BIOS KING BIOCELLULOSE FILM

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features the department's name encircling a symbol of three stylized human profiles facing right. The profiles are stacked on top of each other, creating a sense of depth and unity. The seal is presented in black and white. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 February 10, 2015 CoreLeader Biotech Company, Ltd. Dr. Ya-Wen Kuo Manager, Regulatory Affairs 19F, Building B, Number 100, Section 1, Xintai 5th Road, Xizhi District New Taipei City 22102 Taiwan Re: K141382 Trade/Device Name: Bios King Biocellulose Film Regulatory Class: Unclassified Product Code: FRO Dated: January 14, 2015 Received: January 16, 2015 Dear Dr. 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 {1}------------------------------------------------ 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 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 {2}------------------------------------------------ # Indications for Use Statement 510(k) Number (if known): K141382 Device Name: Bios King Biocellulose Film Indications for Use: Bios King Biocellulose Film is indicated as a topical dressing to manage pressure sores, diabetic ulcers, 1st to 2nd degree burns and skin donor sites. Prescription Use __X ___ (Part 21 CFR 801 Subpart D) Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) AND/OR Concurrence of CDRH, Office of Device Evaluation (ODE) Page 1 of _ 1 _ {3}------------------------------------------------ # 510(k) Summarv | 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: | 2014/04/19 | | Proprietary Name: | Bios King Biocellulose Film | | Common Name: | Topical wound dressing | | Classification: | Unclassified | | Classification Name: | Dressing, Wound, Drug | | Predicate Device: | 1. BioFill Biocellulose Dressing Sterile (The Purdue Frederick Co.)<br>K950621 | | | 2. X-CELL Wound Dressing (Xylos Corporation): K974251 | ## Device Description: Bios King Biocellulose Film is made of bacterial synthesized cellulose mesh with a selectively permeable structure allowing water evaporation, and thus provides a moist but not damp environment for wound healing. Bios King Biocellulose Film is resistible to the tensile force generated from the wound handing. It can adhere to wound beds without fixation devices. ## Indications for Use: Bios King Biocellulose Film is indicated as a topical dressing to manage pressure sores, diabetic ulcers, 1st to 2nd degree burns and skin donor sites. ## Technological Characteristics: Bios King Biocellulose Film is made of biocellulose mesh synthesized by a gram-negative bacteria strain called acetobacter xylinum, which secrets a large quantity of organized and twisted cellulose microfibrils. The pores within the Bios King Biocellulose Film permit water vapor transportation. Bios King Biocellulose Film is removed of water content through lyophilization process. After that, it barely absorbs water. Bios King Biocellulose Film passes endotoxin test, skin irritation test and maximized skin sensitivity test following ISO 10993 protocols. Bios King Biocellulose Film biocellulose film encompasses tensile strength and readily conforms to irregular wound shapes. ## Substantial equivalence: The safety and efficacy of Bios King Biocellulose Film are substantially equivalent to the predicate devices, including BioFill Biocellulose Dressing Sterile (K950621) and X-CELL Wound {4}------------------------------------------------ #### Chapter 5 510(k) Summery Dressing (K974251) in the aspect of indications for use, materials, mode of action, sterility, biocompatibility, water vapor transmission, and directions to use. - Indications for use: Similar to the predicate devices, Bios King Biocellulose Film is intended 1 to be used as a topical dressing to manage pressure sores, diabetic ulcers, 18 to 200 degree burns and skin donor sites. - Mode of action: Similar to the predicate devices, the selectivity of substance transportation 2 though Bios King Biocellulose Film is determined by the fine pores within the film constructed by layers of biocellulose micro fibrils. The pores are small that they allow the entry of water vapor. - ന Materials: Similar to the predicate devices, Bios King Biocellulose Film is made of biocellulose micro fibrils synthesized by a gram-negative bacteria strain called acetobacter xylinum. Biocellulose film is fabricated through a week of exclusive fermentation process and removed of endotoxcity origins through alkine treatment. The water within the biocellulose film is removed though lyophilization process. #### 4 Non-clinical tests - 4.1 Sterility: Similar to the predicate devices, Bios King Biocellulose Film is sterilized to 10 ° SAL using gamma ray. The sterilization validation tests meet the criteria of ISO 11137-1, -2: 2006: Sterilization of health care product radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices; Part 2: Establishing the sterilization dose. - 4.2 Shelf life: The shelf life of Bios King Biocellulose Film is 5 years when the product is stored at room temperature without sun light exposure. The shelf life is determined through the stability test using accelerated aging model. - 4.3 Biocompatibility: Bios King Biocellulose Film is as biocompatible