ECLIPSE FILTER SYSTEM-FEMORAL AND JUGULAR/SUBCLAVIAN DELIVERY KITS

K101431 · C.R. Bard, Inc. · DTK · Jun 25, 2010 · Cardiovascular

Device Facts

• Record ID: K101431
• Device Name: ECLIPSE FILTER SYSTEM-FEMORAL AND JUGULAR/SUBCLAVIAN DELIVERY KITS
• Applicant: C.R. Bard, Inc.
• Product Code: DTK · Cardiovascular
• Decision Date: Jun 25, 2010
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.3375
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The ECLIPSE™ Filter System - Femoral and Jugular/Subclavian Delivery Kits are indicated for use in the prevention of recurrent pulmonary embolism via permanent placement in the vena cava in the following situations: - Pulmonary thromboembolism when anticoagulants are contraindicated. - Failure of anticoagulant therapy for 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. ECLIPSE™ Filter may be removed according to the instructions supplied under the section labeled: Optional Procedure for Filter Removal.

Device Story

Intravascular filter system for permanent placement in inferior vena cava (≤28 mm diameter) to prevent recurrent pulmonary embolism. Device consists of 12 electropolished shape-memory nitinol wires forming two levels of filtration (legs for lower, arms for upper). Delivery kits include introducer catheter, dilator with radiopaque markers for sizing, and pusher system/delivery device. Used in clinical settings by physicians. Physician inserts device via femoral or jugular/subclavian access; contrast medium injected via side port for visualization. Filter deploys to capture emboli. Modification from predicate includes addition of patient brochure and implant card.

Clinical Evidence

Bench testing only. In vitro testing performed for packaging, sterilization, and latex compatibility to demonstrate equivalence to predicate device.

Technological Characteristics

Materials: Electropolished shape-memory nitinol. Design: 12-wire filter with two-level filtration. Delivery: 7F (femoral) or 10F (jugular/subclavian) introducer catheter with radiopaque marker bands for sizing and hemostasis valve. Sterilization: Not specified.

Indications for Use

Indicated for patients requiring prevention of recurrent pulmonary embolism via permanent vena cava placement, specifically those with contraindications to anticoagulants, failure of anticoagulant therapy, or emergency treatment for massive pulmonary embolism.

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

• ECLIPSE™ Filter System - Femoral and Jugular/Subclavian Delivery Kits (K093659)

Submission Summary (Full Text)

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### Response to FDA Questions (K101431) ECLIPSE™ Filter System

Page 11

## ECLIPSE™ Filter System - Femoral and Jugular/Subclavian Delivery Kits 510(k) Summary 21 CFR 807.92

As required by the Safe Medical Devices Act of 1990, coded under Section 513, Part (I)(3)(A) of the Food, Drug and Cosmetic Act, a 510(k) summary upon which substantial equivalence determination is based is as follows:

#### Submitter Information:

- Bard Peripheral Vascular, Inc Applicant: 1625 West 3rd Street Tempe, Arizona 85281
480-638-2906 Phone:

480-449-2546 Fax:

Contact: Joni Creal, Regulatory Affairs Associate

Date: June 21, 2010

#### Subject Device Name:

| Device Trade Name: | ECLIPSE™ Filter System - Femoral<br>Delivery Kit (EC500F) and ECLIPSE™ Filter<br>System – Jugular/Subclavian Delivery Kit<br>(EC500J) |
|-----------------------|---------------------------------------------------------------------------------------------------------------------------------------|
| Common or Usual Name: | Filter, Intravascular, Cardiovascular |
| Classification: | Class II |
| Classification Panel: | Cardiovascular Devices |
| Product Code: | DTK |
| Predicate Devices: | ECLIPSE™ Filter System - Femoral and<br>Jugular/Subclavian Delivery Kits (K003659) |

## Summary of Change:

The primary modification from the predicate device, the ECLIPSE™ Filter System -Femoral and Jugular/Subclavian Delivery System (K093659), to the subject device, the ECLIPSE™ Femoral Filter System and Jugular/Subclavian Delivery System, was an addition of a Patient Brochure and Implant Card to the device labeling. In addition, a

Bard Peripheral Vascular, Inc.

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kangaroo pouch was added to accommodate the Patient Brochure and Implant Card, and minor labeling modifications were made.

#### Device Description:

The ECLIPSE™ Filter consists of twelve electropolished shape-memory nitinol wires emanating from a central electropolished nitinol filter hook. These 12 wires form two levels of embolic filtration: the legs provide the lower level of filtration and the arms provide the upper level of filtration. The ECLIPSE™ Filter is intended to be used in the inferior vena cava with diameters less than or equal to 28 mm.

