Who is the manufacturer of Cytoplast Titanium-Reinforced PTFE Membranes?

Osteogenics Biomedical, Inc. filed the 510(k) submission for Cytoplast Titanium-Reinforced PTFE Membranes (K201187).

What is the FDA product code for Cytoplast Titanium-Reinforced PTFE Membranes?

NPK. It is classified under 21 CFR 872.3930 as a Class 2 device in the Dental panel.

What is the regulatory pathway for Cytoplast Titanium-Reinforced PTFE Membranes?

510(k) clearance (submission type: Traditional).

What are the predicate devices for Cytoplast Titanium-Reinforced PTFE Membranes?

Cytoplast™ Regentex™ Titanium 250 (K972278).

Who can help prepare an FDA 510(k) submission like Cytoplast Titanium-Reinforced PTFE Membranes?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Cytoplast Titanium-Reinforced PTFE Membranes

K201187 · Osteogenics Biomedical, Inc. · NPK · Jan 23, 2021 · Dental

Device Facts

Record ID	K201187
Device Name	Cytoplast Titanium-Reinforced PTFE Membranes
Applicant	Osteogenics Biomedical, Inc.
Product Code	NPK · Dental
Decision Date	Jan 23, 2021
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 872.3930
Device Class	Class 2
Attributes	Therapeutic

Intended Use

Cytoplast™ Titanium-Reinforced PTFE Membranes are a temporarily implantable material (non- resorbable) indicated for use as a space-making barrier in the treatment of alveolar and periodontal bony defect sites.

Device Story

Cytoplast™ Titanium-Reinforced PTFE Membranes are non-resorbable, temporarily implantable barriers used in dental bone grafting. The device consists of a titanium frame embedded between two layers of polytetrafluoroethylene (PTFE). During dental procedures, a clinician places the membrane between the bone graft and the periosteum. The device acts as a space-making barrier, stabilizing and supporting the bone graft while isolating the defect site to allow bone-derived cells to repopulate and repair the bone. The titanium frame allows the clinician to trim and shape the membrane to conform to tissue contours and maintain space for bone growth. The device is provided in various pre-shaped sizes and thicknesses (150 µm and 250 µm). It is intended for single use and is removed after the healing period (up to 12 months).

Clinical Evidence

Bench testing only. Biocompatibility was confirmed via ISO 10993 testing (cytotoxicity, irritation, toxicity, implantation). Sterilization validation performed per ISO 11135-1:2007. Tensile strength testing per ASTM D638-14 confirmed the device meets or exceeds the reference device (Bio-Gide®) specifications. Lamination strength was verified via internal testing.

Technological Characteristics

Materials: 100% PTFE and titanium. Form factor: Titanium frame embedded between two PTFE layers; various pre-shaped sizes; 150 µm or 250 µm thickness. Sterilization: Ethylene Oxide (ISO 11135-1:2007). Tensile testing: ASTM D638-14. Biocompatibility: ISO 10993. Shelf life: 4 years.

Indications for Use

Indicated for use as a space-making barrier in the treatment of alveolar and periodontal bony defect sites in patients requiring dental bone grafting procedures.

Regulatory Classification

Identification

Bone grafting material is a material such as hydroxyapatite, tricalcium phosphate, polylactic and polyglycolic acids, or collagen, that is intended to fill, augment, or reconstruct periodontal or bony defects of the oral and maxillofacial region.

Special Controls

*Classification.* (1) Class II (special controls) for bone grafting materials that do not contain a drug that is a therapeutic biologic. The special control is FDA's “Class II Special Controls Guidance Document: Dental Bone Grafting Material Devices.” (See § 872.1(e) for the availability of this guidance document.)(2) Class III (premarket approval) for bone grafting materials that contain a drug that is a therapeutic biologic. Bone grafting materials that contain a drug that is a therapeutic biologic, such as biological response modifiers, require premarket approval. (c) *Date premarket approval application (PMA) or notice of product development protocol (PDP) is required.* Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.

Predicate Devices

Cytoplast™ Regentex™ Titanium 250 (K972278)

Reference Devices

RPM™ Reinforced PTFE Mesh (K171774)
Bio-Gide® Resorbable Bilayer Membrane (K050466)

Related Devices

K151344 — Cytoflex Tefguard Ti-Enforced Membrane · Unicare Biomedical, Inc. · Nov 19, 2015
K221851 — Lumina-PTFE Titanium · Criteria Industria E Comercio DE Produtos Medicinais · Dec 8, 2023
K210797 — Bio-MEM Ti Reinforced Membrane · B&Medi Co., Ltd. · Aug 18, 2022
K143327 — Neoss Ti Reinforced Membrane · Neoss, Ltd. · Apr 13, 2015
K171774 — RPM Reinforced PTFE Mesh · Osteogenics Biomedical, Inc. · Oct 19, 2017

