← Product Code QSY · K070010 # QUIKCLOT SPORT AND QUIKCLOT SPORT SILVER (K070010) _Z-Medica Corporation · QSY · Jan 25, 2007 · SU · SESE_ **Canonical URL:** https://fda.innolitics.com/device/K070010 ## Device Facts - **Applicant:** Z-Medica Corporation - **Product Code:** QSY - **Decision Date:** Jan 25, 2007 - **Decision:** SESE - **Submission Type:** Special - **Device Class:** Class U - **Review Panel:** SU - **Attributes:** Therapeutic ## Intended Use QuikClot Sport™ & QuikClot Sport Silver™ are intended for temporary external use to stop bleeding of superficial wounds. minor cuts, and abrasions. ## Device Story QuikClot Sport and Sport Silver are hemostatic wound dressings consisting of zeolite beads contained within a mesh bag. Designed for OTC use, the device is applied externally to superficial wounds, minor cuts, and abrasions to accelerate blood clotting. The zeolite material facilitates hemostasis; the Sport Silver variant incorporates silver to provide antimicrobial properties. The device is vacuum-packed in multi-layer pouches to maintain sterility. Upon application, the zeolite interacts with blood to form a clot in under 5 minutes, aiding in hemorrhage control. The device is intended for use by untrained individuals in non-clinical settings. The primary benefit is the rapid cessation of bleeding for minor injuries. ## Clinical Evidence No clinical data. Evidence consists of bench testing: in-vitro whole blood clotting time (clot formation <5 minutes vs >9 minutes for control) and antimicrobial efficacy testing (S. aureus, E. coli, P. aeruginosa, C. albicans) showing >4-log reduction within 60 minutes for the Silver version. Biocompatibility testing performed per ISO 10993-1:1997. ## Technological Characteristics Zeolite beads in mesh bag; reformulated to reduce heat of adsorption. Gamma sterilized (25-50kGy, SAL 10^-6). Vacuum-packed in multi-layer pouches. Sport Silver contains silver for antimicrobial action. No X-ray detectable element. ## Regulatory Identification To temporarily control bleeding and cover external wounds. ## Predicate Devices - Hemosorb™ Granular Hemostatic Agent ([K021581](/device/K021581.md)) - QuikClot 1st Response™ Hemostatic Agent ([K061767](/device/K061767.md)) ## Reference Devices - QuikClot® ([K013390](/device/K013390.md)) - QuikClot ACS™ ([K051955](/device/K051955.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The FDA logo is composed of two parts: the Department of Health and Human Services logo on the left and the FDA acronym with the full name of the agency on the right. The Department of Health and Human Services logo is a stylized representation of a human figure, while the FDA acronym is in blue, followed by the words "U.S. Food & Drug Administration" in a sans-serif font. June 11, 2023 Z-Medica Corporation c/o Giacomo Basadonna, M.D., Ph.D. 4 Fairfield Boulevard Wallingford, Connecticut 06492 Re: K070010 Trade/Device Name: QuikClot Sport™ and QuikClot Sport Silver™ Regulatory Class: Unclassified Product Code: OSY Dear Giacomo Basadonna, M.D., Ph.D.: 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 January 25, 2007. 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 {1}------------------------------------------------ ### 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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles an abstract caduceus or a bird-like figure, composed of three interconnected, curved lines. Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Z-Medica Corporation % Giacomo Basadonna, M.D., Ph.D. 4 Fairfield Boulevard Wallingford, Connecticut 06492 JAN 2 5 2007 Re: K070010 Trade/Device Name: QuikClot Sport™ and Quikclot Sport Silver™ Regulatory Class: Unclassified Product Code: FRO Dated: December 29, 2006 Received: January 3, 2006 Dear Dr. Basadonna: 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. 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 Office of Compliance at (240) 276-0115 Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other {2}------------------------------------------------ Page 2 - Giacomo Basadonna, M.D., Ph.D. 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. Muller Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ ## Indications For Use 510(k) Number (if known): TBD KO70010 Device Trade Names: QuikClot Sport™ & QuikClot Sport Silver™ Device Common Name: Advanced Clotting Sponge Indications For Use: QuikClot Sport™ & QuikClot Sport Silver™ are intended for temporary external use to stop bleeding of superficial wounds. minor cuts, and abrasions. Prescription Use (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (Part 21 CFR 801 Subpart C) Image /page/3/Picture/9 description: The image shows a square box with a check mark inside. The check mark is thick and black, and it fills most of the box. The box is also black and has thick borders. The check mark indicates that a selection has been made. (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, C Concurrence of CDRH, Office of Device Evaluation (ODE) (Division Sign-Off) Division of General, Restorative, and Neurological Devices Page 1 of 1 **510(k) Number** k070010 {4}------------------------------------------------ 510(k) Summary for QuikClot Sport™ & QuikClot Sport Silver™ Page 1 of 2 2070010 Page 1/2 # 510(k) Summary | Trade Name: | QuikClot Sport™ and QuikClot Sport Silver™ | | |-----------------------|---------------------------------------------------|--| | Device Class: | Class 1 | | | Classification Panel: | General and Plastic Surgery | | | Common Name: | JAN 2 5 2007
