(537 days)
The Better-Tubing™ is designed for use as a blood compatible conduit for pumping blood in a roller pump during cardiopulmonary bypass or other extracorporeal applications of up to 6 hours.
The Better-Tubing™ (BT) is a 6 ft. length of ¼' ID tubing for use in an extracorporeal cardiopulmonary bypass circuit. It is biocompatible, has high tensile strength, and has many advantages over standard tubing made from polyvinyl chloride (PVC).
Here's a breakdown of the acceptance criteria and study information for the Better-Tubing™ device, based on the provided 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria / Performance Claim | Better-Tubing™ Reported Performance |
|---|---|
| Biocompatibility | Passed all ISO 10993 Part-1 Biocompatibility Tests (Intracutaneous Toxicity, Cytotoxicity, Sensitization, Systemic Toxicity, Genotoxicity, Implantation with Histopathology, Hemolysis, Whole Blood Coagulation Time, Pyrogenicity) |
| Effect of Temperature on Flow | Minimally affected by fluid temperature. Flow differed by no more than 3% at 22±2°C and 37±2°C. |
| Hemolysis (compared to Tygon® tubing) | Significantly less hemolytic than Tygon® tubing with standard occlusion (p |
§ 870.4210 Cardiopulmonary bypass vascular catheter, cannula, or tubing.
(a)
Identification. A cardiopulmonary bypass vascular catheter, cannula, or tubing is a device used in cardiopulmonary surgery to cannulate the vessels, perfuse the coronary arteries, and to interconnect the catheters and cannulas with an oxygenator. The device includes accessory bypass equipment.(b)
Classification. Class II (performance standards).