BARD G2 FILTER SYSTEM - JUGULAR/SUBCLAVIAN DELIVERY KIT, MODEL RF-320J

K052578 · Bard Peripheral Vascular, Inc. · DTK · Nov 25, 2005 · Cardiovascular

Device Facts

• Record ID: K052578
• Device Name: BARD G2 FILTER SYSTEM - JUGULAR/SUBCLAVIAN DELIVERY KIT, MODEL RF-320J
• Applicant: Bard Peripheral Vascular, Inc.
• Product Code: DTK · Cardiovascular
• Decision Date: Nov 25, 2005
• Decision: SESU
• Submission Type: Special
• Regulation: 21 CFR 870.3375
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The G2™ Filter System - Jugular/Subclavian 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

G2™ Filter System (Jugular/Subclavian Delivery Kit) facilitates permanent vena cava filter placement via jugular or subclavian vein. System includes dilator, 10 French I.D. introducer sheath with radiopaque tip/hemostasis valve, and delivery device with preloaded filter. Dilator accepts 0.038" guidewire; supports contrast power injection up to 800 psi. Delivery device features saline infusion port and mechanical deployment mechanism; includes spline cap to separate filter hooks, preventing leg entanglement. Used by physicians in clinical settings. Output is permanent filter placement to prevent pulmonary embolism. Device is substantially equivalent to femoral delivery version; modification limited to delivery system approach.

Clinical Evidence

Bench testing only. No clinical data provided. Device met all predetermined acceptance criteria for design verification and validation.

Technological Characteristics

Class II cardiovascular intravascular filter. System includes dilator, 10 French I.D. introducer sheath with radiopaque tip and hemostasis valve, and delivery device. Supports 0.038" guidewire and contrast power injection up to 800 psi. Mechanical deployment mechanism with spline cap for hook separation. Sterilization method consistent with predicate.

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 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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NOV 2 5 2005

K0-52578

Special 510(k) G2™ Filter System – Jugular/Subclavian Denvery Kit

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Page 53

### Appendix 4. Summary of Safety and Effectiveness

Bard Peripheral Vascular, Inc

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

BARD

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## G2™ Filter System - Jugular/Subclavian 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:

- 1. Submitter Information:
- Bard Peripheral Vascular, Inc Applicant: 1625 West 3d 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 -<br>Jugular/Subclavian 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)

Image /page/1/Picture/14 description: The image shows the word "BARD" in a stylized, bold font. Each letter is outlined in black, giving it a distinct and prominent appearance. The font style is unique, with sharp angles and geometric shapes forming the letters.

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#### Summary of Change: 4.

The design modification to the G2™ Filter System – Jugular/Subclavian Delivery Kit as represented in this submission is an additional delivery system. The G2TM Filter component of the subject device remains the same as the predicate device.

#### 5. Device Description:

The G2™ Filter System - Juqular/Subclavian Delivery Kit allows for placement of the G2TM Filter via a Jugular or Subclavian vein approach. The G2™ Filter System -Jugular/Subclavian Delivery Kit consists of a dilator and introducer set and a delivery device with a preloaded filter. The dilator accepts a 0.038" guidewire and enables a contrast medium power injection up to 800 psi maximum pressure. The 10 French I.D. 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 consists of a side port for saline infusion and a delivery mechanism to deplov the G2™ Filter. The delivery device contains a spline cap that mechanically separates the filter hooks from one another in a unique pattern to prevent leg entanglement.

#### 6. Intended Use of Device:

The G21M Filter System - Jugular/Subclavian 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 anticoaqulant 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).

Image /page/2/Picture/14 description: The image shows the word "BARD" in a bold, sans-serif font. The letters are all capitalized and evenly spaced. The font is simple and modern, and the word is easy to read. The image is likely a logo or a wordmark for a company or organization named Bard.

