(86 days)
Filter Set:
The Günther Tulip™ Vena Cava Filter Set is indicated 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 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 jugular approach.
The Günther Tulip™ Vena Cava Filter and Retrieval Set is an inferior vena cava filter with a radiopaque band at the tip, which can be introduced via either femoral or jugular vein. The radiopaque retrieval catheter has a braided platinum loop at the distal end.
Acceptance Criteria and Device Performance for Günther Tulip™ Vena Cava Filter and Retrieval Set
This report summarizes the acceptance criteria and the study that demonstrates the Günther Tulip™ Vena Cava Filter and Retrieval Set meets these criteria, based on the provided 510(k) summary.
Note: This 510(k) summary primarily focuses on establishing substantial equivalence based on preclinical testing and clinical experience for safety and retrieval success. It does not present quantitative acceptance criteria in the typical format of a medical device performance study (e.g., sensitivity, specificity, accuracy thresholds) as would be seen for diagnostic AI. Instead, the "acceptance criteria" are implied by successful completion of various tests and a successful clinical retrieval rate.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (Implied) | Reported Device Performance |
|---|---|---|
| I. Filter Set | ||
| Biocompatibility | Meets established biocompatibility standards. | Passed Biocompatibility tests. |
| Material & Stress Analysis | Demonstrates reliable structural integrity and performance under specified conditions. | Passed Material and Stress Analysis tests. |
| Clinical Safety & Effectiveness (Retrieval) | Safe and successful retrieval of the filter. No adverse events during and post-retrieval. | 26 out of 26 attempted retrievals were successful. No adverse events reported in the retrieved filter group. 23 patients followed for 3 months post-retrieval showed no abnormalities. |
| II. Retrieval Set | ||
| Biocompatibility | Meets established biocompatibility standards. | Passed Biocompatibility tests. |
| Tensile Strength | Demonstrates adequate tensile strength for retrieval procedure. | Passed Tensile tests. |
| Clinical Evaluation | Safe and successful retrieval of the filter. No adverse events during and post-retrieval. | 26 out of 26 attempted retrievals were successful. No adverse events reported in the retrieved filter group. 23 patients followed for 3 months post-retrieval showed no abnormalities. |
2. Sample Size and Data Provenance for Test Set (Clinical Evaluation)
- Sample Size for Test Set: 41 patients were enrolled for possible retrieval. Of these, retrieval was attempted in 26 patients.
- Data Provenance: The document does not explicitly state the country of origin for the clinical study data or whether it was prospective or retrospective. However, it describes a "clinical study was conducted," which typically implies a prospective design.
3. Number of Experts and Qualifications for Ground Truth Establishment
This type of study (medical device clinical evaluation for safety and retrieval success) does not typically involve "experts" in the same way an imaging AI study would use radiologists for ground truth. The "ground truth" here is the outcome of the retrieval procedure (successful or not, adverse events or not), which is observed and documented by the medical professionals performing the procedures and follow-up.
4. Adjudication Method for the Test Set
Not applicable. The clinical study focused on direct observation of retrieval success and patient outcomes, not on interpretation or consensus among experts.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, an MRMC comparative effectiveness study was not done. This study is a clinical evaluation of a medical device, not an AI or diagnostic imaging system.
6. Standalone (Algorithm Only) Performance Study
Not applicable. This is a physical medical device (vena cava filter and retrieval set), not an algorithm or software. The "performance" is its physical function in a clinical setting.
7. Type of Ground Truth Used (Clinical Evaluation)
The ground truth used for the clinical evaluation was observed clinical outcomes. This includes:
- Successful retrieval of the filter.
- Absence of adverse events during and immediately after retrieval.
- Absence of abnormalities during a 3-month post-retrieval follow-up.
8. Sample Size for the Training Set
Not applicable. This document describes a medical device, not an AI system. Therefore, there is no "training set" in the context of machine learning. The "training" for such devices would involve design iterations, preclinical testing, and potentially previous clinical experience with similar devices.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no "training set" in the context of an AI device.
§ 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.”