Who is the manufacturer of CORELEADER ALGIPLASTER MODEL AP 050501?

Coreleader Biotech Co., Ltd. filed the 510(k) submission for CORELEADER ALGIPLASTER MODEL AP 050501 (K102942).

What is the FDA product code for CORELEADER ALGIPLASTER MODEL AP 050501?

FRO. as a Class U device in the SU panel.

What is the regulatory pathway for CORELEADER ALGIPLASTER MODEL AP 050501?

510(k) clearance (submission type: Traditional).

What are the predicate devices for CORELEADER ALGIPLASTER MODEL AP 050501?

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

Who can help prepare an FDA 510(k) submission like CORELEADER ALGIPLASTER MODEL AP 050501?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

CORELEADER ALGIPLASTER MODEL AP 050501

K102942 · Coreleader Biotech Co., Ltd. · FRO · Jun 22, 2011 · SU

Device Facts

Record ID	K102942
Device Name	CORELEADER ALGIPLASTER MODEL AP 050501
Applicant	Coreleader Biotech Co., Ltd.
Product Code	FRO · SU
Decision Date	Jun 22, 2011
Decision	SESE
Submission Type	Traditional
Device Class	Class U
Attributes	Therapeutic

Intended Use

The following conditions are considered appropriate for OTC use by the lay person: Coreleader AlgiPlaster is indicated for the management minor abrasions, minor cuts and minor lacerations. The following conditions are considered appropriate for Prescription Use under the supervision of a licensed healthcare provider: Coreleader AlgiPlaster is indicated as a primary dressing for the management of exuding wounds, including acute wounds such as abrasions, lacerations and post-surgical wounds.

Device Story

Coreleader AlgiPlaster is a sterile, non-woven topical wound dressing composed of calcium alginate fibers combined with a thin polyurethane membrane coated with acrylic adhesive. Used in clinics or home settings; applied by healthcare professionals or patients. Dressing acts as a barrier to external contamination while maintaining a moist wound environment by reducing water vapor loss. Upon contact with wound exudate containing sodium ions, fibers absorb fluid and swell; calcium ions are replaced by sodium ions, transforming the dressing into a gel-like consistency. This gel promotes a favorable environment for wound healing. The dressing is permeable to water vapor and oxygen but impermeable to microorganisms. It is intended for single use only.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Materials: Calcium alginate fiber, polyurethane membrane, acrylic adhesive. Principle: Wet-spinning production process for fibers; gelation via ion exchange (calcium/sodium). Form factor: Dense, flat non-woven pad. Sterilization: Gamma radiation (10^6 SAL). Connectivity: None.

Indications for Use

Indicated for management of minor abrasions, cuts, and lacerations (OTC); management of exuding wounds including acute wounds like abrasions, lacerations, and post-surgical wounds (Prescription). Not for dry wounds or third-degree burns.

Predicate Devices

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

Related Devices

K102943 — CORELEADER ALGI-FIBER WOUND DRESSING MODEL ADW 05050 · Coreleader Biotech Co., Ltd. · Apr 12, 2011
K982234 — AL-GEN CALCIUM ALGINATE DRESSING · Innovative Technologies , Ltd. · Sep 8, 1998
K111578 — CORELEADER COLLA-ALGI FIBER MODEL CAW · Coreleader Biotech Co., Ltd. · Sep 23, 2011
K982638 — 3M TEGAGEN HI ALGINATE DRESSING & 3 M TEGAGEN HG ALGINATE DRESSING, MODEL #'S 90110,90112,90114,90120, 90210,90212,90214 · Innovative Technologies , Ltd. · Aug 21, 1998
K963598 — INNOVATIVE TECHNOLOGIES ALIGINATE/PECTIN WOUND DRESSINGS · Innovative Technologies , Ltd. · Nov 27, 1996

Submission Summary (Full Text)

