(72 days)
Not Found
Not Found
No
The description focuses on the mechanical design and materials of a vena cava filter, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is intended for the prevention of recurrent pulmonary embolism by being placed in the vena cava, which directly addresses a medical condition.
No
The device is a vena cava filter, intended to prevent pulmonary embolism by trapping clots. Its function is interventional/therapeutic, not diagnostic.
No
The device description explicitly details physical components such as a filter, introducer sheath system, dilator, and stopcock, all of which are hardware.
Based on the provided text, these devices are not In Vitro Diagnostics (IVDs).
Here's why:
- IVDs are used to examine specimens from the human body. The intended use and device description clearly state that these devices are filters placed within the vena cava (a blood vessel) to prevent pulmonary embolism. They are implanted devices, not used to test samples outside the body.
- The description focuses on the physical characteristics and function of the filter within the body. It details how the filter is constructed, how it is introduced and placed, and how it anchors to the vein walls to trap blood clots. This is consistent with an implantable medical device, not an IVD.
Therefore, the Günther Tulip® Vena Cava Filter and the Cook® Celect® Vena Cava Filter are not IVDs. They are medical devices intended for implantation.
N/A
Intended Use / 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.
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 Cook® Celect® Vena Cava Filter may be retrieved according to the instructions supplied in the section labeled: Optional Retrieval Procedure.
Product codes (comma separated list FDA assigned to the subject device)
DTK
Device Description
Günther Tulip® Vena Cava Filter
The Günther Tulip Vena Cava Filter is available in femoral vein and jugular vein access versions. A universal set is also available, which contains the components necessary for both the jugular and femoral filter delivery approach. The femoral set is introduced through the femoral vein, while the jugular set is introduced through the jugular vein. The device consists of a pre-loaded filter, a coaxial introducer sheath system, a hydrophilic coated dilator, and a three-way stopcock. The filter is introduced and placed via a 7.0 French coaxial introducer sheath system. The introducer dilator is a 7.0 French power iniectable dilator that is 75 centimeters long.
The Günther Tulip Vena Cava Filter is constructed from conichrome. The basic design of the filter is conical with four primary legs. The end of each leg is hooked outward. The hooks are designed to secure the filter to the wall of the inferior vena cava. "Webbed" wires (like tulip petals) between the legs are bent secondary legs which maintain the shape of the filter by pressing outward toward the vein walls. These webs also increase the area into which emboli can be trapped.
Cook® Celect® Vena Cava Filter
The Cook® Celect® Vena Cava Filter is available in femoral vein and jugular vein access versions. A universal set is also available, which contains the components necessary for both the jugular and femoral filter delivery approach. The femoral set is introduced through the femoral vein, while the jugular set is introduced through the jugular vein. The device consists of a pre-loaded filter, a coaxial introducer sheath system, a hydrophilic coated dilator, and a three-way stopcock. The filter is introduced and placed via a 7.0 French coaxial introducer sheath system. The introducer dilator is a 7.0 French power injectable dilator that is 75 centimeters long.
The filter is compatible with placement in vena cavae with diameters between 15 and 30 mm and is constructed from conichrome. 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 secondary legs promote centering of the filter within the vena cava, and assist in caval filtering of sizeable thrombi in the bloodstream.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vena cava, inferior vena cava
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The proposed Günther Tulip® and Cook Celect Vena Cava Filters were subjected to the following tests to assure reliable design and performance under the specified testing parameters.
- 발 Tensile Testing
- 트 Flow Rate Testing
- I Static Burst Testing
- 1 Diameter Retention Testing
- I Leak Testing
- Biocompatibility Testing
- 트 Deployment Testing
- 해 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.”
0
K090140 page 1 of 3
33
Special 510(k): Device Modification Günther Tulip® Vena Cava Filter and Cook® Celect® Vena Cava Filter William Cook Europe ApS 16 January 2009
APR - 3 2009
510(k) SUMMARY
| Submitted By: | Molly Busenbark
William Cook Europe ApS
Sandet 6, DK-4632
Bjaeverskov, Denmark
(812) 339-2235 x 2162 |
| --------------- | ------------------------------------------------------------------------------------------------------------------ |
|---|
Device:
Trade Name:
Proposed Classification:
Günther Tulip® Vena Cava Filter and Cook® Celect® Vena Cava Filter Cardiovascular Intravascular Filter
Indications for Use:
Günther Tulip® Vena Cava Filter
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.
Cook® Celect® Vena Cava Filter
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; ●
1
K090140 page 2 of 3
34
Special 510(k): Device Modification Günther Tulip® Vena Cava Filter and Cook® Celect® Vena Cava Filter William Cook Europe ApS 16 January 2009
- 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 Cook® Celect® Vena Cava Filter may be retrieved according to the instructions supplied in the section labeled: Optional Retrieval Procedure.
