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 compatible CARTO® EP Navigation Systems, the SOUNDSTAR 3D Catheter provides location information.

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 Biosense Webster SOUNDSTAR 3D Ultrasound Catheter, model M-5723-12, Ultrasound Catheter. The catheter has a location sensor (providing location information to CARTO® EP Navigation Systems with ultrasound capability) 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. One leg terminates in the SOUNDSTAR tab connector, which connects via a Swiftlink cable to an 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 SOUNDSTAR 3D Ultrasound Catheter, when connected to a CARTO® EP Navigation System with ultrasound capability, 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

The provided text describes a Special 510(k) submission for the SoundStar 3D Ultrasound Catheter, focusing on an "IEU change to add CARTO 3 Compatibility". This means the submission is for modifying the device's labeling to include compatibility with additional CARTO® EP Navigation Systems, specifically CARTO 3.

Crucially, the document states: "The modified SOUNDSTAR 3D Ultrasound Catheter is physically identical to the predicate device in terms of design, manufacturing methods, materials and performance. There are absolutely no changes to the device whatsoever. The only modification is to the labeling for the device to allow compatibility with multiple CARTO® EP Navigation Systems with ultrasound capability." and "All testing previously submitted for the predicate SOUNDSTAR 3D Ultrasound Catheter, model number M-5723-12, still applies to the modified device as there were no changes to the design, materials, manufacturing methods or performance of the device."

Therefore, this submission is not about proving the performance of the core ultrasound catheter, but rather about demonstrating that the existing catheter functions correctly when connected to the new CARTO 3 system. The acceptance criteria and "study" described are focused on this interoperability, not on the diagnostic accuracy of the ultrasound imaging itself.

Here's a breakdown based on the provided text, acknowledging the specific nature of this 510(k) submission:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance
Functionality with GE Vivid-i/q Ultrasound System and CARTO® 3 System (when connected simultaneously)	"Testing verified that the three components, when connected simultaneously, functioned appropriately as designed."
Equivalence to previous device (model M-5723-05) for testing purposes	"demonstrates equivalence to the modified device (model number M-5723-12)"

2. Sample Size Used for the Test Set and Data Provenance:

The document does not specify a distinct "test set sample size" in terms of patient data or images for evaluating diagnostic performance, as the modification is for compatibility. The testing described is functional testing of the interconnected systems.

Sample Size: Not specified in terms of clinical samples. The "test set" for this submission would involve the devices themselves: a SOUNDSTAR Catheter (model M-5723-05 or M-5723-12), a GE Vivid-i/q Ultrasound System, and a CARTO® 3 System.
Data Provenance: Not applicable in the context of clinical data. This refers to internal functional testing of device compatibility.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

Not applicable. The "ground truth" for this compatibility testing is whether the devices connect and function as intended. There would be engineers or technicians verifying system functionality, but not a panel of clinical experts establishing diagnostic ground truth.

4. Adjudication Method for the Test Set:

Not applicable. This was functional testing, likely an pass/fail assessment by engineering personnel, not clinical adjudication.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study:

No. An MRMC study is designed to evaluate the diagnostic performance of a device or algorithm with and without AI assistance across multiple readers and cases. This submission is for a labeling change regarding system compatibility, not for evaluating diagnostic effectiveness or AI performance.

6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance):

No. This device is an ultrasound catheter that requires human operation and interpretation. There is no mention of a standalone algorithm for diagnostic interpretation in this submission. The "algorithm" here refers to the software within the CARTO system, and the testing is about the catheter's ability to interface with it appropriately.

7. Type of Ground Truth Used:

For the specific testing described (compatibility with CARTO 3), the ground truth was functional performance – whether the interconnected devices functioned "appropriately as designed." This is an engineering ground truth, not a clinical one (e.g., pathology, expert consensus on disease presence).

8. Sample Size for the Training Set:

Not applicable. This device is a hardware component (ultrasound catheter) and its compatibility with a navigation system. There is no mention of an AI algorithm being "trained" as part of this specific submission.

9. How the Ground Truth for the Training Set Was Established:

Not applicable, as no training set for an AI algorithm is mentioned in this submission.

