ChitoGauze™ is a hemostatic dressing for the external, temporary control of severely bleeding wounds. ChitoGauze™ is intended for temporary external use to stop bleeding of minor wounds, minor cuts and minor abrasions.

Device Description

The ChitoGauze dressing is composed of standard polyesterfrayon blend non-woven medical gauze that is coated with chitosan. This submission adds models of various dimensions to the legally marketed four inch by four yard (4" x 4 yds) dressing. ChitoGauze dressings are z-folded and packaged in a peelable foil pouch. The pouched dressing is terminally sterilized with gamma irradiation to a sterility assurance level (SAL) of 10th. The hemostatic properties of chitosan enhance the ability of the medical gauze to control bleeding.

AI/ML Overview

The provided text is a 510(k) summary for the ChitoGauze™ wound dressing, which focuses on an administrative change regarding the device's product code and the addition of various dimensional sizes to the already legally marketed dressing.

Based on the content, this document does not contain the kind of information requested regarding acceptance criteria and a study proving a device meets those criteria, specifically concerning performance metrics like sensitivity, specificity, accuracy, or reader study results. The provided text is a regulatory filing, not a clinical study report.

Here's a breakdown of why the requested information cannot be extracted from this document:

Acceptance Criteria Table & Reported Device Performance: This document does not define quantitative acceptance criteria for device performance (e.g., how effectively it stops bleeding in a clinical or simulated setting) nor does it report device performance against such criteria. The "Log Reduction" table (Image 5) shows antibacterial effectiveness, but this is a characteristic, not a primary hemostatic performance metric with predefined acceptance limits for market clearance in this context. The 510(k) summary explicitly states for the changes under review (addition of various sizes) that "Changing the dimensional size of the dressing has no effect upon the technological characteristics."
Sample Size, Test Set, and Data Provenance: Not applicable. There is no specific test set data for performance outlined for the current submission, as it relates to adding new sizes of an already cleared device.
Number of Experts & Qualifications for Ground Truth: Not applicable. No ground truth was established for performance metrics in this submission using experts.
Adjudication Method: Not applicable. No adjudication process for performance data is described.
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not applicable. This type of study is not mentioned as it's not relevant to the administrative change and size additions. The device is a wound dressing, not an AI-assisted diagnostic tool.
Standalone Performance Study: Not applicable in the context of typical AI/diagnostic device performance. The non-clinical performance data section (Image 5) discusses "Biocompatibility" and "Reduction of Microorganisms" testing, but these are not 'standalone performance' in the sense of an algorithm's output. The antibacterial effectiveness is presented as a characteristic.
Type of Ground Truth Used: Not applicable for performance. The "ground truth" for the antibacterial resistance test would be the measured log reduction against known strains (Image 5), but this isn't presented as meeting a specific acceptance criterion for market clearance on its own, especially for hemostatic claims.
Sample Size for Training Set: Not applicable. This document does not pertain to an AI/machine learning model, so there is no training set.
How Ground Truth for Training Set Was Established: Not applicable.

Summary from the Document:

The provided 510(k) K092357 is an update (superseding a previous letter with an administrative change) and an amendment for adding various dimensional sizes to the ChitoGauze™ wound dressing. The core message is that the changes are administrative (product code) and dimensional, and do not alter the fundamental scientific technology or intended use of the device.

The "Non-Clinical Performance Data" section (Image 5) briefly mentions:

Biocompatibility: Demonstrated per ISO 10993. The document states "Changing the dimensional size of the dressing has no effect upon the biocompatibility."
Reduction of Microorganisms: An eight-ply version of ChitoGauze™ was tested against various bacterial species, showing log reductions typically >4.0 or >5.0. It explicitly states, "The clinical utility of these results is unknown."
Sterility: A sterility validation was completed following ISO 11137:2006 to demonstrate a 10⁻⁶ SAL (Sterility Assurance Level) using the VDmax 25 method. "Changing the dimensional size of the dressing has no effect upon the sterility validation."

The "Clinical Performance Data" section (Image 6) explicitly states: "No clinical data was required for evaluation of this device."

Therefore, this document does not contain the detailed information requested about acceptance criteria and a study proving the device meets them in the context of clinical performance metrics typically associated with diagnostic or AI-powered devices. It focuses on demonstrating that new sizes of an existing device maintain the same safety and performance characteristics as the original cleared device.

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 Director - Quality & Regulatory 10575 SW Cascade Avenue, Suite 130 Portland, Oregon 97223-4363

July 28, 2023

Re: K092357 Trade/Device Name: ChitoGauze™ 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 August 25, 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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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the eagle.

