The Cook Celect™ Vena Cava Filter 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 pulmonary embolism when anticipated . benefits of conventional therapy are reduced; and
Chronic, recurrent pulmonary embolism when anticoagulant therapy has failed or is . contraindicated.

The filter may be retrieved according to the instructions supplied in the section labeled "Optional Retrieval Procedure."

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

Device Description

The Cook Celect Vena Cava Filter is an inferior vena cava filter intended for use in prevention of pulmonary embolism. The filter is intended for percutaneous placement via either the jugular vein or femoral vein for filtration of inferior vena cava (IVC) blood. The Cook Celect Vena Cava Filter is constructed from a biocompatible alloy. The filter is 48 mm long along its main axis when compressed to a diameter of 30 mm. 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 Günther Tulip Vena Cava Filter Retrieval Set consists of a retrieval loop system with a braided platinum wire loop, a coaxial retrieval sheath system, an entry needle, a wire guide, and a dilator. The outer sheath is provided with a radiopaque band on the distal tip for assisting in positioning of the sheath.

AI/ML Overview

Acceptance Criteria and Study for Cook Celect™ Vena Cava Filter and Günther Tulip™ Vena Cava Filter Retrieval Set

This submission (K073374) is for an expansion in the indications for use for the Cook Celect™ Vena Cava Filter and Günther Tulip™ Vena Cava Filter Retrieval Set, specifically to include the retrievability of the Celect filter.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Clinical Study: 95% success rate for retrieval of the Celect filter.	Clinical Study: Achieved a 95% success rate in retrieving the Celect filter.
Kaplan-Meier analysis: Predict an 89% probability of successful retrieval at 52 weeks.	Clinical Study: Kaplan-Meier analysis of the data predicts an 89% probability of successful retrieval at 52 weeks.
Bench Testing: Devices demonstrating that the Celect filter can be retrieved.	Bench Testing: Bench testing successfully demonstrated that the Celect filter can be retrieved.

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

Sample Size: 43 patients.
Data Provenance: Not explicitly stated whether the study was retrospective or prospective, or the country of origin. However, the context of a 510(k) submission for an expanded indication typically relies on prospective clinical data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

This information is not provided in the given text.

4. Adjudication Method for the Test Set

This information is not provided in the given text. The study focuses on retrieval success, which is a clear clinical outcome rather than an interpretation requiring adjudication in the same way as an imaging study might.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. The study was a clinical study demonstrating the retrievability of the device, not an assessment of human reader performance with or without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not Applicable. The device described is a physical medical device (vena cava filter and retrieval set), not an algorithm or AI system. Therefore, standalone algorithm performance is not relevant.

7. The Type of Ground Truth Used

The ground truth was established by clinical outcomes: whether the Cook Celect™ Vena Cava Filter was successfully retrieved from patients using the Günther Tulip™ Vena Cava Filter Retrieval Set.

8. The Sample Size for the Training Set

Not Applicable. As this is a physical medical device, there is no "training set" in the context of an algorithm or AI system. The "training" for the device would be its design, manufacturing, and preclinical testing, which are supported by the "bench testing" mentioned.

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

Not Applicable. (See #8). The product's development and verification would involve standard engineering and medical device testing methodologies. The submission explicitly states "bench testing on the devices demonstrating that the Celect filter can be retrieved" as a basis for the expanded indication.

Summary

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K073374 fige lit 3

Image /page/0/Picture/1 description: The image shows the logo for Cook Medical. The word "COOK" is in large, bold, white letters on a black background. A registered trademark symbol is to the right of the word. Below "COOK" is the word "MEDICAL" in smaller, white letters.

MAR - 7 2008

WILLIAN COOK EUR 32 BJAEVERSKOV, OKMEDICA

Cook Celect™ Vena Cava Filter and Günther Tulip™ Vena Cava Filter Retrieval Set 510(k) Summary 21 CFR 807.92

1. Submitter Information:

Applicant: Address:

Phone Number: Fax Number:

Contact: Contact Address:

William Cook Europe ApS Sandet 6, DK-4632 Bjaeverskov, Denmark 011-45-56-86-86-86 011-45-56-86-86-96

Molly Busenbark, Regulatory Affairs Specialist Cook Incorporated 750 Daniels Way P.O. Box 489 Bloomington, IN 47402 812-339-2235 Ext. 2162 812-332-0281

Contact Phone Number: Contact Fax Number:

2. Device Information:

Filter -
Trade name: Common name: Classification: Regulation: Product Code:

Retrieval Set -Trade name: Common name: Classification: Regulation: Product Code:

Cook Celect™ Vena Cava Filter Inferior Vena Cava Filter Class II 21 CFR 870.3375 DTK

Günther Tulip™ Vena Cava Filter Retrieval Set Percutaneous Retrieval Device Class II 21 CFR 870.5150 MMX

3. Predicate Device:

The Cook Celect Vena Cava Filter Set with its expanded indications for use statement is substantially equivalent (identical) to the Cook Celect Vena Cava Filter (D.C.# K061815, cleared on 20 April 2007).

