The Biosense Webster SOUNDSTAR 3D 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 the CARTO XP EP Navigation System, Version 9.7 or greater, the SOUNDSTAR 3D Catheter provides location information.

Device Description

The modified Biosense Webster SOUNDSTAR Catheter is a 90 cm 10F IntraCardiac Echo (ICE) Catheter with an acoustic array identical to the currently cleared Biosense Webster SOUNDSTAR Catheter and the ACUSON ACUNAV 10F Diagnostic Ultrasound Catheter. The modified SOUNDSTAR Catheter has a location sensor (providing location information to CARTO XP EP Navigation System, Version 9.7 or greater) and an ultrasound transducer (acquiring real time ultrasound images) embedded in the tip. The modified SOUNDSTAR Catheter has a bifurcated 'tail' originating from its handle. One leg terminates in the SOUNDSTAR Flex Tab connector, which connects via a SwiftLink cable to the GE Vivid-i or Vivid-q Ultrasound System. The other leg terminates in the CARTO Hypertronic connector, which connects via a Patient Interface Unit (PIU) extension cable to the CARTO Navigation System. The modified SOUNDSTAR Catheter, when connected to the CARTO XP EP Navigation System, Version 9.7 or greater, and the GE Vivid-i or Vivid-q Ultrasound Systems, will provide real-time integration of ultrasound images with CARTO electromagnetic acquired maps.

AI/ML Overview

This document is a Special 510(k) Premarket Notification for the SoundStar 3D Ultrasound Catheter, specifically for its use with GE Vivid-i/q Ultrasound Systems. The primary purpose of this submission is to demonstrate substantial equivalence to previously cleared devices the SoundStar 3D Ultrasound Catheter (K070242) and the ACUSON ACUNAV 10F Diagnostic Ultrasound Catheter (K071234), following modifications that primarily involve software compatibility and labeling changes.

Summary of Acceptance Criteria and Device Performance:

The provided document describes modifications to an existing device rather than a new device requiring extensive performance testing against novel acceptance criteria. The acceptance criteria in this context relate to ensuring the modified device maintains its established performance and is compatible with the new ultrasound systems.

Acceptance Criteria	Reported Device Performance
Compatibility with GE Vivid-i and Vivid-q Ultrasound Systems: The modified catheter must function effectively when connected to the GE Vivid-i and Vivid-q Ultrasound Systems and the CARTO XP EP Navigation System (Version 9.7 or greater), providing real-time integration of ultrasound images with CARTO electromagnetic acquired maps.	"Testing for compatibility with the GE Vivid-i and Vivid-q Ultrasound Systems in conjunction with the CARTO XP EP Navigation System Version 9.7 was conducted and all tests met the pre-determined specifications for the SOUNDSTAR Catheter, GE Vivid-i and Vivid-q Ultrasound Systems, and the CARTO System." (Pg. 3)
Maintenance of Original Device Performance: The modified catheter's physical design, materials, manufacturing methods, and fundamental performance (acoustic array, distal tip, shaft, etc.) must remain identical to the currently cleared SOUNDSTAR Catheter.	"The modified SOUNDSTAR Catheter is physically identical to the currently cleared SOUNDSTAR Catheter in terms of design, manufacturing methods, materials and performance." (Pg. 2) "All testing previously submitted for the currently cleared SOUNDSTAR Catheter still applies to the modified device as there were no changes to the design, materials, manufacturing methods or performance of the device." (Pg. 3)
Substantial Equivalence: The modified device must be substantially equivalent to the predicate devices (SOUNDSTAR 3D Ultrasound Catheter (K070242) and ACUSON ACUNAV 10F Diagnostic Ultrasound Catheter (K071234)) in terms of intended use, operating principle, technology, design, materials, and other critical characteristics.	The document explicitly states: "The modified SOUNDSTAR Catheter is identical to the currently cleared SOUNDSTAR Catheter in that both of the devices: have the same intended use, use the same operating principle, use the same fundamental scientific technology, incorporate the same design, incorporate the same materials and construction, have the same shelf life, are packaged using the same materials and processes, have the identical Hypertronic connector, use the identical interface cable for connection to CARTO, have the same 64-channel acoustic phased array, have the same acoustic array location and connection, have the same distal tip material and deflection mechanism, have the same shaft material, are radiopaque, are EtO sterilized, are single use devices." (Pg. 3-4)Similar equivalencies are drawn with the ACUNAV predicate device for GE Ultrasound System compatibility components. (Pg. 4)

