ALN OPTIONAL VENA CAVA FILTER-FEMORAL APPROACH, JUGULAR APPROACH, BRACHIAL APPROACH, EXTRACTION KIT, PRECURVED EXTRACTIO

K070514 · Aln Implants Chirurgicaux · DTK · Jan 30, 2008 · Cardiovascular

Device Facts

• Record ID: K070514
• Device Name: ALN OPTIONAL VENA CAVA FILTER-FEMORAL APPROACH, JUGULAR APPROACH, BRACHIAL APPROACH, EXTRACTION KIT, PRECURVED EXTRACTIO
• Applicant: Aln Implants Chirurgicaux
• Product Code: DTK · Cardiovascular
• Decision Date: Jan 30, 2008
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 870.3375
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The ALN Optional Vena Cava Filter is indicated for the prevention of recurrent pulmonary embolism via placement in the vena cava in the following situations: - Pulmonary thromboembolism when anticoagulants are contraindicated: - Failure of anticoagulant therapy in thromboembolic diseases; - Emergency treatment following massive pulmonary embolism where anticipated benefits of conventional therapy are reduced; and - Chronic, recurrent pulmonary embolism where anticoagulant therapy has failed or is contraindicated. The ALN Optional Vena Cava Filter may be retrieved according to the instructions supplied in the Instruction For Use of the ALN Extraction Kit. Extraction kit: The ALN Optional Vena Cava Filter Extraction Kit has been designed for the removal of an implanted ALN Optional Vena Cava Filter in patients who no longer require a filter. The retrieval of the filter can be performed only by jugular approach.

Device Story

Device consists of 9-leg 316L stainless steel vena cava filter and 8-arm 316L stainless steel retrieval forceps. Filter delivered via 7F sheath using jugular, brachial, or femoral approach; retrieval performed via jugular approach. Designed to trap free thrombus in vena cava. Used in clinical settings by physicians. Output is physical capture of thrombus; retrieval kit allows removal when filter no longer needed. Benefits include prevention of pulmonary embolism in high-risk patients where anticoagulation is contraindicated or ineffective.

Clinical Evidence

Clinical evidence based on 14 years of data, including a 2006 study in Chest of 220 patients. Primary endpoints included safety and complication rates. 55 filters were successfully retrieved after a mean of 51 days (range 6-352 days) without complication. Results demonstrate performance similar to predicate devices.

Technological Characteristics

316L stainless steel filter (9 legs) and forceps (8 arms). 7F sheath introducer. Polyethylene catheters. Apical fixation of wires. Non-clinical testing included simulated deployment, clot trapping, filter fracture, caval perforation/migration, thrombogenicity, and MRI compatibility.

Indications for Use

Indicated for patients requiring prevention of recurrent pulmonary embolism due to contraindication 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

• Stainless Steel Greenfiled® Vena Cava Filter With 12F Introducer System (K912035)
• Recovery Cone® Removal System (K031328)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the text "Aln" in a large, bold font. Below the letters, the words "implants chirurgicaux" are written in a smaller font. The text appears to be a logo or brand name for a company that produces surgical implants.

K070514 p. I ofy

JAN 30 2008

# 510(K) SUMMARY

# ALN Optional Vena Cava Filter and Extraction Kit

#### 1. General information

| 510(K) Submitter | ALN Implants Chirurgicaux<br>Mr Alain NIGON<br>589 chemine de Niel<br>93230 BORMES LES MIMOSAS<br>FRANCE<br>Tel.: [phone]<br>Fax: [phone]<br>[e-mail] |
|---------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact | NAMSA Advisory Services<br>Mrs Julianne Slaughter<br>900 Circle 75 Parkway<br>Suite 1240<br>ATLANTA GEORGIA 30339<br>USA<br>Tel.: [phone]<br>Fax: [phone]<br>[e-mail] |
| Date of the summary preparation | January 4th, 2007 |
| Common Name of the Device | Optional Vena Cava Filter and Retrieval Kit |
| Trade Name of the Device | ALN Optional Vena Cava Filter and Extraction Kit |
| Classification Name | Cardiovascular Intravascular Filter (21 CFR 870.3375, Product Code DTK) |
| Class | II |
| Device Panel | Cardiovascular |

