(242 days)
CELOX Topical Hemostatic Paste is indicated for the topical external temporary use to control moderate to sever bleeding and the local management of surface bleeding from vascular access sites and percutaneous tubes for catheters
CELOX Topical Hemostatic Paste OTC is indicated for the topical external temporary use to control bleeding of lacerations, minor cuts and abrasions. It is intended for use to control minor bleeding and to absorb body fluid in superficial lacerations or wounds. Once exudation and bleeding have stopped, a protective dressing can be applied.
For OTC use MedTrade Product's CELOX Topical Hemostatic Paste OTC is indicated for the topical external temporary use to control bleeding of lacerations, minor cuts and abrasions. It is intended for use to control minor bleeding and to absorb body fluid in traumatic superficial lacerations or wounds. Once exudation and bleeding have stopped, a protective dressing can be applied.
For professional use CELOX Topical Hemostatic Paste is indicated for the topical external temporary use to control moderate to sever bleeding and the local management of surface bleeding from vascular access sites and percutaneous tubes for catheters.
The product is designed and packaged to be easily packed, carried and applied. It is well suited for low to moderate eviscerating wounds, to create hemolysis by coagulation.
The CELOX Hemostatic Paste is applied directly over the source of bleeding, creating a physical barrier to blood flow through the application of the adjunctive manual compression. The CELOX Hemostatic Granules then cause hemostasis in which a natural blood clot can build and form a physical barrier to bleeding.
MedTrade Products CELOX Topical Hemostatic Paste is provided in sterile tubes. Packaging will consist of between 1g to 50g of Paste.
Biocompatibility testing summary has been provided.
The device is packed in a tube and is provided sterilized by gamma irradiation. The product will be sterilised by gamma irradiation in accordance with the Sterilisation of Health Care Products -Requirements for Validation and Routine Control - Radiation Sterilisation, 30 Edition (ANSI/AAMI/ISO11137-1994) and Microbiological Methods for Gamma Sterilisation (AAMI TIR8-1991). Qualification will be based on Method 1 for dosimetric release with a sterility assurance level of 10 ° The product will receive a dose of 25 kGys to 35kGys.
This document is a 510(k) summary for the MedTrade Products CELOX Topical Hemostatic Paste. It describes the device, its intended use, and claims substantial equivalence to a legally marketed predicate device (CELOX Topical Hemostatic Granules K061079).
Based on the provided text, there is no information about specific acceptance criteria or a study that rigorously tests the device's performance against those criteria. This type of regulatory document focuses on establishing substantial equivalence based on device description, intended use, and comparison to a predicate, rather than detailing full performance studies with acceptance criteria.
The document mentions "Biocompatibility testing summary has been provided," and details about sterilization, but these refer to general safety aspects rather than specific efficacy performance acceptance criteria.
Therefore, I cannot fulfill the request to describe acceptance criteria and the study that proves the device meets them, nor can I fill in a table of acceptance criteria and reported device performance, or answer the subsequent questions about sample sizes, ground truth, expert involvement, or MRMC studies.
The provided text only contains:
- Device Name: MedTrade Products CELOX Topical Hemostatic Paste
- Intended Use (for OTC): Topical external temporary use to control bleeding of lacerations, minor cuts, and abrasions. It is intended for use to control minor bleeding and to absorb body fluid in superficial lacerations or wounds.
- Intended Use (for professional use): Topical external temporary use to control moderate to severe bleeding and the local management of surface bleeding from vascular access sites and percutaneous tubes for catheters.
- Legally Marketed Predicate Device: Celox Topical Hemostatic Granules K061079
There is no information regarding specific performance metrics such as time to hemostasis, percentage of successful bleeding control, etc., that would be associated with acceptance criteria and a detailed performance study.
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