(161 days)
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.
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 provided text describes a 510(k) premarket notification for the QuikClot Hemostatic Dressing. The submission aims to obtain a new indication for a previously cleared device, the QuikClot eX, and asserts substantial equivalence to a predicate device, the HemCon ChitoFlex Surgical Dressing.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state quantitative acceptance criteria or a specific table detailing "reported device performance" against those criteria in the way a typical diagnostic or AI device study would. Instead, the "acceptance criteria" are implied by the requirements for demonstrating substantial equivalence to existing legally marketed devices, primarily focusing on safety and efficacy.
The device performance is described qualitatively and through the results of specific tests.
| Acceptance Criteria (Implied by Substantial Equivalence Review) | Reported Device Performance |
|---|---|
| Safety: Biocompatibility (cytotoxicity, irritation, sensitization, systemic toxicity, implantation effects) | Satisfied: Passed all biocompatibility tests listed in the table (Cytotoxicity: Non-cytotoxic; Intracutaneous Reactivity: Non-irritating; Sensitization: Non-sensitizing; Systemic Injection: Non-toxic; Repeat Exposure Systemic Toxicity: Non-toxic; Subcutaneous Implantation: Non-reactive). |
| Efficacy: Ability to control bleeding in traumatic wounds. | Satisfied: "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." |
| Technological Characteristics: Similar composition, design, processing, and mechanism of action to predicate devices. | Satisfied: "The QuikClot Hemostatic Dressing is identical to the legally marketed QuikClot eX in composition, design and processing..." and "...substantially equivalent to the predicate device (ChitoFlex Surgical Dressing) 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... Their mechanism of action is also similar..." |
| Intended Use: Comparable to legally marketed predicate devices. | Satisfied: The proposed indications for use are stated to be "substantially equivalent to the predicate device (HemCon ChitoFlex Surgical Dressing)." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document mentions "in vivo testing" for efficacy and various biocompatibility tests. However, it does not specify the sample sizes for these tests (e.g., number of animals or specific experimental units). It also does not mention the country of origin of the data or whether the studies were retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable as the device is a hemostatic dressing, not a diagnostic device requiring expert interpretation for ground truth establishment. The efficacy and safety are assessed through biological and physiological measurements.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable as the device is a hemostatic dressing and does not involve adjudication by multiple experts for interpretive results.
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 a hemostatic dressing and does not involve human readers or AI assistance.
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 a hemostatic dressing and does not involve algorithms or human-in-the-loop performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the safety testing (biocompatibility), the "ground truth" is established through standardized laboratory assays and observations as defined by ISO 10993 series and FDA guidance (G95-1). The conclusions (e.g., "Non-cytotoxic," "Non-irritating," "Non-toxic") are direct results of these validated tests.
For efficacy, the "ground truth" for "achieving hemostasis in traumatic wounds" would be based on physiological measures, such as time to cessation of bleeding, blood loss, or other objective endpoints observed during the "in vivo testing." While the specific metrics are not detailed, it would be direct observation of physiological outcomes.
8. The sample size for the training set
This information is not applicable as the device is a medical device (hemostatic dressing) and does not involve a "training set" in the context of machine learning or AI models. The development and testing paradigm are based on traditional medical device validation.
9. How the ground truth for the training set was established
This information is not applicable for the same reason as above; there is no "training set" for this type of medical device.
{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
{1}------------------------------------------------
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.
{2}------------------------------------------------
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
{3}------------------------------------------------
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
{4}------------------------------------------------
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
{5}------------------------------------------------
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.
{6}------------------------------------------------
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 |
| IntracutaneousReactivity | ISO 10993-10:2002, Amendment 1:2006, 'BiologicalEvaluation of Medical Devices, Part 10; Tests forIrritation and Delayed-Type Hypersensitivity' | Non-irritating |
| Sensitization | ISO 10993-10:2002, Amendment 1:2006, 'BiologicalEvaluation of Medical Devices, Part 10; Tests forIrritation and Delayed-Type Hypersensitivity' | Non-sensitizing |
| SystemicInjection(intraperitonealinjection) | ISO 10993-11:2006, 'Biological Evaluation of MedicalDevices, Part 11: Tests for Systemic Toxicity' | Non-toxic |
| SystemicInjection(intravenousinjection) | ISO 10993-11:2006, 'Biological Evaluation of MedicalDevices, Part 11: Tests for Systemic Toxicity' | Non-toxic |
| Repeat ExposureSystemic Toxicity | Custom Designed Test Program based on ISO 10993-11:2006, 'Biological Evaluation of Medical Devices,Part 11: Tests for Systemic Toxicity' | Non-toxic |
| SubcutaneousImplantation | ISO 10993-6:2007, Biological Evaluation of MedicalDevices, Part 6: Tests for Local Effects AfterImplantation | 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.
{7}------------------------------------------------
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.
N/A