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#### 7. Technological Comparison to Predicate Device:

The technological characteristics of G2™ Filter System - Jugular/Subclavian Delivery Kit are substantially equivalent to those of the predicate device, the G2TM Filter System -Femoral Delivery Kit, in terms of intended use, indication for use, application, user population, basic design, performance, and sterilization method.

#### 8. Conclusions:

The G2™ Filter System - Jugular/Subclavian 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 -Jugular/Subclavian Delivery Kit is substantially equivalent to the legally marketed predicate device, the G2™ Filter System - Femoral Delivery Kit.

Image /page/3/Picture/8 description: The image shows the word "BARD" in a bold, outlined font. The letters are all capitalized and connected to each other. The font style is geometric and modern.

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Image /page/4/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three parallel lines forming the wings of the symbol. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" is arranged in a circular pattern around the caduceus.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 2 5 2005

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

Re: K052578 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: October 25, 2005 Received: October 26, 2005

Dear Ms. Balutowski:

We have reviewed your Section 510(k) premarket notification of intent to market the devices We have reviewed your Section 910(x) premained insubstantially equivalent (the indications felerenced above and nave determined the arrest and as a concess marketed in interstate for use stated in the cities in the enactment date of the Medical Device Amendments, or to commerce prior to May 28, 1776, the enactines with the provisions of the Federal Food, Drug, devices that have been reclassince in accorded the device, subject to the general controls and Cosment Act (Act). Tou may, therefere, the below. The general controls provisions of the provisions of the Act and the immations aration , 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 this truck is The Office of Device Evanation has actorized in the proposed labeling and that such use device will be used for an intended ass mance with Section 513(i)(1)(E) of the Act, the following could cause nami. Therefore, in accordance with between to your 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 I untiler the multunen in pormaise for porchasselling 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.

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Page 2 - Ms. Genevieve Balutowski

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

The FDA finding of substantial equivalence of your device to a legally marketed predicate The FDA Inding of Substantial equivalence or Jour device and permits your device to the town So device results in a classification for your device as described in your Section market. This letter will anow you to ocegni manceing your was added 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 (see above) more regulations affecting your device can be
it may be subject to additional controls. Existing major regulations affecting FDA ma it may be subject to additional controls. Existing major s good to 898. In addition, FDA may
found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addit found in the Code of I odear resguiners in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s issualles of a subscribes with other requirements of the Act
that FDA has made a determination that your device complies with on your that FDA has made a delemmanon alat your are ross be other Federal agencies. You must or any Federal statutes and regulations administered of our not limited to: registration and listing (21)
comply with all the Act's requirements, including, but not limited comply with all the Act S requirements, merialism of the requirements as set
CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as a lectroni CFR Part 807); labeling (21 CFR Fall on ); good manara 820); and if applicable, the electronic
forth in the quality systems (QS) regulation (21 CFR 1000-1050 forth in the quality systems (QD) 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 uppreased at [phone]. Also, 276-0295. Also,
device (21 CFR Part 801), please contact the Office of Compliance at (240) 2 device (21 CFR Fart 801), prease contact and one by reference to premarket notification" please note the regulation entitled, "Misoranding of receiver on your responsibilities under (2) CFR Part 807.97). You may obtain other generalional, and Consumer Assistance at its the Act from the Division of Billan [phone] or at its Internet address ton 1100 na.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Sincerely yours,

o the signature is "J. Tiller"

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):

Device Name: G2TM Filter System - Jugular/Subclavian Delivery Kit

Indications for Use:

The G2™ Filter System – Jugular/Subclavian 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)<br>ווי אותה את ה<br>(Division Sign-Off)<br>Division of Cardiovascular Devices<br>446 16 70 | Page 1 of 1 |
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| 510(k) Numbe<br>I RAUE SECRE I/ CONFIDENTIAL INFORMATION<br>Bard Peripheral Vascular, Inc<br>Notify CR Bard Before Releasing this Document. | |