(95 days)
No
The document describes a standard ultrasound catheter and navigation system without mentioning any AI or ML capabilities for image processing, analysis, or navigation.
No
The device is described as an ultrasound catheter used for visualization and providing location information, not for delivering therapy.
Yes
Explanation: The device is described as an "IntraCardiac Echo (ICE) Catheter" that acquires "real time ultrasound images" to visualize "cardiac and great vessel anatomy and physiology" and other devices in the heart. It also provides "location information" for mapping. These functions are inherently diagnostic as they provide information about the state and location of anatomical structures and other devices within the heart. Furthermore, one of its predicate devices is explicitly named the "ACUSON AcuNav™ 10F Diagnostic Ultrasound Catheter".
No
The device is a physical catheter with embedded hardware (location sensor and ultrasound transducer) and connects to external hardware systems (ultrasound systems and navigation system). While it utilizes software within these systems, the device itself is a hardware component.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples taken from the human body (like blood, urine, tissue). The SOUNDSTAR™ 3D Ultrasound Catheter is used within the body to visualize anatomy and other devices in real-time using ultrasound.
- The intended use is visualization and navigation. The device is used for "intra-cardiac and intra-luminal visualization" and "visualization of other devices in the heart." It also provides "location information" for navigation. These are all in-vivo (within the living body) functions.
- The device description confirms it's an imaging catheter. It's described as an "IntraCardiac Echo (ICE) Catheter" with an "ultrasound transducer" to acquire "real time ultrasound images."
Therefore, the SOUNDSTAR™ 3D Ultrasound Catheter is an in-vivo diagnostic imaging and navigation device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Biosense Webster SOUNDSTAR™ 3D 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 CARTO® XP EP Navigation System Version 9 or greater, the SOUNDSTAR" 3D Ultrasound Catheter provides location information.
Product codes (comma separated list FDA assigned to the subject device)
DRF, DQO, ITX
Device Description
The Biosense Webster SOUNDSTAR" 3D Ultrasound Catheter is a 90 cm 10F IntraCardiac Echo (ICE) Catheter with an acoustic array identical to the ACUSON AcuNav 10F Diagnostic Ultrasound Catheter. The catheter has a location sensor (providing location information to the CARTO® EP XP Navigation System Version 9 - 510(k) submitted separately) and an ultrasound transducer (acquiring real time ultrasound images) embedded in the tip.
The SOUNDSTAR™ 3D Ultrasound Catheter has a bifurcated 'tail' originating from its handle (see Figure 1). One leg terminates in the SOUNDSTAR tab connector, which connects via a Swiftlink™ cable to an ultrasound system (ACUSON) Sequoia " Ultrasound System of the and 510(k) K052331 respectively). The other leg terminates in the CARTO Hypertronic connector, which connects via a Patient Interface Unit (PIU) extension cable to the CARTO® XP EP Navigation System Version 9 (510(k) submitted bundled with the SOUNDSTAR 31) Ultrasound Catheter submission).
The Sequoia and Cypress Ultrasound Systems were designed to acquire two dimensional (2D) ultrasound (U/S) images and display them. The SOUNDSTAR" 3D Ultrasound Catheter connects to either of these ultrasound systems via the appropriate SwiftLink connector cable. The U/S images are Vector" images for wide angle viewing of the heart anatomy. These systems are used to image the anatomy of the heart and also visualize blood flow through Doppler imaging. They are also used to visualize other catheters and devices in the heart.
The imaging software in the Sequoia and Cypress U/S systems that currently drives AcuNav Catheters will be the same software that drives the SOUNDSTAR" 3D Ultrasound Catheter.
The acoustic array used in the SOUNDSTAR™ 3D Ultrasound Catheter is identical to the acoustic array currently used in the AcuNav Catheter.
The CARTO® XP EP Navigation System Version 9 is designed to acquire. analyze, and display electro-anatomical maps of the human heart. The maps are reconstructed using the combination of information gathered from the integration of intracardiac electrograms with their respective endocardial locations. Maps may be displayed as electrical activation maps, electrical propagation maps, electrical potential maps, impedance maps and chamber geometry maps. The acquired patient signals, including body surface ECG and intracardiac electrograms may also be displayed in real-time on the display screen.
The SOUNDSTAR™ 3D Ultrasound Catheter is compatible with the CARTO® XP EP Navigation System Version 9, (Version 8 cleared under 510(k) K042999).
