(216 days)
Not Found
Not Found
No
The 510(k) summary describes a hydrocolloid wound dressing and does not mention any AI or ML components or functionalities.
Yes
The device is indicated for the management and healing of various wounds (burns, ulcers, surgical wounds, etc.), which directly addresses health conditions for therapeutic benefit.
No
The device description indicates it is a wound dressing designed to absorb exudates, protect the wound site, and facilitate healing, rather than to diagnose medical conditions. Its intended use is for the management of burns and wounds, which are therapeutic actions, not diagnostic ones.
No
The device description explicitly states it is made of physical materials (Hydrocolloid, Sodium carboxymethyl cellulose, etc.) and is a 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:
- Intended Use: The intended use clearly states that the device is for the management of various types of wounds (burns, ulcers, surgical wounds, etc.). This is a therapeutic or wound care application, not a diagnostic one.
- Device Description: The description details the materials and function of a wound dressing, which is designed to absorb exudates, protect the wound, and facilitate healing. This aligns with wound care, not in vitro diagnostics.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing information for the diagnosis of a disease or condition.
IVD devices are used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening. This device's function is entirely external and focused on wound management.
N/A
Intended Use / Indications for Use
Coreleader Hydro-clear is indicted for the management of 1st and 2nd degree burns, chronic ulcers, surgical wounds, skin graft and donor sites.
Patient with conditions listed below is considered appropriate for Over-The Counter Use (OTC):
for the management of minor cuts, minor burns (1st degree burns), minor lacerations and minor cuts.
Product codes (comma separated list FDA assigned to the subject device)
FRO
Device Description
Coreleader Hydro-clear is a new product that is made of Hydrocolloid (Sodium carboxymethyl cellulose, Synthetic Elastomer, Tackifier Resins, Mineral Oil and Polyurethane film) by unique production process. With preferable liquid absorbsion ability, gas permeability and ability of water resistant, Hydro-clear is clear of adhesive onto wound, capable to absorb exudates, protect wound site and facilitates would healing 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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
3M™ Tegasorb™ Hydrocolloid Dressings
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
N/A
0
K123394 page 1/2
JUN 0 6 2013
510(k) Summary
Submitted by:
Coreleader Biotech Co., Ltd. 19F, No. 100, Sec. 1, Xintai 5th Rd., Xizhi Dist., New Taipei City, Taiwan, R.O.C. 22102 Phone: +886-2-26968880 FAX: +886-2-26968882
Contact Person: Niko Wei
Date Prepared: Jan 24, 2013
Proprietary Name: Coreleader Hydro-clear Hydrocolloid Wound Dressing
Hydrocolloid Wound Dressing Common Name:
Classification: Unclassified
Classification Name: Topical Wound Dressing Pad
3M™ Tegasorb™ Hydrocolloid Dressings Predicate Device:
Device Description:
Elastomer, Tackifier Resins, Mineral Oil and Polyurethane film) by unique production process. With preferable liquid absorbsion ability, gas permeability and ability of water resistant, Hydro-clear is clear of adhesive onto wound, capable to absorb exudates, protect wound site and facilitates would healing process.
Coreleader Hydro-clear is a new product that is made of Hydrocolloid (Sodium carboxymethyl cellulose, Synthetic
Intended Use: Coreleader Hydro-clear is indicted for the management of 1st and 2nd degree burns, chronic ulcers, surgical wounds, skin graft and donor sites.
Patient with conditions listed below is considered appropriate for Over-The Counter Use (OTC):
for the management of minor cuts, minor burns (155 degree burns), minor lacerations and minor cuts.
1
K 123394 page 2/2
Technological Characteristics:
י
| Thickness | 0.5 mm |
|---|---|
| Peeling Adhesion | 687 g/25 mm |
| Holding Power | 140 min/onch |
| Elongation | 235 % |
| Tensile Strength | 2360 g/25 mm |
2
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird-like figure.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
June 6, 2013
Coreleader Biotech Co., Ltd. % Mr. Niko Wei Regulatory Affair Officer 19F, No. 100, Sec. 1, Xntai 5td Road, Xizhi District New Taipei City, Taiwan, R.O.C. 22102
Re: K123394
Trade/Device Name: Coreleader Hydro-Clear Hydrocolloid Wound Dressing Regulatory Class: Unclassified Product Code: FRO Dated: April 17, 2013 Received: May 03, 2013
Dear Mr. Wei:
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. Iisting 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 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical
3
Page 2 - Mr. Niko Wei
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/ReportalProblem/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/ResourcesforYou/Industrv/default.htm.
Sincerely yours.
For
PeterD:Rümm-S
Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use Statement
510(k) Number (if known): K123394
Device Name: Coreleader Hydro-clear Hydrocolloid Wound Dressing
Indications for Use:
Coreleader Hydro-clear is indicted for the management of 1st and 200 degree burns, chronic ulcers, surgical wounds, skin graft and donor sites.
Patient with conditions listed below is considered appropriate for Over-The Counter Use (OTC): for the management of minor cuts, minor burns (1st degree burns), minor lacerations and minor cuts.
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)
David Krause -S
(Division Sign-Off) Division of Surgical Devices 510(k) Number: K123394
:
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