RECOVERY FILTER SYSTEM, MODEL RF-048F

K022236 · C.R. Bard, Inc. · DTK · Nov 27, 2002 · Cardiovascular

Device Facts

• Record ID: K022236
• Device Name: RECOVERY FILTER SYSTEM, MODEL RF-048F
• Applicant: C.R. Bard, Inc.
• Product Code: DTK · Cardiovascular
• Decision Date: Nov 27, 2002
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.3375
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Recovery™ Filter System 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 anticoagulation 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

Recovery Filter System consists of nitinol vena cava filter and delivery system (7 Fr ID introducer sheath, dilator, pusher). Filter features twelve shape-memory nitinol wires (six arms, six legs) providing two levels of filtration. Prepackaged in storage tube. Used by physicians in clinical settings for permanent placement in inferior vena cava to prevent pulmonary embolism. Delivery system facilitates filter deployment. Device provides mechanical filtration of blood flow to trap emboli, reducing risk of pulmonary embolism in patients where anticoagulation is contraindicated or ineffective. Safety/effectiveness as retrievable or temporary filter not established.

Clinical Evidence

Bench testing only. Testing performed in accordance with FDA guidance document 'Guidance for Cardiovascular Intravascular Filter 510(k) Submission' to demonstrate substantial equivalence to predicate devices.

Technological Characteristics

Filter composed of twelve shape-memory nitinol wires emanating from a central nitinol sleeve. Two-level filtration design (six arms, six legs). Delivery system includes 7 Fr ID introducer sheath, dilator, and pusher. Packaged in Tyvek/film pouches. Non-software device.

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 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

• Simon Nitinol Filter
• Straightline™ System
• Titanium Greenfield® Vena Cava Filter

Submission Summary (Full Text)

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K022236

NOV 2 7 2002

IMPRA A Subsidiary of C. R. Bard, Inc. 1625 West 3rd Street P.O. Box 1740 Tempe, AZ 85280-1740 TEL: [phone] FAX: [phone]

**IMPRA**

### 510(k) SUMMARY OF SAFETY AND EFFECTIVENES INFORMATION

A. Submitter Information:

> Submitter's Name: C.R. Bard, Inc., Impra Submitter's Address: 1625 West 3rd Street Contact Person: Kay Fuller Contact Person's Telephone Number: [phone] Contact Person's FAX Number: [phone] Date of Preparation: July 8, 2002

- B. Device Name:
Recovery™ Filter System

- C. Predicate Devices:
Simon Nitinol Filter/Straightline™ System Titanium Greenfield® Vena Cava Filter

- D. Device Description:
The Recovery Filter System consists of a nitinol vena cava filter and a delivery system. The filter has two levels of filtration and is prepackaged in a storage tube. The delivery system consists of a 7 Fr ID introducer sheath and dilator and a pusher system. Both components of the system are packaged in Tyvek/film pouches.

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 slightly distressed or textured appearance. The overall impression is a simple, yet impactful logo or wordmark.

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#### Intended Use: E.

The Recovery Filter is indicated for use in the prevention of pulmonary embolism via placement in the vena cava in the following situations:

- Pulmonary thromboembolism when anticoagulants are . contraindicated.
- Failure of anticoagulant therapy in 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.
- F. Technological Characteristics Summary:

The filter consists of twelve, shape memory nitinol wires emanating from a central nitinol sleeve. The wires form two levels of filtration: six arms and six legs. The delivery system is used to place the filter into the inferior vena cava.

#### G. Performance Data:

Bench testing was performed per the FDA guidance document, "Guidance for Cardiovascular Intravascular Filter 510(k) Submission". Testing showed that the Recovery Filter is substantially equivalent to the Bard predicate device.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular emblem with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of what appears to be an abstract bird or wave-like design, composed of three curved lines.

### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# NOV 2 7 2002

Ms. Kay Fuller Senior Regulatory Affairs Specialist C. R. Bard, Inc. 1625 West 3rd Street Tempe. AZ 85281

K022236/S2 Re:

> Trade/Device Name: Bard® Recovery™ Filter System, Model RF-048F Regulation Number: 870.3375 Regulation Name: Cardiovascular intravascular filter Regulatory Class: II Product Code: DTK Dated: October 25, 2002 Received: October 29, 2002

Dear Ms Fuller:

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 Recovery™ Filter for use as a retrievable or temporary filter have not been established.

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.

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Page 2 - Ms. Kay Fuller

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.

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 above is added to your labeling, as described.

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.

If you desire specific information about the application of other labeling requirements to your device (21 CFR Part 801 and additionally Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, 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). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html.

Sincerely yours,

Alan Witter My So
Dr. Schultz

Daniel G. Schultz, M.D. Director Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page

510(k) Number (if known): K022236

Device Name: Bard® Recovery™ Filter System, Model RF-048F

FDA's Statement of the Indications For Use for device:

The Recovery™ Filter System 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 anticoagulation 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.

Division of Cardiovascular & Respiratory Devices
510(K) Number K022236

Over-The-Counter Use OR

Prescription Use ✔ (Per 21 CFR 801.109)