The proposed Günther Tulip® Vena Cava Filter is intended for the prevention of recurrent pulmonary embolism via placement in the vena cava in the following situations: Pulmonary thromboembolism when anticoagulant therapy is 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 Günther Tulip® Vena Cava Filter may be retrieved according to the instructions supplied in the section labeled: Optional Retrieval Procedure.

Device Description

Günther Tulip® Vena Cava Filter: The Günther Tulip Vena Cava Filter is available in femoral vein and jugular vein access versions. A universal set is also available, which contains the components necessary for both the jugular and femoral filter delivery approach. The femoral set is introduced through the femoral vein, while the jugular set is introduced through the jugular vein. The device consists of a pre-loaded filter, a coaxial introducer sheath system, a hydrophilic coated dilator, and a three-way stopcock. The filter is introduced and placed via a 7.0 French coaxial introducer sheath system. The introducer dilator is a 7.0 French power iniectable dilator that is 75 centimeters long. The Günther Tulip Vena Cava Filter is constructed from conichrome. The basic design of the filter is conical with four primary legs. The end of each leg is hooked outward. The hooks are designed to secure the filter to the wall of the inferior vena cava. "Webbed" wires (like tulip petals) between the legs are bent secondary legs which maintain the shape of the filter by pressing outward toward the vein walls. These webs also increase the area into which emboli can be trapped.

Cook® Celect® Vena Cava Filter: The Cook® Celect® Vena Cava Filter is available in femoral vein and jugular vein access versions. A universal set is also available, which contains the components necessary for both the jugular and femoral filter delivery approach. The femoral set is introduced through the femoral vein, while the jugular set is introduced through the jugular vein. The device consists of a pre-loaded filter, a coaxial introducer sheath system, a hydrophilic coated dilator, and a three-way stopcock. The filter is introduced and placed via a 7.0 French coaxial introducer sheath system. The introducer dilator is a 7.0 French power injectable dilator that is 75 centimeters long. The filter is compatible with placement in vena cavae with diameters between 15 and 30 mm and is constructed from conichrome. The design of the Cook® Celect® Vena Cava Filter allows the filter to anchor to the vena cava walls by means of the hooks at the ends of the primary legs. The secondary legs promote centering of the filter within the vena cava, and assist in caval filtering of sizeable thrombi in the bloodstream.

AI/ML Overview

This document describes a Special 510(k) submission for modifications to the Günther Tulip® Vena Cava Filter and the Cook® Celect® Vena Cava Filter. It focuses on demonstrating that the modified devices are substantially equivalent to their predicate devices, rather than on proving performance against specific acceptance criteria for a new device. Therefore, much of the requested information regarding study design, ground truth, and expert evaluation is not present in this type of submission.

Here's an analysis of the provided text based on your request:

1. Table of acceptance criteria and reported device performance:

The document doesn't present specific acceptance criteria in terms of clinical performance metrics (e.g., sensitivity, specificity, accuracy) because it's a submission for device modifications, not a new device seeking initial clearance based on clinical performance. Instead, the acceptance criteria are inherent in demonstrating that the modified devices continue to meet the requirements for their intended use through various engineering and material tests, ensuring the modifications do not negatively impact safety or effectiveness.

Test Performed	Reported Device Performance / Outcome
Tensile Testing	The results of these tests provide reasonable assurance that the devices have been designed and tested to assure conformance to the requirements for their intended use.
Flow Rate Testing	The results of these tests provide reasonable assurance that the devices have been designed and tested to assure conformance to the requirements for their intended use.
Static Burst Testing	The results of these tests provide reasonable assurance that the devices have been designed and tested to assure conformance to the requirements for their intended use.
Diameter Retention Testing	The results of these tests provide reasonable assurance that the devices have been designed and tested to assure conformance to the requirements for their intended use.
Leak Testing	The results of these tests provide reasonable assurance that the devices have been designed and tested to assure conformance to the requirements for their intended use.
Biocompatibility Testing	The results of these tests provide reasonable assurance that the devices have been designed and tested to assure conformance to the requirements for their intended use.
Deployment Testing	The results of these tests provide reasonable assurance that the devices have been designed and tested to assure conformance to the requirements for their intended use.
Shipping Testing	The results of these tests provide reasonable assurance that the devices have been designed and tested to assure conformance to the requirements for their intended use.

