(137 days)
The V8 Balloon Aortic Valvuloplasty Catheter is indicated for Balloon Aortic Valvuloplasty.
The V8 Balloon Aortic Valvuloplasty Catheter features an hour glass shaped dilatation balloon on the distal end of a catheter. The catheter is inserted through a percutaneous entry site into the common femoral artery via an introducer sheath and advanced retrograde to the aortic valve. The catheter is always delivered over a guidewire. The balloon is then inflated to dilate the stenotic aortic valve leaflets in an effort to increase valve opening dimensions and systemic blood flow by improving leaflet mobility. The hour glass shaped balloon with the undersized waist segment is intended to minimize over-dilatation of the valve annulus while allowing the full dilation of the valve leaflet. The bulbous proximal balloon segment is appropriately sized for the patient's aortic root dimensions to maximize valve leaflet opening. The V8 Balloon Aortic Valvuloplasty Catheter can be used as both a pre-dilatation and postdilatation device for self-expanding transcatheter heart valves.
While the provided document describes a medical device (V8 Balloon Aortic Valvuloplasty Catheter) and its substantial equivalence to a predicate device for FDA 510(k) clearance, it does not contain the information requested in your prompt regarding acceptance criteria and a study proving a device meets those criteria, particularly in the context of an AI/algorithm-based device.
This document is a 510(k) summary for a physical medical device, not a software or AI medical device. Therefore, the concepts of "test set," "ground truth," "experts to establish ground truth," "adjudication method," "MRMC comparative effectiveness study," or "standalone (algorithm only) performance" are not applicable to the content provided.
The document discusses:
- Device Description: A physical balloon catheter for aortic valvuloplasty.
- Intended Use: Dilate aortic valve tissue.
- Technological Characteristics: Materials, sizes, shape (hourglass), compatibility with guidewire/sheath, radiopaque markers.
- Comparison to Predicate Device: The primary change is a reduced balloon bulb length (from 10mm to 8mm).
- Performance Data (Non-clinical): This section details the types of tests performed to demonstrate substantial equivalence, such as:
- Biocompatibility (not re-tested due to no material change)
- Sterility and shelf-life (not re-tested due to no packaging or worst-case device change)
- Non-clinical performance evaluation of device delivery, inflation, deflation, and removal (summary below lists bond tensile strength, balloon rated burst pressure, balloon compliance).
- In vivo evaluation (stated shape and principles of operation are the same as predicate).
- Crucially, these are engineering/physical performance tests for the catheter itself, not clinical diagnostic accuracy or AI performance metrics.
Therefore, I cannot populate the table or answer the specific questions related to acceptance criteria for an AI/algorithm study based on the provided text. The document focuses on demonstrating that a physical modification to an existing device does not raise new questions of safety or efficacy compared to its predicate.
§ 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.