SOUNDSTAR 3D ULTRASOUND CATHETER, MODEL M-5723-05

K070242 · Biosense Webster, Inc. · OBJ · May 15, 2007 · Cardiovascular

Device Facts

Record IDK070242
Device NameSOUNDSTAR 3D ULTRASOUND CATHETER, MODEL M-5723-05
ApplicantBiosense Webster, Inc.
Product CodeOBJ · Cardiovascular
Decision DateMay 15, 2007
DecisionSESE
Submission TypeTraditional
Regulation21 CFR 870.1200
Device ClassClass 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.

Device Story

10F, 90cm IntraCardiac Echo (ICE) catheter; features acoustic array and location sensor in tip. Connects to ultrasound system (Sequoia/Cypress) for 2D ultrasound imaging and CARTO XP EP Navigation System for location tracking. Bifurcated cable design allows simultaneous connection to both systems. Used by physicians in clinical settings for real-time integration of ultrasound images with electro-anatomical maps. Enables visualization of cardiac anatomy, physiology, and other catheters/devices within the heart. Benefits include improved navigation and anatomical visualization during electrophysiology procedures.

Clinical Evidence

No human clinical data. Evidence consists of extensive bench testing (electrical and functional) and simulated use conditions in animal models. Testing confirmed the device meets performance criteria for visualization and location tracking, demonstrating equivalence to predicate devices.

Technological Characteristics

10F, 90cm catheter; acoustic array identical to AcuNav 10F; integrated electromagnetic location sensor. Connects to external ultrasound systems via SwiftLink cable and CARTO navigation system via Hypertronic connector. Operates as an accessory to existing ultrasound and electro-anatomical mapping systems.

Indications for Use

Indicated for intra-cardiac and intra-luminal visualization of cardiac and great vessel anatomy and physiology, and visualization of other devices in the heart, in patients undergoing cardiac procedures.

Regulatory Classification

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.

Predicate Devices

Reference Devices

Related Devices

Submission Summary (Full Text)

{0}------------------------------------------------ SoundStar 3D Ultrasound Catheter Traditional 510(k) K070242 Pg 1 of 4 # 5 510(K) SUMMARY | Applicant: | Biosense Webster, Inc.<br>3333 Diamond Canyon Rd.<br>Diamond Bar, CA 91765<br>USA<br>Phone: +1-800-729-7272<br>Fax: +1-909-839-8804 | MAY 15 2007 | | | | | | |--------------------------|-------------------------------------------------------------------------------------------------------------------------------------|-------------|--|--|--|--|--| | Date: | January 24, 2007 | | | | | | | | Contact Person: | Melissa Crisostomo<br>Specialist, Regulatory Affairs | | | | | | | | Proprietary Device Name: | SOUNDSTARTM 3D Ultrasound Catheter | | | | | | | | Common Device Name: | Electrophysiologic Mapping/Ultrasound Catheter,<br>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<br>Catheter 510(k) K033650 | | | | | Biosense Webster NAVISTAR® Diagnostic catheter<br>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
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