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The SoundBite® Crossing System - Peripheral (14P) is indicated to facilitate the intraluminal placement of conventional guidewires or treatment devices beyond peripheral artery chronic total occlusions.

The SoundBite® Crossing System - Peripheral (14P) is not intended for use in the carotid arteries.

The SoundBite® Crossing System - Peripheral (14P) is a recanalization tool, designed to help physician's placement of conventional guidewires or treatment devices in the intraluminal space beyond chronic total occlusions in the peripheral vasculature. The SoundBite® Crossing System - Peripheral (14P) consists of the reusable mobile SoundBite® Console, a single-use sterile SoundBite® Active Wire 14P, and their respective accessories.

The SoundBite® Console generates controlled mechanical pulses (i.e., shock waves) which are transmitted to the SoundBite® Active Wire 14P and cause the distal tip of the wire to accelerate axially in a reciprocating motion, acting like a micro-jackhammer.

The SoundBite® Active Wire 14P is similar in construction to the 0.018" CTO crossing wire provided with the predicate device, with a friction reducing PTFE coating (except for the distal tip), a radiopaque marker near the tip, and enhanced flexibility at the distal end. It has an outer diameter of 0.36 mm (0.014") and it is 300 cm long, with a working length of 145 cm. At the proximal end of the SoundBite® Active Wire 14P, a section reducer allows the wire to be connected to the SoundBite® Console. The single-use SoundBite® Active Wire 14P is supplied sterile with a shelf life of 24 months.

This document is a 510(k) summary for the SoundBite® Crossing System - Peripheral (14P), a medical device. It focuses on demonstrating substantial equivalence to a predicate device, not on proving clinical efficacy through a specific study with acceptance criteria for device performance as would be the case for an AI/ML-driven device.

Therefore, the requested information elements related to acceptance criteria, device performance, sample sizes for test sets, expert-driven ground truth, adjudication methods, MRMC studies, standalone performance, and training set details are not applicable to this document. This submission relies on non-clinical testing and comparison to a predicate device.

However, I can provide the available information from the document as it relates to the device and its testing:

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

This document does not specify quantitative acceptance criteria or reported device performance in the manner typically seen for AI/ML device evaluations (e.g., sensitivity, specificity, accuracy thresholds). Instead, it states that "The results from bench testing indicate that the performance characteristics of the SoundBite® Crossing System - Peripheral (14P) are substantially equivalent to the predicate device and do not raise new questions of safety or performance." The performance is evaluated through various non-clinical tests to show substantial equivalence.

Non-Clinical Testing Areas:

• Visual and dimensional inspection
• Simulated use
• Coating integrity
• Tip pull
• Flexibility resistance
• Fracture resistance
• Torque strength
• Tensile strength
• Corrosion resistance
• Torqueability
• Distal temperature
• Tip flexibility
• Catheter qualification
• Lubricity assessment
• Particulate testing
• Shelf-life testing
• Console Output Stability
• Life-Cycle Testing
• Console and Shipping Container Labels Verification
• Electronics and Software Verification
• ANSI AAMI ES60601-1:2005/(R) 2012 and A1:2012
• IEC 60601-1-2 Edition 4.0 2014-02
• Biocompatibility (full panel performed under GLP)
• Usability (summative evaluation)

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

Not applicable. The submission is based on non-clinical bench testing, animal studies, and usability evaluations, not clinical data sets from human subjects with specified sample sizes for testing or training AI/ML alongside provenance.

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)

Not applicable. The ground truth for the non-clinical tests would be established by standard engineering and testing procedures, not by human experts interpreting clinical data.

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

Not applicable. This concept pertains to expert review of clinical data, which is not the basis of this submission.

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

Not applicable. This device is a physical medical device (a catheter system), not an AI/ML-driven diagnostic or assistive tool for human readers.

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

Not applicable. This is not an algorithm-only device. It is a physical medical device used by a physician.

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

The "ground truth" for this device's evaluation comes from established engineering standards, material science, biocompatibility testing protocols, and usability guidelines to ensure safety and performance equivalence to the predicate device. For example, "biocompatibility" is assessed against established biological response criteria, and "tensile strength" against material specifications.

8. The sample size for the training set

Not applicable. This is not an AI/ML device that requires a training set.

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

Not applicable. This is not an AI/ML device that requires a training set.

Summary of the Study (as described in the document):

The submission for the SoundBite® Crossing System - Peripheral (14P) is a 510(k) premarket notification seeking to demonstrate substantial equivalence to an existing predicate device (SoundBite® Crossing System - Peripheral, K192211). The study primarily consists of non-clinical bench testing, animal studies, and usability evaluations.

• Objective: To demonstrate that the SoundBite® Crossing System - Peripheral (14P) is substantially equivalent to its predicate device in intended use, indications for use, fundamental technologies, principles of operation, and labeling.
• Methodology:
  • Non-clinical bench testing: A wide range of physical and mechanical tests were performed on the device components and the system (as listed in point 1 above) to assess its design, performance characteristics, and compliance with recognized standards (e.g., ISO 14971, IEC 62304, ANSI AAMI ES60601-1, IEC 60601-1-2).
  • Biocompatibility testing: A full panel of tests was performed under GLP to ensure materials met biocompatibility requirements.
  • Usability evaluation: Representative users were included in a summative evaluation to confirm safe and effective use.
  • Animal studies: Performance data from animal studies were submitted to support the substantial equivalence claim, particularly concerning the differences in device characteristics (e.g., smaller diameter wire, different pulse repetition rate).
• Conclusion: "The data submitted with this Special 510(k) premarket notification demonstrate that the SoundBite® Crossing System - Peripheral (14P) is substantially equivalent to the predicate device." The differences between the new device and the predicate device (e.g., wire diameter, working length, radiopaque marker position, console setting for pulse repetition rate) were addressed by the non-clinical and animal testing to show they do not raise new questions of safety or performance.

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