{0}------------------------------------------------ K102942 page 1/6 ## 510(k) Summary JUN 2 2 2011 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 Teeming Tsao Contact Person: Date Prepared: September 20, 2010 Coreleader AlgiPlaster Proprietary Name: Topical Wound Dressing Common Name: 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 CORELEADER DRESSING ALGIPLASTER The Seasorb Dressing The Coreleader Device AlgiPlaster is a soft, is a highly absorbent description wound dressing sterile, non-woven dressing of calcium consisting of an calcium sodium alginate fibers alginate/sodium combined with a thin polyurethane carboxymethylcellulose Xerogel cast into a high membrane. It density polyethylene provides a barrier to external contamination net. and produces a moist environment at the surface of the wound {1}------------------------------------------------ K102942 Page 2/6 | Use(single, reusable) | Single | Single by reducing water vapor loss from the exposed tissue. The moist environment provided by the alginate fibers may provide an environment favorable to the wound healing process. | |------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Bio- compatibility | Non-hypersensitivity、 non-cytotoxicity and non-irritant | Non-hypersensitivity、 non-cytotoxicity and non-irritant | | Technological features | Calcium alginate fibers are based heavily upon its unique gelation properties with respect to mono- and divalent cations. | Calcium alginate fibers are based heavily upon its unique gelation properties with respect to mono- and divalent cations. | | 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. | The following conditions are considered appropriate for OTC use by the lay person: Coreleader AlgiPlaster is indicated for the management minor abrasions, minor cuts and minor lacerations. The following conditions are considered appropriate for Prescription Use Under the supervision of a licensed healthcare | | | | provider: Coreleader AlgiPlaster is indicated as a primary dressing for the management of exuding wounds, including acute wounds such as abrasions, lacerations and post-surgical wounds. | | Precautions | Wounds which are solely or mainly caused by arterial insufficiency or complicated diabetic wounds (primarily lower leg and foot) should be inspected by a physician or nurse regularly. A physician should be consulted before using this product on wound with a high risk of infection, or on lesions caused by syphilis, tuberculosis, leprosy or cancer. Comfeel Seasorb dressing must be removed prior to the following treatments: radiation, X-rays, ultrasonic treatment, diathermy and micro waves. Wounds with signs of clinical infection. fever | Rx precautions: The Wound Dressing may be used on high risk of infected wounds only under the care of clinical physicians. AlgiPlaster must not be used as a surgical implant. The dressing can't be left in the wound permanently and should be inspected by a physician or nurse regularly. Wounds with signs of clinical infection, fever and local symptoms such as pain, erythema or pus should have a bacterial swab examination. Use of this product may be continued at the discretion of a physician. Current systemic antibiotic treatment may be give if indicated. The product is for single use only and should not be re-sterilized. Reuse or | | and local symptoms such as pain, erythema or pus should have a bacterial swab examination. Use of this product may be continued at the discretion of a physician. Current systemic antibiotic treatment may be give if indicated. Not recommended for use on dry wounds or third degree burns. Do not use on patients with known hypersensitivity to any of the ingredients. | re-sterilization may also create a risk of contamination of the device and/or cause patient infection or cross-infection. Not recommended for use on dry wounds or third degree burns. Do not use if the package is opened or the seal broken. OTC precautions: Do not use on infected wounds The dressing can't be left in the wound permanently. Reuse or re-sterilization may also create a risk of contamination of the device and/or cause patient infection or cross-infection. The product is for single use only and should not be re-sterilized. Not recommended for use on dry wounds or third degree burns. Do not use if the package is opened or the seal broken. Do not use beyond the expiration date. | | | Sterilization | Sterile | | | Packaging | Polyester pouches laminated with peelable | | | | Sterile | | | | Sterilization pouch: Top material: Medical | | 5-3 {2}------------------------------------------------ . K102942 page 3/6 {3}------------------------------------------------ K102942 Page 4/6 {4}------------------------------------------------ | 1 man - C I ﺍ 2 | 0 ago C 1 g J | |------------------------------------|------------------------------| |------------------------------------|------------------------------| | | polyethylene prior to | grade paper pouches. | |--|-----------------------|------------------------| | | sterilization | Bottom material: | | | | Transparent | | | | see-through film,(made | | | | of PET). | Coreleader AlgiPlaster is composed of Alginate fiber and combined Device with the thin polyurethane membrane coated with a layer of an Description: acrylic adhesive. The dressing combination, which is permeable to both water vapor and oxygen, is impermeable to micro-organisms and once in position, it provides an effective barrier to external contamination, and producing a moist environment at the surface of the wound by reducing water vapor loss from the exposed tissue. The moist environment provided by the alginate fibers may provide an environment favorable to the wound healing process. Coreleader AlgiPlaster is a sterile topical wound dressing, packed in individual pouch and sterilized by r-ray radiation to a 106 SAL. The following conditions are considered appropriate for OTC use by Intended Use: the lay person: > Coreleader AlgiPlaster is indicated for the management minor abrasions, minor cuts and minor lacerations. The following conditions are considered appropriate for Prescription Use under the supervision of a licensed healthcare provider: Coreleader AlgiPlaster is indicated as a primary dressing for the management of exuding wounds, including acute wounds such as abrasions, lacerations and post-surgical wounds. Technological Characteristics Coreleader AlgiPlaster is composed of calcium alginate fiber and PU membrane. The calcium alginate fiber is manufactured by a Wet-Spinning production process. Alginate fiber combined with the thin polyurethane membrane coated with a layer of an acrylic adhesive. The dressing combination, which is permeable to both water vapour and oxygen, is impermeable to micro-organisms and once in position, it provides an effective barrier to external contamination, and producing a moist environment at the surface of the wound by reducing water vapour loss from the exposed tissue. The dressing is presented as a dense, flat non-woven pad for ર-6 {5}------------------------------------------------ K102942 Page 6/6 application to surface wounds. In the presence of exudate or other body fluids containing sodium ions, the fibers absorb liquid and swell. Calcium ions present in the fibers are partially replaced by sodium ions, causing the dressing to take on a gel-like consistency which may provide an environment favorable to the wound healing process. {6}------------------------------------------------ Image /page/6/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a stylized eagle or bird symbol, with three curved lines representing its wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol. The text is in all capital letters and is in a sans-serif font. Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring. MD 20993-0002 Coreleader Biotech Co., Ltd. % Mr. Ian Li 19F, No. 100, Sec 1 Sintai 510 Rd., Sijhih City Taipei, Taiwan 22102 JUN 2 2 2011 Re: K102942 Trade/Device Name: Coreleader AlgiPlaster Regulatory Class: Unclassified Product Code: FRO Dated: May 20, 2011 Received: June 07, 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 {7}------------------------------------------------ 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 (OS) 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, Sincerely yours, k N. Melkerson Mark N. Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {8}------------------------------------------------ # Indications for Use Statement 510(k) Number (if known): K102942 Device Name: Coreleader AlgiPlaster Indications for Use: The following conditions are considered appropriate for OTC use by the lay person: Coreleader AlgiPlaster is indicated for the management minor abrasions, minor cuts and minor lacerations. The following conditions are considered appropriate for Prescription Use under the supervision of a licensed healthcare provider: Coreleader AlgiPlaster is indicated as a primary dressing for the management of exuding wounds, including acute wounds such as abrasions, lacerations and 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) Concurrence of CDRH, Office of Device Evaluation (ODE) Daniel Kane for UKM (Division Sign-Off) Page 1 of _ 1 Division of Surgical, Orthopedic, and Restorative Devices 510(k) Number K102942