(190 days)
Not Found
No
The device description and intended use focus solely on the material composition and physical properties of a wound dressing. There is no mention of any computational or analytical capabilities that would suggest the use of AI or ML.
Yes
The device, Coreleader Algi-Fiber wound dressing, is intended for the management of wounds, including chronic and acute wounds, which directly supports the healing of a pathological condition.
No
The device description clearly states it is a "wound dressing" used to absorb wound exudates and form a hydrogel protection layer, indicating a therapeutic function rather than a diagnostic one. Its indications for use also describe it as a management tool for various wounds, not a tool for identifying or characterizing a medical condition.
No
The device description clearly states it is a wound dressing composed of calcium alginate fiber, which is a physical material, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The description clearly states that the Coreleader Algi-Fiber wound dressing is a "sterile topical wound dressing" applied directly to the wound surface. It absorbs wound exudates and forms a hydrogel layer.
- Intended Use: The intended use is for the management of exuding wounds, which is a topical application for wound care, not an in vitro test on a sample.
The device is a medical device, specifically a wound dressing, but it does not fit the definition of an In Vitro Diagnostic.
N/A
Intended Use / 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)
Product codes
FRO
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.
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
health care professional, lay person
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)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
Chapter 5 510(k) Summary
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 SEASORB
DRESSING | CORELEADER
ALGI-FIBER
WOUND DRESSING | |
|-----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------|
| | Device
description | The Comfeel SeaSorb
Dressing is a highly
absorbent material
composed of a Xerogel
of calcium sodium
alginate cast into a
high density
polyethylene net. | The Coreleader
Algi-Fiber is a highly
absorbent wound
dressing consisting of
an calcium alginate
fiber. |
| | Use(single,
reusable) | Single | Single |
| | COMFEEL SEASORB
DRESSING | CORELEADER
ALGI-FIBER
WOUND DRESSING | |
| Bio-
compatibility | Non-hypersensitivity 、
non-cytotoxicity and
non-irritant | Non-hypersensitivity 、
non-cytotoxicity and
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. | For management of
(under the guidance of
a health care
professional) moderate
to heavily exudating
wounds, including leg
ulcers and pressure
sores, etc. | |
| 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 | Coreleader Algi-Fiber
Wound Dressing
should not be used on
individuals who are
sensitive to or who had
an allergic reaction to
the dressing or its
component.
Algi-Fiber must not be
used as a surgical
implant.
The Wound Dressing
may be used on high
risk of infected wounds
only under the care of
clinical physicians.
The dressing can't be
left in the wound
permanently and
should be inspected by
a physician or nurse
regularly.
Wounds with signs of | |
| | ultrasonic treatment,
diathermy and micro
waves.
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.
Not recommended for
use on dry wounds or
third degree burns.
Do not use on patients
with known
hypersensitivity to any
of the ingredients. 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-sterile.
Reuse or
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. | | |
| Sterilization | Sterile | Sterile | |
| Packaging | Polyester pouches
laminated with
peelable polyethylene
prior to sterilization | Sterilization pouch:
Top material: Medical
grade paper pouches.
Bottom material:
Transparent
see-through film (made
of PET) | |
1
.
KIOZ943
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2
Chapter 5 510(k) Summary
Kiozqucs
3/4
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
3
Chapter 5 510(k) Summary
KLO29603
4/4
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.
4
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
5
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
6
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)
4-2
Concurrence of CDRH, Office of Device Evaluation (ODE)
Daúd Kinstahl MXM
opedic.
Page 1 of
510(k) Number K102943