(28 days)
Not Found
No
The document describes a standard ultrasound catheter for imaging and navigation, with no mention of AI or ML in the intended use, device description, or performance studies.
No.
The device's intended use is explicitly stated as "imaging guidance only, not treatment delivery, during cardiac interventional percutaneous procedures." It is designed for visualization, not for providing therapy or treatment.
Yes
The device is intended for "intracardiac and intra-luminal visualization of cardiac and great vessel anatomy and physiology" and to "provide location information," which are all diagnostic purposes. While it is stated that it is "for imaging guidance only, not treatment delivery," imaging for visualization and location information falls under diagnostic use.
No
The device description clearly states it is a sterile, single-use ultrasound catheter with a physical transducer and other hardware components. It is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The NUVISION™ Ultrasound Catheter is an imaging device used for intracardiac and intra-luminal visualization. It provides real-time images of the heart and great vessels during procedures.
- Method of Use: The device is inserted directly into the body (intracardiac and intraluminal) to acquire images. It does not analyze samples taken from the body.
- Intended Use: The stated intended use is for "imaging guidance only, not treatment delivery." This reinforces its role as a visualization tool, not a diagnostic test performed on a sample.
Therefore, the NUVISION™ Ultrasound Catheter falls under the category of a medical imaging device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The NUVISION™ Ultrasound Catheter is 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 of adult and pediatric patients. The catheter is intended for imaging guidance only, not treatment delivery, during cardiac interventional percutaneous procedures.
The NUVISION™ NA V Utrasound 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 (comma separated list FDA assigned to the subject device)
OBJ
Device Description
The NUVISION™ Catheters are sterile, single use ultrasound catheters. They 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 patients. The catheters are intended for imaging guidance only, not treatment or therapy delivery, during cardiac interventional percutaneous procedures.
The NUVISION Ultrasound Catheter and NUVISION NAV Ultrasound Catheter are sterile, single-use, disposable intracardiac echo (ICE) ultrasound imaging catheters. 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. NUVISION Ultrasound Catheter is compatible with GE Vivid™ S70N and GE E95 Ultrasound System to enable 4D intra-cardiac imaging. While 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 and when coupled with a 3D location sensor enables location mapping in a compatible CARTO 3 System. The transducer array can be rotated independently of the deflection plane of the catheter shaft. The NUVISION NAV Ultrasound Catheter adds integration into the CARTO environment.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
cardiac and great vessel
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The NUVISION Ultrasound Catheter and NUVISION NAV Ultrasound Catheter are substantially equivalent to its currently cleared predicate devices based on the successful completion of nonclinical bench testing, as well as the technological comparison exhibiting similar principles of design, operation, and indications for use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 870.1200 Diagnostic intravascular catheter.
(a)
Identification. An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA text logo on the right. The text logo has the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
June 28, 2024
Biosense Webster, Inc. Sheba Chacko Senior Regulatory Affairs Program Lead 31 Technology Drive, Suite 200 Irvine, California 92618
Re: K241540
Trade/Device Name: NUVISION™ Utrasound Catheter; NUVISION™ NAV Ultrasound Catheter Regulation Number: 21 CFR 870.1200 Regulation Name: Diagnostic intravascular catheter Regulatory Class: Class II Product Code: OBJ Dated: May 30, 2024 Received: May 31, 2024
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 (the 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 available 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.
1
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,
Aneesh S. Deoras -S
Aneesh Deoras Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices
2
Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K241540
Device Name NUVISION™ Ultrasound Catheter NUVISION™ NAV Ultrasound Catheter
Indications for Use (Describe)
The NUVISION™ Ultrasound Catheter is 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 of adult and pediatric patients. The catheter is intended for imaging guidance only, not treatment delivery, during cardiac interventional percutaneous procedures.
The NUVISION™ NA V Utrasound 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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4
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 | May 30, 2024 |
|---|---|
| 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™ Ultrasound Catheter |
| 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 |
| Predicate device(s) | NuVision ICE Catheter [K201775] |
| NUVISION™ NAV Ultrasound Catheter [K2237661] |
1.1 Submitter | 21 CFR 807.92(a) (1)| and Device Information [21 CFR 807.92 (a) (2)|
1.2 Predicate Device Information [21 CFR 807.92(a) (3)|
| Predicate Device Information | |||
|---|---|---|---|
| Predicate Device Name | Manufacturer | 510(k) # | Decision Date |
| NuVision ICE Catheter | Biosense Webster, Inc | K201775 | 05 Mar 2021 |
| NUVISION™ NAV | |||
| Ultrasound Catheter | Biosense Webster, Inc | K223766 | 16 Feb 2023 |
1.3 Description of the Device Subject to Premarket Notification [21 CFR 807.92(a) (4)]
The NUVISION™ Catheters are sterile, single use ultrasound catheters. They 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 patients. The catheters are intended for imaging guidance only, not treatment or therapy delivery, during cardiac interventional percutaneous procedures.
