Who is the manufacturer of QuikClot Control+ Hemostatic Dressing?

Z-Medica, LLC filed the 510(k) submission for QuikClot Control+ Hemostatic Dressing (K220971).

What is the FDA product code for QuikClot Control+ Hemostatic Dressing?

POD. It is classified under 21 CFR 878.4454 as a Class 2 device in the General, Plastic Surgery panel.

What is the regulatory pathway for QuikClot Control+ Hemostatic Dressing?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like QuikClot Control+ Hemostatic Dressing?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

QuikClot Control+ Hemostatic Dressing

K220971 · Z-Medica, LLC · POD · Dec 14, 2022 · General, Plastic Surgery

Device Facts

Record ID	K220971
Device Name	QuikClot Control+ Hemostatic Dressing
Applicant	Z-Medica, LLC
Product Code	POD · General, Plastic Surgery
Decision Date	Dec 14, 2022
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 878.4454
Device Class	Class 2
Attributes	Therapeutic

Intended Use

QuikClot Control+® Hemostatic Dressing is indicated for temporary control of internal organ space bleeding for patients displaying class III or class IV bleeding. It may also be used for control of severely bleeding wounds such as surgical wounds and traumatic injuries. Cardiac surgical procedures: for temporary control of mild and moderate bleeding in cardiac surgical procedures, as well as in patients displaying Class III or class IV bleeding. Bone surfaces following sternotomy: to control bleeding from bone surfaces following a sternotomy.

Device Story

QuikClot Control+® is a sterile, single-use, non-absorbable hemostatic dressing composed of kaolin-impregnated gauze with a calcium alginate binder. Used in clinical settings (OR) by surgeons to manage bleeding during cardiac procedures and sternotomies. The device is packed into or onto the wound site; pressure is applied manually until hemostasis is achieved. The kaolin agent accelerates the natural clotting cascade upon contact with blood. The dressing is x-ray detectable and may be left in place for up to 48 hours. It is compatible with cardiopulmonary bypass systems and autotransfusion equipment. By providing rapid hemostasis in surgical wounds, the device reduces blood loss and improves procedural efficiency for the surgeon.

Clinical Evidence

Prospective, randomized, open-label, multicenter pivotal trial (IDE #G200086) evaluated 231 subjects (153 test, 78 control) undergoing elective cardiac surgery. Primary endpoint: rate of hemostasis (grade 0 bleed) within 10 minutes of compression. Results confirmed QuikClot Control+® achieved clinical hemostasis for mild/moderate bleeding comparable to standard gauze/surgical sponges. Safety profile was comparable to control. Five GLP animal studies (swine/rabbit) also supported safety, assessing hemostasis, bone regrowth, and potential for thromboembolism or kaolin migration.

Technological Characteristics

Materials: Gauze substrate, kaolin (hemostatic agent), calcium alginate (binder). Principle: Kaolin-mediated acceleration of coagulation cascade combined with mechanical compression. Form factor: Various sizes/plies of dressing. Connectivity: None. Sterilization: Gamma irradiation. Shelf-life: 39 months. Biocompatibility: Compliant with ISO 10993-1 for prolonged contact.

Indications for Use

Indicated for temporary control of internal organ space bleeding in patients with class III or IV bleeding, and for control of severely bleeding wounds (surgical/traumatic). Specifically indicated for temporary control of mild/moderate bleeding in cardiac surgical procedures and bleeding from bone surfaces following sternotomy.

Regulatory Classification

Identification

A non-absorbable, hemostatic gauze for temporary internal use is a prescription device intended to be placed temporarily for control of severely bleeding wounds such as surgical wounds and traumatic injuries. The gauze is coated or impregnated with a hemostatic material which may enhance hemostasis by physical means. The device is intended to be removed once the patient is stabilized.

Special Controls

*Classification.* Class II (special controls). The special controls for this device are:(1) Animal performance testing must demonstrate that the device performs as intended under anticipated conditions of use. Specifically testing must: (i) Demonstrate that the device is able to achieve hemostasis; (ii) Demonstrate that the device can be radiographically detected; and (iii) Assess pertinent safety endpoints including vascular obstruction and adhesion formation. (2) The device must be demonstrated to be biocompatible. (3) Non-clinical performance data must demonstrate that the device performs as intended under anticipated conditions of use. The following tests must be performed: (i) In vitro clot assessment; (ii) Particulate release testing; (iii) Physical characterization, including swelling percent and particulate size; (iv) Chemical characterization; (v) Radiopacity testing; and (vi) Mechanical integrity testing, including tensile strength and tear strength. (4) Performance data must demonstrate the sterility of the device. (5) Performance data must support the shelf life of the device by demonstrating continued sterility, package integrity, and device functionality over the identified shelf life. (6) Labeling must include the following: (i) Instructions for use, including an instruction to remove all visible device components by irrigation; (ii) The maximum amount of time the device may be left within the body; (iii) A shelf life; (iv) A contraindication for intravascular use of the device; and (v) A warning regarding the potential for adhesion formation.

