The ChitoGauze dressing is composed of standard polyester/rayon blend non-woven medical gauze that is coated with chitosan. The four inch by four yard (4" x 4 yds) dressing is 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 10-6. 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™ device. It describes the device, its intended use, and non-clinical performance data to demonstrate substantial equivalence to predicate devices. However, the document does not contain acceptance criteria or a study that specifically proves the device meets such criteria in the format of a clinical trial or algorithm performance study with specified metrics like sensitivity, specificity, or AUC.

Instead, the submission focuses on demonstrating substantial equivalence to existing legally marketed predicate devices by showing similar technological characteristics and non-clinical performance.

Here's an analysis based on the provided text, addressing your questions where possible:

1. A table of acceptance criteria and the reported device performance

The document does not specify quantitative acceptance criteria in terms of clinical performance metrics (e.g., stopping bleeding within X minutes for Y% of cases). The evaluations are primarily geared towards demonstrating substantial equivalence through biocompatibility, in vivo efficacy compared to other dressings, reduction of microorganisms, and sterility.

A table summarizing the performance data reported would look like this:

Performance Metric	Acceptance Criteria (Not explicitly stated as such, but implied by comparison)	Reported Device Performance (ChitoGauze™)
Biocompatibility	Compliance with ISO 10993	Demonstrated per ISO 10993
In Vivo Efficacy (Hemostasis)	Substantial equivalence to lap sponges, uncoated gauze, and competitive coated gauze in an extreme trauma model.	Exhibited substantially equivalent efficacy to lap sponges, uncoated gauze, and competitive coated gauze in an extreme trauma model.
Reduction of Microorganisms	Log reduction for various species (no explicit threshold stated for "effectiveness" but high log reductions are shown)	Demonstrated significant log reduction (typically >4.0) for 26 tested bacterial species (see full list in original document for specific values). The clinical utility of these results is unknown.
Sterility	Sterility Assurance Level (SAL) of 10⁻⁶ per ISO 11137:2006	Sterility validation completed following ISO 11137:2006 requirements to demonstrate a 10⁻⁶ SAL using the VDmax® method.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Biocompatibility: Sample sizes are not specified, standard for ISO 10993.
In Vivo Efficacy: The term "extreme trauma model" implies animal testing, but specifics of the model (e.g., animal species, number of animals) and thus sample size are not provided. The data provenance is not stated (e.g., country, retrospective/prospective).
Reduction of Microorganisms: For each microorganism, the "Log Reduction" values are given. This is typically done through in vitro laboratory testing. Sample sizes (number of replicates) are not specified. Data provenance (country, retrospective/prospective) is not provided.
Sterility: This is a validation process against a standard, not a data set in the traditional sense.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This section is not applicable to this submission. The device is a hemostatic dressing, and its performance evaluation does not involve image interpretation or diagnostic tasks that would require human experts to establish ground truth in the way described.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This is not applicable to this submission, as there is no mention of human expert adjudication for the types of tests described (biocompatibility, in vivo efficacy, microbiology, sterility).

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

This is not applicable. The device is a hemostatic dressing, not an AI-powered diagnostic tool. Therefore, MRMC studies involving human readers and AI assistance are not relevant here.

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

This is not applicable, as the device is not an algorithm or AI system.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

Biocompatibility: Ground truth is established by adherence to ISO 10993 standards and accepted biological safety profiles.
In Vivo Efficacy: Ground truth for "efficacy" in stopping bleeding would be direct observation or objective measurement within an animal model, not expert consensus or pathology on a human.
Reduction of Microorganisms: "Ground truth" is the quantitative measurement of bacterial survival after exposure to the device, typically through standard microbiology laboratory techniques (e.g., colony counting).
Sterility: Ground truth is established by demonstrating a Sterility Assurance Level (SAL) of 10⁻⁶ using validated methods and industry standards (ISO 11137:2006).

8. The sample size for the training set

This is not applicable, as there is no AI algorithm being developed or "trained" for this device.

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

This is not applicable, as there is no AI algorithm being developed or "trained" for this device.

In summary:

The provided document is a 510(k) summary for a medical device (hemostatic dressing). It focuses on demonstrating substantial equivalence to existing devices through non-clinical laboratory and animal studies, rather than clinical trial data with specific acceptance criteria and detailed performance metrics characteristic of AI/diagnostic device submissions. The submission explicitly states: "No clinical data was required for evaluation of this device."

