(46 days)
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.
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.
This document is a 510(k) premarket notification for MedTrade Products CELOX Topical Hemostatic Granules, indicating its substantial equivalence to previously marketed devices. It primarily focuses on regulatory approval and comparisons to predicate devices, rather than detailed study results for acceptance criteria.
Therefore, the full depth of information requested to describe acceptance criteria and associated studies is not available within the provided text.
However, I can extract the information that is present and highlight what is missing based on your request.
Here's a breakdown of the available information:
1. A table of acceptance criteria and the reported device performance:
- Acceptance Criteria: Not explicitly stated in terms of quantitative performance metrics (e.g., specific hemostasis rates, time to hemostasis, or reduction in blood loss that would be considered "acceptable"). The document focuses on demonstrating substantial equivalence to predicate devices, implying that their performance is considered acceptable.
- Reported Device Performance:
- Biocompatibility Testing: Dermal Irritation, Dermal Sensitisation, Cytotoxicity, Acute Systemic Toxicity, Hemolysis have been conducted. The results are reported and discussed with the application (though not detailed here).
- Sterilization: The product will be sterilized by gamma irradiation in accordance with ANSI/AAMI/ISO11137-1994 and AAMI TIR8-1991, with a sterility assurance level of 10^-6 and a dose of 25-35 kGys.
| Acceptance Criteria Category | Specific Criteria (Implicit/Explicit) | Reported Device Performance/Characteristics |
|---|---|---|
| Material Chemistry | Substantially equivalent to predicate chitosan-based hemostatic agents. | Chitosan, a material consisting of cellulosic polymer, poly-N-acetylglucosamine. Self-affirmed as GRAS (Generally Recognized As Safe) food ingredient in accordance with 21 CFR s 170.30. (Same as HemCon's HemCon Bandage). |
| Physical Composition | Granular form, similar to predicate granular hemostatic agents. | Granules (Similar to On Site Gas System's / Z-Medica's QuickClot). |
| Indications for Use | For temporary control of severely bleeding wounds to achieve hemostasis in emergency situations, and OTC for lacerations, minor cuts, abrasions. | MedTrade CELOX Topical Hemostatic Granules for external temporary control of severely bleeding wounds to achieve hemostasis and prevent blood loss, intended for emergency use. Also OTC for Bleeding / Lacerations (Substantially equivalent to HemCon Bandage and QuickClot in aspects of emergency use; specific OTC indication noted for MedTrade and HemCon). |
| Packaging | Foil Pouch. | Foil Pouch (Same as HemCon Bandage and QuickClot). |
| Sterilization Method | Gamma Irradiation, meeting specified standards and sterility assurance levels. | Gamma Irradiation in accordance with ANSI/AAMI/ISO11137-1994 and AAMI TIR8-1991. Sterility assurance level of 10^-6. Dose of 25-35 kGys (Same as HemCon Bandage and QuickClot for method, specific standards not listed for predicates but implied for device). |
| Biocompatibility | Acceptable safety profile for topical application. | Biocompatibility testing including Dermal Irritation, Dermal Sensitisation, Cytotoxicity, Acute Systemic Toxicity, Hemolysis has been conducted and results reported and discussed with the application (details not provided in this document, but implied to be acceptable for 510(k) clearance). |
| Ease of Use | Designed for easy packing, carrying, and one-hand application for emergency situations. | "The product is designed and packaged to be easily packed, carried and applied using only one hand." (This is a design characteristic, not a direct performance metric with acceptance criteria from a study in this document). |
Missing Information (Not found in the provided text):
The document does not describe a clinical study with quantitative performance metrics for the MedTrade CELOX Topical Hemostatic Granules against specific acceptance criteria. The approval is based on "substantial equivalence" to predicate devices K023298 (HemCon Bandage) and K013390 (QuickClot). This means the FDA has determined that the new device is as safe and effective as a legally marketed device.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample Size for Test Set: Not applicable/Not provided. The document describes a comparison to predicate devices, not a standalone clinical trial with a "test set" in the context of AI/diagnostic device validation. Biocompatibility testing was mentioned, but no sample sizes for those tests are detailed.
- Data Provenance: Not applicable/Not provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Number of Experts/Qualifications: Not applicable. This information is relevant for studies involving subjective human interpretation (e.g., image reading), which is not the nature of this device or the information provided.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Adjudication Method: Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- MRMC Study: Not applicable. This device is a topical hemostatic granule, not an AI-assisted diagnostic tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Standalone Performance: Not applicable. This is not an algorithmic device. The biocompatibility tests represent "standalone" assessments of the material's safety, but not performance in the clinical sense asked for in your prompt.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Type of Ground Truth: For the purpose of regulatory clearance, the "ground truth" for this 510(k) is the established safety and effectiveness of the predicate devices. The applicant demonstrates that their device shares similar characteristics and performs equivalently to these legally marketed devices. For biocompatibility, the ground truth would be accepted scientific standards for toxicity, irritation, etc.
8. The sample size for the training set:
- Sample Size for Training Set: Not applicable. This is not a machine learning/AI device that requires a training set.
9. How the ground truth for the training set was established:
- Ground Truth for Training Set: Not applicable.
In summary, the provided document details a 510(k) application for a medical device (hemostatic granules) based on substantial equivalence to predicate devices, rather than a clinical study with detailed performance acceptance criteria and study results against those criteria. Therefore, most of the specific questions related to AI/diagnostic study design are not applicable to this document.
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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.
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.
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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.
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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
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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
.
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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_
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SAFETY AND EFFECTIVENESS SUMMARY
and the comments of the comments of
57
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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 | MedTradeCELOX Topical HemostaticGranules | HemCon'sHemCon Bandage | On Site Gas System's /Z-Medica's QuickClot |
| Chemistry | Chitosan, a material consistingof cellulostic polymer, poly-N-acetylglucosamine. Thisformulation has been self-affirmed by the manufacturer asa GRAS (Generally RecognisedAs Safe) food ingredient inaccordance with 21 CFR s170.30. | Chitosan, a materialconsisting of cellulosticpolymer, poly-N-acetylglucosamine. Thisformulation has been self-affirmed by the manufactureras a GRAS (GenerallyRecognised As Safe) foodingredient in accordance with21 CFR s 170.30. | Not Applicable(As it is a syntheticderivative of volcanicrock) |
| Physical Composition | Granules / Granules | Not Applicable(As the Chitosan is made into a foam) | Granules / Granules |
| Indications For Use | MedTrade CELOX TopicalHemostatic Granules isHemostatic Granules for theexternal temporary control ofseverely bleeding wounds toachieve hemostasis and preventblood loss, intended foremergency use.& OTC for Bleeding /Lacerations | HemCon Bandage is aHemostatic dressing for theexternal temporary controlseverely bleeding woundsintended for emergency use.& OTC for Bleeding /Lacerations | QuickClot is intended foremergency use as anexternal temporarytraumatic woundtreatment to achievehemostasis and preventblood 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
Image /page/6/Picture/11 description: The image shows a certification mark with the text "CERT NO FM 53007 ISO 9001:2000 ISO 13485:2003" below it. The certification mark is circular and contains some text around the perimeter. The text below the mark indicates that the organization has been certified to ISO 9001:2000 and ISO 13485:2003 standards, with the certification number FM 53007.
Registered No: 3839609 Registered Office: Electra House, Crewe Business Park, Crewe, Cheshire CW1 6G
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