(87 days)
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
| Acceptance Criteria (Test Performed) | Reported Device Performance |
|---|---|
| Tensile Testing | "provided reasonable assurance that the device has been designed and tested to assure conformance to the requirements for its intended use." (Specific numerical criteria and results not provided within this document) |
| Flow Rate Testing | "provided reasonable assurance that the device has been designed and tested to assure conformance to the requirements for its intended use." (Specific numerical criteria and results not provided within this document) |
| Static Burst Testing | "provided reasonable assurance that the device has been designed and tested to assure conformance to the requirements for its intended use." (Specific numerical criteria and results not provided within this document) |
| Three-Point Bend Testing | "provided reasonable assurance that the device has been designed and tested to assure conformance to the requirements for its intended use." (Specific numerical criteria and results not provided within this document) |
| Drop Testing | "provided reasonable assurance that the device has been designed and tested to assure conformance to the requirements for its intended use." (Specific numerical criteria and results not provided within this document) |
| Biocompatibility Testing | "provided reasonable assurance that the device has been designed and tested to assure conformance to the requirements for its intended use." (Specific numerical criteria and results not provided within this document) |
| Accelerated Aging Testing | "provided reasonable assurance that the device has been designed and tested to assure conformance to the requirements for its intended use." (Specific numerical criteria and results not provided within this document) |
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.
§ 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.”