(74 days)
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.
The provided text is a summary of substantial equivalence for a medical device (Cordis Mega PTA Balloon Catheter) and does not contain any information about acceptance criteria or a study proving device performance against such criteria. The document is a K95 submission (a premarket notification for a Class II medical device) and focuses on demonstrating substantial equivalence to predicate devices, rather than establishing performance against specific acceptance criteria through a clinical study involving AI or human readers.
Therefore, I cannot provide the requested information based on the input text. The questions posed in your request are typically relevant to the evaluation of AI/ML-enabled medical devices or clinical studies, which is not the subject of this document.
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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.
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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
§ 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).