UltraClot, UltraClot OTC

K082601 · Emergency Medical Devices, LLC · QSY · Oct 9, 2008 · SU

Device Facts

• Record ID: K082601
• Device Name: UltraClot, UltraClot OTC
• Applicant: Emergency Medical Devices, LLC
• Product Code: QSY · SU
• Decision Date: Oct 9, 2008
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

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. UltraClot™ OTC is intended as a topical hemostatic dressing for the local management of bleeding from minor cuts, lacerations, and abrasions.

Device Story

UltraClot™ is a clay-based hemostatic powder contained in a dissolving pouch with a non-stick gauze backing. Used in emergency, military, and civilian settings (manufacturing, construction, farming, sports) to treat traumatic injuries. Mechanism: rapid adsorption of blood water content to concentrate platelets and coagulation factors, accelerating clotting. Applied topically to wounds and held in place until hemostasis occurs. Benefits: absence of exothermia, reduced blood loss, and ease of use in scenarios where medical care is delayed. Provided sterile in vacuum-sealed foil packaging.

Clinical Evidence

Bench testing and animal model studies performed. Animal studies demonstrated speed and efficacy at least equivalent to the predicate, with added benefits of no exothermia and reduced blood loss. Biocompatibility testing (mutagenicity, cytotoxicity, intracutaneous) confirmed safety for intended use.

Technological Characteristics

Clay-based powder in a dissolving pouch with non-stick gauze backing. Sterile, vacuum-sealed packaging. Adsorptive hemostatic mechanism. No electronic components or software.

Indications for Use

Indicated for patients requiring hemostasis for moderate to severe bleeding (Rx version) or minor cuts, lacerations, and abrasions (OTC version).

Regulatory Classification

Identification

To temporarily control bleeding and cover external wounds.

Predicate Devices

• QuikClot® (K013390)
• QuikClot® Sport (K070010)

Reference Devices

• Woundstat® OTC (K081183)
• Medtrade Products Celox Topical Hemostatic granules OTC (K061079)
• Bleed Arrest (K070211)
• Bloodstop (K071578)

Submission Summary (Full Text)

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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, [e-mail].

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

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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.

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#### 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 [phone]. 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 [phone]. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. 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 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

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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 ™

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OCT 0 9 2008

K082601
Page 1/3

### rices, LLC Emergency Medical Bey OX SUATERIAS HOPICA I Tel: [phone] / Fax: [phone] [e-mail]

Section 5.

# 510K Summary

#### Submission Date:

#### Submitter Information:

| Company Name: | Emergency Medical Devices, LLC |
|------------------|-----------------------------------------------|
| Company Address: | 1875 Tulip Lane,<br>Wellington, Florida 33414 |
| Contact Person: | Jack Mentkow, Director |
| Telephone: | 561-793-9773 |
| Facsimile: | 561-795-9971 |
| | [e-mail] |

#### Device Information:

| Trade Name: | UltraClot™, UltraClot™ OTC |
|-------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | Wound Dressing |
| Device Class: | Unclassified |
| Product Code: | FRO |
| Predicate Device: | QuikClot®, Z-Medica Corp., K013390<br>QuikClot® Sport, Z-Medica Corp, K070010 |
| Description: | |
| Intended Use: | UltraClot™ is intended as a hemostatic dressing for<br>emergency external use and temporary wound treatment to<br>achieve hemostasis of moderate to severe bleeding. |
| Intended Use: | UltraClot™ OTC is intended as a topical hemostatic<br>dressing for the local management of bleeding from minor<br>cuts, lacerations, and abrasions. |

Emergency Medical Devices, LLC
510(k) UltraClot™

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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

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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™