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510(k) Data Aggregation
(136 days)
The Reprocessed Acunav Diagnostic Ultrasound Catheter is intracardiac and intraluminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart of adult patients,
The reprocessed device is not indicated for use with pediatric patients.
The Reprocessed AcuNav Diagnostic Ultrasound Catheters distal end has an ultrasound transducer providing 2-D imaging. A steering mechanism controls the image plane orientation through four-way articulation of the tip.
This FDA 510(k) summary describes the reprocessed AcuNav Diagnostic Ultrasound Catheters (K153090) and demonstrates their substantial equivalence to a predicate device.
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly define "acceptance criteria" for performance metrics like sensitivity, specificity, or image quality as would be expected for an AI/CADe device. Instead, the focus is on demonstrating that the reprocessed device performs equivalently to the original predicate device and meets safety standards after reprocessing. The "reported device performance" is essentially the successful completion of various validation tests.
| Acceptance Criterion Type | Specific Test/Validation | Reported Device Performance |
|---|---|---|
| Biocompatibility | Biocompatibility testing | Demonstrated that the reprocessed device is biocompatible. |
| Cleaning Effectiveness | Cleaning Validation | Demonstrated that the reprocessing method effectively cleans the device. |
| Sterilization Assurance | Sterilization Validation | Demonstrated that the reprocessing method effectively sterilizes the device. |
| Visual Integrity | Visual Inspection (part of Functional Testing) | Each device inspected and passed for visual integrity after reprocessing. |
| Dimensional Accuracy | Dimensional Verification (part of Functional Testing) | Dimensions of the reprocessed device are verified to be within specifications, matching the original device. |
| Imaging Functionality | Ultrasound Transducer Testing (part of Functional Testing) | Ultrasound transducer performance of the reprocessed device is verified to meet specifications, ensuring 2-D imaging capability. |
| Clinical Performance | Simulated Use (part of Functional Testing) | The reprocessed device performs as intended in a simulated use environment, demonstrating its ability for intracardiac and intraluminal visualization. |
| Mechanical Integrity | Mechanical Characteristics (part of Functional Testing) | Mechanical properties of the reprocessed device are verified to meet specifications, including steering mechanism and four-way articulation. |
| Electrical Safety | Dielectric and Current Leakage (part of Electrical Safety Testing) | Electrical safety parameters (dielectric strength, current leakage) are verified to meet specifications, ensuring electrical safety for patients and users. |
| Packaging Integrity | Packaging Validation | Demonstrated that the packaging effectively maintains the sterility and integrity of the reprocessed device until use. |
| Reprocessing Limit | Reprocessing History Tracking | Reprocessed no more than one (1) time; devices reaching the maximum are rejected. Ensures that devices are not over-reprocessed, maintaining performance and safety. |
| Source Restriction | Restriction on prior reprocessing by other parties | Innovative Health restricts reprocessing to exclude devices previously reprocessed by other reprocessors. This ensures control over the reprocessing quality and history. |
| Substantial Equivalence | Comparison to predicate device (K071234) and reference device (K063076) | The purpose, design, materials, function, and intended use of the Reprocessed Diagnostic Ultrasound Catheters are identical to the predicate devices. No changes to claims, clinical applications, performance specifications, or method of operation. Bench and laboratory testing demonstrated performance (safety and effectiveness) equivalent to the predicate. |
2. Sample Size Used for the Test Set and the Data Provenance:
The document does not specify a "test set" in the context of clinical data for performance evaluation (e.g., a set of patient images). Instead, the "testing" refers to bench and laboratory validation of the reprocessed physical device. The sample sizes for each specific functional and safety test (e.g., how many catheters were subjected to biocompatibility testing, cleaning validation, etc.) are not explicitly stated in this summary.
The provenance of this "data" is from bench and laboratory testing performed by Innovative Health, LLC. It is not clinical data from an in-vivo study on human subjects; rather, it uses reprocessed devices themselves. The country of origin of the data is implicitly the USA, where Innovative Health, LLC is located.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:
This information is not applicable here. There is no "ground truth" derived from expert review of images or clinical outcomes in the traditional sense for an AI/CADe device. The "ground truth" for this reprocessing device is established by engineering specifications, validated test methods (e.g., sterilization effectiveness, dimensional accuracy), and regulatory standards for safety and performance of medical devices.
4. Adjudication Method for the Test Set:
This information is not applicable. There is no adjudication method described as this is not a study involving human reader interpretation or clinical outcomes adjudicated by experts.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
No, an MRMC comparative effectiveness study was not conducted. This submission is for a reprocessed medical device, not an AI or CADe system that assists human readers in interpretation.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This information is not applicable. This is not an AI algorithm; it's a physical medical device.
7. The Type of Ground Truth Used:
The "ground truth" for this device is based on:
- Engineering Specifications: Original device design and performance specifications.
- Regulatory Standards: Compliance with FDA regulations for device safety, sterilization, biocompatibility, and electrical safety.
- Validation Test Results: Data showing that the reprocessed devices meet objective performance criteria through bench and laboratory testing.
8. The Sample Size for the Training Set:
This information is not applicable. There is no "training set" as this device does not involve machine learning or AI.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable. Since there is no training set, there is no ground truth established for one.
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