(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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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA). The HHS logo is a stylized depiction of a human figure, while the FDA logo features the agency's acronym in a blue square, followed by the words "U.S. Food & Drug Administration" in blue text. The logos are placed side by side.
July 28, 2023
MedTrade Products Ltd. c/o Jonathan Ranfield Director, Quality Assurance & Regulatory Affairs Electra House, Crewe Business Park Crewe, Cheshire, CW1 6GL United Kingdom
Re: K090780
Trade/Device Name: MedTrade Products CELOX Topical Hemostatic Paste OTC Regulatory Class: Unclassified Product Code: QSY
Dear Jonathan Ranfield:
The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to vour previous substantial equivalence (SE) determination letter dated November 20, 2009. Specifically, FDA is updating this SE Letter because FDA has better categorized your device technology under product code OSY.
Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Julie Morabito, OHT4: Office of Surgical and Infection Control Devices, 240-402-3839, Julie.Morabito@fda.hhs.gov.
Sincerely. Julie A. Morabito -S
Julie Morabito, Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of two main elements: a circular text element and an abstract symbol. The text element reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular fashion. The abstract symbol is a stylized depiction of a human figure embracing a bird, representing care and protection.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
NOV 2 0 2009
MedTrade Products Ltd. % Mr. Jonathan Ranfield Director, QA and RA Electra House, Crewe Business Park Crewe, Cheshire, CW1 6GI, United Kingdom
Re: K090780
Trade/Device Name: MedTrade Products CELOX Topical Hemostatic Paste OTC Regulation Number: Unclassified Regulation Name: N/A Regulatory Class: Unclassified Product Code: FRO Dated: September 25, 2009 Received: October 5, 2009
Dear Mr. Ranfield:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration. Ilsting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21
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Page 2 - Mr. Jonathan Ranfield
CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrl/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Mark M Milliken
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Kc 90780
Page 1 of 1
Indications for Use
510(k) Number (if known)
Device Name: CELOX Topical Hemostatic Paste
Indications for 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
Prescription Use (Per 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use_________________________________________________________________________________________________________________________________________________ (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE, CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Daniel Keane for WKM
(Division Sign-Off)
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K090780
36
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Indications for Use
510(k) Number (if known)
Device Name: MedTrade Products CELOX Topical Hemostatic Paste OTC
CELOX Topical Hemostatic Paste is intended to be available Over The Counter for the following indication.
Indications for Use:
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.
Prescription Use_ (Per 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 801 Subpart C)
2 .F
(PLEASE DO NOT WRITE BELOW THIS LINE, CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH. Office of Device Evaluation (ODE)
Mark A. Milliken
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number
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11 090780
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Innovative Medical Products
NOV 2 0 2009
510(k) Safety and Effectiveness Summary: MedTrade CELOX Topical Hemostatic Paste
878 - General and Plastic Surgery Classification Name:
Contact: Jonathan Ranfield - Director, Quality Assurance & Regulatory Affairs
Prepared: September 25, 2009.
Legally Marketed Device to which Equivalence is Claimed Celox Topical Hemostatic Granules K061079
Description: 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.
Medtrade Products Ltd Electia House, Crewe Business Park, Crewe, Cheshire CW1 6GL T: ++4 (0) 1270 500019 F: +44 (0) 1270 500045 Pegistered No: 3839609 Registered Office: Electra House, Crewe Business Park, Crewe, Cheshire C.W1 GCL, UK
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N/A