(31 days)
No
The device description and performance studies focus on the material properties and physical action of the hemostatic agent, with no mention of AI or ML.
Yes
The device is described as a hemostatic dressing intended to achieve hemostasis of moderate to severe bleeding (prescription use) and for local management of bleeding from minor cuts, lacerations, and abrasions (OTC use), which are therapeutic actions.
No
The device is described as a hemostatic dressing intended to achieve hemostasis of bleeding, which is a treatment function, not a diagnostic one.
No
The device description clearly states it is a "hemostatic agent comprising a clay-based powder contained in a dissolving pouch with a non-stick gauze pad backing," which are physical components, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to achieve hemostasis (stop bleeding) from external wounds. This is a direct treatment applied to the body, not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: The device is a hemostatic dressing applied topically to a wound.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not fit that description.
N/A
Intended Use / Indications for Use
Prescription, Rx UltraClot is intended as a hemostatic dressing for emergency external use and temporary wound treatment to achieve hemostasis of moderate to severe bleeding.
Over the Counter, OTC
UltraClot OTC is intended as a topical hemostatic dressing for the local management of bleeding from minor cuts, lacerations, and abrasions.
Product codes
QSY, FRO
Device Description
UltraClot™ is a hemostatic agent comprising a clay-based powder contained in a dissolving pouch with a non-stick gauze pad backing that is placed on a moderate to severe wound and held in place until hemostasis is achieved. The device is packaged in a vacuum sealed foil bag and is provided sterile.
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
UltraClot™ was developed to address the need in both the military and civilian markets for a product that is both easy to use and effective. In the military application. UltraClot™ is effective in cases of moderate to severe bleeding leading to death due to uncontrolled hemorrhage, as a result of ballistic wounds and traumatic injuries. In the civilian market UltraClot™ is effective when there is a delay in receiving medical care. Traumatic injuries in the civilian market can occur from accidents in manufacturing, construction, farming, and sports activities.
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
UltraClot™has been tested in animal models. UltraClot™was found to be at least substantially equivalent to Quikclot® in terms of speed and efficacy with the added benefits of absence of exothermia and reduced blood loss.
Biocompatibility testing was performed on UltraClot™which demonstrated UltraClot "to be safe for its intended use. These included mutagenicity, cytotoxicity, and intracutaneous studies.
Key Metrics
Not Found
Predicate Device(s)
QuikClot®, Z-Medica Corp., K013390, QuikClot® Sport, Z-Medica Corp, K070010
Reference Device(s)
Woundstat® OTC (K081183), Quikclot® Sport (K070010), Medtrade Products Celox Topical Hemostatic granules OTC (K061079), Bleed Arrest (K070211), and Bloodstop (K071578).
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
Image /page/0/Picture/0 description: The image contains two logos. On the left is the logo for the Department of Health & Human Services - USA, featuring a stylized human figure. To the right is the logo for the U.S. Food & Drug Administration (FDA), with the FDA acronym in a blue square and the full name "U.S. FOOD & DRUG ADMINISTRATION" in blue text next to it.
Emergency Medical Devices, LLC c/o Jack Mentkow Director 1875 Tulip Lane Wellington, Florida 33414
July 28, 2023
Re: K082601 Trade/Device Name: UltraClot™, UltraClot™ OTC Regulatory Class: Unclassified Product Code: QSY
Dear Jack Mentkow:
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 October 9, 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.
Sincerelv.
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
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The logo is black and white.
OCT 0 9 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Emergency Medical Devices, LLC % Mr. Jack Mentkow Director 1875 Tulip Lane Wellington, Florida 33414
Re: K082601 Trade/Device Name: UltraClot™, UltraClot™OTC Regulatory Class: Unclassified Product Code: FRO Dated: September 5, 2008 Received: September 8, 2008
Dear Mr. Mentkow:
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. Jack Mentkow
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 vours.
Mark N Mulkerson
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Section 4.
Indications for Use
510(k) Number (if known): KOGQOO
Device Name: UltraClot™, UltraClot™ OTC
Indications for Use:
Prescription, Rx UltraClot™ is intended as a hemostatic dressing for emergency external use and temporary wound treatment to achieve hemostasis of moderate to severe bleeding.
Over the Counter, OTC
UltraClot™ OTC is intended as a topical hemostatic dressing for the local management of bleeding from minor cuts, lacerations, and abrasions.