Predicate Devices

QuikClot Control+® Hemostatic Dressing (K200167)

Related Devices

K243553 — QuikClot Control+ Hemostatic Device · Teleflex Medical · Mar 18, 2025
K200167 — QuikClot Control+ · Z-Medica, LLC · Apr 23, 2020
K123387 — QUIKCLOT HEMOSTATIC DRESSING · Z-Medica, LLC · Apr 12, 2013
K181641 — QuikClot Radial · Z-Medica, LLC · Dec 24, 2018
K140757 — D2 HEMOSTANTIC DRESSING · Z-Medica, LLC · Jul 17, 2014

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. December 14, 2022 Z-Medica, LLC Rachel Rehl Senior Regulatory Affairs Specialist 3015 Carrington Mill Blvd Suite 600 Morrisville, North Carolina 27560 Re: K220971 Trade/Device Name: QuikClot Control+® Hemostatic Dressing Regulation Number: 21 CFR 878.4454 Regulation Name: Non-Absorbable, Hemostatic Gauze For Temporary Internal Use Regulatory Class: Class II Product Code: POD Dated: November 11, 2022 Received: November 14, 2022 Dear Rachel Rehl: 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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. {1}------------------------------------------------ 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); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely. Katherine N. Trivedi -5 Katherine Trivedi Acting Assistant Director DHT2B: Division of Circulatory Support, Structural and Vascular Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health ### Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K220971 Device Name QuikClot Control+® Hemostatic Dressing #### Indications for Use (Describe) QuikClot Control+® Hemostatic Dressing is indicated for temporary control of internal organ space bleeding for patients displaying class III or class IV bleeding. It may also be used for control of severely bleeding wounds such as surgical wounds and traumatic injuries. Cardiac surgical procedures: for temporary control of mild and moderate bleeding in cardiac surgical procedures, as well as in patients displaying class III or class IV bleeding. Bone surfaces following sternotomy: to control bleeding from bone surfaces following a sternotomy. X Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ ## 510(k) SUMMARY ### QuikClot Control+® Hemostatic Dressing - Expanded Indications #### 1. Submitter Information | Name: | Z-Medica, LLC | |-------------------|--------------------------| | Address: | 4 Fairfield Boulevard | | | Wallingford, CT 06492 | | Contact Person: | Rachel Rehl | | Telephone Number: | (919) 433-2588 | | Email: | rachel.rehl@teleflex.com | Date Prepared: November 7, 2022 ### 2. Device Name | Device Trade Name: | QuikClot Control+® Hemostatic Dressing | |----------------------|-------------------------------------------------------------| | Common Name: | Temporary, Internal Use Hemostatic Wound Dressing | | Classification Name: | Non-absorbable, hemostatic gauze for temporary internal use | | | (Class II, POD, 21 CFR 878.4454) | ### 3. Predicate Device QuikClot Control+® Hemostatic Dressing (K200167) #### 4. Device Description and Mechanism of Action #### Device Description QuikClot Control+® Hemostatic Dressing is a prescription use non-absorbable device containing kaolin (hemostatic agent) bound to gauze. The hemostatic dressings are x-ray detectable and are provided as a single-use sterile device available in various sizes and configurations. The device is available in single or multipacks. #### Mechanism of Action The QuikClot Control+® Hemostatic Dressings are packed into or on the wound and pressure is applied. Pressure is maintained until the bleeding is controlled and may be left in place up to 48 hours. More than one QuikClot Control+® hemostatic dressing can be used. Hemostasis is achieved through the activity of the hemostatic agent kaolin bound to the gauze in conjunction with compression. #### 5. Indications for Use QuikClot Control+® Hemostatic Dressing is indicated for temporary control of internal organ space bleeding for patients displaying class III or class IV bleeding. It may also be used for control of severely bleeding wounds such as surgical wounds and traumatic injuries. Cardiac surgical procedures: for temporary control of mild and moderate bleeding in cardiac surgical procedures, as well as in patients displaying Class III or class IV bleeding. Bone surfaces following sternotomy: to control bleeding from bone surfaces following a sternotomy. {4}------------------------------------------------ ## 6. Technological Characteristics and Substantial Equivalence The proposed device is identical to the predicate device described in K200167 in design, materials of construction, functional performance, principles of operation, manufacturing, packaging, sterilization, and shelf life. The change to the device is an expansion of the indication for use. Table 1 below provides a comparison of the proposed and predicate