SIMON NITINOL FILTER SYSTEM

K963016 · Nitinol Medical Technologies, Inc. · DTK · Nov 18, 1996 · Cardiovascular

Device Facts

• Record ID: K963016
• Device Name: SIMON NITINOL FILTER 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™ System ("SNF System") is to prevent pulmonary embolisms from migrating to the pulmonary arteries.

Device Story

Simon Nitinol Filter™ System is a vena cava filter designed to prevent pulmonary embolism. Device consists of a nitinol alloy filter with thermal shape memory properties and a delivery system. Filter is straightened for delivery through a 7 French angiographic introducer sheath via the Seldinger technique. Upon reaching body temperature in the vena cava, the filter expands into a dome shape with six legs to secure itself against the vessel wall. Modifications include the addition of gold radiopaque marker bands and expanded labeling for subclavian delivery. The device is used by physicians in a clinical setting. The filter acts as a mechanical barrier to prevent emboli from reaching the pulmonary arteries.

Clinical Evidence

No clinical data provided; substantial equivalence is based on design, intended use, and technological similarities to predicate devices.

Technological Characteristics

Filter material: Nitinol alloy with thermal shape memory. Delivery system: 7 French I.D. angiographic introducer sheath, pusher wire with stainless steel pusher cup/pad. Radiopaque markers: Gold bands (zero, one, or two). Principle: Shape memory expansion at body temperature. Delivery method: Seldinger technique.

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

Submission Summary (Full Text)

{0}

NOV 18 1996
K963076

# 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
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™ System

**Classification Name**

Cardiovascular Intravascular Filter

**Common Name**

Vena Cava Filter System

**Product Code**

DTK

\DOC - 57841/1 - 0309060.01
Page 1

{1}

# Predicate Devices

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

# 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

\ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \

{2}

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.

\DOC - 57841/1 - 0309060.01