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 provided sterile.

AI/ML Overview

This document is a 510(k) premarket notification for the WoundStat™ device, comparing it to a predicate device, QuikClot®. It does not describe a study that uses acceptance criteria in the way a diagnostic AI device would. Instead, it focuses on demonstrating substantial equivalence to a legally marketed predicate device through pre-clinical testing, intended use, and mechanism of action.

Therefore, many of the requested fields regarding acceptance criteria, performance metrics, sample sizes for test/training sets, expert involvement, and ground truth establishment (which are typical for AI/diagnostic studies) are not applicable to this type of regulatory submission.

Here's the information that can be extracted or deduced from the provided documents:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria: Not explicitly stated as quantifiable metrics with thresholds (e.g., sensitivity > X%, specificity > Y%) in the context of a diagnostic or AI device study. The "acceptance criteria" here are generally meeting the requirements of substantial equivalence to the predicate device.
Reported Device Performance:
"WoundStat™ has equivalent, if not better, hemostasis results in terms of speed and effectiveness as QuikClot®."
"The results of these tests demonstrate that WoundStat™ is safe for its intended use."

2. Sample size used for the test set and the data provenance:

Sample Size for Test Set: Not specified in terms of patient or case numbers. Pre-clinical models were used.
Data Provenance: Pre-clinical models.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Number of Experts: Not applicable. Ground truth was not established by human experts in a diagnostic reading context. The "truth" was determined during pre-clinical hemostasis and safety studies.

4. Adjudication method 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: No. This is not an AI device or a diagnostic device evaluated with human readers.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

Standalone Performance: Not applicable. This is a medical device (hemostatic agent), not an algorithm.

7. The type of ground truth used:

Type of Ground Truth: Hemostasis results (speed and effectiveness) in pre-clinical models, and biocompatibility test results (systemic toxicity, cytotoxicity, intracutaneous studies).

8. The sample size for the training set:

Sample Size for Training Set: Not applicable. This device does not involve machine learning or a "training set."

9. How the ground truth for the training set was established:

Ground Truth Establishment for Training Set: Not applicable.

In summary, this document is a regulatory submission for a physical medical device (hemostatic agent) and not an AI or diagnostic device. Therefore, the questions tailored for AI/diagnostic study evaluations are largely not relevant or applicable to the information provided. The "study" referenced is pre-clinical testing to demonstrate safety and effectiveness comparable to a predicate device.

Summary

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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):

K071936

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

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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 RoadSuite 1200Bethesda, MD 20814
	Contact Person:	Rhonda 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:	QuikClot®Z-Medica CorporationK013390
	Intended Use:	WoundStat™ is intended for use in emergency woundmanagement.
	Indications for Use:	WoundStat™ is intended for emergency use only as anexternal temporary traumatic wound treatment to achievehemostasis for moderate to severe bleeding.

Device Description:

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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.

Regulation Number and Section

N/A