(216 days)
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.
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.
The provided document is a 510(k) Summary for the Coreleader Hydro-clear Hydrocolloid Wound Dressing. It describes the device, its intended use, and compares its technological characteristics to a predicate device. However, it does not contain information about a study that assesses the device's performance against acceptance criteria in the context of an AI/algorithm-driven medical device.
The "Technological Characteristics" section lists physical properties like thickness, peeling adhesion, holding power, elongation, and tensile strength. These are likely engineering specifications, not clinical performance metrics derived from a study on patient outcomes or AI accuracy.
Therefore, most of the requested information regarding study details, sample sizes, expert involvement, and ground truth establishment cannot be extracted from this document, as it pertains to the regulatory submission of a physical wound dressing, not an AI-enabled diagnostic or therapeutic tool.
Here's a breakdown of what can be extracted and what cannot:
1. Table of Acceptance Criteria and Reported Device Performance:
The document describes "Technological Characteristics" which serve as specifications for the wound dressing. While these are not explicitly presented as "acceptance criteria" in the context of a clinical study or AI performance evaluation, they represent the product's measured physical properties.
| Characteristic | Acceptance Criteria (from predicate/internal specification) | Reported Device Performance |
|---|---|---|
| Thickness | (Not explicitly stated as criteria, but 0.5 mm is listed) | 0.5 mm |
| Peeling Adhesion | (Not explicitly stated as criteria, but 687 g/25 mm is listed) | 687 g/25 mm |
| Holding Power | (Not explicitly stated as criteria, but 140 min/onch is listed) | 140 min/onch |
| Elongation | (Not explicitly stated as criteria, but 235 % is listed) | 235 % |
| Tensile Strength | (Not explicitly stated as criteria, but 2360 g/25 mm is listed) | 2360 g/25 mm |
Note: The document implies these characteristics are comparable to the predicate device, but specific acceptance criteria (e.g., "must be greater than X" or "within Y range") are not explicitly stated for each characteristic.
The following information cannot be found in the provided document:
- 2. Sample size used for the test set and the data provenance: This document is for a physical wound dressing, not an AI/algorithm device that would have a "test set" of data.
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for an AI device is based on expert labels or pathology, which is not part of this submission for a wound dressing.
- 4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
- 5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs. without AI assistance: Not applicable. This is for an AI-assisted diagnostic.
- 6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
- 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable to a wound dressing for its characteristics listed.
- 8. The sample size for the training set: Not applicable to a wound dressing.
- 9. How the ground truth for the training set was established: Not applicable to a wound dressing.
In summary: The provided document describes the physical and chemical properties of a wound dressing for regulatory approval. It does not concern an AI/algorithm-driven device and therefore lacks all the study-related details typically required for such a device.
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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.
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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 |
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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
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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
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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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