Search Results

Filter Set: The Günther Tulip™ Vena Cava Filter is intended for placement in the vena cava in the following situations: Pulmonary thromboembolism when anticoagulation therapy is contraindicated; failure of anticoagulation therapy in thromboembolic diseases; emergency treatment following massive pulmonary embolism where anticipated benefits of conventional therapy are reduced; and chronic, recurrent pulmonary embolism where anticoagulation 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 the 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 is crafted of an alloy consisting of Co, Cr, NI, Mo and Fe. The basic design of the filter is conical with four legs. The end of each leg is slightly hooked outward. "Webbed" wires (like tulip petals) between the legs are bent strands of the same alloy which maintain the shape of the filter by pressing outward toward the vein walls. These webs also increase the area into which the emboli can be trapped. There are two types of Günther Tulip Vena Cava Filter Sets a femoral set which is introduced through the femoral vein and a jugular set which is introduced through the jugular vein. The jugular set consists of: the Günther Tulip Vena Cava Filter with a protective sleeve, a 10 French Radiopaque Dilator, a 7 French Radiopaque Coaxial Introducer Sheath 65 centimeters long, a filter loading introducer with a pre-attached Günther Tulip Vena Cava Filter, a proximal protective sleeve to introducer, a Radiopaque polyethylene inner catheter, and a three-way stopcock. The femoral set consists of: the Günther Tulip Vena Cava Filter with a protective sleeve, a 10 French Radiopaque Dilator, a 8.5 French Radiopaque Coaxial Introducer Sheath 65 cm long, a Radiopaque polyethylene inner catheter, a three-way stopcock and a 10 French filter loading introducer system preloaded with a Günther Tulip Vena Cava Filter. 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 provided text describes a 510(k) summary for the Günther Tulip Vena Cava Filter Set. It details the device, its intended use, and its substantial equivalence to predicate devices. However, the document does not contain specific acceptance criteria or a detailed study proving the device meets reported performance metrics in the way a clinical trial or algorithm validation study would.

Instead, this 510(k) summary focuses on demonstrating substantial equivalence to previously approved predicate devices based on:

• Intended Use: The indications for use are similar.
• Materials of Construction: The filter is crafted from a cobalt, chromium, nickel, molybdenum, and iron alloy, similar to predicate devices.
• Technological Characteristics: The basic design (conical, four legs, webbed wires) and the method of introduction (femoral or jugular access) are comparable.
• Non-Clinical Testing: A list of general tests performed to assure reliable design and performance is provided, but no specific performance metrics or acceptance criteria are stated in relation to these tests.

Therefore, many of the requested elements for a detailed study are not present in this type of regulatory submission. The 510(k) pathway is primarily about demonstrating substantial equivalence, not necessarily proving new clinical effectiveness or performance against predefined statistical endpoints with ground truth.

Here's a breakdown of the requested information based on the provided document, highlighting what is present and what is absent:

1. A table of acceptance criteria and the reported device performance

Explanation: The document lists several types of tests performed (Simulated Transport, Biocompatibility, Deployment, Package, Lubricity Testing) but does not provide specific acceptance criteria (e.g., "deployment success rate > 95%") or numerical results from these tests (e.g., "deployment success rate was 98%"). The acceptance is based on the general conclusion that these tests "provide reasonable assurance" of conformance to use requirements and that the device is "substantially equivalent" to predicate devices.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size: Not specified. (The listed tests are likely non-clinical bench or in-vitro tests, not human subject studies with a "test set" in the context of AI/clinical studies.)
• Data Provenance: Not applicable/specified. The tests are non-clinical.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Number of Experts: Not applicable.
• Qualifications of Experts: Not applicable.

Explanation: This document describes engineering and biocompatibility tests, not clinical performance evaluations requiring expert-adjudicated ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Adjudication Method: Not applicable.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• Was an MRMC study done? No.
• Effect Size: Not applicable.

Explanation: This device is a physical medical implant (vena cava filter), not an AI diagnostic or assistance system.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Was a standalone study done? No.

Explanation: This is not an algorithm. The "standalone" performance here would relate to the filter itself working as intended, and this is assessed through the non-clinical tests mentioned, not a standalone algorithm study.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Type of Ground Truth: For the non-clinical tests, the "ground truth" would be established engineering standards, material specifications, and regulatory requirements (e.g., ISO standards for biocompatibility). For substantial equivalence, the "ground truth" is that the predicate devices are legally marketed and considered safe and effective.

8. The sample size for the training set

• Sample Size: Not applicable.

Explanation: This is a physical device, not an AI system that requires a "training set."

9. How the ground truth for the training set was established

• Ground Truth Establishment: Not applicable.

In summary, the provided 510(k) document is a regulatory submission for a physical medical device. It demonstrates substantial equivalence to predicate devices through a comparison of design, materials, intended use, and general non-clinical testing. It does not provide the detailed performance metrics, acceptance criteria, or study designs typically found in a clinical trial or a validation study for an AI/diagnostic software product.

Ask a specific question about this device