(30 days)
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.
| 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:
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
§ 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).