as the predicate devices. - Endotoxin Test: The endotoxin level of Bios King Biocellulose Film is lower than 20 4.3.1 EU/device. - Cytotoxicity: Bios King Biocellulose Film passes in vitro cytotoxicity test required in 4.3.2 ISO 10993-5. - 4.3.3 Intracutaneous reactivity: Bios King Biocellulose Film passes the intracutaneous reactivity test required in ISO 10993-10. - Skin sensitization: Bios King Biocellulose Film passes skin sensitization test required 4.3.4 in ISO 10993-10. - 4.3.5 Heavy metal test: CoreLeader Bios King is free of heavy metal contamination, including arsentic, cadmium, copper, lead, and mercury. #### ഗ Performance: - 5.1 Moisture vapor transmission rate: Bios King Biocellulose Film is water vapor permeable. The moisture vapor transmission rate is greater than 800 g/m² x 24hr. The test follows protocols of ASTM E96-95: Standard Test Method for Water Vapor Transmission of Materials and EN 13726-2 (2002): Test methods for primary wound dressings-Part 2: Moisture vapor transmission rate of permeable film dressings {5}------------------------------------------------ - 5.2 Mechanical strength: The tensile strength of Bios King Biocellulose Film larger than 1000 g/25mm. The results and references of non-clinical tests of Bios King Biocellulose Film are listed in Table 1. According to the results of the aforementioned non-clinical tests, the substantial equivalences of Bios King Biocellulose Film to the predicate devices are summarized in Table 2 | | Table 1. The list of non-clinical tests conducted to validate the safety and efficacy of Bios King | | |----------------------------------------------------------|--------------------------------------------------------------------------------------------------------|-----------------------------------------------------------| | Biocellulose Film to achieve the indications as claimed. | | | | Test | Conclusion | Guidance | | Sterilization<br>validation test | Bios King Biocellulose Film is sterile to<br>10-6 SAL after 25kGy gamma radiation. | ISO 11137-1, -2: 2006 | | Shelf life test report | Bios King Biocellulose Film is expired 5<br>years after manufacturing. | ASTM F1980-02 | | Endotoxin test | Bios King Biocellulose Film will not<br>cause endotoxin hazard as a skin wound<br>dressing. | USP <85><br>USP <161> | | Cytotoxicity test | Bios King Biocellulose Film will not<br>cause cytotoxicity hazard as a skin wound<br>dressing. | ISO 10993-5:1999 | | Intracutaneous<br>reactivity test | Bios King Biocellulose Film will not<br>cause skin irritation hazard as a skin<br>wound dressing. | ISO 10993-10: 2002.<br>ISO 10993-12:2012. | | Skin sensitization<br>test | Bios King Biocellulose Film will not<br>cause skin sensitization hazard as a skin<br>wound dressing. | ISO 10993-10: 2010.<br>ISO 10993-12:2012. | | Heavy metal residue<br>test | The arsenic, cadmium, copper, mercury<br>are undetectable. The lead is lower than 5 ppm | ICP-AES analysis | | Moisture vapor<br>transmission test | Moisture vapor rate is over 800 g/m2 x 24 hr | EN 13726-2 (2002)<br>ASTM E96-95 | | Tensile strength | Bios King Biocellulose Film is tensile<br>resistant with tensile strength larger than<br>1000 g/25 mm. | Internal protocol of Taiwan<br>Textile Research Institute | Table 2. Substantial equivalence comparison with the predicate devices. | | Proposed device | Predicate device | | |--|--------------------------------------|--------------------------|---------------------------------------------| | | CoreLeader Bios King<br>Biocellulose | X-CELL Wound<br>Dressing | BIOFILL<br>Biocellulose Dressing<br>Sterile | {6}------------------------------------------------ | Indications | Bios King Biocellulose<br>Film is intended to be<br>used as a topical<br>dressing to manage<br>pressure sores, diabetic<br>ulcers, 1st to 2nd degree<br>burns and skin donor<br>sites. | X-CELL Wound<br>Dressing is intended<br>to cover a wound or<br>burn on a patient's<br>skin to absorb wound<br>exudates, and protect<br>against abrasion,<br>friction, or external<br>contamination. | Chronic wounds | |--------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------| | Ingredient | Bacterial cellulose | Bacterial cellulose | Bacterial cellulose | | Mode of action | Substance<br>transportation though<br>Bios King Biocellulose<br>Film is determined by<br>the pore size of<br>cellulose dressing. | Substance<br>transportation is<br>determined by<br>internal pore size of<br>dressing. | Substance<br>transportation is<br>determined by<br>internal pore size of<br>dressing. | | Sterilization | 25kGy gamma radiation<br>to reach 10-6 SAL | Sterile | Sterile | | Shelf life | 5 years | 3 years | 3 years | | Endotoxin test | Lower than 20<br>EU/device | pass | pass | | In vitro cytotoxicity<br>test | No cytotoxicity | No cytotoxicity | No cytotoxicity | | In vivo rabbit skin<br>irritation test | No skin irritation | No skin irritation | No skin irritation | | In vivo guinea pig<br>skin sensitization<br>test | No skin sensitization | No skin sensitization | No skin sensitization | | Heavy metal test | No heavy metal<br>contamination | No heavy metal<br>contamination | No heavy metal<br>contamination | | Moisture vapor<br>transmission test | Moisture vapor<br>transmissible | Yes | Yes |