The StatGuard® Hemostatic Patch is indicated for use, under the direction of a healthcare professional, in the management and control of surface bleeding from wounds, including vascular access sites.

The StatGuard® Hemostatic Dressing is indicated for use, under the direction of a healthcare professional, in the management and control of surface bleeding from wounds, including vascular access sites.

Device Description

The StatGuard® Devices are based on a non-woven fabric derived from chitosan fibers. The hemostatic properties of chitosan are widely recognized in the biomedical field. When applied directly on a wound with firm pressure, the chitosan material will turn into a gel-like condition to absorb the blood. It promotes control of moderate to severe wound bleeding and exudates absorption, and promotes coagulation. The dressing provides a barrier to bacterial penetration through the dressing and has antibacterial properties that reduce bacterial growth within the dressing. No clinical studies have been conducted on the subject device and the clinical benefit of this antibacterial property is unknown.

The StatGuard® Hemostatic Patch is made of the non-woven fabric derived from chitosan fibers with a polyurethane backing. The StatGuard Hemostatic Patch is a 2" by 2" dressing that is placed directly over a wound for external control of bleeding. The Patch may be used with patients following a vascular procedure, hemodialysis, or other procedures resulting in bleeding wounds.

The StatGuard Hemostatic Patch is individually packaged in a peelable foil pouch and is sterilized by gamma irradiation. The hemostatic properties of chitosan enhance the ability of the StatGuard Hemostatic Patch to control bleeding.

The StatGuard® Hemostatic Dressing is made of the non-woven fabric derived from chitosan fibers with the addition of a backing that extends past the margins of the patch, with a pressure sensitive adhere to adhere to the patient. The StatGuard Hemostatic Dressings are provided in various sizes. The Dressing may be used with patients who have wounds that are bleeding or may be prone to bleeding. The hemostatic properties of chitosan enhance the ability of the StatGuard Hemostatic Dressing to control bleeding. The StatGuard® Hemostatic Dressings are packaged in a polyester laminated film pouch. Sterilization is by gamma radiation.

AI/ML Overview

The provided text describes the StatGuard® Hemostatic Patch and StatGuard® Hemostatic Dressing, which are unclassified wound dressings utilizing chitosan for hemostatic properties. The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to legally marketed predicate devices, rather than an in-depth study proving novel device performance against specific acceptance criteria. Therefore, the information regarding acceptance criteria and a structured study demonstrating the device meets those criteria, as typically found in a clinical trial report for an AI/ML device, is not fully present or applicable in the context of this traditional medical device submission.

However, based on the non-clinical testing section, we can infer some "acceptance criteria" and "reported performance" for specific tests.

1. Table of Acceptance Criteria and Reported Device Performance

Test Category	Specific Test	Acceptance Criteria (Inferred)	Reported Device Performance
Biocompatibility	Cytotoxicity	Meet ISO 10993 requirements (Non-cytotoxic)	Devices are non-cytotoxic.
	Intracutaneous Irritation	Meet ISO 10993 requirements (Non-irritant)	Devices are non-irritants.
	Skin Sensitization	Meet ISO 10993 requirements (Non-sensitizing)	Devices are non-sensitizing.
	Acute Intravenous Systemic Toxicity	Meet ISO 10993 requirements (No significant systemic toxicity)	Devices are non-pyrogenic (implies acceptable systemic toxicity, as pyrogenicity is a measure of acute systemic toxicity). Acute intraperitoneal systemic toxicity and acute intravenous systemic toxicity mentioned, but only pyrogenicity explicitly linked to the non-pyrogenic conclusion.
	Acute Intraperitoneal Systemic Toxicity	Meet ISO 10993 requirements (No significant systemic toxicity)	(Implicitly met if "non-pyrogenic" is stated)
	Endotoxin	Meet ISO 10993 requirements (Acceptable endotoxin levels)	(Presumably met if "non-pyrogenic" is stated)
	Hemolysis	Meet ISO 10993 requirements (Non-hemolytic)	(Implicitly met, no explicit mention but part of bio-compat suite)
	Rabbit Pyrogen	Meet ISO 10993 requirements (Non-pyrogenic)	Devices are non-pyrogenic.
Bench Performance	In-vivo Hemostasis	Substantially equivalent efficacy to predicate device	Exhibited substantially equivalent efficacy in controlling bleeding to the predicate, AnsCare ChitoClot Gauze.
	Antibacterial (within dressing)	> 4 Log Reduction in bacterial growth (AATCC 100)	Met > 4 log reduction for Micrococcus luteus, Streptococcus mutans, Streptococcus pneumoniae, Streptococcus pyogenes, Acinetobacter baumannii, Klebsiella pneumoniae, Proteus mirabilis, Pseudomonas aeruginosa. Did not meet criteria for Escherichia coli (3.88 log reduction).
	Microbial Barrier	Demonstrated barrier properties	Demonstrated microbial barrier properties.
Sterilization	Sterility	10⁻⁶ Sterility Assurance Level (SAL) per ISO 11137	Achieved a 10⁻⁶ SAL using the VDmax25 method and gamma irradiation.

