(41 days)
The Cook Celect Platinum Filter implant is intended or 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 the Instructions for Use 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 Filter Set consists of a filter composed of a paramagnetic cobalt chromium alloy (49 mm long when compressed to a diameter of 30 mm) with platinum markers, preloaded on a femoral filter introducer with a flexible tip; a 7 French coaxial introducer system (compatible with a .035 inch wire guide); and a 10 French pre-dilator with hydrophilic coating for vessel access. The introducer dilator has eight sideports and two radiopaque markers 30 mm apart (end-to-end). The Cook Celect Platinum Filter implant is designed to act as a permanent filter or retrievable filter.
The provided text is a 510(k) summary for the Cook Celect Platinum® Vena Cava Filter Set. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, this document does not contain any information about a study proving the device meets specific acceptance criteria based on performance metrics such as those found in AI/ML medical device submissions.
This 510(k) is for a physical medical device (a vena cava filter), and the "acceptance criteria" here refer to demonstrating substantial equivalence to a legally marketed predicate device, not performance benchmarks from a clinical or technical study. The "performance testing" section explicitly states:
"No changes to the materials, design, manufacturing, packaging, sterilization, or principles of operation have been introduced with the subject devices. Therefore, performance testing was not warranted, and the testing provided for the predicate submission (K171712) remains supportive."
This means the current submission relies on the testing supporting the previous predicate device (K171712) because the device itself hasn't changed. The only updates mentioned are to the device labeling based on post-market surveillance and risk management.
Therefore, I cannot provide the information requested in your prompt as it pertains to a different type of device evaluation (e.g., for AI/ML algorithms). The document does not discuss:
- A table of acceptance criteria and reported device performance (in terms of specific metrics like sensitivity, specificity, or accuracy)
- Sample sizes for test sets or their provenance
- Number/qualifications of experts for ground truth establishment or adjudication methods
- MRMC studies or effect sizes for human readers
- Standalone algorithm performance
- Types of ground truth
- Training set sample sizes or how their ground truth was 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.”