(59 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 if clinically indicated; please refer to the "Optional Filter Retrieval" section of this booklet for more information.
The product is intended for percutaneous placement via a femoral or jugular vein for filtration of inferior vena cava (IVC) blood to prevent PE.
The Cook Celect Platinum Vena Cava Filter is an IVC filter intended for use in prevention of recurrent PE. The filter is intended for percutaneous placement via either the jugular vein or femoral vein for filtration of blood within the IVC. 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 system, a hydrophilic coated pre-dilator, and a three-way stopcock. The filter is introduced and placed via a 7 French coaxial introducer system with a Check-Flo® valve. The femoral filter introducer has a flexible tip. The introducer dilator has 8 sideports and two radiopaque markers 30 mm apart. 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. Radiopaque markers constructed from a platinum tungsten alloy located on each primary leg 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 is a 510(k) summary for the Cook Celect Platinum Vena Cava Filter Sets. It primarily focuses on demonstrating substantial equivalence to a predicate device and updating labeling and shelf-life. As such, it does not describe AI/ML device performance or an acceptance criteria study in the typical sense for a diagnostic AI product.
Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and reported device performance (for an AI product).
- Sample size used for the test set and data provenance.
- Number of experts used to establish ground truth and their qualifications.
- Adjudication method for the test set.
- Multi-reader multi-case (MRMC) comparative effectiveness study results.
- Standalone (algorithm only) performance.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
The document is about a physical medical device (vena cava filter) and its regulatory submission for updating labeling and extending shelf-life, not a diagnostic AI device.
The "Performance Testing" section mentions:
- "No changes to the design, manufacturing, sterilization, or principles of operation have been introduced with the subject devices."
- "Three-year shelf life was supported by nonclinical aging testing, which included packaging testing and performance testing; all test results met the predetermined acceptance criteria."
- "Final clinical study data were provided; interim data have been provided to FDA under previous 510(k)s and a summary of the final data has previously been provided to FDA under an IDE."
This indicates that the "acceptance criteria" here relate to the physical integrity, functionality, and sterility of the device over its extended shelf life, as well as previously conducted clinical studies that established the safety and effectiveness of the original device design. The current submission relies on the substantial equivalence to the predicate device, which itself had established performance.
To summarize for the context of this document:
Acceptance Criteria and Study:
The primary "study" described in this specific 510(k) submission is focused on demonstrating the stability of the device over an extended shelf life and the substantial equivalence to the previously cleared predicate device.
- Acceptance Criteria: For the shelf-life extension, the acceptance criteria relate to the physical and functional integrity of the device and its packaging after accelerated and real-time aging, ensuring it meets its original performance specifications for an extended period (three years). Specific quantitative criteria for these tests are not provided in this summary but would be detailed in the full submission.
- Reported Device Performance: All test results from the nonclinical aging testing (packaging and performance) "met the predetermined acceptance criteria." This implies the device maintains its intended performance and sterile barrier for the new three-year shelf life.
- Clinical Study: The document references "Final clinical study data were provided; interim data have been provided to FDA under previous 510(k)s and a summary of the final data has previously been provided to FDA under an IDE." This indicates that clinical performance (safety and effectiveness, as per the indications for use) was established for the original device through prior studies reviewed by the FDA, leading to its initial clearance and based on which substantial equivalence is claimed. This specific 510(k) does not present new clinical "performance" data beyond confirming the device's stability for an extended shelf-life, as no changes were made to the device itself.
§ 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.”