The proposed Günther Tulip TM 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.

Retrieval Set

The Günther Tulip™ Vena Cava Filter Retrieval Filter 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 the jugular approach.

Device Description

The Günther Tulip 10 Vena Cava Filter is available in femoral version, jugular version, or a universal set. The femoral set is introduced through the femoral vein, while the jugular set is introduced through the jugular vein. The universal set includes both femoral and jugular vein versions. The device consists of a pre-loaded filter introducer, a coaxial introducer sheath system, a hydrophilic coated dilator, and a three-way stopcock. The filter is introduced and placed via an 8.5 French coaxial introducer sheath system. The introducer dilator is an 8.5 French power injectable dilator that is 71 centimeters long. The basic design of the filter is conical with four legs. The filter is supplied sterile in peel-open packages and intended for one-time use.

AI/ML Overview

The provided text describes a Special 510(k) submission for a device modification, not a study evaluating device performance against acceptance criteria in the typical sense of a clinical or AI-powered diagnostic study.

Therefore, many of the requested elements (like sample size for test/training sets, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, and ground truth for training) are not applicable to this type of regulatory submission and the information provided.

The submission focuses on demonstrating substantial equivalence to a predicate device through engineering tests.

Here's a breakdown of what can be extracted and what is not applicable:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Test Performed)	Reported Device Performance
Tensile Testing	"provided reasonable assurance that the device has been designed and tested to assure conformance to the requirements for its intended use." (Specific numerical criteria and results not provided within this document)
Flow Rate Testing	"provided reasonable assurance that the device has been designed and tested to assure conformance to the requirements for its intended use." (Specific numerical criteria and results not provided within this document)
Static Burst Testing	"provided reasonable assurance that the device has been designed and tested to assure conformance to the requirements for its intended use." (Specific numerical criteria and results not provided within this document)
Three-Point Bend Testing	"provided reasonable assurance that the device has been designed and tested to assure conformance to the requirements for its intended use." (Specific numerical criteria and results not provided within this document)
Drop Testing	"provided reasonable assurance that the device has been designed and tested to assure conformance to the requirements for its intended use." (Specific numerical criteria and results not provided within this document)
Biocompatibility Testing	"provided reasonable assurance that the device has been designed and tested to assure conformance to the requirements for its intended use." (Specific numerical criteria and results not provided within this document)
Accelerated Aging Testing	"provided reasonable assurance that the device has been designed and tested to assure conformance to the requirements for its intended use." (Specific numerical criteria and results not provided within this document)

Notes on the table: The document states that the "results of these tests provide reasonable assurance that the device has been designed and tested to assure conformance to the requirements for its intended use." However, it does not explicitly list the acceptance criteria for each test (e.g., "Tensile strength must exceed X N") or the specific numerical results (e.g., "Tensile strength measured at Y N"). It only lists the types of tests performed.

2. Sample size used for the test set and the data provenance

Not Applicable. This document describes a Special 510(k) for a medical device (vena cava filter) modification, not an AI or diagnostic test that would use a test set of patient data. The tests performed are engineering/performance tests (e.g., tensile, flow rate). The "sample size" would refer to the number of devices or components tested, but this detail is not provided in the summary.
Data Provenance: Not applicable in the context of clinical data for a test set. The tests are laboratory-based engineering evaluations.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not Applicable. Ground truth, in this context, usually refers to clinical diagnoses or outcomes for evaluating AI or diagnostic tools. This submission is for hardware device modification, where "ground truth" is determined by engineering specifications and measurements. It doesn't involve clinical expert consensus on patient data.

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

Not Applicable. Adjudication methods are relevant for resolving discrepancies in expert interpretations of clinical data, which is not the subject of this 510(k) summary.

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 a hardware medical device; it is not an AI-assisted diagnostic tool, so MRMC studies involving human readers and AI are irrelevant to this submission.

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

Not Applicable. This applies to AI algorithms. This is a physical medical device.

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

Engineering Specifications/Measurements: For the engineering tests listed (Tensile, Flow Rate, Static Burst, Three-Point Bend, Drop, Biocompatibility, Accelerated Aging), the "ground truth" would be established by validated test methods and predefined engineering specifications or industry standards for the device's acceptable performance.

8. The sample size for the training set

Not Applicable. This is for AI algorithms. There is no concept of a "training set" for the engineering validation of a physical device modification in this context.

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

Not Applicable. As there is no training set, this question is not relevant.

Summary

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K072240
p. 1 of 2
95

Special 510(k): Device Modification Günther Tulip™ Vena Cava Filter COOK INCORPORATED 9 August 2007

510(k) SUMMARY

Submitted By:

Molly Busenbark Cook Incorporated 750 Daniels Way, P.O. Box 489 Bloomington, IN (812) 339-2235 x 2162

NOV
0 8 2007

Device:

Trade Name:	Günther Tulip™ Vena Cava Filter
Proposed Classification:	Cardiovascular Intravascular Filter

Indications for Use:

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.

Retrieval Set

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.

Device Description:

The Günther Tulip 10 Vena Cava Filter is available in femoral version, jugular version, or a universal set. The femoral set is introduced through the femoral vein, while the jugular

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Special 510(k): Device Modification Günther Tulip™ Vena Cava Filter COOK INCORPORATED 9 August 2007

set is introduced through the jugular vein. The universal set includes both femoral and jugular vein versions. The device consists of a pre-loaded filter introducer, a coaxial introducer sheath system, a hydrophilic coated dilator, and a three-way stopcock. The filter is introduced and placed via an 8.5 French coaxial introducer sheath system. The introducer dilator is an 8.5 French power injectable dilator that is 71 centimeters long. The basic design of the filter is conical with four legs. The filter is supplied sterile in peel-open packages and intended for one-time use.

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.

Test Data:

The proposed Günther Tulip™ Vena Cava Filter was subjected to the following tests to assure reliable design and performance under the specified testing parameters.

Tensile Testing 제
I Flow Rate Testing
Static Burst Testing
트 Three-Point Bend Testing
Drop Testing
Biocompatibility Testing
체 Accelerated Aging Testing

The results of these tests provide reasonable assurance that the device has been designed and tested to assure conformance to the requirements for its intended use.

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Image /page/2/Picture/2 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features the department's name encircling a stylized caduceus symbol. The caduceus is represented by a staff with three intertwined snakes, symbolizing medicine and health. The text around the symbol reads "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA".

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 0 8 2007

Cook Incorporated c/o Ms. Molly Busenbark Regulatory Affairs Specialist P.O. Box 489 Bloomington, IN 47402

Re: K072240

Günther Tulip™ Vena Cava Filter Regulation Number: 21 CFR 870.3375 Regulation Name: Cardiovascular intravascular filter Regulatory Class: Class II (two) Product Code: DTK Dated: October 4, 2007 Received: October 9, 2007

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.

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Page 2 - Ms. Molly Busenbark

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 Office of Compliance at (240) 276-0120. 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 may be obtained 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 yours,

R. lochner

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):	K072240
Device Name:	Günther Tulip TM Vena Cava Filter
Indications for Use:	The proposed Günther Tulip TM Vena Cava Filter isintended for the prevention of recurrent pulmonaryembolism via placement in the vena cava in the followingsituations:
	• 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 Caya Filter Retrieval Filter 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 the jugular approach.

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)

(Division Sign-Off) Division of Cardiovascular Devices

510(k) Number_Ko22240

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.”