SIMON NITINOL FILTER/STRAIGHT LINE SYSTEM

K963014 · Nitinol Medical Technologies, Inc. · DTK · Nov 18, 1996 · Cardiovascular

Device Facts

• Record ID: K963014
• Device Name: SIMON NITINOL FILTER/STRAIGHT LINE SYSTEM
• Applicant: Nitinol Medical Technologies, Inc.
• Product Code: DTK · Cardiovascular
• Decision Date: Nov 18, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.3375
• Device Class: Class 2
• Attributes: Therapeutic

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.

Device Story

The Simon Nitinol Filter/Straight Line™ System is a vena cava filter designed to prevent pulmonary embolism. The device consists of a nitinol alloy filter with thermal shape memory properties and a delivery system. The filter is straightened for delivery through a small-diameter catheter; upon reaching body temperature in the vena cava, it expands into a dome shape with six legs to secure itself against the vessel wall. The system is deployed via the Seldinger technique using a 7 French angiographic introducer sheath. Modifications include the addition of gold radiopaque marker bands and expanded delivery routes, including antecubital and subclavian access. The device is operated by clinicians in a clinical setting to provide mechanical filtration of the blood flow.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Filter material: Nitinol alloy (thermal shape memory). Delivery system: 7 French I.D. angiographic introducer sheath, stainless steel pusher wire with pusher cup. Features: Optional gold radiopaque marker bands. Deployment: Mechanical expansion via body temperature. Sterilization: Not specified.

Indications for Use

Indicated for patients requiring prevention of pulmonary embolism via placement of an intravascular filter in the vena cava.

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/Straight Line™ System (K944353)
• Simon Nitinol Filter™ System (K940489)
• Simon Nitinol Filter™ System (K912144)
• Simon Nitinol Filter™ System (K894703)

Submission Summary (Full Text)

{0}

NOV 18 1996
K963014

# 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
Phone: [phone]
Facsimile: [phone]

## Contact Person

Jonathan S. Kahan, Esq.
Hogan & Hartson, L.L.P.
555 13th Street, N.W.
Washington, D.C. 20004-1109
Phone: [phone]
Facsimile: [phone]

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

\DCC-57841/1-0305594.01

{1}

# Predicate Devices

1. Simon Nitinol Filter/Straight Line™ System (K944353)
2. Simon Nitinol Filter™ System (K940489, K912144, and K894703)

# 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

\DOC - 57841/1 - 0305594.01

{2}

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.

\DOC - 57841/1 - 0305594.01