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" 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 and Regulatory 10575 SW Cascade Avenue, Suite 130 Portland, Oregon 97223-4363

July 28, 2023

Re: K090026 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 March 31, 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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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings forming a protective shape. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K090026

Trade/Device Name: ChitoGauze™ Regulatory Class: Unclassified Product Code: FRO Dated: December 30, 2008 Received: January 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 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

MAR 3 1 2009

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Page 2 - Mr. Kevin Hawkins

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 yours, 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

K090026 510(k) Number (if known):

ChitoGauze™ Device Name:

Indications For Use:

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 (21 CFR 807 Subpart C)

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

Daniel Kone for MXM 3/13/2009

Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)

Division of General, Restorative, and Neurological Devices

510(k) Number K090026

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510(k) Summarv

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

Company Name:

Contact Person:

Contact Phone:

Contact Fax:

Company Address:

MAR 3 1 2009

ChitoGauze™ Wound Dressing Dressing FRO HemCon® Bandage (K072486) QuikClot® eX™ (K072474)

HemCon Medical Technologies, Inc. 10575 SW Cascade Avenue, Suite 130 Portland, OR 97223 Kevin Hawkins Director - Quality & Regulatory (503)245.0459 x114 (503)245.1326

Date of Preparation:

20 March 2009

Description of the Device:

The ChitoGauze dressing is composed of standard polyester/rayon blend non-woven medical gauze that is coated with chitosan. The four inch by four yard (4" x 4 yds) dressing is 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 10° The hemostatic properties of chitosan enhance the ability of the medical gauze to control bleeding.

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:

ChitoGauze is technologically similar to at least two predicate devices. The HemCon Bandage has demonstrated the safety and efficacy of a chitosan based hemostatic dressing. QuikClot® eX™has demonstrated the safety and efficacy of a standard, nonwoven medical gauze coated with a hemostatic material. ChitoGauze combines the

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K090026 page 2/3

HemCon ChitoGauze™ 510(k) Summary Page 2 of 3

chitosan material of one predicate with the coated gauze of the other and is therefore technologically similar to both.

Non-Clinical Performance Data:

Biocompatibility

Biocompatibility has been demonstrated per ISO 10993.

In Vivo Efficacy

In vivo testing evaluated the efficacy of ChitoGauze versus lap sponges, uncoated gauze and coated gauze (competitive) in an extreme trauma model. ChitoGauze exhibited substantially equivalent efficaciy.

Reduction of Microorganisms:

ChitoGauze™ was tested for reduction of microorganisms against the following species. The log reduction data demonstrates the level of antibacterial effectiveness. The cinical utility of these results is unknown.

Microorganism	Gram Stain	Log Reduction
Staphylococcus aureus (MRSA) ATCC 33591	+	>4.1
Staphylococcus aureus (MRSA) ATCC BAA-1556	+	>4.2
Staphylococcus epidermidis ATCC 12228	+	>4.2
Pseudomonas aeruginosa ATCC 9027	-	>4.1
Enterococcus faecalis (VRE) ATCC 51299	+	>4.0
Acinetobacter baumanii ATCC 15308	-	>4.4
Citrobacter freundii ATCC 8090	-	>4.3
Enterobacter cloacae ATCC 13047	-	>4.1
Streptococcus mutans ATCC 25175	+	>4.0
Streptococcus pneumoniae ATCC 10015	+	>5.1
Escherichia coli ATCC 8739	-	>4.1
Klebsiella pneumoniae ATCC 4352	-	>4.0
Streptococcus pyogenes ATCC 19615	+	>4.2
Salmonella choleraesius ATCC 10708	-	>4.1
Stenotrophomonas maltophilia ATCC 12714	-	>4.0
Citrobacter koseri ATCC 25408	-	>4.1
Proteus mirabilis ATCC 4630	-	>4.2
Proteus vulgaris ATCC 12454	-	>4.3
Moraxella catarrhalis ATCC 8193	-	>4.1
Clostridium difficile ATCC 9689	+	>4.0
Shigella species ATCC 11126	-	>4.0
Micrococcus luteus ATCC 49732	+	>4.0
Vibrio cholerae ATCC 11558	-	>4.1
Enterobacter aerogenes ATCC 13048	-	4.8
Enterococcus faecalis (VRE) ATCC 700802	+	2.6
Serratia marcescens ATCC 13880	-	5.0

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HemCon ChitoGauze™ 510(k) Summary Page 3 of 3

Sterility

ചാന്തു
A sterility validation for ChitoGauze was completed following ISO 11137:2006
requirements to demonstrate a 10° SAL using the VDmax® method.

Clinical Performance Data:

No clinical data was 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