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

This document details engineering and material tests rather than clinical or performance studies with patient data. Therefore, concepts like "sample size for the test set" and "data provenance" in the context of clinical data are not applicable here. The "test set" refers to the modified devices themselves undergoing various physical and chemical evaluations.

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)

Not applicable. Ground truth, in the sense of expert evaluation of medical images or patient outcomes, is not part of this type of submission. The "ground truth" for these tests would be the established engineering and material standards and specifications that the devices are required to meet.

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

Not applicable. Adjudication methods are relevant for subjective assessments, typically in clinical studies or expert reviews of data. These are objective engineering tests.

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

Not applicable. This is not a study involving human readers or AI assistance.

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

Not applicable. This document is about medical devices (vena cava filters), not an algorithm or AI system.

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

The "ground truth" for the tests performed (Tensile Testing, Flow Rate Testing, etc.) would be the established engineering specifications, material standards, and performance requirements for vena cava filters. These are objective, measurable parameters rather than subjective expert consensus or clinical outcomes.

8. The sample size for the training set

Not applicable. There is no "training set" in the context of device modification testing by engineering methods.

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

Not applicable, as there is no training set.

Summary

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K090140 page 1 of 3

Special 510(k): Device Modification Günther Tulip® Vena Cava Filter and Cook® Celect® Vena Cava Filter William Cook Europe ApS 16 January 2009

APR - 3 2009

510(k) SUMMARY

Submitted By:	Molly BusenbarkWilliam Cook Europe ApSSandet 6, DK-4632Bjaeverskov, Denmark(812) 339-2235 x 2162
---------------	------------------------------------------------------------------------------------------------------------------

Device:

Trade Name:

Proposed Classification:

Günther Tulip® Vena Cava Filter and Cook® Celect® Vena Cava Filter Cardiovascular Intravascular Filter

Indications for Use:

Günther Tulip® Vena Cava Filter

The proposed Günther Tulip® Vena Cava Filter is intended for the prevention of recurrent pulmonary embolism via placement in the vena cava in the following situations:

Pulmonary thromboembolism when anticoagulant therapy is . 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 Günther Tulip® Vena Cava Filter may be retrieved according to the instructions supplied in the section labeled: Optional Retrieval Procedure.

Cook® Celect® Vena Cava Filter

The proposed Günther Tulip® Vena Cava Filter is intended for the prevention of recurrent pulmonary embolism via placement in the vena cava in the following situations:

. Pulmonary thromboembolism when anticoagulant therapy is contraindicated;
Failure of anticoagulant therapy in thromboembolic diseases; ●

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K090140 page 2 of 3

Special 510(k): Device Modification Günther Tulip® Vena Cava Filter and Cook® Celect® Vena Cava Filter William Cook Europe ApS 16 January 2009

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 Cook® Celect® Vena Cava Filter may be retrieved according to the instructions supplied in the section labeled: Optional Retrieval Procedure.

Predicate Device:

The Günther Tulip® Vena Cava Filter is similar in terms of intended use, materials of construction, and technological characteristics to the predicate Günther Tulip® Vena Cava Filter. The Cook Celect Vena Cava Filter is also similar to the predicate device in terms of intended use, materials of construction, and technological characteristics.

Device Description:

Günther Tulip® Vena Cava Filter

The Günther Tulip Vena Cava Filter is available in femoral vein and jugular vein access versions. A universal set is also available, which contains the components necessary for both the jugular and femoral filter delivery approach. The femoral set is introduced through the femoral vein, while the jugular set is introduced through the jugular vein. The device consists of a pre-loaded filter, a coaxial introducer sheath system, a hydrophilic coated dilator, and a three-way stopcock. The filter is introduced and placed via a 7.0 French coaxial introducer sheath system. The introducer dilator is a 7.0 French power iniectable dilator that is 75 centimeters long.

The Günther Tulip Vena Cava Filter is constructed from conichrome. The basic design of the filter is conical with four primary legs. The end of each leg is hooked outward. The hooks are designed to secure the filter to the wall of the inferior vena cava. "Webbed" wires (like tulip petals) between the legs are bent secondary legs which maintain the shape of the filter by pressing outward toward the vein walls. These webs also increase the area into which emboli can be trapped.

