(41 days)
Not Found
No
The 510(k) summary describes a physical medical device (a vena cava filter) and its delivery system. There is no mention of software, algorithms, image processing, AI, or ML. The performance studies section explicitly states "No changes to the design, manufacturing, sterilization, or principles of operation have been introduced," further indicating a lack of new, potentially AI/ML-driven features.
Yes
The device is intended to prevent pulmonary embolism, which is a medical condition, by filtering blood in the vena cava. This intervention aims to treat or prevent a disease, classifying it as therapeutic.
No.
The device is an implantable filter intended to prevent pulmonary embolism, not to diagnose a condition.
No
The device description clearly outlines physical components made of paramagnetic cobalt chromium alloy and other materials, indicating it is a hardware device, not software-only.
Based on the provided information, the Günther Tulip Filter implant is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to prevent pulmonary embolism by physically filtering blood in the vena cava. This is a therapeutic intervention performed in vivo (within the body).
- Device Description: The device is a physical implant designed to be placed within a blood vessel.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are used in vitro (outside the body) to analyze samples and provide diagnostic information. The Günther Tulip Filter is a medical device used in vivo for a therapeutic purpose.
N/A
Intended Use / Indications for Use
The Günther Tulip Filter implant is intended for the prevent 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 Günther Tulip Filter implant may be retrieved if clinically indicated; please refer to the "Optional Filter Retrieval" section of the Instructions for Use 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.
Product codes (comma separated list FDA assigned to the subject device)
DTK
Device Description
The Günther Tulip Filter Set consists of a filter composed of a paramagnetic cobalt chromium alloy (50 mm long when compressed to a diameter of 30 mm), preloaded on a femoral filter introducer; a 7 French coaxial introducer system (compatible with a .035 inch wire guide); and a 10 French predilator with hydrophilic coating for vessel access. The introducer dilator has eight sideports and two radiopaque markers 30 mm apart (end-to-end). The Günther Tulip Filter implant is designed to act as a permanent filter or retrievable filter.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vena cava, inferior vena cava (IVC)
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)
No changes to the design, manufacturing, sterilization, or principles of operation have been introduced with the subject devices. Therefore, no performance testing was not warranted, and the testing provided for the predicate submission (K172557) remains supportive.
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.
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
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
July 28, 2021
William Cook Europe ApS Mie Dyrholm, Director of Regulatory Affairs Sandet 6, Bjaeverskov, 4632 Denmark
Re: K211874
Trade/Device Name: Günther Tulip® Vena Cava Filter Set for Femoral Vein Approach, Günther Tulip® Vena Cava Filter Set for Jugular Vein Approach, Günther Tulip® Vena Cava Filter Set for Femoral and Jugular Vein Approach Regulation Number: 21 CFR 870.3375 Regulation Name: Cardiovascular Intravascular Filter Regulatory Class: Class II Product Code: DTK Dated: June 16, 2021 Received: June 17, 2021
Dear Mie Dyrholm:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
1
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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Gregory O'Connell Assistant Director DHT2C: Division of Coronary and Peripheral Intervention Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K211874
Device Name
Günther Tulip® Vena Cava Filter Set for Femoral Vein Approach Günther Tulip® Vena Cava Filter Set for Jugular Vein Approach Günther Tulip® Vena Cava Filter Set for Femoral and Jugular Vein Approach
Indications for Use (Describe)
INTENDED USE
The Günther Tulip Filter implant is intended for the prevent 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 Günther Tulip Filter implant may be retrieved if clinically indicated; please refer to the "Optional Filter Retrieval" section of the Instructions for Use 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.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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3
| 510(k) Summary | K211874 |
|---|---|
| Date Prepared: | July 27, 2021 |
| Submitted By: | William Cook Europe ApS |
| Sandet 6 | |
| 4632 Bjaeverskov, Denmark | |
| Contact: | Mie Dyrholm |
| Phone: | +45 56 86 84 92 |
| Fax: | +45 56 86 85 68 |
| Email: | Mie.Dyrholm@CookMedical.com |
| Device: | |
| Trade Name: | Günther Tulip® Vena Cava Filter Set for Femoral Vein Approach |
| Günther Tulip® Vena Cava Filter Set for Jugular Vein Approach | |
| Günther Tulip® Vena Cava Filter Set for Femoral and Jugular Vein | |
| Approach | |
| Common Name: | Inferior Vena Cava Filter |
| Classification Name: | Filter, Intravascular, Cardiovascular |
| Regulation/Product Code: | 21 CFR Part 870.3375 / DTK |
| Classification/Panel: | Class II / Cardiovascular |
4
Predicate Devices:
The subject Günther Tulip Vena Cava Filter Sets are substantially equivalent to the predicate devices, the Günther Tulip Vena Cava Filter Sets (K172557, cleared 20 November 2017).
Comparison to Predicate Device:
It has been demonstrated that the subject Günther Tulip Vena Cava Filter Sets are substantially equivalent to the predicate Günther Tulip Vena Cava Filter Sets (K172557). The subject devices are identical to the predicate devices in terms of intended use, principles of operation, materials, design, manufacturing, packaging, and sterilization. The device labeling has been updated based on post-market surveillance information and updated documentation in the risk management system.
Device Description:
The Günther Tulip Filter Set consists of a filter composed of a paramagnetic cobalt chromium alloy (50 mm long when compressed to a diameter of 30 mm), preloaded on a femoral filter introducer; a 7 French coaxial introducer system (compatible with a .035 inch wire guide); and a 10 French predilator with hydrophilic coating for vessel access. The introducer dilator has eight sideports and two radiopaque markers 30 mm apart (end-to-end). The Günther Tulip Filter implant is designed to act as a permanent filter or retrievable filter.
Indications for Use:
The Günther Tulip 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 Günther Tulip Filter implant may be retrieved if clinically indicated; please refer to the "Optional Filter Retrieval" section of the Instructions for Use 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.
5
Performance Testing:
No changes to the design, manufacturing, sterilization, or principles of operation have been introduced with the subject devices. Therefore, no performance testing was not warranted, and the testing provided for the predicate submission (K172557) remains supportive.
Conclusion:
The subject Günther Tulip Vena Cava Filter Sets are substantially equivalent to the predicate devices (K172557). No changes have been made to the IVC filter implant or the delivery systems. Only the device labeling has been updated based on post-market surveillance information and updated documentation in the risk management system.