OssGuide

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo for the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. October 2, 2020 Sk bioland Co., Ltd. % Sanglok Lee Manager WISE COMPANY Inc. RM #303. The Sky Balley-303. 142. Gasan Digital 1-Ro Geumcheon-gu, Seoul 08507 Republic of Korea Re: K200623 Trade/Device Name: OssGuide Regulation Number: 21 CFR 872.3930 Regulation Name: Bone Grafting Material Regulatory Class: Class II Product Code: NPL Dated: September 1, 2020 Received: September 3, 2020 Dear Sanglok Lee: 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. {1}------------------------------------------------ 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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, for Srinivas Nandkumar, Ph.D. Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic. Anesthesia. Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ### Indications for Use 510(k) Number (if known) K200623 Device Name OssGuide Indications for Use (Describe) OssGuide is recommended for: - · Simultaneous use of GBR-membrane (OssGuide) and implants; - · Augmentation around implants placed in immediate extraction sockets; - · Augmentation around implants placed in delayed extraction sockets; - · Localized ridge augmentation for later implantation; - · Alveolar ridge reconstruction for prosthetic treatment; - · Aid regeneration of bone defects after root resection, cystectomy, removal of retained teeth; - · Guided bone regeneration in dehiscence defects 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. 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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.gov "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." {3}------------------------------------------------ ### SK bioland Co., Li 162, Gwahaksaneop 3-ro, Ochang-eup, Cheongwon-gu, Cheongju-si, Chungcheongbuk-do, 28125 Republic of Korea Image /page/3/Picture/2 description: The image shows the logo for SK bioland. The logo consists of the letters "SK" in red, with a stylized orange and red graphic above the letters. To the right of the letters "SK" is the word "bioland" in orange. The logo is simple and modern, and the colors are bright and eye-catching. ### 510(k) Summary - K200623 #### 01. Date of Submission: October 2, 2020 #### 02. Applicant Company name: SK bioland Co., Ltd. Address: 162, Gwahaksaneop 3-ro, Ochang-eup, Cheongwon-gu, Cheongju-si, Chungcheongbuk-do, Republic of Korea TEL: +82 43 240 8633 FAX: +82 43 240 8699 Email: yjchae@sk.com #### 03. Submission Correspondent Sanglok, Lee Wise COMPANY Inc. #303, 142, Gasan digital 1-ro, Geumcheon-gu, Seoul, Korea TEL: +82 70 8812 3619 / +82 2 831 3615 FAX: +82 50 4031 3619 Email: info@wisecompany.org #### 04. Proposed Device Identification Trade Name: OssGuide Common Name: Absorbable collagen membrane Classification Name: Barrier, Animal Source, Intraoral Product Code: NPL Panel: Dental Regulation Number: 21 CFR 872.3930 Device Class: Class II #### 05. Indication for use OssGuide is recommended for: - Simultaneous use of GBR-membrane (OssGuide) and implants; - . Augmentation around implants placed in immediate extraction sockets; - . Augmentation around implants placed in delayed extraction sockets; - . Localized ridge augmentation for later implantation; - Alveolar ridge reconstruction for prosthetic treatment; - Aid regeneration of bone defects after root resection, cystectomy, removal of retained teeth; - Guided bone regeneration in dehiscence defects ● #### 06. Predicate devices 510(k) Number: K050446 Device Name: BIO-GIDE® Manufacturer: Ed. Geistlich Soehne Ag fuer Chemische Industrie #### 07. Device Description OssGuide (Absorbable collagen membrane) is made of purified collagen without further cross-linking or chemical treatment. The collagen is extracted from veterinary certified pigs and is carefully purified to avoid antigenic reactions. The OssGuide is a collagen membrane obtained by a standardized controlled {4}------------------------------------------------ SK biola 162, Gwahaksaneop 3-ro, Ochang-eup, Cheongwon-gu, Cheongju-si, Chungcheongbuk-do, 28125 Republic of Korea Image /page/4/Picture/2 description: The image contains the logo for SK bioland. The logo consists of the letters "SK" in red, followed by the word "bioland" in orange. Above the letters, there is an abstract butterfly-like shape with red and orange wings. The logo is simple and modern, with a focus on the company's name and a visual representation of nature. manufacturing process. The OssGuide has a porous and fibrous microstructure that prevents the ingrowth of fibrous tissue into the bone defect. OssGuide is packed by a packaging material composed of a transparent side and is easy to use by open system