devices. | | Table 1. Substantial Equivalence Comparison to Predicate | | | |------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | Proposed Device | Predicate Device – K200167 | Comparison | | | QuikClot Control+® Hemostatic Dressing (Expanded Indications) | QuikClot Control+® Hemostatic Dressing | | | Indications for Use | QuikClot Control+® Hemostatic Dressing is indicated for temporary control of internal organ space bleeding for patients displaying class III or class IV bleeding. It may also be used for control of severely bleeding wounds such as surgical wounds and traumatic injuries. Cardiac surgical procedures: for temporary control of mild and moderate bleeding in cardiac surgical procedures, as well as in patients displaying Class III or class IV bleeding. Bone surfaces following sternotomy: to control bleeding from bone surfaces following a sternotomy. | QuikClot Control+® Hemostatic Dressing is indicated for temporary control of internal organ space bleeding for patients displaying class III or class IV bleeding. It may also be used for control of severely bleeding wounds such as surgical wounds and traumatic injuries. | Addition of indication for cardiac surgical procedures and bone surfaces. Indications align with proposed indications under IDE G200086. | | Intended Use | To control internal and external bleeding To control bone surface bleeding at the sternotomy access site. To control suture line bleeding following cardiac surgical procedures, such as but not limited to, heart valve repairs or replacements, coronary artery bypass graft surgery (CABG), or aortic aneurysm repairs. To control bleeding due to tears, lacerations, and abrasions to include | To control internal and external bleeding | Addition of specific intended use for cardiac surgical procedures and bone surfaces that aligns with intended use under IDE G200086. | | | Proposed Device QuikClot Control+® Hemostatic Dressing (Expanded Indications) | Predicate Device – K200167 QuikClot Control+® Hemostatic Dressing | Comparison | | | epicardial repairs with or without sutures. To be used with or without the use of cardiopulmonary bypass systems. The dressing can be applied to control bleeding while the patient is 'on or off pump'. To be used with or without autotransfusion (blood salvage) equipment. To be used on patients on anticoagulation / antiplatelet medication | | | | Contraindication | Do not leave QuikClot Control+® in place for more than 48 hours. QuikClot Control+® is not indicated for intraluminal vascular use. | Do not leave QuikClot Control+® in place for more than 48 hours. QuikClot Control+® is not indicated for intraluminal vascular use. | Same | | Materials of Construction | Gauze Substrate, Kaolin (hemostatic agent), and Calcium Alginate (binder) | Gauze Substrate, Kaolin (hemostatic agent), and Calcium Alginate (binder) | Same | | Sizes | Various sizes including 1" x 1", 3 ply; 4" x 2", 6 ply or 10 ply; 4" x 6", 6 ply or 10 ply; 4" x 8", 6 -10 plies; 4" x 12", 9 ply 5" x 5", 4 ply 8" x 8", 2 ply 12" x 12", 3 ply 3" x 4 yards, 1 ply 3" x 2 yards, 1 ply | Various sizes including 1" x 1", 3 ply; 4" x 2", 6 ply or 10 ply; 4" x 6", 6 ply or 10 ply; 4" x 8", 6 -10 plies; 4" x 12", 9 ply 5" x 5", 4 ply 8" x 8", 2 ply 12" x 12", 3 ply 3" x 4 yds, 1 ply | Addition of 1 proposed size (3" x 2 yards, 1 ply). | | Sterilization Method | Gamma Irradiation | Gamma Irradiation | Same | | Shelf-life | 39 months | 39 months | Same | | Single Use | Yes | Yes | Same | | | Proposed Device QuikClot Control+® Hemostatic Dressing (Expanded Indications) | Predicate Device – K200167 QuikClot Control+® Hemostatic Dressing | Comparison | | Packaging | Peelable foil pouch | Peelable foil pouch | Same | | Biocompatibility | Biocompatible materials used (per ISO 10993-1 prolonged contact duration). | Biocompatible materials used (per ISO 10993-1 prolonged contact duration). | Same | #### Table 1. Substantial Equivalence Comparison to Predicate {5}------------------------------------------------ {6}------------------------------------------------ ## 7. Pre-Clinical Animal Studies Five GLP preclinical studies were conducted supporting the use of the device. This includes four GLP large animal (swine) studies including several survival models and a 12-week bone evaluation study conducted on rabbits. An additional non-GLP was also executed. The preclinical animal studies demonstrated the safety and performance of QuikClot Control+®. The studies included assessments such as hemostasis, bone regrowth, addition to hemostasis assessments, the animal survival study also conducted evaluations for blood chemistry (hematology, serum, coagulation), and macroscopic tissue/organ examinations (adhesion, thromboembolism, kaolin migration). The cumulative animal study results support substantial equivalence of the device. ### 8. Clinical Study Clinical study, IDE #G200086, was conducted to support this premarket notification for the proposed expanded indications for the legally marketed QuikClot Control+® Hemostatic Dressing (K200167). The clinical trial was a prospective, randomized, open-label, multicenter, pivotal, evaluation of subjects undergoing elective cardiac surgical procedures. The objective of the study was to assess QuikClot Control+® Hemostatic Dressing in the treatment of mild and moderate bleeding during cardiac surgeries and on bone due to a sternotomy is as safe and effective as the control (standard gauze, disposable surgical sponges or lap sponges). 