(99 days)
No
The device description focuses on the physical components and mechanical function of a balloon catheter. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
This device is a therapeutic device intended for Percutaneous Transluminal Angioplasty (PTA) to treat obstructive lesions in various arteries and for post-dilatation of stents, which are all therapeutic interventions.
No
The device description and intended use clearly indicate that this is a therapeutic device used for balloon angioplasty and stenting, not for diagnosing medical conditions.
No
The device description clearly details a physical catheter with a balloon, lumens, and radiopaque markers, indicating it is a hardware device, not software-only.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a procedure performed within the body (Percutaneous Transluminal Angioplasty) to treat conditions in the peripheral vasculature. IVDs are used to examine specimens from the body (like blood, urine, tissue) to provide information about a person's health.
- Device Description: The description details a physical catheter with a balloon designed for mechanical dilation within blood vessels. This is a therapeutic device, not a diagnostic one that analyzes biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any other components typically associated with in vitro diagnostics.
Therefore, the Cordis AMIIA PTA Balloon Dilatation catheter is a therapeutic medical device used for angioplasty, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Cordis AMIIA PTA Balloon Dilatation catheter is intended for Percutaneous Transluminal Angioplasty in the peripheral vasculature, including iliac, femoral, ilio-femoral, popliteal, infra popliteal, renal, and carotid arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for post-dilatation of balloonexpandable and self-expanding stents in the peripheral vasculature.
Product codes
LIT
Device Description
The Cordis AMIIA PTA Balloon Dilatation Catheter is a catheter with a distal DURALYNTM inflatable balloon. The catheter utilizes a Rapid Exchange design, consisting of a single inflation lumen and a distal guide wire lumen. The guide wire lumen begins at the distal tip and terminates at the guide wire exit port. The guide wire exit port (hole) is approximately 25 cm from the distal tip. The maximum guide wire diameter that may be used is printed on the package label. The catheter tip is tapered to facilitate crossing of tight lesions.
The proximal hub is used as a balloon inflation port. The balloon is inflated by injecting diluted contrast medium through this hub. Two radiopaque marker bands within the balloon indicate the dilating section of the balloon and aid in balloon placement. The nominal balloon diameter and length are printed on the identification band near the hub.
The working pressure range for the balloon is between the nominal pressure and the rated burst pressure. All balloons distend to sizes above the nominal size at pressures greater than the nominal pressure. Consult the compliance table incorporated with the product, for diameters of the balloon at given pressures. The design of this catheter does not incorporate a lumen for distal dye injection.
The balloon catheter with a usable shaft length of 142 cm has two proximal shaft markers (90 cm and 100 cm from the distal tip). Both indicate the relative position of the catheter tip to the distal end of the guiding catheter. An additional marker is located at the distal port exit notch and aids in locating the guide wire exit.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral vasculature, including iliac, femoral, ilio-femoral, popliteal, infra popliteal, renal, and carotid arteries
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 safety and effectiveness of the subject Cordis AMIIA PTA Balloon Safety and Dilatation Catheter has been demonstrated via data collected from non-Performance clinical design verification tests and analyses. No biocompatibility test was Data required, as the original device has not changed and there was no change in the vascular application of the device [circulating blood contact with limited duration (
§ 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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|-----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------|-------------|
| | | FDA 510(k) Notification | |
| | | Cordis AMIIA PTA Balloon Dilatation Catheter | |
| Section 3: | 510(k) Summary (21 CFR 807.92) | | MAR 07 2007 |
| Submitter &
Contact
person: | Cordis Europa, N.V.
Harm Hovinga, Senior Regulatory Affairs Associate
Oosteinde 8
9301 LJ Roden,
The Netherlands | | |
| | Tel: +31 50 50 22479
Fax: +31 50 50 22456
e-mail: hhovinga@crdnl.jnj.com | | |
| Alternate
Contact: | Cordis Corporation
Joan Martin, Manager Regulatory Affairs
7 Powder Horn Drive
Warren, NJ 07059
USA | | |
| | Tel: (+1) 908 412 7250
Fax: (+1) 908 412 3915
e-mail: jmartin@crdus.jnj.com | | |
| Date Prepared | November 23, 2006. | | |
| Trade Name | Cordis AMIIA™ Percutaneous Transluminal Angioplasty (PTA) Balloon
Dilatation Catheter. | | |
| Predicate
Device(s) | The predicate devices for the subject Cordis AMIIA PTA Balloon Dilatation
Catheter are:
Cordis AMIIA PTA Balloon Dilatation Catheter, which was
determined substantially equivalent by FDA (ref. 510(k) number
#K050645, dated April 1, 2005).
Boston Scientific Sterling Monorail PTA Balloon Dilatation
Catheter. This device was determined substantially equivalent by FDA
(ref. 510(k) number #K053118, dated December 16, 2005. | | |
| Device
description | The Cordis AMIIA PTA Balloon Dilatation Catheter is a catheter with a distal
DURALYNTM inflatable balloon. The catheter utilizes a Rapid Exchange
design, consisting of a single inflation lumen and a distal guide wire lumen.
The guide wire lumen begins at the distal tip and terminates at the guide wire
exit port. The guide wire exit port (hole) is approximately 25 cm from the
distal tip. The maximum guide wire diameter that may be used is printed on
the package label. The catheter tip is tapered to facilitate crossing of tight
lesions.
The proximal hub is used as a balloon inflation port. The balloon is inflated
by injecting diluted contrast medium through this hub. Two radiopaque
marker bands within the balloon indicate the dilating section of the balloon
and aid in balloon placement. The nominal balloon diameter and length are
printed on the identification band near the hub.
The working pressure range for the balloon is between the nominal pressure
and the rated burst pressure. All balloons distend to sizes above the nominal
size at pressures greater than the nominal pressure. Consult the compliance
table incorporated with the product, for diameters of the balloon at given
pressures. The design of this catheter does not incorporate a lumen for distal
dye injection.
The balloon catheter with a usable shaft length of 142 cm has two proximal
shaft markers (90 cm and 100 cm from the distal tip). Both indicate the
relative position of the catheter tip to the distal end of the guiding catheter.
An additional marker is located at the distal port exit notch and aids in
locating the guide wire exit. | | |
Classification Name & Device Classification
Classification Name: Percutaneous Catheter (21 CFR 870.1250) Classification: Class II FDA Classification Panel: Cardiovascular Product Code: LIT 1
1
FDA 510(k) Notification
Cordis AMIIA PTA Balloon Dilatation Catheter
2