(338 days)
Coreleader Hemo-Pad is a dressing indicated for topical wound management and for the external topical temporary control of moderate to severe bleeding. The dressing is indicated for the following wounds: abrasions, lacerations, skin surface puncture sites for vascular procedures (arteries and veins)
The Coreleader Hemo-Fiber wound dressing is made from poly-D-glucosamine and poly-N-acetylglucosamine derived from chitosan. The Coreleader Hemo-Fiber is a soft, non-woven topical pad for hemostasis and wound care. The natural biological property of this material carries cation (positively charged ion) that helps to stop external hemorrhage, and the Coreleader Hemo-Fiber wound dressing absorbs the wound exudates to form a hydrogel while providing protection layer layer for an optimal wound-healing environment. Coreleader Hemo-Pad is a sterile topical hemostasis pad, packed in a foil pouch and sterilized by gamma-ray radiation to a 10to SAL.
This is a 510(k) summary for a medical device called "Coreleader Hemo-Pad." 510(k) submissions, particularly older ones, often focus on substantial equivalence to a predicate device rather than presenting detailed standalone performance studies with specific acceptance criteria in the manner one might find for a novel AI/software medical device.
Based on the provided document, here's an attempt to answer your questions, with the caveat that detailed performance study methodology and acceptance criteria as you've outlined for AI/software devices are largely absent from this type of regulatory submission for a physical wound dressing:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state quantitative acceptance criteria or detailed reported device performance in terms of metrics like sensitivity, specificity, accuracy, etc., which are common for AI/software-based devices. Its focus is on establishing substantial equivalence to predicate devices (CLO-SURPLUS P.A.D., ChitoSeal, T-PAD) based on intended use, technological characteristics, and safety/effectiveness.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not mention any specific "test set" in the context of a performance study like those for AI/software devices. There is no information provided regarding the sample size of any study, data provenance (country of origin), or whether any data used was retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
No information is provided regarding the use of experts to establish a "ground truth" for a test set. This type of review is not typically part of a 510(k) for a physical wound dressing.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
No information is provided regarding an adjudication method, as no "test set" and ground truth establishment process are described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No such study was done or is referenced. This type of study (MRMC, human readers, AI assistance) is completely irrelevant to a physical wound dressing like the Coreleader Hemo-Pad.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
A standalone performance study for an algorithm is not applicable, as this is a physical medical device (a wound dressing), not an algorithm or AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The concept of "ground truth" as relevant to AI/software performance evaluation is not applicable here. The safety and effectiveness of the device are implied by its substantial equivalence to legally marketed predicate devices, which would have undergone their own prior evaluations (e.g., biocompatibility testing, perhaps some animal or limited human trials demonstrating hemostasis, but not in the detailed statistical performance metrics of current AI studies). The document refers to "safety and use of chitosan [being] published by researchers over a period of decades," implying reliance on existing scientific literature rather than a new ground truth establishment for this specific device.
8. The sample size for the training set
No "training set" is mentioned or applicable, as this is not an AI/machine learning device.
9. How the ground truth for the training set was established
Not applicable as there is no training set and no AI/machine learning component.
Summary regarding the 510(k) submission and your questions:
The provided document is a 510(k) summary for a physical medical device (wound dressing) and is focused on demonstrating substantial equivalence to existing predicate devices. The framework you've provided for evaluating acceptance criteria and study designs is highly relevant to AI/Machine Learning-based medical devices and software, which require rigorous statistical performance analysis and often human reader studies.
For a physical device like the Coreleader Hemo-Pad, the "proof" often lies in:
- Bench testing: Demonstrating material properties, absorption, sterility, biocompatibility.
- Performance testing: Potentially in-vitro or in-vivo (animal) models to show hemostatic capabilities (e.g., time to hemostasis, blood loss reduction), but these are usually not detailed with specific "acceptance criteria" in the same way as an AI's diagnostic performance.
- Comparisons to predicate devices: Showing that the new device has similar technological characteristics and performs comparably to devices already on the market that have been deemed safe and effective.
- Scientific literature: Referencing established knowledge about the materials used (chitosan in this case) to support claims of biocompatibility, biodegradability, hemostatic, and anti-infectional activity.
The 510(k) summary provided does not contain the level of detail regarding performance studies, sample sizes, expert ground truth, or adjudication methods that would be expected for an AI/software device.