Wound Dressing | | | Classification Name: | Dressing | | | Classification Code: | FRO, UNClassified | | | Predicate Device: | Hemosorb™ Granular Hemostatic Agent (K021581) | | | | QuikClot 1st Response™ Hemostatic Agent (K061767) | | | Submitted By: | Dr. Giacomo Basadonna, M.D., Ph.D. | | | Company Name: | Z-Medica Corporation | | | Company Address: | 4 Fairfield Blvd., Wallingford, CT 06492 | | | Company Phone: | (203) 294-0000 x233 | | | Prepared: | December 29, 2006 | | | | | | ### Description of Device QuikClot Sport™ and QuikClot Sport Silver™ are OTC versions of Z-Medica's prescription product: QuikClot 1st Response™ (K061767). These new devices consist of mesh bags containing zeolite beads. The devices are vacuum-packed in multi-layer pouches to ensure sterility and efficacy. Product attributes of the two new OTC product versions are provided in the table below. | Attribute | QuikClot Sport™ | QuikClot Sport Silver™ | |--------------------------------|---------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------| | Antimicrobial | No | Silver causes >4-log reduction of S. aureus, E. coli, P. aeruginosa, and C. albicans within 60 minutes of exposure | | Net Weight of
Zeolite Beads | 0.88oz & 1.75oz sizes available | 0.88oz & 1.75oz sizes available | | Mesh Bag
Dimensions | 3.5"x3.5" (0.88oz) & 5"x5" (1.75oz) | 3.5"x3.5" (0.88oz) & 5"x5" (1.75oz) | | Primary
Packaging | Individually packaged in multi-
layer pouch, vacuum-packed | Individually packaged in multi-
layer pouch, vacuum-packed | | Sterilization | gamma sterilization – 25-50kGy
(SAL = 10-6) | gamma sterilization – 25-50kGy
(SAL = 10-6) | ### Intended Use of Device For temporary external use to stop bleeding of superficial wounds, minor cuts, and abrasions (Over-The-Counter Use). {5}------------------------------------------------ 510(k) Summary for QuikClot 1st Response™ & QuikClot ACS+" Page 2 of 2 page 2/2 #### Summary of Technological Characteristics Compared to Predicate Devices This is a device modification of QuikClot 1st Response™ Advanced Clotting Sponge (K061767). QuikClot Sport™ and QuikClot Sport Silver™ contain the same zeolite technology that Z-Medica Corporation has incorporated into previous QuikClot® brand hemostatic agents, granular QuikClot® (K013390/K021581) and QuikClot ACS™ (K051955), but this product uses zeolite that has been reformulated to reduce the heat of adsorption. The risk of burns to caregivers and the injured person has been eliminated by the zeolite reformulation. Both sizes of QuikClot Sport™ and QuikClot Sport Silver™ make use of the same mesh fabric used for the predicate device, the same primary package construction, and the same production process. The following are modifications have been made to the predicate device: - The X-ray detectable element has been eliminated (unnecessary for OTC version). 1. - Directions for use were clarified from the directions for the predicate device. 2. Instructions now include diagrams for each step of the instructions to assist untrained users. - The Silver version of the product contains silver that may reduce the risk of infection. 3. #### Discussion of Data to Support Substantial Equivalence ISO Standard 10993-1:1997 was followed for demonstrating biocompatibility of the component materials and the finished device. In-vitro test data measuring the clotting time of whole blood was used to demonstrate that the device modification is not inferior in efficacy to the predicate device. The zeolite formulation used in the predicate device and these two new OTC products took less than 5 minutes to form a clot, while whole blood without zeolite took longer than 9 minutes to form a clot. Antimicrobial properties were demonstrated by in-vitro testing using cultures of S. aureus, E. coli, P. aeruginosa, and C. albicans (common infectious microorganisms). Exposure to QuikClot Sport Silver™ resulted in a greater than a 4-log reduction in viable organisms within 60 minutes. ### Conclusions Based on the design, biocompatibility data, in-vitro test data, and intended use, QuikClot Sport™ and QuikClot Sport Silver™ are substantially equivalent to the predicate device (QuikClot 1* Response™ (K061767) and granular QuikClot®/Hemosorb™ (K013390/K021581). --- **Source:** [https://fda.innolitics.com/device/K070010](https://fda.innolitics.com/device/K070010) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com