(158 days)
Collagen Sponge may be used for the management of wounds such as:
- Pressure ulcers .
- . Venous stasis ulcers
- . Diabetic ulcers
- First and second degree burns .
- Partial and full thickness wounds .
- Superficial injuries .
Collagen Sponge is a collagen matrix sponge intended for topical use. The product is supplied sterile for single use only.
This request asks for acceptance criteria and study data for a medical device from the provided text. However, the provided text is a 510(k) summary for a Collagen Sponge, which focuses on demonstrating substantial equivalence to predicate devices rather than reporting on specific performance acceptance criteria and a detailed study for a new device's performance.
Therefore, the requested information, specifically acceptance criteria and a study proving those criteria are met, is not available in the provided document.
The document states:
- "Collagen Sponge is substantially equivalent in materials of construction and intended use to CollaGUARD (K061746) and to Collieva (K081782) manufactured by Syntacoll GmbH." (Page 5-1, Section 6)
- "There are no new biocompatibility issues arising with the use of Collagen Sponge as the materials of construction and finished product material match that of CollaGUARD (K061746)." (Page 5-2, Section 9)
- "Collagen Sponge is substantially equivalent to the predicate devices delineated in this submission and meets the requirements for premarket notification as defined in CFR21, Part 807." (Page 5-2, Section 10)
This type of submission (510(k)) generally relies on demonstrating equivalence to an already legally marketed device (predicate device) rather than conducting extensive new clinical studies with defined acceptance criteria for novel performance claims.
As a result, I cannot provide the tables and detailed study information as requested.
N/A