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.

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.

AI/ML Overview

The provided document is a 510(k) Summary for the ALN Optional Vena Cava Filter and Extraction Kit. It focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria for a novel AI/ML medical device. Therefore, much of the requested information regarding acceptance criteria and study details for an AI/ML device is not applicable or cannot be extracted from this document.

However, I can provide information on the non-clinical and clinical performances presented to support the device's safety and effectiveness, which serve a similar purpose to demonstrating acceptance criteria.

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

The document does not specify quantitative acceptance criteria in a table format. Instead, it describes general categories of non-clinical tests and highlights that the device "passed all the tests required to demonstrate its non clinical performances." For clinical performance, it discusses "low rates of complication" and successful retrieval.

Here's a summary of the reported performance categories:

Acceptance Criteria Category (Implied)	Reported Device Performance
Non-Clinical Performances
Simulated deployment	Passed all required tests.
Introducer / sheath suitability	Passed all required tests.
Clot trapping ability	Passed all required tests. Bench test comparison with a predicate device showed similar results.
Filter fracture	Passed all required tests.
Caval perforation / filter migration	Passed all required tests.
Thrombogenicity	Passed all required tests.
MRI compatibility	Passed all required tests.
Clinical Performances
Safety and Effectiveness	Demonstrated via clinical data collected for 14 years. "In conformance with the FDA guidance for cardiovascular intravascular filter." Similar to predicate device clinical performances. "Low rates of complication" reported in a 2006 study.
Filter Retrieval Safety and Success	In a clinical study of 220 patients, 55 filters were retrieved "without any complication" after a mean period of 51 days (range: 6 - 352 days).

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

For clinical performance, a study involving 220 patients was cited. The document does not specify the country of origin of the data or whether the study was retrospective or prospective. It mentions the study was published in "Chest in 2006."

For non-clinical performance, specific sample sizes are not provided for each test, but it states "passed all the tests required."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable to this type of device and study. The clinical data involves patient outcomes and complications, which are typically established through medical records and clinical assessments by treating physicians, not by a panel of experts creating "ground truth" in the context of an AI/ML device.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable to the type of safety and effectiveness study described for this medical device. Clinical outcomes and complications are generally recorded by treating clinicians and are not subjected to a multi-reader adjudication process as would be common in an imaging-based AI/ML study.

5. 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

There is no indication that a multi-reader multi-case (MRMC) comparative effectiveness study was performed for this device, nor is there any mention of AI assistance. This document describes a traditional medical device, not an AI/ML diagnostic or assistive tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This information is not applicable as the device is a physical medical implant (vena cava filter) and extraction kit, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For clinical performance, the "ground truth" was based on outcomes data (e.g., complication rates, successful retrieval rates) from the 220-patient clinical investigation. These outcomes would have been observed and recorded by medical professionals.

8. The sample size for the training set

This information is not applicable as this isn't an AI/ML device requiring a training set. The clinical data referenced is to demonstrate the device's performance in real-world use.

9. How the ground truth for the training set was established

This information is not applicable as this isn't an AI/ML device.

Summary

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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 ChirurgicauxMr Alain NIGON589 chemin du Niel83 230 BORMES LES MIMOSASFRANCETel.: +33 4 94 01 05 01Fax: +33 4 94 01 09 01Alain.nigon@aln2b.com
Contact	TWOKSAMrs Cynthia COTTEREAU2 rue Quenot16 200 JARNACFRANCETel.: +33 5 45 32 18 84Fax: +33 9 63 29 41 39Cynthia.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 ExtractionKit
Classification Name	Cardiovascular Intravascular Filter (21 CFR870.3375, 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

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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 FilterWith 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

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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

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

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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.

Technologicalcharacteristic	Present	Predicate 1	Predicate 2	Predicate 3	Predicate 4
Brachialvascularapproach	YES	NO	NO	NO	YES
Filter sheathintroducer	7F	12F	-	7F	7F
Filter material	Stainless steel	Stainless steel	-	Conichrome	Stainless steel
Apical fixationof wires	Set	Welded	-	Welded	Set
Hook on thefilter head	YES	NO	-	YES	NO
Filterconfiguration	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 kitsheathintroducer	9F	-	10F	-	9F
Plastic cone onthe pincer	NO	-	YES	-	NO
Cathetersmaterial	PE	-	Pebax®	-	PE
Forceps design	8 wires	-	10 wires	-	8 wires
Forcepsangulation of90°	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

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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)

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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

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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

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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:

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.

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

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.”