COOK CELECT PLATINUM VENA CAVA FILTER SET FOR FEMORAL APPROACH COOK CELECT PLATIUM VENA CAVA FILTER SET FOR JUGULAR APPR

K121629 · William Cook Europe Aps · DTK · Jul 3, 2012 · Cardiovascular

Device Facts

• Record ID: K121629
• Device Name: COOK CELECT PLATINUM VENA CAVA FILTER SET FOR FEMORAL APPROACH COOK CELECT PLATIUM VENA CAVA FILTER SET FOR JUGULAR APPR
• Applicant: William Cook Europe Aps
• Product Code: DTK · Cardiovascular
• Decision Date: Jul 3, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.3375
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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. Please refer to the Instructions for Use provided with the Günther Tulip Vena Cava Filter Retrieval Set (not included in the filter set). The product is intended for percutaneous placement via a femoral or jugular vein for filtration of inferior vena cava (IVC) blood to prevent pulmonary embolism.

Device Story

The Cook Celect Platinum Vena Cava Filter is a percutaneous implant designed to prevent recurrent pulmonary embolism by filtering blood in the inferior vena cava. The device consists of a cobalt-chromium alloy filter with platinum-tungsten radiopaque markers on its primary legs to improve visibility during fluoroscopic imaging. It is delivered via a 7.0 French coaxial introducer sheath system with a Check-Flo valve, available in femoral (with flexible tip) or jugular configurations. The system includes a 7.5 French injectable dilator with 8 sideports and a three-way stopcock. Used by physicians in clinical settings, the filter is placed percutaneously; it is retrievable using a separate retrieval set. The radiopaque markers assist the clinician in accurate placement and monitoring. The device provides mechanical filtration of the IVC, offering a clinical alternative for patients where anticoagulation is contraindicated or ineffective.

Clinical Evidence

No clinical data provided. Substantial equivalence is supported by non-clinical performance testing, including tensile, bend strength, force measurement, fatigue, radiopacity, deployment, corrosion, MRI, biocompatibility, animal, and shipping testing.

Technological Characteristics

Constructed from cobalt-chromium alloy with platinum-tungsten radiopaque markers. Delivered via 7.0 French coaxial introducer sheath system with Check-Flo valve. Includes 7.5 French injectable dilator with 8 sideports. Mechanical filtration principle. Non-active, implantable device.

Indications for Use

Indicated for patients requiring prevention of recurrent pulmonary embolism (PE) in cases of contraindication to anticoagulation, failure of anticoagulant therapy, or emergency treatment following massive PE. Intended for percutaneous placement in the inferior vena cava via femoral or jugular vein.

Regulatory Classification

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.

Special Controls

*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.”

Predicate Devices

• Cook Celect Vena Cava Filter Sets (K073374)
• Cook Celect Vena Cava Filter Sets (K090140)
• Cook Celect Vena Cava Filter Sets (K121057)

Reference Devices

• Günther Tulip Vena Cava Filter Retrieval Set

Submission Summary (Full Text)

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Il

| Special 510(k): Device Modification |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Cook Celect® Platinum Vena Cava Filter Sets |
| Cook Medical - William Cook Europe ApS<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |

JUL 3 2012

| 510(k) Summary | |
|----------------------|-------------------------------------------------------------------------------|
| Date Prepared: | 31 May 2012 |
| Submitted By: | William Cook Europe ApS |
| | Sandet 6, DK-4632 |
| | Bjaeverskov, Denmark |
| | 0045 5686 8769 |
| Contact: | Camilla Wamberg Munkesoe |
| Phone: | 0045 5686 8769 |
| Fax: | 0045 5686 8568 |
| Email: | [e-mail] |
| Device: | |
| Trade Name: | Cook Celect Platinum Vena Cava Filter Set For Femoral<br>Approach |
| | Cook Celect Platinum Vena Cava Filter Set For Jugular Approach |
| | Cook Celect Platinum Vena Cava Filter Set For Femoral and<br>Jugular Approach |
| Common Name: | Inferior Vena Cava Filter |
| Classification Name: | Cardiovascular Intravascular Filter |
| | (21 CFR 870.3375, Product Code DTK) |
| Classification: | Class II |

# 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; .

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- . 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. Please refer to the Instructions for Use provided with the Günther Tulip Vena Cava Filter Retrieval Set (not included in the filter set).

The product is intended for percutaneous placement via a femoral or jugular vein for filtration of inferior vena cava (IVC) blood to prevent pulmonary embolism.

