(30 days)
The True Dilatation Catheter is indicated for balloon aortic valvuloplasty.
The True Dilatation Catheter is a coaxial catheter with a balloon fixed at the tip used for Balloon Aortic Valvuloplasty (BAV) of the aortic valve. The effective length of the catheter is 110 cm and it has two lumens: one lumen is used to inflate and deflate the balloon and the other permits the use of a guidewire to position the catheter. The balloon inflation luer-lock hub (angled) connects to a syringe inflation device to deliver radiopaque contrast media for inflation. The guidewire luer-lock hub (straight) connects to the guidewire lumen. The balloon functions by connecting an inflation device to the angled luer lock and injecting contrast/sailine into the inflation lumen; which inflates the balloon on the distal end of the catheter. The inflation device plunger is pulled back to deflate the balloon and it can then be withdrawn into the introducer for removal.
The provided text is a 510(k) summary for the True Dilatation Balloon Valvuloplasty Catheter. It describes the device, its intended use, and the functional and safety testing performed to demonstrate its equivalence to a predicate device.
Acceptance Criteria and Device Performance Study
The document does not detail specific quantitative acceptance criteria or a dedicated study that proves the device meets these criteria in the way one might expect for an AI/ML device. Instead, it focuses on demonstrating substantial equivalence to a previously cleared predicate device (True Dilatation Balloon Valvuloplasty Catheter, 510(k) number K121083).
The "study" in this context is the range of Functional and Safety Testing outlined, which serves to verify that the device design met its functional and performance requirements. The acceptance criteria for these tests would implicitly be the successful completion of each test without failure and within specified parameters, demonstrating that the device functions as intended and is safe.
Here's a breakdown of what can be extracted:
1. Table of Acceptance Criteria and Reported Device Performance
Note: The document does not provide explicit "acceptance criteria" with numerical thresholds for performance metrics. Instead, it describes "performance requirements" that were met through testing. The "reported device performance" is the successful completion of these tests.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Biocompatibility in accordance with ISO 10993-1 2009 | Device underwent biocompatibility testing. (Successful) |
| Sterility in accordance with ISO 11135-1 2007 | Device underwent sterility testing. (Successful) |
| Packaging integrity in accordance with ASTM D4169:2009 | Device underwent packaging integrity testing. (Successful) |
| Mechanical testing in accordance with ISO 10555-1 2009 | Device underwent mechanical testing. (Successful) |
| Dimensional verification of inflated balloon | Performed. (Successful, specific values not given) |
| Simulated use for access to annulus, inflation, re-sheathing, and withdrawal | Performed. (Successful) |
| Inflation and deflation time | Performed. (Successful, specific values not given) |
| Rupture, herniation, and leaking | Performed. (Successful, no rupture, herniation, or leaking) |
| Compatibility with introducer | Performed. (Successful) |
| Diameter Variation over Operating Pressure Range (20-26mm) |
§ 870.1255 Balloon aortic valvuloplasty catheter.
(a)
Identification. A balloon aortic valvuloplasty catheter is a catheter with a balloon at the distal end of the shaft, which is intended to treat stenosis in the aortic valve when the balloon is expanded.(b)
Classification. Class II (special controls). The special controls for this device are:(1) The device must be demonstrated to be biocompatible.
(2) Sterility and shelf life testing must demonstrate the sterility of patient-contacting components and the shelf life of these components.
(3) Non-clinical performance evaluation must demonstrate that the device performs as intended under anticipated conditions of use, including device delivery, inflation, deflation, and removal.
(4) In vivo evaluation of the device must demonstrate device performance, including the ability of the device to treat aortic stenosis.
(5) Labeling must include a detailed summary of the device-related and procedure-related complications pertinent to the use of the device.