(63 days)
Not Found
No
The device description and intended use clearly describe a physical implant (vena cava filter) and its delivery system. There is no mention of software, algorithms, or data processing that would suggest the use of AI/ML. The performance studies focus on the physical properties and clinical outcomes related to the filter's placement and function.
Yes
The device is described as an implantable filter intended for the prevention of recurrent pulmonary embolism (PE) by filtering blood in the vena cava. This direct intervention to prevent a harmful medical condition qualifies it as a therapeutic device.
No
These devices (vena cava filters) are intended for the prevention of pulmonary embolism by physically filtering blood. Their function is therapeutic/preventative, not diagnostic.
No
The device description clearly details physical components like filters, introducer systems, and dilators, 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 an implantable filter placed in the vena cava to prevent pulmonary embolism. This is a therapeutic intervention performed in vivo (within the body).
- Device Description: The device description details a physical filter and its delivery system, designed for mechanical filtration of blood within the body.
- 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.) in vitro (outside the body) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are used to perform tests on samples taken from the body, while this device is a physical implant used to treat a condition directly within the body.
N/A
Intended Use / 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 therapv 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.
The 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 anticoaqulant 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 anticoaqulant therapy has failed or is contraindicated.
The Celect Platinum Filter implant mav 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 juqular 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 Celect Platinum Filter Set consists of a filter composed of a paramagnetic cobalt chromium alloy (49 mm long when compressed to a diameter of 30 mm) with platinum markers, preloaded on a femoral filter introducer with a flexible tip; a 7 French coaxial introducer system (compatible with a 0.035 inch wire guide); and a 10 French pre-dilator with hydrophilic coating for vessel access. The introducer dilator has eight sideports and two radiopaque markers 30 mm apart (end-to-end). The Celect Platinum Filter implant is designed to act as a permanent filter or retrievable filter.
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 0.035 inch wire guide); and a 10 French pre-dilator 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)
MRI safety was established in accordance with ASTM F2503-20. Testing included magnetically induced displacement force, magnetically induced torque, and MR image artifact.
Clinical data supporting the updated labeling originated from the Cook IVC Filter Study and the PRESERVE Study, which were Investigational Device Evacuation (IDE) studies. Both studies were multi-center, prospective, studies of commercially available inferior vena cava (IVC) filters that were placed in subjects for the prevention of pulmonary embolism (PE). The primary objective of both studies was to evaluate the safety and effectiveness of commercially available IVC filters (retrievable and permanent) in subjects with a clinical need for an IVC filter. The studies included primary safety and primary effectiveness endpoints, as well as secondary endpoints which included evaluation of device safety measures and filter retrieval measures. The two studies demonstrated favorable safety and effectiveness outcomes. The results from the two studies are consistent with previously reported rates for filter complications, including filter embolization, clinically significant perforation, new DVT, caval thrombotic occlusion, and SAEs.
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
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). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. Food & Drug Administration".
January 18, 2024
William Cook Europe ApS Jennifer Brown Senior Director, Global Regulatory Science, Vascular Division Cook Medical 1 Geddes Way West Lafayette, Indiana 47906
Re: K233680
Trade/Device Name: Celect Platinum® Vena Cava Filter Set for Femoral Vein Approach Celect Platinum® Vena Cava Filter Set for Jugular Vein Approach Celect Platinum® Vena Cava Filter Set for Femoral and Jugular Vein Approach 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: November 15, 2023 Received: November 16, 2023
Dear Jennifer Brown:
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 (the 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 available 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
1
Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 medical devices and radiation-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.
Sincerely,
Ariel G. Ash- Digitally signed by Ariel
G. Ash-shakoor -S
shakoor -S Date: 2024.01.18
16:18:40 -05'00'
2
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
3
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.
Submission Number (if known)
K233680
Device Name
Celect Platinum Vena Cava Filter Set for Femoral Vein Approach (IGTCFS-65-1-FEM-CELECT-PT) Celect Platinum Vena Cava Filter Set for Jugular Vein Approach (IGTCFS-65-1-JUG-CELECT-PT); Celect Platinum Vena Cava Filter Set for Femoral and Jugular Vein Approach (IGTCFS-65-1-UNI-CELECT-PT);
Günther Tulip Vena Cava Filter Set for Femoral Vein Approach (IGTCFS-65-1-FEM-TULIP): Günther Tulip Vena Cava Filter Set for Juqular Vein Approach (IGTCFS-65-1-JUG-TULIP); Günther Tulip Vena Cava Filter Set for Femoral and Juqular Vein Approach (IGTCFS-65-1-UNI-TULIP)
Indications for Use (Describe)
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 therapv 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.
