CORELEADER ALGI-FIBER WOUND DRESSING MODEL ADW 05050

K102943 · Coreleader Biotech Co., Ltd. · FRO · Apr 12, 2011 · SU

Device Facts

• Record ID: K102943
• Device Name: CORELEADER ALGI-FIBER WOUND DRESSING MODEL ADW 05050
• Applicant: Coreleader Biotech Co., Ltd.
• Product Code: FRO · SU
• Decision Date: Apr 12, 2011
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

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

Coreleader Algi-Fiber is a sterile, non-woven topical wound dressing composed of calcium alginate fibers. Applied to wound surfaces of varying location, size, and depth; functions by absorbing wound exudate via hydrophilic properties. Upon contact with sodium-containing body fluids, fibers swell and undergo ion exchange—calcium ions replaced by sodium—transforming the dressing into a protective hydrogel layer. This gel creates a moist micro-environment to facilitate healing. Intended for use by healthcare professionals or lay persons (OTC) for specific wound types. Dressing is single-use; must be removed before radiation, X-ray, or ultrasonic treatments. Not for surgical implantation.

Clinical Evidence

Bench testing only. Biocompatibility testing performed including assessment of accumulative effects, delayed hypersensitivity, cytotoxicity, and irritation. No clinical data provided.

Technological Characteristics

Material: Calcium alginate fiber. Manufacturing: Wet-spinning process. Form: Dense, flat non-woven pad. Mechanism: Hydrophilic absorption and ion exchange (calcium to sodium) forming a hydrogel. Sterilization: Gamma radiation (10^-6 SAL).

Indications for Use

Indicated for management of moderate to heavily exuding partial/full thickness wounds (chronic: leg ulcers, pressure sores; acute: donor sites, abrasions, lacerations, post-surgical) under professional supervision. Also indicated for OTC use for minor exuding wounds (minor abrasions, lacerations, post-surgical). Contraindicated for dry wounds, third-degree burns, or individuals with known hypersensitivity to dressing components.

Predicate Devices

• CALGON VESTAL DIV., K910059, KALTOSTAT WOUND DRESSING
• COLOPLAST CORP., K983519, COMFEEL SEASORB DRESSING

Submission Summary (Full Text)

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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: [phone] FAX: [phone]

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 SEASORB<br>DRESSING | CORELEADER<br>ALGI-FIBER<br>WOUND DRESSING | |
|-----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------|
| | Device<br>description | The Comfeel SeaSorb<br>Dressing is a highly<br>absorbent material<br>composed of a Xerogel<br>of calcium sodium<br>alginate cast into a<br>high density<br>polyethylene net. | The Coreleader<br>Algi-Fiber is a highly<br>absorbent wound<br>dressing consisting of<br>an calcium alginate<br>fiber. |
| | Use(single,<br>reusable) | Single | Single |
| | COMFEEL SEASORB<br>DRESSING | CORELEADER<br>ALGI-FIBER<br>WOUND DRESSING | |
| Bio-<br>compatibility | Non-hypersensitivity 、<br>non-cytotoxicity and<br>non-irritant | Non-hypersensitivity 、<br>non-cytotoxicity and<br>non-irritant | |
| Intended use | For management of<br>(under the guidance of<br>a health care<br>professional) moderate<br>to heavily exudating<br>wounds, including leg<br>ulcers and pressure<br>sores, etc. | For management of<br>(under the guidance of<br>a health care<br>professional) moderate<br>to heavily exudating<br>wounds, including leg<br>ulcers and pressure<br>sores, etc. | |
| Precautions | Wounds which are<br>solely or mainly<br>caused by arterial<br>insufficiency or<br>complicated diabetic<br>wounds (primarily<br>lower leg and foot)<br>should be inspected by<br>a physician or nurse<br>regularly.<br>A physician should be<br>consulted before using<br>this product on wound<br>with a high risk of<br>infection, or on lesions<br>caused by syphilis,<br>tuberculosis, leprosy or<br>cancer.<br>Comfeel Seasorb<br>dressing must be<br>removed prior to the<br>following treatments:<br>radiation X-rays | Coreleader Algi-Fiber<br>Wound Dressing<br>should not be used on<br>individuals who are<br>sensitive to or who had<br>an allergic reaction to<br>the dressing or its<br>component.<br>Algi-Fiber must not be<br>used as a surgical<br>implant.<br>The Wound Dressing<br>may be used on high<br>risk of infected wounds<br>only under the care of<br>clinical physicians.<br>The dressing can't be<br>left in the wound<br>permanently and<br>should be inspected by<br>a physician or nurse<br>regularly.<br>Wounds with signs of | |
| | ultrasonic treatment,<br>diathermy and micro<br>waves.<br>Wounds with signs of<br>clinical infection, fever<br>and local symptoms<br>such as pain, erythema<br>or pus should have a<br>bacterial swab<br>examination. Use of<br>this product may be<br>continued at the<br>discretion of a<br>physician. Current<br>systemic antibiotic<br>treatment may be give<br>if indicated.<br>Not recommended for<br>use on dry wounds or<br>third degree burns.<br>Do not use on patients<br>with known<br>hypersensitivity to any<br>of the ingredients. clinical infection, fever<br>and local symptoms<br>such as pain, erythema<br>or pus should have a<br>bacterial swab<br>examination. Use of<br>this product may be<br>continued at the<br>discretion of a<br>physician. Current<br>systemic antibiotic<br>treatment may be give<br>if indicated.<br>The product is for<br>single use only and<br>should not be re-sterile.<br>Reuse or<br>re-sterilization may<br>also create a risk of<br>contamination of the<br>device and/or cause<br>patient infection or<br>cross-infection.<br>Not recommended for<br>use on dry wounds or<br>third degree burns. | | |
| Sterilization | Sterile | Sterile | |
| Packaging | Polyester pouches<br>laminated with<br>peelable polyethylene<br>prior to sterilization | Sterilization pouch:<br>Top material: Medical<br>grade paper pouches.<br>Bottom material:<br>Transparent<br>see-through film (made<br>of 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 [phone] or [phone] 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:

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.
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.

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510(k) Number K102943