(41 days)
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.
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.
The provided text is related to a 510(k) premarket notification for a medical device called the "Günther Tulip® Vena Cava Filter Set." This document focuses on demonstrating that the updated device is substantially equivalent to a previously cleared predicate device. It explicitly states that no performance testing was warranted for this submission because no changes were made to the device's design, manufacturing, sterilization, or principles of operation.
Therefore, the document does not contain the information requested regarding acceptance criteria, device performance results, sample sizes for test sets, expert involvement, adjudication methods, MRMC studies, standalone performance, or ground truth establishment for a new device's performance evaluation. The submission relies on the performance data from the predicate device (K172557).
To answer your request, if this were a submission requiring new performance testing for an AI/ML medical device, the following information would be necessary:
Hypothetical Study Information (Illustrative, NOT based on the provided document)
Since the provided document states "No performance testing was warranted," I cannot extract the requested information. However, if this were an AI/ML device requiring performance evaluation, the following is an example of what would be expected for a submission.
Acceptance Criteria and Device Performance (Hypothetical Example for an AI/ML Device)
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Metric | Acceptance Threshold | Reported Device Performance | Meets Criteria? |
|---|---|---|---|
| Sensitivity | ≥ 90% | 92.5% | Yes |
| Specificity | ≥ 85% | 88.2% | Yes |
| Positive Predictive Value (PPV) | ≥ 80% | 81.0% | Yes |
| Negative Predictive Value (NPV) | ≥ 95% | 96.8% | Yes |
| Area Under the ROC Curve (AUROC) | ≥ 0.90 | 0.93 | Yes |
| Algorithm Latency |
§ 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.”