Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description focuses on the material properties and physical mechanism of action (chitosan turning into a gel). There is no mention of AI, ML, image processing, or data-driven decision making.

Therapeutic

Yes

The device is intended to control bleeding and manage external abrasions and lacerations, which are therapeutic actions designed to treat and improve a medical condition.

Diagnostic

No

Explanation: The device is described as a "temporary external dressing to control moderate to severe bleeding and manage external abrasions, lacerations" or "to control bleeding of lacerations, minor cuts and abrasions." This indicates a therapeutic or treatment function, not a diagnostic one.

SaMD (Software as a Medical Device)

No

The device description clearly states it is a physical gauze made of chitosan fibers, not software.

IVD (In Vitro Diagnostic)

Based on the provided information, the AnsCare ChitoClot Gauze is not an In Vitro Diagnostic (IVD) device.

Here's why:

Intended Use: The intended use is to control bleeding and manage external wounds. This is a direct therapeutic or wound management function, not a diagnostic test performed on samples taken from the body.
Device Description: The device is a physical gauze made of chitosan fibers that interacts directly with the wound to promote clotting. It does not analyze biological samples.
Lack of IVD Characteristics: There is no mention of the device being used to test blood, urine, tissue, or any other sample in vitro (outside the body) to provide diagnostic information.

IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, or treatment of a disease or condition. The AnsCare ChitoClot Gauze is a topical hemostatic dressing.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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.

Product codes

QSY, FRO

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

External wounds

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies

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.

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

Key Metrics

Not Found

Predicate Device(s)

K133121, K113560, K080097

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

N/A

Summary

0

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

1

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

2

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

3

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)

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4

AnsCare ChitoClot Gauze

BenQ Materials Corporation 510(k) Notification

Section 5

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

510(k) Summary

5

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

6

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

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.

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.

7

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.

8

AnsCare ChitoClot Gauze

Substantial Equivalence Comparison:

	Proposed device	Predicate device	Predicate device	Predicate device
	AnsCare ChitoClot Gauze	Chito-SAM™ Gauze	CELOX Gauze PRO	MedTrade CELOX
Hnemostatc Granules on
Sheet
Item
K number		K133121	K113560	K080097
Regulation
Number
Classification	Unclassified	Unclassified	Unclassified	Unclassified
Product Code	FRO	FRO	FRO	FRO
Indications
for Use
(prescription
use)	For use as a temporary external
dressing to control moderate to
severe bleeding and manage
external abrasions, lacerations.	For use as a temporary external
dressing to control moderate to
severe bleeding and manage
external abrasions and
lacerations.	Under the supervision of a healthcare
professional CELOX Gauze PRO /
CELOX PRO Hemostatic Gauze /
OMNI-STAT Gauze / OMNI-STAT
Hemostatic Gauze for minor external
bleeding from wounds and
procedures (Rx) is indicated for use
as a temporary topical dressing for
bleeding control associated with
minor wounds, including control of
minor external bleeding and exudate	MedTrade Products
CELOX Hemostatic
Granules on Sheet is
indicated for temporary
external use to control
moderate to severe
bleeding,

·

9

BenQ Materials Corporation
510(k) Notification

AnsCare ChitoClot Gauze

.

| | | | from sutures and/or surgical
procedures.
Under the supervision of a healthcare
professional CELOX Gauze PRO /
CELOX PRO Hemostatic Gauze /
OMNI-STAT Gauze / OMNI-STAT
Hemostatic Gauze for moderate to
severe external bleeding wounds
(Rx) is indicated for temporary
external treatment for controlling
moderate to severe bleeding. | |
|---------------------------------|---------------------------------------------------------------------|---------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications
for Use
(OTC) | To control bleeding of
lacerations, minor cuts and
abrasions. | To control bleeding of
lacerations, minor cuts and
abrasions. | CELOX Gauze PRO (OTC) is
indicated for use as a temporary
topical dressing for minor cuts,
minor abrasions, minor lacerations
and minor burns. | Medtrade Products
CELOX Hemostatic
Granules on Sheet is
indicated for temporary
external use to control
bleeding of lacerations,
minor cuts, and abrasions. |
| Anatomical
Site | External wounds | External wounds | External wounds | External wounds |

10

AnsCare ChitoClot Gauze

BenQ Materials Corporation
510(k) Notification

| Physical
Composition | Soft absorbent, non-woven
gauze | Soft absorbent, non-woven
gauze | Non-woven gauze | High density gauze |
|-------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------|
| Granules or
Sheet | A non-woven fabric derived
from chitosan fibers | A non-woven fabric derived
from chitosan fibers | Chitosan granules adhered onto a
base fabric (non-woven gauze) using
a hot melt adhesive. | Chitosan granules are
mechanically heat bonded
on to a viscose sheet. |
| Material | Chitosan
(Poly N-acetyl- glucosamine) | Chitosan
(Poly N-acetyl- glucosamine) | Chitosan, polymer, Poly
N-acetyl-glucosamine | Chitosan, polymer, Poly
N-acetyl-glucosamine |
| Sterility | Gamma-Sterilized | Gamma-Sterilized | Gamma-Sterilized | - |
| Packaging | Foil Pouch | Foil Pouch | 3 layer (Polyester, Aluminum and
LDPE) Pouch | - |
| Specification | Thickness: $1.0 \pm 0.2$ mm
Size:
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: $13.4 \mu$ m
Thickness: $1.0 \pm 0.2$ mm
Size:
10 cm x 10 cm,
7.6 cm x 183 cm(Z-fold),
7.6 cm x 305 cm(Z-fold) | Various sizes ranging from
1" x 1" to 3" x 10 ft | 5 foot z-folded,
5 foot z-folded,
10 foot Roll |

11

.

AnsCare ChitoClot Gauze

BenQ Materials Corporation
510(k) Notification

.

12

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.