Detailed Study Information:

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- The document does not specify a sample size for a test set in the traditional sense of a clinical or analytical performance study with patient data. The testing performed was primarily non-clinical compatibility testing.
- The provenance of any data (e.g., country of origin, retrospective/prospective) is not mentioned because the testing described appears to be bench/engineering testing rather than human subject or animal study data.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- This information is not applicable to the type of testing described in this 510(k) submission. The "ground truth" for compatibility testing would be the pre-determined specifications and functional requirements of the interconnected systems, as evaluated by engineers and technical personnel rather than clinical experts establishing a ground truth for diagnostic accuracy.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- This information is not applicable. Adjudication methods are typically used in clinical studies where expert consensus is needed to resolve discrepancies in diagnoses or interpretations. The testing here focuses on technical compatibility and functional verification.
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:
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This submission is for an ultrasound catheter and its compatibility with new imaging systems, not for an AI-assisted diagnostic tool. Therefore, the effect size of human readers improving with or without AI assistance is irrelevant and not reported.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No, a standalone algorithm performance study was not done. This device is a medical instrument (ultrasound catheter) and its associated system, which inherently involves human operation and interpretation. It is not an AI algorithm meant to function independently.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for the non-clinical tests conducted was the pre-determined specifications and functional requirements for the SOUNDSTAR Catheter itself, the GE Vivid-i and Vivid-q Ultrasound Systems, and the CARTO System. The goal was to confirm that the modified device, when integrated, met these established technical and performance requirements.
The sample size for the training set:
- The document does not mention a training set. This is a 510(k) for a hardware device modification, not a machine learning or AI algorithm development. Therefore, the concept of a training set is not applicable.
How the ground truth for the training set was established:
- As there is no mention of a training set, the establishment of ground truth for such a set is not applicable or discussed in this submission.

Summary

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Special 510(k) Premarket Notification for SoundStar 3D Ultrasound Catheter For Use with GE Vivid-i/q Ultrasound Systems

K092064
Pg 1 of 4

AUG 0 7 2009

15 510(k) Summary

15.1 SPONSOR'S NAME & ADDRESS Biosense Webster, Inc. 3333 Diamond Canyon Road Diamond Bar, CA 91765
Official Correspondent 15.2 Melissa C. Schultz Senior Specialist, Regulatory Affairs Phone: 909-839-8787 Fax: 909-839-8804 Email: MSchult1(@its.jnj.com

15.3WALL CONSULT AND AND IN THE THE LE THE LE STATE LT . THE TT . T	SUBMISSION DATENo. of Children and Concession in the Concession of Children
	July 7, 2009

15.4	TRADE NAME
	SOUNDSTAR 3D Ultrasound Catheter

15.5 COMMON NAME
Electrophysiology Mapping/Ultrasound Catheter

CLASSIFICATION NAME/PRODUCT CODE 15.6 Intravascular Ultrasound Catheter/OBJ .

15.7 CLASSIFICATION
Class II

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K092067
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15.8 PREDICATE DEVICE

The modified SOUNDSTAR 3D Ultrasound Catheter is substantially equivalent to the SOUNDSTAR 3D Ultrasound Catheter (510(k) K070242) cleared on May 15, 2007, and also to the ACUSON ACUNAV 10F Diagnostic Ultrasound Catheter (510(k) K071234) cleared on June 29, 2007.

DESCRIPTION OF MODIFIED DEVICE 15.9

The modified SOUNDSTAR Catheter has a bifurcated 'tail' originating from its handle. One leg terminates in the SOUNDSTAR Flex Tab connector, which connects via a SwiftLink cable to the GE Vivid-i or Vivid-q Ultrasound System. The other leg terminates in the CARTO Hypertronic connector, which connects via a Patient Interface Unit (PIU) extension cable to the CARTO Navigation System.

The modified SOUNDSTAR Catheter, when connected to the CARTO XP EP Navigation System, Version 9.7 or greater, and the GE Vivid-i or Vivid-q Ultrasound Systems, will provide real-time integration of ultrasound images with CARTO electromagnetic acquired maps.

