(41 days)
Not Found
No
The device description and performance studies focus on the material properties and hemostatic function of a clay-based granular agent, with no mention of AI or ML.
No.
A therapeutic device is used to treat a disease, injury, or other condition. While WoundStat™ is used to achieve hemostasis for traumatic wounds, its intended use is for emergency situations for temporary treatment rather than a sustained course of treatment, and it functions as a hemostatic agent rather than a device for therapeutic intervention or long-term management of a condition.
No
Explanation: The device description states WoundStat™ is a "clay-based, granular hemostatic agent" used to achieve hemostasis. Its function is to stop bleeding, not to diagnose a condition.
No
The device description clearly states that WoundStat™ is a "clay-based, granular hemostatic agent," which is a physical substance and not software.
Based on the provided information, WoundStat™ is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "external temporary traumatic wound treatment to achieve hemostasis for moderate to severe bleeding." This describes a treatment applied directly to a wound on the body, not a test performed on a sample taken from the body.
- Device Description: The device is a "clay-based, granular hemostatic agent that is poured on or into a moderate to severe wound." This is a physical material used to stop bleeding externally.
- Lack of Diagnostic Activity: There is no mention of the device being used to diagnose a condition, analyze a biological sample (like blood, urine, or tissue), or provide information about a patient's health status through in vitro testing.
IVDs are devices used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. WoundStat™ does not fit this description.
N/A
Intended Use / Indications for Use
WoundStat™ is intended for emergency use only as an external temporary traumatic wound treatment to achieve hemostasis for moderate to severe bleeding.
Product codes (comma separated list FDA assigned to the subject device)
QSY, FRO
Device Description
WoundStat™ is a clay-based, granular hemostatic agent that is poured on or into a moderate to severe wound and held in place until it adheres to the wound and hemostasis is achieved. The device is packaged in a foil package and is providedasterile.
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)
WoundStat™ has been tested in pre-clinical models. WoundStat™ has equivalent, if not better, hemostasis results in terms of speed and effectiveness as QuikClot®. In addition, biocompatibility testing was completed. Systemic toxicity, cytotoxicity and intracutaneous studies were performed. The results of these tests demonstrate that WoundStat™ is safe for its intended use.
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.
QuikClot®, K013390
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 two logos. The logo on the left is the Department of Health & Human Services - USA logo. The logo on the right is the FDA U.S. Food & Drug Administration logo. The FDA logo is in blue.
TraumaCure Inc. c/o Becker & Associates Consulting, Inc. Campbell T. Hutton MSPH Project Manager 2001 Pennsylvania Avenue, Northwest Suite 950 Washington, District of Columbia 20006
June 11, 2023
Re: K071936 Trade/Device Name: Woundstat™ Regulatory Class: Unclassified Product Code: QSY
Dear Campbell T. Hutton MSPH:
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 August 23, 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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Image /page/1/Picture/2 description: The image shows the address of the Food and Drug Administration. The address is 9200 Corporate Boulevard, Rockville MD 20850. The text is in a simple, sans-serif font and is left-aligned.
AUG 2 3 2007
TraumaCure, Inc. % Becker & Associates Consulting, Inc. Campbell T. Hutton, MSPH Project Manager 2001 Pennsylvania Avenue, Northwest Suite 950 Washington, District of Columbia 20006
Re: K071936
Trade/Device Name: WoundStat™ Regulatory Class: Unclassified Product Code: FRO Dated: August 14, 2007 Received: August 15, 2007
Dear Campbell T. Hutton:
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 - Campbell T. Hutton, MSPH
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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark N. Melkerson
Director
Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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TraumaCure, Inc. Page 13
Section 5 Indications for Use Statement
510(k) Number (if known):
WoundStat™ Device Name:
Indications for Use:
WoundStat™ is intended for emergency use only as an external temporary traumatic wound treatment to achieve hemostasis for moderate to severe bleeding.
Prescription Use X and/or
4
Section 6 510(k) Summary
K071936 page 1 of 2
| Submission Date: | July 12, 2007 | AUG 2 3 2007 |
|---|---|---|
| Submitter Information: | ||
| Company Name: | TraumaCure, Inc. | |
| Company Address: | 7735 Old Georgetown Road | |
| Suite 1200 | ||
| Bethesda, MD 20814 | ||
| Contact Person: | Rhonda Friedman, ScD | |
| President and Chief Operating Officer | ||
| Phone (240) 497-0910 | ||
| Fax (240) 497-0911 | ||
| rfriedman@traumacure.com | ||
| Device Information: | ||
| Trade Name: | WoundStat™ | |
| Common Name: | Wound Dressing | |
| Device Class: | Unclassified | |
| Predicate Device: | QuikClot® | |
| Z-Medica Corporation | ||
| K013390 | ||
| Intended Use: | WoundStat™ is intended for use in emergency wound | |
| management. | ||
| Indications for Use: | WoundStat™ is intended for emergency use only as an | |
| external temporary traumatic wound treatment to achieve | ||
| hemostasis for moderate to severe bleeding. |
Device Description:
WoundStat™ is a clay-based, granular hemostatic agent that is poured on or into a moderate to severe wound and held in place until it adheres to the wound and hemostasis is achieved. The device is packaged in a foil package and is providedasterile.
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TraumaCure, Inc. Page 15
K 671936
WoundStat has been developed to address an unmet need in battlefield, ballistic, and traumatic injuries. Uncontrolled hemorrhage continues to be a leading cause of death in tradinate military and in civilian populations under 35 years of age. The primary issue in these deaths is uncontrolled hemorrhage.
Comparison to Predicate Device:
WoundStat™ has the same mechanism of action and intended use as QuikClot®. Both devices use material that has an unusually high adsorptive effect on liquid for the temporary external treatment of traumatic wounds. The rapid adsorption reduces the quantity of liquid present in the wound in a sponge effect, which concentrates coagulation factors and promotes clotting.
WoundStat™ has been tested in pre-clinical models. WoundStat™ has equivalent, if not better, hemostasis results in terms of speed and effectiveness as QuikClot®. In addition, biocompatibility testing was completed. Systemic toxicity, cytotoxicity and intracutaneous studies were performed. The results of these tests demonstrate that WoundStat™ is safe for its intended use.
Conclusion:
WoundStat™ is a safe and effective traumatic wound dressing that is substantially equivalent to the predicate device, QuikClot®. Therefore, WoundStat™ should be regulated by FDA within the same generic type of device that includes the cited predicate and should be cleared for marketing in the United States.