(22 days)
The MTI HyperForm™ Occlusion Balloon Catheter is indicated for use in the blood vessels of the peripheral and neuro vasculature where temporary occlusion is desired. The MTI Occlusion Balloon Catheter offers a vessel selective technique of temporary vascular occlusion, which is useful in selectively stopping or controlling blood flow.
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 the MTI 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 visualization of the balloon length and facilitate intravascular placement of the balloon prior to inflation. The catheter shaft is hydrophilically coated to assist catheter advancement within the vasculature. The HyperForm catheter is supplied sterile for single use as a system, which includes the required 0.010" guidewire.
The provided document describes the HyperForm™ Occlusion Balloon Catheter and its clearance through the FDA's 510(k) process, which relies on demonstrating substantial equivalence to a predicate device. This type of submission focuses on comparing the new device's characteristics and performance to an already legally marketed device, rather than establishing absolute performance targets through a standalone clinical study with predefined acceptance criteria for a novel AI algorithm.
Therefore, many of the requested elements pertaining to acceptance criteria and detailed study design for AI devices (like sample sizes for test sets, expert adjudication methods, MRMC studies, standalone algorithm performance, and training set details) are not applicable to this traditional medical device submission.
However, I can extract information related to the device's testing and substantial equivalence.
Here's the information that can be extracted from the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
For this type of device (a catheter), the "acceptance criteria" are generally met by demonstrating compliance with recognized standards and substantial equivalence to a predicate device in terms of performance characteristics. There are no explicit quantitative "acceptance criteria" like sensitivity/specificity thresholds for an AI product.
| Performance Characteristic/Test | Acceptance Criteria (Implied by Standards/Predicate) | Reported Device Performance |
|---|---|---|
| Biocompatibility | Compliance with ISO 10993-1 for external communicating, blood contact, short duration ( |
§ 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).