Over the Counter Use: TRAUMASTAT™ Hemostatic Wound Dressing is intended for external temporary use to stop bleeding of superficial wounds, minor cuts, and abrasions.

Device Description

TRAUMASTAT™ Hemostatic Wound Dressing is a unique non-woven substrate comprised of porous polyethylene fibers highly filled with precipitated silica. This substrate is coated with chitosan, manufactured from ChitoClear™, a material consisting of the cellulosic polymer, poly-N-acctylglucosamine which is generally recognized as safe in accordance with 21 CFR 170,30. Each fiber of the wound dressing is approximately 20 to 100 micrometers in diameter. The wound dressing is provided in multiple lengths and widths to accommodate varying clinical situations as appropriate for its intended use. The dressing thickness is approximately 3 mm with an average density of approximately 0.15 gram/cc.

TRAUMATAT Hemostatic Wound Dressing is hermetically sealed in a poly foil pouch and electron beam sterilized.

AI/ML Overview

This document describes the TRAUMASTAT™ Hemostatic Wound Dressing, focusing on its indications for use and the safety and effectiveness information provided in its 510(k) submission (K080648).

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the TRAUMASTAT™ Hemostatic Wound Dressing are implicitly derived from its intended use and comparison to predicate devices, particularly effectiveness in controlling bleeding. The study information provided is limited, but here's a structured view:

Acceptance Criteria Category	Specific Criteria (Implicit/Explicit)	Reported Device Performance
Biocompatibility	No cytotoxicity, sensitization, or skin irritation.	Concluded to be safe based on in-vitro biocompatibility testing (cytotoxicity, sensitization, skin irritation) in accordance with FDA requirements and ISO 10993.
Hemostatic Property	Effective in arresting severe bleeding (for prescription use).	In-vivo animal testing on swine models demonstrated effectiveness in arresting severely bleeding induced traumatic wounds.
Sterility	Must be sterile.	Hermetically sealed in a poly foil pouch and electron beam sterilized.
Material Safety	Components are generally recognized as safe (GRAS) where applicable.	Chitosan manufactured from ChitoClear™, a material consisting of poly-N-acetylglucosamine, is generally recognized as safe in accordance with 21 CFR 170.30.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: The document mentions "in-vivo animal testing conducted on swine models" but does not specify the number of animals (sample size) used in this test set.
Data Provenance: The study was "in-vivo animal testing," specifically using "swine models." The country of origin for the data is not specified, but it's part of a U.S. FDA 510(k) submission, implying a U.S. regulatory context. It is a prospective study as it's an animal efficacy study designed to test the device's performance.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided in the document. For animal studies, surgical teams and veterinary pathologists typically define and assess outcomes, but specific details about the number and qualifications of experts are absent.

4. Adjudication Method for the Test Set

This information is not provided in the document. For animal efficacy studies, adjudication is often performed by blinded observers or a consensus panel, but the specific method is not described here.

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

No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. This type of study is typically relevant for interpretative devices (like AI-powered diagnostic tools) where human readers interact with the output. The TRAUMASTAT™ device is a physical wound dressing, not an AI-assisted diagnostic or interpretative system.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No, a standalone (algorithm only) performance study was not done. As stated above, this is a physical medical device, not a software algorithm. The "standalone performance" of the device in this context refers to its direct hemostatic action, which was assessed in the animal model.

7. The Type of Ground Truth Used

The ground truth for the effectiveness study was based on direct observation of outcomes in an in-vivo animal model. Specifically, the ground truth was the "arresting [of] severely bleeding induced traumatic wounds" in swine models. This is a form of outcomes data directly observed in a biological system.

8. The Sample Size for the Training Set

This information is not applicable/not provided. The device is a physical wound dressing, not an AI/ML algorithm that requires a "training set" in the computational sense. The materials and manufacturing processes are developed based on established scientific principles and prior knowledge of components like chitosan and precipitated silica, rather than a data training set.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable/not provided for the same reasons as point 8.

Summary

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July 28, 2023

Ore-Medix, LLC c/o International Regulatory Consultants, L.C. Donald F. Grabarz Managing Director 7651 South 700 West, Suite 105 Midvale, Utah 84047

Re: K080648

Trade/Device Name: TRAUMASTAT™ Hemostatic Wound Dressing Regulatory Class: Unclassified Product Code: QSY

Dear Donald F. Grabarz:

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 May 7, 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 Department of Health & Human Services, USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES, USA" arranged around the perimeter. Inside the circle is a stylized emblem resembling an eagle or bird-like figure with flowing lines, representing the department's mission related to health and human services.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY - 7 2008

Ore-Medix, LLC % International Regulatory Consultants, LC Mr. Donald F. Grabarz Managing Director 7651 South 700 West, Suite 105 Midvale, Utah 84047

Re: K080648

Trade/Device Name: TRAUMASTAT™ Hemostatic Wound Dressing Regulatory Class: Unclassified Product Code: FRO Dated: April 21, 2008 Received: April 22, 2008

Dear Mr. Grabarz:

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 - Mr. Donald F. Grabarz

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 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 N. Millman

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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Page 1 of 1

Indications for Use Statement

510(k) Number: K080648

Device Name: TRAUMASTAT™ Hemostatic Wound Dressing

Indications For Use:

Prescription Use:

TRAUMASTAT™ Hemostatic Wound Dressing is intended for external temporary use to control moderate to severe blocding.

Over the Counter Use:

TRAUMASTAT™ Hemostatic Wound Dressing is intended for external temporary use to stop bleeding of superficial wounds, minor cuts, and abrasions.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use X (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Nikhil al for an
Sign Off

Division of General, Restorative and Neurological Devices

510(k) Number K080648

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K080648
page 1 of 2

510(k) SUMMARY 5.0

TRAUMASTAT™ Hemostatic Wound Dressing

	MAY - 7 2008
Name and Address of Sponsor:	Ore-Medix, LLC3080 25th Street SESalem, OR 97302
Submitted by:	International Regulatory Consultants, L.C.7651 S. 700 West, Suite 105Salt Lake City, UT 84047

Description of Device:

TRAUMATAT Hemostatic Wound Dressing is hermetically sealed in a poly foil pouch and electron beam sterilized.

Intended Use of Device:

Prescription Use: TRAUMASTAT Hemostatic Wound Dressing is intended for external temporary use to control moderate to severe bleeding.

Over the Counter Use (OTC): TRAUMASTAT Hemostatic Wound Dressing is intended for temporary external use to stop bleeding of superficial wounds, minor cuts, and abrasions.

Substantially Equivalent Predicate/Comparative Devices:

The TRAUMASTAT Hemostatic Wound Dressing is substantially equivalent to the following commercially available devices.

Product Name:	ChitoFlex™ Hemostatic Dressing
Manufacturer:	HemCon Inc.
510(k) Number:	K071519
Product Name:	QuikClot® eX™
Manufacturer:	Z-Medica Corporation
510(k) Number:	K072474

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Safety and Effectiveness:

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Based on in-vitro biocompatibility testing in accordance with FDA requirements and ISO 10993 for external communicating, breached surface blood contact devices for cytotoxicity, sensitization and skin irritation, the TRAUMASTAT Hemostatic Wound Dressing is concluded to be safe for its intended use. In-vivo animal testing conducted on swine models demonstrates the effectiveness of the hemostatic properties in arresting scvcrely bleeding induced traumatic wounds.

Regulation Number and Section

N/A