K Number

Device Name

HEMO-Bandage

Manufacturer

CORELEADER BIOTECH CO., LTD.

Date Cleared

2015-07-31

(87 days)

Product Code

QSY FRO

Regulation Number

N/A

Intended Use

CoreLeader HEMO-Bandage is intended to be used as a topical dressing to temporarily control moderate to severe external bleeding resulted from traumatic or surgical wounds.

Device Description

CoreLeader HEMO-Bandage is woven gauze made of chitosan fiber and rayon fiber. Chitosan is a type of organic polysaccharide carrying positively-charged ions. Appearing light yellow color and inheriting biodegradability and biocompatibility of chitosan. CoreLeader HEMO-Bandage achieves hemostasis by attracting erythrocytes to the injured sites and facilitates blood clot formation. CoreLeader HEMO-Bandage is sterilized by gamma-ray radiation to 10th SAL after packed in a foil bag. With the softness and flexibility, it is readily conformable to various wound shapes.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K080818, K123387, K113560

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description focuses on the material properties and physical mechanism of action for hemostasis. There is no mention of AI or ML in the description, performance studies, or key metrics.

Therapeutic

Yes
The device is intended to control bleeding and facilitate blood clot formation for therapeutic purposes.

Diagnostic

No.
The device is a topical dressing intended to control external bleeding, which is a therapeutic function, not a diagnostic one.

SaMD (Software as a Medical Device)

The device description clearly states it is a woven gauze made of chitosan and rayon fiber, which is a physical material, not software.

IVD (In Vitro Diagnostic)

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

Here's why:

Intended Use: The intended use is "to be used as a topical dressing to temporarily control moderate to severe external bleeding resulted from traumatic or surgical wounds." This describes a device that acts directly on the body to manage bleeding, not a device used to examine specimens from the body to provide diagnostic information.
Device Description: The description details a physical dressing made of chitosan and rayon fibers that works by attracting blood cells and facilitating clot formation. This is a mechanical and chemical action on the wound itself, not a test performed on a sample.
Lack of Diagnostic Function: There is no mention of the device being used to detect, measure, or analyze any substance or characteristic in a biological specimen (like blood, urine, tissue, etc.) to provide diagnostic information about a patient's health status.
Performance Studies: The performance studies focus on the device's ability to control bleeding (hemostasis), not on its ability to provide diagnostic results.

IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens from the human body to provide information for diagnostic, monitoring, or compatibility purposes. CoreLeader HEMO-Bandage is applied in vivo (on the body) to manage bleeding.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

CoreLeader HEMO-Bandage is intended to be used as a topical dressing to temporarily control moderate to severe external bleeding resulted from traumatic or surgical wounds.

Product codes

QSY, FRO

Device Description

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

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 (study type, sample size, AUC, MRMC, standalone performance, key results)

Non-clinical tests performed:

Sterility: CoreLeader HEMO-Bandage is sterile to 10-6 SAL after gamma radiation. Validation tests meet AAMI / ANSI / ISO 11137-1, -2: 2006.
Biocompatibility:
- Cytotoxicity: Passes in vitro cytotoxicity test required in AAMI / ANSI / ISO 10993-5.
- Skin irritation test: Passes in vivo rabbit skin irritation test required in AAMI / ANSI / ISO 10993-10.
- Skin sensitization: Passes in vivo guinea pig skin sensitization test required in AAMI / ANSI / ISO 10993-10.
- Systemic toxicity test: Non-systemic toxic (AAMI / ANSI / ISO 10993-11: 2006)
Heavy metal residue test: Free of heavy metal contamination (Journal of AOAC International, 2006; 89(6): 1447-66)
Performance:
- Water absorption: Fluid absorbent (EN 13726-1:2002 -Part 1)
- Hemostasis achievement: Capable of stopping bleeding due to chitosan. Proved to achieve arterial hemostasis in in vivo swine femoral arterial hemorrhage model. "Achieve hemostasis of femoral artery hemorrhage

Regulation Number and Section

N/A

Summary

Image /page/0/Picture/0 description: The image contains two logos. The logo on the left is the Department of Health & Human Services - USA logo. The logo on the right is the FDA U.S. Food & Drug Administration logo. The FDA logo is blue and white.

Coreleader Biotech Co., Ltd. Ya-Wen Kuo Manager, Regulatory Affairs 19F Build B, No. 100, Sec 1 Xintai 5th Rd, Xizhi Dist. New Taipei City, 22102 Taiwan (R.O.C.)

