← Product Code QSY · K151204 # HEMO-Bandage (K151204) _Coreleader Biotech Co., Ltd. · QSY · Jul 31, 2015 · SU · SESE_ **Canonical URL:** https://fda.innolitics.com/device/K151204 ## Device Facts - **Applicant:** Coreleader Biotech Co., Ltd. - **Product Code:** QSY - **Decision Date:** Jul 31, 2015 - **Decision:** SESE - **Submission Type:** Traditional - **Device Class:** Class U - **Review Panel:** SU - **Attributes:** Therapeutic ## 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 Story CoreLeader HEMO-Bandage is a woven gauze dressing composed of chitosan and rayon fibers. Chitosan, an organic polysaccharide with positively-charged ions, acts as the active hemostatic agent by attracting erythrocytes to the wound site to facilitate clot formation. The device is a flexible, conformable sheet applied directly to bleeding wounds by clinicians or emergency responders. It is used to temporarily control moderate to severe external bleeding in traumatic or surgical settings. The dressing is removed via saline irrigation. The device provides a physical barrier and chemical hemostatic support, aiding in hemorrhage management and potentially reducing blood loss for the patient. ## Clinical Evidence No human clinical data provided. Evidence consists of bench testing and an in vivo animal study. Performance validated via in vivo swine femoral arterial hemorrhage model, demonstrating successful hemostasis in <10 minutes. Bench testing included fluid absorption (EN 13726-1), tensile strength, and heavy metal residue analysis. Biocompatibility testing confirmed no cytotoxicity (ISO 10993-5), no skin irritation or sensitization (ISO 10993-10), and no systemic toxicity (ISO 10993-11). Sterilization validated to 10^-6 SAL per ISO 11137. ## Technological Characteristics Woven gauze dressing composed of chitosan and rayon fibers. Hemostasis via electrostatic attraction of erythrocytes. Flexible, conformable sheet form factor. Sterilized via gamma-ray radiation to 10^-6 SAL. Complies with AAMI/ANSI/ISO 11137-1, -2 (sterilization), ISO 10993-5 (cytotoxicity), ISO 10993-10 (irritation/sensitization), and ISO 10993-11 (systemic toxicity). ## Regulatory Identification To temporarily control bleeding and cover external wounds. ## Predicate Devices - HemCon Chitoflex surgical wound dressing ([K080818](/device/K080818.md)) - QuikClot® Hemostatic Dressing / QuikClot® Combat Gauze ([K123387](/device/K123387.md)) - Celox Gauze PRO/OTC ([K113560](/device/K113560.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ 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 {1}------------------------------------------------ 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 {2}------------------------------------------------ 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 {3}------------------------------------------------ ### 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) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *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: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.qov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {4}------------------------------------------------ ## 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: 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. #### 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, {5}------------------------------------------------ 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 {6}------------------------------------------------ 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 | {7}------------------------------------------------ | | 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 <
10 minutes. | Facilitate
hemostasis | Facilitate
hemostasis | Facilitate
hemostasis | {8}------------------------------------------------ ## Substantial Equivalent Statement Based on the comparison of intended use, design, mode of actions, and performance, CoreLeader HEMO-Bandage is substantial equivalent to its predicate devices. --- **Source:** [https://fda.innolitics.com/device/K151204](https://fda.innolitics.com/device/K151204) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com