← Product Code QSY · K102944 # CORELEADER HEMO-PAD MODEL CPII 02030 (K102944) _Coreleader Biotech Co., Ltd. · QSY · Sep 7, 2011 · SU · SESE_ **Canonical URL:** https://fda.innolitics.com/device/K102944 ## Device Facts - **Applicant:** Coreleader Biotech Co., Ltd. - **Product Code:** QSY - **Decision Date:** Sep 7, 2011 - **Decision:** SESE - **Submission Type:** Traditional - **Device Class:** Class U - **Review Panel:** SU - **Attributes:** Therapeutic ## Intended Use Coreleader Hemo-Pad is a dressing indicated for topical wound management and for the external topical temporary control of moderate to severe bleeding. The dressing is indicated for the following wounds: abrasions, lacerations, skin surface puncture sites for vascular procedures (arteries and veins) ## Device Story Coreleader Hemo-Pad is a sterile, non-woven topical dressing composed of chitosan-derived poly-D-glucosamine and poly-N-acetylglucosamine. Designed for use by clinicians to manage wounds and control external hemorrhage. Principle of operation relies on the cationic (positively charged) nature of the chitosan material, which promotes hemostasis upon contact with blood. The pad absorbs wound exudates, transforming into a hydrogel that provides a protective barrier and an optimal environment for wound healing. The device is applied topically to the wound site; it functions as a physical barrier and hemostatic agent to assist in bleeding control and wound management. ## Clinical Evidence No clinical data provided. Substantial equivalence is supported by the established safety and efficacy profile of chitosan-based wound dressings documented in scientific literature over several decades, alongside bench testing for sterility and performance. ## Technological Characteristics Non-woven topical pad; material: poly-D-glucosamine and poly-N-acetylglucosamine derived from chitosan; mechanism: cationic interaction for hemostasis and hydrogel formation for exudate absorption; sterilization: gamma-ray radiation to 10^-6 SAL; form factor: sterile foil-pouched pad. ## Regulatory Identification To temporarily control bleeding and cover external wounds. ## Predicate Devices - CLO-SURPLUS P.A.D. ([K032986](/device/K032986.md)) - ChitoSeal ([K021062](/device/K021062.md)) - T-PAD ([K030334](/device/K030334.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. On the left is the logo for the Department of Health & Human Services - USA, featuring a stylized human figure. To the right is the logo for the U.S. Food & Drug Administration (FDA), with the FDA acronym in a blue square and the full name "U.S. FOOD & DRUG ADMINISTRATION" in blue text next to it. Coreleader Biotech Co., Ltd. c/o Ian Li Regulatory Manager 19F, No. 100, Sec. 1, Santai 5th Road Sijhih City, Taipei 22102 Taiwan July 28, 2023 Re: K102944 Trade/Device Name: Coreleader Hemo-Pad Model Regulatory Class: Unclassified Product Code: QSY Dear Ian Li: 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 September 7, 2011. 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 and Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract image of an eagle with three lines forming its body and wings. The eagle is facing to the right. Food and Drug Administration 10903 New Hampshire Avenue Document Control Room-WO66-G609 Silver Spring, MID 20993-0002 Coreleader Biotech Co., Ltd. % Mr. Ian Li Regulatory Manager 19F, No. 100, Sec. 1, Santai 500 Road Sijhih City, Taipei 25102 Taiwan Re: K102944 Trade/Device Name: Coreleader Hemo-Pad Regulatory Class: Unclassified Product Code: FRO Dated: August 17, 2011 Received: August 30, 2011 Dear Mr. Li: 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. Drue, 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 - Mr. Ian Li 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. 1f you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH s) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance 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. Sincerely vours Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ #### Chapter 4 Indications for Use Statement ## Indications for Use Statement 510(k) Number (if known): K102944 Device Name: Coreleader Hemo-Pad Indications For Use: Coreleader Hemo-Pad is a dressing indicated for topical wound management and for the external topical temporary control of moderate to severe bleeding. The dressing is indicated for the following wounds: abrasions, lacerations, skin surface puncture sites for vascular procedures (arteries and veins) Prescription Use _ X (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Daniel Kune for Mkm (Division Sign-Off) Page 1 of _ l Division of Surgical, Orthopedic, and Restorative Devices 510(k) Number K102944 4-2 {4}------------------------------------------------ K102944 page 1 of 2 #### Chapter 5 510(k) Summary SEP - 7 2011 ### 510(k) Summary Submitted by: Coreleader Biotech Co., Ltd. 19F, No. 100, Sec. 1, Sintai 5th Rd., Sijhih, Taipei, Taiwan, 22102 Phone: +886-2-26968880 FAX: +886-2-26968882 - Contact Person: Teeming Tsao Date Prepared: September 20, 2010 Proprietary Name: Coreleader Hemo-Pad Common Name: Topical Hemostasis Pad Classification: Unclassified Classification Name: Topical Wound Dressing Pad Scion Cardio-Vascular, Inc., K032986, CLO-SURPLUS Predicate Device: P.A.D. Perclose, Inc., K021062, ChitoSeal T-Scientific, Inc., K030334, T-PAD - Device Description: The Coreleader Hemo-Fiber wound dressing is made from poly-D-glucosamine and poly-N-acetylglucosamine derived from chitosan. The Coreleader Hemo-Fiber is a soft, non-woven topical pad for hemostasis and wound care. The natural biological property of this material carries cation (positively charged ion) that helps to stop external hemorrhage, and the Coreleader Hemo-Fiber wound dressing absorbs the wound exudates to form a hydrogel while providing protection layer layer for an optimal wound-healing environment. {5}------------------------------------------------ K102944 page 2g2 #### Chapter 5 510(k) Summary ੰ ਵ Coreleader Hemo-Pad is a sterile topical hemostasis pad, packed in a foil pouch and sterilized by gamma-ray radiation to a 10to SAL. Coreleader Hemo-Pad is a dressing indicated for topical Intended Use: wound management and for the external topical temporary control of moderate to severe bleeding. The dressing is indicated for the following wounds: abrasions, lacerations, skin surface puncture sites for vascular procedures (arteries and veins) Coreleader Hemo-Pad is a soft, non-woven topical pad Technological made of poly-D-glucosamine and poly-N-acetylglucosamine Characteristics: derived from chitosan. The natural biological property of this material carries cation (positively charged ion) that helps to stop external hemorrhage and the gives the Coreleader Hemo-Pad an advantage as an effective barrier while providing for an optimal bacterial wound-healing environment. In addition, it has superb ventilation texture and high absorption ability that are compatible to human skin. Besides, the safety and use of chitosan have been published by researchers over a period of decades. This formulation has many useful and advantageous properties in their application as a wound dressing, namely biocompatibility, biodegradability, hemostatic and anti-infectional activity. --- **Source:** [https://fda.innolitics.com/device/K102944](https://fda.innolitics.com/device/K102944) **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