(53 days)
For use in the blood vessels of the peripheral and neurovasculature where temporary occlusion is desired. These catheters offer a vessel selective technique of temporary vascular occlusion which is useful in selectively stopping or controlling blood flow and for balloon assisted embolization of intracranial aneurysms.
For use in the peripheral vasculature for the infusion of diagnostic agents, such as contrast media, and therapeutic agents, such as embolization materials.
For neurovascular use for the infusion of diagnostic agents, such as contrast media, and therapeutic agents, such as embolization materials, that have been approved or cleared for use in the neurovasculature and are compatible with the inner diameter of the Scepter C/XC Balloon Catheter.
The Scepter C and XC Occlusion Balloon Catheter is a dual coaxial lumen catheter with a nondetachable low inflation pressure compliant balloon attached to the distal end of the catheter. The catheter is designed to track over a steerable guidewire. The inner lumen can be used for infusion/delivery of diagnostic and therapeutic agents. The outer lumen is used for the inflation and deflation of the balloon independent of guidewire position. Radiopaque marker bands are located at ends of the balloon and distal tip of the catheter to facilitate fluoroscopic visualization. The outer surface of the catheter is coated with a hydrophilic polymer to increase lubricity. A luer fitting on the microcatheter hub is used for the attachment of accessories. The catheters are packaged sterile for single use only.
The Scepter C and XC Occlusion Balloon Catheter is intended for temporary occlusion in peripheral and neurovasculature, controlling blood flow for balloon-assisted embolization of intracranial aneurysms, and infusing diagnostic and therapeutic agents in peripheral and neurovascular applications.
Here's an analysis of the provided text regarding acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance:
The document describes pre-clinical testing performed on the Scepter C and XC Occlusion Balloon Catheter. The acceptance criterion for each test is implicitly "Pass," indicating that the device must meet the specified performance standards for each category.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Visual Inspection must pass | Pass |
| Tensile strength must pass | Pass |
| Leakage (liquid and air) must pass | Pass |
| Static and dynamic burst pressure must pass | Pass |
| Simulated use must pass | Pass |
| Catheter flexural fatigue must pass | Pass |
| Compatibility with diagnostic and therapeutic agents must pass | Pass |
| Delivery of embolization materials (i.e. Onyx®) must pass | Pass |
| Balloon testing (burst, compliance, deflation time, fatigue) must pass | Pass |
| DMSO Compatibility must pass | Pass |
| Biocompatibility testing (Cytotoxicity, Sensitization/Irritation, Hemocompatibility, Systemic Toxicity) must pass | Pass |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state the sample sizes used for each pre-clinical test. The testing is referred to as "Pre-clinical Testing," which typically involves laboratory-based assessments rather than human or animal studies with large sample sizes.
- Sample Size for Test Set: Not explicitly stated.
- Data Provenance: The document does not specify the country of origin for the data or whether the studies were retrospective or prospective. Given it's pre-clinical testing for a 510(k) submission, it's virtually certain to be prospective, laboratory-based testing conducted by the manufacturer, MicroVention, Inc., based in Tustin, California, U.S.A.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
Not applicable. For pre-clinical engineering and biocompatibility tests, ground truth is established by standardized test methods and criteria, not by expert consensus on clinical images or patient outcomes. The "ground truth" is defined by the physical or chemical properties being measured against established regulatory standards (e.g., ISO standards for biocompatibility).
4. Adjudication Method for the Test Set:
Not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical trials or image interpretation studies where there's variability in expert assessment. For pre-clinical engineering tests, results are typically objective measurements against defined pass/fail criteria.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for evaluating diagnostic devices, especially those involving human interpretation of medical images (e.g., radiologists reading scans with and without AI assistance). The Scepter C and XC Occlusion Balloon Catheter is an interventional device, not a diagnostic one.
6. Standalone (Algorithm Only) Performance Study:
No, a standalone (algorithm only) performance study was not done. This type of study is specifically for evaluating the performance of AI algorithms without human intervention. The Scepter C and XC Occlusion Balloon Catheter is a physical medical device, not an AI algorithm.
7. Type of Ground Truth Used:
The ground truth used for these pre-clinical tests is based on engineering specifications, standardized test methods, and regulatory requirements (e.g., ISO 10993 for biocompatibility). For example, "Tensile strength Pass" implies the device met a pre-defined tensile strength threshold established by engineering design and industry standards; "Cytotoxicity (ISO 10993-5) Pass" means the device met the criteria outlined in that specific ISO standard for cytotoxicity.
8. Sample Size for the Training Set:
Not applicable. The Scepter C and XC Occlusion Balloon Catheter is a physical medical device, not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set for this device.
§ 870.4450 Vascular clamp.
(a)
Identification. A vascular clamp is a surgical instrument used to occlude a blood vessel temporarily.(b)
Classification. Class II (performance standards).