of easy peel type. It is easy to check the OssGuide, because one side of packaging is transparent closed by double packing system in order to protect OssGuide from microbial formation and moisture penetration. Then this packaged OssGuide is sterilized by gamma irradiation. The packaging contains the OssGuide and one Tyvek material template. The surgical procedure consists of placing of an occlusive physical barrier between the connective tissue and the bone defect to prevent the migration of the epithelial and connective tissue cells into the defect. The periodontal defect or bone defect is exposed by a mucoperosteal flap and basic surgical procedures (e.g. curettage) are performed. The clinician should perform thorough debridement and efficient planing of the defect. Space-making material such as autologous bone or bone substitute may be used to fill the defect. OssGuide can be placed either dry or hydrated. OssGuide can be trimmed to the size and shape of the defect in a dry or wet state using scissors. A piece of sterile Tyvek may be used as a template for membrane sizing and trimming. OssGuide should overlap the walls of the defect by at least 2 mm to allow complete bone contact and to prevent gingival connective tissue invasion below the material. The membrane may be secured in place with sutures, tacks, or by means of sufficient contact with the mucoperiosteal flap to avoid displacement and micro motion during healing. To facilitate proper healing, ensure that there is tension-free primary closure of the soft tissue flap covering the membrane. OssGuide a bioresorbable scaffold that is eventually resorbed by host tissue. OssGuide is substantially resorbed within 24 weeks after implantation. The OssGuide is available to the United Sates market in 5 sizes as shown below. They are supplied sterile and intended for single use only. | Model No. | Size | Packaging<br>(ea/box) | |-----------|-----------|-----------------------| | TG-1 | 15 x 20mm | 1 | | TG-2 | 20 x 30mm | 1 | | TG-3 | 30 x 40mm | 1 | | TG-4 | 15 x 30mm | 1 | | TG-5 | 25 x 25mm | 1 | #### 08. Non-Clinical Test Conclusion The determination of substantial equivalence was based on an assessment of non-clinical performance data obtained from in vitro characterization studies, an in vivo animal study, biocompatibility testing. In vitro product characterization testing was performed to demonstrate substantial equivalence of the subject device to its predicate device in biochemical, mechanical properties. The test results demonstrated that the proposed device complies with the following standards: - · Physicochemical Characterization per ASTM F2212 - Tensile strength testing - · Suture pull-out strength testing {5}------------------------------------------------ # SK bioland 162, Gwahaksaneop 3-ro, Ochang-eup, Cheongwon-gu, Cheongju-si, Chungcheongbuk-do, 28125 Republic of Korea Image /page/5/Picture/2 description: The image contains the logo for SK bioland. The logo consists of the letters "SK" in red, followed by the word "bioland" in orange. Above the text is a stylized butterfly-like shape, with the left side in red and the right side in orange. Validation of packaging, shelf life, transport and sterilization are performed as following: - · Validation of Primary and Secondary barrier packaging per ISO 11607-2 - Validation of shelf life per ASTM F1980 using age accelerated and real-time aged samples - · Validation of transport packaging per ASTM D4169 - · Validation of sterilization parameters per ISO 11137 Biocompatibility of the subject device was evaluated in accordance with ISO 10993-1 as followings: - · Cytotoxicity per ISO 10993-5 - · Sensitization per ISO 10993-10 - · Irritation per ISO 10093-10 - · Subchronic Toxicity per ISO 10993-11 - · Genotoxicity per ISO 10993-3 - · Implantation per ISO 10993-6 - · Material mediated pyrogenicity per USP Results indicate that the device's biocompatibility profile is acceptable. The pyrogenicity of OssGuide was tested in vivo using the Rabbit Pyrogen Test as per USP <151>, and the test article was judged as nonpyrogenicity sample testing plan, the endotoxin (LAL) testing will be conducted on every batch of OssGuide products. The manufacturing control of animal tissue components is performed as following: - · Controls on sourcing, collection, and handling per ISO 22442-2 - · Viral Inactivation per ISO 22442-3 Animal study was conducted in the alveolar bone defect of beagle dogs to evaluate the in vivo performance and degradation of the OssGuide, supporting substantial equivalence. The study was conducted on 20 animals followed for 4, 8, 12 and 24 weeks. When comparing OssGuide with the predicate device, Bio-Gide with Bio-Oss bone graft material as a positive control, it showed