(84 days)
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.
The Günther Tulip Vena Cava Filter is an IVC filter intended for use in prevention of recurrent PE. The filter is intended for percutaneous placement via either the jugular vein or femoral vein for filtration of blood within the IVC. The Günther Tulip Vena Cava Filter Set is available in a femoral vein access version and in a universal vein access version consisting of components for both femoral and jugular vein approaches. Each set consists of a filter preloaded on the set for femoral approach, a coaxial introducer system, a hydrophilic coated pre-dilator, and a three-way stopcock. The filter is introduced and placed via a 7 French coaxial introducer system with a Check-Flo® valve. The femoral filter introducer has a flexible tip. The introducer dilator has 8 sideports and two radiopaque markers 30 mm apart. The Günther Tulip Vena Cava Filter is constructed from a cobalt chromium alloy. The end of each leg is hooked outward; this hook design enables securement of 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. The filter is approximately 50 mm long along its main axis when compressed to a diameter of 30 mm.
This document is a 510(k) summary for the Günther Tulip Vena Cava Filter Set, which states that no changes have been made to the filter or its delivery system. The submission primarily addresses updates to labeling and an extension of the device's shelf life. Therefore, the information provided does not describe a new study proving the device meets acceptance criteria in the context of clinical performance or effectiveness for this submission. Instead, it refers to nonclinical aging testing to support a shelf life extension.
Here's an analysis based on the provided text, addressing your questions where possible:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (for Shelf Life Extension) | Reported Device Performance (Nonclinical Aging Testing) |
|---|---|
| Predetermined acceptance criteria for packaging testing | All test results met the predetermined acceptance criteria. |
| Predetermined acceptance criteria for performance testing | All test results met the predetermined acceptance criteria. |
| Shelf life | Extended to three years. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify sample sizes for the nonclinical aging testing. It also doesn't provide information on data provenance (e.g., country of origin, retrospective/prospective) for clinical effectiveness, as no new clinical study was performed for this submission. The submission states, "No changes have been made to the Günther Tulip Vena Cava Filter or its delivery systems," and is primarily for labeling updates and shelf life extension based on "post-market experience".
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not applicable to the provided document, as no clinical study requiring expert ground truth establishment for a test set is described.
4. Adjudication Method
This information is not applicable, as no clinical study requiring adjudication is described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC study was done, as this submission concerns labeling updates and shelf life extension, not a comparative effectiveness study of the device's clinical performance.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
This information is not applicable, as the device is a Vena Cava Filter, not an AI algorithm.
7. Type of Ground Truth Used
For the shelf life extension, the "ground truth" would be the observed physical and functional integrity of the device and its packaging after accelerated and/or real-time aging, evaluated against predefined engineering specifications (performance testing).
8. Sample Size for the Training Set
This information is not applicable, as this is a medical device, not an AI algorithm requiring a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable, as this is a medical device, not an AI algorithm.
Summary of what the document does state:
The primary purpose of this 510(k) submission (K172584) is to update device labeling and extend the shelf life of the Günther Tulip Vena Cava Filter Sets. The manufacturer asserts substantial equivalence to the predicate device (K121057) because:
- No changes have been made to the filter or its delivery systems.
- The indications for use, principles of operation, design, materials, manufacturing, sterilization process, and basic technological characteristics remain identical to the predicate.
The acceptance criteria relevant to this specific submission relate to the nonclinical aging testing performed to support the three-year shelf life extension. The reported performance is that "all test results met the predetermined acceptance criteria" for both packaging and performance testing after aging. No details on these specific criterion values or test methodologies are provided in this summary.
§ 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.”