The SOUNDSTAR™ 3D Ultrasound Catheter, when connected to the CARTO® XP EP Navigation System Version 9, and the Sequoia or the Cypress Ultrasound Systems, will provide real-time integration of ultrasound images with CARTO electromagnetic acquired maps.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Intra-cardiac and intra-luminal, cardiac and great vessel anatomy
Indicated Patient Age Range
Not Found
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 SOUNDSTAR 3D Ultrasound Catheter underwent extensive bench and electrical testing. The catheter passed all intended criteria in accordance with appropriate acceptance criteria and standards.
The non-clinical studies demonstrate that the SOUNDSTAR™ 3D Ultrasound Catheter is safe and effective for:
- . Intra-cardiac and intra-luminal visualization of cardiac and great vessel anatomy and physiology.
- . Visualization of other devices in the heart.
- Acquisition of location information for CARTO mapping.
The SOUNDSTAR™ 3D Ultrasound Catheter was also tested under simulated use conditions in animals.
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.
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
SoundStar 3D Ultrasound Catheter Traditional 510(k)
K070242
Pg 1 of 4
5 510(K) SUMMARY
| Applicant: | Biosense Webster, Inc.
3333 Diamond Canyon Rd.
Diamond Bar, CA 91765
USA
Phone: +1-800-729-7272
Fax: +1-909-839-8804 | MAY 15 2007 | | | | | |
|--------------------------|-------------------------------------------------------------------------------------------------------------------------------------|-------------|--|--|--|--|--|
| Date: | January 24, 2007 | | | | | | |
| Contact Person: | Melissa Crisostomo
Specialist, Regulatory Affairs | | | | | | |
| Proprietary Device Name: | SOUNDSTARTM 3D Ultrasound Catheter | | | | | | |
| Common Device Name: | Electrophysiologic Mapping/Ultrasound Catheter,
Class II Device | | | | | | |
| Classification Name: | Classification Name CFR# Product Code Electrode Recording Catheter 21 CFR 870.1220 DRF | | | | | | |
| Electrode Recording Catheter | 21 CFR 870.1220 | DRF | |
|---|---|---|---|
| Diagnostic Intravascular Catheter | 21 CFR 870.1200 | DQO | |
| Diagnostic Ultrasound Catheter | 21 CFR892.1570 | ITX | |
| Predicate Devices: | ACUSON AcuNav™ 10F Diagnostic Ultrasound | ||
| Catheter 510(k) K033650 | |||
| Biosense Webster NAVISTAR® Diagnostic catheter | |||
| 510(k) K954390 | |||
| Manufacturer: | Biosense Webster, Inc. | ||
| 3333 Diamond Canyon Road | |||
| Diamond Bar, CA 91765 |
Biosense Webster, Inc
1
K070242
pg 2 of 4
ਦੇ. 1 Substantially Equivalent To
Biosense Webster SOUNDSTAR™ The 3D Ultrasound Catheter is substantially equivalent to a combination of the ACUSON AcuNav 10F Diagnostic Ultrasound Catheter 510(k) K033650, cleared February 24, 2004 for whole heart for Sequoia, Aspen and Cypress Ultrasound Systems and the Biosense Webster NAVISTAR® Diagnostic catheter 510(k) K954390, cleared December 21, 1995.
5.2 Intended Use
The Biosense Webster SOUNDSTAR™ 3D 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 CARTO® XP EP Navigation System Version 9 or greater, the SOUNDSTAR" 3D Ultrasound Catheter provides location information.
ર્સ્ડે General Device Description
The Biosense Webster SOUNDSTAR" 3D Ultrasound Catheter is a 90 cm 10F IntraCardiac Echo (ICE) Catheter with an acoustic array identical to the ACUSON AcuNav 10F Diagnostic Ultrasound Catheter. The catheter has a location sensor (providing location information to the CARTO® EP XP Navigation System Version 9 - 510(k) submitted separately) and an ultrasound transducer (acquiring real time ultrasound images) embedded in the tip.
The SOUNDSTAR™ 3D Ultrasound Catheter has a bifurcated 'tail' originating from its handle (see Figure 1). One leg terminates in the SOUNDSTAR tab connector, which connects via a Swiftlink™ cable to an ultrasound system (ACUSON) Sequoia " Ultrasound System of the and 510(k) K052331 respectively). The other leg terminates in the CARTO Hypertronic connector, which connects via a Patient Interface Unit (PIU) extension cable to the CARTO® XP EP Navigation System Version 9 (510(k) submitted bundled with the SOUNDSTAR 31) Ultrasound Catheter submission).
Image /page/1/Figure/9 description: The image shows a medical device that connects to both the CARTO system and the Ultrasound system. The device is long and thin, with a pointed tip on one end. The text labels indicate the device's compatibility with the CARTO and Ultrasound systems, suggesting its use in medical imaging or navigation procedures. The device appears to be designed for precise and targeted applications within the body.
