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.

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. The device is available in single or multipacks.

AI/ML Overview

This document is a 510(k) summary for the QuikClot Control+ Hemostatic Dressing, which is a device used for temporary control of internal organ space bleeding and severely bleeding wounds. The summary focuses on demonstrating substantial equivalence to a predicate device.

Here's an analysis of the provided text in relation to the requested information about acceptance criteria and study details:

1. Table of Acceptance Criteria and Reported Device Performance

The document lists performance specifications but doesn't present them in a direct table format with explicit acceptance criteria values alongside reported performance values. Instead, it states that the device "meets the required specifications" generally. Here's a reconstructed table based on the provided text:

Acceptance Criteria Category	Reported Device Performance (as stated in the document)
Biocompatibility (ISO 10993-1)	Device showed acceptable performance for prolonged patient contact (>24 hours to 30 days) as an external communicating device with tissue/bone/dentin contact, covering:
- Cytotoxicity	Met (L929 Neutral Red Uptake Method)
- Irritation	Met (Intracutaneous Injection)
- Sensitization	Met (Guinea Pig Maximization Sensitization Test)
- Systemic Injection (Acute Systemic Toxicity)	Met (Intravenous Injection and Intraperitoneal Injection)
- Implantation (Rabbit)	Met (4-week sub-cutaneous, 1-week muscle, 4-week muscle, 4-week bone, 8-week bone)
- Genotoxicity	Met (Salmonella Typhimurium and Escherichia Coli Reverse Mutation Assay, Chromosomal Aberration Study, Peripheral Blood Micronucleus Study)
- Carcinogenicity	Met (Clonal Transformation Assay using SHE Cells for 7-days)
- Repeat Exposure System Toxicity	Met (6-month animal survival study using custom test for Kaolin)
- Systemic Intravenous Injection	Met (for Kaolin Extract)
- Systemic Intraperitoneal Injection	Met (for Kaolin Extract)
- Pyrogen Test	Met
X-Ray Detectability	Meets required specifications.
Bench Testing	Meets required specifications and acceptance criteria for:
- Tensile Strength	Met
- Elongation	Met
- Clotting	Met
- Kaolin Release	Met
Preclinical Animal Study (Safety & Effectiveness)	Demonstrated the safety and effectiveness of QuikClot Control+. Observations included hemostasis, blood chemistry (hematology, serum, coagulation), and macroscopic/microscopic tissue/organ examinations (adhesion, thromboembolism, kaolin migration). The results supported substantial equivalence.
Stability	Testing supports a 39-month expiration date.

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

Sample Size:
- Bench Testing: Not specified for each test (tensile strength, elongation, clotting, kaolin release).
- Biocompatibility Tests: Sample sizes are inherent to the specific ISO 10993 tests mentioned (e.g., L929 cells for cytotoxicity, guinea pigs for sensitization, rabbits for implantation, mice for genotoxicity). Specific numbers are not provided in this summary.
- Preclinical Animal Study: "Three GLP large animal (swine), to include a survival model" and "one non-GLP study." The specific number of animals per GLP study is not detailed beyond "three."
Data Provenance: The studies are preclinical (animal studies) and bench tests. The document does not specify country of origin for the studies, but they were conducted under GLP (Good Laboratory Practice) for the animal studies, indicating a controlled and ethical environment. They are inherently prospective for the purpose of this submission.

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

This information is not provided in the document. The studies described are preclinical animal studies and bench tests, not human reader studies requiring expert adjudicated ground truth. The "ground truth" for these studies is derived from direct measurements, observations, and histological/pathological analyses by qualified laboratory personnel and veterinarians within the study protocols.

4. Adjudication Method for the Test Set

This is not applicable as the studies are preclinical animal studies and bench tests, not clinical studies involving human interpretation or 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

There is no mention of an MRMC comparative effectiveness study or any AI component in this document. The device is a hemostatic dressing, not an AI-powered diagnostic or assistive tool.

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

This is not applicable as the device is a physical hemostatic dressing and does not involve any algorithm or AI.

7. The Type of Ground Truth Used

For Biocompatibility: Laboratory results (e.g., cell viability, tissue reactions, genetic mutations) from established ISO 10993 standard test methods.
For Bench Testing: Direct physical measurements (e.g., tensile strength, elongation), in vitro clotting assays, and chemical analysis for kaolin release.
For Preclinical Animal Study:
- Physiological observations: Direct assessment of hemostasis (cessation of bleeding).
- Laboratory analyses: Blood chemistry (hematology, serum, coagulation panel results).
- Pathological examinations: Macroscopic and microscopic tissue/organ examinations by veterinary pathologists for adhesion, thromboembolism, and kaolin migration.

8. The Sample Size for the Training Set

This is not applicable as the device is a physical medical device and does not involve machine learning or a training set.

9. How the Ground Truth for the Training Set Was Established

This is not applicable as the device is a physical medical device and does not involve machine learning or a training set.

Summary

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April 23, 2020

Z-Medica, LLC Soraya King Director, Regulatory Affairs 4 Fairfield Boulevard Wallingford, Connecticut 06492

Re: K200167

Trade/Device Name: QuikClot Control+ Regulation Number: 21 CFR 878.4454 Regulation Name: Non-Absorbable, Hemostatic Gauze For Temporary Internal Use Regulatory Class: Class II Product Code: POD Dated: March 26, 2020 Received: March 27, 2020

Dear Soraya King:

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.

