K Number
K050769
Device Name
QUIKCLOT BRAND HEMOSTATIC AGENT - ADVANCED BEADED FORMULATION - 100G - 1.9MM - 2.4MM., MODEL 100172
Date Cleared
2005-04-14

(20 days)

Product Code
Regulation Number
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
QuikClot® Brand Hemostatic Agent is intended for emergency use only as an external temporary traumatic wound treatment to achieve hemostasis for moderate to severe bleeding.
Device Description
The new bead form of QuikClot® Brand Hemostatic Agent, also called "Advanced Beaded Formulation", is intended for emergency use as an external temporary traumatic wound treatment to achieve hemostasis and prevent blood loss. The beads consist of a synthetic molecular sieve (zeolite) that accelerates the body's natural clotting processes by increasing the concentration of platelets and clotting factors at the wound site. Individual sieve particles of the hemostatic agent adsorb water molecules. As the water is removed from the blood, the platelets and clotting factors are concentrated. The platelets have been activated by the normal response to injury. This adsorption process is exothermic. The resultant increase in temperature at the site of application increases the rate of the clotting reactions and platelet aggregation and adhesion. Both of the mechanisms described above, concentration of clotting factors and the increase in rates of platelet aggregation/adhesion, work together to increase the clotting rate. This would be consistent with what is known about the effects of temperature and concentration on coagulation enzyme activity and platelet function. 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 direct pressure, QuikClot® Brand Hemostatic Agent, Advanced Beaded Formulation reduces blood loss dramatically, and significantly increases survivability of high volume catastrophic wounds.
More Information

Not Found

No
The device description focuses on the chemical and physical properties of the zeolite material and its interaction with blood to promote clotting. There is no mention of algorithms, data processing, or learning capabilities.

Yes
The device is intended to treat bleeding by promoting hemostasis, which is a therapeutic action.

No

Explanation: The device is a hemostatic agent intended to stop bleeding by accelerating the body's natural clotting processes, not to diagnose a condition or disease.

No

The device description clearly describes a physical product consisting of synthetic molecular sieve beads, which is a hardware component, not software.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use is "external temporary traumatic wound treatment to achieve hemostasis for moderate to severe bleeding." This describes a direct treatment applied to a wound on the body.
  • Device Description: The description details a material (synthetic molecular sieve/zeolite) that interacts directly with blood at the wound site to promote clotting. It describes a physical and chemical process happening externally on the body.
  • Lack of In Vitro Activity: IVDs are designed to examine specimens (like blood, urine, tissue) outside of the body to provide information about a person's health or condition. This device does not involve the analysis of a specimen in a laboratory setting.
  • Anatomical Site: The anatomical site is an "external temporary traumatic wound," which is on the body.

In summary, the QuikClot® Brand Hemostatic Agent is a topical hemostatic agent applied directly to a wound on the body, not a device used to test specimens in vitro.

N/A

Intended Use / Indications for Use

QuikClot® Brand Hemostatic Agent is intended for emergency use only as an external temporary traumatic wound treatment to achieve hemostasis for moderate to severe bleeding.

Product codes (comma separated list FDA assigned to the subject device)

QSY, FRO

Device Description

The new bead form of QuikClot® Brand Hemostatic Agent, also called "Advanced Beaded Formulation", is intended for emergency use as an external temporary traumatic wound treatment to achieve hemostasis and prevent blood loss.

The beads consist of a synthetic molecular sieve (zeolite) that accelerates the body's natural clotting processes by increasing the concentration of platelets and clotting factors at the wound site. Individual sieve particles of the hemostatic agent adsorb water molecules. As the water is removed from the blood, the platelets and clotting factors are concentrated. The platelets have been activated by the normal response to injury. This adsorption process is exothermic. The resultant increase in temperature at the site of application increases the rate of the clotting reactions and platelet aggregation and adhesion.

Both of the mechanisms described above, concentration of clotting factors and the increase in rates of platelet aggregation/adhesion, work together to increase the clotting rate. This would be consistent with what is known about the effects of temperature and concentration on coagulation enzyme activity and platelet function.

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 direct pressure, QuikClot® Brand Hemostatic Agent, Advanced Beaded Formulation reduces blood loss dramatically, and significantly increases survivability of high volume catastrophic wounds.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

external traumatic wound

Indicated Patient Age Range

Not Found

Intended User / Care Setting

emergency use

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

In-Vivo testing on swine was performed at the Portsmouth Naval Hospital in Virginia. Tests demonstrated that the bead form performs at least as well as the current granular product in the swine femoral artery model. A summary of that testing is included with this pre-market submission.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K013390

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

N/A

0

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a smaller font.

