The ALN Optional Vena Cava Filter and the ALN Optional Vena Cava Filter with Hook are indicated for the prevention of recurrent pulmonary embolism via placement 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 with the ALN Extraction and/or Repositioning Kit according to the Instructions For Use of these devices.

The ALN Optional Vena Cava Filter with Hook may be also retrieved with a Standard Gooseneck Snare according to the Instructions For Use of this medical device.

The ALN Extraction and/or Repositioning Kit is indicated for the removal of an implanted ALN Optional Vena Cava Filter and 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.

Device Description

The ALN Optional Vena Cava Filter and ALN Extraction and/or Repositioning Kit consists of a 9 leg 316L stainless steel vena cava filter with or without a retrieval hook supplied with a delivery kit, and a retrieval kit with an 8 arm 316L stainless steel clamp. The ALN Optional Vena Cava Filter is designed to stop free thrombus in the vena cava of high risk patients. The filter design consists of legs with barbs that are intended to help stabilize the device inside the vein and prevent migration.

The filter is prepackaged in a filter holder designed to facilitate the insertion of the filter in the introducer sheath. The insertion of the filter can be made by jugular, brachial or femoral approach with a 7F sheath. The retrieval can be made only by the jugular approach.

AI/ML Overview

The provided document is a 510(k) summary for a medical device (ALN Optional Vena Cava Filter and ALN Extraction and/or Repositioning Kit). This document focuses on modifications to the device's packaging and does not contain information about the device's clinical performance or the studies one would typically associate with proving a device meets acceptance criteria for its intended clinical use.

Therefore, I cannot provide the detailed information requested in your prompt regarding acceptance criteria, study details, expert qualifications, ground truth, or MRMC studies. The document only mentions performance testing related to the packaging modification, not the fundamental function or safety of the Vena Cava Filter itself.

Here's what I can extract from the provided text regarding "Performance Testing," which in this context refers only to the change in device packaging:

1. A table of acceptance criteria and the reported device performance:

Acceptance Criteria (for Packaging)	Reported Device Performance (for Packaging)
Package testing requirements met	The results of these tests meet the established expectations.
Sterilization validation and residuals testing successful	The results of these tests meet the established expectations and demonstrate conformity of the device with the requirements for its use.
USP 661 testing for plastics used to package medical devices met	The results of these tests meet the established expectations.

Missing Information (Not Available in the Provided Text):

Sample sized used for the test set and the data provenance: Not specified for packaging tests, and certainly not for clinical performance.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable for packaging tests, and not provided for clinical performance.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable for packaging tests, and not provided for clinical performance.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable, as this is not an AI/imaging device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is not an AI/imaging device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable for packaging tests, and not provided for clinical performance.
The sample size for the training set: Not applicable, as this is not an AI/machine learning device.
How the ground truth for the training set was established: Not applicable, as this is not an AI/machine learning device.

Summary of the Document's Focus:

The core message of this 510(k) submission (K163699) is that a modification to the device packaging for the ALN Optional Vena Cava Filter and ALN Extraction and/or Repositioning Kit does not raise new questions of safety and effectiveness, and therefore the device remains substantially equivalent to its predicate device (K113124). The "performance testing" mentioned is specifically limited to this packaging change (e.g., integrity of the sterile barrier, extractables from plastics). It is not a re-evaluation of the filter's clinical performance, efficacy in preventing pulmonary embolism, or retrieval success rates.

Summary

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

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

ALN Implants Chirurgicaux Jagoda Rewers Research and Development Assistant 589 Chemin du Niel Bormes les Mimosas 83230 France

Re: K163699

Trade/Device Name: ALN Optional Vena Cava Filter and ALN Extraction and/or Repositioning Kit Regulation Number: 21 CFR 870.3375 Regulation Name: Cardiovascular Intravascular Filter Regulatory Class: Class II Product Code: DTK Dated: August 1, 2017 Received: August 4, 2017

Dear Jagoda Rewers:

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

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

with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical devicerelated 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 contact the Division of Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education 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,

