The Günther Tulip Filter implant is intended for the prevention of recurrent pulmonary embolism (PE) 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 PE where anticipated benefits of conventional therapy are reduced; and
. Chronic, recurrent PE where anticoagulant therapy has failed or is contraindicated.

The Günther Tulip Filter implant may be retrieved if clinically indicated; please refer to the "Optional Filter Retrieval" section of the Instructions for Use for more information.

The product is intended for percutaneous placement via a femoral or jugular vein for filtration of inferior vena cava (IVC) blood to prevent PE.

Device Description

The Günther Tulip Vena Cava Filter is an IVC filter intended for use in prevention of recurrent PE. The filter is intended for percutaneous placement via either the jugular vein or femoral vein for filtration of blood within the IVC. The Günther Tulip Vena Cava Filter Set is available in a femoral vein access version and in a universal vein access version consisting of components for both femoral and jugular vein approaches. Each set consists of a filter preloaded on the set for femoral approach, a coaxial introducer system, a hydrophilic coated pre-dilator, and a three-way stopcock. The filter is introduced and placed via a 7 French coaxial introducer system with a Check-Flo® valve. The femoral filter introducer has a flexible tip. The introducer dilator has 8 sideports and two radiopaque markers 30 mm apart. The Günther Tulip Vena Cava Filter is constructed from a cobalt chromium alloy. The end of each leg is hooked outward; this hook design enables securement of 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. The filter is approximately 50 mm long along its main axis when compressed to a diameter of 30 mm.

AI/ML Overview

This document is a 510(k) summary for the Günther Tulip Vena Cava Filter Set, which states that no changes have been made to the filter or its delivery system. The submission primarily addresses updates to labeling and an extension of the device's shelf life. Therefore, the information provided does not describe a new study proving the device meets acceptance criteria in the context of clinical performance or effectiveness for this submission. Instead, it refers to nonclinical aging testing to support a shelf life extension.

Here's an analysis based on the provided text, addressing your questions where possible:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (for Shelf Life Extension)	Reported Device Performance (Nonclinical Aging Testing)
Predetermined acceptance criteria for packaging testing	All test results met the predetermined acceptance criteria.
Predetermined acceptance criteria for performance testing	All test results met the predetermined acceptance criteria.
Shelf life	Extended to three years.

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify sample sizes for the nonclinical aging testing. It also doesn't provide information on data provenance (e.g., country of origin, retrospective/prospective) for clinical effectiveness, as no new clinical study was performed for this submission. The submission states, "No changes have been made to the Günther Tulip Vena Cava Filter or its delivery systems," and is primarily for labeling updates and shelf life extension based on "post-market experience".

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not applicable to the provided document, as no clinical study requiring expert ground truth establishment for a test set is described.

4. Adjudication Method

This information is not applicable, as no clinical study requiring adjudication is described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC study was done, as this submission concerns labeling updates and shelf life extension, not a comparative effectiveness study of the device's clinical performance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

This information is not applicable, as the device is a Vena Cava Filter, not an AI algorithm.

7. Type of Ground Truth Used

For the shelf life extension, the "ground truth" would be the observed physical and functional integrity of the device and its packaging after accelerated and/or real-time aging, evaluated against predefined engineering specifications (performance testing).

8. Sample Size for the Training Set

This information is not applicable, as this is a medical device, not an AI algorithm requiring a training set.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable, as this is a medical device, not an AI algorithm.

Summary of what the document does state:

The primary purpose of this 510(k) submission (K172584) is to update device labeling and extend the shelf life of the Günther Tulip Vena Cava Filter Sets. The manufacturer asserts substantial equivalence to the predicate device (K121057) because:

No changes have been made to the filter or its delivery systems.
The indications for use, principles of operation, design, materials, manufacturing, sterilization process, and basic technological characteristics remain identical to the predicate.

The acceptance criteria relevant to this specific submission relate to the nonclinical aging testing performed to support the three-year shelf life extension. The reported performance is that "all test results met the predetermined acceptance criteria" for both packaging and performance testing after aging. No details on these specific criterion values or test methodologies are provided in this summary.

