(168 days)
Not Found
No
The device description and performance studies focus on the physical and chemical properties of the hemostatic material, with no mention of AI or ML algorithms for analysis, diagnosis, or treatment.
Yes
The device is described as a "topical dressing for the management of bleeding wounds" that "accelerate[s] the coagulation process to form a stable clot," indicating it is used for treatment, which falls under the definition of a therapeutic device.
No
Explanation: The device is a topical hemostatic wound dressing intended to manage bleeding by accelerating the coagulation process, not to diagnose a medical condition.
No
The device description clearly states it is comprised of "plant based polysaccharides" in powder and foam forms, which are physical materials, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The CoAg Medical StopsBleeding™ Topical Hemostat Powder and Foam are described as topical wound dressings applied directly to the surface of bleeding wounds. Their mechanism of action is to accelerate the natural clotting process at the wound site.
- No Sample Analysis: The device does not involve the analysis of any biological samples taken from the body. It acts externally on the wound.
Therefore, the device falls under the category of a topical hemostatic agent or wound dressing, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The CoAg Medical, LLC StopsBleeding™ Topical Hemostat Powder and Foam are intended for use as a topical dressing for the management of bleeding wounds and are available for prescription use and over-the-counter use.
Prescription: StopsBleeding™ Rx Topical Hemostat Powder and Foam are indicated for use as a topical dressing for the temporary treatment of moderate to severely bleeding wounds such as surgical wounds (post-operative, donor sites, dermatological), cuts and lacerations and are also indicated for control of bleeding from the skin at percutaneous needle access, vascular access and percutaneous catheter access sites. StopsBleeding™ Rx is intended for use under the care of a health care professional.
OTC: StopsBleeding™ OTC Topical Hemostat Powder and Foam are indicated for use as a topical dressing on minor bleeding wounds such as cuts, lacerations and abrasions and for minor nose bleeds.
Product codes (comma separated list FDA assigned to the subject device)
QSY, LYA, FRO
Device Description
The CoAg Medical StopsBleeding™ Topical Hemostat Powder and Foam are sterile, topical wound dressings comprised of plant based polysaccharides that accelerate the coagulation process to form a stable clot. The hemostatic particles contained in both the powder form and the foam form accomplish this by quickening the natural drying process at the wound site and by concentrating the vital nutrients (proteins and platelets etc.) that the body uses to naturally form a clot. When more of these nutrients are present at a wound site, the body is able to accelerate the cessation of bleeding and allow the healing process to more quickly and naturally occur on its own.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Skin / bleeding wounds (surgical wounds, post-operative, donor sites, dermatological, cuts, lacerations, abrasions, percutaneous needle access, vascular access, percutaneous catheter access sites, minor nose bleeds)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription product intended for use under the care of a health care professional. Over-the-counter product for general use.
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)
Bench Testing: Design verification testing was performed on StopsBleeding™ Topical Hemostat Powder and Foam to demonstrate physical and functional requirements were met.
Performance Testing: Comparative water holding capability bench testing and bleeding cessation testing in a porcine animal model demonstrated that the StopsBleeding™ Topical Hemostat Powder and Foam performed substantially equivalent to the primary predicate devices.
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
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April 21, 2023
CoAg Medical LLC Bernard Horwath Regulatory Affairs Consultant 4486 Timberline Ct. Vadnais Heights, Minnesota 55127
Re: K140313
Trade/Device Name: Stops Bleeding Topical Hemostat Powder and Foam Regulatory Class: Unclassified Product Code: QSY, LYA
Dear Bernard Horwath:
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 July 28, 2014 and correction letter dated September 10, 2015. Specifically, FDA is updating this SE Letter because FDA has better categorized your device technology under product codes QSY and LYA.
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 features the department's name in a circular arrangement around a symbol. The symbol consists of a stylized depiction of three human profiles facing to the right. The profiles are stacked on top of each other, creating a sense of depth and unity.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 10, 2015
Mr. Bernard Horwath Regulatory Affairs Consultant 4486 Timberline Ct Vadnais Heights, MN 55127
Re: K140313
Trade/Device Name: Stops Bleeding topical Hemostat Powder and Foam Regulation Number: N/A Regulation Name: Dressing Regulatory Class: Unclassified Product Code: FRO Dated: June 27, 2014: Received: July 1, 2014:
Dear Mr. Horwath:
This letter corrects our substantially equivalent letter of July 28, 2014.
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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
2
comply with all the Act's requirements, including, but not limited to: registration and listing (21 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 (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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801, please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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/MedicalDevices/Safety/ReportaProblem/default.htm 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
David Krause -S
- for Binita Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
3
Indications for Use
510(k) Number (if known) K140313
Device Name
CoAg StopsBleeding™ Topical Hemostat Powder and Foam
Indications for Use (Describe)
The CoAg Medical, LLC StopsBleeding™ Topical Hemostat Powder and Foam are intended for use as topical dressings for the management of bleeding wounds and are available for prescription use and over-the-counter use.
Prescription: StopsBleeding™ Rx Topical Hemostat Powder and Foam are indicated for use as a topical dressing for the temporary treatment of moderate to severely bleeding wounds such as surgical wounds (post-operative, donor sites, dermatological), cuts and lacerations and are also indicated for control of bleeding from the skin at percutaneous needle access, vascular access and percutaneous catheter access sites. StopsBleeding™ Rx is intended for use under the care of a health care professional.
