STAINLESS STEEL GREENFIELD VENA CAVA FILTER WITH 12F INTRODUCER SYSTEM

K964284 · Boston Scientific Corp · DTK · Jan 6, 1997 · Cardiovascular

Device Facts

• Record ID: K964284
• Device Name: STAINLESS STEEL GREENFIELD VENA CAVA FILTER WITH 12F INTRODUCER SYSTEM
• Applicant: Boston Scientific Corp
• Product Code: DTK · Cardiovascular
• Decision Date: Jan 6, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.3375
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Stainless Steel Greenfield® Vena Cava Filter with 12F Introducer System is indicated for the prevention of pulmonary embolism via placement in the vena cava in the following situations: Venous thrombosis or pulmonary thromboembolism when anticoagulants are contraindicated or inadequate for management of venous thrombosis with significant risk of, or following, pulmonary thromboembolism. Failure of anticoagulant therapy in thromboembolic disease. Emergency treatment following massive pulmonary embolism where anticipated benefits of conventional therapy are reduced. Chronic, recurrent pulmonary embolism where anticoagulant therapy has failed or is contraindicated.

Device Story

System comprises sequential vascular dilators, guidewire, introducer sheath, and introducer catheter; used for percutaneous placement of Greenfield vena cava filter. Guidewire facilitates navigation of introducer sheath/dilator to implant site; introducer catheter transports pre-loaded filter through sheath over guidewire for deployment. Used in clinical settings by physicians to prevent pulmonary embolism in patients with thromboembolic disease. Device provides mechanical filtration of blood flow in vena cava to trap emboli.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench and animal testing.

Technological Characteristics

System includes stainless steel filter, vascular dilators, guidewire, introducer sheath, and catheter. Biocompatibility evaluated per ISO-10993 and Tripartite Biocompatibility Guidance (#G87-1).

Indications for Use

Indicated for prevention of pulmonary embolism in patients with venous thrombosis/thromboembolism where anticoagulants are contraindicated/inadequate, anticoagulant therapy failure, massive pulmonary embolism, or chronic recurrent pulmonary embolism. Contraindicated in patients with IVC diameter >28 mm, thrombus at femoral/iliac/IVC sites, or confirmed pregnancy.

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

• Stainless Steel Greenfield® Vena Cava Filter with 12F Introducer System (K912035)

Submission Summary (Full Text)

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Boston Scientific Corporation
One Boston Scientific Place
Natick, MA 01760-1537
508·650·8000
K964284
Jan 4, 1997

# 510(k) Summary

Pursuant to §513(i)(3)(A) of the Food, Drug, and Cosmetic Act, Boston Scientific Corporation is required to submit with this Premarket Notification “... adequate summary of any information respecting safety and effectiveness or state that such information will be made available upon request of any person.” Boston Scientific Corporation chooses to submit a summary of information respecting safety and effectiveness.

**Trade Name:**
Stainless Steel Greenfield®
Vena Cava Filter with
12F Introducer System

**Manufacturer:**
Boston Scientific Corporation
480 Pleasant Street
Watertown, MA 02172

**Device Generic Name:**
Guidewire for Vena Cava Filter System

**Classification:**
According to Section 513 of the Federal Food, Drug and Cosmetic Act, FDA has classified cardiovascular intravascular filters in Class III, 21 CFR § 870.3375, under guidance by the Circulatory Systems Devices Panel. Although 21 CFR § 870.3375 requires premarket approval for cardiovascular intravascular filters, no effective date has been established for the requirement of PMA's for these devices at this time.

**Predicate Device:**
Stainless Steel Greenfield®
Vena Cava Filter with
12F Introducer System

**Device Description:**
The Stainless Steel Greenfield® Vena Cava Filter with 12F Introducer System consists of sequential vascular dilators for percutaneous access; a guidewire to guide the Introducer Sheath and Dilator into place; an Introducer Sheath and Dilator to create a passageway to guide the Introducer Catheter to the implant site; and an Introducer Catheter to transport the pre-loaded filter through the sheath and over the guidewire to the implant site for filter deployment.

**Indications For Use:**
The Stainless Steel Greenfield® Vena Cava Filter with 12F Introducer System is indicated for the prevention of pulmonary embolism via placement in the vena cava in the following situations:

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Boston Scientific Corporation

- Venous thrombosis or pulmonary thromboembolism when anticoagulants are contraindicated or inadequate for management of venous thrombosis with significant risk of, or following, pulmonary thromboembolism.
- Failure of anticoagulant therapy in thromboembolic disease.
- Emergency treatment following massive pulmonary embolism where anticipated benefits of conventional therapy are reduced.
- Chronic, recurrent pulmonary embolism where anticoagulant therapy has failed or is contraindicated.

## Contraindications:

Patients in whom the diameter of the inferior vena cava exceeds 28 mm are contraindicated for the placement of the Stainless Steel Greenfield® Vena Cava Filter with 12F Introducer System.

- Presence of thrombus at the femoral puncture site, in the iliac vein, or in the inferior vena cava risks the dislodgement of thrombus during catheter manipulation.
- Patients in whom pregnancy has been confirmed.

## Safety and Performance:

Bench and Animal testing were performed and the data supported the substantial equivalence of the proposed guidewire for the *Juguler Stainless Steel Greenfield® Vena Cava Filter* with 12F Introducer System to the current guidewire of the *Juguler Stainless Steel Greenfield® Vena Cava Filter* with 12F Introducer System.

The biocompatibility of the Stainless Steel Greenfield® Vena Cava Filter with 12F Introducer System (K912035) was previously established through biocompatibility testing performed on the predicate in accordance with the *Tripartite Biocompatibility Guidance* (#G87-1). This testing is also in accordance with blue book memorandum #G95-1, "Use of International Standard ISO-10993, *Biologically Evaluation of Medical Devices Part 1: Evaluation and Testing* with FDA-modified matrix.

## Conclusion:

Based upon the indications for use, technological characteristics, and safety and performance testing, the guidewire for the *Juguler Stainless Steel Greenfield® Vena Cava Filter* with 12F Introducer System meets the requirements for its intended use.