(29 days)
The Micrus Ascent and Summit Occlusion Balloon Catheters are intended for use in the blood vessels of the peripheral and neuro vasculature where temporary occlusion is desired and offers a vessel selective technique of temporary vascular occlusion which is useful in selectively stopping or controlling blood flow. The Micrus Ascent and Summit Occlusion Balloon Catheters are also intended to assist in the delivery of diagnostic agents such as contrast media, and therapeutic agents such as occlusion coils, into the peripheral and neuro vasculature.
The Micrus Ascent and Summit Occlusion Balloon Catheters are coaxial dual lumen balloon catheters comprised of an inner guidewire lumen and a separate outer lumen to inflate and deflate the balloon. The balloon catheter is designed for use over any .014" or smaller guidewire. The balloon can be inflated and deflated independently of guidewire position. The balloon is equipped with a vent hole for easy preparation and removal of air from the balloon, and with two radiopaque markers for balloon positioning.
The provided text is a 510(k) Premarket Notification for medical devices (Micrus Occlusion Balloon Catheters). This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting clinical study data to prove the device meets specific acceptance criteria related to efficacy or performance in a clinical setting.
Therefore, most of the requested information regarding acceptance criteria, study design, sample sizes, ground truth establishment, expert involvement, and comparative effectiveness studies is not present in this 510(k) summary.
Here's a breakdown of what can be inferred and what is explicitly unobtainable from the provided text:
1. A table of acceptance criteria and the reported device performance
- UNOBTAINABLE from this document. This 510(k) focuses on demonstrating "substantial equivalence" based on design, specifications, materials, and intended use, not on specific performance metrics or clinical acceptance criteria. There are no performance criteria or corresponding results reported.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- UNOBTAINABLE from this document. There is no mention of a "test set" or clinical study data in the traditional sense. The submission likely relies on non-clinical (bench) testing and comparisons to the predicate device to demonstrate equivalence.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- UNOBTAINABLE from this document. As no specific clinical test set is described, there's no mention of experts establishing ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- UNOBTAINABLE from this document. No clinical test set means no adjudication method.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- UNOBTAINABLE from this document. This document describes a medical device (balloon catheter), not an AI-assisted diagnostic tool. Therefore, an MRMC study or AI-related effectiveness is irrelevant and not mentioned.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- UNOBTAINABLE from this document. This is not an algorithm or AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- UNOBTAINABLE from this document. No clinical ground truth is established or discussed. The "ground truth" for a 510(k) submission like this is primarily the established safety and effectiveness of the predicate device.
8. The sample size for the training set
- UNOBTAINABLE from this document. This is not an AI device, so there's no concept of a "training set."
9. How the ground truth for the training set was established
- UNOBTAINABLE from this document. Not applicable.
Summary of Device and 510(k) Approach (based on the provided text):
The Micrus Ascent and Summit Occlusion Balloon Catheters are being submitted for 510(k) clearance by claiming substantial equivalence to an existing predicate device: K080861, Micrus Ascent Occlusion Balloon Catheter.
Key points from the document regarding the "study" (which is primarily a comparison for substantial equivalence):
- Rationale for Equivalence: The submission asserts that the new devices are substantially equivalent to the predicate in terms of intended use, design, specifications, methods and materials in construction, packaging, and sterilization and materials. The modification to the device (new sizes or slight variations) has not altered the fundamental technology of the predicate devices.
- Intended Use: The devices are intended for temporary occlusion in peripheral and neuro vasculature, to stop/control blood flow, and to assist in the delivery of diagnostic/therapeutic agents.
- Device Description: Coaxial dual lumen balloon catheters with an inner guidewire lumen and an outer inflation/deflation lumen. Designed for use over 0.014" or smaller guidewires, with a vent hole and two radiopaque markers.
- Predicate Device: Micrus Ascent Occlusion Balloon Catheter (4x7mm) cleared under K080861.
In essence, the "study" here is the compilation of documentation and analysis demonstrating that the new devices are so similar to an already cleared device that they do not raise new questions of safety or effectiveness, and therefore do not require extensive clinical trials or performance studies as would be seen for novel devices.
§ 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).