QuikClot® Interventional™ hemostatic bandage is applied topically as an adjunct to manual compression and is indicated for the local management and control of surface bleeding from vascular access sites, percutaneous catheters or tubes utilizing introducer sheaths up to 12 Fr.

Device Description

QuikClot® Interventional™ hemostatic bandage is a kit that consists of a hemostatic pad and an adhesive bandage. The adhesive bandage is a 3M Tegaderm® 4" x 4-3/4" bandage (reference K973036). The hemostatic pad is a hemostatic dressing made of soft, white, kaolin impregnated gauze, configured in a 1 ½" long by 1 ½" wide by ½" thick multi-layer pad. The pad is held secured in place by stitching with polyester thread. QuikClot® Interventional™ hemostatic bandage is packaged in a plastic tray within a peelable foil pouch and irradiated to a SAL of 104.

AI/ML Overview

The QuikClot® Interventional™ hemostatic bandage is intended for topical application as an adjunct to manual compression for the local management and control of surface bleeding from vascular access sites, percutaneous catheters, or tubes utilizing introducer sheaths up to 12 Fr.

Here's an analysis of the acceptance criteria and the study that supports the device's performance:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Objective)	Reported Device Performance
Achieve hemostasis following removal of percutaneous vascular access catheters.	The device demonstrated hemostasis in a preclinical porcine model following the removal of percutaneous vascular access catheters using either an 8 French or a 12 French tissue dilator. It successfully controlled all bleeding in all 25 vascular access procedures.
Performanceเทียบเท่ากับอุปกรณ์Predicate (for bleeding control)	The device controlled bleeding as effectively as the predicate devices: ChitoFlex-Surgical dressing and D-Stat Dry™ Hemostatic Bandage.
Biocompatibility	The device is composed of identical materials as the QuikClot® eX™ device. Therefore, the successful biocompatibility testing (MEM Elution, Kligman Maximization, and Intracutaneous Injection) for QuikClot® eX™ device applies to QuikClot® Interventional™ hemostatic bandage.

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

Sample Size for Test Set: 25 vascular access procedures.
Data Provenance: Pre-clinical porcine model testing (animal study). The country of origin is not specified but it is an animal-based study, not human. Given the context of a 510(k) submission, it is retrospective to the submission date.

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

The document does not specify the number or qualifications of experts used to establish the ground truth for the pre-clinical porcine model testing. Given it's an animal model, the ground truth would typically be established by veterinarians, researchers, or technicians competent in animal surgery and hemostasis assessment.

4. Adjudication method for the test set:

The document does not explicitly state an adjudication method. In a pre-clinical animal study, adjudication is often implicitly handled by the experimental design, observation protocols, and direct measurement of bleeding cessation by the researchers.

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:

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a hemostatic bandage, not an AI-powered diagnostic or assistive tool, so such a study would not be applicable.

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

No, a standalone (algorithm only) performance study was not done. This device is a physical hemostatic product, not an algorithm.

7. The type of ground truth used:

The ground truth used was the observed cessation of bleeding (hemostasis) in the pre-clinical porcine model following vascular access procedures. This is a direct outcome measurement.

8. The sample size for the training set:

This information is not applicable and therefore not provided. The QuikClot® Interventional™ hemostatic bandage is a physical medical device, not an AI or machine learning model that requires a "training set." The studies conducted were for performance validation.

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

This information is not applicable for the same reason as point 8.

Summary

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July 28, 2023

Z-Medica Corporation c/o Ronald E. Peterson Director of Quality Assurance and Regulatory 4 Fairfield Boulevard Wallingford, Connecticut 06492

Re: K090620 Trade/Device Name: Quikclot® Inteventional™ Regulatory Class: Unclassified Product Code: QSY

Dear Ronald E. 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 April 8, 2009. 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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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR - 8 2009

Z-Medica Corporation % Mr. Ronald E. Peterson Director of Ouality Assurance and Regulatory 4 Fairfield Boulevard Wallingford, Connecticut 06492

Re: K090620

Trade/Device Name: QuikClot® Interventional™ Regulatory Class: Unclassified Product Code: FRO Dated: March 5, 2009 Received: March 9, 2009

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

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Page 2 - Mr. Ronald E. Peterson

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.

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 vours.

Sincerely yours,

Mark M. Millerson

Mark N. Melkerson 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

K090620 510(k) Number (if known):

Device Trade Name: QuikClot® Interventional™

Indications for Use:

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)

Daniel Krone for MXM

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

510(k) Number K090620

March 5, 2009 Z-Medica Corporation 4 Fairfield Blvd., Wallingford, CT 06492, Tel: +1.203.294.0000, Fax: +1.203.294.0688

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K090620

510(k) Summary

APR - 8 2009

Trade Name:	QuikClot® Interventional™ hemostatic bandage
Device Class:	Unclassified
Classification Panel:	General and Plastic Surgery
Classification Name:	Dressing
Classification Code:	FRO
Predicate Device(s):	QuikClot® eX™ (K072474)D-Stat Dry™ Hemostatic Bandage (K061219)ChitoFlex-Surgical dressing (K080818)
Submitted By:	Ronald E. Peterson, Dir. of QA and Regulatory
Company Name:	Z-Medica Corporation
Company Address:	4 Fairfield Blvd., Wallingford, CT 06492
Company Phone:	+1-203-294-0000 x262
Prepared:	March 5, 2009

Description of Device

Intended Use of Device

Prescription Use: QuikClot® Interventional™ hemostatic bandage is applied topically as an adjunct to manual compression and is indicated for the local management and control of surface bleeding from vascular access sites, percutaneous catheters or tubes utilizing introducer sheaths up to 12 Fr.

Discussion of Data to Support Substantial Equivalence

In pre-clinical porcine model testing, QuikClot® Interventional™ hemostatic bandage has demonstrated hemostasis following the removal of percutaneous vascular access catheters. The dressing successfully controlled all bleeding following 25 vascular access procedures when either an 8French or a 12French tissue dilator was used. QuikClot® Interventional™ hemostatic bandage controlled bleeding as effectively as the ChitoFlex-Surgical dressing and the D-Stat Dry™ Hemostatic Bandage predicate devices. QuikClot® Interventional™ hemostatic bandage is composed of identical materials as the QuikClot® eX™ device, therefore the successful biocompatibility testing for QuikClot® eX™ device (MEM Elution, Kligman Maximization, and Intracutaneous Injection) also applies to the QuikClot® Interventional™ hemostatic bandage.

Conclusion

Based on the in-vivo test data and the device description, the QuikClot® Interventional™ hemostatic bandage is substantially equivalent in indications for use and technology to the predicate devices (QuikClot® eX™ (K072474), D-Stat Dry™ Hemostatic Bandage (K061219) and ChitoFlex-Surgical dressing (K080818)).

Regulation Number and Section

N/A