HemCon GuardaCare™XR is a hemostatic dressing intended for the temporary control of severely bleeding wounds such as surgical wounds and traumatic injuries.

Device Description

The GuardaCare™XR dressing is composed of a radiopaque element attached to standard polyester/ravon blend non-woven medical gauze that is coated with chitosan. The product is produced in multiple sizes; e.q. two (2) inches by two (2) inches, eightply: four (4) inches by four (4) inches, eight-ply; and four (4) inches by two (2) yards (zfolded 4"x4"). All sizes are a single continuous length that is z-folded to the appropriate size. The products are double-pouched. The inner pouch is peelable foil and the outer pouch is clear peelable polvethylene terephthalate (PET). The pouched dressings are terminally sterilized with gamma irradiation to a sterility assurance level (SAL) of 10 °. The hemostatic properties of chitosan enhance the ability of the medical gauze to control bleeding. The radiopaque element allows for easy detection via x-ray to prevent the dressing from being inadvertently left in a surgical cavity.

AI/ML Overview

This document describes the GuardaCare™XR hemostatic dressing, and its substantial equivalence (SE) to a predicate device, mRDH Bandage (K082703). The information provided is primarily focused on demonstrating this substantial equivalence through non-clinical performance data, rather than detailing a specific clinical study with acceptance criteria. Therefore, most of the requested information regarding acceptance criteria, sample sizes, expert ground truth, and adjudication methods for a clinical study is not available in the provided text.

However, I can extract the available information regarding the device's performance and the non-clinical studies conducted.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document does not explicitly state "acceptance criteria" for each test in a quantitative manner as would typically be found in a clinical study report. Instead, it describes what each test demonstrated or determined in relation to the predicate device or a standard.

Performance Attribute	Acceptance Criteria (Implicit from Study Outcomes)	Reported Device Performance
Biocompatibility	Demonstrated per ISO 10993.	Demonstrated.
Hemostatic Efficacy	Control bleeding at least as well as a competitive hemostatic dressing.	Successfully controlled bleeding at least as well as the competitive product used as a reference.
Sterility	Achieve a sterility assurance level (SAL) of 10⁻⁶ per ISO 11137:2006.	Achieved a 10⁻⁶ SAL using the VDmax method.
Radiopacity	Equivalent to the radiopacity of the ASTM Radiopacity Standard (101x76x0.9 millimeter 99+% 1100 alloy aluminum sheet).	Found to be equivalent to the ASTM Radiopacity Standard and therefore determined to be acceptable.

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

The document describes in vivo efficacy studies in swine.

Sample Size: Not explicitly stated as a numerical value for each group, but refers to "a swine" in singular for each type of injury. This implies animal models were used.
Provenance: Animal study (swine model), likely prospective within the context of the study design. The country of origin is not specified but is implied to be where the studies were conducted for regulatory submission in the US.

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

Not applicable / Not provided. The studies described are non-clinical in vivo (animal model) and laboratory tests (biocompatibility, sterility, radiopacity), not human clinical trials requiring expert-established ground truth.

4. Adjudication Method for the Test Set

Not applicable / Not provided. This information is typically relevant for studies involving human interpretation or subjective assessments, which are not detailed here.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No such study was mentioned. The document explicitly states: "Based upon the substantial equivalence determination for the predicate device, no clinical data is required for evaluation of this device."

6. Standalone (Algorithm Only Without Human-in-the-loop Performance) Study

Not applicable. This device is a physical wound dressing, not a software algorithm.

7. Type of Ground Truth Used

For in vivo efficacy: Direct observation of bleeding control in a live animal model (swine). This is a functional outcome.
For biocompatibility: Laboratory test results against ISO 10993 standards.
For sterility: Laboratory validation following ISO 11137:2006 requirements.
For radiopacity: Laboratory testing in accordance with ASTM F640-07 Method C against a specified standard.

8. Sample Size for the Training Set

Not applicable / Not provided. This concept of a "training set" is primarily relevant for machine learning algorithms. The studies described are traditional non-clinical performance evaluations.

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

Not applicable / Not provided. As mentioned above, there is no "training set" in the context of these device evaluations.

