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 ACUSON AcuNav" 10F Diagnostic 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 Sequoia or the Cypress Ultrasound Systems, will provide real-time integration of ultrasound images with CARTO electromagnetic acquired maps.

AI/ML Overview

This document is a 510(k) summary for the SOUNDSTAR™ 3D Ultrasound Catheter. It describes a modification to an existing device rather than a new device. Therefore, the information provided focuses on the substantial equivalence to the predicate device and does not include new studies to prove acceptance criteria for the modified device.

Here's an analysis based on the provided text, explaining why certain sections of your request cannot be fulfilled:

1. A table of acceptance criteria and the reported device performance

This information is not available in the provided text. The document states: "All testing previously submitted for the SOUNDSTAR™ 3D Ultrasound Catheter still applies to the modified device as there were no changes to the design, materials, manufacturing methods or performance of the device." This implies that the acceptance criteria and performance were established for the predicate device (K070242), and are not re-evaluated or reported in this submission for the modified device.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not available. Since no new performance studies were conducted for the modified device, there's no test set, sample size, or data provenance to report. The submission re-affirms that prior testing for the predicate device still applies.

3. 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 available. As no new performance studies were conducted, there's no new ground truth establishment for this 510(k) submission.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not available. No new performance studies were conducted.

5. 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

This information is not available. The device described is an ultrasound catheter, not an AI-driven diagnostic tool that would typically involve MRMC studies or AI assistance for human readers.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

This information is not available. The device is an ultrasound catheter that provides real-time images and location information to a CARTO® EP Navigation System, implying human-in-the-loop operation. It is not a standalone algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

This information is not available for this specific submission as no new performance studies were conducted.

8. The sample size for the training set

This information is not available. As the device is not an AI algorithm, there is no concept of a training set in this context.

9. How the ground truth for the training set was established

This information is not available. Not applicable as there is no training set.

Summary of the K091352 Submission:

The core of this 510(k) submission (K091352) is a demonstration of substantial equivalence to an already cleared predicate device (SOUNDSTAR™ 3D Ultrasound Catheter, K070242). The only modification to the device is to its labeling to ensure compatibility with multiple CARTO® EP Navigation Systems.

The key points of the submission are:

No physical changes to the device: "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."
Prior testing applies: "All testing previously submitted for the SOUNDSTAR™ 3D Ultrasound Catheter still applies to the modified device as there were no changes to the design, materials, manufacturing methods or performance of the device."
Compatibility testing: Compatibility with the CARTO® 3 EP Navigation Systems was submitted in the CARTO® 3 System's own 510(k) and is not part of this submission's new testing.
Substantial Equivalence Justification: The modified device is stated to be substantially equivalent to the predicate device because they:
- 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.

Therefore, for this particular 510(k) submission, there are no new acceptance criteria or new studies proving performance because the device itself and its performance characteristics are deemed unchanged from its predicate.

Summary

{0}------------------------------------------------

DEC - 4 zuug

Image /page/0/Picture/1 description: The image shows handwritten text. The text at the top reads "K091352". Below that, the text reads "pg. 1 of 3". The text appears to be a page number or identifier within a larger document.

11 510(k) Summary

11.1 SPONSOR'S NAME & ADDRESS

Biosense Webster, Inc. 3333 Diamond Canyon Road Diamond Bar, CA 91765

11.2 Official Correspondent Balaka Das Senior Specialist, Regulatory Affairs Phone: 909-839-8599 Fax: 909-839-8804 Email: bdas2@its.jnj.com

11.3 SUBMISSION DATE May 6, 2009

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 (K070242) cleared on May 15, 2007.

{1}------------------------------------------------

Image /page/1/Picture/0 description: The image shows handwritten text. The first line reads 'K0913552'. The second line reads 'pg 2 of 3'. The text appears to be a page number or identifier within a larger document.

11.9 DESCRIPTION OF DEVICE

The SOUNDSTAR™ 3D Ultrasound Catheter, when connected to a CARTO® EP Navigation System with ultrasound capability, and the Sequoia or the Cypress Ultrasound Systems, will provide real-time integration of
ultrasound images with CARTO electromagnetic acquired maps.

11.10 INDICATIONS FOR USE

The Biosense Webster SOUNDSTARTM 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.

DESCRIPTION OF MODIFICATION 11.11

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.

SUMMARY OF NONCLINICAL TESTS 11.12

All testing previously submitted for the SOUNDSTAR™ 3D Ultrasound Catheter still applies to the modified device as there were no changes to the design, materials, manufacturing methods or performance of the

{2}------------------------------------------------

K091352
pg 3 of 3

device. Testing for compatibility with the CARTO® 3 EP Navigation Systems was submitted in the CARTO® 3 System 510(k). Therefore, no additional testing is submitted in this Premarket Notification.

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.

{3}------------------------------------------------

Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle or bird symbol, composed of three curved lines, representing the department's mission of promoting health and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird symbol. The logo is in black and white.

DEPARTMENT OF HEALTH & HUMAN SERVICES

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

DEC 0 4 2009

Biosense Webster, Inc. Balaka Das, Senior Specialist, Regulatory Affairs 3333 Diamond Canyon Rd. Diamond Bar, CA 91765

Re: K091352

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: November 3, 2009 Received: November 5, 2009

Dear Ms. Das:

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

{4}------------------------------------------------

Page 2 - Ms. Balaka Das

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/CDRH0ffices/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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Bram D. Zuckerman, M.D.

Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{5}------------------------------------------------

Indications for Use

510(k) Number (if known): K091352

Device Name: Soundstar 3D Ultrasound Catheter

Indications For Use:

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRN Office of Device Evaluation (ODE)
(Division Sign-Off) Division of Cardiovascular Devices	Page 1 of 1
510(k) Number	K091352

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).