Filter Set: The Günther Tulip™ Vena Cava Filter is intended for placement in the vena cava in the following situations: Pulmonary thromboembolism when anticoagulation therapy is contraindicated; failure of anticoagulation therapy in thromboembolic diseases; emergency treatment following massive pulmonary embolism where anticipated benefits of conventional therapy are reduced; and chronic, recurrent pulmonary embolism where anticoagulation 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 the 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 is crafted of an alloy consisting of Co, Cr, NI, Mo and Fe. The basic design of the filter is conical with four legs. The end of each leg is slightly hooked outward. "Webbed" wires (like tulip petals) between the legs are bent strands of the same alloy which maintain the shape of the filter by pressing outward toward the vein walls. These webs also increase the area into which the emboli can be trapped. There are two types of Günther Tulip Vena Cava Filter Sets a femoral set which is introduced through the femoral vein and a jugular set which is introduced through the jugular vein. The jugular set consists of: the Günther Tulip Vena Cava Filter with a protective sleeve, a 10 French Radiopaque Dilator, a 7 French Radiopaque Coaxial Introducer Sheath 65 centimeters long, a filter loading introducer with a pre-attached Günther Tulip Vena Cava Filter, a proximal protective sleeve to introducer, a Radiopaque polyethylene inner catheter, and a three-way stopcock. The femoral set consists of: the Günther Tulip Vena Cava Filter with a protective sleeve, a 10 French Radiopaque Dilator, a 8.5 French Radiopaque Coaxial Introducer Sheath 65 cm long, a Radiopaque polyethylene inner catheter, a three-way stopcock and a 10 French filter loading introducer system preloaded with a Günther Tulip Vena Cava Filter. 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.

AI/ML Overview

The provided text describes a 510(k) summary for the Günther Tulip Vena Cava Filter Set. It details the device, its intended use, and its substantial equivalence to predicate devices. However, the document does not contain specific acceptance criteria or a detailed study proving the device meets reported performance metrics in the way a clinical trial or algorithm validation study would.

Instead, this 510(k) summary focuses on demonstrating substantial equivalence to previously approved predicate devices based on:

Intended Use: The indications for use are similar.
Materials of Construction: The filter is crafted from a cobalt, chromium, nickel, molybdenum, and iron alloy, similar to predicate devices.
Technological Characteristics: The basic design (conical, four legs, webbed wires) and the method of introduction (femoral or jugular access) are comparable.
Non-Clinical Testing: A list of general tests performed to assure reliable design and performance is provided, but no specific performance metrics or acceptance criteria are stated in relation to these tests.

Therefore, many of the requested elements for a detailed study are not present in this type of regulatory submission. The 510(k) pathway is primarily about demonstrating substantial equivalence, not necessarily proving new clinical effectiveness or performance against predefined statistical endpoints with ground truth.

Here's a breakdown of the requested information based on the provided document, highlighting what is present and what is absent:

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

Acceptance Criteria (Explicitly Stated in Document)	Reported Device Performance (Explicitly Stated in Document)
Not explicitly stated as quantifiable metrics.	Not explicitly stated as quantifiable metrics.
Implicit Acceptance Criteria (from 510(k) pathway): Substantial equivalence to predicate devices (K000855 and K032426) in terms of intended use, materials, and technological characteristics. Safety and reliable performance under specified testing parameters.	Implicit Reported Performance: The device was "subjected to the following tests to assure reliable design and performance" and "The results of these tests provide reasonable assurance that the device has been designed and tested to assure conformance to the requirements for its use as a vena cava filter set."

Explanation: The document lists several types of tests performed (Simulated Transport, Biocompatibility, Deployment, Package, Lubricity Testing) but does not provide specific acceptance criteria (e.g., "deployment success rate > 95%") or numerical results from these tests (e.g., "deployment success rate was 98%"). The acceptance is based on the general conclusion that these tests "provide reasonable assurance" of conformance to use requirements and that the device is "substantially equivalent" to predicate devices.