{1}------------------------------------------------

KO7O514 0. 2 ot

Image /page/1/Picture/1 description: The image shows the text "AIn implants chirurgicaux". The letters "AIn" are in a large, bold font, while the words "implants chirurgicaux" are in a smaller font below. The text is black against a white background. The image appears to be a logo or branding for a company that manufactures surgical implants.

## 2. Predicate Devices

Predicate device 1:

| Trade Name | Stainless Steel Greenfiled® Vena Cava Filter<br>With 12F Introducer System |
|---------------------|----------------------------------------------------------------------------|
| 510(k) Number | K 912035 |
| Common Name | Permanent Vena Cava Filter |
| Classification Name | Cardiovascular Intravascular filter |
| Class | II |
| Product Code | DTK |
| CFR Section | 870.3375 |
| Device Panel | Cardiovascular |

Predicate device 2:

| Trade Name | Recovery Cone® Removal System |
|---------------------|-------------------------------------|
| 510(k) Number | K 031328 |
| Common Name | Vena Cava Filter |
| Classification Name | Cardiovascular Intravascular filter |
| Class | II |
| Product Code | DTK |
| CFR Section | 870.3375 |
| Device Panel | Cardiovascular |

#### 3. Device Description

The ALN Optional Vena Cava Filter and Extraction Kit consists of a 9 legs 316L stainless steel vena cava filter sold with a delivery kit, and an extraction kit with an 8 arms 316L stainless steel forceps. The filter is prepackaged in a filter holder designed to facilitate the insertion of the filter in the introducer catheter. The filter and the delivery kit are packaged together in Tyvek/film pouches and the extraction kit is packaged alone in the same type of pouches.

The ALN Optional Vena Cava Filter is designed to stop free thrombus in the vena cava in high risk patients. The insertion of the filter can be made by jugular, brachial or femoral approach and are very little traumatic, as the sheath has a 7F diameter. The extraction can be made only by jugular approach.

{2}------------------------------------------------

KO70514 D. 30 f 4

Image /page/2/Picture/1 description: The image shows the text "Aln" in a bold, sans-serif font. Below the letters, the words "implants chirurgicaux" are written in a smaller, sans-serif font. The text is black against a white background.

## 4. Intented Use

The ALN Optional Vena Cava Filter is indicated for the prevention of recurrent pulmonary embolism via placement in the vena cava in the following situations:

- Pulmonary thromboembolism when anticoagulants are contraindicated: -
- Failure of anticoagulant therapy in thromboembolic diseases; -
- Emergency treatment following massive pulmonary embolism where anticipated benefits of conventional therapy are reduced; and
- Chronic, recurrent pulmonary embolism where anticoagulant therapy has failed or is contraindicated.

The ALN optional filter may be removed according to the instructions supplied in the Instruction for Use of the ALN Extraction Kit.

## 5. Technological Characteristics

The ALN Optional Vena Cava Filter has the same technological characteristics as the two predicate devices except for the items listed below which all shown no additional risk for safety and effectiveness:

- 7F Sheath introducer (present) vs 12F or 10F Sheath introducer (predicate) -
- -BRACHIAL Vascular approach (present)
- Apical fixation of wires: set (present) vs welded (predicate) -
- Filter configuration: 9 wires (present) vs 6 wires (predicate) -
- -No plastic cone on the extraction kit (present) vs urethane cone (predicate)
- Polyethylene catheters (present) vs Pebax® catheters (predicate) -
- Forceps design: 8 wires (present) vs 10 wires (predicate) -

#### 6. Non-clinical Performances

The ALN Optional Vena Cava Filter and Extraction Kit passed all the tests required to demonstrate its non clinical performances:

- Simulated deployment -
- r Introducer / sheath suitability
- Clot trapping ability -
- Filter fracture -
- Caval perforation / filter migration -
- Thrombogenicity -
- -MRI compatibility

Moreover, the filtering performances were assessed by a bench test in comparison with the predicate device (results are similar for the two devices).