June 11, 2023

Z-Medica Corporation Robert V. Packard Quality Assurance Manager 4 Fairfield Boulevard Wallingford, Connecticut 06492

Re: K050769 Trade/Device Name: QuikClot® Brand Hemostatic Agent Regulatory Class: Unclassified Product Code: QSY

Dear Robert V. Packard:

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 April 14, 2005. 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, Center for Devices and Radiological Health. The letter begins with the salutation, "Sincerely,"

1

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 border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. Inside the circle is a stylized image of an eagle or bird-like figure, represented by three curved lines that suggest wings and a head.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 1 4 2005

Mr. Robert V. Packard Quality Assurance Manager Z-Medica Corporation 4 Fairfield Boulevard Wallingford, Connecticut 06492

Re: K050769

Trade/Device Name: QuickClot® Brand Hemostatic Agent Regulatory Class: Unclassified Product Code: FRO Dated: March 23, 2005 Received: March 25, 2005

Dear Mr. Packard:

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.

2

Page 2 - Mr. Robert V. Packard

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) 276-0120 . Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html.

Sincerely yours,

Miriam C. Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

3

K050769

10

STATEMENT OF INDICATIONS FOR USE

QuikClot® Brand Hemostatic Agent is intended for emergency use only as an external temporary traumatic wound treatment to achieve hemostasis for moderate to severe bleeding.

Prescription Use ) (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Nostorative

Page 1 of

4

K050769 A

APR 1 4 2005

QuikClot® Advanced Beaded Formulation Trade Name: Class 1 Device Class: General and Plastic Surgery Classification Panel: Traumatic Wound Dressing Common Name: Dressing Classification Name: FRO Classification Code: OuikClot® Brand Hemostatic Granules Predicate Device: 510(k) No. K013390 Robert V. Packard, QA Manager Submitted By: Z-Medica Corporation Company Name: 4 Fairfield Blvd., Wallingford, CT 06492 Company Address: (203) 294-0000 Company Phone: March 23, 2005 Prepared:

510(k) Summary

Device Description

The new bead form of QuikClot® Brand Hemostatic Agent, also called "Advanced Beaded Formulation", is intended for emergency use as an external temporary traumatic wound treatment to achieve hemostasis and prevent blood loss.

The beads consist of a synthetic molecular sieve (zeolite) that accelerates the body's natural clotting processes by increasing the concentration of platelets and clotting factors at the wound site. Individual sieve particles of the hemostatic agent adsorb water molecules. As the water is removed from the blood, the platelets and clotting factors are concentrated. The platelets have been activated by the normal response to injury. This adsorption process is exothermic. The resultant increase in temperature at the site of application increases the rate of the clotting reactions and platelet aggregation and adhesion.

Both of the mechanisms described above, concentration of clotting factors and the increase in rates of platelet aggregation/adhesion, work together to increase the clotting rate. This would be consistent with what is known about the effects of temperature and concentration on coagulation enzyme activity and platelet function.

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 direct pressure, QuikClot® Brand Hemostatic Agent, Advanced Beaded Formulation reduces blood loss dramatically, and significantly increases survivability of high volume catastrophic wounds.

In-Vivo testing on swine was performed at the Portsmouth Naval Hospital in Virginia. Tests demonstrated that the bead form performs at least as well as the current

14

5

K050769 page 2/2

15

granular product in the swine femoral artery model. A summary of that testing is included with this pre-market submission.

This application for Special 510(k) clearance concerns the same hemostatic agent in two different physical sizes with a round bead shape instead of granular. The intended use of the product, however, is the same: temporary external use only. The granular and bead forms have the same chemical composition. but the physical size and shape are different. Chemical analysis, performed by the manufacturer of the synthetic molecular sieve, verified the compositions of both sizes of round beads are identical to the current granular product. Therefore, Z-Medica Corporation has determined that repeating the biocompatibility testing is not required. The original biocompatibility testing was completed by ISO 17025 Certified MicroTest Laboratories, Inc., of Agawam, Mass. The tests included:

TestSample #Dated
Agar Overlay Cytotoxicity Test02-0048001/29/02
Water Adsorption Rate02-0025401/21/02
Skin Sensitization01-0655612/21/01
Skin Irritation01-0655512/07/01
Intracutaneous Test01-0655411/30/01
Muscle Implant01-0647601/08/02
Long-Term Muscle Implant03-0124711/13/03

QuikClot® Brand Hemostatic Agent, Advanced Beaded Formulation is a safe, effective, low cost traumatic wound dressing which is substantially alike in purpose, characteristic, process, and result to the QuikClot® Brand Hemostatic Granules, and thereby eligible for approval under 510(k).