Summary

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K101138 pg 1 of 3

Special 510(k) for SoundStar 3D Ultrasound Catheter: IEU change.to add CARTO 3 Compatibility

11 510(k) Summary

11.1 SPONSOR'S NAME & ADDRESS Biosense Webster, Inc. 3333 Diamond Canyon Road Diamond Bar, CA 91765
JUN 2 2 2010
11.2 OFFICIAL CORRESPONDENT Melissa C. Schultz Project Manager, Regulatory Affairs Phone: 909-839-8787 Fax: 909-839-8804 Email: MSchult1@its.jnj.com
11.3 SUBMISSION DATE April 21, 2010
11.4 TRADE NAME SOUNDSTAR 3D Ultrasound Catheter
11.5 COMMON NAME Electrophysiology Mapping/Ultrasound Catheter
CLASSIFICATION NAME/PRODUCT CODE 11.6 Intravascular Ultrasound Catheter/OBJ
11.7 CLASSIFICATION Class II
11.8 PREDICATE DEVICE SOUNDSTAR 3D Ultrasound Catheter, model M-5723-12 (K092064) cleared on August 7, 2009.

BIOSENSE WEBSTER INC.

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11.9 DESCRIPTION OF DEVICE

pg 20f3

11 101138

The SOUNDSTAR 3D Ultrasound Catheter has a bifurcated 'tail' originating from its handle. One leg terminates in the SOUNDSTAR tab connector, which connects via a Swiftlink cable to an 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 SOUNDSTAR 3D Ultrasound Catheter, when connected to a CARTO® EP Navigation System with ultrasound capability, and the GE Vivid-i or Vivid-q Ultrasound Systems, will provide real-time integration of ultrasound images with CARTO® electromagnetic acquired maps.

11.10 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 compatible CARTO® EP Navigation Systems, the SOUNDSTAR 3D Catheter provides location information.

11.11 DESCRIPTION OF MODIFICATION

The modified SOUNDSTAR 3D Ultrasound Catheter is physically identical to the predicate device in terms of design, manufacturing methods, materials and performance. There are absolutely no changes to the device whatsoever. The only modification is to the labeling for the device to allow compatibility with multiple CARTO® EP Navigation Systems with ultrasound capability.

11.12 SUMMARY OF NONCLINICAL TESTS

All testing previously submitted for the predicate SOUNDSTAR 3D Ultrasound Catheter, model number M-5723-12, still applies to the modified device as there were no changes to the design, materials,

BIOSENSE WEBSTER. INC.

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manufacturing methods or performance of the device. In addition, various functionality testing was performed on the SOUNDSTAR Catheter, model number M-5723-05, with GE Vivid-i/q Ultrasound System and CARTO® 3 System functionality. Testing verified that the three components, when connected simultaneously, functioned appropriately as designed. This additional functionality testing which was performed on the SOUNDSTAR Catheter, model number M-5723-05, demonstrates equivalence to the modified device (model number M-5723-12), as SOUNDSTAR Catheter, model number M-5723-05 is nearly identical to the predicate SOUNDSTAR Catheter, model number M-5723-12, with the exception that the identification codes in the catheter connectors are different. The predicate device, the SOUNDSTAR Catheter, model number M-5723-12, is physically identical to the modified device (model number M-5723-12), which is the subject of this submission. The only modification to model number M-5723-12 is to the labeling of the device to allow compatibility with multiple CARTO® EP Navigation Systems with ultrasound capability. Testing for compatibility with the CARTO 3 EP Navigation Systems is referenced in the Compatibility Summary Report found in Appendix 3.

11.13 SUBSTANTIAL EQUIVALENCE

The modified SOUNDSTAR 3D Ultrasound Catheter is identical to the previously cleared SOUNDSTAR 3D Ultrasound Catheter in that 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, and .
are packaged using the same materials and processes. .

In summary, the SOUNDSTAR 3D Ultrasound Catheter described in this submission is substantially equivalent to the predicate device.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird in flight, rendered in black lines. The bird is oriented towards the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the bird.

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

Biosense Webster, Inc c/o Ms. Melissa Schultz Project Manager, Regulatory Affairs 3333 Diamond Canyon Rd Diamond Bar, CA 91765

JUN 2 2 2010

Re: K101138

Trade/Device Name: Soundstar 3D Ultrasound Catheter Regulation Number: 21 CFR 870.1220 Regulation Name: Diagnostic intravascular catheter Regulatory Class: Class II (two) Product Code: OBJ Dated: May 25, 2010 Received: May 26, 2010

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. 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 statutes and regulations administered by other Federal agencies. You must

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Page 2 - Ms. Melissa Schultz

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 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/ucm11.5809.htm fou 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" (21CFF) Patt 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/ReportalProblem/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 no mber (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

M. A. Hillemann

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

Enclosure

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Indications for Use ব

510(k) No (if known): __ K |0 || 38

Device Name: SOUNDSTAR 3D Ultrasound Catheter

Indications for Use:

Over-The-Counter Prescription Use Use N -- 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)

Page 1 of 1

M. A. Hillemeier

Division Sign-Off) Jivision of Cardiovascular Devices

510(k) Number_K101) 38

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).