WOUNDSTAT, MODEL TC1001

K071936 · Traumacure, Inc. · QSY · Aug 23, 2007 · SU

Device Facts

• Record ID: K071936
• Device Name: WOUNDSTAT, MODEL TC1001
• Applicant: Traumacure, Inc.
• Product Code: QSY · SU
• Decision Date: Aug 23, 2007
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

WoundStat™ is intended for emergency use only as an external temporary traumatic wound treatment to achieve hemostasis for moderate to severe bleeding.

Device Story

WoundStat™ is a clay-based, granular hemostatic agent designed for emergency management of moderate to severe traumatic wounds. The device is applied by pouring the granules directly onto or into the wound site. It functions via a high-adsorptive effect, acting as a sponge to rapidly remove liquid from the wound, thereby concentrating endogenous coagulation factors to promote clotting and achieve hemostasis. It is intended for use in battlefield, ballistic, and civilian traumatic injury settings. The device is provided sterile in a foil package. By accelerating hemostasis, the device aims to reduce uncontrolled hemorrhage, a leading cause of mortality in trauma patients.

Clinical Evidence

No clinical data. Evidence consists of pre-clinical bench and animal model testing. Biocompatibility testing included systemic toxicity, cytotoxicity, and intracutaneous studies. Performance testing compared hemostasis speed and effectiveness against the predicate device.

Technological Characteristics

Clay-based granular hemostatic agent. Sterile, foil-packaged. Mechanism: high-adsorptive effect for liquid removal and coagulation factor concentration. No electronic components or software.

Indications for Use

Indicated for emergency use as an external temporary traumatic wound treatment to achieve hemostasis for moderate to severe bleeding in patients with traumatic injuries.

Regulatory Classification

Identification

To temporarily control bleeding and cover external wounds.

Predicate Devices

• QuikClot® (K013390)

Submission Summary (Full Text)

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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, [e-mail].

> 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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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 [phone]. 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 [phone] or [phone] 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 Road<br>Suite 1200<br>Bethesda, MD 20814 |
| | Contact Person: | Rhonda Friedman, ScD<br>President and Chief Operating Officer<br>Phone [phone]<br>Fax [phone]<br>[e-mail] |
| Device Information: | | |
| | Trade Name: | WoundStat™ |
| | Common Name: | Wound Dressing |
| | Device Class: | Unclassified |
| | Predicate Device: | QuikClot®<br>Z-Medica Corporation<br>K013390 |
| | Intended Use: | WoundStat™ is intended for use in emergency wound<br>management. |
| | Indications for Use: | WoundStat™ is intended for emergency use only as an<br>external temporary traumatic wound treatment to achieve<br>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.