G2 EXPRESS FILTER SYSTEM - FEMORAL AND JUGULAR/SUBCLAVIAN DELIVERY KITS

K082305 · C.R. Bard, Inc. · DTK · Oct 31, 2008 · Cardiovascular

Device Facts

• Record ID: K082305
• Device Name: G2 EXPRESS FILTER SYSTEM - FEMORAL AND JUGULAR/SUBCLAVIAN DELIVERY KITS
• Applicant: C.R. Bard, Inc.
• Product Code: DTK · Cardiovascular
• Decision Date: Oct 31, 2008
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.3375
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The G2 EXPRESS™ 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. G2 EXPRESS™ Filter may be removed according to the instructions supplied under the section labeled: Optional Procedure for Filter Removal.

Device Story

The G2 EXPRESS™ Filter System is an intravascular device designed for permanent placement in the inferior vena cava (diameters ≤ 28 mm) to prevent pulmonary embolism. The filter consists of 12 shape-memory nitinol wires arranged in two levels (legs for lower filtration, arms for upper filtration) emanating from a central sleeve with a snare tip. The system is provided in two delivery configurations: a 10 Fr jugular/subclavian kit (introducer sheath/dilator) and a 7 Fr femoral kit (introducer catheter/dilator). The device is operated by a physician in a clinical setting to gain venous access and deploy the filter via the delivery mechanism. The filter captures emboli, reducing the risk of pulmonary embolism in patients where anticoagulation is contraindicated or has failed. The device is designed for permanent placement but includes an optional removal procedure.

Clinical Evidence

No clinical data provided. Substantial equivalence is supported by design verification and validation testing demonstrating that the device meets all predetermined acceptance criteria.

Technological Characteristics

Device consists of 12 shape-memory nitinol wires. Delivery systems include 10 Fr I.D. introducer sheath/dilator (jugular/subclavian) or 7 Fr I.D. introducer catheter/dilator (femoral). Operates via mechanical deployment of a self-expanding nitinol filter. Intended for vena cava diameters ≤ 28 mm.

Indications for Use

Indicated for patients requiring prevention of recurrent pulmonary embolism via permanent vena cava placement. Applicable for patients with contraindications to anticoagulants, failure of anticoagulant therapy, or emergency treatment for massive pulmonary embolism. Filter is removable per instructions.

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

• G2 EXPRESS™ Filter System - Femoral Delivery Kit (K080668)
• G2 EXPRESS™ Filter System - Jugular/Subclavian Delivery Kit (K080668)

Submission Summary (Full Text)

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KOR2305

### G2 EXPRESS™ 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 summary of the information upon which substantial equivalence determination is based as follows:

- 1. Submitter Information:

| Applicant: | Bard Peripheral Vascular, Inc<br>1625 West 3rd Street<br>PO Box 1740<br>Tempe, Arizona 85280 | OCT 31 2008 |
|------------|----------------------------------------------------------------------------------------------|-------------|
| Phone: | 480-303-2524 | |
| Fax: | 480-449-2546 | |
| Contact: | Genevieve Balutowski<br>Associate Project Manager, Regulatory Affairs | |

### 2. Subject Device:

| Device Trade Name: | G2 EXPRESS™ Filter System – Femoral Delivery Kit<br>and G2 EXPRESS™ Filter System –<br>Jugular/Subclavian Delivery Kit |
|-----------------------|------------------------------------------------------------------------------------------------------------------------|
| Common or Usual Name: | Filter, Intravascular, Cardiovascular |
| Classification: | Class II |
| Classification Panel: | Cardiovascular |

### 3. Predicate Device:

G2 EXPRESS™ Filter System -- Femoral Delivery Kit (K080668)

G2 EXPRESS™ Filter System - Jugular/Subclavian Delivery Kit (K080668)

Image /page/0/Picture/13 description: The image shows the word "BARD" in a bold, sans-serif font. The letters are outlined in black, giving them a distinct and clear appearance. The overall design is simple and straightforward, focusing on the legibility of the word.

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# 4. Summary of Change:

The modification from the predicate device, the G2 EXPRESS™ Filter System -Femoral and Jugular/Subclavian Delivery System, to the subject device, the G2 EXPRESS™ Filter System Femoral and Jugular/Subclavian Delivery System, consisted of design improvements of the femoral and jugular/subclavian delivery kits.