# Predicate Devices:

The Cook Celect Platinum Vena Cava Filter Sets are substantially equivalent to the predicate Cook Celect Vena Cava Filter Sets (K073374, K090140, K121057). The femoral introducer is identical to the femoral introducer of the predicate Cook Celect Vena Cava Filter Set with Flexible Tip (K121057), and the jugular introducer is identical to the jugular introducer of the predicate Cook Celect Vena Cava Filter Set (K090140). The Cook Celect Platinum Vena Cava Filter implant is substantially equivalent to the Cook Celect Vena Cava Filter implant of the predicate Cook Celect Vena Cava Filter Sets (K073374, K090140, K121057). Compared to the predicate devices, the Cook Celect Platinum Vena Cava Filter Sets have identical indications for use, the same fundamental technological characteristics, and similar materials of construction.

#### Device Description:

The Cook Celect Platinum Vena Cava Filter is an inferior vena cava filter intended for use in prevention of recurrent 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 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 sheath system, a hydrophilically coated pre-dilator, and a three-way stopcock. The filter is introduced and placed via a 7.0 French coaxial introducer sheath system with a Check-Flo® valve. The femoral filter introducer has a flexible tip. The introducer dilator is a 7.5 French injectable dilator with 8 sideports. 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. The radiopaque marker

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on each primary leg is constructed from a platinum tungsten allov; the radiopaque markers 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.

## Technological Characteristics:

The Cook Celect Platinum Vena Cava Filter Sets have the same intended use, the same fundamental technological characteristics, and similar materials of construction as the predicate Cook Celect Vena Cava Filter Sets. The jugular and femoral introducers of the filter sets are physically identical to the predicate devices. The filter implant has a radiopaque marker on each primary leg to enhance filter visibility on procedural imaging.

### Non-clinical Performance Data:

The Cook Celect Platinum Vena Cava Filter Sets were subjected to the following tests to assure reliable design and performance under the specified testing parameters.

- . Tensile Testing
- . Bend Strength Testing
- . Force Measurement Testing
- Fatigue Testing
- . Radiopacity Testing
- · Deployment Testing
- Corrosion Testing
- . MRI Testing
- t Biocompatibility Testing
- Animal Testing .
- . Shipping Testing

The results of these tests provide reasonable assurance that the devices have been designed and tested to assure conformance to the requirements for their intended use.

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines forming its body and wings. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

#### Public Health Service

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

William Cook Europe ApS C/O Ms. Jennifer Brown MED Institute Inc. 1 Geddes Way West Lafayette, IN 47906

3 2012 JUL

Re: K121629

K121027
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 1, 2012 Received: June 4, 2012

Dear Ms. Brown:

We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Section 9 ro(ts) premained as a minimally equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosule) to regally interest cate of the Medical Device Amendments, or to
commerce prior to May 28, 1976, the enactment date of the Red Forley Host Re commerce pro- 10 May 28, 1970, the chasiness with the provisions of the Federal Food, Drug, devices that have been reclassified in accordance will a premarket approval approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a premarket app You may, therefore, market the device, subject to the general controls provisions of the Act. "The
You may, therefore, market the device, subject to the general controls pro You may, merelore, market the device, sayest to the genirements for annual registration, listing of general controls provisions of the Prec libeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability adulteration. Flease note. CDICI does not ovacate increase that his and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (See above) finio cinner major regulations affecting your device can be may be subject to additional confrois. DAIsting mayor organity found in the Code of I cacial Regulations) concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised filial FDA s issualler of a subscription with other requirements of the Act
that FDA has made a determination that your device of acception. The must that FDA has made a decemmanon that Jour end by other Federal agencies. You must or any Federal statules and regulations administration for registration and listing (21
comply with all the Act's requirements, including, but not stages ting of medical comply with an the Act STequirements, mortaling, on and of the reporting of medical

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Page 2 - Ms. Jennifer Brown

device-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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address

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

Sincerely yours,

s Hillen

& 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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Special 510(k): Device Modification Cook Celect® Platinum Vena Cava Filter Sets Cook Medical - William Cook Europe ApS

## Indications for Use

510(k) Number (if known): _

Cook Celect® Platinum Vena Cava Filter Set For Femoral Approach Device Name: Cook Celect® Platinum Vena Cava Filter Set For Jugular Approach Cook Celect® Platinum Vena Cava Filter Set For Femoral and Jugular Approach

### The following Indication for Use statement is identical to the predicate devices:

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. Please refer to the Instructions for Use provided with the Günther Tulip Vena Cava Filter Retrieval Set (not included in the filter set).

The product is intended for percutaneous placement via a femoral or jugular vein for filtration of inferior vena cava (IVC) blood to prevent pulmonary embolism.

Prescription Use XX

OR Over-the-Counter Use

(Part 21 CFR 801 Subpart D)

(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)

WM Y. Holleber

Page 1 of

(Division Sign-Off) Division of Cardiovascular Devices

¥121629 510(k) Number_