(91 days)
The Attain™ Prevail® Steerable Catheter Set is indicated to provide a pathway for delivery of transvenous devices to the coronary sinus and coronary vasculature of the heart.
The Medtronic Attain™ Prevail® Steerable Catheter Set features a steerable catheter and accessories to provide a pathway for delivery of transvenous devices to the coronary sinus and coronary vasculature of the heart.
The Prevail Steerable Catheter has a single lumen for passage of devices up to 0.035" (0.89 mm) diameter or injection of contrast solutions. Transvenous devices with an inner diameter of 7 French (2.3 mm) or larger can be loaded on and delivered with the Prevail catheter. The catheter features a steerable distal section controlled by the catheter handle. The catheter is radiopaque for visibility under fluoroscopy.
The Prevail Steerable Catheter Set features a guide wire and guide wire torque tool to assist in cannulating the coronary sinus ostium and coronary vasculature. Fluid management components include a Y-connector with an adjustable hemostasis valve. extension tube and 3-way stopcock. The adjustable hemostasis valve is used to reduce blood loss during the procedure. The Y-connector with side port and stopcock are used to aspirate air or inject solutions during the procedure.
The Prevail Steerable Catheter Set is provided STERILE and is intended for single use only.
The provided text describes the 510(k) submission for the Medtronic Attain™ Prevail® Steerable Catheter Set. This device is a catheter and, as such, is subject to performance testing rather than studies involving interpretation of medical images or data by experts. Therefore, many of the requested categories are not applicable.
Here's an analysis of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The submission states that "The Attain Prevail Steerable Catheter Set met all specified design and performance requirements." However, specific numerical acceptance criteria or performance metrics (e.g., tensile strength, steerability angles, flow rates) are not detailed in this summary document. The studies were focused on device integrity, biocompatibility, and sterilization validation.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Mechanical Testing | All specified design and performance requirements were met. |
| Functional Testing | All specified design and performance requirements were met. |
| Packaging Testing | All specified design and performance requirements were met. |
| Biocompatibility | All specified biocompatibility requirements (consistent with ISO-10993 Part 1) were met. |
| Sterilization Validation | Ethylene Oxide (EtO) sterilization process was validated. |
2. Sample size used for the test set and the data provenance
The document does not specify the sample sizes for the various mechanical, functional, packaging, or biocompatibility tests. The data provenance is internal to Medtronic, Inc. as these are laboratory and validation tests. These studies are prospective in nature, as they involve testing newly manufactured devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This is not applicable as the device is a catheter and its performance is evaluated through engineering tests, not by expert interpretation of medical data. The "ground truth" is established by the test methods and specifications themselves, which are typically developed by engineers and quality assurance personnel.
4. Adjudication method for the test set
This is not applicable for this type of device and testing. Test results are typically compared against pre-defined specifications without an adjudication process involving multiple experts.
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 is not applicable. The device is a physical catheter, not an AI-assisted diagnostic tool.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This is not applicable. The device is a physical catheter.
7. The type of ground truth used
The "ground truth" for the device's performance is established by engineering specifications and recognized standards (e.g., ISO-10993 for biocompatibility). For mechanical and functional tests, the ground truth would be the pre-defined performance limits or acceptable ranges for each parameter.
8. The sample size for the training set
This is not applicable. The device is a physical medical device and does not involve a "training set" in the context of machine learning or AI.
9. How the ground truth for the training set was established
This is not applicable.
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).