(120 days)
Not Found
No
The device description and performance studies focus on the physical and mechanical properties of the catheter and balloon, with no mention of AI or ML capabilities.
Yes
The device is used to dilate stenotic aortic valve leaflets, which is a therapeutic intervention aimed at improving patient health outcomes rather than diagnosing, preventing, or monitoring.
No
The device is a therapeutic catheter used for balloon aortic valvuloplasty to dilate stenotic aortic valve leaflets, not to diagnose a condition.
No
The device description clearly details a physical catheter with a balloon, intended for insertion into the body. This is a hardware medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The V8 Transluminal BAV Catheter is a medical device used for a therapeutic procedure (Balloon Aortic Valvuloplasty). It is inserted directly into the body to physically interact with and modify the aortic valve.
- Lack of Sample Analysis: The device does not analyze any biological samples taken from the patient. Its function is mechanical and interventional.
Therefore, the V8 Transluminal BAV Catheter falls under the category of an interventional medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The V8 Transluminal BAV Catheter is indicated for Balloon Aortic Valvuloplasty.
Product codes (comma separated list FDA assigned to the subject device)
OZT
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Aortic valve
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The V8 Transluminal BAV Catheter System is tested and meets all its physical and performance specifications including:
- Balloon rated burst pressure
- Balloon compliance
- Critical dimension verifications
- Guidewire and introducer compatibility
- Fluoroscopic visualization
- Deflation times
- Repeat inflation
- Leak
- Tensile
- Kink
- Torque
- Luer lock compatibility
- Distribution
In addition, the device was tested for biocompatibility 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.
0
K123111
OLIBRAMEDICAL
JAN 3 1 2013
5. 510(K) SUMMARY
ADMINISTRATIVE INFORMATION 5.1
5.1.1 Sponsor
Mark Ungs InterValve, Inc. 16200 State Highway 7, Unit B Minnetonka, MN 55345 Phone: 952-303-3539 Fax: 952-303-6310 Email: mark@intervalveinc.com
Date Prepared: September 28, 2012
5.1.2 Primary Contact Person
Julie Bodmer Regulatory Consultant, Libra Medical Inc. 8401 73td Ave North, Suite 63 Minneapolis, MN 55428 Phone: 612-910-3412 Fax: 763-477-6357 Email: jbodmer@libramed.com
5.1.3 Secondary Contact Person
Sew-Wah Tay, PhD Regulatory Consultant, Libra Medical Inc. 8401 73td Ave North, Suite 63 Minneapolis, MN 55428 Phone: 612-801-6782 Fax: 763-477-6357 Email: swtay@libramed.com
5.2 DEVICE NAME
Trade Name
.
V8
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Page 5-1
1
K123111
Common Name Classification Name Classification Product Code
Balloon Aortic Valvuloplasty Catheter Catheter, Balloon Aortic Valvuloplasty II . OZT
PREDICATE DEVICE 5.3
The device is substantially equivalent to the NuMed NuCLEUS-X BAV Catheter (K082776).
5.4 DEVICE DESCRIPTION
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.
INDICATIONS FOR USE/INTENDED USE 5.5
The V8 Transluminal BAV Catheter is indicated for Balloon Aortic Valvuloplasty.
The V8 and predicate device are indicated for balloon aortic valvuloplasty for both a palliative treatment as well as to predilate the annulus prior to transcatheter aortic valve replacement surgery. There are no differences in indications and therefore do not raise any new questions about the safety and effectiveness of the device.
TECHNOLOGICAL CHARACTERISTICS 5.6
The V8 balloon has an hour glass shape at low and at rated burst pressures. The V8 balloon is intended to provide a means for dilation of stenotic valve leaflets while minimizing dilation of the aortic annulus by virtue of its hour-glass shape. The V8 balloon is made of clear non-compliant polymeric material. The balloon will be available in four diameter sizes (22mm -28mm). The waist of the hour glass balloon is sized such that it is smaller than the bulb diameter up to the rated burst pressure.
The catheter will be available in standard working lengths (107cm - 113cm) and is compatible with a 12F or 14F introducer sheath. It is introduced through the femoral artery via the introducer sheath and tracked over a 0.035" wire. The catheter's inner shaft beneath the balloon is marked with radiopaque platinum iridium marker bands. one at the center of the waist, and one each at the outside edges of the proximal and distal balloon shoulders. The catheter is packaged in a heat sealed Tyvek pouch and provided sterilized. It is intended for single use only. These characteristics are comparable with the predicate device.
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Page 5-2
2
The predicate device also has an hour-glass shape at low pressures. However, it loses its shape at the working pressure and the rated burst pressure. In contrast, the V8 balloon's hour-glass shape is retained even at rated burst pressure. However, this difference in the balloon shape does not raise new or different questions of safety and effectiveness. The effectiveness of the device is determined by the bulbous section of the balloon and this is similar in diameter to the predicate device. The waist of the V8 balloon reduces the probability of annular distention and hence the risk of dissection. Hence, no new questions of safety are raised.
The shaft of the V8 catheter is similar in construction to that of the predicate device. Both device shafts are dual lumen with each lumen terminating in a female luer at the proximal hub.
5.7 PERFORMANCE DATA
The V8 Transluminal BAV Catheter System is tested and meets all its physical and performance specifications including:
- Balloon rated burst pressure ●
- Balloon compliance ●
- Critical dimension verifications .
- Guidewire and introducer compatibility .
- Fluoroscopic visualization .
- Deflation times .
- Repeat inflation
- Leak
- Tensile
- Kink
- Torque
- Luer lock compatibility
- Distribution
In addition, the device was tested for biocompatibility per ISO 10993-1 for short duration contact with blood (