(134 days)
The Stent Graft Balloon Catheter is intended for temporary occlusion of large vessels, or to expand vascular prostheses.
The Stent Graft Balloon Catheter is a multi-lumen catheter which has a compliant polyurethane balloon with a maximum diameter of 50mm. The device is available in two usable lengths, 65 cm and 100 cm. The device is designed to accommodate a 0.038" diameter or smaller guidewire. Two radiopaque marker bands are placed within the balloon to facilitate balloon placement prior to inflation. The device is a single use, sterile device.
This document is a 510(k) summary for a medical device (Stent Graft Balloon Catheter). It describes the device, its intended use, and states that it underwent non-clinical testing to verify its safety and effectiveness.
However, this document does not contain the specific information requested in your prompt regarding acceptance criteria and a study proving the device meets those criteria.
Here's why and what information is missing:
- No Acceptance Criteria or Performance Data Table: The document explicitly states "No performance standards applicable to this product have been developed under Section 514 of the Act." While "mechanical, performance, and biocompatibility testing" were done, specific acceptance criteria for these tests (e.g., burst pressure, fatigue life) and the actual numerical results from these tests are not provided.
- No Description of a Clinical Study: The document refers to "non-clinical testing" which typically means bench testing and potentially animal studies, not human clinical trials. There is no mention of:
- Sample sizes for test sets (human patients).
- Data provenance (country of origin, retrospective/prospective).
- Number or qualifications of experts for ground truth.
- Adjudication methods.
- Multi-reader multi-case (MRMC) comparative effectiveness studies.
- Standalone algorithm performance.
- Type of ground truth used (pathology, outcomes data).
- Sample size for training sets (as this is not an AI/algorithm-based device).
- How ground truth for a training set was established.
Therefore, I cannot fulfill your request for the specific details outlined in your prompt based solely on the provided text. The document is a regulatory submission demonstrating substantial equivalence to predicate devices, primarily through non-clinical testing, rather than a detailed report of a study involving clinical performance acceptance criteria.
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).