(108 days)
The intended use of Nitinol Medical Technologies, Inc.'s ("NMT") Simon Nitinol Filter™ System ("SNF System") is to prevent pulmonary embolisms from migrating to the pulmonary arteries.
The cleared SNF System and the proposed models of the SNF 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 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 The pusher wire is held in position while the sheath is withdrawn.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 make two types of modifications to the cleared SNF System. First, NMT intends to market models of the SNF System with zero, one, and two gold, radiopaque marker bands. Second, NMT intends to expand the device's delivery methods to include subclavian delivery using the same delivery system as used for jugular delivery.
The provided text is a 510(k) summary for a medical device (Simon Nitinol Filter™ System) and does not contain the acceptance criteria, study details, or performance results as requested in your prompt.
A 510(k) summary primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than providing a detailed clinical study report with acceptance criteria and performance data in the way you've outlined for AI/diagnostic devices.
Therefore, I cannot fulfill your request with the information provided. The document describes:
- Device Name: Simon Nitinol Filter™ System
- Intended Use: To prevent pulmonary embolisms from migrating to the pulmonary arteries.
- Modifications: Addition of radiopaque marker bands and expansion of delivery methods to include subclavian delivery (in addition to jugular).
- Predicate Devices: Previous iterations of the Simon Nitinol Filter™ System.
- Claim of Substantial Equivalence: Based on similar intended use, principle of operation, and a determination that the minor technological differences do not raise new questions of safety or effectiveness.
To answer your questions, I would need a different type of document, such as a clinical study report or a detailed premarket approval (PMA) application, which would typically include comprehensive performance data and predefined acceptance criteria.
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NOV 1 8 1996
510(k) Summary
Nitinol Medical Technologies, Inc.'s
Simon Nitinol Filter™ System
Submitter's Name, Address, and Telephone Number
Nitinol Medical Technologies, Inc. 263 Summer Street, 7th Floor Boston, MA 02210 (617) 737-0930 Phone: Facsimile: (617) 737-0924
Contact Person
Jonathan S. Kahan, Esq. Hogan & Hartson, L.L.P. 555 13th Street, N.W. Washington, D.C. 20004-1109 Phone: (202) 637-5794 Facsimile: (202) 637-5910
as Regulatory Counsel to Nitinol Medical Technologies, Inc.
Date Prepared
August 2, 1996
Name of Device
Simon Nitinol Filter™ System
Classification Name
Cardiovascular Intravascular Filter
Common Name
Vena Cava Filter System
Product Code
DTK
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Predicate Devices
- Simon Nitinol Filter™ System (K940489, K912144, and K894703) 1. Simon Nitinol Filter/Straight Line™ System (K944353) 2.
Intended Use
The intended use of Nitinol Medical Technologies, Inc.'s ("NMT") Simon Nitinol Filter™ System ("SNF System") is to prevent pulmonary embolisms from migrating to the pulmonary arteries.
Substantial Equivalence
The cleared SNF System and the proposed models of the SNF 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 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 make two types of modifications to the cleared SNF System. First, NMT intends to market models of the SNF System with zero, one, and two gold, radiopaque marker bands. Second, 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 System have the same intended use as the cleared SNF System and the SNF/SL 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 Filter through a sheath inserted into a vein to the inferior vena cava. The minor technological differences between the proposed models of the SNF System and the
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cleared SNF System, namely the addition of one or two radiopaque marker bands to some models and the revision of device labeling to include subclavian delivery of the device does not raise any new questions of safety or effectiveness. Thus, the proposed models of the SNF System are substantially equivalent to the cleared SNF 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.”