(63 days)
No
The summary does not mention AI or ML, and the device description focuses on hardware components and basic imaging functionality.
No
Explanation: The device is explicitly stated to be "for imaging guidance only, not treatment delivery." This indicates its diagnostic rather than therapeutic purpose.
Yes
The device description explicitly states, "The NUVISION™ NAV Ultrasound Catheter is a 10F sterile, single-use, disposable diagnostic ultrasound imaging catheter designed for intracardiac use."
No
The device description clearly details a physical catheter with a transducer, ASIC, and mechanical components (knobs for deflection and rotation), indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "intra-cardiac and intraluminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart." This is a diagnostic imaging device used within the body to visualize structures.
- Device Description: The description details an "intracardiac use" ultrasound imaging catheter with a transducer for real-time imaging.
- Nature of IVDs: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to detect diseases, conditions, or infections. This device does not perform tests on samples; it provides real-time imaging of internal structures.
The device is a diagnostic imaging catheter used in vivo (within a living organism), not in vitro (in glass or outside the body).
N/A
Intended Use / Indications for Use
The NUVISION™ NA V Ultrasound Catheter and related accessory devices are indicated for intra-cardiac and intraluminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart. When used with the compatible CARTO™ 3 EP Navigation System, the catheter provides location information. The catheter is intended for imaging guidance only, not treatment delivery, during cardiac interventional percutaneous procedures.
Product codes
OBJ
Device Description
The NUVISION™ NAV Ultrasound Catheter is a 10F sterile, single-use, disposable diagnostic ultrasound imaging catheter designed for intracardiac use. The distal tip of the catheter contains a 4D ICE ultrasound transducer, comprised of a 2D acoustic element array and ASIC, for real-time 2D, 3D, and multiplane intracardiac imaging. It is coupled with a sensor providing real-time 3D location information to the compatible CARTO™ 3 EP Navigation System with ultrasound capability. Knobs on the catheter handle allow the user to deflect the catheter and rotate the transducer array independently of the deflection of the catheter shaft. The imaging field emanates from one side of the catheter tip, perpendicular to the catheter. The catheter may also be referred to as a probe in some instances. The catheter is validated for use only with the GE Vivid™ S70N Ultrasound System (K223832), and the CARTO™ 3 EP Navigation System with CARTOSOUND™ 4D (K223733). The NUVISION™ Connector Cable is used to connect the catheter to the GE Ultrasound System and the multipin SOUNDSTAR™ eco Cable is used to connect the catheter to the CARTO™ 3 System.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Intra-cardiac and intra-luminal visualization of cardiac and great vessel anatomy.
Indicated Patient Age Range
Adult
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
The NUVISION NA V Ultrasound Catheter underwent bench, and biocompatibility testing to demonstrate substantial equivalence. Testing included mechanical integrity, deflection, device functionality, simulated use, biocompatibility, electrical properties, visualization, packaging, shelf life, device maneuverability and signal quality, and animal testing to assess device effectiveness and safety. The catheter passed all intended criteria in accordance with appropriate test criteria and standards.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
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).