15.10 INDICATIONS FOR USE

The Biosense Webster SOUNDSTAR 3D Diagnostic 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 CARTO XP EP Navigation System, Version 9.7 or greater, the SOUNDSTAR 3D Catheter provides location information.

15.11 DESCRIPTION OF MODIFICATION

The modified SOUNDSTAR Catheter is physically identical to the currently cleared SOUNDSTAR Catheter in terms of design, manufacturing methods, materials and performance. The only modifications were made to the Indications for Use, identification code on the catheter Flex Tab connector, and also to the labeling for the device. Specifically, the Flex Tab connector of the modified SOUNDSTAR Catheter has been modified to include a different identification code so that the modified catheter may

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K092064
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only be compatible with the GE Vivid-i and Vivid-q Ultrasound Systems. The modification to the labeling was to include reference of the new GE Vivid-i and Vivid-q Ultrasound Systems in the Instructions for Use, and to provide version specificity of the CARTO System (Version 9.7 or greater) which the modified SOUNDSTAR Catheter has been validated with. Additionally, the package label of the modified SOUNDSTAR Catheter will be a different color from the currently cleared SOUNDSTAR Catheter and will include the statement "Not For Use on Siemens Systems". The purpose for this labeling change will enable users to differentiate between the modified SOUNDSTAR Catheter and the currently cleared SOUNDSTAR Catheter.

SUMMARY OF NONCLINICAL TESTS 15.12

All testing previously submitted for the currently cleared SOUNDSTAR Catheter still applies to the modified device as there were no changes to the design, materials, manufacturing methods or performance of the device. Testing for compatibility with the GE Vivid-i and Vivid-q Ultrasound Systems in conjunction with the CARTO XP EP Navigation System Version 9.7 was conducted and all tests met the pre-determined specifications for the SOUNDSTAR Catheter, GE Vivid-i and Vivid-q Ultrasound Systems, and the CARTO System. Please reference the Special 510(k) submission for the GE Vivid-i and Vivid-q Ultrasound Systems (which will be submitted by the end of July 2009), for details regarding systems interface testing.

15.13 SUBSTANTIAL EQUIVALENCE CONCLUSION

The modified SOUNDSTAR Catheter is identical to the currently cleared SOUNDSTAR Catheter in that both of the devices:

have the same intended use
use the same operating principle
use the same fundamental scientific technology .
incorporate the same design .
incorporate the same materials and construction .
have the same shelf life .
are packaged using the same materials and processes .
have the identical Hypertronic connector .
use the identical interface cable for connection to CARTO a
have the same 64-channel acoustic phased array
have the same acoustic array location and connection
have the same distal tip material and deflection mechanism
have the same shaft material
are radiopaque

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Special 510(k) Premarket Notification for SoundStar 3D Ultrasound Catheter For Use with GE Vivid-ilq Ultrasound Systems

K092064
pg 4 of 4

are EtO sterilized
are single use devices

With regards to the ACUNAV predicate device, both the modified SOUNDSTAR Catheter and the ACUNAV Catheter compatible with GE Ultrasound Systems:

have the identical identification code in the catheter Flex Tab . connector to allow compatibility with the GE Ultrasound Systems
connect to the identical SwifiLink cable which allows interface . with the GE Vivid-i and Vivid-q Ultrasound Systems
have the same 64-channel acoustic phased array t
have the same acoustic array location and connection .
have the same distal tip material and deflection mechanism .
have the same shaft material .
are radiopaque .
are EtO sterilized .
are single use devices .

In summary, the modified SOUNDSTAR Catheter described in this submission is substantially equivalent to the currently cleared SOUNDSTAR Catheter and the ACUNAV Catheter predicate devices.

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Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three tail feathers, representing the department's commitment to health, human services, and science. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002

AUG 0 7 2009

Biosense Webster, Inc. Melissa C. Schultz, MMS, Senior Specialist, Regulatory Affairs 3333 Diamond Canyon Rd. Diamond Bar, CA 91765

Re: K092064

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: July 7, 2009 Received: July 8, 2009

Dear Ms. Schultz:

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. 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.

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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical

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device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Dama R. Valmer

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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7 Indications for Use

510(k) No (if known):

Device Name: SOUNDSTAR 3D Ultrasound Catheter

Indications for Use:

Over-The-Counter Use Prescription Use AND/OR (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of 1

Ninna R. W. Ames

scular Devices

510(k) Number K092064

Page 33 of 215

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).