QUIKCLOT HEMOSTATIC DRESSING

K123387 · Z-Medica, LLC · QSY · Apr 12, 2013 · SU

Device Facts

• Record ID: K123387
• Device Name: QUIKCLOT HEMOSTATIC DRESSING
• Applicant: Z-Medica, LLC
• Product Code: QSY · SU
• Decision Date: Apr 12, 2013
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

QuikClot® Hemostatic Dressing is intended for use as a topical dressing for local management of bleeding wounds such as cuts, lacerations and abrasions. It may also be used for temporary treatment of severely bleeding wounds such as surgical wounds (operative, postoperative, dermatological, etc.) and traumatic injuries.

Device Story

QuikClot Hemostatic Dressing is a sterile, topical wound dressing designed for local bleeding management. It consists of kaolin (a mineral hemostatic agent) bound to medical gauze using glycerin. When applied to a bleeding wound, the kaolin triggers an electrostatic interaction with blood, accelerating the natural clotting process. The dressing is designed to conform readily to wound surfaces. It is intended for use in clinical settings, such as surgical environments or for traumatic injury management, by healthcare professionals. By promoting rapid hemostasis, the device assists in controlling bleeding from surgical incisions, dermatological procedures, and traumatic wounds, potentially reducing blood loss and improving patient outcomes in acute care scenarios.

Clinical Evidence

Bench and in vivo testing were performed. Biocompatibility testing followed ISO 10993 standards, including cytotoxicity, intracutaneous reactivity, sensitization, systemic toxicity, and subcutaneous implantation, all yielding non-toxic/non-reactive results. In vivo efficacy testing demonstrated the device's ability to achieve hemostasis in traumatic wounds compared to the predicate ChitoFlex Surgical Dressing.

Technological Characteristics

Materials: Kaolin USP (hemostatic agent), medical gauze, glycerin USP. Form factor: Layered dressing in various sizes (1" D to 4" x 4 YDS). Mechanism: Electrostatic interaction with blood to trigger clotting. Biocompatibility: Tested per ISO 10993-1, 5, 6, 10, and 11. Sterilization: Sterile. Connectivity: None.

Indications for Use

Indicated for local management of bleeding wounds (cuts, lacerations, abrasions) and temporary treatment of severely bleeding wounds (surgical, traumatic) in patients requiring topical hemostasis.

Regulatory Classification

Identification

To temporarily control bleeding and cover external wounds.

Predicate Devices

• QuikClot eX (K072474)
• HemCon ChitoFlex Surgical Dressing (K071519)

Submission Summary (Full Text)

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April 21, 2023

Z-Medica, LLC Sheila Wallin Vice President of Clinical and Regulatory Affairs 4 Fairfield Blvd. Wallingford, Connecticut 06492

Re: K123387 Trade/Device Name: QuikClot Hemostatic Dressing Regulatory Class: Unclassified Product Code: QSY

Dear Sheila Wallin:

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 12, 2013. 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, [e-mail].

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

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

April 12, 2103

Z-Medica, LLC % Ms. Sheila Wallin Vice President of Clinical and Regulatory Affairs 4 Fairfield Boulevard Wallingford, Connecticut 06492

Re: K123387

> Trade/Device Name: QuikClot Hemostatic Dressing Regulatory Class: Unclassified Product Code: FRO Dated: March 11, 2013 Received: March 13, 2013

Dear Ms. Wallin:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and have determined the device is substantially equivalent to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, FDA will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, the Food and Drug Administration (FDA) may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections \$31 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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### Page 2 - Ms. Sheila Wallin

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. An 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, but it does not mean that FDA approves your device. Therefore, you may not promote or in any way represent your device or its labeling as being approved by FDA.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or at [phone].

Sincerely yours, FOR

# Peter D厚Ryimm -S

- Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

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## Indications for Use

Applicant: Z-Medica, LLC 510(k) Number (if known): Not yet assigned Device Name: QuikClot Hemostatic Dressing

Indications for Use:

QuikClot® Hemostatic Dressing is intended for use as a topical dressing for local management of bleeding wounds such as cuts, lacerations and abrasions.

It may also be used for temporary treatment of severely bleeding wounds such as surgical wounds (operative, postoperative, dermatological, etc.) and traumatic injuries.

Prescription Use x (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)

## David Krauses

(Division Sign-Off) Division of Surgical Devices 510(k) Number: K123387

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# 123387

APR 1 2 2013

# 510(k) Summary for Z-Medica, LLC QuikClot Hemostatic Dressing

#### 1. SUBMITTER/510(K) HOLDER

Z-Medica, LLC 4 Fairfield Blvd. Wallingford, CT 06492 Contact Person: Sheila K Wallin Telephone: [phone] x 308

Date Prepared: April 11, 2013

#### 2. DEVICE NAME

Proprietary Name: QuikClot® Hemostatic Dressing Common/Usual Name: Dressing, Wound, Drug Classification: Unclassified Classification Name: Dressing Product Code: FRO

#### 3. PREDICATE DEVICES

- K072474 QuikClot® eX (also marketed as QuikClot Combat Gauze) ●
- K071519 HemCon ChitoFlex Surgical Dressing .

#### 4. DEVICE DESCRIPTION

The purpose of this 510(k) is to obtain a new indication for the previously cleared QuikClot® eX, subject of K072474. The QuikClot Hemostatic Dressing is identical to the legally marketed QuikClot eX in composition, design and processing and the only modification is on the intended use. The new indication will be substantially equivalent to the HemCon ChitoFlex Surgical Dressing cleared August 6, 2007 in K071519.

