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 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.

AI/ML Overview

The document provided is a 510(k) summary for the QuikClot Control+® Hemostatic Dressing, seeking approval for expanded indications. It does not describe an AI medical device. Therefore, the requested information about acceptance criteria, study details, ground truth, and MRMC studies related to AI performance cannot be extracted from this document.

However, I can provide the clinical acceptance criteria and the summary of the clinical study presented in the document for the QuikClot Control+® Hemostatic Dressing in relation to its expanded indications.

Here's the information based on the provided text, structured as closely as possible to your request, but acknowledging the device is not an AI device:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Primary Endpoint)	Reported Device Performance (Effectiveness)
Rate at which subjects achieve hemostasis (grade 0 bleed) through up to 10 minutes of application and compression at the bleeding site.	The report states: "QuikClot Control+® achieved clinical hemostasis in cardiac surgery for mild to moderate bleeding as compared to control (i.e., standard gauze)." Specific numerical rates are not provided in this summary.

2. Sample Size Used for the Test Set and Data Provenance

Test Set (Clinical Study Participants):
- Total Randomized Subjects: 231
- QuikClot Control+® (Test Article): 153 subjects
- Standard Gauze (Control): 78 subjects
- Additional Roll-in Subjects (not randomized, treated with QuikClot Control+®): 21 (3 per site)
Data Provenance: The study was a "prospective, randomized, open-label, multicenter, pivotal, evaluation." The country of origin is not explicitly stated, but clinical trials for FDA submissions are often conducted in the US or include international sites adhering to Good Clinical Practice (GCP) guidelines.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not applicable as the study involves a physical medical device (hemostatic dressing) and direct clinical observations of bleeding, not an AI output requiring expert ground truth establishment for diagnostic accuracy. The "ground truth" here is the direct clinical observation of hemostasis by the surgical team.

4. Adjudication Method for the Test Set

This information is not applicable as the study involves direct clinical observation of hemostasis, not AI output requiring expert adjudication.

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

This information is not applicable as the device is not an AI medical device and therefore no MRMC study was performed in the context of AI assistance to human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

This information is not applicable as the device is not an AI medical device.

7. The type of ground truth used

The "ground truth" for the clinical study was based on direct clinical observation of hemostasis (grade 0 bleed) by the surgical team during elective cardiac surgical procedures.

8. The Sample Size for the Training Set

This information is not applicable as the device is not an AI medical device and therefore does not have a "training set" in the context of machine learning.

9. How the ground truth for the training set was established

This information is not applicable as the device is not an AI medical device.

Summary

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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.

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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

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Indications for Use

510(k) Number (if known) K220971

Device Name QuikClot Control+® Hemostatic Dressing

Indications for Use (Describe)

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)

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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

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

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.

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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 forUse	QuikClot Control+® HemostaticDressing is indicated for temporarycontrol of internal organ spacebleeding for patients displaying classIII or class IV bleeding. It may also beused for control of severely bleedingwounds such as surgical wounds andtraumatic injuries.Cardiac surgical procedures: fortemporary control of mild andmoderate bleeding in cardiac surgicalprocedures, as well as in patientsdisplaying Class III or class IV bleeding.Bone surfaces following sternotomy:to control bleeding from bone surfacesfollowing a sternotomy.	QuikClot Control+® HemostaticDressing is indicated for temporarycontrol of internal organ spacebleeding for patients displaying classIII or class IV bleeding. It may also beused for control of severely bleedingwounds such as surgical wounds andtraumatic injuries.	Addition ofindication forcardiac surgicalprocedures andbone surfaces.Indications alignwith proposedindicationsunder IDEG200086.
Intended Use	To control internal and externalbleedingTo control bone surface bleeding at thesternotomy access site.To control suture line bleedingfollowing cardiac surgical procedures,such as but not limited to, heart valverepairs or replacements, coronaryartery bypass graft surgery (CABG), oraortic aneurysm repairs.To control bleeding due to tears,lacerations, and abrasions to include	To control internal and externalbleeding	Addition ofspecificintendeduse forcardiacsurgicalproceduresand bonesurfacesthat alignswithintendeduse underIDEG200086.
	Proposed DeviceQuikClot Control+®Hemostatic Dressing(Expanded Indications)	Predicate Device – K200167QuikClot Control+®Hemostatic Dressing	Comparison
	epicardial repairs with or withoutsutures.To be used with or without the use ofcardiopulmonary bypass systems. Thedressing can be applied to controlbleeding while the patient is 'on or offpump'.To be used with or withoutautotransfusion (blood salvage)equipment.To be used on patients onanticoagulation / antiplateletmedication
Contraindication	Do not leave QuikClot Control+® inplace for more than 48 hours.QuikClot Control+® is not indicated forintraluminal vascular use.	Do not leave QuikClot Control+® inplace for more than 48 hours.QuikClot Control+® is not indicated forintraluminal vascular use.	Same
Materials ofConstruction	Gauze Substrate, Kaolin (hemostaticagent), and Calcium Alginate (binder)	Gauze Substrate, Kaolin (hemostaticagent), and Calcium Alginate (binder)	Same
Sizes	Various sizes including1" 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 ply5" x 5", 4 ply8" x 8", 2 ply12" x 12", 3 ply3" x 4 yards, 1 ply3" x 2 yards, 1 ply	Various sizes including1" 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 ply5" x 5", 4 ply8" x 8", 2 ply12" x 12", 3 ply3" x 4 yds, 1 ply	Addition of 1proposed size(3" x 2 yards, 1ply).
Sterilization Method	Gamma Irradiation	Gamma Irradiation	Same
Shelf-life	39 months	39 months	Same
Single Use	Yes	Yes	Same
	Proposed DeviceQuikClot Control+®Hemostatic Dressing(Expanded Indications)	Predicate Device – K200167QuikClot Control+®Hemostatic Dressing	Comparison
Packaging	Peelable foil pouch	Peelable foil pouch	Same
Biocompatibility	Biocompatible materials used (per ISO10993-1 prolonged contact duration).	Biocompatible materials used (per ISO10993-1 prolonged contact duration).	Same

Table 1. Substantial Equivalence Comparison to Predicate

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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

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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.

Regulation Number and Section

§ 878.4454 Non-absorbable, hemostatic gauze for temporary internal use.

(a)
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.(b)
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.