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

Sample Size: Not specified. (The listed tests are likely non-clinical bench or in-vitro tests, not human subject studies with a "test set" in the context of AI/clinical studies.)
Data Provenance: Not applicable/specified. The tests are non-clinical.

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)

Number of Experts: Not applicable.
Qualifications of Experts: Not applicable.

Explanation: This document describes engineering and biocompatibility tests, not clinical performance evaluations requiring expert-adjudicated ground truth.

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

Adjudication Method: Not applicable.

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

Was an MRMC study done? No.
Effect Size: Not applicable.

Explanation: This device is a physical medical implant (vena cava filter), not an AI diagnostic or assistance system.

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

Was a standalone study done? No.

Explanation: This is not an algorithm. The "standalone" performance here would relate to the filter itself working as intended, and this is assessed through the non-clinical tests mentioned, not a standalone algorithm study.

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

Type of Ground Truth: For the non-clinical tests, the "ground truth" would be established engineering standards, material specifications, and regulatory requirements (e.g., ISO standards for biocompatibility). For substantial equivalence, the "ground truth" is that the predicate devices are legally marketed and considered safe and effective.

8. The sample size for the training set

Sample Size: Not applicable.

Explanation: This is a physical device, not an AI system that requires a "training set."

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

Ground Truth Establishment: Not applicable.

In summary, the provided 510(k) document is a regulatory submission for a physical medical device. It demonstrates substantial equivalence to predicate devices through a comparison of design, materials, intended use, and general non-clinical testing. It does not provide the detailed performance metrics, acceptance criteria, or study designs typically found in a clinical trial or a validation study for an AI/diagnostic software product.

Summary

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Image /page/0/Picture/1 description: The image shows the text "K043509" on the first line and "1 of 2" on the second line. The text is written in a handwritten style. The numbers and letters are clearly visible and legible.

COOK®

Cook Incorporated P.O. Box 489 Bloomington, IN 47402-0489 Phone: 800 468-1379 www.cookqroup.com

510(k) Summary

Submitted By:

COOK INCORPORATED P.O. Box 489, 750 Daniels Way Bloomington, IN 47402

Contact:

Earl E. Knight III, MPA Regulatory Affairs Phone: (812) 339-2235 Fax: (812) 322-0281

Date Prepared: February 18, 2005

Device:

Trade Name:	Günther Tulip Vena Cava Filter Set
Proposed Classification:	870.3375 DTK
	Class II, Cardiovascular

Predicate Devices:

The Günther Tulip Vena Cava Filter Set is similar in terms of intended use, materials of construction and technological characteristics as the predicate Günther Tulip MReye™ Vena Cava Filter Set (K000855) and the Günther Tulip™ Vena Cava Filter and Retrieval Set (K032426).

Device Description:

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There are two types of Günther Tulip Vena Cava Filter Sets a femoral set which is introduced through the femoral vein and a jugular set which is introduced through the jugular vein.

The jugular set consists of: the Günther Tulip Vena Cava Filter with a protective sleeve, a 10 French Radiopaque Dilator, a 7 French Radiopaque Coaxial Introducer Sheath 65 centimeters long, a filter loading introducer with a pre-attached Günther Tulip Vena Cava Filter, a proximal protective sleeve to introducer, a Radiopaque polyethylene inner catheter, and a three-way stopcock.

The femoral set consists of: the Günther Tulip Vena Cava Filter with a protective sleeve, a 10 French Radiopaque Dilator, a 8.5 French Radiopaque Coaxial Introducer Sheath 65 cm long, a Radiopaque polyethylene inner catheter, a three-way stopcock and a 10 French filter loading introducer system preloaded with a Günther Tulip Vena Cava Filter.

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.

Substantial Equivalence:

This device will be manufactured according to specified process controls and a Quality Assurance Program. This device will undergo packaging similar to the devices currently marketed and distributed by Cook Incorporated. This device will undergo sterilization similar to the devices currently marketed and distributed. Being similar with respect to indications for use, materials and physical construction to predicate devices, we believe this device meets the requirements for section 510(k) substantial equivalence.

