(75 days)
Reprocessed 3D Diagnostic Ultrasound Catheters are indicated for intracardiac and intraluminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart. The 3D Diagnostic Ultrasound Catheter provides location information when used with the CARTO® XP EP Navigation System Version 9 or greater.
3D Diagnostic Ultrasound Catheters are specially designed catheters that provide two-dimensional imaging using an ultrasound transducer and three-dimensional location information using a location sensor. The ultrasound transducer and location sensor are at the distal tip of the catheter and can be positioned for ultrasound imaging and 3D mapping by a steering mechanism that rotates the catheter tip and variable deflection. 3D Diagnostic Ultrasound Catheters incorporate a handpiece, a flexible shaft and a distal tip section containing an ultrasound transducer and a location sensor. The SOUNDSTAR™ 3D Diagnostic Ultrasound Catheter 3-D location sensor provides location information to the CARTO® XP EP Navigation System (mapping system). The SOUNDSTAR™ 3D Diagnostic Ultrasound Catheter is 10 French with a 90 cm insertion length.
The provided text describes a 510(k) summary for "Reprocessed 3D Diagnostic Ultrasound Catheters." This submission is for a reprocessed medical device, not a new AI-powered diagnostic system. Therefore, most of the requested information regarding AI performance metrics, ground truth, expert consensus, and training/test sets is not applicable to this document.
The document focuses on demonstrating that the reprocessed devices perform as originally intended and are substantially equivalent to the predicate device.
Here's a breakdown of the relevant information from the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Safety and Effectiveness | Bench and laboratory testing demonstrated performance (safety and effectiveness). |
| Biocompatibility | Biocompatibility testing was conducted. |
| Reprocessing Validation | Validation of reprocessing was conducted. |
| Sterilization Validation | Sterilization Validation was conducted. |
| Function Test(s) | Function test(s) were conducted. |
| Packaging Validation | Packaging Validation was conducted. |
| Substantial Equivalence | Ascent Healthcare Solutions concluded that the modified devices are safe, effective, and substantially equivalent to the predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance:
- Not Applicable. This submission is for reprocessed physical devices, and the "test set" refers to the physical units tested in bench and laboratory settings, not a data set for an algorithm. The document does not specify the number of reprocessed units tested for each criterion.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
- Not Applicable. Ground truth in the context of expert review for diagnostic accuracy is not relevant here. The "ground truth" for a reprocessed device is whether it meets its original performance specifications after reprocessing.
4. Adjudication Method for the Test Set:
- Not Applicable. Adjudication methods like 2+1 or 3+1 are for reconciling disagreements among human readers on image interpretation. This is not a human-in-the-loop diagnostic study.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
- No. This is not an MRMC study. It is a submission for a reprocessed physical medical device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
- No. This device is a physical diagnostic ultrasound catheter, not an algorithm. Therefore, "standalone algorithm performance" is not applicable.
7. The Type of Ground Truth Used:
- The "ground truth" for this type of submission is the original performance specifications and functional requirements of the predicate device. The studies conducted (bench, lab, biocompatibility, sterilization, function, packaging validation) aim to prove that the reprocessed device meets these identical standards.
8. The Sample Size for the Training Set:
- Not Applicable. There is no "training set" in the context of an AI algorithm for this submission.
9. How the Ground Truth for the Training Set Was Established:
- Not Applicable. There is no "training set" or explicit "ground truth" establishment in the AI sense for 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).