April 21, 2023

Re: K151204 Trade/Device Name: CoreLeader HEMO-Bandage Regulatory Class: Unclassified Product Code: QSY

Dear Ya-Wen Kuo:

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 July 31, 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

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 circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an emblem featuring a stylized representation of three human profiles facing to the right, resembling a bird-like shape.

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

July 31, 2015

CoreLeader Biotech Company, LTD. Ms. Ya-Wen Kuo Manager, Regulatory Affairs 19F Build B, No. 100, Sec 1 Xintai 51H Road New Taipei City, 22102 Taiwan (R.O.C.)

Re: K151204

Trade/Device Name: CoreLeader HEMO-Bandage Regulatory Class: Unclassified Product Code: FRO Dated: July 13, 2015 Received: July 16, 2015

Dear Ms. Kuo:

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 (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/Resourcesfor You/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

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

Enclosure

Indications for Use

510(k) Number (if known) K151204

Device Name CoreLeader HEMO-Bandage

CoreLeader HEMO-Bandage is intended to be used as a topical dressing to temporarily control moderate to severe external bleeding resulted from traumatic or surgical wounds.

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

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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510(k) Summary

Submitted by:	Coreleader Biotech Co., Ltd.
	19F, No. 100, Sec. 1, Xintai 5th Rd., Xizhi Dist., New Taipei
	City, Taiwan, R.O.C. 22102
	Phone: +886-2-26968880 FAX: +886-2-26968882
Contact Person:	Ya-Wen Kuo
Date Prepared:	2014/03/19
Proprietary Name:	CoreLeader HEMO-Bandage
Common Name:	Topical hemostasis wound dressing
Classification:	Unclassified
Classification
Name:	Dressing, Wound, Drug
Predicate Device:	1. HemCon Chitoflex surgical wound dressing (HemCon
	Medical Technologies, Inc): K080818
	2. QuikClot® Hemostatic Dressing, as known as QuikClot®
	Combat Gauze (Z-Medica, LLC): K123387
	3. Celox Gauze PRO/OTC (Medtrade Products Ltd): K113560

Device Description:

Indications for Use:

CoreLeader HEMO-Bandage is intended to be used as a topical dressing to temporarily control moderate to severe external bleeding resulted from traumatic or surgical wounds.

Substantial equivalence:

The safety and efficacy of CoreLeader HEMO-Bandage wound dressing are substantially equivalent to the predicate devices, including HemCon Chitoflex surgical wound dressing (HemCon Medical Technologies, Inc, K080818) and QuikClot® Hemostatic Dressing, as known as QuikClot® Combat Gauze (Z-Medica, LLC, K123387), in the aspect of the mode of action, dressing form, indications for use,

biocompatibility, sterilization degree and hemostasis efficacy.

Indications for use: Similar to HemCon Chitoflex surgical wound dressing and 1 QuikClot® Combat Gauze, CoreLeader HEMO-Bandage is intended to be used as a topical dressing to temporarily control moderate to severe external bleeding resulted from traumatic or surgical wounds.

Mode of action in hemostasis: 2

Similar to HemCon Chitoflex and Celox Gauze, the effective ingredient of CoreLeader HEMO-Bandage that helps stop bleeding is chitosan, which facilitates hemostatic activity.

ന Form:

Similar to HemCon Chitoflex surgical wound dressing and QuikClot® Combat Gauze, CoreLeader HEMO-Bandage appears as flat sheet of gauze with various sizes to fit in different shape of wounds.

Materials: ব

Chitosan: Similar to HemCon Chitoflex surgical wound dressing, CoreLeader HEMO-Bandage uses chitosan to facilitate hemostasis activity. Rayon: Similar to HemCon Chitoflex surgical wound dressing and QuikClot® Combat Gauze, CoreLeader HEMO-Bandage incorporates a textile in addition to effective ingredient to form the gauze dressing.

Non-clinical tests ഗ

6.1 Sterility: Similar to HemCon Chitoflex surgical wound dressing and QuikClot® Combat Gauze, CoreLeader HEMO-Bandage is sterilized to 10 ° SAL using gamma ray. The sterilization validation tests meet the criteria of AAMI / ANSI / ISO 11137-1, -2: 2006.

