AnsCare ChitoClot Gauze (prescription use): For use as a temporary external dressing to control moderate to severe bleeding and manage external abrasions, lacerations.

AnsCare ChitoClot Gauze (over-the-counter use): To control bleeding of lacerations, minor cuts and abrasions.

Device Description

The AnsCare ChitoClot Gauze is made of a non-woven fabric derived from chitosan fibers. The device is made of 100% chitosan - it is not coated or impregnated with chitosan granules. Chitosan is a naturally occurring polysaccharide usually derived from shellfish, and its hemostatic properties are widely recognized in the biomedical field. When applied directly on a wound with firm pressure, the AnsCare ChitoClot Gauze will turn into a gel-like condition to absorb the blood and seal the wound. The AnsCare ChitoClot Gauze also contains acetic acid as an acidity regulator and Polysorbate 20 as a surfactant.

AI/ML Overview

The provided text does not contain information about acceptance criteria for a device's performance that would typically be described with metrics like accuracy, sensitivity, or specificity, nor does it include a study that proves the device meets such criteria.

The document discusses the regulatory approval (510(k)) of the "AnsCare ChitoClot Gauze" device, asserting its substantial equivalence to predicate devices based on non-clinical testing. The non-clinical testing included biocompatibility tests, bench performance tests, and animal testing. However, the exact acceptance criteria for these tests and their numerical results are not provided.

Therefore, I cannot fulfill your request for:

A table of acceptance criteria and the reported device performance: The document lists types of tests conducted but does not provide specific criteria or performance metrics in a quantifiable way.
Sample size used for the test set and the data provenance: No details about sample sizes for the "test set" (which here refers to non-clinical testing as opposed to a clinical AI model test set) or data provenance are given.
Number of experts used to establish the ground truth... and their qualifications: This information is not relevant to the type of non-clinical testing described.
Adjudication method: Not relevant to the non-clinical testing described.
Multi Reader Multi Case (MRMC) comparative effectiveness study: This type of study is used for diagnostic algorithms or medical imaging devices involving human readers and AI performance, which is not applicable to the "AnsCare ChitoClot Gauze" as described.
Standalone (i.e. algorithm only without human-in-the loop performance) study: Again, this is for AI algorithms, not the type of medical device described.
The type of ground truth used: The "ground truth" in the context of this device's testing would be the measured outcomes of the non-clinical tests (e.g., cytotoxicity, pH, hemostasis in animal models). No specific ground truth definition is stated beyond the test results themselves.
The sample size for the training set: Not applicable, as this is not an AI/algorithm-based device.
How the ground truth for the training set was established: Not applicable.

The document focuses on demonstrating substantial equivalence for regulatory purposes, primarily through comparisons of intended use, materials, design, and general safety/performance claims with already cleared predicate devices.

Information that can be extracted related to testing:

Non-clinical Testing Conducted (listed in Section 5.8):

Biocompatibility testing:
- Cytotoxicity Test
- Skin Irritation Test
- Skin Sensitization Test (Closed-patch Method)
- Acute Systemic Toxicity (intraperitoneal and intravenous)
- Hemolysis Test Report
- Pyrogen, Protein content and Residual solvent Testing Report
Bench performance testing:
- Absorb Test
- pH
- Tensile Strength (wet and dry)
- Platelet Aggregation
- Extreme Environmental Conditions Test
- Competitor analysis
Animal Testing:
- In-vivo Hemostasis Test

The conclusion states: "All the test results demonstrate that AnsCare ChitoClot meet the requirements of its pre-defined acceptance criteria and intended uses." However, the specific acceptance criteria and the detailed test results are not enumerated in this document.

Summary

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Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the U.S. Food & 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 is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

April 21, 2023

BenQ Materials Corporation Ms. Kenix Chang Regulatory Affairs Specialist No. 29, Jianguo E. Rd. Gueishan 33341 Taoyuan, Taiwan (R.O.C.)

Re: K143462 Trade/Device Name: AnsCare ChitoClot Gauze Regulatory Class: Unclassified Product Code: QSY

Dear Ms. Kenix Chang:

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 May 8, 2015 and the correction letter dated June 12, 2015. 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 is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The eagle is facing to the right. The logo is simple and recognizable.

Public Health Service

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

June 12, 2015

BenQ Materials Corporation Ms. Kenix Chang Regulatory Affairs Specialist 29, Jianguo E. Road Gueishan 33341. Taoyuan, Taiwan (R.O.C)

Re: K143462

Trade/Device Name: AnsCare ChitoClot Gauze Regulatory Class: Unclassified Product Code: FRO Dated: February 4, 2015 Received: February 9, 2015

Dear Ms. Chang:

This letter corrects our substantially equivalent letter of May 8, 2015.

