Search Results

The proposed Günther Tulip® Vena Cava Filter is intended 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.

Günther Tulip® Vena Cava Filter: The Günther Tulip Vena Cava Filter is available in femoral vein and jugular vein access versions. A universal set is also available, which contains the components necessary for both the jugular and femoral filter delivery approach. The femoral set is introduced through the femoral vein, while the jugular set is introduced through the jugular vein. The device consists of a pre-loaded filter, a coaxial introducer sheath system, a hydrophilic coated dilator, and a three-way stopcock. The filter is introduced and placed via a 7.0 French coaxial introducer sheath system. The introducer dilator is a 7.0 French power iniectable dilator that is 75 centimeters long. The Günther Tulip Vena Cava Filter is constructed from conichrome. The basic design of the filter is conical with four primary legs. The end of each leg is hooked outward. The hooks are designed to secure 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.

Cook® Celect® Vena Cava Filter: The Cook® Celect® Vena Cava Filter is available in femoral vein and jugular vein access versions. A universal set is also available, which contains the components necessary for both the jugular and femoral filter delivery approach. The femoral set is introduced through the femoral vein, while the jugular set is introduced through the jugular vein. The device consists of a pre-loaded filter, a coaxial introducer sheath system, a hydrophilic coated dilator, and a three-way stopcock. The filter is introduced and placed via a 7.0 French coaxial introducer sheath system. The introducer dilator is a 7.0 French power injectable dilator that is 75 centimeters long. The filter is compatible with placement in vena cavae with diameters between 15 and 30 mm and is constructed from conichrome. The design of the Cook® Celect® Vena Cava Filter allows the filter to anchor to the vena cava walls by means of the hooks at the ends of the primary legs. The secondary legs promote centering of the filter within the vena cava, and assist in caval filtering of sizeable thrombi in the bloodstream.

This document describes a Special 510(k) submission for modifications to the Günther Tulip® Vena Cava Filter and the Cook® Celect® Vena Cava Filter. It focuses on demonstrating that the modified devices are substantially equivalent to their predicate devices, rather than on proving performance against specific acceptance criteria for a new device. Therefore, much of the requested information regarding study design, ground truth, and expert evaluation is not present in this type of submission.

Here's an analysis of the provided text based on your request:

1. Table of acceptance criteria and reported device performance:

The document doesn't present specific acceptance criteria in terms of clinical performance metrics (e.g., sensitivity, specificity, accuracy) because it's a submission for device modifications, not a new device seeking initial clearance based on clinical performance. Instead, the acceptance criteria are inherent in demonstrating that the modified devices continue to meet the requirements for their intended use through various engineering and material tests, ensuring the modifications do not negatively impact safety or effectiveness.

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

This document details engineering and material tests rather than clinical or performance studies with patient data. Therefore, concepts like "sample size for the test set" and "data provenance" in the context of clinical data are not applicable here. The "test set" refers to the modified devices themselves undergoing various physical and chemical evaluations.

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)

Not applicable. Ground truth, in the sense of expert evaluation of medical images or patient outcomes, is not part of this type of submission. The "ground truth" for these tests would be the established engineering and material standards and specifications that the devices are required to meet.

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

Not applicable. Adjudication methods are relevant for subjective assessments, typically in clinical studies or expert reviews of data. These are objective engineering tests.

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

Not applicable. This is not a study involving human readers or AI assistance.

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

Not applicable. This document is about medical devices (vena cava filters), not an algorithm or AI system.

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

The "ground truth" for the tests performed (Tensile Testing, Flow Rate Testing, etc.) would be the established engineering specifications, material standards, and performance requirements for vena cava filters. These are objective, measurable parameters rather than subjective expert consensus or clinical outcomes.

8. The sample size for the training set

Not applicable. There is no "training set" in the context of device modification testing by engineering methods.

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

Not applicable, as there is no training set.

Ask a specific question about this device

The proposed Günther Tulip TM Vena Cava Filter is intended 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 Filter 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 the jugular approach.

The Günther Tulip 10 Vena Cava Filter is available in femoral version, jugular version, or a universal set. The femoral set is introduced through the femoral vein, while the jugular set is introduced through the jugular vein. The universal set includes both femoral and jugular vein versions. The device consists of a pre-loaded filter introducer, a coaxial introducer sheath system, a hydrophilic coated dilator, and a three-way stopcock. The filter is introduced and placed via an 8.5 French coaxial introducer sheath system. The introducer dilator is an 8.5 French power injectable dilator that is 71 centimeters long. The basic design of the filter is conical with four legs. The filter is supplied sterile in peel-open packages and intended for one-time use.

The provided text describes a Special 510(k) submission for a device modification, not a study evaluating device performance against acceptance criteria in the typical sense of a clinical or AI-powered diagnostic study.

Therefore, many of the requested elements (like sample size for test/training sets, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, and ground truth for training) are not applicable to this type of regulatory submission and the information provided.

The submission focuses on demonstrating substantial equivalence to a predicate device through engineering tests.

Here's a breakdown of what can be extracted and what is not applicable:

1. Table of Acceptance Criteria and Reported Device Performance

Notes on the table: The document states that the "results of these tests provide reasonable assurance that the device has been designed and tested to assure conformance to the requirements for its intended use." However, it does not explicitly list the acceptance criteria for each test (e.g., "Tensile strength must exceed X N") or the specific numerical results (e.g., "Tensile strength measured at Y N"). It only lists the types of tests performed.

2. Sample size used for the test set and the data provenance

• Not Applicable. This document describes a Special 510(k) for a medical device (vena cava filter) modification, not an AI or diagnostic test that would use a test set of patient data. The tests performed are engineering/performance tests (e.g., tensile, flow rate). The "sample size" would refer to the number of devices or components tested, but this detail is not provided in the summary.
• Data Provenance: Not applicable in the context of clinical data for a test set. The tests are laboratory-based engineering evaluations.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not Applicable. Ground truth, in this context, usually refers to clinical diagnoses or outcomes for evaluating AI or diagnostic tools. This submission is for hardware device modification, where "ground truth" is determined by engineering specifications and measurements. It doesn't involve clinical expert consensus on patient data.

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

• Not Applicable. Adjudication methods are relevant for resolving discrepancies in expert interpretations of clinical data, which is not the subject of this 510(k) summary.

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

• Not Applicable. This is a hardware medical device; it is not an AI-assisted diagnostic tool, so MRMC studies involving human readers and AI are irrelevant to this submission.

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

• Not Applicable. This applies to AI algorithms. This is a physical medical device.

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

• Engineering Specifications/Measurements: For the engineering tests listed (Tensile, Flow Rate, Static Burst, Three-Point Bend, Drop, Biocompatibility, Accelerated Aging), the "ground truth" would be established by validated test methods and predefined engineering specifications or industry standards for the device's acceptable performance.

8. The sample size for the training set

• Not Applicable. This is for AI algorithms. There is no concept of a "training set" for the engineering validation of a physical device modification in this context.

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

• Not Applicable. As there is no training set, this question is not relevant.

Ask a specific question about this device

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