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.

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.

AI/ML Overview

This document is a 510(k) summary for the QuikClot® eX™ device, which describes its substantial equivalence to predicate devices based on in-vitro, in-vivo, and biocompatibility testing. It is a regulatory submission, not a study report, and therefore does not contain acceptance criteria in the typical sense of a clinical trial or algorithm performance study.

Here's an analysis of the provided information in the context of your request:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state numerical acceptance criteria in the format of a table. Instead, it describes the data used to support substantial equivalence and implies that "effectiveness" and "safety" are the underlying criteria.

Acceptance Criteria (Implied)	Reported Device Performance
Efficacy (hemostasis)	• Clotted whole sheep's blood faster than untreated controls (in-vitro).• More effective than untreated controls in the swine model for transection of femoral vessels (in-vivo).• Effective in stopping bleeding of liver, spleen, and mesenteric injuries.
Safety (without burning)	• Promotes hemostasis without the associated heat generation and risk of burning (compared to QuikClot® Hemostatic Agent).• Successfully tested for biocompatibility in four separate laboratory tests.
Substantial Equivalence	• Substantially equivalent in efficacy to QuikClot® Hemostatic Agent (K013390) & QuikClot® Sport™ (K070010).• Substantially equivalent in safety to Nu Gauze® All Purpose Dressing (K821150) and QuikClot® Sport™ (K070010).

2. Sample size used for the test set and the data provenance

The document does not explicitly state specific sample sizes for the "test set" in the context of an AI-driven device. However, it mentions:

In-vitro testing: "whole sheep's blood" - no specific quantity mentioned. Provenance: laboratory.
In-vivo testing: "swine model transection of the femoral vessels" and "liver, spleen and mesenteric injuries" - no specific number of animals mentioned. Provenance: laboratory/animal study.

This is a pre-market notification (510(k)) for a medical device (hemostatic gauze), not an AI algorithm. Therefore, "test set" and "data provenance" as typically understood in AI studies (e.g., country of origin of patient data, retrospective/prospective) are not applicable or detailed in this type of submission. The data provenance is from laboratory and animal studies.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided in the document. For a physical device like a hemostatic gauze, the "ground truth" would be objectively measured physiological outcomes (e.g., time to hemostasis, blood loss, tissue healing) rather than expert interpretation of images or data needing adjudication.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable and not mentioned. Adjudication methods are typically used in studies where human readers provide interpretations (e.g., radiology studies). Here, the "ground truth" is measured directly through laboratory and animal experiments.

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

Not applicable and not mentioned. This type of study is for evaluating the impact of AI algorithms on human reader performance, which is not relevant for a physical hemostatic device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not Applicable. This device is not an algorithm. Its performance is inherent to its physical and chemical properties.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The ground truth for the "studies" mentioned appears to be based on:

In-vitro: Direct measurement of clotting time in sheep's blood.
In-vivo: Direct observation and measurement of hemostasis (stopping bleeding) in a swine model, and assessment of tissue injuries (liver, spleen, mesenteric).
Safety: Biocompatibility testing results (laboratory tests) and lack of heat generation.

These are essentially direct physiological outcomes data from controlled laboratory and animal experiments.

8. The sample size for the training set

Not applicable. This device is not an AI algorithm that requires a "training set."

9. How the ground truth for the training set was established

Not applicable. No training set for an AI algorithm is mentioned or relevant here.

Summary

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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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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.

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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

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Indications For Use

K072474

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

Intended Use of Device

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).

Regulation Number and Section

N/A