ALN OPTIONAL VANA CAVA FILTER

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo for a company called "Aln implants chirurgicaux". The logo features the letters "Aln" in a bold, sans-serif font, with the "A" being the largest letter. Below the letters, the words "implants chirurgicaux" are written in a smaller, sans-serif font. The logo is simple and modern, and it is likely used to represent the company's brand. K113124 # 510(K) SUMMARY NOV 9 2012 # ALN Optional Vena Cava Filter and Extraction Kit ### 1. General information | 510(K) Submitter | ALN Implants Chirurgicaux<br>Mr Alain NIGON<br>589 chemin du Niel<br>83 230 BORMES LES MIMOSAS<br>FRANCE<br>Tel.: +33 4 94 01 05 01<br>Fax: +33 4 94 01 09 01<br>Alain.nigon@aln2b.com | |---------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Contact | TWOKSA<br>Mrs Cynthia COTTEREAU<br>2 rue Quenot<br>16 200 JARNAC<br>FRANCE<br>Tel.: +33 5 45 32 18 84<br>Fax: +33 9 63 29 41 39<br>Cynthia.cottereau@twoksa.com | | Date of the summary preparation | May 22nd, 2012 | | Common Name of the Device | Optional Vena Cava Filter and Retrieval Kit | | Trade Name of the Device | ALN Optional Vena Cava Filter and Extraction<br>Kit | | Classification Name | Cardiovascular Intravascular Filter (21 CFR<br>870.3375, Product Code DTK) | | Class | II | | Device Panel | Cardiovascular | Bureaux : 589, Chemin du Niel 83230 Bormes les Mimosas -Tél : 33 (0) 4.94.01.05.01 - Fax : 33 (0) 4.94.01.09.01 S.A.R.L. au capital de 1 000 000 €.- RCS BASTIA B 4 1 237 704 - SIRET 41 1 237 704 00019 - APE 3250A - Nº TVA: FR.00 411 237 704 Adresse Email : contact@aln2b.com - Home page : www.aln2b.com {1}------------------------------------------------ Image /page/1/Picture/0 description: The image shows the text "Aln" in a bold, sans-serif font. Below "Aln" is the text "implants chirurgicaux" in a smaller, sans-serif font. The text is black against a white background. # 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 | Predicate device 3: | Trade Name | Gunther Tulip Vena Cava Filter | |---------------------|-------------------------------------| | 510(k) Number | K 090140 | | Common Name | Vena Cava Filter | | Classification Name | Cardiovascular Intravascular filter | | Class | II | | Product Code | DTK | | CFR Section | 870.3375 | | Device Panel | Cardiovascular | {2}------------------------------------------------ Image /page/2/Picture/0 description: The image shows a logo with the letters 'Aln' in a bold, sans-serif font. The 'A' and 'l' are capitalized, while the 'n' is lowercase. Below the letters, the words 'implants chirurgicaux' are written in a smaller, sans-serif font. The text is black against a white background. #### Predicate device 4: | Trade Name | ALN Optional Vena Cava Filter and Retrieval Kit | |---------------------|-------------------------------------------------| | 510(k) Number | K 070514 | | 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 with or without a retrieval hook 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 Tyvel/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. ### 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 Vena Cava Filter may be removed according to the instructions supplied in the Instruction for Use of the ALN Extraction Kit. The ALN Optional Vena Cava Filter with Hook optional filter may be removed according to the instructions supplied in the Instruction for Use of the ALN Extraction Kit or with a Standard Gooseneck · Snare. Bureaux : 589, Chemin du Niel 83230 Bornes les Mimosas -Tél : 33 (0) 4.94.01.05.01 - Fax : 33 (0) 4.94.01.09.01 S.A.R.L. au capital de 1 000 000 €. - RCS BASTIA B 411 237 704 - SIRET 411 237 704 00019 - APE 3250A - Nº TVA: FR.00 411 237 704 . Adresse Email : contact@aln2b.com - Home page : www.aln2b.com {3}------------------------------------------------ Image /page/3/Picture/0 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 font. The text is black and the background is white. # 5. Technological Characteristics The ALN Optional Vena Cava Filter and Extraction Kit has the same technological characteristics as the four predicate devices except for the items listed in the table below which all shown no additional risk for safety and effectiveness because it share each technological characteristic with at least of the predicates. | Technological<br>characteristic | Present | Predicate 1 | Predicate 2 | Predicate 3 | Predicate 4 | |----------------------------------------|-----------------|-----------------|-------------|-------------|-----------------| | Brachial<br>vascular<br>approach | YES | NO | NO | NO | YES | | Filter sheath<br>introducer | 7F | 12F | - | 7F | 7F | | Filter material | Stainless steel | Stainless steel | - | Conichrome | Stainless steel | | Apical fixation<br>of wires | Set | Welded | - | Welded | Set | | Hook on the<br>filter head | YES | NO | - | YES | NO | | Filter<br>configuration | 9 wires | 6 wires | - | 4 wires | 9 wires | | Base diameter | 28-32 mm | 28 mm | - | 30 mm | 28-32 mm | | Filter height | 55 mm | 50 mm | - | 50 mm | 55 mm | | Extraction kit<br>sheath<br>introducer | 9F | - | 10F | - | 9F | | Plastic cone on<br>the pincer | NO | - | YES | - | NO | | Catheters<br>material | PE | - | Pebax® | - | PE | | Forceps design | 8 wires | - | 10 wires | - | 8 wires | | Forceps<br>angulation of<br>90° | YES | - | YES | - | NO | # 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 - Siège Social : Route de la Gare 20240 Ghisonaccia Bureaux : 589, Chemin du Niel 83230 Bornes les Mimosas -Tél : 33 (0) 4.94.01.05.01 - Fax : 33 (0) 4.94.01.09.01 S.A.R.L. au capital de 1 000 000 €. - RCS BASTIA B 41 237 704 - SIRET 4 l 1 237 704 00019 - APE 3250A - Nº TVA: FR.00 411 237 704 Adresse Email : contact(@aln2b.com - Home page : www.aln2b.com {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the text "Aln" in a large, bold font. Below the text "Aln" is the text "implants chirurgicaux" in a smaller font. The text is black and the background is white. - 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 one the predicate device (results are similar for the two devices). #### 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 intravascular 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 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) - Gunther Tulip Vena Cava Filter (K 090140) - ALN Optional Vena Cava Filter and Retrieval Kit (K 070514) {5}------------------------------------------------ Image /page/5/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of what appears to be a caduceus, a symbol often associated with medicine and healthcare. The image is black and white. #### Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002 ALN Implants Chirurgicaux c/o Ms. Cynthia Couttereau TWOKSA Conseil 2 Rue Quenot Jarnac France 16200 9 2012 NOV Re: K113124 Trade/Device Name: ALN Optional Vena Cava Filter Regulation Number: 21 CFR 870.3375 Regulation Name: Cardiovascular Intravascular Filter Regulatory Class: Class II Product Code: DTK Dated: October 24, 2012 Received: October 26, 2012 Dear Ms. Couttereau: 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. 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 {6}------------------------------------------------ CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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 advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. 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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely yours, Mrs Kelleher Ar Bram Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {7}------------------------------------------------ Abbreviated 510(k) Premarket Notification aln optional vena cava filter and retrieval kit #### Indication for Use Statement ਪੈ #### 510(k) Number (if know): V (13124 #### Device Name: ALN Optional Vena Cava Filter and Extraction Kit #### Indications for Use: The ALN Optional Vena Cava Filter and the ALN Optional Vena Cava Filter with Hook 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 and the ALN Optional Vena Cava Filter with Hook may be retrieved according to the instructions supplied in the Instruction For Use of the ALN Extraction Kit. The ALN Optional Vena Cava Filter with Hook may be retrieved with a standard GooseNeck Snare according to the instructions supplied in the Instruction For Use of this medical device. Extraction kit: The ALN Optional Vena Cava Filter Extraction Kit has been designed for the removal of an implanted ALN Optional Vena Cava Filter or ALN Optional Vena Cava Filter with Hook in patients who no longer require a filter. The retrieval of the filter can be performed only by jugular approach. Over-The-Counter Use □ AND/OR Prescription Use M (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) C.M.S. Hillehen (Division Sign-Off) (Division of Cardiovascular Devices 510(k) Number 1/11/3124 Page 1 of 1 1/1