6.2 Biocompatibility: CoreLeader HEMO-Bandage is as biocompatible as all the predicates.

6.2.1 Cytotoxicity: CoreLeader HEMO-Bandage passes in vitro cytotoxicity test required in AAMI / ANSI / ISO 10993-5.
Skin irritation test: CoreLeader HEMO-Bandage passes in vivo rabbit 6.2.2 skin irritation test required in AAMI / ANSI / ISO 10993-10.
Skin sensitization: CoreLeader HEMO-Bandage passes in vivo guinea pig 6.2.3

skin sensitization test required in AAMI / ANSI / ISO 10993-10.

6.3 Performance:

6.3.1 Water absorption: As the above mentioned predicate devices. CoreLeader HEMO-Bandage is fluid absorbent.
6.3.2 Hemostasis achievement: CoreLeader HEMO-Bandage is capable of stop bleeding due to the nature of chitosan. CoreLeader HEMO-Bandage is proved to achieve arterial hemostasis in in vivo swine femoral arterial hemorrhage model.
7 Directions to use: The direction of use of CoreLeader HEMO-Bandage is similar to those of HemCon Chitoflex surgical wound dressing and QuikClot® Combat Gauze. CoreLeader HEMO-Bandage should be directly packed or pressed against the bleeding wounds until the hemostasis is achieved. Proper saline irrigation should be applied when removing CoreLeader HEMO-Bandage from the wound.

Table 1. The list of non-clinical tests conducted to validate the safety and efficacy of CoreLeader HEMO-Bandage to achieve the indications as claimed.

Test	Result	Guidance
Sterilization validation tests	CoreLeader HEMO-Bandage is sterile to 10-6 SAL after gamma radiation.	AAMI / ANSI / ISO 11137-1, -2: 2006
In vitro cytotoxicity test	No cytotoxicity	AAMI / ANSI / ISO 10993-5:2009
In vivo guinea pig skin sensitization test	No skin sensitization	AAMI / ANSI / ISO 10993-10: 2010.
In vivo rabbit skin irritation test	No skin irritation	AAMI / ANSI / ISO 10993-10: 2010.
In vivo systemic toxicity test	Non-systemic toxic	AAMI / ANSI / ISO 10993-11: 2006.
Heavy metal residue test	Free of heavy metal contamination	Journal of AOAC International, 2006; 89(6): 1447-66
Fluid absorption rate	CoreLeader HEMO-Bandage is water absorbent.	EN 13726-1:2002
-Part 1
Tensile strength	CoreLeader HEMO-Bandage is tensile resistant.	In-house protocol
In vivo hemostasis test	CoreLeader HEMO-Bandage	In-house protocol

| | can temporarily control
moderate to severe bleedings
resulted from traumatic or
surgical wounds. | |

--	-----------------------------------------------------------------------------------------------------------	--

Table 2. A comparison of non-clinical testing results of CoreLeader HEMO-Bandage
with the predicate devices

	Proposed device	Predicate device
	CoreLeader
HEMO-Bandage	HemCon®
Chitoflex	CELOX Gauze
PRO	QuikClot®
Combat Gauze
K number	K141198	K0808018	K113560	K123387
Indications	CoreLeader
HEMO-Bandage
is intended to be
used as a topical
dressing to
temporarily
control
moderate to
severe bleeding
resulted from
traumatic or
surgical wounds.	QuikClot®
Combat Gauze is
intended to use as
a topical dressing
for local
management of
bleeding wounds
such as cuts,
lacerations and
abrasions. It may
also be used for
temporary
treatment of
severely bleeding
wounds such as
surgical wounds
(operative,
postoperative,
dermatological,
etc.) and
traumatic
injuries.	CELOX
Gauze PRO is
indicated for
minor wound
control,
including
control of
minor external
bleeding and
exudate from
sutures and/or
surgical
procedures	Rx indication:
Hemostatic
dressing for
temporary
control of
severely
bleeding
wounds
intended for
emergency
use.
Mode of
action	Chitosan attracts
erythrocytes and
facilitates
hemostasis.	Chitosan attracts
erythrocytes and
facilitates
hemostasis.	Chitosan
attracts
erythrocytes
and facilitates
hemostasis.	Kaolin
initiates blood
coagulation
Sterilization	Gamma
radiation to 10-6
SAL	Gamma radiation	Gamma
radiation	Gamma
radiation
Cytotoxicity
test	Negative	Negative	Negative	Negative
Skin
irritation
test	Negative	Negative	Negative	Negative
Skin
sensitization
test	Negative	Negative	Negative	Negative
Systemic
toxicity test	Negative	Negative	Negative	Negative
In vivo
swine
hemostasis
test	Achieve
hemostasis of
femoral artery
hemorrhage