(120 days)
The V8 Transluminal BAV Catheter is indicated for Balloon Aortic Valvuloplasty.
The V8 Transluminal BAV Catheter System 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 provided text describes a 510(k) premarket notification for the "V8 Transluminal BAV Catheter" and references a predicate device, the "NuMed NuCLEUS-X BAV Catheter (K082776)". The study provided focuses on establishing substantial equivalence to the predicate device rather than presenting a performance study with detailed acceptance criteria against clinical efficacy.
Therefore, the response will focus on the engineering and biocompatibility aspects, as these are the primary details provided regarding performance.
Acceptance Criteria for the V8 Transluminal BAV Catheter and Reported Device Performance
| Acceptance Criteria | Reported Device Performance/Comparison to Predicate |
|---|---|
| Physical and Performance Specifications | The V8 Transluminal BAV Catheter System is tested and meets all its physical and performance specifications, including: |
| Balloon rated burst pressure | Met specifications. |
| Balloon compliance | Met specifications. The V8 balloon maintains its hour-glass shape at low and rated burst pressures, unlike the predicate device which loses its shape at working pressure. This difference is not deemed to raise new safety/effectiveness questions as the effectiveness is determined by the bulbous section (similar to predicate) and the waist reduces probability of annular distention, hence risk of dissection. |
| Critical dimension verifications | Met specifications. The V8 balloon is available in four diameter sizes (22mm - 28mm). The waist is smaller than the bulb diameter up to rated burst pressure. Catheter available in standard working lengths (107cm - 113cm). |
| Guidewire and introducer compatibility | Met specifications. Compatible with a 12F or 14F introducer sheath and tracked over a 0.035" wire. (Predicate also compatible with 0.035" wire). |
| Fluoroscopic visualization | Met specifications. Radiopaque platinum iridium marker bands are present on the inner shaft beneath the balloon (one at the center of the waist, and one each at the outside edges of the proximal and distal balloon shoulders). |
| Deflation times | Met specifications. |
| Repeat inflation | Met specifications. |
| Leak | Met specifications. |
| Tensile | Met specifications. |
| Kink | Met specifications. |
| Torque | Met specifications. |
| Luer lock compatibility | Met specifications. |
| Distribution | Met specifications. |
| Biocompatibility | Tested per ISO 10993-1 for short duration contact with blood ( |
§ 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.