(86 days)
The Evolution® Mechanical Dilator Sheath Set, Evolution® Shortie Mechanical Dilator Sheath Set, SteadySheath™ Evolution® Tissue Stabilization Sheath, and SteadySheath™ Evolution® Shortie Tissue Stabilization Sheath are intended for use in patients requiring the percutaneous dilation of tissue surrounding cardiac leads, indwelling catheters and foreign objects.
The Evolution® Mechanical Dilator Sheath Set is constructed of two coaxial sheaths connected to a handle capable of mechanically rotating the inner sheath. In use, the coaxial sheaths are advanced over an indwelling catheter or cardiac lead. The inner sheath (available in 9, 11, and 13 French diameters) is designed to rotate in a clockwise manner by pulling the trigger in the handle assembly. As the inner sheath is advanced, the rotation of the sheath assists in dilation of any binding tissue which may be anchoring the catheter or lead to the inner vascular or inner cardiac wall. The outer coaxial sheath can be used to stabilize the cardiac wall at the point of lead/catheter tip attachment to allow for detachment and removal (counter traction technique). The device has a working length of 40.6 centimeters.
The Evolution® Shortie Mechanical Dilator Sheath Set is constructed of two coaxial sheaths connected to a handle capable of mechanically rotating the inner sheath. The outer sheath has winged control tabs located at its proximal (handle) end. The sheaths are advanced over an indwelling catheter or cardiac lead. The inner sheath (available in 9 and 11 French diameters) is designed to rotate in clockwise manner by pulling the trigger in the handle assembly. As the inner sheath is advanced, the rotation of the sheath assists in dilation of any binding tissue which may be anchoring the catheter or lead to the inner vascular or inner cardiac wall. The outer coaxial sheath can be used to stabilize the cardiac wall at the point of lead/catheter tip attachment to allow for detachment and removal (counter traction technique). The device has a working length of 13.6 centimeters.
The SteadySheath™ Evolution® Tissue Stabilization Sheath and SteadySheath™ Evolution® Shortie Tissue Stabilization Sheath are designed to be used in place of the standard outer sheath that is supplied as part of the Evolution family of mechanical/controlled-rotation dilator sheath sets. They are provided for use in situations where better sheath tip visibility and/or tissue stabilization is desired. In its role as an Evolution outer sheath, the SteadySheath™ works in concert with the inner Evolution braided inner sheath to assist in the removal of cardiac leads or related catheters by bypassing and/or disrupting transvenous binding scar tissue. The SteadySheath™ has a highly radiopaque, textured stainless steel tip that helps stabilize tissue so that better binding scar tissue control and disruption can be achieved.
The provided document is a 510(k) premarket notification for a medical device. It focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria in a clinical study for a novel device. Therefore, a direct fit for all requested categories for a standalone performance or MRMC study as typically seen with AI algorithms will not be available.
However, I can extract the information relevant to the device's engineering performance testing which serves as its "acceptance criteria" for substantial equivalence.
Here's the information derived from the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Performed | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Push and Flex Testing | Device must remain functional after 50 cycles of flexing between 45° and 90° within a simulated use model. | Predetermined acceptance criteria were met. |
| Push and Rotate Testing | Device must remain functional after 50 cycles of insertion, 90° rotation, and removal from a simulated use model. | Predetermined acceptance criteria were met. |
| Pull Testing | Device must withstand no less than 10 pounds of pull force prior to failure. | Predetermined acceptance criteria were met. |
| Sterility Testing | Acceptable bioburden levels, endotoxin levels, and ethylene oxide and ethylene chlorohydrin residuals. | Sterility was deemed acceptable based on evaluations. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify exact sample sizes for each design verification test performed (e.g., how many devices were subjected to Push and Flex testing). The data provenance is internal laboratory testing simulating use, not clinical data from patients or a specific country of origin. This was retrospective in the sense that the testing was performed on manufactured devices to support the 510(k) submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This question is not applicable. The "ground truth" for these engineering tests is defined by the physical properties and functionality of the device under simulated stress, as measured by standard laboratory equipment and protocols, not by expert human interpretation.
4. Adjudication Method for the Test Set
This question is not applicable. The tests are objective design verification tests with pass/fail criteria, not subjective assessments requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. This is a medical device for percutaneous dilation (mechanical tool), not an AI-based diagnostic or assistive software. Therefore, an MRMC study is not relevant.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
No. This is a physical medical device. The "standalone performance" is documented by the engineering tests described in the table above, not an algorithm's performance.
7. The Type of Ground Truth Used
The "ground truth" for these engineering tests is determined by objective physical measurements demonstrating the device's mechanical integrity, functionality, and sterility under specified simulated use conditions. This is based on engineering specifications and performance standards, not pathology, outcomes data, or expert consensus in a clinical context.
8. The Sample Size for the Training Set
This question is not applicable. This device is not an AI algorithm requiring a training set. The performance is assessed on physical prototypes or production units subjected to engineering tests.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable for the same reason as point 8.
§ 870.1310 Vessel dilator for percutaneous catheterization.
(a)
Identification. A vessel dilator for percutaneous catheterization is a device which is placed over the guide wire to enlarge the opening in the vessel, and which is then removed before sliding the catheter over the guide wire.(b)
Classification. Class II (performance standards).