Test Data:

The Günther Tulip Vena Cava Filter Set was subjected to the following tests to assure reliable design and performance under the specified testing parameters. These tests were comprised of:

Simulated Transport Testing 1.
Biocompatibility Testing 2.
Deployment Testing 3.
Package Testing 4.
Lubricity Testing న్ :

The results of these tests provide reasonable assurance that the device has been designed and tested to assure conformance to the requirements for its use as a vena cava filter set.

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Public Health Service

Image /page/2/Picture/2 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features an eagle-like emblem with three stylized human profiles facing right. The emblem is surrounded by the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" in a circular arrangement.

MAY - 5 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Cook Incorporated c/o Earl E. Knight III, MPA Regulatory Affairs Specialist 750 N. Daniels Way P.O. Box 489 Bloomington, IN 47402

K043509 Re:

K043309
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: April 4, 2005 Received: April 5, 2004

Dear Mr. Knight:

We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Section 910(x) premainted is substantially equivalent (for the indications
referenced above and have determined the device is subscripes marketed in int referenced above and nave decemblicated the arrood predicate devices marketed in interstate for use stated in the encrosule for tegally manoved per the Medical Device American by to commerce prior to May 28, 1970, the charters and stime of the Federal Food, Drug, devices that have been reciassified in accordance while toproval application (PMA).
and Cosmetic Act (Act) that do not require approval of a provisions of the Act . The and Cosmetic Act (Act) that do not require approvile controls provisions of the Act. The You may, therefore, market the device, salgost to the genirements for annual registration, listing of
general controls provisions of the Act include requirements for annual r general controls provisions of the rict mendes - - - 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 If your device is classified (sec above) mls. Titler on the miner of the column of the edition. FDA may may be subject to such additional controlis. Existing may on 898. In addition, FDA may
be found in the Code of Federal Regulations, Title 21, Parts 800 to 898 Personal be found in the Code of Federal Regarations of the Federal Register.

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Page 2 - Earl E. Knight III, MPA

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that IDA 3 issualled of a backen............................................................................................................................ that IDA has made a determination administered by other Federal agencies. You must or any Federal statutes and regulations and institutions but not limited to: registration and listing (21 Comply with an the Act 3 requirements, noteness, were and acturing practice requirements as set CFK Fart 807), labeling (21 OF R Part 820); and if applicable, the electronic form in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control provisions (Declients on 1 evice as described in your Section 510(k) This letter with anow you to ocgin marketing your antial equivalence of your device to a legally premarket notheation: "The PDF Intelligences casionally in the spermits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you desire specific advice for your ac (240) 276-0120. Also, please more the regulation entitled, colliation of Compilance as (= + (= + +) + + + + + + 8 07.97) you may obtain.
"Misbranding by reference to premarket notification" (21 CFR Part 807.97) you may obtain. Misolallumg of telefone to premation on your responsibilities under the Act may be obtained from the Oiler general mionmation on your responsible 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 yours,

Dima R. Vochner

A 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: K043509

Device Name: Günther Tulip™ Vena Cava Filter Set

Indications For Use:

Filter Set

r heer Oct rno Santher Tamilism via placement in the vena cava in the following situations:

Pulmonary thromboembolism when antico agulation therapy is . contraindicated;
failure of anticoagulation therapy in thromboembolic diseases; t
emergency treatment following massive pulmonary embolism where . anticipated benefits of conventional therapy are reduced; and
chronic, recurrent pulmonary embolism where anticoagulation 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 rno Gunther Tulip™ Vena Cava Filter in patients who no longer require a filter. Retrieval of the filter can be performed only by jugular approach

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Duna R. Vachner
(Division Sign-Off)

Division of Cardiovascular Devices

Page 1 of ____________________________________________________________________________________________________________________________________________________________________

510(k) Number_k643509

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.”