(39 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 0.010" quidewire. Balloon inflation is accomplished by advancement of the quidewire through the open distal end of the balloon, redirecting inflation media to the balloon through side holes in the catheter wall. The HYPERGLIDE Occlusion Balloon System is currently cleared for commercial distribution in sizes 4x10, 4x15, 4x20, 5x15 and 5x20. The System is packaged with a 0.010" X-pedion™ hydrophilic guidewire, also manufactured by Micro Therapeutics Inc. d/b/a ev3 Neurovascular, and cleared under K982543. The System is packaged in a sterile pouch and is for single use only.
The provided 510(k) summary (K092495) describes a modification to the HYPERGLIDE™ Occlusion Balloon System. This submission pertains to an occlusion balloon catheter, a physical medical device, not an AI/ML or diagnostic software device. Therefore, many of the requested criteria related to AI/ML device studies (such as MRMC studies, training/test sets, ground truth establishment, expert qualifications, adjudication methods, and standalone performance) are not applicable to this type of submission.
The summary focuses on demonstrating substantial equivalence to previously cleared predicate devices through nonclinical bench testing.
Here's a breakdown of the applicable information:
1. Table of Acceptance Criteria and Reported Device Performance
The submission states that the device was subjected to various tests to demonstrate substantial equivalence. The specific acceptance criteria themselves are not numerically detailed in this summary; rather, it implies that the new 3mm balloon size met the same performance specifications as the existing cleared sizes.
| Acceptance Criterion Type | Reported Device Performance |
|---|---|
| Dimensional Verifications | Conforms to specifications (Implied: new 3mm balloon meets dimensional requirements consistent with predicate device and intended use). |
| Balloon Compliance | Conforms to specifications (Implied: new 3mm balloon expands and conforms as expected, similar to predicate device). |
| Balloon Fatigue | Conforms to specifications (Implied: new 3mm balloon withstands repeated inflation/deflation cycles without failure, similar to predicate device). |
| Burst Testing | Conforms to specifications (Implied: new 3mm balloon withstands specified burst pressures, similar to predicate device). |
| Inflation/Deflation Timing | Conforms to specifications (Implied: new 3mm balloon inflates and deflates within acceptable timeframes, similar to predicate device). |
Study Proving Acceptance Criteria Met:
The study proving the device meets its acceptance criteria is referred to as "various testing" or "nonclinical data". This involved a series of bench tests that are standard for evaluating the mechanical and physical performance of medical devices like occlusion balloon catheters.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated in the summary. For nonclinical bench testing, the sample size would typically refer to the number of devices or components tested for each specific test (e.g., N=10 for burst testing, N=X for fatigue testing). The summary does not provide these specific numbers.
- Data Provenance: The data is nonclinical (bench testing), meaning it was generated in a lab setting, not from patients or animals. Therefore, concepts like "country of origin of the data" or "retrospective/prospective" studies are not applicable.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
- Not Applicable. This is not an AI/ML or diagnostic study requiring expert adjudication of data. The "ground truth" for these tests are physical measurements and outcomes based on engineering specifications and test protocols (e.g., a balloon either bursts at a certain pressure or it doesn't; its dimensions are X or Y).
4. Adjudication Method for the Test Set
- Not Applicable. As mentioned above, this is nonclinical bench testing. The results are typically objectively measured and verified against predetermined engineering specifications, not subject to expert adjudication in the way clinical diagnostic studies are.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No. An MRMC study is relevant to diagnostic interpretation by human readers, often with and without AI assistance, using clinical images/cases. This submission is for a physical medical device (balloon catheter), not a diagnostic tool, and involves no human interpretation of data for diagnostic purposes in the context of this submission.
- Effect Size of Human Readers Improvement with AI vs. without AI Assistance: Not Applicable.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- No. "Standalone performance" in this context refers to AI algorithm performance. This device is not an algorithm.
7. The Type of Ground Truth Used
- Engineering Specifications and Test Protocols: The "ground truth" for the nonclinical tests would be the established engineering specifications for the device (e.g., a minimum burst pressure, maximum inflation/deflation time, specific dimensional tolerances). The actual test results are then compared against these objective criteria.
8. The Sample Size for the Training Set
- Not Applicable. There is no "training set" as this is not an AI/ML device.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. There is no "training set" for this type of submission.
§ 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).