0
Image /page/0/Picture/0 description: The image contains 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, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
February 16, 2023
Biosense Webster, Inc. Sheba Chacko Senior Regulatory Affairs Program Lead 31 Technology Drive, Suite 200 Irvine, California 90618
Re: K223766
Trade/Device Name: NUVISION™ NAV Ultrasound Catheter Regulation Number: 21 CFR 870.1200 Regulation Name: Diagnostic Intravascular Catheter Regulatory Class: Class II Product Code: OBJ Dated: December 13, 2022 Received: December 15, 2022
Dear Sheba Chacko:
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
1
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 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 (QS) 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 medical devices and radiation-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,
Aneesh S. Deoras -S
Aneesh Deoras Assistant 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) K223766
Device Name NUVISION™ NAV Ultrasound Catheter
Indications for Use (Describe)
The NUVISION™ NA V Ultrasound Catheter and related accessory devices are indicated for intra-cardiac and intraluminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart. When used with the compatible CARTO™ 3 EP Navigation System, the catheter provides location information. 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) | |
|---|---|
| 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
This 510(k) Summary is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92
| Date Summary Prepared | 15 February 2023 |
|---|---|
| Applicant | Biosense Webster, Inc. |
| 31 Technology Drive, Suite 200 | |
| Irvine, CA 92618 | |
| Establishment Registration Number: 9044811 | |
| Official Correspondent | Sheba Chacko |
| Senior Regulatory Affairs Program Lead | |
| Telephone: (949) 450-6058 | |
| Fax: (949) 450-6886 | |
| Trade Name | NUVISION™ NAV Ultrasound Catheter |
| Common Name | Intracardiac Echocardiography Catheter |
| Classification Name | Diagnostic Intravascular Catheters |
| Device Classification | Class II, 21 CFR 870.1200 |
| FDA Product Code | OBJ |
| Classification Panel | Cardiovascular |
1. Submitter [ 21 CFR 807.92(a) (1)] and Device Information [21 CFR 807.92 (a) (2)]
Table 1:Submitter and Device Information
2. Predicate Device and Reference Device Information [21 CFR 807.92(a) (3)]
| Predicate Device Information | |||
|---|---|---|---|
| Predicate Device Name | Manufacturer | 510(k) # | Decision Date |
| NUVISION ICE | |||
| Catheter, 10F | NuVera Medical, Inc. | K201775 | March 5, 2021 |
| Reference Device Information | |||
| SoundStar eco | |||
| 10F Ultrasound | |||
| Catheter | Biosense Webster, Inc. | K112050 | Nov 11, 2011 |
Table 2: Predicate and Reference Device Information
3. Description of the Device Subject to Premarket Notification [21 CFR 807.92(a) (4)]
The NUVISION™ NAV Ultrasound Catheter is a 10F sterile, single-use, disposable diagnostic ultrasound imaging catheter designed for intracardiac use. The distal tip of the catheter contains a 4D ICE ultrasound transducer, comprised of a 2D acoustic element array and ASIC, for real-time 2D, 3D, and multiplane intracardiac imaging. It is coupled with a sensor providing real-time 3D location information to the compatible CARTO™ 3 EP Navigation System with ultrasound capability. Knobs on the catheter handle allow the user to deflect the catheter and rotate the
4
transducer array independently of the deflection of the catheter shaft. The imaging field emanates from one side of the catheter tip, perpendicular to the catheter. The catheter may also be referred to as a probe in some instances.
The catheter is validated for use only with the GE Vivid™ S70N Ultrasound System (K223832), and the CARTO™ 3 EP Navigation System with CARTOSOUND™ 4D (K223733). The NUVISION™ Connector Cable is used to connect the catheter to the GE Ultrasound System and the multipin SOUNDSTAR™ eco Cable is used to connect the catheter to the CARTO™ 3 System.
4. Intended Use [21 CFR 807.92(a) (5)]
The NUVISION™ NAV Ultrasound 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.
4.1 Indications for Use:
The NUVISION™ NAV Ultrasound Catheter and related accessory devices are indicated for intracardiac and intra-luminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart. When used with the compatible CARTO™ 3 EP Navigation System, the catheter provides location information. The catheter is intended for imaging guidance only, not treatment delivery, during cardiac interventional percutaneous procedures.