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William Cook Europe ApS William Cook Laroper - Tilter and Günther Tulip™ Vena Cava Filter Retrieval Set 510(k) - Premarket Notification

The Günther Tulip Vena Cava Filter Retrieval Set with its expanded indications for use statement is substantially equivalent (identical) to the Günther Tulip Vena Cava Filter Retrieval Set (D.C.# K032426, cleared on October 31, 2003).

4. Device Description:

There have been no changes in the design, dimensions, or materials of either device.

5. Intended Use:

The Cook Celect Vena Cava Filter 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 pulmonary embolism when anticipated . benefits of conventional therapy are reduced; and
Chronic, recurrent pulmonary embolism when anticoagulant therapy has failed or is . contraindicated.

The filter may be retrieved according to the instructions supplied in the section labeled "Optional Retrieval Procedure."

The Günther Tulip Vena Cava Filter Retrieval Set has been designed for retrieval of implanted Günther Tulip and Cook Celect Vena Cava Filters in patients who no longer require a filter. Retrieval of the filter can be performed only by jugular approach. The Günther Tulip Vena Cava Filter Retrieval Set is supplied sterile in peel-open packages and intended for one-time use.

Factor 3 of 3

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6. Technological Characteristics:

The Cook Celect Vena Cava Filter described in this submission is physically identical to the predicate deployment system and filter (Cook Celect Vena Cava Filter) in terms of technological characteristics (design, dimensions, and materials).

The Günther Tulip Vena Cava Filter Retrieval Set described in this submission is physically identical to the predicate device (Günther Tulip Vena Cava Filter Retrieval Set) in terms of technological characteristics (design, dimensions, and materials).

7. Reason for Filing:

This submission is for an expansion in the indications for use - a change in labeling only - in the Celect Vena Cava Filter and Günther Tulip Vena Cava Filter Retrieval Set.

This expansion is supported by bench testing on the devices demonstrating that the Celect filter can be retrieved. This expansion is supported by the results of a clinical study on 43 patients demonstrating that the Celect filter can be retrieved with a 95% success rate. A Kaplan-Meier analysis of the data predicts an 89% probability of a successful retrieval at 52 weeks.

There has been no change to the design, dimensions, or materials of the existing, cleared devices.

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Public Health Service

Image /page/3/Picture/2 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features the department's emblem, which is a stylized representation of an eagle. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" are arranged in a circular pattern around the emblem.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR - 7 2008

William Cook Europe ApS c/o Ms. Molly Busenbark Cook Incorporated 750 Daniels Way P.O. Box 489 Bloomington, IN 47402

Re: K073374

Trade/Device Name: Cook Celect™ Vena Cava Filter and Günther Tulip™ Vena Cava Filter Retrieval Set Regulation Number: 21 CFR 870.3375 Regulation Name: Cardiovascular intravascular filter Regulatory Class: Class II (two) Product Code: DTK Dated: February 11, 2008 Received: February 12, 2008

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 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,

Donna R. Kirchner

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

Enclosure

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4. Indications for Use Statement

Indications for Use

510(k) Number (if known): K073374

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

Indications for Use for Cook Celect™ Vena Cava Filter:

The Cook Celect™ Vena Cava Filter 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 pulmonary embolism when anticipated . benefits of conventional therapy are reduced; and
Chronic, recurrent pulmonary embolism when anticoagulant therapy has failed or is . contraindicated.

The filter may be retrieved according to the instructions supplied in the section labeled "Optional Retrieval Procedure."

Indications for Use for Günther Tulip™ Vena Cava Filter Retrieval Set:

Prescription Use × (Part 21 CFR 801 Subpart D)

AND/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)

DVAAA R. la Ame
(Signature of Owner)

(Division Sir.n-Off) Division of Cardiovascular Devices

510(k) Number Ko73374

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.”