(108 days)
Not Found
No
The device description focuses on the material composition and physical properties of a wound dressing, with no mention of software, algorithms, or data processing.
Yes
The device is indicated for the management of various types of wounds, including diabetic ulcers and second-degree burns. Its function is to provide a moist wound environment favorable to the healing process, which aligns with the definition of a therapeutic device.
No
The device is a wound care dressing designed to manage exuding wounds and facilitate healing by maintaining a moist environment, not to diagnose medical conditions.
No
The device description clearly states it is a wound care dressing composed of collagen and calcium alginate fibers, which are physical materials, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a wound dressing for managing exuding wounds. This is a topical application for wound care, not a diagnostic test performed on samples taken from the body.
- Device Description: The description details the composition and function of a wound dressing designed to absorb exudate and promote a moist wound environment. It does not describe any components or processes related to analyzing biological samples for diagnostic purposes.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting specific analytes or markers
- Providing diagnostic information about a disease or condition
- Using reagents or instruments for in vitro testing
The device is a wound care product, which falls under the category of medical devices used for treatment and management of wounds, not for diagnosis.
N/A
Intended Use / 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 .
Product codes
FRO
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. 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
FIBRACOL COLLAGEN-ALGINATE DRESSING (K925548), FIBRCOL PLUS COLLAGEN WOUND DRESSING WITH ALGINATE (K982597), KALTOSTAT FORTEX WOUND DRESSING (K921009), KALTOSTAT WOUND DRESSING (K910059)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
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
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