(150 days)
The MTI HyperForm™ Occlusion Balloon Catheters are indicated for use in blood vessels of the peripheral and neuro vasculature where temporary occlusion is desired. These catheters offer (1) a vesscl selective technique of temporary vascular occlusion, which is useful in selectively stopping or controlling blood flow, and (2) for balloonassisted embolization of intracranial aneurysms,
The MTI HyperGlide™ Occlusion Balloon Catheters are indicated for use in blood vessels of the peripheral and neuro vasculature where temporary occlusion is desired. These catheters offer (1) a vessel selective technique of temporary vascular occlusion, which is useful in selectively stopping or controlling blood flow, and (2) for balloonassisted embolization of intracranial aneurysms.
The HyperForm™ Occlusion Balloon Catheter is a single lumen tapered catheter with a non-detachable low inflation pressure compliant balloon attached to the distal end of the catheter. The catheter is designed to track over a 0.010" guidewire, and requires insertion of the guidewire to occlude the catheter shaft lumen to allow inflation of the balloon. Two platinum markers provide angiographic
The provided 510(k) summary for the HyperForm™ and HyperGlide™ Occlusion Balloon Catheters does not include any acceptance criteria or details of a study that proves the device meets specific acceptance criteria related to its performance.
Instead, the submission primarily focuses on demonstrating substantial equivalence to predicate devices. The approach taken is that no new performance data specific to these devices was deemed necessary.
Here's a breakdown based on the information provided:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| No specific acceptance criteria are defined in terms of measurable performance metrics (e.g., occlusion effectiveness, inflation/deflation times, material strength, clinical outcomes). | No new performance data is reported for the HyperForm™ and HyperGlide™ Occlusion Balloon Catheters. The submission states that "No bench testing and biocompatibility testing was performed to support a determination of substantial equivalence." |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size for Test Set: Not applicable, as no new performance testing data is provided or referenced for these specific devices.
- Data Provenance: Not applicable. The basis for equivalence relies on the established performance and safety of predicate devices.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Not applicable, as no new clinical or performance test data requiring expert review for ground truth establishment is presented.
4. Adjudication Method for the Test Set:
- Not applicable, as there is no test set or related adjudication process described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
- No MRMC comparative effectiveness study was done or reported. The submission does not involve AI assistance or human-in-the-loop performance studies.
6. If a Standalone (algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a medical catheter, not an algorithm or AI system.
7. The Type of Ground Truth Used:
- Not applicable. As no new performance or clinical studies were conducted for these devices, there was no ground truth established for them. The safety and effectiveness are inferred from the predicate devices.
8. The Sample Size for the Training Set:
- Not applicable. This device is not an AI/ML device that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable.
Summary of the Study Proving Device Meets Acceptance Criteria (based on the provided document):
The "study" proving the device meets acceptance criteria is primarily a comparison to predicate devices to demonstrate substantial equivalence, rather than direct performance testing of the new devices.
- Mechanism of Proof: The submission aims to prove substantial equivalence by highlighting the shared characteristics with legally marketed predicate devices. The core argument is stated as: "The proposed HyperForm™ and HyperGlide™ Occlusion Balloon Catheters are identical to the predicate devices and use the same basic technology as the predicate devices."
- Key Similarities Listed for Substantial Equivalence:
- Same intended use (all predicates)
- Same balloon technology and specifications (all predicates)
- Same catheter technology and characteristics (all predicates)
- Same other product technology and specifications (all predicates)
- Predicate Devices:
- Equinox Occlusion Balloon Catheter (K001237)
- HyperForm Occlusion Balloon Catheter (K011656) (Note: This suggests an update or re-submission for an existing HyperForm catheter)
- HyperGlide Occlusion Balloon Catheter (K011526, K090728) (Note: Similar to HyperForm, suggests updates/re-submissions for existing HyperGlide catheters)
- Conclusion: Based on these similarities in intended use, technological characteristics, and prior performance (of the predicate devices), Micro Therapeutics, Inc. (dba ev3 Neurovascular) concluded that the HyperForm™ and HyperGlide™ Occlusion Balloon Catheters are substantially equivalent to the listed predicate devices. The FDA concurred with this determination for market clearance.
§ 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).