Search Results

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 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.

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.

Ask a specific question about this device