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

This document is for a traditional physical medical device (hemostatic patch/dressing), not an AI/ML device. Therefore, the concepts of "test set" and "data provenance" in the context of AI/ML are not directly applicable. The non-clinical tests typically involve in-vitro, in-vivo (animal), and laboratory tests on device samples, not a clinical "test set" of patient data.

Sample sizes for non-clinical tests: Not explicitly stated for each test (e.g., number of animals for in-vivo hemostasis, number of samples for antibacterial test).
Data Provenance: The tests are laboratory-based, conducted on device samples. The country of origin of the data is not specified, but it would be from the testing facilities performing the evaluations according to the mentioned standards (e.g., ISO, AATCC). The studies are retrospective in the sense that they are conducted on manufactured devices before market release, but they are prospective in design, meaning the tests were planned and executed to evaluate the device.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This concept is not relevant for this traditional medical device submission. Ground truth, in the AI/ML sense, does not apply here. The "truth" is established by direct measurement against scientific and regulatory standards (e.g., ISO 10993 for biocompatibility, AATCC 100 for antibacterial properties).

4. Adjudication Method

Not applicable. Adjudication methods (like 2+1, 3+1) are for resolving discrepancies in expert interpretations, typically for image reviews or clinical assessments in AI/ML studies. This device's testing involves objective laboratory measurements.

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

No. This is not an AI/ML device, and therefore, an MRMC comparative effectiveness study comparing human readers with and without AI assistance was not conducted. The comparison is between the performance of the StatGuard device and its predicate devices based on non-clinical characteristics and established safety/efficacy.

6. Standalone (Algorithm Only) Performance Study

No. This is a physical medical device. There is no algorithm to evaluate in a standalone manner.

7. Type of Ground Truth Used

The "ground truth" for this device's evaluation is primarily based on:

Established Industry and Regulatory Standards: E.g., ISO 10993 for biocompatibility, AATCC 100 for antibacterial effectiveness, ISO 11137 for sterilization.
Performance Metrics: Measured against predefined benchmarks or directly compared to predicate device performance (e.g., "substantially equivalent efficacy in the ability to control bleeding").
Objective Laboratory Measurements: Data obtained from chemical analysis, biological assays, and physical tests.

8. Sample Size for the Training Set

Not applicable. This is not an AI/ML device that requires a training set. The device manufacturing processes and materials are developed through R&D, not trained on data.

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

Not applicable. As there is no training set for an AI/ML algorithm, this question is not relevant to the StatGuard Hemostatic Patch/Dressing.

Summary

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April 21, 2023

StatGuard, LLC Gary Mills President 7555 Cason Lane Gladstone, Oregon 97027

Re: K172155

Trade/Device Name: StatGuard Hemostatic Patch, StatGuard Hemostatic Dressing Regulatory Class: Unclassified Product Code: QSY

Dear Gary Mills:

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 12, 2018. 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/8 description: The image shows the signature block of Julie A. Morabito. It includes her name, followed by "-S". Below that is her name again, followed by "Ph.D.", and her title as Assistant Director. The block also lists DHT4B: Division of Infection Control and Plastic Surgery Devices, OHT4: Office of Surgical and Infection Control Devices, and Office of Product Evaluation and Quality.

