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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.

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.

The SoundStar 3D Ultrasound Catheter underwent extensive non-clinical studies to establish its substantial equivalence to predicate devices, namely the ACUSON AcuNav 10F Diagnostic Ultrasound Catheter and the Biosense Webster NAVISTAR Diagnostic catheter.

1. Table of Acceptance Criteria and Reported Device Performance:

The provided text states that the device "passed all intended criteria in accordance with appropriate acceptance criteria and standards" for extensive bench and electrical testing. However, specific quantitative acceptance criteria and detailed performance metrics are not explicitly provided in the given document. The information outlines the general areas of performance that were evaluated.

• 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. |
  | Equivalence to Predicate Devices| The studies establish equivalence of the SOUNDSTAR™ 3D Ultrasound Catheter to the predicate devices, the NAVISTAR Diagnostic catheter and the AcuNav 10F Ultrasound Catheter. This implies that its performance in the key areas listed above is comparable to or better than the legally marketed predicate devices. |
  | Simulated Use Conditions | The SOUNDSTAR™ 3D Ultrasound Catheter was also tested under simulated use conditions in animals. (This implies successful operation and performance in a physiological environment that mimics human use, though specific outcomes are not detailed). |

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

• Sample Size: Not specified. The document mentions "extensive bench and electrical testing" and "simulated use conditions in animals" but does not quantify the number of units tested or the number of animals used.
• Data Provenance: The studies were non-clinical, implying they were conducted in a controlled environment (bench testing) and an animal model. The country of origin for the data is not specified, but the applicant and manufacturer are based in the USA. The studies are prospective in nature, as they are conducted for the purpose of demonstrating device performance prior to market clearance.

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

This information is not provided in the document. As this is a traditional 510(k) for a hardware device focused on substantial equivalence to existing technology, it's unlikely a formal expert-driven ground truth establishment process (as seen in AI/imaging diagnostic devices) was explicitly documented in this summary. The "ground truth" for electrical and bench testing would rely on established engineering specifications and measurement standards, and for animal studies, it would be based on physiological observations and established medical assessment methods.

4. Adjudication Method for the Test Set:

This information is not provided. Given the nature of the device (hardware/catheter), an adjudication method for test results as typically described for diagnostic algorithms (e.g., 2+1, 3+1 for discrepancies) is not directly applicable. Performance would likely be assessed against predetermined pass/fail criteria on a per-test basis.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done:

No, an MRMC comparative effectiveness study was not explicitly mentioned or implied. This type of study is more common for diagnostic imaging algorithms where human reader performance is a key metric. The focus here is on the device's physical and functional equivalence to predicate devices, and its ability to provide clear visualization and location information.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

The device itself is a "Diagnostic Ultrasound Catheter" and an "Electrophysiologic Mapping/Ultrasound Catheter." It provides real-time ultrasound images and location information for human interpretation and use within a larger system (CARTO XP EP Navigation System). Therefore, its performance is inherently linked to human-in-the-loop operation, as it generates data for human clinicians to act upon. While individual components (like the acoustic array) underwent standalone testing, the complete device is designed for human interaction. The summary focuses on the device's ability to "acquire real-time ultrasound images" and "provide location information," which are standalone functions of the algorithm/hardware working.

7. The Type of Ground Truth Used:

• Bench and Electrical Testing: Ground truth would be based on engineering specifications, established measurement standards, and physical principles. For example, electrical impedance measurements would be compared against a known standard or internal specification.
• Animal Studies: Ground truth would be established through physiological observations, direct visualization during the procedure, and potentially post-mortem examination or correlation with other established diagnostic methods.
• Equivalence to Predicate Devices: The primary "ground truth" for equivalence is the performance and characteristics of the legally marketed predicate devices, against which the SoundStar 3D Ultrasound Catheter was compared.

8. The Sample Size for the Training Set:

This question is not applicable in the context of this traditional 510(k) for a physical medical device. "Training set" typically refers to data used to train an artificial intelligence or machine learning algorithm. This submission describes a hardware device with an acoustic array (identical to a predicate device) and a location sensor. There's no indication of AI or machine learning being used in a way that would require a "training set" in the conventional sense. The "imaging software" in the ultrasound systems that drives the catheter is the same as that used for the predicate, suggesting no new algorithm development requiring a training set for this specific device.

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

This question is not applicable for the same reasons as point 8. No training set for an algorithm is mentioned in the filing.

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