# 5. Device Description:

The G2 EXPRESS™ Filter consists of 12 shape-memory nitinol wires emanating from a central nitinol sleeve with a snare tip. These 12 wires form two levels of emboli filtration: the legs provide the lower level of filtration and the arms provide the upper level of filtration. The G2 EXPRESS™ Filter is intended to be used in the inferior vena cava with diameters less than or equal to 28 mm.

The G2 EXPRESS™ Filter System – Jugular/Subclavian Delivery Kit consists of a 10 Fr I.D. introducer sheath and dilator set and a delivery device preloaded with the G2 EXPRESS™ Filter. The introducer sheath and dilator are used to gain access to the inferior vena cava via a jugular approach. The delivery device fits within the introducer sheath and consists of a delivery mechanism to deploy the G2 EXPRESS™ Filter.

The G2® EXPRESS™ Filter System - Femoral Delivery Kit consists of a 7 Fr I.D. introducer catheter and dilator set and a storage tube preloaded with the G2 EXPRESS™ Filter and delivery device. The introducer sheath and dilator are used to gain access to the inferior vena cava via a femoral approach. The delivery device fits within the introducer sheath and consists of a delivery mechanism to deploy the G2 EXPRESS™ Filter.

## 6. Indication for Use of Device:

The G2 EXPRESS™ 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. .

Image /page/1/Picture/13 description: The image shows the word "BARD" in a bold, outlined font. The letters are large and blocky, with a distinct, geometric style. The black outlines of the letters stand out against the white background, creating a clear and legible design. The overall impression is one of strength and simplicity.

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- 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.
- G2 EXPRESS™ Filter may be removed according to the instructions supplied . under the section labeled: Optional Procedure for Filter Removal.

# 7. Technological Comparison to Predicate Device:

The technological characteristics of the subject device, the G2 EXPRESS™ Filter System – Femoral and Jugular/Subclavian Delivery Kits, are substantially equivalent to those of the predicate devices, the G2 EXPRESS™ Filter System - Femoral and Jugular/Subclavian Delivery Kits (K080668), in terms of intended use, indications for use, application, user population, basic design, fundamental scientific technology, performance, and sterilization method.

### 8. Conclusions:

The G2 EXPRESS™ Filter System – Femoral and Jugular/Subclavian Delivery Kits met all predetermined acceptance criteria of design verification and validation as specified by applicable standards, guidance, test protocols and/or customer inputs. The G2 EXPRESS™ Filter System - Femoral and Jugular/Subclavian Delivery Kits is substantially equivalent to the legally marketed predicate device, the G2 EXPRESS™ Filter System - Femoral and Jugular/Subclavian Delivery Kits.

Image /page/2/Picture/10 description: The image shows the word "BARD" in a bold, outlined font. The letters are all capitalized and evenly spaced. The font style gives the word a blocky, almost three-dimensional appearance.

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Public Health Service

Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circle around the eagle. The eagle is black, and the text is also black. The logo is simple and recognizable.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 3 1 2008

Bard Peripheral Vascular, Inc. Ms. Genevieve Balutowski Senior Regulatory Affairs Specialist P.O. Box 1740 Tempe, AZ 85280

Re: K082305

Trade/Device Name: G2 Express Filter System – Fcmoral and Jugular/Subclavian Delivery Kits Regulation Number: 21 CFR 870.3375 Regulation Name: Cardiovascular Intravascular Filter Regulatory Class: Class II (two) Product Code: DTK Dated: September 29, 2008 Received: September 30, 2008

Dear Ms. Balutowski:

We have reviewed your Section 510(k) premarket notification of intent to market the device w on to roviewed your we determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for ass surfed in the May 28, 1976, the enactment date of the Medical Device Amendments, or to conniferoo pror to Hay 2003 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 r ou may, therefore, issues of the Act include requirements for annual registration, listing of general voltable profilering 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 rr your do roo to existing (controls. Existing major regulations affecting your device can may or subject to back as a substions, 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. Genevieve Balutowski

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 (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. 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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/industry/support/index.html.

Sincerely yours,

signature

Bran 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

510(k) Number (if known):

Device Name: G2 EXPRESS™ Filter System - Femoral and Jugular/Subclavian Delivery Kits

# Indications for Use:

The G2 EXPRESS™ 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.
- G2 EXPRESS™ Filter may be removed according to the instructions supplied . under the section labeled: Optional Procedure for Fitter 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 | K082205 |
| Bard Peripheral Vascular, Inc. | TRADE SECRET/CONFIDENTIAL INFORMATION<br>Notify CR Bard Before Releasing this Document. |
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