Center for Devices and Radiological Health

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April 12, 2018

StatGuard, LLC Gary Mills President 7555 Cason Lane Gladstone, Oregon 97027

Re: K172155

Trade/Device Name: StatGuard Hemostatic Patch, StatGuard Hemostatic Dressing Regulatory Class: Unclassified Product Code: FRO Dated: March 1, 2018 Received: March 6, 2018

Dear Gary Mills:

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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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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Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

David Krause -S

for Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K172155

Device Name

StatGuard® Hemostatic Patch and StatGuard® Hemostatic Dressing

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
☑ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary K172155

StatGuard, LLC Submitter's name: 7555 Cason Lane Gladstone, OR 97027

Contact name and address:	Gary Mills, President
	7555 Cason Lane
	Gladstone, OR 97027
	(503-657-4059)

Date summary prepared: 12 March 2018

Device name:

Proprietary name:	StatGuard® Hemostatic Patch
	StatGuard® Hemostatic Dressing
Common or usual name:	Wound Dressing
Classification:	Unclassified
Classification name:	Dressing, Wound, Drug
Classification product code:	FRO

Legally marketed devices for substantial equivalence comparison:

The primary predicate device for this submission is the AnsCare ChitoClot Gauze from BenQ Materials Corp. (K143462). Additional predicate devices are identified as ChitoGauze from HemCon Medical Technologies, Inc. (K090026), and CELOX Vascular from Medtrade Products Ltd. (K093519).

Description of the device:

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Dressing	Chitosan pad size	Overall size
StatGuard ® Hemostatic Dressing, Small	2 cm x 3 cm	4 cm x 6 cm
StatGuard ® Hemostatic Dressing, Regular	4 cm x 6 cm	8 cm x 10 cm
StatGuard ® Hemostatic Dressing, Large	5 cm x 7 cm	10 cm x 12 cm

The StatGuard® Hemostatic Dressings are initially provided in sizes as shown:

Intended use of the device:

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Technological characteristics:

The device features of the StatGuard® Hemostatic Patch and of the StatGuard® Hemostatic Dressing are similar to predicate devices, in that all use the hemostatic properties of chitosan to promote hemostasis of a bleeding wound. The Hemostatic Patch is a pad with a backing layer adhered on the back of the pad, only. The Hemostatic Dressing is a pad with an adhesive backing that extends past the margins of the patch to provide adhesion to the patient. Release liners are removed as the dressing is applied to the patient.

Non-clinical Testing:

Biocompatibility Testing:

Cytotoxicity -
Intracutaneous Irritations -
-Skin Irritation
-Skin Sensitization
Acute Intravenous Systemic Toxicity -
Acute Intraperitoneal Systemic Toxicity -
-Endotoxin
Hemolysis -
Rabbit Pyrogen -

Bench Performance Testing Including Function Testing:

-Platelet Aggregation
-Thromboelasticity
-Antibacterial within the dressing
-Microbial Barrier
Heavy Metal -
Protein Content -
Residual Ethanol -
Sterilization Validation -
Package Validation -
Shelf Life -

Animal Test:

In-vivo Hemostasis
StatGuard® Hemostatic Patches and Hemostatic Dressings were subjected a series of non-clinical studies. All the test results demonstrate that the submitted devices meet the requirements of the pre-defined acceptance criteria, specifications, and intended uses and are substantially equivalent to the predicate devices. Biocompatibility testing included cytotoxicity, sensitization, irritation, acute system toxicity, hemolysis, and pyrogenicity was conducted in accordance with ISO 10993. Antibacterial activity has been demonstrated within the dressing per AATCC 100,

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Assessment of Antibacterial Finishes on Textile Materials. Microbial Barrier performance testing has also been conducted.

The StatGuard® Hemostatic Patches and StatGuard® Hemostatic Dressings exhibited substantially equivalent efficacy in the ability to control bleeding to their predicate, AnsCare ChitoClot Gauze. All tests demonstrated the materials and processes used in the design and manufacture of the devices are non-cytotoxic, non-sensitizing, non-irritants and non-pyrogenic. The StatGuard® Hemostatic Patch and StatGuard® Hemostatic Dressing demonstrated microbial barrier properties.

