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510(k) Data Aggregation
(120 days)
The Reprocessed SoundStar 3D Diagnostic Ultrasound Catheter is intra-cardiac and intra-luminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart.
The SoundStar 3D Diagnostic Ultrasound Catheter provides location information when used with the CARTO EP Navigation Systems.
The Reprocessed SoundStar 3D Diagnostic Ultrasound Catheters (hereinafter Catheter) is an imaging catheter. The distal end of the catheter has an ultrasound transducer providing two-dimensional imaging and a three-dimensional location sensor providing location information to compatible CARTO EP Navigation Systems with ultrasound capability. A steering mechanism controls the image plane orientation by rotating both the catheter tip and the variable direction.
This document is a 510(k) premarket notification for a reprocessed medical device, specifically a Reprocessed SoundStar 3D Diagnostic Ultrasound Catheter. It is not an AI/ML-enabled device, and therefore, many of the requested categories related to AI performance, ground truth, and expert evaluation are not applicable.
Here's an analysis based on the provided text, focusing on the available information regarding the reprocessed device's acceptance criteria and studies:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Test/Characteristic | Acceptance Criteria | Reported Device Performance (Summary) |
|---|---|---|---|
| Functional & Safety | Biocompatibility | Not explicitly stated (implied to meet standards for initial device) | Not detailed, but "bench and laboratory testing was conducted to demonstrate performance (safety and effectiveness)" |
| Cleaning Validation | Not explicitly stated (implied to ensure removal of visible soil and decontamination) | "includes removal of visible soil and decontamination" | |
| Sterilization Validation | Not explicitly stated (implied to ensure sterility) | "Sterilization Validation" was conducted | |
| Visual Inspection | Not explicitly stated (implied to ensure no visible defects) | "Each device is inspected" | |
| Dimensional Verification | Not explicitly stated (implied to match original specifications) | "Dimensional Verification" was conducted | |
| Ultrasound Transducer Testing | Not explicitly stated (implied to meet original performance specifications) | "Ultrasound Transducer Testing" was conducted | |
| Simulated Use | Not explicitly stated (implied to function correctly in a simulated environment) | "Simulated Use" was conducted | |
| Mechanical Characteristics | Not explicitly stated (implied to meet original mechanical strength/integrity) | "Mechanical Characteristics" were tested | |
| Electrical Safety Testing | Not explicitly stated (implied to meet electrical safety standards) | Conducted, includes Dielectric and Current Leakage | |
| Packaging Validation | Not explicitly stated (implied to maintain sterility and integrity) | "Packaging Validation" was conducted | |
| Reprocessing Limits | Maximum Reprocessing Cycles | No more than one (1) time | "The Reprocessed Diagnostic Ultrasound Catheters are reprocessed no more than one (1) time." |
| Material/Design Identity | Purpose, Design, Materials, Function, Intended Use | Identical to predicate devices | "The purpose, design, materials, function, and intended use of the Reprocessed Diagnostic Ultrasound Catheters are identical to the predicate devices." |
Study Proving Device Meets Acceptance Criteria:
The document broadly states that "Bench and laboratory testing was conducted to demonstrate performance (safety and effectiveness) of Reprocessed Diagnostic Ultrasound Catheters."
2. Sample Size Used for the Test Set and the Data Provenance:
- Sample Size: The document does not specify the sample size for any of the tests. It only lists the types of tests performed.
- Data Provenance: Not applicable in the context of reprocessed physical devices. The testing was conducted by Innovative Health, LLC as part of their reprocessing validation.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:
- Not applicable. This is not a study involving human interpretation of data where "ground truth" needs to be established by experts. The "ground truth" for a reprocessed device's acceptance is its adherence to predefined engineering, safety, and functional specifications, compared to the original device.
4. Adjudication Method for the Test Set:
- Not applicable. No adjudication method described as it's not a performance study requiring human interpretation or consensus.
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:
- No. This is a reprocessed medical device, not an AI/ML device. Therefore, no MRMC study or AI assistance evaluation was performed or is relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No. This is a reprocessed medical device, not an AI/ML device.
7. The Type of Ground Truth Used:
- The "ground truth" for this reprocessed device is its ability to meet the original device's specifications and performance characteristics after reprocessing, along with ensuring safety (biocompatibility, sterility, electrical safety) and functional integrity. This is established through the various functional, safety, and sterilization validation tests mentioned.
8. The Sample Size for the Training Set:
- Not applicable. This device does not involve a "training set" as it is not an AI/ML system.
9. How the Ground Truth for the Training Set was Established:
- Not applicable. This device does not involve a "training set."
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