| Description | NUVISION
NAV
Ultrasound
Catheter
(Subject
Device) | NUVISION ICE
Catheter (Predicate
Device) K201775 | SOUNDSTAR eco 10F/10FG
Ultrasound Catheter
(Reference Device)
K112050 |
|--------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Classification | Class II | Class II | Class II |
| Regulation | 21 CFR 870.1200 | 21 CFR 870.1200 | 21 CFR 870.1200 |
| Product code | OBJ | OBJ | OBJ |
| Indications of Use | The NUVISION NAV
Ultrasound Catheter and
related accessory devices
are indicated 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. When
used with the compatible
CARTO™ 3 EP Navigation
System, the catheter
provides location
information. The catheter is
intended for imaging
guidance only, not
treatment delivery, during
cardiac interventional | 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 Biosense Webster
SOUNDSTAR® eco Diagnostic
Ultrasound Catheter and related
accessory devices are indicated
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. When used with
compatible CARTO® 3 EP
Navigation Systems, the
SOUNDSTAR® eco Catheter
provides location information. |
5. Summary of Substantial Equivalence [21 CFR 807.92 (a) (6)]
5
| Description | NUVISION
NAV
Ultrasound
Catheter
(Subject | NUVISION ICE
Catheter (Predicate
Device) K201775 | SOUNDSTAR eco 10F/10FG
Ultrasound Catheter
(Reference Device)
K112050 |
|------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------|
| | Device) | | |
| | percutaneous procedures. | | |
| Patient
Population | Adult | Adult and Pediatric | Adult |
| Single Use | Yes | Yes | Yes |
| Sterilization
Method | Ethylene Oxide | Ethylene Oxide | Ethylene Oxide |
| Outside Diameter | 10F | 10F | 10F |
| Insertable length | 90cm | 90cm | 90cm |
| Acoustic Array | Multi-element 2D
phased array-on-ASIC
ultrasound
transducer at distal tip | Multi-element 2D phased
array-on-ASIC ultrasound
transducer at distal tip | Multi-element linear phased
array ultrasound transducer at
distal tip. |
| Ultrasound
Imaging
Frequency | 4-10 MHz | 4-10 MHz | 4-10 MHz |
| 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 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 |
| Biocompatibility | ISO 10993, Externally
Communicating Device,
Circulating Blood category | ISO 10993, Externally
Communicating Device,
Circulating Blood category | ISO 10993, Externally
Communicating Device, Circulating
Blood category |
Table 3: Substantial Equivalence Table
6. Performance Testing: [21 CFR 807.92(b)(1)]
6.1 Technical Characteristics:
The NUVISION NA V Ultrasound Catheter is a sterile, single-use, disposable intracardiac echo (ICE) ultrasound imaging catheter. It is built around the core design and technology of the existing NUVISION ICE Catheter (predicate device), 10 Fr. The distal end of the catheter has an ultrasound transducer with 2D acoustic element array on ASIC enabling real time 2D, 3D, and multiplane imaging. The NUVISION NAV Ultrasound Catheter's grid transducer combines the processing power of the GE Vivid™ S70N Ultrasound System to enable 4D intra-cardiac imaging. Additionally, it is also coupled with a 3D location sensor enabling location mapping in a compatible CARTO 3 System. The transducer array can be rotated independently of the deflection plane of the catheter shaft. The new catheter will integrate the handling, mechanical performance, and imaging capability of the NUVISION catheter and add integration into the CARTO environment.
6
6.2 Performance Data:
The NUVISION NA V Ultrasound Catheter underwent bench, and biocompatibility testing to demonstrate substantial equivalence. Testing included mechanical integrity, deflection, device functionality, simulated use, biocompatibility, electrical properties, visualization, packaging, shelf life, device maneuverability and signal quality, and animal testing to assess device effectiveness and safety. The catheter passed all intended criteria in accordance with appropriate test criteria and standards.
7. Conclusion on Safety and Effectiveness [21 CFR 807.92(b) (3)]
The NUVISION NAV Ultrasound Catheter is substantially equivalent to the currently marketed NUVISION ICE Catheter (K201775) and SOUNDSTAR eco 10F/10FG Ultrasound Catheter (K112050) devices based on the successful completion of nonclinical bench testing and pre- clinical studies, as well as the technological comparison exhibiting similar principles of design, operation, and indications for use.