(42 days)
No
The device description and performance studies focus on the material properties and biological effects of the gauze and clay mineral, with no mention of software, algorithms, or data processing that would indicate AI/ML. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
Yes
The device is intended to control traumatic bleeding and stop bleeding of superficial wounds, minor cuts, and abrasions, which are therapeutic actions.
No
The device description and intended use clearly state that QuikClot® eX™ is a hemostatic agent designed to control bleeding, not to diagnose medical conditions.
No
The device description clearly states it consists of physical components: non-woven medical gauze, a clay mineral (Kaolin), and Glycerin, packaged in a foil pouch. This is a physical medical device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states "temporary external use to control traumatic bleeding" and "temporary external use to stop bleeding of superficial wounds, minor cuts, and abrasions." This describes a device used directly on the body to treat a condition, not a device used to examine specimens from the body to provide diagnostic information.
- Device Description: The description details a gauze-based product with a hemostatic agent (Kaolin) for external application. This is consistent with a topical hemostatic device, not an IVD.
- Lack of IVD Characteristics: The description does not mention any components or processes typically associated with IVDs, such as reagents, analyzers, or the analysis of biological samples (blood, urine, tissue, etc.) for diagnostic purposes.
- Performance Studies: The performance studies described involve in-vitro testing with sheep's blood (which is a common way to test the clotting ability of a hemostatic agent, not a diagnostic test) and in-vivo testing in a swine model, which are relevant to evaluating the effectiveness of a hemostatic device applied to a living organism.
In summary, QuikClot® eX™ is a topical hemostatic device intended for direct application to wounds to control bleeding, not a device used to perform diagnostic tests on biological samples.
N/A
Intended Use / Indications for Use
Prescription Use: QuikClot® eX™ is intended for temporary external use to control traumatic bleeding.
Over-The-Counter Use: QuikClot® eX™ is intended for temporary external use to stop bleeding of superficial wounds, minor cuts, and abrasions.
Product codes
QSY, FRO
Device Description
QuikClot® eX™ consists of standard non-woven medical gauze that has a clay mineral (Kaolin) bound to the gauze with Glycerin. Kaolin promotes hemostasis in a similar mechanism as QuikClot® Hemostatic Agent (K013390), but without the associated heat generation and risk of burning. QuikClot® eX™ is packaged as a four ply square sponge 4" x 4" sealed in a foil pouch and irradiated to a SAL of 10-6. The foil package has the same material composition and construction as the QuikClot® Hemostatic Agent package.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
External use
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-vitro testing: proven to clot whole sheep's blood faster than untreated controls.
in-vivo testing: swine model transection of the femoral vessels, proven to be more effective than untreated controls.
efficacy: effective in stopping bleeding of liver, spleen and mesenteric injuries.
biocompatibility: successfully tested in four separate laboratory tests.
Key Metrics
Not Found
Predicate Device(s)
QuikClot® Hemostatic Agent (K013390), QuikClot® Sport™ (K070010), Nu Gauze® All Purpose Dressing (K821150)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services 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.
June 11, 2023
Z-Medica Corporation Ronald Peterson Director of RA/QA 4 Fairfield Boulevard Wallingford, Connecticut 06492
Re: K072474 Trade/Device Name: QuikClot® eXTM Regulatory Class: Unclassified Product Code: QSY
Dear Ronald Peterson:
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 October 16, 2007. 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., Assistant Director at the FDA. The signature block includes her name, title, and the name of her division and office. The division is DHT4B: Division of Infection Control and Plastic Surgery Devices, and the office is OHT4: Office of Surgical and Infection Control Devices. The signature block also includes the Office of Product Evaluation and Quality.
Center for Devices and Radiological Health
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Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle or other bird with its wings spread, rendered in a simple, abstract design.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 16 2007
Re: K072474
Z-Medica Corporation
% Mr. Ronald Peterson Director of RA/QA 4 Fairfield Boulevard
Wallingford, Connecticut 06492
Trade/Device Name: QuikClot® eX™ Regulatory Class: Unclassified Product Code: FRO Dated: October 1, 2007 Received: October 2, 2007
Dear Mr. Peterson:
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. Ronald Peterson
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) 276-0115. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
For P.B. Now
Mark N. Melkerson DE P.E.
Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications For Use
510(k) Number (if known):
Device Trade Names: QuikClot® eX™
Device Common Name: Hemostatic Gauze Sponge
Indications For Use:
Prescription Use
QuikClot® eX™ is intended for temporary external use to control traumatic bleeding.
Over-The-Counter Use
QuikClot® eXT™ is intended for temporary external use to stop bleeding of superficial wounds, minor cuts, and abrasions.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (Part 21 CFR 801 Subpart C)
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(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Division Sign-Off Oivision of General, Restorative, and Neurological Devices
Number ___ `/072474
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510(k) Summary - K072474
| Trade Name: | QuikClot® eX™ |
|---|---|
| Device Class: | Class 1 |
| Classification Panel: | General and Plastic Surgery |
| Common Name: | Hemostatic Gauze Sponge |
| Classification Name: | Dressing |
| Classification Code: | FRO |
| Predicate Device(s): | QuikClot® Hemostatic Agent (K013390) |
| QuikClot® Sport™ (K070010) | |
| Nu Gauze® All Purpose Dressing (K821150) | |
| Submitted By: | Ronald E. Peterson, Dir. of Regulatory Affairs and QA |
| Company Name: | Z-Medica Corporation |
| Company Address: | 4 Fairfield Blvd., Wallingford, CT 06492 |
| Company Phone: | +1-203-294-0000 x262 |
| Prepared: | August 31, 2007 |
| Revised: | October 4, 2007 |
Description of Device
QuikClot® eX™ consists of standard non-woven medical gauze that has a clay mineral (Kaolin) bound to the gauze with Glycerin. Kaolin promotes hemostasis in a similar mechanism as QuikClot® Hemostatic Agent (K013390), but without the associated heat generation and risk of burning. QuikClot® eX™ is packaged as a four ply square sponge 4" x 4" sealed in a foil pouch and irradiated to a SAL of 10-6. The foil package has the same material composition and construction as the QuikClot® Hemostatic Agent package.
Intended Use of Device
Prescription Use: QuikClot® eX™ is intended for temporary external use to control traumatic bleeding. Over-The-Counter Use: QuikClot® eX™ is intended for temporary external use to stop bleeding of superficial wounds, minor cuts, and abrasions.
Discussion of Data to Support Substantial Equivalence
QuikClot® eX™ has been proven to clot whole sheep's blood faster than untreated controls during in-vitro testing, and has proven to be more effective during in-vivo testing of the swine model transection of the femoral vessels than untreated controls. QuikClot® eX™ has also proven to be effective in stopping bleeding of liver, spleen and mesenteric injuries, and has been successfully tested for biocompatibility in four separate laboratory tests.
Conclusion
Based on the in-vitro and in-vivo test data, and the biocompatibility data, QuikClot® eX™ is substantially equivalent in efficacy to the predicate devices (QuikClot® Hemostatic Agent (K013390) & QuikClot® Sport™ (K070010)) and in safety to Nu Gauze® All Purpose Dressing (K821150) and QuikClot® Sport™ (K070010).