(55 days)
WoundStat™ wound dressing for OTC is indicated for temporary external use to control bleeding from minor cuts and abrasions of the skin.
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.
This document is a 510(k) premarket notification for WoundStat™, a wound dressing intended for over-the-counter (OTC) use to control bleeding from minor cuts and abrasions. It's an administrative update to a previous 510(k) K071936 which originally cleared WoundStat™ for prescription (Rx) use.
Here's an analysis of the acceptance criteria and supporting study information:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly define specific performance acceptance criteria (e.g., stopping bleeding within X seconds for Y% of cases) for the OTC version of WoundStat™. Instead, the core of the submission relies on demonstrating substantial equivalence to its own previously cleared Rx version and other legally marketed OTC hemostatic agents.
The reported device performance, therefore, is primarily that:
- Mechanism of action is unchanged from the Rx version.
- It is demonstrated to be as safe and effective as the WoundStat™ for Rx use (K071936).
- It is similar to other legally marketed OTC wound management devices in terms of intended use and effectiveness for temporary external use to control bleeding from minor cuts and abrasions.
| Acceptance Criteria (Explicitly Stated in Document) | Reported Device Performance |
|---|---|
| Safety & Effectiveness (as compared to Rx version) | Deemed "as safe and effective" as WoundStat™ for Rx use (K071963). |
| Meeting OTC labeling requirements | Labeling revised "in conformance with 21 CFR 801 Subpart C" and "modeled after legally marketed OTC wound management devices". |
| Similar mechanism of action | Mechanism of action is "unchanged" from the Rx version. |
2. Sample Sizes Used for the Test Set and Data Provenance:
The document does not describe a new clinical study or test set specifically for this OTC 510(k) submission. Instead, it leverages the previous clearance of WoundStat™ for Rx use (K071936). The basis for "as safe and effective" likely stems from data or analyses provided in the K071936 submission. Without access to K071936, the specifics of its test set sample size and data provenance cannot be determined from this document.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
This document does not mention the use of experts to establish a ground truth for a new test set for the OTC clearance. The assessment is based on comparison to existing cleared devices and the previous Rx clearance. Any expert involvement would have been part of the K071936 submission or the development of the predicate devices.
4. Adjudication Method:
Not applicable, as no new specific test set or clinical study requiring adjudication is described in this document for the OTC clearance.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
Not applicable. This document is for a medical device (wound dressing), not an AI/imaging diagnostic tool. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant.
6. Standalone (Algorithm Only) Performance Study:
Not applicable. This is a physical wound dressing, not an algorithm or software. Its performance is inherent to its physical and chemical properties when applied.
7. Type of Ground Truth Used:
For this OTC submission, the "ground truth" implicitly relies on:
- Previous FDA clearance of its own Rx version (K071936): This implies that the Rx version was found safe and effective based on its own ground truth (e.g., animal studies, clinical data on hemostasis).
- Established safety and effectiveness of predicate OTC devices: The comparison to other legally marketed OTC hemostatic agents (QuikClot Sport™, CELOX, BleedArrest™, BloodStop) suggests that the "ground truth" for these devices' performance in controlling minor bleeding is generally accepted by the FDA for OTC applications.
8. Sample Size for the Training Set:
Not applicable. This is a physical device, not a machine learning model, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set for a physical device.
Summary of Device Meeting Acceptance Criteria:
The device, WoundStat™ for OTC use, meets the "acceptance criteria" by demonstrating substantial equivalence to its own previously cleared prescription version (K071936) and other legally marketed OTC hemostatic agents. The study proving this essentially refers back to the data and rationale provided in the K071936 submission, along with a revised labeling conforming to OTC regulations (21 CFR 801 Subpart C). The core logic is that if the Rx version was safe and effective for its broader indications, and the mechanism of action remains the same, then the OTC version with more limited indications (minor cuts and abrasions) and appropriate labeling is also safe and effective. No new clinical trials or performance studies are described in this specific 510(k) update for the OTC clearance.
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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
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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 RoadSuite 1200Bethesda, MD 20814 |
| Contact Person: | Rhonda B. Friedman, ScDPresident and Chief Operating OfficerPhone (240) 497-0910Fax (240) 497-0911rfriedman@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 woundmanagement. |
| Indications for Use: | WoundStat™ wound dressing for OTC is indicated fortemporary 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.
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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).
N/A