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

Enclosure

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

K163699

510(k) Summary

ALN Optional Vena Cava Filter and ALN Extraction and/or Repositioning Kit

510(K) Submitter	ALN Implants ChirurgicauxMr. Alain NIGON589 Chemin du Niel83230 Bormes les mimosasFranceTel: +33 494 01 05 01Fax: +33 494 01 09 01alain.nigon@aln2b.com	Trade Name	ALN Optional Vena Cava Filter and ALN Extraction and/or Repositioning Kit
Contact	Ms. Jagoda REWERS589 Chemin du Niel83230 Bormes les mimosasFranceTel: +33 494 01 05 01Fax: +33 494 01 09 01jagoda.rewers@aln2b.com	510(k) Number	K113124
Date Prepared	October 26, 2016	Common Name	Vena Cava Filter and Retrieval Kit
Trade Name of the Device	ALN Optional Vena Cava Filter - Femoral ApproachALN Optional Vena Cava Filter – Jugular ApproachALN Optional Vena Cava Filter - Brachial ApproachALN Optional Vena Cava Filter – Femoral Approach with HookALN Optional Vena Cava Filter – Jugular Approach with HookALN Optional Vena Cava Filter – Brachial Approach with HookALN Extraction and/or Repositioning Kit - Straight RSALN Extraction and/or Repositioning Kit – Pre-curved RSALN Extraction and/or Repositioning Kit – 2 in 1 RS	Classification Name	Cardiovascular Intravascular filter
Common Name of the Device	Vena Cava Filter and Retrieval Kit	Class	II
Classification Name	Cardiovascular Intravascular Filter(21 CFR 870.3375, Product Code DTK)	Product Code	DTK
Device Class, Panel	II, Cardiovascular	CFR Section	870.3375
Device Panel	Cardiovascular

Siège Social : Route de la Gare 20240 Ghisonaccia

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

Image /page/3/Picture/0 description: The image is a logo for a company called "Aln implants chirurgicaux". The logo features the letters "Aln" in a bold, blue font, with the "A" being larger than the "l" and "n". To the left of the letters, there are three vertical bars in a light gray color. Below the letters, the words "implants chirurgicaux" are written in a smaller font.

Device Description:

Indications for Use:

The ALN Optional Vena Cava Filter and the ALN Optional Vena Cava Filter with Hook are indicated for the prevention of recurrent pulmonary embolism via placement 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 with Hook may be also retrieved with a Standard Gooseneck Snare according to the Instructions For Use of this medical device.

Predicate Devices:

ALN Optional Vena Cava Filter and ALN Extraction and/or Repositioning Kit

Siège Social : Route de la Gare 20240 Ghisonaccia

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

Image /page/4/Picture/0 description: The image shows the logo for "Aln implants chirurgicaux". The logo features three gray vertical bars on the left side, followed by the word "Aln" in blue. Below the bars and the word "Aln", the words "implants chirurgicaux" are written in a smaller font size.

Comparison to Predicate Device

The purpose of this submission is to modify the device packaging. The subject ALN Optional Vena Cava Filter and Extraction and/or Repositioning Kit, presented in Tyvek/film sterile barrier system, on a transparent blister and/or plastic tray has the same technological characteristics as the predicate device and presents no additional risk for safety and effectiveness. The subject device is identical to the predicate device in terms of intended use, principles of operation, design, materials of construction, manufacturing process, and technological characteristics.

Performance Testing:

The ALN Optional Vena Cava Filter and Extraction and/or Repositioning Kit were subjected to the following tests to support the change in device packaging:

Package testing,
-Sterilization validation and residuals testing,
USP 661 testing for plastics used to package medical devices. ।

The results of these tests meet the established expectations and demonstrate conformity of the device with the requirements for its use.

Substantial Equivalence:

The comparison of technological characteristics and the performance testing demonstrate that the modification to the device packaging does not raise new questions of safety and effectiveness and support substantial equivalence of the subject device to the predicate device.

Siège Social : Route de la Gare 20240 Ghisonaccia

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

Please wait...

If this message is not eventually replaced by the proper contents of the document, your PDF viewer may not be able to display this type of document.

You can upgrade to the latest version of Adobe Reader for Windows®, Mac, or Linux® by visiting http://www.adobe.com/go/reader_download.

For more assistance with Adobe Reader visit http://www.adobe.com/go/acrreader.

Windows is either a registered trademark of Microsoft Corporation in the United States and/or other countries. Mac is a trademark of Apple Inc., registered in the United States and other countries. Linux is the registered trademark of Linus Torvalds in the U.S. and other countries.

Regulation Number and Section

§ 870.3375 Cardiovascular intravascular filter.

(a)
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.(b)
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.”