(242 days)
Not Found
No
The device description focuses on the physical and chemical properties of a hemostatic paste and its application method, with no mention of AI or ML.
Yes
The device is described as a hemostatic paste that controls bleeding, which is a therapeutic function.
No
The device is a hemostatic paste intended to control bleeding, not to diagnose a condition or disease. Its purpose is therapeutic (stopping bleeding) rather than diagnostic.
No
The device is a topical paste provided in sterile tubes, indicating it is a physical substance and not software. The description details its application as a physical barrier and its sterilization process, further confirming it is a hardware/substance-based medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for "topical external temporary use to control bleeding" and "local management of surface bleeding." This describes a device that is applied directly to the body surface to manage bleeding, not a device used to examine specimens derived from the human body for diagnostic purposes.
- Device Description: The description details a paste that is applied externally to create a physical barrier and promote hemostasis. It does not mention any analysis of biological samples or diagnostic testing.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing blood, urine, tissue, or other body fluids.
- Providing information for diagnosis, monitoring, or prognosis of a disease or condition.
- Using reagents or assays to detect specific substances.
The device is a topical hemostatic agent, which falls under the category of medical devices used for wound management and bleeding control.
N/A
Intended Use / 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.
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.
Product codes (comma separated list FDA assigned to the subject device)
QSY, FRO
Device 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Biocompatibility testing summary has been provided.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
N/A
0
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
1
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
2
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
3
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
4
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
5
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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