The QuikClot® Hemostatic Dressing utilizes a layered clay hemostat, kaolin USP, which is bound to medical gauze using glycerin USP. QuikClot Hemostatic Dressings are provided in a sterile, intuitive, simple to use dressing format that conforms readily to the wound. The QuikClot Hemostatic Dressing that is the subject of this submission is described in detail in K072474.

The proposed indications for use are substantially equivalent to the predicate

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device (HemCon ChitoFlex Surgical Dressing): QuikClot® Hemostatic Dressing is intended for use as a topical dressing for local management of bleeding wounds such as cuts, lacerations and abrasions. It may also be used for temporary treatment of severely bleeding wounds such as surgical wounds (operative, postoperative, dermatological, etc.) and traumatic injuries.

In vivo testing evaluated the efficacy of the QuikClot Hemostatic Dressing versus predicate (ChitoFlex Surgical Dressing) to control bleeding in traumatic wounds. The data supports the effectiveness of QuikClot Hemostatic Dressings in achieving hemostasis in traumatic wounds.

#### ನ. INTENDED USE

QuikClot® Hemostatic Dressing is intended for use as a topical dressing for local management of bleeding wounds such as cuts, lacerations and abrasions.

It may also be used for temporary treatment of severely bleeding wounds such as surgical wounds (operative, postoperative, dermatological, etc.) and traumatic injuries.

#### 6. TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE

The QuikClot Hemostatic Dressing is identical to the legally marketed QuikClot eX (K072474) (also marketed as QuikClot Combat Gauze) in composition, design and processing. The QuikClot Hemostatic Dressing is substantially equivalent to the predicate device (ChitoFlex Surgical Dressing - K071519) in that both devices share the same intended use. Both devices are intended for use as a topical dressing for local management of bleeding wounds such as cuts, lacerations and abrasions. It may also be used for temporary treatment of severely bleeding wounds such as surgical wounds (operative, postoperative, dermatological, etc.) and traumatic injuries.

The QuikClot Hemostatic Dressing and the predicate devices are substantially equivalent in that they contain a hemostatic agent that functions to control bleeding. Their mechanism of action is also similar: In QuikClot Hemostatic Dressing, the hemostatic agent is kaolin, a mineral, which triggers an electrostatic interaction when in contact with blood to promote clotting. ChitoFlex uses a different hemostatic agent, chitosan, which is a polymer that also works by electrostatic interaction. Although the hemostatic components of these two products are different, their mechanism of action and outcome is substantially similar.

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The QuikClot Hemostatic Dressing is offered in several configurations including a 1" D, 5/8" D, 2" x 2", 4" x 4", 12" x 12", 3" x 4 YDS and 4" x 4 YDS.

#### 7. PERFORMANCE TESTING

QuikClot Hemostatic Dressing has undergone extensive safety testing in accordance with the FDA 510(k) Memorandum #G95-1 and ISO-10993-1, the biocompatibility tests for a device based on the duration that the device is in contact with the body and the type of contact between the device and the body. Per these guidance documents biological evaluation testing was categorized as limited contact duration, external communicating device, tissue/bone/dentin QuikClot Hemostatic Dressing has passed the following communicating. biocompatibility tests:

| Test | Description | Conclusion |
|---------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------|
| Cytotoxicity | L929 MEM Elution test according to ISO 10993-<br>5:1999, 'Biological Evaluation of Medical Devices,<br>Part 5: Tests for In Vitro Cytotoxicity'<br>L929 Neutral Red Uptake according to ISO 10993-<br>5:2009, 'Biological Evaluation of Medical Devices,<br>Part 5: Tests for In Vitro Cytotoxicity' | Non-cytotoxic |
| Intracutaneous<br>Reactivity | ISO 10993-10:2002, Amendment 1:2006, 'Biological<br>Evaluation of Medical Devices, Part 10; Tests for<br>Irritation and Delayed-Type Hypersensitivity' | Non-irritating |
| Sensitization | ISO 10993-10:2002, Amendment 1:2006, 'Biological<br>Evaluation of Medical Devices, Part 10; Tests for<br>Irritation and Delayed-Type Hypersensitivity' | Non-sensitizing |
| Systemic<br>Injection<br>(intraperitoneal<br>injection) | ISO 10993-11:2006, 'Biological Evaluation of Medical<br>Devices, Part 11: Tests for Systemic Toxicity' | Non-toxic |
| Systemic<br>Injection<br>(intravenous<br>injection) | ISO 10993-11:2006, 'Biological Evaluation of Medical<br>Devices, Part 11: Tests for Systemic Toxicity' | Non-toxic |
| Repeat Exposure<br>Systemic Toxicity | Custom Designed Test Program based on ISO 10993-<br>11:2006, 'Biological Evaluation of Medical Devices,<br>Part 11: Tests for Systemic Toxicity' | Non-toxic |
| Subcutaneous<br>Implantation | ISO 10993-6:2007, Biological Evaluation of Medical<br>Devices, Part 6: Tests for Local Effects After<br>Implantation | Non-reactive |

Complete protocols and reports of the testing have been provided.

## 8. SAFETY AND EFFICACY

In vivo testing evaluated the efficacy of the QuikClot Hemostatic Dressing. The results of bench and safety testing indicated that the new device is as safe and as effective as the predicate devices.

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Protocols and test reports of the in vivo testing can be found in Section 19 of this submission.

## 9. Conclusion

Z-Medica believes that based on the indications for use, technological characteristics, and comparison to predicate devices the QuikClot Hemostatic Dressing has been shown to be substantially equivalent to the predicate and is safe and effective for its intended use.