SIMON NITINOL FILTER/STRAIGHT LINE SYSTEM

K970099 · Nitinol Medical Technologies, Inc. · DTK · Apr 16, 1997 · Cardiovascular

Device Facts

• Record ID: K970099
• Device Name: SIMON NITINOL FILTER/STRAIGHT LINE SYSTEM
• Applicant: Nitinol Medical Technologies, Inc.
• Product Code: DTK · Cardiovascular
• Decision Date: Apr 16, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.3375
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The intended use of both Systems is to prevent embolisms from migrating to the pulmonary arteries.

Device Story

Vena cava filter system designed to prevent pulmonary embolism. Device consists of nitinol alloy filter with thermal shape memory properties; filter assumes dome shape with six legs at body temperature. Delivered via Seldinger technique using 7 French angiographic introducer sheath; pusher wire advances filter through sheath into inferior vena cava. Sheath withdrawal releases filter, which expands to secure against vessel wall. Modification involves changing gold radiopaque marker band from deposited to mechanically swaged application on introducer sheath. Used by physicians in clinical settings to provide mechanical filtration of emboli.

Clinical Evidence

No clinical data provided; substantial equivalence based on design and technological comparison to predicate devices.

Technological Characteristics

Nitinol alloy filter with thermal shape memory; 7 French I.D. angiographic introducer sheath; stainless steel pusher wire with distal cup/pad; gold radiopaque marker band (mechanically swaged).

Indications for Use

Indicated for patients requiring prevention of pulmonary embolism via placement of a vena cava filter.

Regulatory Classification

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.

Special Controls

*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.”

Predicate Devices

• Simon Nitinol Filter/StraightLine™ System (K963014)
• Simon Nitinol Filter™ System (K963016)

Submission Summary (Full Text)

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APR 15 1997
K970099

510(k) Summary
Simon Nitinol Filter™ System and
Simon Nitinol Filter/Straight Line™ System

Submitter's Name, Address, and Telephone Number

Nitinol Medical Technologies, Inc.
27 Wormwood St. 02210
Phone: [phone]
Facsimile: [phone]

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

1. Simon Nitinol Filter/StraightLine™ System (“SNF/SL System”) (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.

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