GUNHTER TULIP VENA CAVA MREYE FILTER AND RETRIEVAL SET

K032426 · Cook, Inc. · DTK · Oct 31, 2003 · Cardiovascular

Device Facts

• Record ID: K032426
• Device Name: GUNHTER TULIP VENA CAVA MREYE FILTER AND RETRIEVAL SET
• Applicant: Cook, Inc.
• Product Code: DTK · Cardiovascular
• Decision Date: Oct 31, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.3375
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

Filter Set: The Günther Tulip™ Vena Cava Filter Set is indicated for the prevention of recurrent pulmonary embolism via placement in the vena cava in the following situations: - Pulmonary thromboembolism when anticoagulant therapy is contraindicated; . - Failure of anticoagulant therapy in thromboembolic diseases; . - Emergency treatment following massive pulmonary embolism where anticipated . benefits of conventional therapy are reduced; and - . Chronic, recurrent pulmonary embolism where anticoagulant therapy has failed or is . contraindicated. The Günther Tulip™ Vena Cava Filter may be retrieved according to the instructions supplied in the section labeled: Optional Retrieval Procedure. Retrieval Set: The Günther Tulip™ Vena Cava Filter Retrieval Set has been designed for retrieval of an implanted Günther Tulip™ Vena Cava Filter in patients who no longer require a filter. Retrieval of the filter can be performed only by jugular approach.

Device Story

Inferior vena cava filter; radiopaque tip; introduced via femoral or jugular vein. Retrieval set includes radiopaque catheter with braided platinum loop at distal end. Used in clinical settings by physicians. Filter captures emboli to prevent pulmonary embolism; retrieval set allows removal of filter when no longer clinically indicated. Benefits include prevention of recurrent PE and flexibility for temporary placement. Clinical study (n=41) demonstrated successful retrieval up to 14+ days post-implantation with no adverse events.

Clinical Evidence

Clinical study of 41 patients (19 female, 22 male) evaluated safety of filter retrieval. Indications included trauma, prophylaxis, and anticoagulation failure. 26 attempted retrievals were successful; 15 patients required permanent implantation. Retrieval performed between 2-20 days (mean 11.4 days). No adverse events reported in retrieved group. 23 patients followed for 3 months post-retrieval with no reported abnormalities.

Technological Characteristics

Inferior vena cava filter with radiopaque tip; retrieval catheter features braided platinum loop. Materials subjected to biocompatibility, stress, and tensile testing. Device is non-powered, mechanical, and radiopaque for visualization.

Indications for Use

Indicated for patients requiring prevention of recurrent pulmonary embolism due to contraindication or failure of anticoagulant therapy, or following massive pulmonary embolism. Applicable to patients requiring temporary filter placement with subsequent retrieval via jugular approach.

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

• Günther Tulip™ Vena Cava MReye® Filter (K000855)
• Amplatz Goose Neck Snare (K972511)
• Radius Microsnare (K022201)

Submission Summary (Full Text)

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OCT 3 1 2003

# 510(k) SUMMARY

| Submitted By: | Cook Incorporated |
|----------------|--------------------------------|
| Contact: | Jennifer Bosley, MBA |
| | Regulatory Affairs Coordinator |
| | Tel: [phone] |
| | Fax: [phone] |
| Date Prepared: | October 31, 2003 |

## Device:

| Trade Name: | Günther Tulip™ Vena Cava Filter and Retrieval Set |
|--------------------------------------------|-----------------------------------------------------------------------------------------|
| Common/Usual Name | Inferior Vena Cava Filter and Retrieval Set |
| Proposed Classification:<br>& Product Code | Filter, Intravascular, Cardiovascular<br>21 CFR §870.3375, Class II, DTK—Cardiovascular |

# Intended Use:

Filter Set:

The Günther Tulip™ Vena Cava Filter Set is indicated for the prevention of recurrent pulmonary embolism via placement in the vena cava in the following situations:

- Pulmonary thromboembolism when anticoagulant therapy is contraindicated; .
- Failure of anticoagulant therapy in thromboembolic diseases; .
- Emergency treatment following massive pulmonary embolism where anticipated . benefits of conventional therapy are reduced; and
- . Chronic, recurrent pulmonary embolism where anticoagulant therapy has failed or is contraindicated.

The Günther Tulip™ Vena Cava Filter may be retrieved according to the instructions supplied in the section labeled: Optional Retrieval Procedure.

# Retrieval Set:

The Günther Tulip™ Vena Cava Filter Retrieval Set has been designed for retrieval of an implanted Günther Tulip™ Vena Cava Filter in patients who no longer require a filter. Retrieval of the filter can be performed only by jugular approach.

