(85 days)
Not Found
No
The device description and performance studies focus on the mechanical and physical properties of a balloon dilatation catheter. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is intended to "dilate stenosis 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," which is a therapeutic purpose.
No
The device is a Rapid Exchange Balloon Dilatation Catheter intended to dilate stenoses (open narrowed blood vessels), which is a therapeutic function, not a diagnostic one.
No
The device description clearly details a physical catheter with a balloon, guidewire lumen, and other hardware components. There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is used to dilate stenosis in various arteries and for the treatment of obstructive lesions. This is a therapeutic intervention performed directly on the patient's body.
- Device Description: The description details a physical catheter with a balloon designed for mechanical dilation within blood vessels. This is consistent with a medical device used for treatment, not for analyzing samples outside the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are used to perform tests on samples taken from the body to provide diagnostic information. This device is used to physically treat a condition within the body.
N/A
Intended Use / Indications for Use
The RapidCross™ PTA Rapid Exchange 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.
Product codes (comma separated list FDA assigned to the subject device)
LIT, DQY
Device Description
The RapidCross PTA Rapid Exchange Balloon Dilatation Catheter (RapidCross catheter) is a rapid exchange (RX) coaxial 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 an 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. On the 150 mm and 210 mm devices, two additional marker bands denote the middle of the balloon body. A guidewire lumen starts at a guidewire port located 35 cm from the catheter tip and extends to the distal tip. The 90 cm useable length devices have proximal depth marks printed on the proximal shaft at lengths of 55 cm and 65 cm from the distal tip while the 170 cm useable length devices have depth marks at 90 cm and 100 cm to serve as a reference during catheter insertion.
The RapidCross catheter is available in balloon sizes ranging from 2 mm to 4 mm in diameter and 20 mm to 210 mm in length; and, all sizes are compatible with 4 F sheaths.
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, arteriovenous dialysis fistulae.
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)
Bench testing and biocompatibility testing were performed to support a determination of substantial equivalence.
Using internal Risk Analysis procedures, the following tests were performed:
• Crossing Profile
• Balloon Burst Strength
• Balloon Compliance
• Balloon OD
• Inflation/Deflation Time
• Balloon Fatigue
• Bond Tensile Strength
• Kink
• Device Tracking
• Insertion Force
• Balloon Pull-back Force
• Repeat Inflations (In Stent)
• Torque Strength
• Radiopacity
• Presence of Coating
• Coating Durability
• Particle Generation
• Pushability
• Support Wire Securement
• Tip ID / RX Port ID
• Tip / Lesion Entry Profile
• Re-Insertion Force
• Catheter Working Length
• RX Port Length
• RX Port OD
The device was tested for biocompatibility per ISO 10993-1 for
§ 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).
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K1235244
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Image /page/0/Picture/1 description: The image shows the logo for ev3, a medical device company. The logo consists of the letters "ev3" in a stylized font, with three black circles above the letters. To the right of the logo is the tagline "Your endovascular company."
510(k) Summary
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FEB 1 2 2013
Page 1 of 3
| | FEB 1 2 20
RapidCross™ PTA Rapid Exchange Balloon Dilatation Catheter |
|----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Summary | This 510(k) summary information is submitted in accordance
with the requirements of 21 C.F.R §807.92. |
| Applicant | ev3 Inc. |
| Submitter | ev3 Inc.
3033 Campus Drive
Plymouth, MN 55441-2651 |
| Contact Person | Laura J. Lind |
| Date Prepared | February 6, 2013 |
| Device Trade Name | RapidCross™ PTA Rapid Exchange Balloon Dilatation Catheter |
| Device Common Name | PTA Dilatation Catheter |
| Classification Name | Catheter, Angioplasty, Peripheral, Transluminal
(21 CFR 870.1250, Product Codes LIT, DQY) |
| Classification Panel | Cardiovascular |
| Predicate Devices | NanoCross™ .014 OTW PTA Dilatation Catheter (K082854,
K090849), PowerCross™ .018 OTW PTA Dilatation Catheter
(K093286), Sterling™ Monorail™ PTA Balloon Dilatation
Catheter (K053118), and Advance® 14LP Low Profile PTA
Balloon Dilatation Catheters (K090822). |
| Intended use | The RapidCross™ PTA Rapid Exchange Balloon Dilatation
Catheter is intended to dilate stenosis 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. |
| Device Description | The RapidCross PTA Rapid Exchange Balloon Dilatation
Catheter (RapidCross catheter) is a rapid exchange (RX) coaxial
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 an inflation lumen, which is used
to inflate and deflate the dilatation balloon with a mixture of |
| | Tel: 763-398-7000
Fax: 763-591-3248 |
ev3 Corporate World Headquarters / Peripheral Vascular - 3053 Campus Dive, Flynnesh, MN 55441, USA - Ph - 1763 398 7050
ev3 Neurovascular • 9775 Tolodo V/ay, Irvine, CA 92618 • Ph • 1 949 837 3700
.
ev3 Europe / International Headquarters • 108/108 ₪e La Reètie. 75008 Paris, Firaco • Ph +33 156 89 59 1 3
1
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. On the 150 mm and 210 mm devices, two additional marker bands denote the middle of the balloon body. A guidewire lumen starts at a guidewire port located 35 cm from the catheter tip and extends to the distal tip. The 90 cm useable length devices have proximal depth marks printed on the proximal shaft at lengths of 55 cm and 65 cm from the distal tip while the 170 cm useable length devices have depth marks at 90 cm and 100 cm to serve as a reference during catheter insertion.
The RapidCross catheter is available in balloon sizes ranging from 2 mm to 4 mm in diameter and 20 mm to 210 mm in length; and, all sizes are compatible with 4 F sheaths.
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:
| • Crossing Profile | • Radiopacity |
|---|---|
| • Balloon Burst Strength | • Presence of Coating |
| • Balloon Compliance | • Coating Durability |
| • Balloon OD | • Particle Generation |
| • Inflation/Deflation Time | • Pushability |
| • Balloon Fatigue | • Support Wire Securement |
| • Bond Tensile Strength | • Tip ID / RX Port ID |
| • Kink | • Tip / Lesion Entry Profile |
| • Device Tracking | • Re-Insertion Force |
| • Insertion Force | • Catheter Working Length |
| • Balloon Pull-back Force | • RX Port Length |
| • Repeat Inflations (In Stent) | • RX Port OD |
| • Torque Strength |
The device was tested for biocompatibility per ISO 10993-1 for