integrated 4-way deflection ofcatheter.	Similar to predicatedevice. Both devices usepull-lines to deflect thecatheter tip. NuVision ICECatheter allowsindependent rotation ofthe catheter tip.
TemperatureSensor	Incorporates a thermistor within the probetip. The ultrasound system reads thethermistor and adjusts power to assure theprobe never reaches temperature limit of43° C.	Ultrasound system energy delivery wascalibrated to assure probe never reachestemperature limit of 43° C.	Similar to predicatedevice. NuVision ICECatheter allows use ofreal-time probetemperature feedback tomake energy adjustments.

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Traditional 510(k) Notification

NuVision™ ICE Catheter

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Traditional 510(k) Notification

NuVision™ ICE Catheter

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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.

Regulation Number and Section

§ 870.1200 Diagnostic intravascular catheter.

(a)
Identification. An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.(b)
Classification. Class II (performance standards).