(220 days)
QuikClot is intended for emergency use only as an external temporary traumatic wound treatment to achieve hemostasis for moderate to severe bleeding.
QuikClot is a bulk granular hemostatic agent, which is placed on or into a moderate to severe wound to effect adsorption, and coagulation of same.
QuikClot is intended for emergency use as an external temporary traumatic wound treatment to achieve hemostasis and prevent blood loss.
The effect of QuikClot is purely physical, not chemical in nature. QuikClot has an unusually high adsorptive effect on liquid. This rapid adsorption of water as a blood component serves to concentrate platelets, and increase the speed and effect of their clotting capabilities. This rapid adsorption also diminishes the volume of the liquid present in the wound as a sponge effect, to facilitate clotting.
The product is designed and packaged to be easily packed, carried and applied using only one hand. It is well suited for moderate to large eviscerating wounds, to create hemostasis by coagulation.
Used in conjunction with a sterile bandage and pressurizing wrap, QuikClot will reduce blood loss dramatically, and significantly increase survivability of highvolume catastrophic wounds.
I am sorry, but based on the provided text, there is no information available about acceptance criteria, device performance, sample size for testing or training, expert involvement, adjudication methods, or MRMC studies.
The document is a 510(k) summary for a device called "QuikClot." It focuses on demonstrating substantial equivalence to a legally marketed predicate device (RDH Bandage) rather than detailing specific performance against acceptance criteria in the context of an AI/ML device.
Here's why the requested information cannot be extracted:
- Device Type: QuikClot is described as a "bulk granular hemostatic agent," which is a physical device, not an AI/ML device. The questions you've asked are highly specific to AI/ML device validation.
- Study Focus: The studies mentioned ("Invitro and Invivo testing on rats, rabbits and larger mammals," "biocompatibility testing") are geared towards demonstrating the hemostatic properties and safety of the physical product, not the performance of an algorithm.
- Regulatory Context: A 510(k) submission generally focuses on demonstrating substantial equivalence to a predicate device, meaning it's as safe and effective as a device already on the market. It doesn't typically require the type of detailed performance criteria and AI-specific studies you've inquired about.
Therefore, I cannot populate the table or answer the specific questions about acceptance criteria, AI performance, expert review, or data origins.
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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the words "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue text.
On Site Gas Systems, Inc. C. Burton Gullong Vice President 100 Production Court New Britain, Connecticut 06051 June 11, 2023
Re: K013390 Trade/Device Name: QuickClot Regulatory Class: Unclassified Product Code: QSY
Dear C. Burton Gullong:
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 23, 2002. 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.
Image /page/0/Picture/7 description: The image shows the signature block of Julie A. Morabito, Ph.D., who is the Assistant Director at DHT4B: Division of Infection Control and Plastic Surgery Devices. She also works at OHT4: Office of Surgical and Infection Control Devices. Her office is the Office of Product Evaluation and Quality, and she works at the Center for Devices and Radiological Health. The letter is signed, "Sincerely,"
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized graphic of three abstract shapes resembling birds in flight. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the graphic.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 3 2002
Mr. C. Burton Gullong Vice President On Site Gas Systems, Inc. 100 Production Court New Britain, CT 06051
Re: K013390
Trade/Device Name: QuikClot Regulatory Class: Unclassified Product Code: FRO Dated: March 27, 2002 Received: March 29, 2002
Dear Mr. Gullong:
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. C. Burton Gullong
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Mark N. Melbern
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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STATEMENT OF INDICATIONS FOR USE
QuikClot is intended for emergency use only as an external temporary traumatic wound treatment to achieve hemostasis for moderate to severe bleeding.
