(93 days)
The intended use of both Systems is to prevent embolisms from migrating to the pulmonary arteries.
The cleared SNF/SL and SNF Systems and the proposed models of the SNF/SL and SNF Systems are composed of a SN Filter and a delivery system. The SN Filter component is made of a nitinol alloy which has thermal shape memory properties. These properties allow the nitinol alloy wires to be formed into the shape of a filter. When cooled, the wires can be straightened to allow delivery through a small diameter catheter. The SN Filter resumes its original shape, a dome with six legs, when warmed to body temperature in the vena cava.
The SN Filters are delivered via the Seldinger technique, using a 7 French I.D. angiographic introducer sheath and a preliminary venacavogram. The sheath is introduced into the vein and positioned in the vena cava. When the sheath is positioned in the vena cava, the dilator is removed and the delivery system for the SN Filter is attached to the sheath. The SN Filter is then advanced through the sheath using the pusher wire until the SN Filter is at the tip of the sheath in the vena cava. The pusher wire has a stainless steel pusher cup or pad on the distal end of the pusher wire. The pusher wire is held in position while the sheath is withdrawn. This action releases the SN Filter into the vena cava; the SN Filter expands to its original shape which secures it against the vena cava. The sheath is then removed.
NMT intends to modify the gold radiopaque marker band from one which is deposited onto the introducer sheath to one which is mechanically swaged onto the introducer sheath.
The provided text does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. The document is a 510(k) summary for the Simon Nitinol Filter™ System and Simon Nitinol Filter/Straight Line™ System, focusing on substantial equivalence to predicate devices. It describes the device's design, intended use, and a minor modification to a radiopaque marker band, but it does not detail any performance studies, clinical trials, or established acceptance metrics for device performance.
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510(k) Summary Simon Nitinol Filter™ System and Simon Nitinol Filter/Straight Line™ System
APR 1 5 1997
Submitter's Name, Address, and Telephone Number
Nitinol Medical Technologies, Inc. 27 Wormwood St. 02210 Phone: (617) 737-0930 (617) 737-0932 Facsimile:
Contact Person
Sherrie Coval-Goldsmith V.P. Regulatory Affairs 27 Wormwood Street Boston, Mass 02210
Date Prepared
January 10, 1997
Name of Device
Simon Nitinol Filter™ System and Simon Nitinol Filter/Straight Line™ System
Classification Name
Cardiovascular Intravascular Filter
Common Name
Vena Cava Filter System
Product Code
DTK
0000172
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Predicate Devices
Simon Nitinol Filter/StraightLine™ System ("SNF/SL System") 1. (K963014) and Simon Nitinol Filter™ System ("SNF System") (K963016).
Intended Use
The intended use of both Systems is to prevent embolisms from migrating to the pulmonary arteries.
Substantial Equivalence
The cleared SNF/SL and SNF Systems and the proposed models of the SNF/SL and SNF Systems are composed of a SN Filter and a delivery system. The SN Filter component is made of a nitinol alloy which has thermal shape memory properties. These properties allow the nitinol alloy wires to be formed into the shape of a filter. When cooled, the wires can be straightened to allow delivery through a small diameter catheter. The SN Filter resumes its original shape, a dome with six legs, when warmed to body temperature in the vena cava.
The SN Filters are delivered via the Seldinger technique, using a 7 French I.D. angiographic introducer sheath and a preliminary venacavogram. The sheath is introduced into the vein and positioned in the vena cava. When the sheath is positioned in the vena cava, the dilator is removed and the delivery system for the SN Filter is attached to the sheath. The SN Filter is then advanced through the sheath using the pusher wire until the SN Filter is at the tip of the sheath in the vena cava. The pusher wire has a stainless steel pusher cup or pad on the distal end of the pusher wire. The pusher wire is held in position while the sheath is withdrawn. This action releases the SN Filter into the vena cava; the SN Filter expands to its original shape which secures it against the vena cava. The sheath is then removed.
NMT intends to modify the gold radiopaque marker band from one which is deposited onto the introducer sheath to one which is mechanically swaged onto the introducer sheath.
The proposed models of SNF/SL and SNF Systems have the same intended use as both cleared systems. These devices are intended to prevent embolisms from migrating to the pulmonary arteries. They have equivalent principles of operation as they use a pusher wire to push the SN Filter through a sheath inserted into a vein in order to deliver the filter to the inferior vena cava. The minor technological difference between the proposed models of SNF/SL and SNF System and the cleared SNF/SL and SNF System, namely the method by which the gold radiopaque marker
0000173
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band(s) are applied to the sheath, does not raise any new questions of safety or effectiveness. Thus, the proposed models of SNF/SL and SNF Systems are substantially equivalent to the cleared SNF/SL and SNF System respectively.
§ 870.3375 Cardiovascular intravascular filter.
(a)
Identification. A cardiovascular intravascular filter is an implant that is placed in the inferior vena cava for the purpose of preventing pulmonary thromboemboli (blood clots generated in the lower limbs and broken loose into the blood stream) from flowing into the right side of the heart and the pulmonary circulation.(b)
Classification. Class II. The special controls for this device are:(1) “Use of International Standards Organization's ISO 10993 ‘Biological Evaluation of Medical Devices Part I: Evaluation and Testing,’ ” and
(2) FDA's:
(i) “510(k) Sterility Review Guidance and Revision of 2/12/90 (K90-1)” and
(ii) “Guidance for Cardiovascular Intravascular Filter 510(k) Submissions.”