The Cook Celect Platinum 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 Cook Celect Platinum Filter implant may be retrieved if clinically indicated; please refer to the "Optional Filter Retrieval" section of this booklet 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 Cook Celect Platinum 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 Cook Celect Platinum Vena Cava Filter Set is available in a Femoral Set and a Jugular Set. Each set consists of a preloaded filter, 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 Cook Celect Platinum Vena Cava Filter Set is also available in a universal vein access version consisting of components for both femoral and jugular vein approaches. The Cook Celect Platinum Vena Cava Filter is constructed from a cobalt chromium alloy. Radiopaque markers constructed from a platinum tungsten alloy located on each primary leg enhance filter visibility on procedural imaging. The filter is approximately 49 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 Cook Celect Platinum Vena Cava Filter Sets. It primarily focuses on demonstrating substantial equivalence to a predicate device and updating labeling and shelf-life. As such, it does not describe AI/ML device performance or an acceptance criteria study in the typical sense for a diagnostic AI product.

Therefore, I cannot fulfill your request for:

A table of acceptance criteria and reported device performance (for an AI product).
Sample size used for the test set and data provenance.
Number of experts used to establish ground truth and their qualifications.
Adjudication method for the test set.
Multi-reader multi-case (MRMC) comparative effectiveness study results.
Standalone (algorithm only) performance.
Type of ground truth used.
Sample size for the training set.
How ground truth for the training set was established.

The document is about a physical medical device (vena cava filter) and its regulatory submission for updating labeling and extending shelf-life, not a diagnostic AI device.

The "Performance Testing" section mentions:

"No changes to the design, manufacturing, sterilization, or principles of operation have been introduced with the subject devices."
"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."
"Final clinical study data were provided; interim data have been provided to FDA under previous 510(k)s and a summary of the final data has previously been provided to FDA under an IDE."

This indicates that the "acceptance criteria" here relate to the physical integrity, functionality, and sterility of the device over its extended shelf life, as well as previously conducted clinical studies that established the safety and effectiveness of the original device design. The current submission relies on the substantial equivalence to the predicate device, which itself had established performance.

To summarize for the context of this document:

Acceptance Criteria and Study:

The primary "study" described in this specific 510(k) submission is focused on demonstrating the stability of the device over an extended shelf life and the substantial equivalence to the previously cleared predicate device.

Acceptance Criteria: For the shelf-life extension, the acceptance criteria relate to the physical and functional integrity of the device and its packaging after accelerated and real-time aging, ensuring it meets its original performance specifications for an extended period (three years). Specific quantitative criteria for these tests are not provided in this summary but would be detailed in the full submission.
Reported Device Performance: All test results from the nonclinical aging testing (packaging and performance) "met the predetermined acceptance criteria." This implies the device maintains its intended performance and sterile barrier for the new three-year shelf life.
Clinical Study: The document references "Final clinical study data were provided; interim data have been provided to FDA under previous 510(k)s and a summary of the final data has previously been provided to FDA under an IDE." This indicates that clinical performance (safety and effectiveness, as per the indications for use) was established for the original device through prior studies reviewed by the FDA, leading to its initial clearance and based on which substantial equivalence is claimed. This specific 510(k) does not present new clinical "performance" data beyond confirming the device's stability for an extended shelf-life, as no changes were made to the device itself.

Summary

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510(k) Summary

Date Prepared:	26 July 2017
Submitted By:	William Cook Europe ApSSandet 64632 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:	Cook Celect® Platinum Vena Cava Filter Set for Femoral VeinApproach
	Cook Celect® Platinum Vena Cava Filter Set for Jugular VeinApproach
	Cook Celect® Platinum Vena Cava Filter Set for Femoral andJugular Vein 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 Cook Celect Platinum 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 Cook Celect Platinum Filter implant may be retrieved if clinically indicated; please refer to the "Optional Filter Retrieval" section of this booklet 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 Cook Celect Platinum Vena Cava Filter Sets are substantially equivalent to the predicate devices:

. Cook Celect Platinum Vena Cava Filter Sets cleared under K121629 on 03 July 2012.

Comparison to Predicate Device:

It has been demonstrated that the subject Cook Celect Platinum Vena Cava Filter Sets are substantially equivalent to the predicate Cook Celect Platinum Vena Cava Filter Sets (K121629). No changes have been made to the Cook Celect Platinum Vena Cava Filter or its delivery systems; the Cook Celect Platinum Vena Cava Filter Sets are identical to the predicate devices in terms of intended 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 Cook Celect Platinum Vena Cava Filter Sets was 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. 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. Final clinical study data were provided; interim data have been provided to FDA under previous 510(k)s and a summary of the final data has previously been provided to FDA under an IDE.

Conclusion:

The Cook Celect Platinum 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 changes being made included updates to device labeling and an extension of the device shelf life.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/4/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

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

Re: K171712

Trade/Device Name: Cook Celect Platinum Vena Cava Filter Sets Regulation Number: 21 CFR 870.3375 Regulation Name: Cardiovascular Intravascular Filter Regulatory Class: Class II Product Code: DTK Dated: June 7, 2017 Received: June 9, 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 (reporting of medical device

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related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

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

Enclosure

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.”