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Image /page/0/Picture/0 description: The image contains two logos. On the left is the logo for the Department of Health & Human Services - USA, featuring a stylized human figure. To the right is the logo for the U.S. Food & Drug Administration (FDA), with the FDA acronym in a blue square and the full name "U.S. FOOD & DRUG ADMINISTRATION" in blue text next to it.
Coreleader Biotech Co., Ltd. c/o Ian Li Regulatory Manager 19F, No. 100, Sec. 1, Santai 5th Road Sijhih City, Taipei 22102 Taiwan
July 28, 2023
Re: K102944 Trade/Device Name: Coreleader Hemo-Pad Model Regulatory Class: Unclassified Product Code: QSY
Dear Ian Li:
The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated September 7, 2011. Specifically, FDA is updating this SE Letter because FDA has better categorized your device technology under product code QSY.
Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Julie Morabito, OHT4: Office of Surgical and Infection Control Devices, 240-402-3839, Julie.Morabito@fda.hhs.gov.
Sincerely,
Julie A. Morabito -S
Julie Morabito, Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract image of an eagle with three lines forming its body and wings. The eagle is facing to the right.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room-WO66-G609 Silver Spring, MID 20993-0002
Coreleader Biotech Co., Ltd. % Mr. Ian Li Regulatory Manager 19F, No. 100, Sec. 1, Santai 500 Road Sijhih City, Taipei 25102 Taiwan
Re: K102944
Trade/Device Name: Coreleader Hemo-Pad Regulatory Class: Unclassified Product Code: FRO Dated: August 17, 2011 Received: August 30, 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. Drue, 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
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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.
1f 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 vours
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Chapter 4 Indications for Use Statement
Indications for Use Statement
510(k) Number (if known): K102944
Device Name: Coreleader Hemo-Pad
Indications For Use:
Coreleader Hemo-Pad is a dressing indicated for topical wound management and for the external topical temporary control of moderate to severe bleeding.
The dressing is indicated for the following wounds:
abrasions, lacerations, skin surface puncture sites for vascular procedures (arteries and veins)
Prescription Use _ X (Part 21 CFR 801 Subpart 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)
Daniel Kune for Mkm
(Division Sign-Off)
Page 1 of _ l
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K102944
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K102944
page 1 of 2
Chapter 5 510(k) Summary
SEP - 7 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 Name: Coreleader Hemo-Pad
Common Name: Topical Hemostasis Pad
Classification: Unclassified
Classification Name: Topical Wound Dressing Pad
Scion Cardio-Vascular, Inc., K032986, CLO-SURPLUS Predicate Device: P.A.D. Perclose, Inc., K021062, ChitoSeal T-Scientific, Inc., K030334, T-PAD
- Device Description: The Coreleader Hemo-Fiber wound dressing is made from poly-D-glucosamine and poly-N-acetylglucosamine derived from chitosan. The Coreleader Hemo-Fiber is a soft, non-woven topical pad for hemostasis and wound care. The natural biological property of this material carries cation (positively charged ion) that helps to stop external hemorrhage, and the Coreleader Hemo-Fiber wound dressing absorbs the wound exudates to form a hydrogel while providing protection layer layer for an optimal wound-healing environment.
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K102944
page 2g2
Chapter 5 510(k) Summary
ੰ ਵ
Coreleader Hemo-Pad is a sterile topical hemostasis pad, packed in a foil pouch and sterilized by gamma-ray radiation to a 10to SAL.
Coreleader Hemo-Pad is a dressing indicated for topical Intended Use: wound management and for the external topical temporary control of moderate to severe bleeding. The dressing is indicated for the following wounds: abrasions, lacerations, skin surface puncture sites for vascular procedures (arteries and veins)
Coreleader Hemo-Pad is a soft, non-woven topical pad Technological made of poly-D-glucosamine and poly-N-acetylglucosamine Characteristics: derived from chitosan. The natural biological property of this material carries cation (positively charged ion) that helps to stop external hemorrhage and the gives the Coreleader Hemo-Pad an advantage as an effective barrier while providing for an optimal bacterial wound-healing environment. In addition, it has superb ventilation texture and high absorption ability that are compatible to human skin.
Besides, the safety and use of chitosan have been published by researchers over a period of decades. This formulation has many useful and advantageous properties in their application as a wound dressing, namely biocompatibility, biodegradability, hemostatic and anti-infectional activity.
N/A