(261 days)
Not Found
No
The device description focuses on the material composition and physical properties of the wound dressing, with no mention of AI or ML capabilities. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
Yes
The device is indicated for the management of various types of wounds, and its mechanism of action involves creating a moist environment favorable to the wound healing process. This directly relates to the treatment or management of a medical condition, making it a therapeutic device.
No
The device description clearly states it is a "sterile topical wound dressing" used for the management of wounds by providing a moist environment, not for diagnosing conditions.
No
The device description clearly states it is composed of physical materials (Alginate fiber, polyurethane membrane, acrylic adhesive) and is a sterile topical wound dressing, indicating it is a physical medical device, 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 Function: The Coreleader AlgiPlaster is a topical wound dressing. Its function is to cover and manage wounds on the surface of the body, providing a protective barrier and a moist environment for healing. It does not analyze samples taken from the body.
- Intended Use: The intended use clearly describes its application to wounds on the skin.
- Device Description: The description focuses on the physical composition and properties of the dressing itself, not on any analytical or diagnostic capabilities.
Therefore, the Coreleader AlgiPlaster falls under the category of a medical device, specifically a wound dressing, rather than an In Vitro Diagnostic.
N/A
Intended Use / 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.
Product codes
FRO
Device Description
Coreleader AlgiPlaster is a soft, sterile, non-woven dressing consisting of an calcium alginate/sodium carboxymethylcellulose Xerogel cast into a high density polyethylene net. It provides a barrier to external contamination and produces 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 composed of Alginate fiber and combined Device 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.
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
Lay person (OTC use); licensed healthcare provider (Prescription Use)
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
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