Summary

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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

HemCon Medical Technologies, Inc. c/o Kevin Hawkins VP, Quality & Regulatory Affairs 10575 SW Cascade Avenue, Suite 130 Portland, Oregon 97223-4363

July 28, 2023

Re: K103641 Trade/Device Name: Guardacare™ XR Regulatory Class: Unclassified Product Code: QSY

Dear Kevin Hawkins:

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 June 16, 2011. 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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Image /page/1/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines forming its body and wings. The bird is positioned to the right of a circular emblem that contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference of the circle. The text is in uppercase letters and is oriented to follow the curve of the circle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

HemCon Medical Technologies, Inc. % Mr. Kevin Hawkins VP, Quality & Regulatory Affairs 10575 SW Cascade Avenue, Suite 130 Portland, Oregon 97223-4363

Re: K103641

Trade/Device Name: GuardaCare™ XR Regulatory Class: Unclassified Product Code: FRO Dated: June 13, 2011 Received: June 14, 2011

JUN 1 6 201

Dear Mr. Hawkins:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Mr. Kevin Hawkins

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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.html for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Eric S. Keith

Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Section 4: Indications for Use Statement

Applicant: HemCon Medical Technologies, Inc. 510(k) Number: K103641 Device Name: GuardaCare™XR

Indications for Use:

HemCon GuardaCare™XR is a hemostatic dressing intended for the temporary control of severely bleeding wounds such as surgical wounds and traumatic injuries.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use | (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)

Daniel Kurebeki MXU

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K103641

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JUN 1 6 2011

Section 5: 510(k) Summary

Trade Name:	GuardaCare™XR
Common Name:	Wound Dressing
Classification Name:	Dressing
Product Code:	FRO/KMF
Predicate Device(s):	mRDH Bandage - K082703
Company Name:	HemCon Medical Technologies, Inc.
Company Address:	10575 SW Cascade Avenue, Suite 130
	Portland, OR 97223
Contact Person:	Kevin Hawkins
	Director - Quality & Regulatory
Contact Phone:	(503)245.0459 x114
Contact Fax:	(503)245.1326
Date of Preparation:	10 June 2011

Description of the Device:

The hemostatic properties of chitosan enhance the ability of the medical gauze to control bleeding. The radiopaque element allows for easy detection via x-ray to prevent the dressing from being inadvertently left in a surgical cavity.

Intended Use:

GuardaCare™XR is a hemostatic dressing intended for the temporary control of severely bleeding wounds such as surgical wounds and traumatic injuries.

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Technological Characteristics:

GuardaCare™XR is technologically similar to the predicate device. The mRDH dressing has demonstrated the safety and efficacy of a poly-N-acetylglucosamine based dressing for use in surgical procedures. It also has demonstrated the safety and efficacy of a gauze product with an integrated radiopaque element. GuardaCare ™XR is a poly-Nacetylglucosamine-based hemostatic with an x-ray detectable feature. It is therefore technologically similar to the mRDH dressing.

Non-Clinical Performance Data:

Biocompatibility

Biocompatibility has been demonstrated per ISO 10993.

In Vivo Efficacy

Two separate in vivo studies were designed and conducted to establish the hemostatic efficacy of the product in different injury types that were created to represent the likely use of the different product sizes. In both studies the device was tested side-by-side against a competitive hemostatic dressing. The first study tested the ability of the 4 inch by 4 yard size to control bleeding in 6mm femoral perforation injury in a swine. The second study measured the ability of a two inch by two inch 8-ply size to control bleeding in a splenic capsular strip injury in a swine. In both cases, the device proved to successfully control bleeding at least as well as the competitive product used as a reference.

Sterility

A sterility validation for GuardaCare™XR was completed following ISO 11137:2006 requirements to demonstrate a 10-8 SAL using the VDmax method.

Radiopacity:

The radiopacity of GuardaCareXR was determined via testing performed in accordance with ASTM F640-07 Method C (Standard Test Methods for Determining the Radiopacity for Medical Use). The product was found to be equivalent to the radiopacity of the ASTM Radiopacity Standard (101x76x0.9 millimeter 99+% 1100 alloy aluminum sheet) and was therefore determined to be acceptable.

Clinical Performance Data:

Based upon the substantial equivalence determination for the predicate device, no clinical data is required for evaluation of this device.

Substantial Equivalence:

The conclusion drawn from the technological characteristics and non-clinical performance data is that the device is as safe and effective as the predicate devices.

Regulation Number and Section

N/A