(21 days)
Not Found
No
The device description and performance studies focus on the physical characteristics and mechanical performance of a balloon catheter, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is intended to dilate stenoses in various arteries and treat obstructive lesions, as well as for stent post-dilatation, which directly addresses and treats a medical condition.
No
This device is a therapeutic device (balloon dilatation catheter) used to dilate stenoses, not diagnose them.
No
The device description clearly details a physical medical device (catheter with a balloon) and its components, not a software-only product.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health. These tests are performed outside of the body.
- Device Function: The NanoCross™ Elite 0.014" Over-the-Wire PTA Balloon Dilatation Catheter is a device used inside the body to physically dilate blood vessels. It's a therapeutic device, not a diagnostic one.
- Intended Use: The intended use clearly describes a procedure performed within the body to treat blockages in arteries and fistulae. It does not mention any testing of samples.
- Device Description: The description details the physical components of a catheter designed for insertion and manipulation within the vascular system.
Therefore, based on the provided information, the NanoCross™ Elite 0.014" Over-the-Wire PTA Balloon Dilatation Catheter is a therapeutic medical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The NanoCross™ Elite 0.014" Over-the-Wire PTA Balloon Dilatation Catheter is intended to dilate stenoses in the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for stent post-dilatation in the peripheral vasculature.
Product codes
LIT
Device Description
The NanoCross catheter is an over-the-wire (OTW) coaxial lumen percutaneous transluminal angioplasty (PTA) balloon catheter compatible with 0.014"guidewires with a distally mounted semi-compliant inflatable balloon and an atraumatic tapered tip. The distal portion of the catheter has a lubricious coating. The manifold includes a lumen marked "THRU". This is the central lumen of the catheter, which terminates at the distal tip. This lumen is used to pass the catheter over a guidewire with a maximum diameter of 0.014". The lumen marked "BALLOON" is the balloon inflation lumen, which is used to inflate and deflate the dilatation balloon with a mixture of contrast medium and saline solution. The balloon has two radiopaque markers for positioning the balloon relative to the stenosis. The radiopaque marker bands indicate the dilating or working section of the balloon.
The NanoCross Elite catheter is available in balloon sizes ranging from 1.5 mm to 4 mm in diameter, and from 20 mm to 210 mm in length; reference labeling for introducer sheath compatibility.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae, peripheral vasculature.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
physician
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)
Bench testing and biocompatibility testing were performed to support a determination of substantial equivalence. Results from this testing provide assurance that the proposed device has been designed and tested to assure conformance to the requirements for its intended use.
Using internal Risk Analysis procedures, the following tests were performed for one or more model sizes:
• Balloon Dimensional Verification
• Catheter Dimensional Verification
• Balloon Rated Burst Pressure (Unconstrained and In Stent)
• Balloon Fatigue (Unconstrained and In Stent)
• Balloon Compliance
• Inflation/Deflation Time
• Catheter Bond Strength
• Kink
• Device Tracking
• Insertion Force
• Balloon Pull-back Force
• Torque Strength
• Radiopacity
• Presence of Coating
• Re-Insertion Force
• Pushability
Using the same Risk Analysis procedures, the following tests were leveraged from predicate devices for one or more model sizes:
• Balloon Dimensional Verification
• Balloon Rated Burst Pressure (Unconstrained and In Stent)
• Balloon Fatigue (Unconstrained and In Stent)
• Balloon Compliance
• Coating Durability
• Particle Generation
The device was tested for biocompatibility per ISO 10993-1 for short duration contact with blood (
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/1 description: The image shows the logo for "ev3", which is described as "Your endovascular company." The logo consists of the letters "ev3" in a stylized font, with three circles above the letters. The text "Your endovascular company." is written in a smaller font to the right of the letters.
510(k) Summary
NanoCross™ Elite 0.014" Over-the-Wire PTA Balloon Dilatation Catheter
| 510(k) Summary | This 510(k) summary information is submitted in accordance
with the requirements of 21 CFR §807.92. | |
|----------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Applicant | ev3 Inc. | |
| Submitter | ev3 Inc.
