(29 days)
The Cook Celect Platinum Filter implant is intended for the prevention of recurrent 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 Cook Celect Platinum Filter implant may be retrieved. Please refer to the Instructions for Use provided with the Günther Tulip Vena Cava Filter Retrieval Set (not included in the filter set).
The product is intended for percutaneous placement via a femoral or jugular vein for filtration of inferior vena cava (IVC) blood to prevent pulmonary embolism.
The Cook Celect Platinum Vena Cava Filter is an inferior vena cava filter intended for use in prevention of recurrent pulmonary embolism. The filter is intended for percutaneous placement via either the jugular vein or femoral vein for filtration of inferior vena cava (IVC) blood. The Cook Celect Platinum Vena Cava Filter Set is available in a Femoral Set and a Jugular Set. Each Set consists of a preloaded filter, a coaxial introducer sheath system, a hydrophilically coated pre-dilator, and a three-way stopcock. The filter is introduced and placed via a 7.0 French coaxial introducer sheath system with a Check-Flo® valve. The femoral filter introducer has a flexible tip. The introducer dilator is a 7.5 French injectable dilator with 8 sideports. The Cook Celect Platinum Vena Cava Filter Set is also available in a universal vein access version consisting of components for both femoral and jugular vein approaches. The Cook Celect Platinum Vena Cava Filter is constructed from a cobalt chromium alloy. The radiopaque marker on each primary leg is constructed from a platinum tungsten allov; the radiopaque markers enhance filter visibility on procedural imaging. The filter is approximately 49 mm long along its main axis when compressed to a diameter of 30 mm.
This document describes a Special 510(k) for device modification related to the Cook Celect® Platinum Vena Cava Filter Sets. The information provided is primarily focused on demonstrating substantial equivalence to predicate devices and detailing the non-clinical performance data.
Therefore, the input does not contain information about:
- Acceptance criteria in the context of device performance metrics (e.g., sensitivity, specificity, accuracy).
- Any "study" that would typically refer to a clinical study or a study involving human subjects or AI algorithm performance.
- Sample sizes for test sets or training sets.
- Data provenance, expert qualifications, adjudication methods, or MRMC studies.
- Ground truth establishment for training or test sets.
The document lists "Non-clinical Performance Data" as having been evaluated, but does not provide specific acceptance criteria or reported performance values in a format that would allow for the direct creation of the requested table for an AI/diagnostic device.
Based on the provided text, here is what can be inferred and what cannot be provided:
1. A table of acceptance criteria and the reported device performance
The document lists several types of non-clinical tests performed, but it does not provide specific quantitative acceptance criteria or reported performance values for these tests that could be presented in the requested table format for a diagnostic or AI device. The statement "The results of these tests provide reasonable assurance that the devices have been designed and tested to assure conformance to the requirements for their intended use" is a general conclusion, not specific performance data.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document as it pertains to non-clinical testing of a physical medical device, not a diagnostic or AI algorithm.
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)
This information is not provided. The document details non-clinical engineering and material tests, not clinical evaluations requiring expert ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided. Adjudication methods are relevant for clinical studies, which are not described here.
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
An MRMC comparative effectiveness study was not conducted or mentioned. This document is about a physical device modification, not an AI or diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
A standalone algorithm performance study was not conducted or mentioned. This document is about a physical medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The concept of "ground truth" as typically applied to diagnostic or AI studies is not applicable here. The non-clinical tests likely used engineering specifications and physical measurements as "ground truth" for evaluating parameters like tensile strength, bend strength, etc.
8. The sample size for the training set
This information is not provided. There is no "training set" as this is not an AI/ML device.
9. How the ground truth for the training set was established
This information is not provided. There is no "training set" as this is not an AI/ML device.
Summary based on the document:
The provided document is a 510(k) summary for device modification of the Cook Celect® Platinum Vena Cava Filter Sets. It focuses on demonstrating substantial equivalence to predicate devices and lists non-clinical performance data (e.g., tensile testing, fatigue testing, radiopacity testing) that were conducted to assure reliable design and performance. However, it does not include the type of information requested about acceptance criteria, device performance metrics, sample sizes, ground truth, or study methodologies that would be relevant for an AI/diagnostic device or a clinical outcome study. The "study" mentioned refers to non-clinical engineering and material tests, not a clinical trial or AI algorithm validation.
§ 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.”