The 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 anticoaqulant 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 anticoaqulant therapy has failed or is contraindicated.
The Celect Platinum Filter implant mav 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 juqular vein for filtration of inferior vena cava (IVC) blood to prevent PE.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
4
510(k) Summary
| Date Prepared: | November 15, 2023 |
|---|---|
| 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: | Celect Platinum® Vena Cava Filter Set for Femoral Vein Approach |
| Celect Platinum® Vena Cava Filter Set for Jugular Vein Approach | |
| Celect Platinum® Vena Cava Filter Set for Femoral and Jugular Vein Approach | |
| 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 |
Predicate Devices:
The Cook Celect Platinum Vena Cava Filter Sets (K211875, cleared 28 July 2021) and the Günther Tulip Vena Cava Filter Sets (K211874, cleared 28 July 2021).
5
Device Description:
The Celect Platinum Filter Set consists of a filter composed of a paramagnetic cobalt chromium alloy (49 mm long when compressed to a diameter of 30 mm) with platinum markers, preloaded on a femoral filter introducer with a flexible tip; a 7 French coaxial introducer system (compatible with a 0.035 inch wire guide); and a 10 French pre-dilator with hydrophilic coating for vessel access. The introducer dilator has eight sideports and two radiopaque markers 30 mm apart (end-to-end). The Celect Platinum Filter implant is designed to act as a permanent filter or retrievable filter.
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 0.035 inch wire guide); and a 10 French pre-dilator 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.
Intended Use:
Celect Platinum Filter
The 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 Celect Platinum Filter implant may be retrieved if clinically indicated; please refer to "Optional Filter Retrieval" section of the Instructions for Use for more information.
The product is intended for percutaneous placement via a femoral vein or jugular vein for filtration of inferior vena cava (IVC) blood to prevent PE.
6
Günther Tulip Filter
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 vein or jugular vein for filtration of inferior vena cava (IVC) blood to prevent PE.
Comparison to Predicate Device:
The Celect Platinum Vena Cava Filter Sets and the Günther Tulip 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. For both devices, the Instructions for Use has been updated to include clinical evidence. For the Celect Platinum Vena Cava Filter Sets, the MRI safety information in the device labeling was also updated. The design requirements and risk assessment are not impacted by the labeling updates and the MRI safety status for the Celect Platinum Vena Cava Filter has not changed. Therefore, the subject Celect Platinum Vena Cava Filter Sets are substantially equivalent to the predicate Cook Celect Platinum Vena Cava Filter Sets (K211875) and the subject Günther Tulip Vena Cava Filter Sets are substantially equivalent to the predicate Günther Tulip Vena Cava Filter Sets (K211874).
Performance Testing:
MRI safety was established in accordance with ASTM F2503-20. Testing included magnetically induced displacement force, magnetically induced torque, and MR image artifact.
7
Clinical data supporting the updated labeling originated from the Cook IVC Filter Study and the PRESERVE Study, which were Investigational Device Exemption (IDE) studies. Both studies were multi-center, prospective, studies of commercially available inferior vena cava (IVC) filters that were placed in subjects for the prevention of pulmonary embolism (PE). The primary objective of both studies was to evaluate the safety and effectiveness of commercially available IVC filters (retrievable and permanent) in subjects with a clinical need for an IVC filter. The studies included primary safety and primary effectiveness endpoints, as well as secondary endpoints which included evaluation of device safety measures and filter retrieval measures. The two studies demonstrated favorable safety and effectiveness outcomes. The results from the two studies are consistent with previously reported rates for filter complications, including filter embolization, clinically significant perforation, new DVT, caval thrombotic occlusion, and SAEs.
Conclusion:
The subject Celect Platinum Vena Cava Filter Sets and Gunther Tulip Vena Cava Filter Sets are substantially equivalent to the predicate devices (K211875 and K211874). No changes have been made to the IVC filter implant or the delivery systems; only the device labeling has been updated to include clinical evidence and updated MRI safety information.