QuikClot 1st Response™ and QuikClot ACS+™ are essentially the same device, but in two different sizes. Both devices are mesh bags containing zeolite beads. The devices are vacuum packed in multi-layer pouches to ensure sterility and efficacy.

AI/ML Overview

This document ([K061767](https://www.accessdata.fda.gov/cdrh_docs/reviews/[K061767](https://510k.innolitics.com/search/K061767).pdf)) is a 510(k) summary for the QuikClot 1st Response™ & QuikClot ACS+™ devices. It focuses on demonstrating substantial equivalence to a predicate device, rather than defining specific acceptance criteria for performance against a clinical endpoint. Therefore, the information provided below is extracted from the 510(k) summary regarding the studies conducted to support substantial equivalence, particularly focusing on the safety improvement and non-inferiority in efficacy.

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria (Implied) and Reported Device Performance

Parameter / Test	Acceptance Criteria (Implied)	Reported Device Performance
Biocompatibility	All component materials and the finished device must pass ISO Standard 10993-1:1997.	All component materials and the finished device passed ISO Standard 10993-1:1997.
Heat Reduction (Safety)	Eliminate the risk of burns to caregivers and patients.	In-vitro: Peak temperature reduced from 190°F (predicate device) to 90°F (device modification) when mixed with an excess of water.In-vivo (preclinical animal wound model): Caregivers experienced a peak temperature of 106°F and agreed that the risk of burns was eliminated, describing the heat generated as "warm."
Clotting Efficacy (Non-inferiority)	Maintain clotting efficacy not inferior to the predicate device.	In-vitro: Both the predicate device zeolite and the reformulated zeolite took less than 3 minutes to form a clot, while whole blood without zeolite took longer than 6 minutes. (Demonstrates efficacy comparable to predicate and superior to no treatment).
In-vivo Efficacy (Non-inferiority)	Demonstrate substantial equivalence to the predicate device in in-vivo models.	In-vivo testing in various swine models was used to demonstrate substantial equivalence to the predicate device. (Specific quantitative results are not provided in the summary, but the conclusion states substantial equivalence was demonstrated).

2. Sample Size Used for the Test Set and Data Provenance

Heat Reduction Studies:
- In-vitro: "an excess of zeolite was mixed with water." No specific numerical sample size is given for the in-vitro heat test.
- In-vivo (preclinical animal wound model): "Care givers that evaluated the product in a preclinical animal wound model..." While an animal model is mentioned, the exact number of animals or trials within this model is not specified.
- Data Provenance: The document does not specify the country of origin for these studies. It implies they are part of the manufacturer's pre-clinical testing. It is retrospective data as it supports a 510(k) submission.
Clotting Time Studies:
- In-vitro: No specific numerical sample size for the samples tested (e.g., number of blood samples, replicates) is given for the in-vitro clotting time test. It compares "the zeolite formulation used in the predicate device," "the reformulated zeolite," and "whole blood without zeolite."
- Data Provenance: The document does not specify the country of origin for these studies. It implies they are part of the manufacturer's pre-clinical testing. Retrospective data.
In-vivo Efficacy Studies:
- "In-vivo testing in various swine models..." No specific numerical sample size (number of swine or trials) is provided.
- Data Provenance: The document does not specify the country of origin for these studies. It implies they are part of the manufacturer's pre-clinical testing. Retrospective data.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

Heat Reduction (In-vivo): "Care givers that evaluated the product in a preclinical animal wound model experienced a peak temperature of 106 F and agreed that the risk of burns was eliminated."
- Number of Experts: Not specified beyond "Care givers" (plural).
- Qualifications: Referred to as "Care givers." No specific qualifications (e.g., type of medical professional, years of experience) are provided.
Other Studies (Biocompatibility, Clotting Time, In-vivo Efficacy): The document does not describe the use of human experts to establish "ground truth" for the test sets in these studies in the way a clinical trial might, but rather relies on objective measurements (temperature, clotting time) or expert interpretation of animal model outcomes, which is inherent in pre-clinical research.