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

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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 (OS) 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,

Cindy Chowdhury, Ph.D., M.B.A. Acting 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

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K200167

Device Name QuickClot Control+@ Hemostatic Dressing

Indications for Use (Describe)

QuickClot 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.

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)

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SECTION 5: 510(k) SUMMARY (K200167)

510(k) Number:

Submitter:	Z-Medica, LLC4 Fairfield BoulevardWallingford, CT 06492
Contact Person:	Soraya King, Director Regulatory Affairs
Preparation Date:	21 January 2020
Trade/Device Name:	QuikClot Control+® Hemostatic Dressing
Regulatory Descriptionand Classification:	Common Name: Temporary, Internal Use Hemostatic Wound DressingGeneric Name: Non-absorbable, hemostatic gauze for temporaryinternal use.Device Classification: Class IIRegulation Number: 21 CFR §878.4454Product Code: POD
Predicate Device:	Z-Medica, LLC QuikClot Control+® Hemostatic Dressing (DEN160012,cleared as D2 Dressing)
Reference Device:	Z-Medica, LLC QuikClot Control+® Hemostatic Dressing (K140757,cleared as D2 Dressing)
Indications for Use:	QuikClot Control+® Hemostatic Dressing is indicated for temporarycontrol of internal organ space bleeding for patients displaying class IIIor class IV bleeding. It may also be used for control of severely bleedingwounds such as surgical wounds and traumatic injuries.
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 asingle-use sterile device available in various sizes. The device is availablein single or multipacks.
Special Controls:	Device complies with the requirements as per 21 CFR 878.4454 for non-absorbable, hemostatic gauze for temporary internal use.
Mechanism of Action:	The QuikClot Control+® Hemostatic Dressings are packed into or on thewound and pressure is applied. Pressure is maintained until thebleeding is controlled and may be left in place up to 48 hours. More

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510(k) Summary Z-Medica, LLC QuikClot Control+® Hemostatic Dressing – Line Extension

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.

Summary of Technological The fundamental scientific and technological characteristics of the Characteristics: modified device are identical to the predicate (DEN160012). The key characteristics are as follows:

Mechanism of Action
Materials of Construction
Formulation
Packaging Materials
Sterilization Method ●
Performance Specifications
Indications/Intended Uses

Performance Testing:

The QuikClot Control+® Hemostatic Dressing complies with the special controls identified in 21 CFR 878.4454. All of the size offerings are the manufactured with the same exact materials and formulation. The device meets the following performance specifications:

. Biocompatibility as per ISO 10993-1 for a device with prolonged patient contact duration (>24 hours to 30 days) for external communicating device with tissue/bone/dentin contact.
- O Cytotoxicity (L929 Neutral Red Uptake Method)
- Irritation (Intracutaneous Injection) o
- o Sensitization (Guinea Pig Maximization Sensitization Test)
- Systemic Injection (Intravenous Injection and Intraperitoneal o Injection – Acute Systemic Toxicity)
- Implantation (Rabbit Implantation Tests Tissue, Muscle, о and Bone)
  - 4-week implantation study in subcutaneous tissue
  - 1-week implantation study in muscle
  - 4-week implantation study in muscle
  - 4-week implantation study in bone
  - 8-week implantation study in bone
- Genotoxicity O
  - Salmonella Typhimurium and Escherichia Coli Reverse Mutation Assay
  - I Chromosomal Aberration Study in Mammalian Cells
  - I Peripheral Blood Micronucleus Study in Mouse
- Additional Supporting Tests o
  - 트 Carcinogenicity (Clonal Transformation Assay using SHE Cells for 7-days
  - I Repeat Exposure System Toxicity for Kaolin (6month animal survival study, custom test)
  - ' Systemic Intravenous Injection for Kaolin Extract
  - Systemic Intraperitoneal Injection for Kaolin Extract

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510(k) Summary

Z-Medica, LLC QuikClot Control+® Hemostatic Dressing – Line Extension

' Pyrogen Test

X-Ray Detectable Material - meets required specifications.
. Bench – the device meets the required specifications and acceptance criteria for tensile strength, elongation, clotting, and kaolin release.
. Preclinical Animal Study – Three GLP large animal (swine), to include a survival model, and one non-GLP study demonstrated the safety and effectiveness of QuikClot Control+. The studies included assessments such as hemostasis. In addition to hemostasis assessments, the animal survival study also conducted evaluations for blood chemistry (hematology, serum, coagulation), and macroscopic and microscopic tissue/organ examinations (adhesion, thromboembolism, kaolin migration). The cumulative animal study results support the substantial equivalence of the device.
. Stability - testing supports a 39-month expiration date.

Conclusion The subject devices are identical to the predicate in terms of materials of construction, hemostatic agent used, mode of operation, scientific technological characteristics, indications for use and intended uses. Same as the predicate device, the new size options will be provided sterile utilizing existing validated packaging systems. The additional size offerings do not raise new types of questions of safety and effectiveness and is substantially equivalent to the predicate device.

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.