CORELEADER ALGI-FIBER WOUND DRESSING MODEL ADW 05050 by CORELEADER BIOTECH CO., LTD.

Coreleader Algi-Fiber wound dressing is indicated as a primary dressing for the management of moderate to heavily exuding wounds, partial and full thickness wounds including chronic wounds such as leg ulcers, pressure sores and acute wounds such as donor sites, abrasions, lacerations and post-surgical wounds.

The following conditions are considered appropriate for OTC use by the lay person:

· Coreleader Algi-Fiber wound dressing is indicated as a primary dressing for the management of minor exuding wounds such as minor abrasions, minor lacerations and minor post-surgical wounds.

Device Description

Coreleader Algi-Fiber wound dressing is composed of calcium alginate fiber. It is softness and therefore Coreleader Algi-Fiber wound dressing is suitable for wound surface regardless the location, size, sinus and depth of a patient. Due to its highly hydrophilic property, the Coreleader Algi-Fiber wound dressing absorbs the wound exudates to form a hydrogel protection layer. The Coreleader Algi-Fiber wound dressing is biocompatibility. It has been tested and shown on accumulative effects, no evidence of delay hypersensitivity · non-cytotoxicity and is non-irritant. Coreleader Algi-Fiber is a sterile topical wound dressing, packed in individual pouch and sterilized by r-ray radiation to a 10° SAL.

AI/ML Overview

The provided text describes a wound dressing device and its substantial equivalence to predicate devices, focusing on its physical properties, intended use, and biocompatibility. However, it does not include acceptance criteria for a device's performance that would typically be evaluated through a clinical study (e.g., sensitivity, specificity, accuracy for a diagnostic device, or a specific functional outcome for a therapeutic device).

Therefore, a table of acceptance criteria and reported device performance, information about sample sizes for test and training sets, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone performance, or ground truth types cannot be extracted from this document. This document is a 510(k) Summary for a medical device (Coreleader Algi-Fiber Wound Dressing), which primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed performance study results with specific acceptance criteria as one would find for an AI-powered diagnostic or similar complex device.

Here's an analysis of what can be extracted:

Acceptance Criteria and Device Performance (Based on Substantial Equivalence Comparison):

The table provided in the document compares the proposed device (Coreleader Algi-Fiber Wound Dressing) with a predicate device (Comfeel SeaSorb Dressing) across several attributes to establish substantial equivalence.

Acceptance Criteria (Predicate)	Reported Device Performance (Coreleader Algi-Fiber)
Device Description: Highly absorbent material composed of a Xerogel of calcium sodium alginate cast into a high density polyethylene net.	Device Description: Highly absorbent wound dressing consisting of an calcium alginate fiber. (Further described as made of non-woven from calcium alginate fiber, absorbing exudates to form a hydrogel, and suitable for various wound surfaces.)
Use: Single	Use: Single
Biocompatibility: Non-hypersensitivity, non-cytotoxicity, and non-irritant	Biocompatibility: Non-hypersensitivity, non-cytotoxicity, and non-irritant. (Explicitly stated: "It has been tested and shown on accumulative effects, no evidence of delay hypersensitivity · non-cytotoxicity and is non-irritant.")
Intended Use: For management of (under the guidance of a health care professional) moderate to heavily exudating wounds, including leg ulcers and pressure sores, etc.	Intended Use: For management of (under the guidance of a health care professional) moderate to heavily exudating wounds, partial and full thickness wounds including chronic wounds such as leg ulcers, pressure sores and acute wounds such as donor sites, abrasions, lacerations and post-surgical wounds. (Also includes OTC use for minor exuding wounds.)
Precautions: (Extensive list including arterial insufficiency, complicated diabetic wounds, high infection risk, syphilis, tuberculosis, leprosy, cancer, removal for radiation/ultrasonic/diathermy/microwaves, clinical infection signs, not for dry wounds or third degree burns, no known hypersensitivity ingredients.)	Precautions: (Extensive list including hypersensitivity, not for surgical implant, high risk infected wounds only under physician care, not left permanently, not for dry wounds or third degree burns, single-use only, no re-sterilization.) Many precautions are similar to the predicate, demonstrating alignment in safety considerations.
Sterilization: Sterile	Sterilization: Sterile (Further specified as "sterilized by γ-ray radiation to a 10⁻⁶ SAL.")
Packaging: Polyester pouches laminated with peelable polyethylene prior to sterilization	Packaging: Sterilization pouch: Top material: Medical grade paper pouches. Bottom material: Transparent see-through film (made of PET). (This differs slightly in material but serves the same sterile packaging function.)

