(74 days)
Cordis Savvy PTA Balloon Catheter, Cordis Opta 5 PTA Balloon Catheter, Cordis Small Vessel PTA Balloon Catheter, Schneider SofTrac
Not Found
No
The summary describes a mechanical device (balloon catheter) and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is described as "designed for dilatation of stenotic lesions within the peripheral vessels," which is a therapeutic intervention aimed at treating medical conditions.
No
Explanation: The device is described as a "PTA Balloon Catheter" designed for "dilatation of stenotic lesions within the peripheral vessels," which is a therapeutic function, not a diagnostic one. It is used to treat a condition rather than to identify or analyze it.
No
The device description clearly describes a physical catheter with a balloon, lumens, and a hub, indicating it is a hardware device, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "dilatation of stenotic lesions within the peripheral vessels." This describes a therapeutic procedure performed directly on the patient's body, not a test performed on a sample taken from the body.
- Device Description: The description details a catheter with a balloon for physical intervention within blood vessels. This is consistent with a medical device used for treatment, not for diagnostic testing of samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information based on laboratory testing.
IVD devices are designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device is a therapeutic device used for physical intervention.
N/A
Intended Use / Indications for Use
The Cordis Mega PTA Balloon Catheters are designed for dilatation of stenotic lesions within the peripheral vessels.
Product codes
Not Found
Device Description
Mega catheters have a coaxial design (tube within a tube) with a balloon on the distal tip. Two (2) lumens, an inner and outer lumen, are split on the proximal end by a Y-shaped one piece hub. The inner lumen (denoted by "thru") molded into the hub) is used for contrast medium or saline injections and guidewire insertion (maximum guidewire diameter is 0.018"). The outer lumen (denoted by "balloon" molded into the hub) is used for inflation and deflation of the balloon. Two (2) radiopaque marker bands placed within the balloon working length aid the physician in proper balloon placement.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral vessels
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)
Physical testing of the Mega PTA Balloon Catheters demonstrates equivalent performance to previously and existing PTA catheter designs.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Cordis Savvy PTA Balloon Catheter, Cordis Opta 5 PTA Balloon Catheter, Cordis Small Vessel PTA Balloon Catheter, Schneider SofTrac
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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
COPYRIGHT 2010
Summary of Substantial Equivalence
Section 513(i) of the Federal, Drug and Cosmetic Act
December 1995
27 DEC. 95
General Provisions 】
Classification Name
None established
Common/Usual Name
Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter
Proprietary Name
Cordis Mega PTA Balloon Catheter
Name and Address of Applicant II.
Cordis Corporation P.O. Box 025700 Miami, FL 33102-5700
Contact Name:
Martine D. Schneider
Martine D. Schneider, Regulatory and Clinical Affairs
Name of Predicate Devices III.
Cordis Savvy PTA Balloon Catheter Cordis Opta 5 PTA Balloon Catheter Cordis Small Vessel PTA Balloon Catheter Schneider SofTrac
Classification IV.
PTA Balloon Catheters are classified as class II devices.
1
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V. Performance Standards
Performance standards for PTA Balloon Catheters have not been established under Section 514 of the Food, Drug and Cosmetic Act.
VI. Intended Use and Product Description
The Cordis Mega PTA Balloon Catheters are designed for dilatation of stenotic lesions within the peripheral vessels. Mega catheters have a coaxial design (tube within a tube) with a balloon on the distal tip. Two (2) lumens, an inner and outer lumen, are split on the proximal end by a Y-shaped one piece hub. The inner lumen (denoted by "thru") molded into the hub) is used for contrast medium or saline injections and guidewire insertion (maximum guidewire diameter is 0.018"). The outer lumen (denoted by "balloon" molded into the hub) is used for inflation and deflation of the balloon. Two (2) radiopaque marker bands placed within the balloon working length aid the physician in proper balloon placement.
Biocompatibility VII.
All appropriate biocompatibility tests were performed and successfully passed on the materials used in the Mega PTA Balloon Catheter, as specified in the Tripartite Guidance Document.
VIII. Summary of Substantial Equivalence
The Cordis Mega Percutaneous Transluminal Angioplasty (PTA) Balloon catheters are designed for dilatation of stenotic lesions within peripheral vessels. Mega catheters have the same intended use and several of the same materials, design characteristics and dimensions as other currently marketed devices and the previously concurred Savvy catheters. Physical testing of the Mega PTA Balloon Catheters demonstrates equivalent performance to previously and existing PTA catheter designs.
0.998