(253 days)
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No
The document describes a physical medical device (vena cava filter and retrieval kit) and its intended use, materials, and performance testing related to packaging and sterilization. There is no mention of software, algorithms, data analysis, or any terms related to AI or ML.
Yes
The device is indicated for the "prevention of recurrent pulmonary embolism" and "emergency treatment following massive pulmonary embolism," which are therapeutic aims to treat or prevent a medical condition.
No
Explanation: The device described is a vena cava filter, which is an implantable device used to prevent pulmonary embolism. Its function is to physically stop thrombus, not to diagnose a condition.
No
The device description clearly states it is a physical vena cava filter made of stainless steel, a delivery kit, and a retrieval kit with a stainless steel clamp. These are hardware components, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The description clearly states that the ALN Optional Vena Cava Filter is a physical device designed to be implanted in the vena cava (a large vein) to prevent pulmonary embolism. It is a mechanical filter.
- Intended Use: The intended use describes the placement and retrieval of a physical filter within the body to address a medical condition. It does not involve testing samples outside the body.
Therefore, this device falls under the category of an implantable medical device, not an in vitro diagnostic.
N/A
Intended Use / 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 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.
Product codes (comma separated list FDA assigned to the subject device)
DTK
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
Not Found
Anatomical Site
vena cava
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.”
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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
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510(k) Summary
ALN Optional Vena Cava Filter and ALN Extraction and/or Repositioning Kit
| 510(K) Submitter | ALN Implants Chirurgicaux
Mr. Alain NIGON
589 Chemin du Niel
83230 Bormes les mimosas
France
Tel: +33 494 01 05 01
Fax: +33 494 01 09 01
alain.nigon@aln2b.com | Trade Name | ALN Optional Vena Cava Filter and ALN Extraction and/or Repositioning Kit |
|---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------|---------------------------------------------------------------------------|
| Contact | Ms. Jagoda REWERS
589 Chemin du Niel
83230 Bormes les mimosas
France
Tel: +33 494 01 05 01
Fax: +33 494 01 09 01
jagoda.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 Approach
ALN Optional Vena Cava Filter – Jugular Approach
ALN Optional Vena Cava Filter - Brachial Approach
ALN Optional Vena Cava Filter – Femoral Approach with Hook
ALN Optional Vena Cava Filter – Jugular Approach with Hook
ALN Optional Vena Cava Filter – Brachial Approach with Hook
ALN Extraction and/or Repositioning Kit - Straight RS
ALN Extraction and/or Repositioning Kit – Pre-curved RS
ALN 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:
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.
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 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.
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
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