Summary

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November 20, 2017

William Cook Europe ApS Henriette S. Christiansen Director of Regulatory Affairs Sandet 6, 4632 Bjaeverskov Denmark

Re: K172584

Trade/Device Name: Günther Tulip Vena Cava Filter Set for Femoral Vein Approach, Günther Tulip Vena Cava Filter Set for Femoral and Jugular Vein Approach Regulation Number: 21 CFR 870.3375 Regulation Name: Cardiovascular Intravascular Filter Regulatory Class: Class II Product Code: DTK Dated: August 25, 2017 Received: August 28, 2017

Dear Henriette S. Christiansen:

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 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good

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manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Nicole G. Ibrahim -S

for 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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Indications for Use

510(k) Number (if known) K172584

Device Name

Günther Tulip Vena Cava Filter Set for Femoral Vein Approach Günther Tulip Vena Cava Filter Set for Femoral and Jugular Vein Approach

Indications for Use (Describe)

The Günther Tulip Filter implant is intended for the prevention of recurrent pulmonary embolism (PE) 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 PE where anticipated benefits of conventional therapy are reduced; and
· Chronic, recurrent PE where anticoagulant therapy has failed or is contraindicated.

The Günther Tulip Filter implant may be retrieved if clinically indicated; please refer to the "Optional Filter Retrieval" section of the Instructions for Use for more information.

The product is intended for percutaneous placement via a femoral or jugular vein for filtration of inferior vena cava (IVC) blood to prevent PE.

Type of Use (Select one or both, as applicable)

☑ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary	K172584
Date Prepared:	25 August 2017
Submitted By:	William Cook Europe ApS
	Sandet 6
	4632 Bjaeverskov, Denmark
Contact:	Henriette Stordal Christiansen
Phone:	+45 56 86 87 56
Fax:	+45 56 86 86 96
Email:	Henriette.Christiansen@CookMedical.com
Device:
Trade Name:	Günther Tulip® Vena Cava Filter Set for Femoral Vein Approach
	Günther Tulip® Vena Cava Filter Set for Femoral and JugularVein Approach
Common Name:	Inferior Vena Cava Filter
Review Panel:	Cardiovascular
Classification Name:	Intravascular Filter (21 CFR 870.3375, Product Code DTK)
Classification:	Class II

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Indications for Use:

The Günther Tulip Filter implant is intended for the prevention of recurrent pulmonary embolism (PE) 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 PE where anticipated benefits of conventional therapy are reduced; and
. Chronic, recurrent PE where anticoagulant therapy has failed or is contraindicated.

The Günther Tulip Filter implant may be retrieved if clinically indicated; please refer to the "Optional Filter Retrieval" section of the Instructions for Use for more information.

The product is intended for percutaneous placement via a femoral or jugular vein for filtration of inferior vena cava (IVC) blood to prevent PE.

Predicate Device:

The Günther Tulip Vena Cava Filter Sets are substantially equivalent to the predicate devices:

. Günther Tulip Vena Cava Filter Sets cleared under K121057 on 04 May 2012.

Comparison to Predicate Device:

It has been demonstrated that the subject Günther Tulip Vena Cava Filter Sets are substantially equivalent to the predicate Günther Tulip Vena Cava Filter Sets (K121057). No changes have been made to the Günther Tulip Vena Cava Filter or its delivery systems; the Günther Tulip Vena Cava Filter Sets are identical to the predicate devices in terms of indications for use, principles of operation, design, materials of construction, manufacturing processes, sterilization process, and basic technological characteristics. The purpose of this submission is to update device labeling based on safety and performance information gathered from post-market experience and to align with current international and regulatory standards. In addition, the shelf life of the Günther Tulip Vena Cava Filter has been extended to three years.

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Device Description:

Performance Testing:

No changes to the design, manufacturing, sterilization, or principles of operation have been introduced with the subject devices. A three-year shelf life was supported by nonclinical aging testing, which included packaging testing and performance testing; all test results met the predetermined acceptance criteria.

Conclusion:

The Günther Tulip Vena Cava Filter Sets are substantially equivalent to the predicate devices. No changes have been made to the filter implant or the delivery systems. The only changes being made are updates to the device labeling and an extension of the device shelf life.

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.”