The Günther Tulip™ Vena Cava Filter Set is indicated 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.

Retrieval Set:

The Günther Tulip™ Vena Cava Filter Retrieval Set has been designed for retrieval of an implanted Günther Tulip™ Vena Cava Filter in patients who no longer require a filter. Retrieval of the filter can be performed only by jugular approach.

Device Description

The Günther Tulip™ Vena Cava Filter and Retrieval Set is an inferior vena cava filter with a radiopaque band at the tip, which can be introduced via either femoral or jugular vein. The radiopaque retrieval catheter has a braided platinum loop at the distal end.

AI/ML Overview

Acceptance Criteria and Device Performance for Günther Tulip™ Vena Cava Filter and Retrieval Set

This report summarizes the acceptance criteria and the study that demonstrates the Günther Tulip™ Vena Cava Filter and Retrieval Set meets these criteria, based on the provided 510(k) summary.

Note: This 510(k) summary primarily focuses on establishing substantial equivalence based on preclinical testing and clinical experience for safety and retrieval success. It does not present quantitative acceptance criteria in the typical format of a medical device performance study (e.g., sensitivity, specificity, accuracy thresholds) as would be seen for diagnostic AI. Instead, the "acceptance criteria" are implied by successful completion of various tests and a successful clinical retrieval rate.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria (Implied)	Reported Device Performance
I. Filter Set
Biocompatibility	Meets established biocompatibility standards.	Passed Biocompatibility tests.
Material & Stress Analysis	Demonstrates reliable structural integrity and performance under specified conditions.	Passed Material and Stress Analysis tests.
Clinical Safety & Effectiveness (Retrieval)	Safe and successful retrieval of the filter. No adverse events during and post-retrieval.	26 out of 26 attempted retrievals were successful. No adverse events reported in the retrieved filter group. 23 patients followed for 3 months post-retrieval showed no abnormalities.
II. Retrieval Set
Biocompatibility	Meets established biocompatibility standards.	Passed Biocompatibility tests.
Tensile Strength	Demonstrates adequate tensile strength for retrieval procedure.	Passed Tensile tests.
Clinical Evaluation	Safe and successful retrieval of the filter. No adverse events during and post-retrieval.	26 out of 26 attempted retrievals were successful. No adverse events reported in the retrieved filter group. 23 patients followed for 3 months post-retrieval showed no abnormalities.

2. Sample Size and Data Provenance for Test Set (Clinical Evaluation)

Sample Size for Test Set: 41 patients were enrolled for possible retrieval. Of these, retrieval was attempted in 26 patients.
Data Provenance: The document does not explicitly state the country of origin for the clinical study data or whether it was prospective or retrospective. However, it describes a "clinical study was conducted," which typically implies a prospective design.

3. Number of Experts and Qualifications for Ground Truth Establishment

This type of study (medical device clinical evaluation for safety and retrieval success) does not typically involve "experts" in the same way an imaging AI study would use radiologists for ground truth. The "ground truth" here is the outcome of the retrieval procedure (successful or not, adverse events or not), which is observed and documented by the medical professionals performing the procedures and follow-up.

4. Adjudication Method for the Test Set

Not applicable. The clinical study focused on direct observation of retrieval success and patient outcomes, not on interpretation or consensus among experts.

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

No, an MRMC comparative effectiveness study was not done. This study is a clinical evaluation of a medical device, not an AI or diagnostic imaging system.

6. Standalone (Algorithm Only) Performance Study

Not applicable. This is a physical medical device (vena cava filter and retrieval set), not an algorithm or software. The "performance" is its physical function in a clinical setting.

7. Type of Ground Truth Used (Clinical Evaluation)

The ground truth used for the clinical evaluation was observed clinical outcomes. This includes:

Successful retrieval of the filter.
Absence of adverse events during and immediately after retrieval.
Absence of abnormalities during a 3-month post-retrieval follow-up.

8. Sample Size for the Training Set

Not applicable. This document describes a medical device, not an AI system. Therefore, there is no "training set" in the context of machine learning. The "training" for such devices would involve design iterations, preclinical testing, and potentially previous clinical experience with similar devices.

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

Not applicable, as there is no "training set" in the context of an AI device.

