(87 days)
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No
The document describes a physical medical device (a vena cava filter) and its mechanical properties and testing. There is no mention of software, algorithms, image processing, or any terms related to AI or ML.
Yes.
The device is intended to prevent recurrent pulmonary embolism, which is a medical condition, making it a therapeutic device.
No
The device description clearly states its purpose is for the prevention of recurrent pulmonary embolism by acting as a filter in the vena cava. It is a therapeutic device, not one used to identify or diagnose a condition.
No
The device description clearly details physical components like a filter, introducer, sheath system, dilator, and stopcock, indicating it is a hardware medical device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for the "prevention of recurrent pulmonary embolism via placement in the vena cava." This describes a therapeutic intervention performed within the patient's body.
- Device Description: The description details a physical implantable device (a filter) and its delivery system (introducer, sheath, dilator). These are surgical/interventional tools and implants, not devices used to examine specimens in vitro (outside the body).
- Lack of IVD Characteristics: There is no mention of analyzing biological specimens (blood, urine, tissue, etc.), reagents, or any process that would be performed in a laboratory setting to diagnose a condition.
IVD devices are used to examine specimens obtained from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device is a physical implant used to prevent a medical event within the body.
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.
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.
Product codes
DTK
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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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
- Flow Rate Testing
- Static Burst Testing
- Three-Point Bend Testing
- Drop Testing
- Biocompatibility Testing
- 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Günther Tulip "Vena Cava Filter
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.”
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K072240
p. 1 of 2
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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
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.
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
1
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.
2
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.
3
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
4
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 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 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