231 subjects were randomized and treated at a 2:1 ratio (test article to control). 153 subjects were treated with QuikClot Control+® (test article) and 78 subject with standard gauze (control). In addition, 21 roll-in subjects, 3 per site, were not randomized and treated with QuikClot Control+®. The eligible subject population were ≥ 18 years of age, willing to give prior written informed consent, and required open heart surgery. Subject demographics were similar between groups. Mean age was 64.5 ± 12.2 years and subjects were predominantly male (68.8%) and Caucasian (94.8%). Categories of baseline medications were balanced between randomized arms. Of note, 41/153 (26.8%) QuikClot Control+® subjects and 17/78 (21.8%) control subjects were on an anticoagulant medication (P=0.258). Accordingly, a higher proportion of QuikClot Control+® subjects had baseline INR >1.1 (19/91=21%) compared to the standard gauze arm (7/47=15%). All baseline subjects completed blood count measurements and vital signs were balanced between randomized arms, except for systolic blood pressure (BP; QuikClot Control+® 135.5 ± 19.5; control: 141.4 ± 21.1; P = 0.037). The use of QuikClot Control+® Hemostatic Dressing during a sternotomy case or cardiac surgeries is intended to be used where surgical wounds result in mild and moderate bleeding throughout the procedure. As such, the surgical wounds evaluated in the trial were created at the sternotomy access site, suture lines (as part of the repair with native or synthetic material), tears, lacerations, and epicardial repairs {7}------------------------------------------------ ### QuikClot Control+® Hemostatic Dressing - Expanded Indications Traditional 510(k) (with or without sutures). The injury types that were evaluated in the study are typical in cardiac surgical procedures, such as: - Coronary artery bypass graft (CABG) with or without valve repair/replacement – open heart sternotomy, thoracotomy or mini sternotomy - Valve repair/replacement – open heart sternotomy, thoracotomy, or mini-sternotomy - Aortic aneurysm surgery During the mentioned surgeries, wounds that meet the mild (grade 1) or moderate (grade 2) bleeding severity criteria will have either QuikClot Control (i.e., standard gauze) applied during one of the injury types below: - Sternal bleeding - . Suture line bleeding (native tissue or synthetic material) - Tears, lacerations or abrasions to include epicardial repairs with or without sutures ● The primary and secondary endpoints are described below: - Primary endpoint: Rate at which subjects achieve hemostasis (grade 0 bleed) through up to 10 minutes of application and compression at the bleeding site. - . Secondary endpoint: Proportion of subjects achieving hemostasis (grade 0 bleed) measured at 5 and 10 minutes of application and compression at the bleeding site. QuikClot Control+® achieved clinical hemostasis in cardiac surgery for mild to moderate bleeding as compared to control (i.e., standard gauze). The safety of QuikClot Control+® was comparable to control (i.e., standard gauze). The clinical investigation evaluated the expanded indications for use and intended uses described in Table 1 above with confirmation that the subject device is substantially equivalent for its intended use. ### 9. Conclusions The subject device is identical to the predicate in terms of materials of construction, hemostatic agent used, formulation, performance specifications, mode of operation/mechanism of action, scientific technological characteristics, and shelf-life. Design modifications or manufacturing process changes were not required to support the additional labeling. All previously executed performance testing (animal, biocompatibility, bench, stability) remain applicable. In conclusion, the subject device is the exact same as the predicate device. The subject device retained the same device properties as the predicate. The additional and clinical studies to evaluate mild and moderate bleeding with the described following a sternotomy and/or during cardiac surgeries confirmed that QuikClot Control+® is substantially equivalent to the predicate.