(87 days)
CoreLeader HEMO-Bandage is intended to be used as a topical dressing to temporarily control moderate to severe external bleeding resulted from traumatic or surgical wounds.
CoreLeader HEMO-Bandage is woven gauze made of chitosan fiber and rayon fiber. Chitosan is a type of organic polysaccharide carrying positively-charged ions. Appearing light yellow color and inheriting biodegradability and biocompatibility of chitosan. CoreLeader HEMO-Bandage achieves hemostasis by attracting erythrocytes to the injured sites and facilitates blood clot formation. CoreLeader HEMO-Bandage is sterilized by gamma-ray radiation to 10th SAL after packed in a foil bag. With the softness and flexibility, it is readily conformable to various wound shapes.
This document is a 510(k) summary for the CoreLeader HEMO-Bandage, a device intended to control bleeding. The primary purpose of this submission is to demonstrate substantial equivalence to legally marketed predicate devices. The study detailed focuses on non-clinical performance and safety rather than a clinical trial with human subjects for diagnostic accuracy.
Here's an analysis of the provided information:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria seem to be implicit in demonstrating equivalence to previously approved predicate devices, particularly regarding safety and certain aspects of performance. The performance data is presented in a table comparing the proposed device against predicate devices based on various tests.
| Test Category | Acceptance Criteria (Implicit, based on predicate device performance) | Reported Device Performance (CoreLeader HEMO-Bandage) |
|---|---|---|
| Sterility | Sterile to 10⁻⁶ SAL (Sterility Assurance Level) | Sterile to 10⁻⁶ SAL after gamma radiation (Meets AAMI / ANSI / ISO 11137-1, -2: 2006) |
| Biocompatibility | No cytotoxicity, skin irritation, skin sensitization, or systemic toxicity. | Cytotoxicity: Negative (Passes AAMI / ANSI / ISO 10993-5:2009) Skin Irritation: Negative (Passes AAMI / ANSI / ISO 10993-10: 2010) Skin Sensitization: Negative (Passes AAMI / ANSI / ISO 10993-10: 2010) Systemic Toxicity: Non-systemic toxic (Passes AAMI / ANSI / ISO 10993-11: 2006) |
| Material Safety | Free of heavy metal contamination | Free of heavy metal contamination (Journal of AOAC International, 2006; 89(6): 1447-66) |
| Physical Properties | Water absorbent | Water absorbent (Meets EN 13726-1:2002 - Part 1) Tensile resistant (In-house protocol) |
| Hemostasis Achievement | Capable of effective hemostasis | Achieves hemostasis of femoral artery hemorrhage in swine in <10 minutes (In-house protocol) |
2. Sample Size Used for the Test Set and Data Provenance
The provided document describes non-clinical tests, primarily in-vitro and animal studies, not human clinical trials.
- Sample Size for Biocompatibility (animal studies):
- Skin Irritation Test: In vivo rabbit skin irritation test. (Specific number of rabbits not stated).
- Skin Sensitization Test: In vivo guinea pig skin sensitization test. (Specific number of guinea pigs not stated).
- Systemic Toxicity Test: In vivo systemic toxicity test. (Specific animal type and number not stated).
- Sample Size for Hemostasis Test: In vivo swine femoral arterial hemorrhage model. (Specific number of swine not stated).
- Data Provenance: The document does not explicitly state the country of origin for the non-clinical test data. However, the submitting company is CoreLeader Biotech Co., Ltd. from New Taipei City, Taiwan (R.O.C.), suggesting the studies were likely conducted or overseen in Taiwan. All tests are referred to as "non-clinical tests." These are prospective tests conducted on the device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable as the described tests are non-clinical (laboratory and animal studies) and do not involve human diagnostic decisions or expert-established ground truth in the context of clinical accuracy.