{3}------------------------------------------------

Korosiy p. 40fy

Image /page/3/Picture/1 description: The image shows the text "Aln" in a large, bold font. Below this, the words "implants chirurgicaux" are written in a smaller font. The text appears to be a logo or heading, possibly for a company or product related to surgical implants.

#### 7. Clinical Performances

The safety and effectiveness of the ALN Optional Vena Cava Filter and Extraction Kit have been demonstrated via clinical data collected for 14 years. Every clinical investigation is in conformance with the FDA guidance for cardiovascular filter and a review of the literature underlines that clinical performances of ALN Optional Vena Cava Filter and Extraction Kit are similar to the clinical performances of the two predicates. The last clinical study about ALN Optional Vena Cava Filter and Extraction Kit was published in chest in 2006. It includes 220 patients who receive an ALN Optional Vena Cava Filter for prevention of venous thromboembolism. Results show low rates of complication. On the 220 filters, 55 were retrieved after a mean period of 51 days (range: 6 - 352 days) without any complication.

#### 8. Substantial Equivalence

The design, material, components, fundamental technology, intended use, non clinical and clinical performances of the ALN Optional Vena Cava Filter and Extraction Kit are identical and therefore substantially equivalent to the predicates :

- Stainless steel Greenfield® vena cava filter with 12F introducer system (K 912035)

- Recovery Cone® Removal System (K 031328)

{4}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/4/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or bird-like figure.

JAN 30 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

ALN Implants Chirurgicaux c/o Ms. Julianne Slaughter NAMSA Advisory Services 900 Circle 75 Parkway Suite 1240 Atlanta, GA 30339

Re: K070514

Trade/Device Name: ALN Optional Vena Cava Filter and Extraction Kit Regulation Number: 21 CFR 870.3375 Regulation Name: Cardiovascular intravascular filter Regulatory Class: Class II (two) Product Code: DTK Dated: November 5, 2007 Received: November 13, 2007

Dear Ms. Slaughter:

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) 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 general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing 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 may be subject to such 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.

{5}------------------------------------------------

Page 2 - Ms. Julianne Slaughter

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 Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding 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 vours.

Nuna R. lohner

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{6}------------------------------------------------

Abbreviated 510(k) Premarket Notification ALN OPTIONAL VENA CAVA FILTER AND RETRIEVAL KIT

#### Indication for Use Statement ব

510(k) Number (if know): K070514

#### Device Name: ALN Optional Vena Cava Filter and Extraction Kit

#### Indications for Use:

The ALN Optional Vena Cava Filter is indicated for the prevention of recurrent pulmonary embolism via placement in the vena cava in the following situations:

- Pulmonary thromboembolism when anticoagulants are contraindicated: -
- Failure of anticoagulant therapy in thromboembolic diseases;
- Emergency treatment following massive pulmonary embolism where ﮯ anticipated benefits of conventional therapy are reduced; and
- -Chronic, recurrent pulmonary embolism where anticoagulant therapy has failed or is contraindicated.

The ALN Optional Vena Cava Filter may be retrieved according to the instructions supplied in the Instruction For Use of the ALN Extraction Kit.

Extraction kit: The ALN Optional Vena Cava Filter Extraction Kit has been designed for the removal of an implanted ALN Optional Vena Cava Filter in patients who no longer require a filter. The retrieval of the filter can be performed only by jugular approach.

Prescription Use ☑ AND/OR (Part 21 CFR 801 Subpart D)

Over-The-Counter Use □ (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

> sunna R. Iro. (Division Sign-Off)

Division of Cardiovascular Devices

510(k) Number_K070514

Page 1 of 1