4. Adjudication Method for the Test Set

Heat Reduction (In-vivo): For the in-vivo heat assessment, it states "Care givers...agreed that the risk of burns was eliminated." This implies a consensus or agreement among the unspecified number of caregivers. It does not describe a formal adjudication method like 2+1 or 3+1.
Other studies: Adjudication methods are not applicable nor described for the objective measurements in the other pre-clinical tests.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This document describes pre-clinical testing for a device modification, focusing on safety (heat reduction) and non-inferiority in efficacy in lab and animal models, not on human reader performance with or without AI assistance.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

This question is not applicable. The device is a physical medical product (hemostatic dressing), not an algorithm or AI system. Therefore, standalone algorithm performance is not relevant.

7. The Type of Ground Truth Used

Biocompatibility: Demonstrated by passing ISO Standard 10993-1:1997. The ground truth is adherence to the standard's requirements, likely via lab testing and analysis by qualified personnel.
Heat Reduction:
- In-vitro: Objective temperature measurements. The ground truth is the peak temperature recorded.
- In-vivo: Direct observation and subjective feedback ("warm," "risk of burns eliminated") from "Care givers" in a preclinical animal model.
Clotting Efficacy: Objective measurement of clotting time in a controlled in-vitro setting. The ground truth is the time to clot formation.
In-vivo Efficacy: Outcomes from "various swine models." The specific endpoints for "substantial equivalence" are not detailed but would typically involve measures of blood loss, time to hemostasis, or survival rates compared to the predicate device in controlled injury models.

8. The Sample Size for the Training Set

This question is not applicable. This is a physical medical device, not an AI/ML algorithm that requires a "training set."

9. How the Ground Truth for the Training Set Was Established

This question is not applicable, as there is no "training set" for this physical medical device.

Summary

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June 11, 2023

Z-Medica Corporation c/o Robert V. Packard Director of Regulatory Affairs 4 Fairfield Boulevard Wallingford, Connecticut 06492

Re: K061767 Trade/Device Name: QuikClot 1st ResponseTM & QuikClot ACS+TM Regulatory Class: Unclassified Product Code: QSY

Dear Robert V. Packard:

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 July 19, 2006. 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: This image shows the closing of a letter, including the name and title of the sender. The sender is Julie A. Morabito, Ph.D., who is the Assistant Director of DHT4B: Division of Infection Control and Plastic Surgery Devices. The letter also includes the sender's office, which is OHT4: Office of Surgical and Infection Control Devices, Office of Product Evaluation and Quality, and Center for Devices and Radiological Health.

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JUL 1 9 2006

Z-Medica Corporation % Mr. Robert V. Packard Director of Regulatory Affairs 4 Fairfield Boulevard Wallingford, Connecticut 06492

Re: K061767

Trade/Device Name: QuikClot 1st Response™ & QuikClot ACS+"" Regulatory Class: Unclassified Product Code: FRO Dated: June 22, 2006 Received: June 23, 2006

Dear Mr. Packard:

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. 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

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Page 2 - Mr. Robert V. Packard

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,

Barbara Buechner

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

510(k) Number (if known): TBD Ko 61-76 7

Device Trade Names: QuikClot 1st Response™ & QuikClot ACS+""

Device Common Name: Advanced Clotting Sponge

Indications For Use:

This device is intended for temporary external use to control traumatic bleeding.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (Part 21 CFR 801 Subpart C)

(Part 21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Barbara Buchmo
Division Sign Off

Division of General, Restorative, and Neurological Devices

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510(k) Number K061767

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510(k) Summary for QuikClot 1* Response™ & QuikClot ACS+™

