(123 days)
Not Found
No
The device description and performance studies focus on the physical and chemical properties of the hemostatic granules and soluble bag, with no mention of AI or ML technologies.
Yes.
The device is intended to achieve hemostasis and control severe topical bleeding, which are therapeutic actions.
No
The device is described as "Topical Hemostatic Granules" intended to "achieve hemostasis" and "control of severe topical bleeding," which indicates a therapeutic or treatment-oriented function rather than a diagnostic one.
No
The device is described as "Topical Hemostatic Granules" and "Topical Hemostatic Granules in Soluble Bag," which are physical products intended for external wound treatment. The description focuses on the physical properties and application of these granules and bags, with no mention of software as a component or the primary function of the device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to achieve hemostasis (stop bleeding) in emergency situations and for the local management of bleeding from wounds. This is a direct treatment applied to the body, not a test performed on a sample taken from the body.
- Device Description: The description details a topical hemostatic granule product applied directly to a wound. It describes its physical form and how it works to control bleeding.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), performing tests in a lab setting, or providing diagnostic information about a patient's health condition.
IVD devices are used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening. This device is a therapeutic device used to treat a physical condition (bleeding).
N/A
Intended Use / Indications for Use
MedTrade Products CELOX Topical Hemostatic Granules are intended to be used to achieve hemostasis in emergency situations for the temporary control of severe topical bleeding.
MedTrade Products CELOX Topical Hemostatic Granules OTC are indicated for the local management of bleeding such as lacerations, minor cuts and abrasions.
Product codes (comma separated list FDA assigned to the subject device)
QSY, FRO
Device Description
MedTrade Products CELOX Topical Hemostatic Granules and MedTrade Products CELOX Topical Hemostatic Granules in Soluble Bag are essentially the same product. In that the CELOX Topical Hemostatic Granules are exactly as in our 510(k) K061079 and the Soluble Bag prevents any accidental spillage of the granules whilst opening the sachet and provides a controlled and accurate delivery System to ensure that the CELOX Topical Hemostatic Granules are applied directly onto the wound site as quickly and efficiently as possible. On contact with liquid the soluble bag will dissolve in 30 to 70 seconds
MedTrade CELOX Topical Hemostatic Granules in Soluble Bag are intended as a temporary external wound treatment for the control of severely bleeding wound for emergency use and are intended for emergency use as an external temporary traumatic wound treatment to achieve Hemostatis and prevent blood loss. The product is designed and packaged to be easily packed, carried and applied using only one hand. It is well suited for moderate to large eviscerating wounds, to create hemolysis by coagulation.
Biocompatibility testing including: Dermal Irritation, Dermal Sensitisation, Cytotoxicity, Acute Systemic Toxicity, Hemolysis, has been conducted on the CELOX Granules Dermal Irritation, Dermal Sensitisation and Cytotoxicity, has been conducted on the Soluble Bag. Cytoloxicity and Systemic injection have been conducted on the CELOX Granules in the Soluble Bag and the results reported and discussed with the application.
The device is packed in a foil sachet and is provided sterile It is sterilized by gamme irradiation. The product will be sterilised by gamma irradiation in accordance with the Sterliisation 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 25gKys to 35kGys.
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)
Not Found
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 logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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: K072328
Trade/Device Name: MedTrade Products CELOX Topical Hemostatic Granules OTC; MedTrade Products CELOX Topical Hemostatic Granules in Soluble Bag 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 your previous substantial equivalence (SE) determination letter dated December 21, 2007. 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
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DEC 2 1 2007
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MedTrade Products, Ltd. % Mr. Jonathan Ranfield Director. Quality Assurance & Regulatory Affairs Electra House Crewe Business Park Crewe, Cheshire, United Kingdom CW1 6GL
Re: K072328
Trade/Device Name: MedTrade Products CELOX Topical Hemostatic Granules OTC MedTrade Products CELOX Topical Hemostatic Granules in Soluble Bag Regulatory Class: Unclassified Product Code: FRO Dated: December 12, 2007 Received: December 17, 2007
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, listing 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 such 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance. please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark N Millican
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
K072328
page 1 of 2
Page 1-of 1
Indications for Use
510(k) Number (if known)
Device Name: MedTrade Products CELOX Topical Hemostatic Granules in Soluble Bag
Indications for Use:
MedTrade Products CELOX Topical Hemostatic Granules are intended to be used to achieve hemostasis in emergency situations for the temporary control of severe topical bleeding.
X 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 De vice Evaluation (ODE)
Alasha Wilkerson
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number
4
A,gokridia 15
Indications for Use
272328
KO72328 510(k) Number (if known)
Device Name: MedTrade Products CELOX Topical Hemostatic Granules OTC
MedTrade Products CELOX Topical Hemostatic Granules are intended to be available Over The Counter for the following indication.
Indications for Use:
MedTrade Products CELOX Topical Hemostatic Granules OTC are indicated for the local management of bleeding such as lacerations, minor cuts and abrasions.
