(61 days)
Not Found
No
The device description focuses on the material composition and physical properties of a hemostatic wound dressing, with no mention of software, algorithms, or data processing that would indicate the use of AI/ML. The performance studies described are standard biocompatibility and animal model tests, not related to AI/ML performance metrics.
Yes
The device is described as a "Hemostatic Wound Dressing" intended to control or stop bleeding, which is a therapeutic action.
No.
The device is a hemostatic wound dressing intended to control bleeding, not to diagnose a medical condition.
No
The device description clearly outlines a physical wound dressing made of specific materials (polyethylene fibers, precipitated silica, chitosan) and provided in various sizes. It is a tangible product, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for "external temporary use to control moderate to severe bleeding" and "to stop bleeding of superficial wounds, minor cuts, and abrasions." This describes a device used directly on the body to manage bleeding, not a device used to examine specimens from the body to provide diagnostic information.
- Device Description: The description details a wound dressing made of specific materials designed to promote hemostasis (stopping bleeding). It does not describe any components or functions related to analyzing biological samples.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological specimens (blood, urine, tissue, etc.)
- Providing diagnostic information about a disease or condition
- Using reagents or assays
- Outputting test results
The device is a topical hemostatic dressing, which falls under a different regulatory category than IVDs.
N/A
Intended Use / Indications for Use
TRAUMASTAT™ Hemostatic Wound Dressing is intended for external temporary use to control moderate to severe blocding.
TRAUMASTAT™ Hemostatic Wound Dressing is intended for external temporary use to stop bleeding of superficial wounds, minor cuts, and abrasions.
Product codes (comma separated list FDA assigned to the subject device)
QSY, FRO
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
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.
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.
Not Found
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 shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and then the word "ADMINISTRATION" in a smaller font size, also in blue.
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.
2
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, LLC |
| 3080 25th Street SE | |
| Salem, OR 97302 | |
| Submitted by: | International Regulatory Consultants, L.C. |
| 7651 S. 700 West, Suite 105 | |
| Salt Lake City, UT 84047 |
Description of Device:
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.
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.