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

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Page 2 - Ms. Kenix Chang

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 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 contact the Division of Industry and Consumer Education 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. 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 Industry and Consumer Education 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.

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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K143462

Device Name AnsCare ChitoClot Gauze

Indications for Use (Describe) AnsCare ChitoClot Gauze (prescription use): For use as a temporary external dressing to control moderate to severe bleeding and manage external abrasions, lacerations.

AnsCare ChitoClot Gauze (over-the-counter use): To control bleeding of lacerations, minor cuts and abrasions.

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

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Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

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AnsCare ChitoClot Gauze

BenQ Materials Corporation 510(k) Notification

Section 5

............. : ------

510(k) Summary

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BenQ Materials Corporation 510(k) Notification

AnsCare ChitoClot Gauze

・

510(k) Summary

5.1	Type of Submission:	Traditional
5.2	Preparation Date:	25th November, 2014
5.3	Submitter:	BenQ Materials Corporation
	Address:	29, Jianguo E. Rd., Gueishan 33341,Taoyuan, Taiwan (R.O.C)
	Phone:	+886-3-3748800
	Fax:	+886-3-3763030
	Contact:	Kenix Chang, Regulatory Affairs Specialist(Kenix.Chang@BenQMaterials.com)

5.4 Identification of the Device:

Proprietary/Trade name:	AnsCare ChitoClot Gauze
Classification Name:	Dressing, Wound, Drug
Device Classification:	Unclassified
Regulation Number:	–
Panel:	General & Plastic Surgery
Product Code:	FRO

5.5 Identification of the Predicate Device:

Predicate Device Name:	Chito-SAM™ Gauze
Manufacturer:	SAM Medical Products
Product Code:	FRO
510(k) Number:	K133121
Predicate Device Name:	CELOX Gauze PRO
Manufacturer:	MedTrade Products Ltd.
Product Code:	FRO

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510(k) Number:	K113560
Predicate Device Name:	CELOX Hemostatic Granules on Sheet
Manufacturer:	MedTrade Products Ltd.
Product Code:	FRO
510(k) Number:	K080097

5.6 Intended Use and Indications for Use of the subject device.

AnsCare ChitoClot Gauze (prescription use):

For use as a temporary external dressing to control moderate to severe bleeding and manage external abrasions, lacerations.

AnsCare ChitoClot Gauze (over-the-counter use): To control bleeding of lacerations, minor cuts and abrasions.

5.7 Device Description

5.8 Non-clinical Testing

A series of non-clinical studies were conducted on the proposed device. All the test results demonstrate that AnsCare ChitoClot meet the requirements of its pre-defined acceptance criteria and intended uses.

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Biocompatibility testing:

Cytotoxicity Test
. Skin Irritation Test
. Skin Sensitization Test (Closed-patch Method)
Acute Systemic Toxicity (intraperitoneal and intravenous)
. Hemolysis Test Report
. Pyrogen, Protein content and Residual solvent Testing Report

Bench performance testing included functional testing for:

. Absorb Test
. pH
. Tensile Strength (wet and dry)
. Platelet Aggregation
Extreme Environmental Conditions Test
. Competitor analysis

Animal Testing:

. In-vivo Hemostasis Test

5.9 Substantial Equivalence Determination

The AnsCare ChitoClot Gauze submitted in this 510(k) file is substantially equivalent in intended use, main materials, design, safety and performance claims to the cleared Chito-SAM™ Gauze (K133121), CELOX Gauze PRO (K113560) and CELOX Hemostatic Granules on Sheet (K080097). Differences between the devices cited in this section do not raise any new issues of safety or effectiveness.