The ECLIPSE™ Filter System - Femoral Delivery Kit consists of a 7 French inner diameter (I.D.) introducer catheter and dilator set and a storage tube preloaded with the ECLIPSE™ Filter and pusher system. The dilator is fitted with 2 radiopaque marker bands spaced 28 mm apart for caval sizing. The introducer sheath contains a radiopaque tip and hemostasis valve with a side port for injecting contrast medium via a syringe. The storage tube and pusher system attach to the introducer and allow for delivery and deployment of the ECLIPSE™ Filter.

The ECLIPSE™ Filter System – Jugular/Subclavian Delivery Kit consists of a 10 French I.D. introducer catheter and dilator set and a delivery device preloaded with the ECLIPSE™ Filter. The dilator is fitted with 2 radiopaque marker bands spaced 28 mm apart for caval sizing. The introducer sheath contains a radiopaque tip and hemostasis valve with a side port for injecting contrast medium via a syringe. The delivery device fits within the introducer sheath and has a delivery mechanism to deploy the ECLIPSE™ Filter.

#### Indications for Use of Device:

The subject device, the ECLIPSE™ Filter Systems - Femoral and Jugular/Subclavian Delivery Kits, are indicated for use in the prevention of recurrent pulmonary embolism via permanent placement in the vena cava in the following situations:

- Pulmonary thromboembolism when anticoagulants are contraindicated. .
- Failure of anticoagulant therapy for thromboembolic disease. .
- Emergency treatment following massive pulmonary embolism where anticipated . benefits of conventional therapy are reduced.

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#### Response to FDA Questions (K101431) ECLIPSE™ Filter System

- Chronic, recurrent pulmonary embolism where anticoagulant therapy has failed . or is contraindicated.
ECLIPSE™ Filter may be removed according to the instructions supplied under the section labeled: Optional Procedure for Filter Removal.

## Technological Comparison to Predicate Devices:

The technological characteristics of the subject device, the ECLIPSE™ Filter System -Femoral and Jugular/Subclavian Delivery Kits, are substantially equivalent to those of the predicate device, the ECLIPSE™ Filter System - Femoral and Jugular/Subclavian Delivery System (K093659), in terms of intended use, indications for use, application, user population, same operating principle, filter design, delivery system design, fundamental scientific technology, performance, and sterilization method.

#### Performance Testing Summary:

To demonstrate substantial equivalence of the subject device, the ECLIPSE™ Filter System - Femoral and Jugular/Subclavian Delivery Kits to the predicate device, the technological characteristics and performance criterion were evaluated using in vitro testing performed as outlined below:

- Packaging Testing .
- Sterilization Testing .
- Latex Testing .

The results from these tests demonstrate that the technological characteristics and performance criteria of the ECLIPSE™ Filter System – Femoral and Jugular/Subclavian Delivery Kits are comparable to the predicate device and that it can perform in a manner equivalent to devices currently on the market for the same intended use.

#### Conclusions:

The ECLIPSE™ Filter Systems - Femoral and Jugular/Subclavian Delivery Kits are y substantially equivalent to the legally marketed predicate device, the ECLIPSE™ Filter System - Femoral and Jugular/Subclavian Delivery System (K093659).

Bard Peripheral Vascular, Inc.

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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing right, resembling a bird in flight. The profiles are stacked on top of each other, creating a sense of depth and movement.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002

JUN 2 5 2010

Bard Peripheral Vascular, Inc. c/o Joni Creal Regulatory Affairs Associate 1625 West 3rd Street Tempe, AZ 85281

Re: K101431

Trade Name: ECLISPE Filter System - Femoral Delivery Kit and ECLISPE Filter System - Jugular/Subclavian Delivery Kit Regulation Number: 21 CFR 870.3375 Regulation Name: Cardiovascular intravascular filter Regulatory Class: Class II Product Code: DTK Dated: June 21, 2010 Received: June 22, 2010

Dear Ms. Creal:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.

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

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# Page 2 - Ms. Creal

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Duna R. Vahner

ABram 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

510(k) Number (if known): K101431

Device Name: ECLIPSE™ Filter System - Femoral and Jugular/Subclavian Delivery Kits

### Indications for Use:

The ECLIPSE™ Filter System - Femoral and Jugular/Subclavian Delivery Kits are indicated for use in the prevention of recurrent pulmonary embolism via permanent placement in the vena cava in the following situations:

- . Pulmonary thromboembolism when anticoagulants are contraindicated.
- . Failure of anticoagulant therapy for 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.

ECLIPSE™ Filter may be removed according to the instructions supplied under the section labeled: Optional Procedure for Filter Removal.

Prescription Use_X (Part21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Cardiovascular Devices

| 510(k) Number | K101431 |
|---------------|---------|
|---------------|---------|

Bard Peripheral Vascular, Inc.