(108 days)
The intended use of Nitinol Medical Technologies, Inc.'s ("NMT") Simon Nitinol Filter/Straight Line™ System ("SNF/SL System") is to prevent pulmonary embolisms from migrating to the pulmonary arteries.
The cleared SNF/SL System and the proposed models of the SNF/SL System 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 placed in saline, the wires become soft and can be straightened to allow delivery through a small diameter catheter. The SN Filter reassumes 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 ("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 The pusher wire is held in position while the sheath is withdrawn.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.
This 510(k) summary for the "Simon Nitinol Filter/Straight Line™ System" does not contain the information requested for acceptance criteria and a study proving those criteria are met.
The document primarily focuses on:
- Device identification: Names, classification, product code, and contact information.
- Predicate devices: Listing previously cleared versions of the device.
- Intended use: Preventing pulmonary embolisms.
- Device description and principle of operation: How the filter works and is deployed.
- Substantial equivalence claim: Arguing that the modifications (radiopaque markers, new delivery methods like antecubital and subclavian) do not raise new safety or effectiveness concerns compared to previously cleared versions.
There is no mention of:
- Acceptance criteria: Specific performance metrics (e.g., filter efficacy, complication rates, deployment success rates) that the device must achieve.
- A study or clinical trial: No data is presented from a study to demonstrate the device meets any particular performance criteria. The document states that the minor modifications "do not raise any new questions of safety or effectiveness," which is an argument for substantial equivalence, not a report of a new study to prove efficacy or safety against specific benchmarks.
- Specific performance numbers: There are no reported device performance values against which acceptance criteria could be compared.
- Sample sizes, data provenance, expert qualifications, ground truth methods, MRMC studies, or standalone performance. These details would typically be found in a study report.
Therefore, I cannot populate the requested table or provide the detailed information about a study based on the provided text. The document's purpose is to argue for substantial equivalence based on minor modifications, not to present a new clinical efficacy or safety study.
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NOV 1 8 1996
510(k) Summary
Nitinol Medical Technologies, Inc.'s
Simon Nitinol Filter/Straight Line™ System
Submitter's Name, Address, and Telephone Number
Nitinol Medical Technologies. Inc. 263 Summer Street, 7th Floor Boston, MA 02210 (617) 737-0930 Phone: (617) 737-0924 Facsimile:
Contact Person
Jonathan S. Kahan, Esq. Hogan & Hartson, L.L.P. 555 13th Street, N.W. Washington, D.C. 20004-1109 (202) 637-5794 Phone: Facsimile: (202) 637-5910
as Regulatory Counsel to Nitinol Medical Technologies, Inc.
Date Prepared
August 2, 1996
Name of Device
Simon Nitinol Filter/Straight Line™ System
Classification Name
Cardiovascular Intravascular Filter
Common Name
Vena Cava Filter System
Product Code
DTK
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Predicate Devices
- Simon Nitinol Filter/Straight Line™ System (K944353) 1. Simon Nitinol Filter™ System (K940489, K912144, and K894703) 2.
Intended Use
The intended use of Nitinol Medical Technologies, Inc.'s ("NMT") Simon Nitinol Filter/Straight Line™ System ("SNF/SL System") is to prevent pulmonary embolisms from migrating to the pulmonary arteries.
Substantial Equivalence
The cleared SNF/SL System and the proposed models of the SNF/SL System 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 placed in saline, the wires become soft and can be straightened to allow delivery through a small diameter catheter. The SN Filter reassumes 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 ("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 make three types of modifications to the cleared SNF/SL System. First, NMT intends to market models of SNF/SL System with zero, one, and two gold, radiopaque marker bands. Second, NMT intends to expand the delivery methods of the cleared SNF/SL System to include antecubital delivery and to modify the device's delivery system to allow antecubital delivery. Third. NMT intends to expand the device's delivery methods to include subclavian delivery using the same delivery system as used for jugular delivery.
The proposed models of SNF/SL System have the same intended use as the cleared SNF/SL System and the SNF System. These devices are intended to prevent pulmonary embolisms from migrating to the pulmonary arteries. They have equivalent principles of operation as they deliver a pusher wire to push the SN
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Filter through a sheath inserted into a vein to the inferior vena cava. The minor technological differences between the proposed models of SNF/SL System and the cleared SNF/SL System, namely the removal of one or both radiopaque marker bands from some models, the revision of device labeling to include antecubital and subclavian delivery of the devices, and the modifications in the length of the device's sheath and pusher wire to allow antecubital delivery, do not raise any new questions of safety or effectiveness. The minor technological differences between the proposed models of the SNF/SL System and the SNF System, namely the SNF System's circular plastic storage and deployment system to advance the pusher wire, also do not raise any new questions of safety or effectiveness. Thus, the proposed models of SNF/SL System are substantially equivalent to the cleared SNF/SL System.
§ 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.”