Study Details (Limited Information for this Type of Device Submission):

Sample Size for the Test Set and Data Provenance: Not applicable/not provided for performance evaluation in this 510(k) summary. The submission focuses on substantial equivalence based on product characteristics and previous testing data (e.g., biocompatibility testing).
Number of Experts Used to Establish Ground Truth and Qualifications: Not applicable/not provided. Biocompatibility testing results are typically from laboratory analyses, not expert consensus on clinical cases.
Adjudication Method: Not applicable/not provided.
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: No, this type of study is not mentioned as it's not relevant for this class of wound dressing.
Standalone Performance (Algorithm Only): Not applicable. This is a physical wound dressing, not an algorithm.
Type of Ground Truth Used: For biocompatibility, the "ground truth" would be established by standardized in vitro and in vivo biological tests (e.g., ISO 10993 series for cytotoxicity, irritation, sensitization). The document states the device "has been tested and shown on accumulative effects, no evidence of delay hypersensitivity · non-cytotoxicity and is non-irritant."
Sample Size for the Training Set: Not applicable/not provided.
How the Ground Truth for the Training Set Was Established: Not applicable/not provided.

Summary of Device and Evidence Presented:

The Coreleader Algi-Fiber Wound Dressing gained acceptance by demonstrating substantial equivalence to legally marketed predicate devices (CALGON VESTAL DIV., K910059, KALTOSTAT WOUND DRESSING and COLOPLAST CORP., K983519, COMFEEL SEASORB DRESSING). The evidence for this equivalence relies on direct comparison of material composition (calcium alginate fiber vs. calcium sodium alginate xerogel), intended use, single-use nature, sterilization methods, packaging, and critically, biocompatibility.

The biocompatibility of the Coreleader Algi-Fiber Wound Dressing was tested and shown to meet the standards of being non-hypersensitive, non-cytotoxic, and non-irritant. While no specific study names or detailed results are provided in this summary, the statement "It has been tested and shown on accumulative effects, no evidence of delay hypersensitivity · non-cytotoxicity and is non-irritant" confirms that the necessary biological evaluation tests were performed and passed. This type of submission does not typically include detailed clinical trial data or performance metrics beyond the basic safety and functional comparisons required to demonstrate substantial equivalence to an existing device.

Summary

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Chapter 5 510(k) Summary

K102943

APR 1 2 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 Coreleader Algi-Fiber Wound Dressing

Name:

Common Name: Topical Wound Dressing

Classification: Unclassified

Hydrophilic Wound and Burn Dressing Classification

Name:

CALGON VESTAL DIV., K910059, KALTOSTAT WOUND Predicate

Device: DRESSING

COLOPLAST CORP., K983519, COMFEEL SEASORB

DRESSING

	COMFEEL SEASORBDRESSING	CORELEADERALGI-FIBERWOUND DRESSING
	Devicedescription	The Comfeel SeaSorbDressing is a highlyabsorbent materialcomposed of a Xerogelof calcium sodiumalginate cast into ahigh densitypolyethylene net.	The CoreleaderAlgi-Fiber is a highlyabsorbent wounddressing consisting ofan calcium alginatefiber.
	Use(single,reusable)	Single	Single
	COMFEEL SEASORBDRESSING	CORELEADERALGI-FIBERWOUND DRESSING
Bio-compatibility	Non-hypersensitivity 、non-cytotoxicity andnon-irritant	Non-hypersensitivity 、non-cytotoxicity andnon-irritant
Intended use	For management of(under the guidance ofa health careprofessional) moderateto heavily exudatingwounds, including legulcers and pressuresores, etc.	For management of(under the guidance ofa health careprofessional) moderateto heavily exudatingwounds, including legulcers and pressuresores, etc.
Precautions	Wounds which aresolely or mainlycaused by arterialinsufficiency orcomplicated diabeticwounds (primarilylower leg and foot)should be inspected bya physician or nurseregularly.A physician should beconsulted before usingthis product on woundwith a high risk ofinfection, or on lesionscaused by syphilis,tuberculosis, leprosy orcancer.Comfeel Seasorbdressing must beremoved prior to thefollowing treatments:radiation X-rays	Coreleader Algi-FiberWound Dressingshould not be used onindividuals who aresensitive to or who hadan allergic reaction tothe dressing or itscomponent.Algi-Fiber must not beused as a surgicalimplant.The Wound Dressingmay be used on highrisk of infected woundsonly under the care ofclinical physicians.The dressing can't beleft in the woundpermanently andshould be inspected bya physician or nurseregularly.Wounds with signs of
	ultrasonic treatment,diathermy and microwaves.Wounds with signs ofclinical infection, feverand local symptomssuch as pain, erythemaor pus should have abacterial swabexamination. Use ofthis product may becontinued at thediscretion of aphysician. Currentsystemic antibiotictreatment may be giveif indicated.Not recommended foruse on dry wounds orthird degree burns.Do not use on patientswith knownhypersensitivity to anyof the ingredients. clinical infection, feverand local symptomssuch as pain, erythemaor pus should have abacterial swabexamination. Use ofthis product may becontinued at thediscretion of aphysician. Currentsystemic antibiotictreatment may be giveif indicated.The product is forsingle use only andshould not be re-sterile.Reuse orre-sterilization mayalso create a risk ofcontamination of thedevice and/or causepatient infection orcross-infection.Not recommended foruse on dry wounds orthird degree burns.
Sterilization	Sterile	Sterile
Packaging	Polyester poucheslaminated withpeelable polyethyleneprior to sterilization	Sterilization pouch:Top material: Medicalgrade paper pouches.Bottom material:Transparentsee-through film (madeof PET)

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Chapter 5 510(k) Summary

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Device Description: Coreleader Algi-Fiber wound dressing is composed of calcium alginate fiber. It is softness and therefore Coreleader Algi-Fiber wound dressing is suitable for wound surface regardless the

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Chapter 5 510(k) Summary

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location, size, sinus and depth of a patient. Due to its highly hydrophilic property, the Coreleader Algi-Fiber wound dressing absorbs the wound exudates to form a hydrogel protection layer. The Coreleader Algi-Fiber wound dressing is biocompatibility. It has been tested and shown on accumulative effects, no evidence of delay hypersensitivity · non-cytotoxicity and is non-irritant. Coreleader Algi-Fiber is a sterile topical wound dressing, packed in individual pouch and sterilized by r-ray radiation to a 10° SAL.

Intended Use: Coreleader Algi-Fiber wound dressing is indicated as a primary dressing for the management of moderate to heavily exuding wounds, partial and full thickness wounds including chronic wounds such as leg ulcers, pressure sores and acute wounds such as donor sites, abrasions, lacerations and post-surgical wounds.

Technological Coreleader Algi-Fiber wound dressing is manufactured by a Characteristics: Wet-Spinning production process. Made of non-woven from calcium alginate fiber. The dressing is presented as a dense, flat non-woven pad for application to surface wounds. In the presence of exudate or other body fluids containing sodium ions, the fibers absorb liquid and swell and calcium ions present in the fibers are partially replaced by sodium ions, causing the dressing to take on a gel-like appearance. This overlays the wound and provides a micro-environment that is believed to facilitate wound healing.

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Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with three lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

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

Coreleader Biotech Co., Ltd. % Mr. Ian Li 19F, No. 100, Sec. 1, Sintai 5th Rd. Sijhih. Taipei. Taiwan 22102

APR 1 2 2911

Re: K102943

Trade/Device Name: Coreleader Algi-Fiber Wound Dressing Regulatory Class: Unclassified Product Code: FRO Dated: February 11, 2011 Received: February 18, 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 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

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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.

If 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 yours.

Az B. n h

Mark N. Melker Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use Statement

510(k) Number (if known): K102943

Device Name: Coreleader Algi-Fiber Wound Dressing

Indications for Use:

The following indications for use of the product should be managed under the supervision of a health care professional:

The following conditions are considered appropriate for OTC use by the lay person:

· Coreleader Algi-Fiber wound dressing is indicated as a primary dressing for the management of minor exuding wounds such as minor abrasions, minor lacerations and minor post-surgical wounds.
Prescription Use V (Part 21 CFR 801 Subpart D) AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

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Concurrence of CDRH, Office of Device Evaluation (ODE)
Daúd Kinstahl MXM

opedic.

Page 1 of

510(k) Number K102943

Regulation Number and Section

N/A