OTC: StopsBleeding™ OTC Topical Hemostat Powder and Foam are indicated for use as a topical dressing on minor bleeding wounds such as cuts, lacerations and abrasions and for minor nose bleeds.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Jivoung Dana -S
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4
510(k) Summary
CoAg StopsBleeding™ Topical Hemostat Powder and Foam
| Date Prepared: | February 7, 2014 (corrected July 23, 2015) |
|---|---|
| Submitter: | CoAg Medical LLC |
| 545 Atwater Circle | |
| St Paul, MN 55103 | |
| Telephone: (877)-601-7867 | |
| Fax: (651)-305-7637 | |
| Contact: | Mr. Bernard Horwath |
| Regulatory Affairs Consultant | |
| 4486 Timberline Ct | |
| Vadnais Heights, MN 55127 | |
| Telephone: 651- 231-1761 |
Proprietary Name: StopsBleeding™ Topical Hemostat Powder and Foam
Common/Usual Name: Topical hemostatic particles
| Classification Name: Dressing, Pre-Amendment Unclassified |
|---|
| Product Code – FRO General and Plastic Surgery |
Description:
The CoAg Medical StopsBleeding™ Topical Hemostat Powder and Foam are sterile, topical wound dressings comprised of plant based polysaccharides that accelerate the coagulation process to form a stable clot. The hemostatic particles contained in both the powder form and the foam form accomplish this by quickening the natural drying process at the wound site and by concentrating the vital nutrients (proteins and platelets etc.) that the body uses to naturally form a clot. When more of these nutrients are present at a wound site, the body is able to accelerate the cessation of bleeding and allow the healing process to more quickly and naturally occur on its own.
Indications for Use:
The CoAg Medical, LLC StopsBleeding™ Topical Hemostat Powder and Foam are intended for use as a topical dressing for the management of bleeding wounds and are available for prescription use and over-the-counter use.
Prescription: StopsBleeding™ Rx Topical Hemostat Powder and Foam are indicated for use as a topical dressing for the temporary treatment of moderate to severely bleeding wounds such as surgical wounds (post-operative, donor sites, dermatological), cuts and lacerations and are also indicated for control of bleeding from the skin at percutaneous needle access, vascular access and percutaneous catheter access sites. StopsBleeding™ Rx is intended for use under the care of a health care professional.
OTC: StopsBleeding™ OTC Topical Hemostat Powder and Foam are indicated for use as a topical dressing on minor bleeding wounds such as cuts, lacerations and for minor nose bleeds.
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Substantial Equivalence:
The CoAg Medical StopsBleeding™ Topical Hemostat Powder and Foam are substantially equivalent to the following predicate devices:
| Manufacturer | Brand Name | 510(k) Number |
|---|---|---|
| Hemostasis, LLC | TraumArrest®/BleedArrest® | K070211 |
| Medafor | Bleed-XTM/TraumadexTM | K013225 |
StopsBleeding™ Topical Hemostat Powder and Foam are technically identical hemostats as the predicates and have the same intended use. The Hemostasis, LLC hemostat is considered the primary predicate for indications for use, technical composition and performance, while the Medafor hemostat predicate has substantially equivalent packaging.
Technological Characteristics:
Technically, the StopsBleeding™ Topical Hemostat Powder and Foam have the same plant based polysaccharide material composition as the predicates. The use of this same plant based polysaccharide in the CoAg and Hemostasis hemostats results in the same mechanism of action, namely dehydration of blood cells and hemoconcentration of platelets and serum proteins leading to clotting.
Biocompatibility:
The CoAg Medical StopsBleeding™ Topical Hemostat Powder and Foam and the predicate hemostats are categorized as a surface device for breached or compromised skin surfaces with prolonged exposure of 24 hours to 30 days in accordance with ISO 10993-1 Biological Evaluation of Medical Devices. These plant based polysaccharides hemostats have demonstrated compliance to cytotoxicity, sensitization and irritation biocompatibility testing and have a long history of safe and effective use.
Sterilization:
The CoAg Medical StopsBleeding™ Topical Hemostat Powder and Foam are sterilized using a gamma radiation method to assure a sterilization assurance level (SAL) of 10 °. The CoAg devices are packaged in the same manner as the predicate devices to assure sterility over their labeled shelf life.
Bench Testing:
Design verification testing was performed on StopsBleeding™ Topical Hemostat Powder and Foam to demonstrate physical and functional requirements were met.
Performance Testing:
Comparative water holding capability bench testing and bleeding cessation testing in a porcine animal model demonstrated that the StopsBleeding™ Topical Hemostat Powder and Foam performed substantially equivalent to the primary predicate devices.
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Conclusion:
Through the data and information presented, CoAg Medical, LLC considers the StopsBleeding™ Topical Hemostat Powder and Foam substantially equivalent to the predicate devices already on the market (cleared by the 510(k) process) in terms of indications for use, scientific technology, material composition, design, functional performance, and sterility/packaging and present no new concerns about safety and effectiveness.