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

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

AUG 2 5 2009

Re: K092357

Trade/Device Name: ChitoGauze™ Regulatory Class: Unclassified Product Code: FRO Dated: July 29, 2009 Received: August 5, 2009

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.

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.htm 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/cdrh/mdr/ 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

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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Indications for Use

510(k) Number (if known): K092357

Device Name: ChitoGauze™

Indications for Use (Rx):

ChitoGauze™ is a hemostatic dressing for the external, temporary control of severely bleeding wounds.

Indications for Use (OTC):

ChitoGauze™ is intended for temporary external use to stop bleeding of minor wounds, minor cuts and minor abrasions.

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

Over-The-Counter Use X (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Daniel Krone

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

510(k) Number K072357

Page 1 of 1

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AUG 2 5 2009

K092357
page 1/3

Section 6: 510(k) Summary

Trade Name: Common Name: Classification Name: Product Code: Predicate Device(s):

ChitoGauze™ Wound Dressing Dressing FRO Modification to ChitoGauze™ (K090026)

Company Name: Company Address: HemCon Medical Technologies, Inc. 10575 SW Cascade Avenue, Suite 130 Portland, OR 97223

Director - Quality & Regulatory

Contact Person:

Contact Phone: Contact Fax:

Date of Preparation:

29 July 2009

Kevin Hawkins

(503)245.1326

(503)245.0459 x114

Description of the Device:

Intended Use:

ChitoGauze™ is intended to be a hemostatic wound dressing.

Indications for Use (Rx):

ChitoGauze is a hemostatic dressing for the external, temporary control of severely bleeding wounds.

Indications for Use (OTC):

ChitoGauze is intended for temporary external use to stop bleeding of minor wounds, minor cuts and minor abrasions.

Technological Characteristics:

Changing the dimensional size of the dressing has no effect upon the technological characteristics.

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K092357
page 2/3

Non-Clinical Performance Data:

Biocompatibility

Biocompatibility has been demonstrated per ISO 10993. Changing the dimensional size of the dressing has no effect upon the biocompatibility.

Reduction of Microorganisms:

An eight-ply version of ChitoGauze™ that represents the smallest product size, was tested for reduction of microorganisms against the following species. The log reduction data demonstrates the level of antibacterial effectiveness. The clinical utility of these results is unknown.

Microorganism	Gram Stain	Log Reduction
Staphylococcus aureus (MRSA) ATCC 33591	+	>5.0
Staphylococcus aureus (MRSA) ATCC BAA-1556	+	>5.1
Staphylococcus epidermidis ATCC 12228	+	>4.4
Pseudomonas aeruginosa ATCC 9027	-	>5.1
Enterococcus faecalis (VRE) ATCC 51299	+	>5.4
Acinetobacter baumanii ATCC 15308	-	>5.2
Citrobacter freundii ATCC 8090	-	>5.2
Enterobacter cloacae ATCC 13047	-	>4.9
Streptococcus mutans ATCC 25175	+	>4.7
Streptococcus pneumoniae ATCC 10015	+	>5.4
Escherichia coli ATCC 8739	-	>4.9
Klebsiella pneumoniae ATCC 4352	-	>5.2
Streptococcus pyogenes ATCC 19615	+	5.0
Salmonella choleraesius ATCC 10708	-	>4.6
Stenotrophomonas maltophilia ATCC 12714	-	>5.1
Citrobacter koseri ATCC 25408	-	>4.7
Proteus mirabilis ATCC 4630	-	>5.0
Proteus vulgaris ATCC 12454	-	>4.6
Moraxella catarrhalis ATCC 8193	-	>4.9
Clostridium difficile ATCC 9689	+	>5.0
Shigella species ATCC 11126	-	>4.3
Micrococcus luteus ATCC 49732	+	>5.0
Vibrio cholerae ATCC 11558	-	>4.0
Enterobacter aerogenes ATCC 13048	-	>5.0
Enterococcus faecalis (VRE) ATCC 700802	+	>5.3
Serratia marcescens ATCC 13880	-	>4.5

Sterility

A sterility validation for ChitoGauze™ was completed following ISO 11137:2006 requirements to demonstrate a 10° SAL using the VDmax 25 method. Changing the dimensional size of the dressing has no effect upon the sterility validation.

510(k) HemCon ChitoGauze Size & Model Num

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K092357
page 3/3

Clinical Performance Data:

No clinical data was required for evaluation of this device.

Conclusion:

The modification to ChitoGauze to provide various dimensional sizes is neither a change to the intended use, nor an alteration of the fundamental scientific technology of the device.

Special STO(Id) - Hem Con ChitoGauze Sizes & Model Numbers

Regulation Number and Section

N/A