(28 days)
The Günther Tulip Vena Cava 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 Gunther Tulip Vena Cava 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 vein for filtration of inferior vena cava (IVC) blood to prevent PE.
The Cook Celect 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 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 vein for filtration of inferior vena cava (IVC) blood to prevent pulmonary embolism.
Günther Tulip Vena Cava Filter Set: The Günther Tulip Vena Cava Filter is an inferior vena cava filter intended for use in prevention of 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 Günther Tulip Vena Cava Filter Set For Femoral Approach consists of a preloaded filter, a coaxial introducer sheath system, a hydrophilically coated predilator, and a threeway stopcock. The filter is introduced and placed via a 7.0 French coaxial introducer sheath system with a Check-Flo® valve. The filter introducer has a flexible tip. The introducer dilator is a 7.5 French injectable dilator with 8 sideports. The Günther Tulip Vena Cava Filter Set is also available in a universal vein access version consisting of components necessary for both femoral and jugular vein approaches. The femoral introducer in the Günther Tulip Vena Cava Filter Set For Femeral and Jugular Approach also has a flexible tip. The Günther Tulip Vena Cava Filter is constructed from conichrome. The filter is 50 mm long along its main axis when compressed to a diameter of 30 mm.
Cook Celect Vena Cava Filter Set: The Cook Celect Vena Cava Filter is an inferior vena cava filter intended for use in prevention of 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 Vena Cava Filter Set For Femoral Approach consists of a preloaded filter, a coaxial introducer sheath system, a hydrophilically coated predilator, and a threeway stopcock. The filter is introduced and placed via a 7.0 French coaxial introducer sheath system with a Check-Flo valye. The filter introducer has a flexible tip. The introducer dilator is a 7.5 French injectable dilator with 8 sideports. The Cook Celect Vena Cava Filter Set is also available in a universal vein access version consisting of components for both femoral and jugular vein approaches. The femoral introducer in the proposed Cook Celect Vena Cava Filter Set For Femoral and Jugular Approach also has a flexible tip. The Cook Celect Vena Cava Filter is constructed from conichrome. The filter is 48 mm long along its main axis when compressed to a diameter of 30 mm.
The provided text is a 510(k) summary for a medical device (Günther Tulip® and Cook Celect® Vena Cava Filter Sets) and does not describe or involve an AI-powered device or a study comparing the device to an AI. Instead, it describes modifications to existing vena cava filters and demonstrates their substantial equivalence to predicate devices through non-clinical performance data.
Therefore, the requested information (acceptance criteria, device performance, sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC study details, and standalone performance for an AI device) is not applicable to this document.
The document discusses:
- Device Modifications: The primary change is an enhanced trackability in the tip of the femoral introducer for both filter sets.
- Predicate Devices: The modified filter sets are compared to their previous versions (K090140) and found to be substantially equivalent.
- Non-clinical Performance Data: The filter sets were subjected to Deployment Testing, Trackability Testing, Tensile Testing, and Biocompatibility Testing to assure reliable design and performance. The results provide reasonable assurance of conformance to requirements for intended use.
This is a regulatory submission for a physical medical device, not a software-based or AI-driven diagnostic/therapeutic tool.
§ 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.”