(28 days)
The HyperGlide™ Occlusion Balloon System is indicated for use in the blood vessels of the peripheral and neuro vasculature where temporary occlusion is desired. The HyperGlide™ Occlusion Balloon offers a vessel selective technique of temporary vascular occlusion, which is useful in selectively stopping or controlling blood flow.
The HyperGlide™ Occlusion Balloon System is a single lumen, open-ended balloon catheter designed for advancement into the vasculature over a .010" quidewire. Balloon inflation is accomplished by advancement of the quidewire through the open distal end, redirecting inflation media to the balloon through side-holes in the catheter wall. The HyperGlide™ Occlusion Balloon System is currently cleared for commercial distribution for sizes 4x10, 4x15, 4x20, and 4x30. The HyperGlide™ Occlusion Balloon System is packaged with a .010" Xpedian™ hydrophilic guidewire, manufactured by Micro Therapeutics, Inc., d/b/a ev3 Neurovascular and cleared under K982543. The device is sold and packaged with a .010" guidewire in a sterile pouch and for single use only.
Here's an analysis of the provided text regarding the HyperGlide™ Occlusion Balloon System, focusing on acceptance criteria and study details:
1. Table of Acceptance Criteria and Reported Device Performance
The submission references compliance with recognized standards rather than specific quantitative acceptance criteria that are often seen for AI/ML devices. Therefore, the table below reflects this approach.
| Acceptance Criteria Category | Specific Criteria (Standard/Test) | Reported Device Performance |
|---|---|---|
| Performance Testing | ISO 10555 (Sterile, Single Use Intravascular Catheters - Parts 1 and 4) | Met or exceeded the requirements of these standards. |
| Dimensional Verification | (Implicit in ISO 10555) | Test results demonstrated compliance. |
| Balloon Fatigue | (Implicit in ISO 10555) | Test results demonstrated compliance. |
| Catheter Tensile Strength | (Implicit in ISO 10555) | Test results demonstrated compliance. |
| Torque Strength | (Implicit in ISO 10555) | Test results demonstrated compliance. |
| Flexibility | (Implicit in ISO 10555) | Test results demonstrated compliance. |
| Burst Testing | (Implicit in ISO 10555) | Test results demonstrated compliance. |
| Substantial Equivalence | Comparison to predicate devices (intended use, design, specifications, materials, manufacturing, packaging, sterilization) | Found substantially equivalent. "The HyperGlide™ Occlusion Balloon (5mm version) is substantially equivalent..." |
2. Sample Sizes and Data Provenance
This submission is for a medical device (occlusion balloon catheter), not an AI/ML device. Therefore, it does not involve test sets or data provenance in the context of AI/ML algorithm evaluation. The "data" here refers to engineering test results and comparisons to predicate devices. The document does not specify exact sample sizes for each individual engineering test (e.g., how many balloons were burst tested), but indicates a comprehensive battery of tests was performed.
3. Number of Experts and Qualifications
Not applicable. This is a traditional medical device submission, not an AI/ML submission requiring expert ground truth establishment for an algorithm.
4. Adjudication Method
Not applicable for a traditional medical device submission.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This is not an AI/ML device, so there's no "human readers improve with AI vs without AI assistance" study.
6. Standalone (Algorithm Only) Performance Study
Not applicable. This is not an AI/ML algorithm.
7. Type of Ground Truth Used
The "ground truth" for this device, in a physical sense, is established by:
- Engineering Standards: Adherence to recognized international standards like ISO 10555.
- Mechanical Properties: Direct measurement and verification of physical and mechanical performance metrics (e.g., burst pressure, tensile strength, fatigue life).
- Predicate Device Equivalence: Direct comparison of design, materials, and performance to previously cleared, similar devices.
8. Sample Size for the Training Set
Not applicable. There is no concept of a "training set" for this type of medical device submission.
9. How the Ground Truth for the Training Set was Established
Not applicable.
Summary of the Study Proving Device Meets Acceptance Criteria:
The study proving the HyperGlide™ Occlusion Balloon System meets its acceptance criteria is described as a series of performance verification and testing activities. These tests were conducted according to established international standards, specifically ISO 10555 (Sterile, Single Use Intravascular Catheters - Parts 1 and 4).
The testing encompassed various critical aspects of the device's functionality and safety, including:
- Dimensional verification
- Balloon fatigue
- Catheter tensile strength
- Torque strength
- Flexibility
- Burst testing
The submission explicitly states that "The test results demonstrated in this submission meet or exceed the requirements of these standards". This statement serves as the primary evidence that the device satisfies its performance acceptance criteria.
Furthermore, a significant part of the "proof" also relies on demonstrating substantial equivalence to predicate devices (the HyperGlide™ Occlusion Balloon family and HyperForm™ Occlusion Balloon System). This involved showing that the new 5mm version shared identical intended use, design, specifications, materials, construction methods, packaging, and sterilization processes with its cleared predecessors. The FDA's issuance of the 510(k) clearance signifies their agreement that these tests and demonstrations are sufficient to establish safety and effectiveness for marketing.
§ 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).