(161 days)
No
The device description and intended use focus on the material properties of the dressing (kaolin clay) for hemostasis, with no mention of AI or ML technologies.
Yes
The device is described as "Hemostatic Dressing" intended for "local management of bleeding wounds" and "temporary treatment of severely bleeding wounds," indicating a direct therapeutic action to stop bleeding.
No
The device, QuikClot Hemostatic Dressing, is intended for the local management of bleeding wounds and for the temporary treatment of severely bleeding wounds. It functions to control bleeding (hemostasis) and does not gather or analyze data for diagnosis.
No
The device description clearly states it is a "layered clay hemostat, kaolin USP, which is bound to medical gauze using glycerin USP," indicating a physical, material-based device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's a "topical dressing for local management of bleeding wounds." This describes a device that is applied directly to the body to treat a physical condition (bleeding).
- Device Description: The description details a physical dressing made of gauze and a hemostatic agent (kaolin). This is a physical device, not something used to test samples outside the body.
- Lack of IVD Characteristics: There is no mention of analyzing samples (like blood, urine, or tissue) in vitro (outside the living body) to provide diagnostic information. IVDs are used to diagnose diseases or conditions, monitor treatments, or screen for health issues by examining these samples.
Therefore, the QuikClot Hemostatic Dressing is a medical device used for wound management, not an in vitro diagnostic device.
N/A
Intended Use / 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.
Product codes
QSY, FRO
Device Description
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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
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.
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 communicating. QuikClot Hemostatic Dressing has passed the following biocompatibility tests:
- Cytotoxicity (L929 MEM Elution test, L929 Neutral Red Uptake) - Non-cytotoxic
- Intracutaneous Reactivity (ISO 10993-10:2002, Amendment 1:2006) - Non-irritating
- Sensitization (ISO 10993-10:2002, Amendment 1:2006) - Non-sensitizing
- Systemic Injection (intraperitoneal injection) (ISO 10993-11:2006) - Non-toxic
- Systemic Injection (intravenous injection) (ISO 10993-11:2006) - Non-toxic
- Repeat Exposure Systemic Toxicity (Custom Designed Test Program based on ISO 10993-11:2006) - Non-toxic
- Subcutaneous Implantation (ISO 10993-6:2007) - Non-reactive
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.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
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 USA logo. To the right of that is the FDA logo, which 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.
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, Julie.Morabito@fda.hhs.gov.
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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Image /page/1/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles an abstract human figure.
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 (301) 796-6570. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or at (240) 276-3150.
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: 203-294-0000 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- | |
| 5:1999, 'Biological Evaluation of Medical Devices, | ||
| Part 5: Tests for In Vitro Cytotoxicity' | ||
| L929 Neutral Red Uptake according to ISO 10993- | ||
| 5:2009, 'Biological Evaluation of Medical Devices, | ||
| Part 5: Tests for In Vitro Cytotoxicity' | Non-cytotoxic | |
| Intracutaneous | ||
| Reactivity | ISO 10993-10:2002, Amendment 1:2006, 'Biological | |
| Evaluation of Medical Devices, Part 10; Tests for | ||
| Irritation and Delayed-Type Hypersensitivity' | Non-irritating | |
| Sensitization | ISO 10993-10:2002, Amendment 1:2006, 'Biological | |
| Evaluation of Medical Devices, Part 10; Tests for | ||
| Irritation and Delayed-Type Hypersensitivity' | Non-sensitizing | |
| Systemic | ||
| Injection | ||
| (intraperitoneal | ||
| injection) | ISO 10993-11:2006, 'Biological Evaluation of Medical | |
| Devices, Part 11: Tests for Systemic Toxicity' | Non-toxic | |
| Systemic | ||
| Injection | ||
| (intravenous | ||
| injection) | ISO 10993-11:2006, 'Biological Evaluation of Medical | |
| Devices, Part 11: Tests for Systemic Toxicity' | Non-toxic | |
| Repeat Exposure | ||
| Systemic Toxicity | Custom Designed Test Program based on ISO 10993- | |
| 11:2006, 'Biological Evaluation of Medical Devices, | ||
| Part 11: Tests for Systemic Toxicity' | Non-toxic | |
| Subcutaneous | ||
| Implantation | ISO 10993-6:2007, Biological Evaluation of Medical | |
| Devices, Part 6: Tests for Local Effects After | ||
| 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.