OpenTex

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of 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. Purgo Biologics Inc. Byungsun Kim RA Team Manager #812, 27 Dunchon-daero 457beon-gil, Jungwon-gu Seongnam-si, Gyeonggi-do 13219 Korea. South 5/11/23 ### Re: K222549 Trade/Device Name: OpenTex Regulation Number: 21 CFR 872.3930 Regulation Name: Bone Grafting Material Regulatory Class: Class II Product Code: NPK Dated: April 10, 2023 Received: April 11, 2023 ### Dear Byungsun Kim: 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. Sherrill Lathrop Blitzer for Andrew Steen Assistant Director DHT1B: Division of Dental and ENT 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}------------------------------------------------ Image /page/2/Picture/0 description: The image contains a logo for "Purgo Dental Biologics Solution". The logo features a gray circular icon with a smaller circle inside and a line extending upwards, resembling a stylized atom or molecule. To the right of the icon, the word "Purgo" is written in a bold, purple font. Further to the right, the words "Dental Biologics Solution" are stacked vertically, also in purple, but in a smaller font size. # Indication for use 510(k) Number: K222549 Device Name: OpenTex Indication for use: OpenTex is a temporarily implantable material (non-resorbable) for as a space-making barrier in the treatment of periodontal defects. Prescription Use (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 OF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Indication for use {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the logo for Purgo Dental Biologics Solution. The logo features a gray atom-like symbol on the left, followed by the word "Purgo" in a bold, purple font. To the right of "Purgo" are the words "Dental Biologics Solution" stacked on top of each other, also in purple. # 510(k) Summary 05/10/2023 ## 1. Company | | Submitter | |----------------|------------------------------------------------------------------------------------------| | Name | Purgo Biologics Inc. | | Address | #812, 27 Dunchon-daero 457beon-gil, Jungwon-gu, Seongnam-si,<br>Gyeonggi-do, Korea 13219 | | Phone/Fax | Tel. +82-70-4827-0451, Fax. +82-70-8673-0660 | | Contact person | Byungsun Kim / RA<br>kimbs@purgobio.com | | Summary Date | 05/10/2023 | ## 2. Device Name | Proprietary name | : | OpenTex | |------------------------|---|------------------------------| | Regulation number | : | 21 CFR 872.3930 | | Regulation Description | : | Bone Grafting Material | | Product code | : | NPK | | Classification name | : | Barrier, Synthetic, Intraora | | Device class | : | Class II | | Classification Panel | : | Dental | ### 3. Predicate Device | Primary predicate device | | |--------------------------|-----------------------------------------------| | K160493 | Salvin CytoSurg™ Non-Resorbable PTFE Membrane | Reference device K964342 Cytoplast GBR ### 510(k) Summary {4}------------------------------------------------ ### 4. Indication for use OpenTex is a temporarily implantable material (non-resorbable) for as a space-making barrier in the treatment of periodontal defects. ### 5. Description OpenTex is a non-resorbable PTFE membrane composed of proprietary 100% polytetrafluoroethylene (PTFE) sheet with inert biological features and predictable barrier effect. OpenTex is designed to function as a physical barrier to avoid gingival cell invasion, thus providing a favorable environment for neovascularization and bone derived cells to repopulate and repair the defect. Since space-making is critical to this procedure, the membrane is sufficiently stiff to prevent spontaneous collapse but supple enough to conform easily to tissue contours. OpenTex is supplied sterile and intended for single use only. It is available in various sizes as shown below. | Size | Thickness | Packaging | |------------|-----------|------------| | 12 x 20 mm | 0.16 mm | | | 14 x 24 mm | | | | 17 x 25 mm | | 1ea / box | | 20 x 25 mm | | 5ea / box | | 24 x 30 mm | | 10ea / box | | 30 x 40 mm | | | ### 6. Performance Data Non-clinical testing was performed in accordance with FDA recognized consensus standards and FDA guidance as applicable. · Performance testing was performed to demonstrate substantial equivalence of the subject device to its primary predicate device as table below. The test results of the subject device met the criteria and was equal or higher than that of the predicate device. ### 510(k) Summary {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the logo for Purgo Dental Biologics Solution. The logo features a gray circular icon with a smaller circle inside, followed by the word "Purgo" in a purple, bold font. To the right of "Purgo" are the words "Dental Biologics Solution" stacked on top of each other in a smaller, purple font. | Test item | Test method | Criteria | Results | |------------------------------|--------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------| | pH | pH measurement test | Difference between the blank<br>and the extracts<br><br>< 1.5 (Internal)<br>* pH measured<br>- Blank: 6.23<br>- Subject device: 6.23<br>- Predicate device: 6.21 | The results of both devices met<br>the criteria. | | Dissolution<br>/ Solubility | Evaporation residue test | Evaporation residue of the<br>extraction liquid<br>$\leq$ 1.0mg | The results of both devices met<br>the criteria. | | Tensile strength | ASTM D882 | ≥ 34 MPa (Internal) | The result of the subject device<br>met the criteria and was higher<br>than that of predicate device. | | Tear resistance | ISO 6383-1 | ≥ 1.5 kgf/mm (Internal) | The result of the subject device<br>met the criteria and was higher<br>than that of predicate device. | | Suture retention<br>strength | ANSI/AAMI/ISO 7198 | Criteria for the subject device<br>was established as