← Product Code FRO · K111578 # CORELEADER COLLA-ALGI FIBER MODEL CAW (K111578) _Coreleader Biotech Co., Ltd. · FRO · Sep 23, 2011 · SU · SESE_ **Canonical URL:** https://fda.innolitics.com/device/K111578 ## Device Facts - **Applicant:** Coreleader Biotech Co., Ltd. - **Product Code:** FRO - **Decision Date:** Sep 23, 2011 - **Decision:** SESE - **Submission Type:** Traditional - **Device Class:** Class U - **Review Panel:** SU - **Attributes:** Therapeutic ## Intended Use Coreleader Colla-Algi Fiber Dressing is indicated for management of exuding wounds including: Full-thickness and partial-thickness wounds . Pressure ulcers . Venous ulcers Ulcers caused by mixed vascular etiologies . Diabetic ulcers ● Second-degree burns ● Donor sites and other bleeding surface wounds ● Abrasions Traumatic wounds healing by secondary intention . Dehisced surgical incisions . ## Device Story Coreleader Colla-Algi Fiber is a sterile, topical wound dressing composed of 10% bovine collagen and calcium alginate fibers. Manufactured via a wet-spinning process, the dressing combines collagen's structural support with alginate's gel-forming properties. When applied to an exuding wound, the dressing interacts with exudate to maintain a moist healing environment. It is non-adherent, conformable, and maintains integrity when wet. Used in clinical settings for various wound types, it is applied by healthcare providers to manage exudate and facilitate healing. The dressing is removed easily without leaving fibers in the wound. ## Clinical Evidence No clinical data provided. Biocompatibility studies demonstrated the dressing is non-irritating, non-sensitizing, and non-cytotoxic. ## Technological Characteristics Topical wound dressing composed of bovine collagen and medical-grade calcium alginate. Manufactured via wet-spinning process. Sterile, soft, absorbent, and conformable sheet. Sterilized by gamma-ray radiation to a 10^-6 SAL. ## Predicate Devices - FIBRACOL COLLAGEN-ALGINATE DRESSING ([K925548](/device/K925548.md)) - FIBRCOL PLUS COLLAGEN WOUND DRESSING WITH ALGINATE ([K982597](/device/K982597.md)) - KALTOSTAT FORTEX WOUND DRESSING ([K921009](/device/K921009.md)) - KALTOSTAT WOUND DRESSING ([K910059](/device/K910059.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}------------------------------------------------ K 11:1578 page 1 of 2 # 510(k) Summary SEP 2 3 2011 Submitted by: Coreleader Biotech Co., Ltd. 19F, No. 100, Sec. 1, Sintai 5th Rd., Sijhih District, New Taipei city, Taiwan(R.O.C), 22102 Phone: +886-2-26968880 FAX: +886-2-26968882 Contact Person: Teeming Tsao Date Prepared: May 25, 2011 Proprietary Name: Coreleader Colla-Algi Fiber Common Name: Topical Wound dressing Classification: Unclassified Classification Name: Dressing, Wound Predicate Device: Coreleader Colla-Algi Fiber Dressing is substantially equivalent to: FIBRACOL COLLAGEN-ALGINATE DRESSING (K925548). Manufactured by JOHNSON & JOHNSON MEDICAL, INC. FIBRCOL PLUS COLLAGEN WOUND DRESSING WITH ALGINATE (K982597). Manufactured by JOHNSON & JOHNSON MEDICAL, INC. KALTOSTAT FORTEX WOUND DRESSING (K921009). Manufactured by CALGON VESTAL DIV. KALTOSTAT WOUND DRESSING (K910059). Manufactured by CALGON VESTAL DIV. Device Description: Coreleader Colla-Alig Fiber Dressing with Alginate is wound care dressing with 10% collagen composition. Colla-Alig Fiber Wound Dressing with Alginate combines with exudate to maintain a moist wound environment. {1}------------------------------------------------ The moist environment provided by the Colla-algi fibers may provide an environment favorable to the wound healing process. It is non-adherent, removes easily and leaves wound free of fiber. It maintains initial integrity when wet. Soft, conformable sheet can be cut to fit any size wound. Biocompatibility studies have demonstrated the Coreleader Colla-Algi Fiber Dressing to be non-irritating, non-sensitizing, and non-cytotoxic. Coreleader Colla-Algi Fiber Dressing is a sterile topical wound dressing, packed in a pouch and a foil bag, and sterilized by gamma-ray radiation to a 10 SAL. Coreleader Colla-Algi Fiber Dressing is indicated for management of exuding wounds including Full-thickness and partial-thickness wounds, Pressure ulcers, Venous ulcers, Ulcers caused by mixed vascular etiologies, Diabetic ulcers, Second-degree burns, Donor sites and other bleeding surface wounds, Abrasions and Traumatic wounds healing by secondary intention, Dehisced surgical incisions. Coreleader Colla-Algi Fiber Dressing with Alginate is an advanced wound care device composed of collagen and calcium alginate fibers. Its unique combination of natural biopolymers created by Wet-Spinning process combines the structure support of collagen and gel forming properties of alginates into a sterile, soft, absorbent. conformable topical wound dressing. The dressing is manufactured from bovine collage and medical grade alginate. > The source of bovine collagen is from bovine hide splits from Australia. The hides are from healthy cattle slaughtered under process further in a controlled clean room in order to avoid the possibility of bovine spongiform encephalopathy (BSE) contamination. The collagen is linked with the calcium alginate using a Wet-Spinning process. Intended Use: ## Technological Characteristics: 5-3 {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows a circular logo for the Department of Health & Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol consists of three curved lines that resemble a stylized human figure or a flowing design. Food and Drug Administration 10905 New Hampshire Avenue Document Control Room - WQ66-G609 Silver Spring, MD 20993-0002 Coreleader Biotech Co.. Ltd. % Mr. lan Li 19F', No. 100, Sec. 1, Sintai 5th Rd Sijhih Dist., New Taipei City Taiwan (R.O.C) 22102 SEP 2 3 2011 Re: K111578 Trade/Device Name: Coreleader Colla-Algi Fiber Regulatory Class: Unclassified Product Code: FRO Dated: August 16, 2011 Received: August 26, 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. 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 hiability 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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set {3}------------------------------------------------ Page 2 - Mr. Ian Li 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. ff you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.ida.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/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometries/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 yours, Erine Keith - for Mark N. Melkerson Director Division of Surgical. Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ ### Indications for Use Statement #### K 111578 510(k) Number (if known): Device Name: Coreleader Colla-Algi Fiber Indications For Use: Coreleader Colla-Algi Fiber Dressing is indicated for management of exuding wounds including: - Full-thickness and partial-thickness wounds . - Pressure ulcers . - � Venous ulcers - Ulcers caused by mixed vascular etiologies . - Diabetic ulcers ● - Second-degree burns ● - Donor sites and other bleeding surface wounds ● - Abrasions � - Traumatic wounds healing by secondary intention . - Dehisced surgical incisions . Prescription Use (Part 21 CFR 801 Subpan 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) (Division Sign-Off) Pans Division of Surgical, Orthopedic, and Restorative Devices 510(k) Number K111578 4-2 Page 1 of __ 1 --- **Source:** [https://fda.innolitics.com/device/K111578](https://fda.innolitics.com/device/K111578) **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. 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