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.

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 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.

AI/ML Overview

Here's an analysis of the provided text regarding the ALN Optional Vena Cava Filter and Extraction Kit, focusing on the acceptance criteria and the study used to demonstrate fulfillment:

I. Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of quantitative acceptance criteria with specific thresholds for the ALN Optional Vena Cava Filter and Extraction Kit. Instead, it describes a series of non-clinical tests and refers to clinical data. The acceptance is implied by successfully passing these tests and showing similar performance to predicate devices.

Acceptance Criteria Category (Implied)	Reported Device Performance
Non-Clinical Performance
Simulated deployment	Passed all required tests.
Introducer / sheath suitability	Passed all required tests.
Clot trapping ability	Passed all required tests; filtering performances were assessed by a bench test in comparison with the predicate device, and results were similar for the two devices.
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 Performance
Safety (complication rates)	Low rates of complication reported in the latest clinical study. 55 out of 220 filters were retrieved after a mean period of 51 days (range: 6 - 352 days) without any complication.
Effectiveness (prevention of PE)	"Clinical performances of ALN Optional Vena Cava Filter and Extraction Kit are similar to the clinical performances of the two predicates." The study included 220 patients who received the filter for prevention of venous thromboembolism, implying it serves this purpose effectively.
Retrievability	55 filters retrieved without any complication, demonstrating successful retrievability.
Substantial Equivalence	The device was determined to be substantially equivalent to predicate devices based on design, material, components, fundamental technology, intended use, non-clinical, and clinical performances.

II. Study Details for Demonstrating Acceptance Criteria

The document references both non-clinical (bench) testing and clinical data.

Non-Clinical Performance Studies:

Sample Size: Not explicitly stated for each non-clinical test (simulated deployment, introducer/sheath suitability, filter fracture, caval perforation/migration, thrombogenicity, MRI compatibility). For "clot trapping ability," it involved a bench test comparison, but the number of tests or samples is not specified.
Data Provenance: Implied to be laboratory/bench testing. No country of origin is mentioned for these specific non-clinical tests.
Ground Truth: The "ground truth" for these non-clinical tests would be the established engineering/materials standards and performance metrics for such devices. Not applicable for expert review.
Adjudication Method: Not applicable for non-clinical tests described.
MRMC Comparative Effectiveness Study: Not applicable for non-clinical tests.
Standalone Performance: Yes, the non-clinical tests evaluate the device's inherent performance characteristics independently.
Type of Ground Truth: Engineering specifications, material properties, and established test methodologies (e.g., ISO standards for medical devices, although not explicitly named).
Training Set Sample Size & Ground Truth: Not applicable; these are performance validation tests, not machine learning model training.

Clinical Performance Study:

Study Description: The document states, "The safety and effectiveness of the ALN Optional Vena Cava Filter and Extraction Kit have been demonstrated via clinical data collected for 14 years." It then specifically mentions: "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."
Sample Size (Test Set): 220 patients.
Data Provenance: Not explicitly stated (e.g., country of origin, retrospective or prospective). However, the publication in "Chest" in 2006 suggests it was a published, likely prospective, clinical trial. The long data collection period (14 years) implies either a series of studies or long-term follow-up from a prospective study.
Number of Experts & Qualifications (Ground Truth): Not specified in the provided text. Clinical studies typically involve physicians (e.g., interventional radiologists, vascular surgeons) for patient selection, procedure performance, and outcome assessment, but the number and qualifications of those establishing study endpoints or ground truth directly are not detailed here.
Adjudication Method: Not specified. Clinical trials often employ independent clinical event committees (CEC) or data safety monitoring boards (DSMB) for adjudication, but this detail is absent.
MRMC Comparative Effectiveness Study: No, this was a study on the ALN filter itself, not a comparative effectiveness study involving human readers with/without AI assistance.
Standalone Performance (Clinical): Yes, this clinical study assessed the standalone performance of the ALN Optional Vena Cava Filter in patients.
Type of Ground Truth (Clinical): "Outcomes data." The study assessed clinical outcomes such as complication rates and successful retrieval. The fundamental "ground truth" for efficacy would be the absence of pulmonary embolism or the successful treatment of conditions leading to PE prevention.
Training Set Sample Size & Ground Truth: Not applicable. This is a clinical trial evaluating device performance, not a machine learning model. The "training set" for the device's development would involve iterative design and bench testing, but not a dataset in the AI sense.

Summary

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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 ChirurgicauxMr Alain NIGON589 chemine de Niel93230 BORMES LES MIMOSASFRANCETel.: +33 4 94 01 05 01Fax: +33 4 94 01 09 01Alain.nigon@aln2b.com
Contact	NAMSA Advisory ServicesMrs Julianne Slaughter900 Circle 75 ParkwaySuite 1240ATLANTA GEORGIA 30339USATel.: 770 563 1665Fax: 770 563 1661jslaughter@namsa.com
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

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KO7O514 0. 2 ot

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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

3. Device Description

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KO70514 D. 30 f 4

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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).

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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)

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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.

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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 (240) 276-0120. 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 (800) 638-2041 or (240) 276-3150 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

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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.

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

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.”