Mark N Milken
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number K013390
3-1 Revised 5/20/02
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KO13390
5/23/02
510(k) Summary
SUBMITTED BY
FRANCIS X. HURSEY PRESIDENT
ON SITE GAS SYSTEMS, INC. 35 BUDNEY ROAD NEWINGTON, CT 06111 860.667.8888
PREPARED: OCTOBER 10, 2001
REVISED: May 29, 2002
4-1 Revised 05/29/02
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510(k) Summary
| Trade Name | QuikClot |
|---|---|
| Device Class | Class I |
| Classification Panel | General and Plastic Surgery |
| Common Name | Traumatic Wound Dressing |
| Predicate Device | RDH Bandage, 510(K)Number-K002550 |
| Submitted By | Francis X. Hursey, President |
| Company Name | On Site Gas Systems |
| Company Address | 35 Budney RoadNewington, CT 06111 |
| Company Phone # | 860.667.8888 |
| Prepared | October 10, 2001 |
| Revised | May 29, 2002 |
Device Description
QuikClot is a bulk granular hemostatic agent, which is placed on or into a moderate to severe wound to effect adsorption, and coagulation of same.
QuikClot is intended for emergency use as an external temporary traumatic wound treatment to achieve hemostasis and prevent blood loss.
The effect of QuikClot is purely physical, not chemical in nature. QuikClot has an unusually high adsorptive effect on liquid. This rapid adsorption of water as a blood component serves to concentrate platelets, and increase the speed and effect of their clotting capabilities. This rapid adsorption also diminishes the volume of the liquid present in the wound as a sponge effect, to facilitate clotting.
The product is designed and packaged to be easily packed, carried and applied using only one hand. It is well suited for moderate to large eviscerating wounds, to create hemostasis by coagulation.
Used in conjunction with a sterile bandage and pressurizing wrap, QuikClot will reduce blood loss dramatically, and significantly increase survivability of highvolume catastrophic wounds.
QuikClot has been tested in-house at On Site, at Hartford Hospital, by Johnson & Johnson, and at the University of Connecticut by Micro Test Laboratories, and at USUHS for the military. Testing and results are enclosed.
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In Invitro and Invivo testing on rats, rabbits and larger mammals at the University of Connecticut, QuikClot consistently performed well above Avitene in rate of coagulation and reduction of bleeding time.
Tests of QuikClot by the UConn Chemistry Department showed a lower toxicity score of rat histopathology following application of compound to stop bleeding than other hemostatic agents. Toxicity was only 10% higher than the inert control device used.
Tests by the Chief of Surgery at VAMC, Newington, CT, conducted at Hartford Hospital on rats and plas' livers and skin, found QuikClot was superior to other hemostatic agents in its ability to stop bleeding.
During March 2002, testing on large mammals was completed. USUHS and the Office of Naval Research developed a large animal model of lethal uncontrolled hemorrhage. This was used to test whether the use of various hemostatic agents (in addition to standard dressing) would decrease bleeding and improve early survival. The study was highly controlled. The following is a brief summary of QuikClot's successful results:
| Mortality Rate: | No Dressing = 80% |
|---|---|
| Standard Dressing = 33.4% | |
| Standard Dressing with QuikClot = 0% | |
| Blood Loss | QuikClot = lowest volume of blood loss oftested hemostatic agents. |
Biocompatibility testing was completed by ISO 17025 Certified MicroTest Laboratories, Inc., of Agawarn, Mass. The tests included:
| Test | Sample # | Dated |
|---|---|---|
| Agar Overlay Cytotoxicity Test | 02-00480 | 01/29/02 |
| Water Adsorption Rate | 02-00254 | 01/21/02 |
| Skin Sensitization | 01-06558 | 12/21/01 |
| Skin Irritation | 01-06555 | 12/07/01 |
| Intracutaneous Test | 01-06554 | 11/30/01 |
| MEM Elution Cytotoxicity Test | 01-06492 | 11/08/01 |
| Muscle Implant | 01-06476 | 01/08/01 |
In summary, QuikClot performed extremely well.
QuikClot is a safe, effective, low cost traumatic wound dressing which is substantially alike in purpose, characteristic, process, and result to the RDH bandage, and thereby eligible for approval under 510(k.)
4-3 Revised 05/29/02
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