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AnsCare ChitoClot Gauze

Substantial Equivalence Comparison:

	Proposed device	Predicate device	Predicate device	Predicate device
	AnsCare ChitoClot Gauze	Chito-SAM™ Gauze	CELOX Gauze PRO	MedTrade CELOXHnemostatc Granules onSheet
Item
K number		K133121	K113560	K080097
RegulationNumber
Classification	Unclassified	Unclassified	Unclassified	Unclassified
Product Code	FRO	FRO	FRO	FRO
Indicationsfor Use(prescriptionuse)	For use as a temporary externaldressing to control moderate tosevere bleeding and manageexternal abrasions, lacerations.	For use as a temporary externaldressing to control moderate tosevere bleeding and manageexternal abrasions andlacerations.	Under the supervision of a healthcareprofessional CELOX Gauze PRO /CELOX PRO Hemostatic Gauze /OMNI-STAT Gauze / OMNI-STATHemostatic Gauze for minor externalbleeding from wounds andprocedures (Rx) is indicated for useas a temporary topical dressing forbleeding control associated withminor wounds, including control ofminor external bleeding and exudate	MedTrade ProductsCELOX HemostaticGranules on Sheet isindicated for temporaryexternal use to controlmoderate to severebleeding,

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BenQ Materials Corporation
510(k) Notification

AnsCare ChitoClot Gauze

			from sutures and/or surgicalprocedures.Under the supervision of a healthcareprofessional CELOX Gauze PRO /CELOX PRO Hemostatic Gauze /OMNI-STAT Gauze / OMNI-STATHemostatic Gauze for moderate tosevere external bleeding wounds(Rx) is indicated for temporaryexternal treatment for controllingmoderate to severe bleeding.
Indicationsfor Use(OTC)	To control bleeding oflacerations, minor cuts andabrasions.	To control bleeding oflacerations, minor cuts andabrasions.	CELOX Gauze PRO (OTC) isindicated for use as a temporarytopical dressing for minor cuts,minor abrasions, minor lacerationsand minor burns.	Medtrade ProductsCELOX HemostaticGranules on Sheet isindicated for temporaryexternal use to controlbleeding of lacerations,minor cuts, and abrasions.
AnatomicalSite	External wounds	External wounds	External wounds	External wounds

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AnsCare ChitoClot Gauze

BenQ Materials Corporation
510(k) Notification

PhysicalComposition	Soft absorbent, non-wovengauze	Soft absorbent, non-wovengauze	Non-woven gauze	High density gauze
Granules orSheet	A non-woven fabric derivedfrom chitosan fibers	A non-woven fabric derivedfrom chitosan fibers	Chitosan granules adhered onto abase fabric (non-woven gauze) usinga hot melt adhesive.	Chitosan granules aremechanically heat bondedon to a viscose sheet.
Material	Chitosan(Poly N-acetyl- glucosamine)	Chitosan(Poly N-acetyl- glucosamine)	Chitosan, polymer, PolyN-acetyl-glucosamine	Chitosan, polymer, PolyN-acetyl-glucosamine
Sterility	Gamma-Sterilized	Gamma-Sterilized	Gamma-Sterilized	-
Packaging	Foil Pouch	Foil Pouch	3 layer (Polyester, Aluminum andLDPE) Pouch	-
Specification	Thickness: $1.0 \pm 0.2$ mmSize:3" x 6' (7.6 cm x 183 cm)(Roll)2" x 16" (5.1 cm x 41 cm)(8 ply)4" x 32" (10 cm x 81 cm)(8 ply)3" x 4' (7.6 cm x 122 cm)(Roll)	Fiber Diameter: $13.4 \mu$ mThickness: $1.0 \pm 0.2$ mmSize:10 cm x 10 cm,7.6 cm x 183 cm(Z-fold),7.6 cm x 305 cm(Z-fold)	Various sizes ranging from1" x 1" to 3" x 10 ft	5 foot z-folded,5 foot z-folded,10 foot Roll

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AnsCare ChitoClot Gauze

BenQ Materials Corporation
510(k) Notification

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BenQ Materials Corporation 510(k) Notification

5.10 Similarity and differences

The main predicate of this application is Chito-SAM™ Gauze produced by SAM Medical Products (K133121). The AnsCare ChitoClot Gauze is substantially equivalent in intended use, main materials, design, safety and performance claims to Chito-SAM™ Gauze (K133121). The only difference between the proposed device and predicate device is the specification. There are multiple specifications for proposed device. The predicate devices of Chito-SAM™ Gauze (K133121), CELOX Gauze PRO (K113560) and CELOX Hemostatic Granules on Sheet (K080097), also used to demonstrate the substantial equivalence with AnsCare ChitoClot Gauze in this submission. The difference of proposed device and predicate devices did not raise any problems of safety or effectiveness. The proposed device is substantially equivalent to the predicate devices in intended use, main materials, design, safety and performance claims.

5.11 Conclusion

After analyzing bench tests and safety testing data, it can be concluded that AnsCare ChitoClot Gauze is substantially equivalent to the predicate devices.

Regulation Number and Section

N/A