(261 days)
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.
Coreleader AlgiPlaster is composed of Alginate fiber and combined with the thin polyurethane membrane coated with a layer of an 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 provided text is a 510(k) summary for a wound dressing, the Coreleader AlgiPlaster. It describes the device, its intended use, technological features, and compares it to predicate devices. However, this document does not contain information about acceptance criteria or a study proving the device meets those criteria, as typically understood for AI/ML-based medical devices.
The submission is for a medical device that falls under the "Unclassified" category, meaning it does not require a PMA (Premarket Approval) and is subject to general controls. The review process outlined in the document confirms that the device is "substantially equivalent" to legally marketed predicate devices. This substantial equivalence is based on the device's technological characteristics and intended use being similar to existing cleared devices, rather than on a performance study against specific acceptance criteria for a new clinical claim.
Therefore, I cannot provide the requested table and study details because the provided document does not contain this information. The K102942 submission is not an AI/ML device and thus does not include the typical elements of an AI/ML device submission such as test sets, ground truth establishment, expert adjudication, or MRMC comparative effectiveness studies.
The document is a traditional 510(k) submission for a wound dressing and focuses on demonstrating substantial equivalence to predicate devices based on physical and functional characteristics, biocompatibility, and intended use.
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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
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| Use(single, reusable) | Single | Singleby reducing watervapor loss from theexposed tissue. Themoist environmentprovided by thealginate fibers mayprovide anenvironment favorableto the wound healingprocess. |
|---|---|---|
| Bio-compatibility | Non-hypersensitivity、non-cytotoxicity andnon-irritant | Non-hypersensitivity、non-cytotoxicity andnon-irritant |
| Technologicalfeatures | Calcium alginate fibersare based heavily uponits unique gelationproperties with respectto mono- and divalentcations. | Calcium alginate fibersare based heavily uponits unique gelationproperties with respectto mono- and divalentcations. |
| Intended use | For management of(under the guidance ofa health careprofessional) moderateto heavily exudatingwounds, including legulcers and pressuresores, etc. | The followingconditions areconsidered appropriatefor OTC use by the layperson:Coreleader AlgiPlasteris indicated for themanagement minorabrasions, minor cutsand minor lacerations.The followingconditions areconsidered appropriatefor Prescription UseUnder the supervisionof a licensed healthcare |
| provider:Coreleader AlgiPlasteris indicated as aprimary dressing forthe management ofexuding wounds,including acutewounds such asabrasions, lacerationsand post-surgicalwounds. | ||
| Precautions | Wounds which aresolely or mainly causedby arterial insufficiencyor complicated 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,ultrasonic treatment,diathermy and microwaves.Wounds with signs ofclinical infection. fever | Rx precautions:The Wound Dressingmay be used on highrisk of infectedwounds only under thecare of clinicalphysicians.AlgiPlaster must notbe used as a surgicalimplant.The dressing can't beleft in the woundpermanently andshould be inspected bya physician or nurseregularly.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.The product is forsingle use only andshould not bere-sterilized.Reuse or |
| and 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. | re-sterilization mayalso create a risk ofcontamination of thedevice and/or causepatient infection orcross-infection.Not recommended foruse on dry wounds orthird degree burns.Do not use if thepackage is opened orthe seal broken.OTC precautions:Do not use on infectedwoundsThe dressing can't beleft in the woundpermanently.Reuse orre-sterilization mayalso create a risk ofcontamination of thedevice and/or causepatient infection orcross-infection.The product is forsingle use only andshould not bere-sterilized.Not recommended foruse on dry wounds orthird degree burns.Do not use if thepackage is opened orthe seal broken.Do not use beyond theexpiration date. | |
| Sterilization | Sterile | |
| Packaging | Polyester poucheslaminated with peelable | |
| Sterile | ||
| Sterilization pouch:Top material: Medical |
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| 1man- CIﺍ2 | 0agoC1gJ |
|---|---|
| ------------------------------------ | ------------------------------ |
| 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
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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.
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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
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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 (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
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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
N/A