(46 days)
Not Found
No
The device description and intended use focus on the physical properties and application of hemostatic granules, with no mention of AI or ML technologies. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
Yes
The device is described as an external wound treatment to achieve hemostasis and prevent blood loss, which is a therapeutic function.
No
Explanation: The device description states it is a "Topical Hemostatic Granule" intended for "temporary control of severe topical bleeding" and to "achieve Hemostatis and prevent blood loss." This indicates a therapeutic function, not a diagnostic one.
No
The device description clearly states it is "Topical Hemostatic Granules" and is "packed in a foil sachet and is provided sterile," indicating a physical, non-software component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use is for achieving hemostasis (stopping bleeding) in emergency situations and for the local management of bleeding from lacerations, cuts, and abrasions. This is a direct treatment applied to a wound on the body.
- Device Description: The description clearly states it's a "temporary external wound treatment" and is applied to "severely bleeding wound for emergency use."
- Lack of IVD Characteristics: An IVD device is used to examine specimens (like blood, urine, tissue) taken from the human body to provide information about a physiological state, health, or disease. This device does not involve the analysis of such specimens.
The device is a topical hemostatic agent applied directly to a wound, which falls under the category of a medical device used for treatment, not diagnosis.
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 Granuies are intended to be available Over The Counter for the following indication.
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 CELOX Topical Hemostatic Granules are intended as a temporary external wound treatment for the control of severely bleeding wound for emergency use. MedTrade CELOX Topical Hemostatic Granules is 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.
The device is packed in a foil sachet and is provided sterile. It is sterilized by gamma irradiation
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 including: Dermal Irritation, Dermal Sensitisation, Cytotoxicity, Acute Systemic Toxicity, Hemolysis, has been conducted and results reported and discussed with the applic tion.
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.
June 11, 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: K061079
Trade/Device Name: MedTrade Products CELOX Topical Hemostatic Granules 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 June 2, 2006. Specifically, FDA is updating this SE Letter because FDA has better categorized your device technology under product code QSY.
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.
Image /page/0/Picture/8 description: This image shows the end of a letter with the signature of Julie A. Morabito, Ph.D., Assistant Director. The letter is from DHT4B: Division of Infection Control and Plastic Surgery Devices. It also mentions OHT4: Office of Surgical and Infection Control Devices. The letter is from the 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 and Human Services. The logo consists of a stylized eagle with three lines representing its wings and body. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN - 2 2006
MedTrade Products, Ltd. % Mr. Jonathan Ranfield Director, Quality Assurance & Regulatory Affairs Electra House, Crewe Business Park Crew, Cheshire CW1 6GL, UK
Re: K061079
Trade/Device Name: MedTrade Products CELOX Topical Hemostatic Granules Regulation Class: Unclassified Product Code: FRO Dated: March 31, 2006 Received: April 20, 2006
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 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.
2
Page 2 - Mr. Jonathan Ranfield
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 Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Herbert Lerner mo
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known)
Device Name: MedTrade Products CELOX Topical Hemostatic Granules
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.
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)
Halent Lemmer
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number K061079
.
4
Indications for Use
510(k) Number (if known)
Device Name: MedTrade Products CELOX Topical Hemostatic Granules OTC
MedTrade Products CELOX Topical Hemostatic Granuies 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.
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)
Helene Steme
(Division Sign-Off) Division of General, Restorative. and Neurological Devices
Kob1079 510(k) Number_
5
SAFETY AND EFFECTIVENESS SUMMARY
and the comments of the comments of
57
6
MedTrade Products Ltd
Safety & Effectiveness: MedTrade CELOX Topical Hemostatic Granules
Classification Name: 878 - General and Plastic Surgery
Contact: Jonathan Ranfield - Director, Quality Assurance & Regulatory Affairs
Prepared: October 28, 2005.
Description: MedTrade CELOX Topical Hemostatic Granules are intended as a temporary external wound treatment for the control of severely bleeding wound for emergency use. MedTrade CELOX Topical Hemostatic Granules is 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 and results reported and discussed with the applic tion.
The device is packed in a foil sachet and is provided sterile. It is sterilized by gamma irradiation The product will be sterlised by gamma irradiation in accordance with the Sterilisation of Health Care Products – Requirements for Validation and Routine Control - Radiation Sterilisation, 31 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.
| COMPARATIVE FEATURES | |||
|---|---|---|---|
| Characteristics | MedTrade | ||
| CELOX Topical Hemostatic | |||
| Granules | HemCon's | ||
| HemCon Bandage | On Site Gas System's / | ||
| Z-Medica's QuickClot | |||
| 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 | Not Applicable | |
| (As the Chitosan is made in | |||
| to a foam) | Granules / Granules | ||
| 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. | |||
| & OTC for Bleeding / | |||
| Lacerations | HemCon Bandage is a | ||
| Hemostatic dressing for the | |||
| external temporary control | |||
| severely bleeding wounds | |||
| intended for emergency use. | |||
| & OTC for Bleeding / | |||
| Lacerations | QuickClot is intended for | ||
| emergency use as an | |||
| external temporary | |||
| traumatic wound | |||
| treatment to achieve | |||
| hemostasis and prevent | |||
| blood loss | |||
| Packaging | Foil Pouch | Foil Pouch | Foil Pouch |
| Sterilisation Method | Gamma Irradiation | Gamma Irradiation | Gamma Irradiation |
Med Trade CELOX Topical Hemostatic Granules is substantially equivalent in chemistry and technology to: HemCon Incorporated, HemCon Bandage K023298 and in physical state and application to: On Site Gas Systems / Z-Medica's, QuickClot K013390
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 Business Park, Crewe, Cheshire CW1 6G