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510(k) Summary

			JUL 19 2006
Trade Names:	QuikClot 1st Response™ & QuikClot ACS+™
Device Class:	Class 1
Classification Panel:	General and Plastic Surgery
Common Name:	Traumatic Wound Dressing
Classification Name:	Dressing
Classification Code:	FRO
Predicate Device:	QuikClot ACS™ Advanced Clotting Sponge510(k) No. K051955
Submitted By:	Robert V. Packard, Dir. of Regulatory Affairs
Company Name:	Z-Medica Corporation
Company Address:	4 Fairfield Blvd., Wallingford, CT 06492
Company Phone:	+1-203-294-0000 x262
Prepared:	June 22, 2006

Description of Device

QuikClot 1* Response™ and QuikClot ACS+'" are essentially the same device, but in two different sizes. Both devices are mesh bags containing zeolite beads. The devices are vacuum packed in multi-layer pouches to ensure sterility and efficacy. Product attributes of the two sizes are provided in the table below.

Attribute	QuikClot 1st Response™	QuikClot ACS+™
Intended Use	For Temporary External Use ToControl Traumatic Bleeding	For Temporary External Use ToControl Traumatic Bleeding
Mesh Bags PerUnit	One	One
Net Weight ofZeolite	0.88oz	3.5oz
Mesh BagDimensions	3.5"x3.5"	10"x5"
Baffling	No baffles – 1 compartment with3.5oz of zeolite	3 baffles – creating 4 compartmentswith 0.88oz of zeolite each
PrimaryPackaging	4.5"x4.5" multi-layer pouch,vacuum-packed	6"x6.5" multi-layer pouch, vacuum-packed
Sterilization	gamma sterilization - 25-50kGy(SAL = 10-6)	gamma sterilization - 25-50kGy(SAL = 10-6)

Intended Use of Device

For temporary external use to control traumatic bleeding (prescription only).

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Summary of Technological Characteristics Compared to Predicate Device

This is a device modification of QuikClot ACS™ Advanced Clotting Sponge (K051955). Both sizes of the device modification make use of the same mesh fabric used for the predicate device, the same primary package construction, and the same production process. The following are improvements made to the predicate device:

1. The zeolite beads were reformulated to reduce the heat of adsorption. Although generation of heat remains an intimate part of zeolite's mechanism of action, the risk of burns to caregivers and patients has been eliminated by the device modification.
1. A blue silicone rod, Class VI medical grade, with barium sulfate has been added to each mesh bag. This change allows medical personnel to locate the mesh bag with an X-ray if accidentally left in a wound.
Baffles were added to the larger size mesh bag, 10″x5″, to facilitate application of the 3. zeolite beads to larger wounds.
Directions for use were simplified from the directions for the predicate device. The 4. predicate device instructed the care giver to use pressure to control the bleeding first, and then apply the product if pressure failed to control bleeding. Since this device modification eliminates the risk of burns, the care giver is not instructed to control bleeding with pressure alone first.

Discussion of Data to Support Substantial Equivalence

ISO Standard 10993-1:1997 was followed for demonstrating biocompatibility of the component materials and the finished device—all passed. In order to substantiate that the risk of burns has been eliminated, in-vitro and in-vivo temperature measurements were made. In in-vitro testing, an excess of zeolite was mixed with water. The peak temperature was reduced from 190 F (predicate device) to 90 F (device modification). Care givers that evaluated the product in a preclinical animal wound model experienced a peak temperature of 106 F and agreed that the risk of burns was eliminated. Care givers described the heat generated as "warm".

In-vitro test data measuring the clotting time of whole blood was used to demonstrate that the device modification is not inferior in efficacy to the predicate device. The zeolite formulation used in the predicate device and the reformulated zeolite took less than 3 minutes to form a clot, while whole blood without zeolite took longer than 6 minutes to form a clot. In-vivo testing in various swine models was used to demonstrate substantial equivalence to the predicate device.

Conclusions

Based on the design, biocompatibility data, in-vitro test data, pre-clinical test results, and intended use, QuikClot 1* Response™ and QuikClot ACS+™ are substantially equivalent to the predicate device (QuikClot ACS™ - Advanced Clotting Sponge K051955).

Regulation Number and Section

N/A