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. The Cook Celect Vena Cava Filter is also similar to the predicate device in terms of intended use, materials of construction, and technological characteristics.
Device Description:
Günther Tulip® Vena Cava Filter
The Günther Tulip Vena Cava Filter is available in femoral vein and jugular vein access versions. A universal set is also available, which contains the components necessary for both the jugular and femoral filter delivery approach. The femoral set is introduced through the femoral vein, while the jugular set is introduced through the jugular vein. The device consists of a pre-loaded filter, a coaxial introducer sheath system, a hydrophilic coated dilator, and a three-way stopcock. The filter is introduced and placed via a 7.0 French coaxial introducer sheath system. The introducer dilator is a 7.0 French power iniectable dilator that is 75 centimeters long.
The Günther Tulip Vena Cava Filter is constructed from conichrome. The basic design of the filter is conical with four primary legs. The end of each leg is hooked outward. The hooks are designed to secure the filter to the wall of the inferior vena cava. "Webbed" wires (like tulip petals) between the legs are bent secondary legs which maintain the shape of the filter by pressing outward toward the vein walls. These webs also increase the area into which emboli can be trapped.
Cook® Celect® Vena Cava Filter
The Cook® Celect® Vena Cava Filter is available in femoral vein and jugular vein access versions. A universal set is also available, which contains the components necessary for both the jugular and femoral filter delivery approach. The femoral set is introduced through the femoral vein, while the jugular set is introduced through the jugular vein. The device consists of a pre-loaded filter, a coaxial introducer sheath system, a hydrophilic coated dilator, and a three-way stopcock. The filter is introduced and placed via a 7.0 French coaxial introducer sheath system. The introducer dilator is a 7.0 French power injectable dilator that is 75 centimeters long.
2
K090140 page 3 of 3
Special 510(k): Device Modification Günther Tulip® Vena Cava Filter and Cook® Celect® Vena Cava Filter William Cook Europe ApS 16 January 2009
The filter is compatible with placement in vena cavae with diameters between 15 and 30 mm and is constructed from conichrome. 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 secondary legs promote centering of the filter within the vena cava, and assist in caval filtering of sizeable thrombi in the bloodstream.
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.
William Cook Europe ApS currently markets the predicate Cook® Celect® Vena Cava Filter, which is substantially equivalent to the proposed Cook® Celect® Vena Cava Filter. The similar indications for use and technological characteristics of the Cook" Celect® Vena Cava Filter as compared to the predicate device support a determination of substantial equivalence.
Test Data:
The proposed Günther Tulip® and Cook Celect Vena Cava Filters were subjected to the following tests to assure reliable design and performance under the specified testing parameters.
- 발 Tensile Testing
- 트 Flow Rate Testing
- I Static Burst Testing
- 1 Diameter Retention Testing
- I Leak Testing
- Biocompatibility Testing
- 트 Deployment Testing
- 해 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.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the eagle. The eagle is drawn with thick, black lines, and the text is in a simple, sans-serif font. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR - 3 2009
William Cook Europe ApS c/o Ms. Molly Busenbark Regulatory Affairs Specialist Cook Incorporated 750 Daniels Way Bloomington, IN 47402
Re: K090140
Trade/Device Name: Gunther Tulip and Cook Celect Vena Cava Filters Regulation Number: 21 CFR 870.3375 Regulation Name: Cardiovascular intravascular filter Regulatory Class: Class II Product Code: DTK Dated: March 9, 2009 Received: March 10, 2009
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.
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
4
Page 2 .- Ms. Molly Busenbark
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,
una R. vicher
Bram Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
4
Special 510(k): Device Modification Günther Tulip Vena Cava Filter and Cook Celect® Vena Cava Filter William Cook Europe ApS 16 January 2009
Indications for Use
K090140 510(k) Number (if known):
Günther Tulip® Vena Cava Filter and Cook® Celect® Vena Cava Filter Device Name:
Indications for Use for Günther Tulip® Vena Cava Filter:
The 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 when anticipated . benefits of conventional therapy are reduced; and
- Chronic, recurrent pulmonary embolism when anticoagulant therapy has failed or ● is contraindicated.
Indications for Use for Cook® Celect® Vena Cava Filter:
The Cook® Celect® 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 when anticipated . benefits of conventional therapy are reduced; and
- . Chronic, recurrent pulmonary embolism when anticoagulant therapy has failed or is contraindicated.
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)
uma R. bochmer
(Division Sign-Off) Division of Cardiovascular Devices
510(k) Number_kog 0 \40