Cook® Celect® Vena Cava Filter

The Cook® Celect® Vena Cava Filter is available in femoral vein and jugular vein access versions. A universal set is also available, which contains the components necessary for both the jugular and femoral filter delivery approach. The femoral set is introduced through the femoral vein, while the jugular set is introduced through the jugular vein. The device consists of a pre-loaded filter, a coaxial introducer sheath system, a hydrophilic coated dilator, and a three-way stopcock. The filter is introduced and placed via a 7.0 French coaxial introducer sheath system. The introducer dilator is a 7.0 French power injectable dilator that is 75 centimeters long.

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K090140 page 3 of 3

Special 510(k): Device Modification Günther Tulip® Vena Cava Filter and Cook® Celect® Vena Cava Filter William Cook Europe ApS 16 January 2009

The filter is compatible with placement in vena cavae with diameters between 15 and 30 mm and is constructed from conichrome. The design of the Cook® Celect® Vena Cava Filter allows the filter to anchor to the vena cava walls by means of the hooks at the ends of the primary legs. The secondary legs promote centering of the filter within the vena cava, and assist in caval filtering of sizeable thrombi in the bloodstream.

Substantial Equivalence:

Cook Incorporated currently markets the predicate Günther Tulip® Vena Cava Filter, which is substantially equivalent to the Günther Tulip® Vena Cava Filter, subject of this submission. The similar indications for use and technological characteristics of the Günther Tulip® Vena Cava Filter as compared to the predicate device support a determination of substantial equivalence.

William Cook Europe ApS currently markets the predicate Cook® Celect® Vena Cava Filter, which is substantially equivalent to the proposed Cook® Celect® Vena Cava Filter. The similar indications for use and technological characteristics of the Cook" Celect® Vena Cava Filter as compared to the predicate device support a determination of substantial equivalence.

Test Data:

The proposed Günther Tulip® and Cook Celect Vena Cava Filters were subjected to the following tests to assure reliable design and performance under the specified testing parameters.

발 Tensile Testing
트 Flow Rate Testing
I Static Burst Testing
1 Diameter Retention Testing
I Leak Testing
Biocompatibility Testing
트 Deployment Testing
해 Shipping Testing

The results of these tests provide reasonable assurance that the devices have been designed and tested to assure conformance to the requirements for their intended use.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the eagle. The eagle is drawn with thick, black lines, and the text is in a simple, sans-serif font. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR - 3 2009

William Cook Europe ApS c/o Ms. Molly Busenbark Regulatory Affairs Specialist Cook Incorporated 750 Daniels Way Bloomington, IN 47402

Re: K090140

Trade/Device Name: Gunther Tulip and Cook Celect Vena Cava Filters Regulation Number: 21 CFR 870.3375 Regulation Name: Cardiovascular intravascular filter Regulatory Class: Class II Product Code: DTK Dated: March 9, 2009 Received: March 10, 2009

Dear Ms. Busenbark:

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.

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

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Page 2 .- Ms. Molly Busenbark

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 the reporting 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 yours,

una R. vicher

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

Enclosure

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Special 510(k): Device Modification Günther Tulip Vena Cava Filter and Cook Celect® Vena Cava Filter William Cook Europe ApS 16 January 2009

Indications for Use

K090140 510(k) Number (if known):

Günther Tulip® Vena Cava Filter and Cook® Celect® Vena Cava Filter Device Name:

Indications for Use for Günther Tulip® Vena Cava Filter:

The Günther Tulip® Vena Cava Filter is intended for the prevention of recurrent pulmonary embolism via placement in the vena cava in the following situations:

Pulmonary thromboembolism when anticoagulant therapy is contraindicated; .
Failure of anticoagulant therapy in thromboembolic diseases; ●
Emergency treatment following massive pulmonary embolism when anticipated . benefits of conventional therapy are reduced; and
Chronic, recurrent pulmonary embolism when anticoagulant therapy has failed or ● is contraindicated.

Indications for Use for Cook® Celect® Vena Cava Filter:

The Cook® Celect® Vena Cava Filter is intended for the prevention of recurrent pulmonary embolism via placement in the vena cava in the following situations:

Pulmonary thromboembolism when anticoagulant therapy is contraindicated; �
. Failure of anticoagulant therapy in thromboembolic diseases;
Emergency treatment following massive pulmonary embolism when anticipated . benefits of conventional therapy are reduced; and
. Chronic, recurrent pulmonary embolism when anticoagulant therapy has failed or is contraindicated.

Prescription Use XX (Part 21 CFR 801 Subpart D) OR 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)

uma R. bochmer

(Division Sign-Off) Division of Cardiovascular Devices

510(k) Number_kog 0 \40

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.”