AND/OR Over-The-Counter Use Prescription Use (Per 21 CFR 801 Subpart D) (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)
Mark A. Millner
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number K072328
Table of Contents
5
MedTrade Products Ltd
510(k) SUMMARY MedTrade CELOX Topical Hemostatic Granules in Soluble Bag 878 - General and Plastic Surgery Classification Name Contact, Jonathan Ranfield - Director, Quality Assurance & Regulatory Affairs Prepared: August 10, 2007
DEC 2 1 2007
Description: MedTrade Products CELOX Topical Hemostatic Granules and MedTrade Products CELOX Topical Hemostatic Granules in Soluble Bag are essentially the same product. In that the CELOX Topical Hemostatic Granules are exactly as in our 510(k) K061079 and the Soluble Bag prevents any accidental spillage of the granules whilst opening the sachet and provides a controlled and accurate delivery System to ensure that the CELOX Topical Hemostatic Granules are applied directly onto the wound site as quickly and efficiently as possible. On contact with liquid the soluble bag will dissolve in 30 to 70 seconds
MedTrade CELOX Topical Hemostatic Granules in Soluble Bag are intended as a temporary external wound treatment for the control of severely bleeding wound for emergency use and are intended for emergency use as an external temporary traumatic wound treatment to achieve Hemostatis and prevent blood loss. The product is designed and packaged to be easily packed, carried and applied using only one hand. It is well suited for moderate to large eviscerating wounds, to create hemolysis by coagulation.
Biocompatibility testing including: Dermal Irritation, Dermal Sensitisation, Cytotoxicity, Acute Systemic Toxicity, Hemolysis, has been conducted on the CELOX Granules Dermal Irritation, Dermal Sensitisation and Cytotoxicity, has been conducted on the Soluble Bag. Cytoloxicity and Systemic injection have been conducted on the CELOX Granules in the Soluble Bag and the results reported and discussed with the application.
The device is packed in a foil sachet and is provided sterile It is sterilized by gamme irradiation. The product will be sterilised by gamma irradiation in accordance with the Sterliisation 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 25gKys to 35kGys.
Med Trade Products CELOX Topical Hemostatic Granules in Soluble Bag are identical in chemistry and technology to Med Trade Products CELOX Topical Hemostatic Granules K061079 and substantially equivalent in physical state and application via bag to Z-Medica Corporation QuikClot ACS K051955. A table of comparative features may be found below. COMPARATIVE FEATURES
| Characteristics | COMPARATIVE FEATURES | ||
|---|---|---|---|
| MedTrade Product's | |||
| CELOX Topical Hemostatic | |||
| Granules | MedTrade Product's CELOX | ||
| Topical Hemostatic Granules in | |||
| Soluble Bag | Z-Medica's QuikClot | ||
| ACS | |||
| Chemistry | Chitosan, a material consisting of | ||
| cellulostic polymer, poly-N- | |||
| acetylglucosamine. This | |||
| formulation has been self-affirmed | |||
| by the manufacturer as a GRAS | |||
| (Generally Recognised As Safe) | |||
| food ingredient in accordance with | |||
| 21 CFR s 170.30. | Chitosan, a material consisting of | ||
| cellulostic polymer, poly-N- | |||
| acetylglucosamine. This | |||
| formulation has been self-affirmed | |||
| by the manufacturer as a GRAS | |||
| (Generally Recognised As Safe) | |||
| food ingredient in accordance with | |||
| 21 CFR s 170.30. | Not Applicable | ||
| (As it is a synthetic | |||
| derivative of volcanic | |||
| rock) | |||
| Physical | |||
| Composition | Granules | Granules in Soluble Bag | Granules in mesh bag |
| Indications For | |||
| Use | MedTrade CELOX Topical | ||
| Hemostatic Granules is | |||
| Hemostatic Granules for the | |||
| external temporary control of | |||
| severely bleeding wounds to | |||
| achieve hemostasis and prevent | |||
| blood loss, intended for | |||
| emergency use. | MedTrade CELOX Topical | ||
| Hemostatic Granules is | |||
| Hemostatic Granules for the | |||
| external temporary control of | |||
| severely bleeding wounds to | |||
| achieve hemostasis and prevent | |||
| blood loss. intended for | |||
| emergency use. | QuickClot is intended for | ||
| emergency use as an | |||
| external temporary | |||
| traumatic wound | |||
| treatment to achieve | |||
| hemostasis and prevent | |||
| blood loss | |||
| & OTC for Bleeding / Lacerations | & OTC for Bleeding / Lacerations | ||
| Packaging | |||
| Sterilisation | Foil Pouch | ||
| Gamma Irradiation | Foil Pouch | ||
| Gamma Irradiation | Foil Pouch | ||
| Gamma Irradiation | |||
| Electra House, Crewe Business Park, Crewe, Cheshire CW1 6GL, UK |
Tel: +44 (0) 1270 500019 Fax: +44 (0) 1270 500045
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Registered No 3839609 Registered Office. Electra House, Crewe, Crewe, Cheshire CW1 6GL. UK