Figure 1: SOUNDSTAR 3D™ Handle with bifurcated connectors
The Sequoia and Cypress Ultrasound Systems were designed to acquire two dimensional (2D) ultrasound (U/S) images and display them. The SOUNDSTAR" 3D Ultrasound Catheter connects to either of these
Biosense Webster, Inc
Page 19 of 761
2
K070242
pg 3 of 4
ultrasound systems via the appropriate SwiftLink connector cable. The U/S images are Vector" images for wide angle viewing of the heart anatomy. These systems are used to image the anatomy of the heart and also visualize blood flow through Doppler imaging. They are also used to visualize other catheters and devices in the heart.
The imaging software in the Sequoia and Cypress U/S systems that currently drives AcuNav Catheters will be the same software that drives the SOUNDSTAR" 3D Ultrasound Catheter.
The acoustic array used in the SOUNDSTAR™ 3D Ultrasound Catheter is identical to the acoustic array currently used in the AcuNav Catheter.
The CARTO® XP EP Navigation System Version 9 is designed to acquire. analyze, and display electro-anatomical maps of the human heart. The maps are reconstructed using the combination of information gathered from the integration of intracardiac electrograms with their respective endocardial locations. Maps may be displayed as electrical activation maps, electrical propagation maps, electrical potential maps, impedance maps and chamber geometry maps. The acquired patient signals, including body surface ECG and intracardiac electrograms may also be displayed in real-time on the display screen.
The SOUNDSTAR™ 3D Ultrasound Catheter is compatible with the CARTO® XP EP Navigation System Version 9, (Version 8 cleared under 510(k) K042999).
The SOUNDSTAR™ 3D Ultrasound Catheter, when connected to the CARTO® XP EP Navigation System Version 9, and the Sequoia or the Cypress Ultrasound Systems, will provide real-time integration of ultrasound images with CARTO electromagnetic acquired maps.
For a complete description of the Sequoia Ultrasound System, the Cypress Ultrasound System, or the CARTO® XP EP Navigation System Version 8, please refer to cleared 510(k) submissions, 510(k) K052410, 510(k) K052331 and 510(k) K042999 respectively.
5.4 Performance Data and Conclusion
The SOUNDSTAR 3D Ultrasound Catheter underwent extensive bench and electrical testing. The catheter passed all intended criteria in accordance with appropriate acceptance criteria and standards.
The non-clinical studies demonstrate that the SOUNDSTAR™ 3D Ultrasound Catheter is safe and effective for:
- . Intra-cardiac and intra-luminal visualization of cardiac and great vessel anatomy and physiology.
- . Visualization of other devices in the heart.
- Acquisition of location information for CARTO mapping.
Biosense Webster, Inc
Page 20 of 761
3
SoundStar 3D Ultrasound Catheter Traditional 510(k)
K070242
pg 4 of 4
The SOUNDSTAR™ 3D Ultrasound Catheter was also tested under simulated use conditions in animals.
The studies establish equivalence of the SOUNDSTAR™ 3D Ultrasound Catheter to the predicate devices, the NAVISTAR Diagnostic catheter and the AcuNav 10F Ultrasound Catheter.
Biosense Webster, Inc
Page 21 of 761
4
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 1 5 2007
Biosense Webster c/o Neelu Medhekar Manager, Regulatory Affairs 3333 Diamond Canyon Rd. Diamond Bar, CA 91765
Re: K070242
Trade/Device Name: SoundStar 3D Ultrasound Catheter Regulation Number: 21 CFR 870.1200 Regulation Name: Diagnostic intravascular catheter Regulatory Class: Class II Product Code: OBJ Dated: April 6, 2007 Received: April 9, 2007
Dear Ms. Medhekar:
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, Or ve and Cosmetic Act (Act) that do not require approval of a premarket approval application (DMA), You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, insting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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, CDA may publish further announcements concerning your device in the Federal Register.
5
Page 2 - Ms. Medhekar
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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Bzimmina for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
INDICATIONS FOR USE STATEMENT 4
510(k) No (if known): KO70242
Device Name: SOUNDSTAR™ 3D ULTRASOUND CATHETER
Indications for Use:
The Biosense Webster SOUNDSTAR™ 3D Ultrasound Catheter and related accessory devices are indicated for intra-cardiac and intra-luminal visualization of cardiao and great vessel anatomy and physiology as well as visualization of other devices and the SOUNDSTAR™ 3D Ultrasound Catheter provides location information .
Prescription Use X Over-The-Counter Use - AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Blummunon
(Division Sign-Off) Division of Cardiovaşcular Devis 510(k) Number
Page 1_ of 1
Biosense Webster, Inc