4. Adjudication Method for the Test Set
This information is not applicable for the same reason as point 3.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A multi-reader multi-case (MRMC) comparative effectiveness study, which typically involves human readers assessing diagnostic performance with and without an AI device, was not performed or described. The device is a "topical hemostasis wound dressing," not a diagnostic AI tool.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
This concept is not directly applicable as the CoreLeader HEMO-Bandage is a physical medical device (wound dressing) and not a software algorithm. The "standalone performance" presented here refers to the device's inherent physical, chemical, and biological properties and its ability to achieve hemostasis in an animal model, independent of human interaction beyond application.
7. Type of Ground Truth Used
The "ground truth" for the non-clinical studies was established by:
- Standardized laboratory protocols: For sterility, cytotoxicity, irritation, sensitization, systemic toxicity, heavy metal residue, fluid absorption, and tensile strength, the "ground truth" is defined by the results meeting or not meeting the specified international standards (e.g., AAMI/ANSI/ISO 11137-1, AAMI/ANSI/ISO 10993 series, EN 13726-1) or established methods (Journal of AOAC International).
- Physiological observation/measurement in animal models: For the in vivo hemostasis test in swine, the ground truth was the observable cessation of bleeding from a femoral artery hemorrhage within a specified time (<10 minutes).
8. Sample Size for the Training Set
This device is not an AI/machine learning algorithm, so there is no "training set" in the context of algorithm development. The non-clinical tests described are validation tests for the physical product.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as there is no training set for an AI algorithm.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image contains two logos. The logo on the left is the Department of Health & Human Services - USA logo. The logo on the right is the FDA U.S. Food & Drug Administration logo. The FDA logo is blue and white.
Coreleader Biotech Co., Ltd. Ya-Wen Kuo Manager, Regulatory Affairs 19F Build B, No. 100, Sec 1 Xintai 5th Rd, Xizhi Dist. New Taipei City, 22102 Taiwan (R.O.C.)
April 21, 2023
Re: K151204 Trade/Device Name: CoreLeader HEMO-Bandage Regulatory Class: Unclassified Product Code: QSY
Dear Ya-Wen Kuo:
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 July 31, 2015. 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
{1}------------------------------------------------
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an emblem featuring a stylized representation of three human profiles facing to the right, resembling a bird-like shape.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 31, 2015
CoreLeader Biotech Company, LTD. Ms. Ya-Wen Kuo Manager, Regulatory Affairs 19F Build B, No. 100, Sec 1 Xintai 51H Road New Taipei City, 22102 Taiwan (R.O.C.)
Re: K151204
Trade/Device Name: CoreLeader HEMO-Bandage Regulatory Class: Unclassified Product Code: FRO Dated: July 13, 2015 Received: July 16, 2015
Dear Ms. Kuo:
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 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
{2}------------------------------------------------
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 contact the Division of Industry and Consumer Education 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. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
David Krause -S
Binita S. Ashar, M.D., M.B.A., F.A.C.S. for Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{3}------------------------------------------------
Indications for Use
510(k) Number (if known) K151204
Device Name CoreLeader HEMO-Bandage
CoreLeader HEMO-Bandage is intended to be used as a topical dressing to temporarily control moderate to severe external bleeding resulted from traumatic or surgical wounds.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.qov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{4}------------------------------------------------
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: | Ya-Wen Kuo |
| Date Prepared: | 2014/03/19 |
| Proprietary Name: | CoreLeader HEMO-Bandage |
| Common Name: | Topical hemostasis wound dressing |
| Classification: | Unclassified |
| ClassificationName: | Dressing, Wound, Drug |
| Predicate Device: | 1. HemCon Chitoflex surgical wound dressing (HemCon |
| Medical Technologies, Inc): K080818 | |
| 2. QuikClot® Hemostatic Dressing, as known as QuikClot® | |
| Combat Gauze (Z-Medica, LLC): K123387 | |
| 3. Celox Gauze PRO/OTC (Medtrade Products Ltd): K113560 |
Device Description:
CoreLeader HEMO-Bandage is woven gauze made of chitosan fiber and rayon fiber. Chitosan is a type of organic polysaccharide carrying positively-charged ions. Appearing light yellow color and inheriting biodegradability and biocompatibility of chitosan. CoreLeader HEMO-Bandage achieves hemostasis by attracting erythrocytes to the injured sites and facilitates blood clot formation. CoreLeader HEMO-Bandage is sterilized by gamma-ray radiation to 10th SAL after packed in a foil bag. With the softness and flexibility, it is readily conformable to various wound shapes.