Summary

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OCT 3 1 2003

510(k) SUMMARY

Submitted By:	Cook Incorporated
Contact:	Jennifer Bosley, MBA
	Regulatory Affairs Coordinator
	Tel: (812) 339-2235
	Fax: (812) 332-0281
Date Prepared:	October 31, 2003

Device:

Trade Name:	Günther Tulip™ Vena Cava Filter and Retrieval Set
Common/Usual Name	Inferior Vena Cava Filter and Retrieval Set
Proposed Classification:& Product Code	Filter, Intravascular, Cardiovascular21 CFR §870.3375, Class II, DTK—Cardiovascular

Intended Use:

Filter Set:

The Günther Tulip™ Vena Cava Filter Set is indicated 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.

Retrieval Set:

Predicate Devices:

The subject devices are substantially equivalent to predicate devices: Günther Tulip™ Vena Cava MReye® Filter, #K000855 (Cook Incorporated); Amplatz Goose Neck Snare, #K972511 (Microvena Corp.); and the Radius Microsnare, #K022201 (Radius Medical Technologies).

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Device Description:

Substantial Equivalence:

The subject device is similar with respect to intended use, materials and functional characteristics of commercially available predicate devices in terms of section 510(k) substantial equivalence; any differences that may exist do not significantly affect the safety and effectiveness of the device.

Test Data:

The Günther Tulip™ Vena Cava Filter and Retrieval Set have been subjected to and have passed the following tests to ensure reliable design and performance under the specified testing parameters:

Filter Set:

· Biocompatibility
Material and stress analysis tests
· Clinical experience

Retrieval Set:

· Biocompatibility
· Tensile
Clinical evaluation

Clinical Experience:

To evaluate the safety of retrieving the Günther Tulip™ Vena Cava Filter, a clinical study was conducted in which 41 patients [female (n=19); male (n=22)] were enrolled for possible retrieval of the filter. Indications for placement of retrievable filter in the study included: bleeding while anticoagulated (n=2), recent bleeding not anticoagulated (n=0), prophylactic pre-op (n=12), prophylactic post-op (n=3), failure of anticoagulation resulting in recurrent PE (n=1), failure of anticoagulation resulting in extension of DVT (n=0), prophylaxis following PE (n=3), prophylaxis with extensive DVT (n=3), trauma (n=13) and other (n=4).

Retrieval was not attempted in 15 patients due to the continued need for permanent implantation of the filter. A total of 26 attempted retrievals in 26 patients were successful. [n= number of filters retrieved] Retrieval of filter immediately after deployment at Day 0 (n=1), Day 2 (n=1), Day 7 (n=1), Day 9 (n=3), Day 10 (n=6), Day 11(n=2), Day 12 (n=1), Day 13 (n=4), Day 14 (n=6), Day 20 (n=1). No adverse events were reported in the retrieved filter group. 23 patients in whom a filter was retrieved were followed for three months post retrieval with no abnormalities reported. Results from the clinical study showed that the filter could be safely retrieved up to 14 days or longer in patients who no longer required an inferior vena cava filter. Time to retrieval ranged from 2-20 days with a mean implantation time of 11.4 days.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with three stripes representing the three levels of government: federal, state, and local. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA". The seal is black and white.

Public Health Service

OCT 3 1 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Cook Incorporated c/o Ms. Jennifer J. Bosley Regulatory Affairs Coordinator P.O. Box 489 Bloomington, IN 47402-0489

Re: K032426

Günther Tulip™ Vena Cava MReye® Filter and Retrieval Set Regulation Number: 21 CFR 870.3375 Regulation Name: Cardiovascular intravascular filter Regulatory Class: Class II Product Code: DTK Dated: August 5, 2003 Received: August 6, 2003

Dear Ms. Bosley:

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. Jennifer J. Bosley

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 (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. 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 Office of Compliance at (301) 594-4646. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely vours.

Ashley B. Boane

Image /page/3/Picture/5 description: The image shows a signature in black ink on a white background. The signature appears to be stylized and cursive, with looping strokes and connected letters. The overall impression is that of a quick, fluid, and practiced signature.

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 Statement

K032426 510(k) Number (if known): ____

Günther Tulip™ Vena Cava Filter and Retrieval Set Device Name:

Filter Set

The Günther Tulip™ Vena Cava Filter Set is indicated 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.

Retrieval Set

PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use_ (Per 21 CFR 801.109)

Over-The-Counter Use (Optional Format 1-2-96)

Ashley B. Boane

(Division Sign-Off)
Division of Cardiovascular Devices

510(k) Number K032426

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.”