# Predicate Devices:

The subject devices are substantially equivalent to predicate devices: Günther Tulip™ Vena Cava MReye® Filter, #K000855 (Cook Incorporated); Amplatz Goose Neck Snare, #K972511 (Microvena Corp.); and the Radius Microsnare, #K022201 (Radius Medical Technologies).

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## Device Description:

The Günther Tulip™ Vena Cava Filter and Retrieval Set is an inferior vena cava filter with a radiopaque band at the tip, which can be introduced via either femoral or jugular vein. The radiopaque retrieval catheter has a braided platinum loop at the distal end.

### Substantial Equivalence:

The subject device is similar with respect to intended use, materials and functional characteristics of commercially available predicate devices in terms of section 510(k) substantial equivalence; any differences that may exist do not significantly affect the safety and effectiveness of the device.

## Test Data:

The Günther Tulip™ Vena Cava Filter and Retrieval Set have been subjected to and have passed the following tests to ensure reliable design and performance under the specified testing parameters:

Filter Set:

- · Biocompatibility
- Material and stress analysis tests
- · Clinical experience

Retrieval Set:

- · Biocompatibility
- · Tensile
- Clinical evaluation

## Clinical Experience:

To evaluate the safety of retrieving the Günther Tulip™ Vena Cava Filter, a clinical study was conducted in which 41 patients [female (n=19); male (n=22)] were enrolled for possible retrieval of the filter. Indications for placement of retrievable filter in the study included: bleeding while anticoagulated (n=2), recent bleeding not anticoagulated (n=0), prophylactic pre-op (n=12), prophylactic post-op (n=3), failure of anticoagulation resulting in recurrent PE (n=1), failure of anticoagulation resulting in extension of DVT (n=0), prophylaxis following PE (n=3), prophylaxis with extensive DVT (n=3), trauma (n=13) and other (n=4).

Retrieval was not attempted in 15 patients due to the continued need for permanent implantation of the filter. A total of 26 attempted retrievals in 26 patients were successful. [n= number of filters retrieved] Retrieval of filter immediately after deployment at Day 0 (n=1), Day 2 (n=1), Day 7 (n=1), Day 9 (n=3), Day 10 (n=6), Day 11(n=2), Day 12 (n=1), Day 13 (n=4), Day 14 (n=6), Day 20 (n=1). No adverse events were reported in the retrieved filter group. 23 patients in whom a filter was retrieved were followed for three months post retrieval with no abnormalities reported. Results from the clinical study showed that the filter could be safely retrieved up to 14 days or longer in patients who no longer required an inferior vena cava filter. Time to retrieval ranged from 2-20 days with a mean implantation time of 11.4 days.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with three stripes representing the three levels of government: federal, state, and local. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA". The seal is black and white.

Public Health Service

OCT 3 1 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Cook Incorporated c/o Ms. Jennifer J. Bosley Regulatory Affairs Coordinator P.O. Box 489 Bloomington, IN 47402-0489

Re: K032426

Günther Tulip™ Vena Cava MReye® Filter and Retrieval Set Regulation Number: 21 CFR 870.3375 Regulation Name: Cardiovascular intravascular filter Regulatory Class: Class II Product Code: DTK Dated: August 5, 2003 Received: August 6, 2003

Dear Ms. Bosley:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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#### Page 2 - Ms. Jennifer J. Bosley

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely vours.

Ashley B. Boane

Image /page/3/Picture/5 description: The image shows a signature in black ink on a white background. The signature appears to be stylized and cursive, with looping strokes and connected letters. The overall impression is that of a quick, fluid, and practiced signature.

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center, for Devices and Radiological Health

Enclosure

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### Indications for Use Statement

#### K032426 510(k) Number (if known): ____

Günther Tulip™ Vena Cava Filter and Retrieval Set Device Name:

#### Filter Set

The Günther Tulip™ Vena Cava Filter Set is indicated for the prevention of recurrent pulmonary embolism via placement in the vena cava in the following situations:

- Pulmonary thromboembolism when anticoagulant therapy is contraindicated; .
- Failure of anticoagulant therapy in thromboembolic diseases; .
- Emergency treatment following massive pulmonary embolism where anticipated benefits of . conventional therapy are reduced; and
- Chronic, recurrent pulmonary embolism where anticoagulant therapy has failed or is . contraindicated.

The Günther Tulip™ Vena Cava Filter may be retrieved according to the instructions supplied in the section labeled: Optional Retrieval Procedure.

#### Retrieval Set

The Günther Tulip™ Vena Cava Filter Retrieval Set has been designed for retrieval of an implanted Günther Tulip™ Vena Cava Filter in patients who no longer require a filter. Retrieval of the filter can be performed only by jugular approach.

# PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use_ (Per 21 CFR 801.109)

OR

Over-The-Counter Use (Optional Format 1-2-96)

Ashley B. Boane

(Division Sign-Off)
Division of Cardiovascular Devices

510(k) Number K032426