(163 days)
The Sentinel Cerebral Protection System is indicated for use as an embolic protection device to capture and remove thrombus/debris while performing transcatheter aortic valve replacement procedures. The diameters of the arteries at the site of filter placement should be between 9 - 15 mm for the brachiocephalic and 6.5 - 10 mm in the left common carotid.
The Sentinel™ Cerebral Protection System (Sentinel CPS) is a 6 French, 95 cm working length, single use, temporary, percutaneously delivered embolic protection device, inserted into the radial or brachial artery. The system is designed to capture and remove debris dislodged during transcatheter aortic valve replacement (TAVR) procedures. The Sentinel CPS utilizes an embolic filter delivered to the brachiocephalic artery (Proximal Filter) and a second embolic filter delivered to the left common carotid artery (Distal Filter). At the completion of the procedure, the filters and debris are recaptured into the catheter and removed from the patient. The device is provided sterile and is single-use only.
The Sentinel CPS is available with a Proximal Filter size of 15 mm (target vessel size of 9 - 15 mm) and a Distal Filter size of 10 mm (target vessel size of 6.5 - 10 mm).
Here's a breakdown of the acceptance criteria and study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Test/Performance Metric | Reported Device Performance |
|---|---|---|
| Mechanical Performance | Simulated Use Proximal and Distal Filter Deployment Force | Met all previously established acceptance criteria. |
| Simulated Use Proximal and Distal Filter Retrieval Force | Met all previously established acceptance criteria. | |
| Dimensional Verification Filter Pore Size | Met all previously established acceptance criteria. | |
| Tensile Characterization Filter Film | Met all previously established acceptance criteria. | |
| Material/Biocompatibility | MEM Elution Cytotoxicity | Results confirm that the modified device remains biocompatible. |
| Guinea Pig Maximization Sensitization | Results confirm that the modified device remains biocompatible. | |
| Intracutaneous Reactivity | Results confirm that the modified device remains biocompatible. | |
| Acute Systemic Injection | Results confirm that the modified device remains biocompatible. | |
| Material Mediated Rabbit Pyrogen | Results confirm that the modified device remains biocompatible. | |
| Hemolysis (direct and extract methods) | Results confirm that the modified device remains biocompatible. | |
| Complement Activation (SC5b-9 method) | Results confirm that the modified device remains biocompatible. | |
| USP Physiochemical test | Results confirm that the modified device remains biocompatible. | |
| Natural Rubber Latex ELISA Inhibition Assay for Antigenic Protein | Results confirm that the modified device remains biocompatible. | |
| Partial Thromboplastin Time (PTT) | Results confirm that the modified device remains biocompatible. | |
| Platelet/Leucocyte testing | Results confirm that the modified device remains biocompatible. | |
| Shelf Life | Shelf Life Evaluation | Met all previously established acceptance criteria. |
2. Sample Size Used for the Test Set and Data Provenance
The provided text does not specify the exact sample sizes used for the non-clinical performance and biocompatibility tests. It broadly mentions "testing" and "verification and validation activities."
- Data Provenance: The studies are non-clinical (laboratory/in-vitro/animal) and therefore do not involve patient data or geographical provenance in the typical sense of clinical trials. The testing was conducted to assess modifications to a previously cleared device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable to the type of study described. The study is a non-clinical assessment of material and functional changes to a medical device. Ground truth, in the context of expert consensus, pathology, or outcomes data, typically refers to clinical trials or diagnostic accuracy studies involving human interpretation or clinical outcomes. Here, the "ground truth" is defined by the technical specifications and performance requirements of the device, assessed through direct measurement and laboratory tests.
4. Adjudication Method for the Test Set
This is not applicable as there are no human interpretations or clinical decisions being made that would require adjudication. The evaluation is based on objective measurements and established test methodologies.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This study focuses on the technical performance and biocompatibility of a modified device, not on assessing human reader performance with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, a standalone algorithm-only performance study was not done. The device (Sentinel Cerebral Protection System) is a physical medical device, not an AI algorithm.
7. The Type of Ground Truth Used
The "ground truth" for this study is based on pre-established acceptance criteria derived from engineering specifications, regulatory guidelines (e.g., FDA Guidance, ISO 10993-1), and the performance of the predicate device. These criteria define what constitutes acceptable performance for each test (e.g., specific force ranges, pore sizes, biological response limits).
8. The Sample Size for the Training Set
The concept of a "training set" is not applicable here. This is a non-clinical verification and validation study for a physical medical device, not a machine learning model.
9. How the Ground Truth for the Training Set Was Established
As the concept of a training set is not applicable, this question is not relevant.
§ 870.1251 Temporary catheter for embolic protection during transcatheter intracardiac procedures.
(a)
Identification. This device is a single use percutaneous catheter system that has (a) blood filter(s) at the distal end. This device is indicated for use while performing transcatheter intracardiac procedures. The device is used to filter blood in a manner that may prevent embolic material (thrombus/debris) from the transcatheter intracardiac procedure from traveling towards the cerebral circulation.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be tested:
(i) Simulated-use testing in a clinically relevant bench anatomic model to assess the following:
(A) Delivery, deployment, and retrieval, including quantifying deployment and retrieval forces, and procedural time; and
(B) Device compatibility and lack of interference with the transcatheter intracardiac procedure and device.
(ii) Tensile strengths of joints and components, tip flexibility, torque strength, torque response, and kink resistance.
(iii) Flow characteristics.
(A) The ability of the filter to not impede blood flow.
(B) The amount of time the filter can be deployed in position and/or retrieved from its location without disrupting blood flow.
(iv) Characterization and verification of all dimensions.
(2) Animal testing must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be assessed:
(i) Delivery, deployment, and retrieval, including quantifying procedural time.
(ii) Device compatibility and lack of interference with the transcatheter intracardiac procedure and device.
(iii) Flow characteristics.
(A) The ability of the filter to not impede blood flow.
(B) The amount of time the filter can be deployed in position and/or retrieved from its location without disrupting blood flow.
(iv) Gross pathology and histopathology assessing vascular injury and downstream embolization.
(3) All patient contacting components of the device must be demonstrated to be biocompatible.
(4) Performance data must demonstrate the sterility of the device components intended to be provided sterile.
(5) Performance data must support the shelf life of the device by demonstrating continued sterility, package integrity, and device functionality over the identified shelf life.
(6) Labeling for the device must include:
(i) Instructions for use;
(ii) Compatible transcatheter intracardiac procedure devices;
(iii) A detailed summary of the clinical testing conducted; and
(iv) A shelf life and storage conditions.
(7) Clinical performance testing must demonstrate:
(i) The ability to safely deliver, deploy, and remove the device;
(ii) The ability of the device to filter embolic material while not impeding blood flow;
(iii) Secure positioning and stability of the position throughout the transcatheter intracardiac procedure; and
(iv) Evaluation of all adverse events including death, stroke, and vascular injury.