(87 days)
CoreLeader HEMO-Bandage is intended to be used as a topical dressing to temporarily control moderate to severe external bleeding resulted from traumatic or surgical wounds.
CoreLeader HEMO-Bandage is woven gauze made of chitosan fiber and rayon fiber. Chitosan is a type of organic polysaccharide carrying positively-charged ions. Appearing light yellow color and inheriting biodegradability and biocompatibility of chitosan. CoreLeader HEMO-Bandage achieves hemostasis by attracting erythrocytes to the injured sites and facilitates blood clot formation. CoreLeader HEMO-Bandage is sterilized by gamma-ray radiation to 10th SAL after packed in a foil bag. With the softness and flexibility, it is readily conformable to various wound shapes.
This document is a 510(k) summary for the CoreLeader HEMO-Bandage, a device intended to control bleeding. The primary purpose of this submission is to demonstrate substantial equivalence to legally marketed predicate devices. The study detailed focuses on non-clinical performance and safety rather than a clinical trial with human subjects for diagnostic accuracy.
Here's an analysis of the provided information:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria seem to be implicit in demonstrating equivalence to previously approved predicate devices, particularly regarding safety and certain aspects of performance. The performance data is presented in a table comparing the proposed device against predicate devices based on various tests.
| Test Category | Acceptance Criteria (Implicit, based on predicate device performance) | Reported Device Performance (CoreLeader HEMO-Bandage) |
|---|---|---|
| Sterility | Sterile to 10⁻⁶ SAL (Sterility Assurance Level) | Sterile to 10⁻⁶ SAL after gamma radiation (Meets AAMI / ANSI / ISO 11137-1, -2: 2006) |
| Biocompatibility | No cytotoxicity, skin irritation, skin sensitization, or systemic toxicity. | Cytotoxicity: Negative (Passes AAMI / ANSI / ISO 10993-5:2009) |
| Skin Irritation: Negative (Passes AAMI / ANSI / ISO 10993-10: 2010) | ||
| Skin Sensitization: Negative (Passes AAMI / ANSI / ISO 10993-10: 2010) | ||
| Systemic Toxicity: Non-systemic toxic (Passes AAMI / ANSI / ISO 10993-11: 2006) | ||
| Material Safety | Free of heavy metal contamination | Free of heavy metal contamination (Journal of AOAC International, 2006; 89(6): 1447-66) |
| Physical Properties | Water absorbent | Water absorbent (Meets EN 13726-1:2002 - Part 1) |
| Tensile resistant (In-house protocol) | ||
| Hemostasis Achievement | Capable of effective hemostasis | Achieves hemostasis of femoral artery hemorrhage in swine in |
N/A