Indications for Use:
CoreLeader HEMO-Bandage is intended to be used as a topical dressing to temporarily control moderate to severe external bleeding resulted from traumatic or surgical wounds.
Substantial equivalence:
The safety and efficacy of CoreLeader HEMO-Bandage wound dressing are substantially equivalent to the predicate devices, including HemCon Chitoflex surgical wound dressing (HemCon Medical Technologies, Inc, K080818) and QuikClot® Hemostatic Dressing, as known as QuikClot® Combat Gauze (Z-Medica, LLC, K123387), in the aspect of the mode of action, dressing form, indications for use,
{5}------------------------------------------------
biocompatibility, sterilization degree and hemostasis efficacy.
- Indications for use: Similar to HemCon Chitoflex surgical wound dressing and 1 QuikClot® Combat Gauze, CoreLeader HEMO-Bandage is intended to be used as a topical dressing to temporarily control moderate to severe external bleeding resulted from traumatic or surgical wounds.
Mode of action in hemostasis: 2
Similar to HemCon Chitoflex and Celox Gauze, the effective ingredient of CoreLeader HEMO-Bandage that helps stop bleeding is chitosan, which facilitates hemostatic activity.
ന Form:
Similar to HemCon Chitoflex surgical wound dressing and QuikClot® Combat Gauze, CoreLeader HEMO-Bandage appears as flat sheet of gauze with various sizes to fit in different shape of wounds.
Materials: ব
Chitosan: Similar to HemCon Chitoflex surgical wound dressing, CoreLeader HEMO-Bandage uses chitosan to facilitate hemostasis activity. Rayon: Similar to HemCon Chitoflex surgical wound dressing and QuikClot® Combat Gauze, CoreLeader HEMO-Bandage incorporates a textile in addition to effective ingredient to form the gauze dressing.
Non-clinical tests ഗ
6.1 Sterility: Similar to HemCon Chitoflex surgical wound dressing and QuikClot® Combat Gauze, CoreLeader HEMO-Bandage is sterilized to 10 ° SAL using gamma ray. The sterilization validation tests meet the criteria of AAMI / ANSI / ISO 11137-1, -2: 2006.
6.2 Biocompatibility: CoreLeader HEMO-Bandage is as biocompatible as all the predicates.
- 6.2.1 Cytotoxicity: CoreLeader HEMO-Bandage passes in vitro cytotoxicity test required in AAMI / ANSI / ISO 10993-5.
- Skin irritation test: CoreLeader HEMO-Bandage passes in vivo rabbit 6.2.2 skin irritation test required in AAMI / ANSI / ISO 10993-10.
- Skin sensitization: CoreLeader HEMO-Bandage passes in vivo guinea pig 6.2.3
{6}------------------------------------------------
skin sensitization test required in AAMI / ANSI / ISO 10993-10.
6.3 Performance:
- 6.3.1 Water absorption: As the above mentioned predicate devices. CoreLeader HEMO-Bandage is fluid absorbent.
- 6.3.2 Hemostasis achievement: CoreLeader HEMO-Bandage is capable of stop bleeding due to the nature of chitosan. CoreLeader HEMO-Bandage is proved to achieve arterial hemostasis in in vivo swine femoral arterial hemorrhage model.
- 7 Directions to use: The direction of use of CoreLeader HEMO-Bandage is similar to those of HemCon Chitoflex surgical wound dressing and QuikClot® Combat Gauze. CoreLeader HEMO-Bandage should be directly packed or pressed against the bleeding wounds until the hemostasis is achieved. Proper saline irrigation should be applied when removing CoreLeader HEMO-Bandage from the wound.
