(123 days)
MedTrade Products CELOX Topical Hemostatic Granules in Soluble Bag 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.
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.
The provided document is a 510(k) premarket notification letter from the FDA for MedTrade Products CELOX Topical Hemostatic Granules. It primarily discusses the substantial equivalence of the device to previously marketed predicates and its regulatory classification. It does not contain information about specific acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, or MRMC studies for AI/device performance.
Therefore, I cannot provide details on those points based on the given text. The document focuses on regulatory approval rather than clinical study results or performance metrics in the way your request frames it (e.g., acceptance criteria for a diagnostic AI device).
The only relevant information that can be extracted is:
- Device Name: MedTrade Products CELOX Topical Hemostatic Granules OTC; MedTrade Products CELOX Topical Hemostatic Granules in Soluble Bag
- Intended Use (CELOX Topical Hemostatic Granules in Soluble Bag): Intended to be used to achieve hemostasis in emergency situations for the temporary control of severe topical bleeding.
- Intended Use (CELOX Topical Hemostatic Granules OTC): Indicated for the local management of bleeding such as lacerations, minor cuts and abrasions.
- Predicate Devices mentioned:
Summary of what cannot be provided from the document:
- Table of acceptance criteria and reported device performance: This document does not describe specific performance metrics or acceptance criteria for the device's hemostatic capabilities.
- Sample sizes used for the test set and data provenance: No clinical study details (including sample sizes, country of origin, retrospective/prospective nature) are provided.
- Number of experts used to establish the ground truth for the test set and their qualifications: Not applicable as no such test set or ground truth establishment is described.
- Adjudication method: Not applicable.
- MRMC comparative effectiveness study: Not mentioned.
- Standalone (algorithm only) performance: Not applicable, as this is a physical medical device, not an algorithm.
- Type of ground truth used: Not applicable.
- Sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
The document states that biocompatibility testing was conducted, including: Dermal Irritation, Dermal Sensitisation, Cytotoxicity, Acute Systemic Toxicity, and Hemolysis for the CELOX Granules. Dermal Irritation, Dermal Sensitisation, and Cytotoxicity were conducted on the Soluble Bag. Cytotoxicity and Systemic injection were conducted on the CELOX Granules in the Soluble Bag. However, it does not provide acceptance criteria or specific results for these tests.
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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
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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
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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
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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
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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
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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'sCELOX Topical HemostaticGranules | MedTrade Product's CELOXTopical Hemostatic Granules inSoluble Bag | Z-Medica's QuikClotACS | |
| Chemistry | Chitosan, a material consisting ofcellulostic polymer, poly-N-acetylglucosamine. Thisformulation has been self-affirmedby the manufacturer as a GRAS(Generally Recognised As Safe)food ingredient in accordance with21 CFR s 170.30. | Chitosan, a material consisting ofcellulostic polymer, poly-N-acetylglucosamine. Thisformulation has been self-affirmedby the manufacturer as a GRAS(Generally Recognised As Safe)food ingredient in accordance with21 CFR s 170.30. | Not Applicable(As it is a syntheticderivative of volcanicrock) |
| PhysicalComposition | Granules | Granules in Soluble Bag | Granules in mesh bag |
| Indications ForUse | MedTrade CELOX TopicalHemostatic Granules isHemostatic Granules for theexternal temporary control ofseverely bleeding wounds toachieve hemostasis and preventblood loss, intended foremergency use. | MedTrade CELOX TopicalHemostatic Granules isHemostatic Granules for theexternal temporary control ofseverely bleeding wounds toachieve hemostasis and preventblood loss. intended foremergency use. | QuickClot is intended foremergency use as anexternal temporarytraumatic woundtreatment to achievehemostasis and preventblood loss |
| & OTC for Bleeding / Lacerations | & OTC for Bleeding / Lacerations | ||
| PackagingSterilisation | Foil PouchGamma Irradiation | Foil PouchGamma Irradiation | Foil PouchGamma 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
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