(31 days)
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.
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.
The provided text is a 510(k) summary for the UltraClot™ and UltraClot™ OTC devices. These documents are typically for medical devices seeking FDA clearance based on substantial equivalence to a predicate device, rather than requiring extensive clinical trials to prove efficacy against defined acceptance criteria in the same way a new drug or high-risk medical device might.
The key information regarding "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the context of this 510(k) is related to demonstrating substantial equivalence to a predicate device through non-clinical testing, particularly animal models and biocompatibility.
Here's an analysis of the provided text in relation to your questions, noting that many of the requested details for AI/software studies are not applicable to this type of device submission:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" in a quantitative, tabular format as one might find for a software-based diagnostic AI. Instead, the "acceptance criteria" for this 510(k) are implicitly met by demonstrating substantial equivalence to the predicate device, Quikclot®, in terms of mechanism, safety, and efficacy.
| Acceptance Criteria (Implied for Substantial Equivalence) | Reported Device Performance (UltraClot™) |
|---|---|
| Similar adsorptive mechanism | Has a similar adsorptive mechanism to Quikclot®. |
| Equivalent speed of hemostasis | Found to be at least substantially equivalent to Quikclot® in terms of speed of hemostasis. |
| Equivalent efficacy of hemostasis | Found to be at least substantially equivalent to Quikclot® in terms of efficacy. |
| Absence of exothermia | Demonstrates absence of exothermia. |
| Reduced blood loss | Demonstrates reduced blood loss. |
| Biocompatibility (safety for intended use) | Biocompatibility testing demonstrated UltraClot™ to be safe for its intended use (mutagenicity, cytotoxicity, intracutaneous studies). |
| Similar indications for use | Intended as a hemostatic dressing for emergency external use and temporary wound treatment to achieve hemostasis of moderate to severe bleeding (similar to predicate). |
| OTC version labeling conformance | Labeling modified in conformance with 21CFR 801 Subpart C, consistent with other legally marketed OTC wound management devices. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: The document mentions "animal models" for testing speed and efficacy. However, it does not specify the number of animals (sample size) used in these models.
- Data Provenance: Not explicitly stated, but clinical studies are generally prospective. Animal studies are experimental. The document does not specify the country of origin. This is a non-clinical study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This is not applicable to the type of device and study described. The evaluation in animal models would typically be based on physiological measurements (e.g., clotting time, blood loss) rather than expert interpretation of images or clinical assessments requiring a panel of human experts to establish "ground truth."
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is not a study involving human readers or adjudicators of a test set in the context of diagnostic AI.
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
Not applicable. This is a physical hemostatic device, not an AI or software-based diagnostic tool. No MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical hemostatic device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" in the animal model studies would be objective physiological measures of hemostasis, such as:
- Time to hemostasis
- Volume of blood loss
- Presence/absence of exothermic reaction
These are direct measurements of the device's physical and physiological effect in a controlled animal setting, rather than subjective expert consensus or pathology in the context of diagnostic performance.
8. The sample size for the training set
Not applicable. This is not a machine learning or AI-based device that requires a training set.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this type of device.
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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
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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 (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
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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: 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., K013390QuikClot® Sport, Z-Medica Corp, K070010 |
| Description: | |
| Intended Use: | UltraClot™ is intended as a hemostatic dressing foremergency external use and temporary wound treatment toachieve hemostasis of moderate to severe bleeding. |
| Intended Use: | UltraClot™ OTC is intended as a topical hemostaticdressing for the local management of bleeding from minorcuts, 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™
N/A