Table 1. The list of non-clinical tests conducted to validate the safety and efficacy of CoreLeader HEMO-Bandage to achieve the indications as claimed.
| Test | Result | Guidance |
|---|---|---|
| Sterilization validation tests | CoreLeader HEMO-Bandage is sterile to 10-6 SAL after gamma radiation. | AAMI / ANSI / ISO 11137-1, -2: 2006 |
| In vitro cytotoxicity test | No cytotoxicity | AAMI / ANSI / ISO 10993-5:2009 |
| In vivo guinea pig skin sensitization test | No skin sensitization | AAMI / ANSI / ISO 10993-10: 2010. |
| In vivo rabbit skin irritation test | No skin irritation | AAMI / ANSI / ISO 10993-10: 2010. |
| In vivo systemic toxicity test | Non-systemic toxic | AAMI / ANSI / ISO 10993-11: 2006. |
| Heavy metal residue test | Free of heavy metal contamination | Journal of AOAC International, 2006; 89(6): 1447-66 |
| Fluid absorption rate | CoreLeader HEMO-Bandage is water absorbent. | EN 13726-1:2002-Part 1 |
| Tensile strength | CoreLeader HEMO-Bandage is tensile resistant. | In-house protocol |
| In vivo hemostasis test | CoreLeader HEMO-Bandage | In-house protocol |
{7}------------------------------------------------
| can temporarily controlmoderate to severe bleedingsresulted from traumatic orsurgical wounds. | ||
|---|---|---|
| -- | ----------------------------------------------------------------------------------------------------------- | -- |
| Table 2. A comparison of non-clinical testing results of CoreLeader HEMO-Bandage |
|---|
| with the predicate devices |
| Proposed device | Predicate device | |||
|---|---|---|---|---|
| CoreLeaderHEMO-Bandage | HemCon®Chitoflex | CELOX GauzePRO | QuikClot®Combat Gauze | |
| K number | K141198 | K0808018 | K113560 | K123387 |
| Indications | CoreLeaderHEMO-Bandageis intended to beused as a topicaldressing totemporarilycontrolmoderate tosevere bleedingresulted fromtraumatic orsurgical wounds. | QuikClot®Combat Gauze isintended to use asa topical dressingfor localmanagement ofbleeding woundssuch as cuts,lacerations andabrasions. It mayalso be used fortemporarytreatment ofseverely bleedingwounds such assurgical wounds(operative,postoperative,dermatological,etc.) andtraumaticinjuries. | CELOXGauze PRO isindicated forminor woundcontrol,includingcontrol ofminor externalbleeding andexudate fromsutures and/orsurgicalprocedures | Rx indication:Hemostaticdressing fortemporarycontrol ofseverelybleedingwoundsintended foremergencyuse. |
| Mode ofaction | Chitosan attractserythrocytes andfacilitateshemostasis. | Chitosan attractserythrocytes andfacilitateshemostasis. | Chitosanattractserythrocytesand facilitateshemostasis. | Kaolininitiates bloodcoagulation |
| Sterilization | Gammaradiation to 10-6SAL | Gamma radiation | Gammaradiation | Gammaradiation |
| Cytotoxicitytest | Negative | Negative | Negative | Negative |
| Skinirritationtest | Negative | Negative | Negative | Negative |
| Skinsensitizationtest | Negative | Negative | Negative | Negative |
| Systemictoxicity test | Negative | Negative | Negative | Negative |
| In vivoswinehemostasistest | Achievehemostasis offemoral arteryhemorrhage <10 minutes. | Facilitatehemostasis | Facilitatehemostasis | Facilitatehemostasis |
{8}------------------------------------------------
Substantial Equivalent Statement
Based on the comparison of intended use, design, mode of actions, and performance,
CoreLeader HEMO-Bandage is substantial equivalent to its predicate devices.
N/A