5
Intended Use [21 CFR 807.92(a) (5)] 1.4
Intended Use for NUVISION Ultrasound Catheter: The NUVISION™ 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.
Indications for Use for NUVISION™ Ultrasound Catheter: The NUVISION™ Ultrasound Catheter is 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 of adult and pediatric patients. The catheter is intended for imaging guidance only, not treatment delivery, during cardiac interventional percutaneous procedures.
Intended Use for NUVISION NAV Ultrasound Catheter: 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.
Indications for Use for NUVISION™ NAV Ultrasound Catheter: 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 percutaneous procedures.
Summary of Substantial Equivalence [21 CFR 807.92 (a) (6)] 1.5
| Element of Comparison | Proposed/Subject Device | Predicate Device
[K201775] |
|-----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | NUVISION™ Ultrasound
Catheter | NuVision ICE Catheter |
| 510(k) | Subject Device | K201775 |
| Manufacturer | Biosense Webster, Inc. | Biosense Webster, Inc. |
| Regulation | 21 CFR 870.1200 | 21 CFR 870.1200 |
| Classification | Class II | Class II |
| Product code | OBJ | OBJ |
| Indications for Use | The NUVISION™ Ultrasound
Catheter is 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 of adult and
pediatric patients. The catheter is
intended for imaging guidance
only, not treatment delivery,
during cardiac interventional
percutaneous procedures. | The NUVISION™ Ultrasound
Catheter is 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 of adult and
pediatric patients. The catheter is
intended for imaging guidance
only, not treatment delivery,
during cardiac interventional
percutaneous procedures. |
NUVISION™ Ultrasound Catheter:
6
NUVISION™ Ultrasound Catheter NUVISION™ NAV Ultrasound Catheter
| Patient Population | Adult and Pediatric | Adult and Pediatric |
|---|---|---|
| Outside Diameter | 10F | 10 F |
| Imaging Modes | B-Mode (2D and 3D) | B-Mode (2D and 3D) |
| M-Mode | M-Mode | |
| Doppler Pulsed Wave Doppler | Doppler Pulsed Wave Doppler | |
| Continuous Wave Doppler | Continuous Wave Doppler | |
| Color Doppler (2D and 3D) | Color Doppler (2D and 3D) | |
| Power Doppler | Power Doppler | |
| Acoustic Array | Multi-element 2D phased array- | |
| on-ASIC ultrasound transducer at | on-ASIC ultrasound transducer at | |
| distal tip | distal tip | |
| Sterilization Method | EtO | EtO |
NUVISION NAV Ultrasound Catheter:
| Element of Comparison | Proposed/Subject Device | Predicate Device [K223766] |
|---|---|---|
| Device Name | NUVISION™ NAV Ultrasound Catheter | NUVISION™ NAV Ultrasound Catheter |
| 510(k) | Subject Device | K223766 |
| Manufacturer | Biosense Webster, Inc. | Biosense Webster, Inc. |
| Regulation | 21 CFR 870.1200 | 21 CFR 870.1200 |
| Classification | Class II | Class II |
| Product code | OBJ | OBJ |
| Indications for 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 percutaneous procedures. | The NUVISION™ NAV 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 |
| Patient Population | Adult | Adult |
| Outside Diameter | 10.5 F | 10 F |
| 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 | ||
| 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 |
| Sterilization Method | EtO | EtO |
7
NUVISION™ Ultrasound Catheter NUVISION™ NAV Ultrasound Catheter
1.6 Performance Testing: [21 CFR 807.92(b)(1)]
The NUVISION Ultrasound Catheter and NUVISION NAV Ultrasound Catheter are sterile, single-use, disposable intracardiac echo (ICE) ultrasound imaging catheters. 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. NUVISION Ultrasound Catheter is compatible with GE Vivid™ S70N and GE E95 Ultrasound System to enable 4D intra-cardiac imaging. While 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 and when coupled with a 3D location sensor enables location mapping in a compatible CARTO 3 System. The transducer array can be rotated independently of the deflection plane of the catheter shaft. The NUVISION NAV Ultrasound Catheter adds integration into the CARTO environment. Both catheters met all acceptance criteria in accordance with appropriate test criteria and standards.
1.7 Conclusion on Safety and Effectiveness [21 CFR 807.92(b) (3)|
The NUVISION Ultrasound Catheter and NUVISION NAV Ultrasound Catheter are substantially equivalent to its currently cleared predicate devices based on the successful completion of nonclinical bench testing, as well as the technological comparison exhibiting similar principles of design, operation, and indications for use.