The gauze used in the StatGuard® Hemostatic Patch and StatGuard® Hemostatic Dressing was tested for antibacterial effectiveness against gram- and gram- bacterial strains per invitro testing based on a modified AATCC Test Method 100:

Microorganism:	Gram Stain	Log Reduction
Micrococcus luteus ATCC 4698	+	> 4
Streptococcus mutans ATCC 25175	+	> 4
Streptococcus pneumoniae ATCC 33400	+	> 4
Streptococcus pyogenes ATCC 12344	+	> 4
Acinetobactor baumannii ATCC 19606	-	> 4
Klebsiella pneumoniae ATCC 4352	-	> 4
Proteus mirabilis ATCC 25933	-	> 4
Pseudomonas aeruginosa ATCC 9027	-	> 4
Escherichia coli ATCC 8739	-	3.88 *

Test results for E. coli did not meet the > 4 log reduction acceptance criteria.

The data demonstrates the bacteriostatic and bactericidal effectiveness within the dressing of the StatGuard® Hemostatic Patch and the StatGuard® Hemostatic Dressing.

Sterility Testing:

The StatGuard® Hemostatic Patch and the StatGuard® Hemostatic Dressing are gamma radiation sterilized. Sterility testing was conducted per ISO 11137 requirements to demonstrate a 10° SAL using the VDmax25 method.

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Substantial Equivalence Comparison:

	Submitted Device	Predicate Device	Predicate Device	Predicate Device
Item	StatGuard® Hemostatic	AnsCare ChitoClot	ChitoGauze	CELOX Vascular
	Patch and Dressing	Gauze	(HemCon Medical	(Medtrade Products,
		(BenQ Materials Corp.)	Technologies, Inc.)	LTD)
K number	K172155	K143462	K090026	K093519
Classification	Unclassified	Unclassified	Unclassified	Unclassified
Product Code	FRO	FRO	FRO	FRO
Combination Product	No	No	No	No
Common or Usual	Wound Dressing	Dressing	Dressing	Dressing
Name
Applicable Device	None	None	None	None
Standards
Prescriptive Use	Yes	Yes	Yes	Yes
Indications for Use	The StatGuard®	For use as a temporary	ChitoGauze is a	CELOX Vascular is
(prescriptive use)	Hemostatic Patch is	external dressing to	hemostatic dressing for	indicated for the local
	indicated for use, under	control moderate to	the external, temporary	management and control
	the direction of a	severe bleeding and	control of severely	of surface bleeding from
	healthcare professional,	manage external	bleeding wounds.	vascular access sites,
	in the management and	abrasions, lacerations.		percutaneous catheters
	control of surface			or tubes utilizing
	bleeding from wounds,			introducer sheaths up to
	including vascular			16 French.
	access sites.

	The StatGuard®
	Hemostatic Dressing is
	indicated for use, under
	the direction of a
	healthcare professional,
	in the management andcontrol of surface
	bleeding from wounds,
	including vascular
	access sites.
Physical Composition	Soft absorbent, non-	Soft absorbent, non-	Polyester/rayon blend	CELOX hemostatic
	woven gauze, with	woven gauze	non-woven medical	granules heat bonded
	backing material or with		grade gauze coated with	onto a viscous sheet
	adhesive dressing		chitosan
Requires separate	Yes (patch)	Yes	Yes	Yes
wrap or adhesive	No (dressing)

Hemostatic Material	Chitosan (Poly N-	Chitosan (Poly N-	Chitosan	Chitosan
	acetyl-glucosamine)	acetyl-glucosamine)
Chitosan Form	Non-woven fabric	Non-woven fabric	Coated on gauze	Granules
	derived from chitosan	derived from chitosan
	fibers	fibers
Antibacterial within the	Yes	Not claimed	Yes	Not claimed
dressing
Sterility	Gamma-Sterilized	Gamma-Sterilized	Gamma-Sterilized	Gamma-Sterilized
Packaging	Foil pouch (patch)	Foil pouch	Foil pouch	Foil pouch
	Polyester pouch
	(dressing)
Duration of use	Temporary	Temporary	Temporary	Temporary
Specifications	2" x 2" (patch)	Various widths and roll	4" x 4 yds.,	2" x 2"
	various (dressing)	lengths	z-folded

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Summary of Substantial Equivalence:

The StatGuard® Hemostatic Patch and the StatGuard® Hemostatic Dressing passed all testing and are as safe and effective and substantially equivalent to the indicated predicate devices. Any differences in technological characteristics between the StatGuard® Hemostatic Patch and the StatGuard® Hemostatic Dressings and the predicate devices do not raise new questions about safety and effectiveness.

Regulation Number and Section

N/A