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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.

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.

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:

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.

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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.

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.

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.

Detailed Study Information:

1. 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.

2. 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.

3. 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.

4. 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.

5. 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.

6. 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.

7. 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.

8. 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.

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