sufficient GBR effect for the alveolar bone regeneration on the alveolar bone defect of beagle dogs. OssGuide maintained their contour until 8 weeks, lost most of its integrity after 12 weeks, and disappeared by biodegradation at 24 weeks. #### 09. Substantially Equivalent Conclusion #### Table 1: Substantial Equivalence Comparison | Product<br>Name | SUBJECT Device<br>OssGuide | PREDICATE Device<br>BIO-GIDE® (K050446) | Equivalence Discussion | |-------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------| | Product<br>code | NPL | NPL | Identical | | Regulatory<br>class | Class II | Class II | Identical | | Regulation<br>Number | 21 CFR 872.3930 | 21 CFR 872.3930 | Identical | | Intended use | OssGuide is recommended<br>for; | Bio-Gide® is recommended<br>for; | Equivalent<br>The indications for the su<br>bject device are a subset | | | - Simultaneous use of GBR-<br>membrane (OssGuide)<br>and implants;<br>- Augmentation around implants placed in immediate extraction sockets;<br>- Augmentation around implants placed in delayed extraction sockets;<br>- Localized ridge augmentation for later implantation;<br>-Alveolar ridge reconstruction for prosthetic treatment;<br>- Aid regeneration of bone defects after root resection, cystectomy, removal of retained teeth;<br>- Guided bone regeneration in dehiscence defects | - Simultaneous use of GBR-<br>membrane (BIO-GIDE) and implants;<br>- Augmentation around implants placed in immediate extraction sockets;<br>- Augmentation around implants placed in delayed extraction sockets;<br>- Localized ridge augmentation for later implantation;<br>-Alveolar ridge reconstruction for prosthetic treatment;<br>- Aid regeneration of bone defects after root resection, cystectomy, removal of retained teeth;<br>- Guided bone regeneration in dehiscence defects; and<br>- Guided tissue regeneration procedures in periodontal defects. | of the indications for the predicate devices. | | Mode of Action | OssGuide functions as a barrier when applied between bone graft material and soft tissue. The membrane serves as a bioresorbable scaffold that is eventually remodeled, resorbed, and replaced by host tissue. | Bio-Gide® functions as a barrier when applied between bone graft material and soft tissue. The membrane serves as a bioresorbable scaffold that is eventually remodeled, resorbed, and replaced by host tissue. | Identical | | Operating<br>Principles | Cell-Occlusive<br>Implantable<br>Resorbable<br>Biocompatible | Cell-Occlusive<br>Implantable<br>Resorbable<br>Biocompatible | Identical | | Material | Purified collagen | Purified collagen | Identical<br>Equivalent | | Collagen<br>source | Porcine pericardium | Porcine peritoneum | Using the tissue extracted from porcine is the same, but the parts of tissue used are different. | | Form | Membrane | Membrane | Identical | | Structure | Bilayer structure | Bilayer structure | Identical | | Color | White to off-white | White to off-white | Identical<br>Equivalent | | Product<br>Size | 15x20mm, 20x30mm,<br>30x40mm,<br>15x30mm, 25x25mm | 13x25mm, 25x25mm,<br>40x50mm | Both devices are provided in clinically relevant sizes for intra-oral surgical procedures | | Resorption<br>time | Substantially resorbed by<br>24 Weeks | Substantially resorbed by<br>24 Weeks | Identical | | Sterilization | Gamma Irradiation | Gamma Irradiation | Identical | | Singe Use/<br>Reuse | Single use only | Single use only | Identical | | Packaging | Double pouch pack | Double blister pack | Identical | | Shelf -life | 36 months | 36 months | Identical | {6}------------------------------------------------ # SK bioland Co., Ltd. 162, Gwahaksaneop 3-ro, Ochang-eup, Cheongwon-gu, Cheongju-si, Chungcheongbuk-do, 28125 Republic of Korea Image /page/6/Picture/2 description: The image shows the logo for SK bioland. The logo consists of the letters "SK" in red, followed by the word "bioland" in orange. Above the letters "SK" is a stylized butterfly shape, with the left wing in red and the right wing in orange. The logo is simple and modern, and the colors are bright and eye-catching. {7}------------------------------------------------ ## SK bioland Co., Ltd. 162, Gwahaksaneop 3-ro, Ochang-eup, Cheongwon-gu, Cheongju-si, Chungcheongbuk-do, 28125 Republic of Korea Image /page/7/Picture/2 description: The image shows the logo for SK bioland. The logo consists of the letters "SK" in red, followed by the word "bioland" in orange. Above the letters "SK" is a stylized butterfly-like shape with red and orange colors. The logo is simple and modern, and the colors are bright and eye-catching. The proposed device, OssGuide, is determined to be Substantially Equivalent (SE) to the predicate devices, BIO-GIDE® (K050446) in respect of safety and effectiveness.