3033 Campus Drive
Plymouth, MN 55441-2651
Tel: 763-398-7000
Fax: 763-591-3248 | |
| | SEP 2 6 2013 | |
| Contact Person | Laura J. Lind | |
| Date Prepared | July 22, 2013 | |
| Device Trade Name | NanoCross™ Elite
0.014" Over-the-Wire
PTA Balloon Dilatation Catheter | |
| Device Common Name | PTA Dilatation Catheter | |
| Classification Name | Catheter, Angioplasty, Peripheral, Transluminal
(21 CFR §870.1250, Product Code LIT) | |
| Classification Panel | Cardiovascular | |
| Predicate Devices | NanoCross™ .014" OTW PTA Dilatation Catheter (K082854,
K090849), RapidCross™ PTA Rapid Exchange Balloon
Dilatation Catheter (K130911). | |
| Intended use | The NanoCross™ Elite 0.014" Over-the-Wire PTA Balloon
Dilatation Catheter is intended to dilate stenoses in the iliac,
femoral, ilio-femoral, popliteal, infra-popliteal, and renal
arteries, and for the treatment of obstructive lesions of native or
synthetic arteriovenous dialysis fistulae. This device is also
indicated for stent post-dilatation in the peripheral vasculature. | |
| Device Description | The NanoCross catheter is an over-the-wire (OTW) coaxial
lumen percutaneous transluminal angioplasty (PTA) balloon
catheter compatible with 0.014"guidewires with a distally
mounted semi-compliant inflatable balloon and an atraumatic
tapered tip. The distal portion of the catheter has a lubricious
coating. The manifold includes a lumen marked "THRU". This
is the central lumen of the catheter, which terminates at the distal | |
| • Balloon Dimensional
Verification | • Catheter Dimensional
Verification | |
| • Balloon Rated Burst Pressure
(Unconstrained and In Stent) | • Balloon Fatigue (Unconstrained
and In Stent) | |
| • Balloon Compliance | • Inflation/Deflation Time | |
| • Catheter Bond Strength | • Kink | |
| • Device Tracking | • Insertion Force | |
| • Balloon Pull-back Force | • Torque Strength | |
| • Radiopacity | • Presence of Coating | |
| • Re-Insertion Force | • Pushability | |
ev3 Corporate World Headquarters / Peripheral Vascular . 3033 Carryus Drive. Plynouth: MN 55441, USA . Ph +1 763 398 7000 eva Neurovascular - 9775 Tolodo Way, Irving, CA 92618 - Ph 11 949 837 3700 ev3 Europe / International Headquarters . 103/108 г.ю LB Boete, 75008 Paris: France . Ph +33 156 86 59 : 10
1
tip. This lumen is used to pass the catheter over a guidewire with a maximum diameter of 0.014". The lumen marked "BALLOON" is the balloon inflation lumen, which is used to inflate and deflate the dilatation balloon with a mixture of contrast medium and saline solution. The balloon has two radiopaque markers for positioning the balloon relative to the stenosis. The radiopaque marker bands indicate the dilating or working section of the balloon.
The NanoCross Elite catheter is available in balloon sizes ranging from 1.5 mm to 4 mm in diameter, and from 20 mm to 210 mm in length; reference labeling for introducer sheath compatibility.
Performance data
Bench testing and biocompatibility testing were performed to support a determination of substantial equivalence. Results from this testing provide assurance that the proposed device has been designed and tested to assure conformance to the requirements for its intended use.
Using internal Risk Analysis procedures, the following tests were performed for one or more model sizes:
Using the same Risk Analysis procedures, the following tests were leveraged from predicate devices for one or more model sizes:
| • Balloon Dimensional
Verification | • Balloon Rated Burst Pressure
(Unconstrained and In Stent) |
|---------------------------------------------------|----------------------------------------------------------------|
| • Balloon Fatigue
(Unconstrained and In Stent) | • Balloon Compliance |
| • Coating Durability | • Particle Generation |
The device was tested for biocompatibility per ISO 10993-1 for short duration contact with blood (