MODIFICATION TO G2 FILTER SYSTEM-FEMORAL DELIVERY KIT, MODEL RF-310F

K062887 · Bard Peripheral Vascular · DTK · Oct 26, 2006 · Cardiovascular

Device Facts

• Record ID: K062887
• Device Name: MODIFICATION TO G2 FILTER SYSTEM-FEMORAL DELIVERY KIT, MODEL RF-310F
• Applicant: Bard Peripheral Vascular
• Product Code: DTK · Cardiovascular
• Decision Date: Oct 26, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.3375
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The G2™ Filter System - Femoral Delivery Kit is 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.

Device Story

Vena cava filter delivery system; used for permanent placement of G2 filter in inferior vena cava. Kit includes 7 French introducer catheter, dilator, and storage tube with preloaded filter and pusher system. Physician gains venous access via Seldinger technique; introducer catheter features radiopaque markers for positioning; pusher system uses nitinol wire to deploy filter. Device intended for permanent placement; safety/effectiveness for retrievable/temporary use not established. Used in clinical settings by physicians to prevent recurrent pulmonary embolism in patients where anticoagulation is contraindicated or failed.

Clinical Evidence

Bench testing only. No clinical data provided. Device met all predetermined acceptance criteria of design verification and validation as specified by applicable standards, guidance, and test protocols.

Technological Characteristics

7 French introducer catheter; dilator accepts 0.038" guidewire; nitinol pusher wire; radiopaque marker bands. Permanent vena cava filter. Sterilization method not specified. No software or electronic components.

Indications for Use

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

• G2™ Filter System - Femoral Delivery Kit (K050558)

Submission Summary (Full Text)

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K062887

Page 64

OCT 2 6 2006

# G2™ Filter System - Femoral Delivery Kit 510(k) Summary of Safety and Effectiveness 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 safety and effectiveness information upon which substantial equivalence determination is based as follows:

- Submitter Information: 1.
- Bard Peripheral Vascular, Inc Applicant: 1625 West 3rd Street P.O. Box 1740 Tempe, Arizona 85280
- 480-303-2524 Phone:
- 480-449-2546 Fax:
- Contact: Genevieve Balutowski, Senior Regulatory Affairs Specialist

### 2. Subject Device Name:

| Device Trade Name: | G2™ Filter System - Femoral<br>Delivery Kit |
|-----------------------|---------------------------------------------|
| Common or Usual Name: | Vena Cava Filter |
| Classification: | Class II |
| Classification Panel: | Cardiovascular |

#### 3. Predicate Device:

G2 ™ Filter System - Femoral Delivery Kit (K050558, cleared 8/29/05)

### Summary of Change: 4.

The design modification to the G2™ Filter System - Femoral Delivery Kit, as represented in this submission, is a modification to a component of the current delivery system. The G2TM Filter component of the subject device remains the same as the predicate device.

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#### Device Description: 5.

The G2™ Filter System – Femoral Delivery Kit consists of a 7 French inner diameter (1.D.) introducer catheter and dilator set (Kit A) and a storage tube preloaded with the G2™ Filter and pusher system (Kit B). Kit A (introducer catheter and dilator) is used to gain access to the inferior vena cava using the Seldinger technique. The dilator accepts a 0.038" guidewire and the introducer catheter has 2 radiopaque marker bands on distal end to assist in filter delivery. The pusher system (Kit B), designed to pass through the introducer catheter, consists a grooved segment designed to hold and properly orient the filter legs and a flexible nitinol wire with a pad at the end that pushes on the filter apex.

### Intended Use of Device: 6.

The G2™ Filter System – Femoral Delivery Kit is 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.

The subject device has the same intended use and indications of use as the predicate device, the G2™ Filter System - Femoral Delivery Kit (K050558, cleared 08/29/05).

### 7. Technological Comparison to Predicate Device:

The technological characteristics of G2™ Filter System - Femoral Delivery Kit are substantially equivalent to those of the predicate device, the G2™ Filter System -Femoral Delivery Kit, in terms of intended use, indication for use, application, user population, basic design, fundamental scientific technology, performance, and sterilization method.

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#### Conclusions: 8.

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

Bard Peripheral Vascular, Inc.

TRADE SECRET/CONFIDENTIAL INFORMATION Notify CR Bard Before Releasing this Document.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 2 6 2006

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

Re: K062887

Trade Name: G2 Filter System Regulation Number: 21 CFR 870.3375 Regulation Name: Cardiovascular Intravascular Filter Regulatory Class: Class II (two) Product Code: DTK Dated: September 25, 2005 Received: September 26, 2005

Dear Ms. Balutowski:

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). You may, therefore, market the device, subject to the general controls provisions of the Act and the limitations described below. 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.

The Office of Device Evaluation has determined that there is a reasonable likelihood that this device will be used for an intended use not identified in the proposed labeling and that such use could cause harm. Therefore, in accordance with Section 513(i)(1)(E) of the Act, the following limitation must appear in the Precautions section of the device's labeling and in promotional materials:

The safety and effectiveness of the G2 Filter System for use as a retrievable or temporary filter have not been established.

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# Page 2 - Ms. Genevieve Balutowski

Furthermore, the indication for permanent placement of the G2 Filter System must be prominently displayed in all labeling, including pouch box, and carton labels, instructions for use, and other promotional materials, in close proximity to the trade name, of a similar point size, and in bold print.

Please note that the above labeling limitations are required by Section 513(i)(1)(E) of the Act. Therefore, a new 510(k) is required before these limitations are modified in any way or removed from the device's labeling.

The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and permits your device to proceed to the market. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification if the limitation statement described above is added to your labeling.

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 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.

If you desire specific information about the application of other labeling requirements to your device (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). You may obtain other general information on your responsibilities under

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Page 3 - Ms. Genevieve Balutowski

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,

Clinton MD for

Donna-Bea Tillman, Ph.D. Director Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known): K062887

Device Name: G2TM Filter System – Femoral Delivery Kit

# Indications for Use:

The G2™ Filter System – Femoral Delivery Kit is 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.

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)

Page 1 of 1

Druce E. Ladner

ivision of Cardiovascular Devices

510(k) Number_KO67 88 +