(29 days)
The Denali® Filter is indicated for use in the prevent pulmonary embolism via placement in the vena cava in the following situations:
-Pulmonary thromboembolism when anticoagulants are contraindicated.
-Failure of anticoagulant therapy for thromboembolic disease.
-Emergency treatment following massive pulmonary embolism where anticipated benefits of conventional therapy are reduced.
-Chronic. recurrent pulmonary embolism where anticoagulant therapy has failed or is contraindicated.
The Denali® Filter may be removed according to the instructions supplied under the Section labeled: Optional Procedure for Filter Removal.
The Denali® Vena Cava Filter is a venous interruption device designed to prevent pulmonary embolism. The Denali® Filter can be delivered via the femoral and jugular/subclavian approaches. A separate delivery system is available for each approach. The Denali® Filter is designed to act as a permanent filter. When clinically indicated, the Denali® Filter may be percutaneously removed after implantation according to the instructions provided under the "Optional Procedure for Filter Removal" section.
The Denali® Filter of twelve shape-memory laser-cut nickel-titanium appendages. These twelve appendages form two levels of filtration with the legs providing the lower level of filtration and the arms providing the upper level of filtration. The Denal® Filter is intended to be used in the inferior vena cava (IVC) with a diameter less than or equal to 28mm.
The Denali®Vena Cava Filter System consists of a short, 15cm, 10 French dilator, an introducer sheath, a long, 55cm, 8 French dilator, and a preloaded Denall® Filter in a storage tube with a pusher. The 15cm, 10 French dilator accepts a 0.035" quidewire and is intended for pre-dilatation. The long, 55cm, 8 French dilator accepts a 0.035" quidewire and allows for an 800 psi maximum pressure contrast power injection. Radiopaque marker bands on the end of the dilator aid in measuring the maximum indicated IVC diameter. They are spaced at a distance of 28mm (outer-to-outer). The 55cm, 8.4 French I.D. introducer sheath contains a radiopaque marker and hemostasis valve with a side port. The pusher advances the filter through the introducer sheath to the predeployment mark and is then used to fix the filter in place while the filter is unsheathed.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Denali Filter System, structured according to your request:
Based on the provided document, the Denali Filter System is a medical device, and the submission is a 510(k) premarket notification. This type of submission generally relies on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting detailed clinical studies with specific acceptance criteria like those for a novel drug or a high-risk de novo device. Therefore, the information you're asking for, particularly quantitative performance metrics and clinical study details (like sample size for test/training sets, expert qualifications, MRMC studies, standalone performance), is typically not included in this type of submission summary.
The document focuses on in vitro testing to show that the modified device (Denali® Filter System - Femoral and Jugular/Subclavian Delivery Kit) is substantially equivalent to its predicate.
Here's what can be extracted and inferred from the text:
1. Table of Acceptance Criteria and Reported Device Performance
Given that this is a 510(k) summary for a substantial equivalence determination based on in vitro testing, explicit numerical acceptance criteria and performance metrics for clinical outcomes are not provided in the document. The "performance" is reported qualitatively as meeting the criteria for substantial equivalence.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Mechanical/Physical | Qualitative statements: |
- "The results from these tests demonstrate that the technological characteristics and performance of the Denali® Filter System - Femoral and Jugular/Subclavian Delivery Kit is comparable to the predicate device."
- "The subject Denali Filter System met all predetermined acceptance criteria of design verification and validation as specified by applicable standards, guidance, test protocols and/or customer inputs."
Specific In-Vitro Tests Performed (implying criteria were met for these): - Dimensional and Visual Inspection
- Delivery System Component Tensile Testing
- Simulated Use Testing
- Packaging Testing |
| Functional Equivalence | Qualitative statements: - "The technological characteristics of the subject device... are substantially equivalent to those of the predicate devices, in terms of the following:
- Intended use
- Indications for use
- Target population
- Delivery system design
- Filter design and material
- Fundamental scientific technology
- Packaging configuration (with addition of the extra dilator)
- Sterility Assurance and method of Sterilization"
- "The subject device can perform in a manner substantially equivalent to the predicate device with the same intended use." |
Note: For a 510(k), "acceptance criteria" usually refers to successful completion of specific engineering tests to ensure the new device performs as intended and is safe and effective when compared to a predicate, rather than clinical performance metrics. The document confirms these engineering criteria were met.
2. Sample Size for the Test Set and Data Provenance
- Sample Size for Test Set: Not specified in the provided document. The performance testing section mentions "In Vitro Delivery System Testing." These are typically bench tests or simulated use tests, not clinical human subject trials.
- Data Provenance: The document refers to "in vitro testing" without details on where these tests were conducted or the specific samples used. Given it's in vitro, there isn't human data provenance in the sense of country of origin or retrospective/prospective status for patients.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
This information is not applicable and therefore not provided in the document. In vitro testing does not typically involve expert consensus for "ground truth" in the way clinical studies with image interpretation or pathology do. The "truth" for these tests would be defined by engineering specifications and measurements.
4. Adjudication Method for the Test Set
Not applicable. As noted above, in vitro testing does not involve adjudication methods for human interpretation.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. The document explicitly states that the equivalence was demonstrated via "in vitro testing."
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This device is a physical medical implant (a vena cava filter) and its associated delivery system, not an algorithm or AI.
7. The type of ground truth used
For the in vitro performance testing, the "ground truth" would be the engineering specifications, established mechanical properties, and functional requirements against which the device's performance was measured. For example, for "Dimensional and Visual Inspection," the ground truth would be the design specifications and manufacturing tolerances.
8. The sample size for the training set
Not applicable. This is not an AI/algorithm device, so there is no "training set."
9. How the ground truth for the training set was established
Not applicable. Since there is no training set, there's no ground truth for it to be established.
§ 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.”