MODIFICATION TO: RECOVERY FILTER SYSTEM, MODEL RF-210F

K050558 · C.R. Bard, Inc. · DTK · Aug 29, 2005 · Cardiovascular

Device Facts

• Record ID: K050558
• Device Name: MODIFICATION TO: RECOVERY FILTER SYSTEM, MODEL RF-210F
• Applicant: C.R. Bard, Inc.
• Product Code: DTK · Cardiovascular
• Decision Date: Aug 29, 2005
• Decision: SESU
• Submission Type: Traditional
• Regulation: 21 CFR 870.3375
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The G2 Filter 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

The G2 Filter System is an endovascular device designed for permanent placement in the vena cava to prevent pulmonary embolism. It functions as a mechanical filter to capture thrombi. The device is deployed by a physician in a clinical setting using a delivery system. The filter geometry is modified from the predicate device to improve performance. The physician uses the device to provide mechanical prophylaxis against pulmonary embolism in patients where anticoagulation is not viable or has failed. The device provides a physical barrier to emboli, potentially reducing the risk of life-threatening pulmonary events.

Clinical Evidence

No clinical data provided; substantial equivalence is based on design verification and validation activities.

Technological Characteristics

Endovascular vena cava filter; permanent placement; delivery system modified for geometry; materials identical to predicate; sterilization method identical to predicate.

Indications for Use

Indicated for patients requiring permanent vena cava filtration to prevent recurrent pulmonary embolism, specifically those with contraindications to anticoagulants, failure of anticoagulant therapy, or emergency cases of massive pulmonary embolism where conventional therapy benefits are reduced.

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

• Recovery Filter System (K022236)

Reference Devices

• K031328

Submission Summary (Full Text)

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# KOSOSSB 0 1 of 3 Page 54

### Summary of Safety and Effectiveness

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: A..
- Bard Peripheral Vascular, Inc Applicant: 1625 West 3rd Street P.O. Box 1740 Tempe, Arizona 85280
- 480-303-2539 Phone:
- Fax: [phone]
- Shari L. Allen, Director of Regulatory Affairs and Clinical Research Contact:

#### G2 Filter System Subject Device Name: B.

Vena Cava Filter Common or Usual Name:

Class II with Special Controls Classification:

The special controls for this device are compliant with the following:

- FDA's "Guidance for Cardiovascular Intravascular Filter 510(k) Submissions", issued l on November 26, 1999.
- BS EN 12006-3:1999 entitled, "Non-Active Surgical Implants Particular । Requirements for Cardiac and Vascular Implants - Part 3: Endovascular Devices".

#### Predicate Device C.

Recovery Filter System (K022236, cleared 11/27/02) Device Name(s):

Class II with Special Controls Classification:

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### Subject Device Description: D.

The G2 Filter System (subject) description is identical to the Recovery Filter System (predicate) description and indications for use. The modifications made to the predicate filter device and delivery system are primarily dimensional. No material changes or additional components have been incorporated.

The predicate filter device has been modified as a result of continued product improvement. The predicate delivery system has been modified to accommodate the geometry modifications of the predicate filter.

### Statement of Intended Use for Subject Device: E.

The G2 Filter 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.

Image /page/1/Picture/12 description: The image shows the word "BARD" in a bold, outlined font. The letters are all capitalized and evenly spaced. The letter "A" is stylized with a triangular shape at the top. The overall impression is a strong and simple logo or wordmark.

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p. 3 of 3

### Page 56

#### Substantial Equivalence: F.

The subject device has the following similarities to the predicate device that received clearance to market via K022236 on 11/27/02 and K031328 on 07/25/03:

- । Same intended use;
- Same filter and delivery system materials; -
- Same operating principle; -
- Same fundamental scientific technology; -
- Same packaging configuration and materials; -
- Same sterility assurance level and method of sterilization. -

The design, material, components, fundamental technology and intended use featured with the G2 Filter System are substantially equivalent to those featured with the predicate Recovery Filter System based on the design verification and validation activities.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized symbol resembling an abstract human figure with three flowing lines above it.

Public Health Service

AUG 2 9 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Bard Peripheral Vascular, Inc. Shari Allen Director of Regulatory Affairs and Clinical Research P.O. Box 1740 Tempe, AZ 85280

Re: K050558 Trade Name: G2 Filter System Regulation Number: 870.3375 Regulation Name: Cardiovascular intravascular filter Regulatory Class: II Product Code: DTK Dated: August 10, 2005 Received: August 11, 2005

Dear Ms. Allen:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your security for the device is substantially equivalent (for the indications ferenced above and maye dotermined in the enclosed devices marketed in interstate for use stated in the encrosure) to regally manatinent to the Medical Device American be of the d. Days commerce prior to May 26, 1976, the enaordance with the provisions of the Federal Food, Drag, devices that have been reclassified in acefore, market the device, subject to the general controls and Cosment Act (Act (Act (Act may) thereferal controls provisions of the provisions of the Act and the inmulties are tools , 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 The Office of Device Livanuation has actorined in the proposed labeling and that such use device will be used for an missiaed coomance with Section 513(i)(1)(E) of the Act, the following Could cause harm. "Therefore, in according 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.

Furthermore, the indication for permanent placement of the G2 Filter System must be Fulthermore, the murcation for permations pouch box, and carton labels, instructions for promilently displayed in an aboung, morading point.
use, and other promotional materials, in close proximity to the trade name, of a similar point size, and in bold print.

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Page 2 - Ms. Shari L. Allen

Please note that the above labeling limitations are required by Section 513(i)(1)(2) of the Act Please note that the above labeling innitations are required of Bourner ( ( ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) from the device's labeling.

The FDA finding of substantial equivalence of your device to a legally marketed predicate I he FDA Iniding of substantial equirance or your device and permits your device to proceed to the device results in a classification for your device and perior as described in your Section market. This letter will anow you to ovegal manceling your are and really and ed to your labeling.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), If your device is classified (Sec above) into enable requations affecting your device can be
it may be subject to additional controls. Existing major read this an EDA move it may be subject to additional controls. Extreme migral of 898. In addition, FDA may
found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FD found in the Code of Feacharting your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised hial IDA's issualled of a backed complies with other requirements of the Act
est for that FDA has made a decertimation that Jour as receral agencies. You must or any Federal slatutes and regulations daministered of on timited to: registration and listing (21 comply with all the Act s requirements, more on the comments as set a CFR Part 807), labeling (21 CFR Part 800), good if applicable, the electronic forth in the quality systems (QS) regulation (Sections 531-542 of the Act); 21 CFR 1000-1050.
product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-

If you desire specific information about the application of other labeling requirements to your If you desire specific information about the applicance at [phone]. Also, and device (21 CFR Fart 801), prease contact and one by reference to premarket notification" please note the regulation chance, "Misorananing of responsibilities under
(21 CFR Part 807.97). You may obtain other general information on your responsibilities under (2) CFR Part 807.97). 100 thay ovean other generalian and Consumer Assistance at its the Act from the Driston of 241 or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours

V. Oatin

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

Enclosure

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## Indications For Use Statement

G2 Filter System Device Name:

Indications for Use: The G2 Filter is indicated for use in the prevention of recurrent multudions for 0001 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

Over-The-Counter Use_ OR

(Per 21 CFR 801.109)0

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Vocate

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

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