No
The summary describes a physical, clay-based hemostatic agent and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
No
The device is a wound dressing designed to control bleeding, not to treat or cure a disease or condition. Its function is to facilitate hemostasis.
No
The device is described as a hemostatic agent used to control bleeding, which is a therapeutic function, not a diagnostic one.
No
The device description clearly states it is a "clay-based, granular hemostatic agent" which is a physical substance, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "control bleeding from minor cuts and abrasions of the skin." This is a direct therapeutic action on the body, not a diagnostic test performed on samples taken from the body.
- Device Description: The description details a "clay-based, granular hemostatic agent that is poured on a moderate to severe wound." This is a physical material applied externally to a wound.
- Lack of IVD Characteristics: There is no mention of analyzing samples (like blood, urine, tissue), detecting biomarkers, or providing information for diagnosis, monitoring, or screening.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic purposes. WoundStat™ is a topical hemostatic agent used to stop bleeding, which is a treatment, not a diagnostic process.
N/A
Intended Use / Indications for Use
WoundStat™ wound dressing for OTC is indicated for temporary external use to control bleeding from minor cuts and abrasions of the skin.
Product codes (comma separated list FDA assigned to the subject device)
QSY, FRO
Device Description
WoundStat™ is a clay-based, granufar hemostatic agent that is poured on 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 provided sterile.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
skin
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)
Not Found
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.
K070010, K061079, K070211, K071578, K013390
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. On the left is the logo for the Department of Health & Human Services - USA, which features a stylized emblem with three figures. To the right of that is the logo for the U.S. Food & Drug Administration (FDA). The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
TraumaCure, Inc. c/o Becker & Associates Consulting, Inc. Campbell T. Hutton, MSPH 2001 Pennsylvania Ave., NW, Suite 950 Washington, District of Columbia 20006
July 28, 2023
Re: K081183 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 June 19, 2008. 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.
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 consists of a stylized eagle with three stripes forming its body and wing. The eagle faces right. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 1 9 2008
Traumacure, Inc. % Becker & Associates Consulting, Inc. Campbell T. Hutton, MSPH 2001 Pennsylvania NW, Suite 950 Washington, District of Columbia 20006
Re: K081183
Trade Name: WoundStat™ Regulatory Class: Unclassified Product Code: FRO Dated: June 5, 2008 Received: June 6. 2008
Dear Campbell 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. Ilsting 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 mav 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.
lf 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 M. Mulhern
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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Section 5 Indications for Use Statement
510(k) Number (if known): _k081183
Device Name:
Indications for Use:
WoundStat™ wound dressing for OTC is indicated for temporary external use to control bleeding from minor cuts and abrasions of the skin.
WoundStat™
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use X AND/OR (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE QF NEEDED --
ign-(Division of General, Restorative, and Neurological Devices
510(k) Number K081183
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JUN 1 9 2008
TraumaCure, Inc. Page 14
Section 6 510(k) Summary
| Submission Date: | April 25, 2008 |
|---|---|
| Submitter Information: | |
| Company Name: | TraumaCure, Inc. |
| Company Address: | 7735 Old Georgetown Road |
| Suite 1200 | |
| Bethesda, MD 20814 | |
| Contact Person: | Rhonda B. 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: | WoundStat™ |
| TraumaCure, Inc. | |
| K071936 | |
| Intended Use: | WoundStat™ is intended for use in emergency wound |
| management. | |
| Indications for Use: | WoundStat™ wound dressing for OTC is indicated for |
| temporary external use to control bleeding from minor cut |
Device Description:
WoundStat™ is a clay-based, granufar hemostatic agent that is poured on 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 provided sterile.
and abrasions of the skin.
5
WoundStat™ was developed to address an unmet need in battlefield, ballistic, and traumatic injuries. A similar need exists in rural areas where there is a delay in obtaining medical care. For example, traumatic injuries can be sustained in manufacturing, construction, farming, and outdoor activities such as hunting and rock climbing. Uncontrolled hemorrhage continues to be a leading cause of death in both the military and in civilian populations under 35 years of age. The primary issue in these deaths is uncontrolled hemorrhage. OTC availability of WoundStat™ is consistent with numerous other legally marketed OTC wound management devices, such as QuikClot Sport™ (K070010), MedTrade Products CELOX Topical Hemostatic Granules OTC (K061079), BleedArrest™ (K070211), and BloodStop (K071578). It should be noted that WoundStat™ cleared for Rx use (K071936) was determined to be substantially equivalent to QuikClot® (K013390), a prescription device now cleared as QuikClot Sport™ (K070010) for OTC use.
Comparison to Predicate Device:
WoundStat™ for OTC use is highly similar to WoundStat™ cleared for Rx use (K071936). The mechanism of action and the indications for use in emergency wound management are unchanged. The intended use has been modified, from Rx use to OTC use, and the labeling has been revised in conformance with 21 CFR 801 Subpart C.
WoundStat™ for Rx use has been previously demonstrated to be as safe and effective as marketed wound management devices (K071936). New labeling has been developed for the OTC device, in conformance with 21 CFR 801 Subpart C and modeled after legally marketed OTC wound management devices, including QuikClot Sport™ (K070010). MedTrade Products CELOX Topical Hemostatic Granules OTC (K061079). BleedArrest™ (K070211), and BloodStop (K071578).
Conclusion :
WoundStat™ for OTC use is as safe and effective as the WoundStat™ for Rx use described in 510(k) K071936. Therefore. WoundStat™ for OTC use is substantially equivalent, 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 (US).