equivalent<br>to result of predicate device. | The result of the subject device<br>was higher than that of predicate<br>device. | · Biocompatibility was evaluated in accordance with ISO 10993 series as followings. - Biocompatibility risk assessment per ISO 10993-1 - Cytotoxicity per ISO 10993-5 - Irritation per ISO 10093-10 - Sensitization per ISO 10993-10 - Genotoxicity per ISO 10993-3 - Acute toxicity per ISO 10993-11 - Subacute toxicity per ISO 10993-11 - Implantation per ISO 10993-6 - Material mediated pyrogenicity per ISO 10993-11 {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the logo for Purgo Dental Biologics Solution. The logo features a gray atom-like symbol on the left, followed by the word "Purgo" in a purple sans-serif font. To the right of "Purgo" are the words "Dental Biologics Solution" stacked vertically, also in purple. · EO(Ethylene Oxide) gas sterilization process validation was performed accordance with ISO 11135 demonstrating a sterility assurance level (SAL) of 10-6. No clinical data were included in this submission. ### 7. Technological Characteristics The following comparison table of the technological characteristics of the subject device and the predicate device outlines and provides the substantial equivalency of the subject device and the predicate. | | Subject device | Predicate device | | | |------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | | Primary predicate<br>device | Reference device | Discussion | | Device name | OpenTex | Salvin CytoSurg™<br>Non-Resorbable PTFE<br>Membrane | Cytoplast GBR | - | | Manufacturer | Purgo Biologics Inc. | Salvin Dental<br>Specialties | Osteogenics<br>Biomedical, Inc. | - | | 510(k) Number | New Device | K160493 | K964342 | - | | Indication for<br>use | OpenTex is a temporarily<br>implantable material (non-<br>resorbable) for as a space-<br>making barrier in the<br>treatment of periodontal<br>defects. | The Salvin CytoSurg™<br>Non-Resorbable PTFE<br>Membrane is<br>temporarily implantable<br>material<br>(non-resorbable) for as<br>a space-making barrier<br>in the treatment of<br>periodontal defects. | A temporarily<br>implantable material<br>(non-resorbable) for use<br>as a space-making<br>barrier in the treatment<br>of periodontal defects. | Substantially equivalent | | Materials | PTFE | PTFE | PTFE | Equivalent<br>The subject and predicate<br>devices are composed of<br>PTFE. | | Form | Membrane<br>(Plain, Textured type) | Membrane<br>(Textured type) | Membrane<br>(Textured type) | Equivalent<br>The subject device is<br>provided in plain and<br>textured type while the<br>predicate devices are<br>provided in textured type.<br>Textured type is<br>manufactured by giving | | | | | | PTFE sheet a textured<br>surface through the 'patten<br>input' process. Because this<br>process does not affect the<br>properties of PTFE sheet,<br>the property of plain and<br>textured type is same. The<br>equivalence of performance<br>to the predicate device was<br>verified trough the bench<br>testing.<br>Equivalent | | Size | 12 x 20 mm, 14 x 24 mm<br>17 x 25 mm, 20 x 25 mm<br>24 x 30 mm, 30 x 40 mm | 12 x 24 mm, 25 x 30<br>mm | 12 x 24 mm, 25 x 30<br>mm | Equivalent<br>The subject and predicate<br>devices are provided in<br>various sizes for intra-oral<br>surgical procedures. | | Thickness | 0.16 mm | 0.25 mm | 0.25 mm | Equivalent<br>The subject is thinner than<br>the predicate, but the<br>equivalence of performance<br>was verified trough the<br>bench testing. | | Sterilization | Sterile<br>(ETO, SAL 10-6) | Sterile<br>(ETO, SAL 10-6) | Sterile<br>(ETO, SAL 10-6) | Identical | | Shelf-life | 5 years | Unknown | 5 years | Equivalent<br>The shelf-life of the subject<br>device is equivalent to the<br>referemce device. | | pH | 6.23 | 6.21 | Unknown | Equivalent | | Dissolution<br>/ Solubility | 0 mg | 0 mg | Unknown | Equivalent<br>The performance test results<br>of the subject device met the<br>criteria and was equal or<br>higher than that of the<br>predicate device. | | Tensile strength | 72.1524 MPa | 33.8444 MPa | Unknown | | | Tear resistance | 5.9254 kgf/mm | 1.288 kgf/mm | Unknown | | | Suture retention<br>strength | 1.083 MPa | 0.842 MPa | Unknown | | | Use | Prescription | Prescription | Prescription | | | Single Use Only | Yes | Yes | Yes | Identical | | Duration of<br>implantation | Less than 30 days | Less than 30 days | Less than 30 days | Equivalent<br>The subject and predicate<br>devices are temporarily<br>implantable materials and<br>intended to be removed<br>within 30 days. | ### Comparison of Characteristics {7}------------------------------------------------ Image /page/7/Picture/0 description: The image contains a logo for a dental biologics solution. The logo features a gray atom-like symbol on the left, followed by the word "Purgo" in a purple, bold font. To the right of "Purgo", the words "Dental Biologics Solution" are stacked vertically, also in purple. The subject device is substantially equivalent to the primary predicate device K160493 in indication for use, material, design(form), sterilization and duration of implantation. Both devices are provided ### 510(k) Summary {8}------------------------------------------------ Image /page/8/Picture/0 description: The image is a logo for Purgo Dental Biologics Solution. The logo features a gray atom-like symbol on the left, followed by the word "Purgo" in a purple sans-serif font. To the right of "Purgo" are the words "Dental Biologics Solution" stacked vertically, also in purple. in various sizes for intra-oral surgical procedures. The subject device is thinner than the predicate devices, but the equivalence of performance was verified through tensile strength and tear resistance tests. ## 8. Conclusion Based on the information provided, the subject device is substantially equivalent to the primary predicate device.