Prescription Use Over-The-Counter Use AND/OR (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device, Evaluation
Mark Miller
(Division Sign-Off) (Division Sign-On)
Division of General, Restorative, Division of General, Division of General Division of or organization of Neurological Devices
510(k) Number
Emergency Medical Devices, LLC 510(k) UltraClot ™
4
OCT 0 9 2008
K082601
Page 1/3
rices, LLC Emergency Medical Bey OX SUATERIAS HOPICA I Tel: 581-783-9773 / Fax: 561-785-0071 emeddevices@ballsouth.net
Section 5.
510K Summary
Submission Date:
Submitter Information:
| Company Name: | Emergency Medical Devices, LLC |
|---|---|
| Company Address: | 1875 Tulip Lane, |
| Wellington, Florida 33414 | |
| Contact Person: | Jack Mentkow, Director |
| Telephone: | 561-793-9773 |
| Facsimile: | 561-795-9971 |
| emeddevices@bellsouth.net |
Device Information:
| Trade Name: | UltraClot™, UltraClot™ OTC |
|---|---|
| Common Name: | Wound Dressing |
| Device Class: | Unclassified |
| Product Code: | FRO |
| Predicate Device: | QuikClot®, Z-Medica Corp., K013390 |
| QuikClot® Sport, Z-Medica Corp, K070010 | |
| Description: | |
| Intended Use: | UltraClot™ is intended as a hemostatic dressing for |
| emergency external use and temporary wound treatment to | |
| achieve hemostasis of moderate to severe bleeding. | |
| Intended Use: | UltraClot™ OTC is intended as a topical hemostatic |
| dressing for the local management of bleeding from minor | |
| cuts, lacerations, and abrasions. |
Emergency Medical Devices, LLC
510(k) UltraClot™
5
K082601
page 2/3
Device Description:
UltraClot™ is a hemostatic agent comprising a clay-based powder contained in a dissolving pouch with a non-stick gauze pad backing that is placed on a moderate to severe wound and held in place until hemostasis is achieved. The device is packaged in a vacuum sealed foil bag and is provided sterile.
UltraClot" was developed to address the need in both the military and civilian markets for a product that is both easy to use and effective. In the military application. UltraClot" is effective in cases of moderate to severe bleeding leading to death due to uncontrolled hemorrhage, as a result of ballistic wounds and traumatic injuries. In the civilian market UltraClot™ is effective when there is a delay in receiving medical care. Traumatic injuries in the civilian market can occur from accidents in manufacturing, construction, farming, and sports activities.
Comparison to Predicate Device:
UltraClot™ has a similar adsorptive mechanism and indication for use as Quikclot® Both devices rapidly adsorb the water content of the blood thereby concentrating the platelets and other coagulating factors, accelerating clotting and hemostasis.
UltraClot™has been tested in animal models. UltraClot™was found to be at least substantially equivalent to Quikclot® in terms of speed and efficacy with the added benefits of absence of exothermia and reduced blood loss.
Biocompatibility testing was performed on UltraClot™which demonstrated UltraClot "to be safe for its intended use. These included mutagenicity, cytotoxicity, and intracutaneous studies.
UltraClot™OTC is very similar to UltraClot™. The adsorptive mechanism and indications for use in emergency wound care remain unchanged. The indications for use of UltraClot™ OTC have been modified from the Rx version, and the labeling has been revised in conformance with 21CFR 801 Subpart C. This labeling is modeled after and consistent with other legally marketed OTC wound management devices, including Woundstat® OTC (K081183), Quikclot® Sport (K070010), Medtrade Products Celox Topical Hemostatic granules OTC (K061079), Bleed Arrest (K070211), and Bloodstop (K071578).
Conclusion:
UltraClot" is a safe and effective wound dressing which is at least substantially equivalent to the predicate device Quickclot®.
UltraClot" OTC as labeled in conformance with 21CFR 801 Subpart C is substantially equivalent in labeling to the aforementioned OTC predicate devices. Woundstars OTC (K081183), Quikclot® Sport (K070010), Medtrade Products Celox Topical Hemostatic granules OTC (K061079), Bleed Arrest (K070211), and Bloodstop (K071578).
Emergency Medical Devices, LLC 510(k) UltraClot
6
K082601
page 3/3
Therefore, UltraClot™ and UltraClot™ OTC should be regulated by the FDA within the same respective generic types of devices which includes the cited predicate and OTC labeling and cleared for marketing in the U.S.
Emergency Medical Devices, LLC
510(k) UltraClot™