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue. Osteogenics Biomedical, Inc. Shane Shuttlesworth President 4620 71st St., Bldg. 78 Lubbock, Texas 79424 Re: K201187 Trade/Device Name: Cytoplast™ Titanium-Reinforced PTFE Membranes Regulation Number: 21 CFR 872.3930 Regulation Name: Bone Grafting Material Regulatory Class: Class II Product Code: NPK Dated: December 28, 2020 Received: December 28, 2020 Dear Shane Shuttlesworth: 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 (OS) 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. Andrew Steen Assistant Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K201187 Device Name Cytoplast™ Titanium-Reinforced PTFE Membranes Indications for Use (Describe) Cytoplast™ Titanium-Reinforced PTFE Membranes are a temporarily implantable material (non- resorbable) indicated for use as a space-making barrier in the treatment of alveolar and periodontal bony defect sites. 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.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}------------------------------------------------ # K201187 510(k) Summary This 510(k) summary is being submitted in accordance with the requirements of 21 CFR 807.92. #### l. SUBMITTER | Applicant Name: | Osteogenics Biomedical, Inc. | |-----------------|------------------------------------------------| | Address: | 4620 71st St, Bldg. 78 Lubbock, Texas 79424 | | Phone: | (806) 796-1923 | | Fax: | (806) 796-0059 | | Contact Person: | Shane Shuttlesworth President | | Date Prepared: | January 22, 2021 | #### II. DEVICE | Trade Name: | Cytoplast™ Titanium-Reinforced PTFE Membranes | |--------------------|-----------------------------------------------| | Common Name: | PTFE Membrane | | Regulation Name: | Bone Grafting Material | | Regulation Number: | 21 CFR 872.3930 | | Regulatory Class: | II | | Product Code: | NPK (Barrier, Synthetic, Intraoral) | #### lll. PRIMARY PREDICATE DEVICE Cytoplast™ Regentex™ Titanium 250 (Osteogenics Biomedical, Inc.) Primary Predicate K972278 Device: RPM™ Reinforced PTFE Mesh (K171774) and Bio-Gide® Resorbable Bilayer Membrane (K050466) were used as a reference devices in this submission. #### IV. DEVICE DESCRIPTION Cytoplast™ Titanium-Reinforced PTFE Membranes are placed between bone grafts and the periosteum in dental bone grafting procedures to stabilize and support the bone graft. The PTFE membrane helps create the space needed for bone-derived cells to repopulate and repair the defect. Cytoplast™ Titanium-Reinforced PTFE Membranes are composed of proprietary 100% polytetrafluoroethylene sheets reinforced with a titanium frame. The titanium frame is embedded between two layers of PTFE. PTFE is biologically nearly inert and a tissue-compatible material. {4}------------------------------------------------ The PTFE membranes are designed to maintain space and conform to tissue contours. Cytoplast™ Titanium-Reinforced PTFE Membranes are provided in two different thicknesses (approximately 150 µm & 250 µm) and are pre-shaped in a variety of shapes and sizes. Outer dimensions include: - 12 mm x 20 mm - . 12 mm x 24 mm - . 12 mm x 30 mm - 13 mm x 18 mm - 13 mm x 19 mm - 14 mm x 24 mm - 17 mm x 25 mm - . 20 mm x 25 mm - 24 mm x 38 mm - 25 mm x 36 mm - 25 mm x 30 mm - 30 mm x 41 mm - . 30 mm x 40 mm - . 38 mm x 38 mm - . 40 mm x 50 mm #### V. INDICATIONS FOR USE Cytoplast™ Titanium-Reinforced PTFE Membranes are a temporarily implantable material (nonresorbable) indicated for use as a space-making barrier in the treatment of alveolar and periodontal bony defect sites. #### VI. COMPARISON OF INDICATIONS FOR USE WITH THE PRIMARY PREDICATE DEVICE The term "alveolar defects" has been added to the indication for use for the subject device. The term "alveolar defects" includes any bony defect found within the alveolus, both in the mandible and the maxilla. Using the term alveolar defects focuses the indication on the location of the defect rather than the etiology of bone loss and still aligns with how the devices are being used clinically. #### VII. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICES Cytoplast™ Titanium-Reinforced PTFE Membranes are substantially equivalent to the primary predicate device, Cytoplast™ Regentex™ Titanium 250. Cytoplast™ Titanium-Reinforced PTFE Membranes are identical in design, function, composition, biocompatibility, sterilization, sizes, packaging, shelf life, physical properties, and intended use to the legally marketed primary predicate device, Cytoplast™ Regentex™ Titanium 250. See comparison table below: {5}------------------------------------------------ | | Cytoplast™ Titanium- Reinforced PTFE Membranes (K201187) Osteogenics Biomedical, Inc. | Cytoplast™ Regentex™ Titanium 250 (K972278) Osteogenics Biomedical, Inc. | RPM™ Reinforced PTFE Mesh (K171774) Osteogenics Biomedical, Inc. | Bio-Gide® Resorbable Bilayer Membrane (K050466) Geistlich, Pharma | |----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Product Code | NPK | LYC | NPK | NPL | | Indications for Use | A temporarily implantable material (non- resorbable) indicated for use as a space-making barrier in the treatment of alveolar and periodontal bony defect sites. Rx Only | A temporarily implantable material (non- resorbable) for use as a space-making barrier in the treatment of periodontal defects. Rx Only | For stabilization and support of bone grafts in alveolar bony defect sites. Rx Only | Simultaneous use of GBR-membrane 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; filling of bone defects after root resection, cystectomy, removal of retained teeth; guided bone regeneration in dehiscence defects; guided tissue regeneration procedures in periodontal defects. Rx Only | | Operational Principles | Cytoplast™ Titanium- Reinforced PTFE Membranes are placed between bone grafts and the periosteum in dental bone grafting procedures to stabilize and support the bone | Cytoplast™ Regentex™ Titanium 250 is placed between bone grafts and the periosteum in dental bone grafting procedures to stabilize and support the bone grafting | RPM™ Reinforced PTFE Mesh is placed between bone grafts and the periosteum in dental bone grafting procedures to stabilize and support the bone graft. The PTFE | BIO-GIDE® resorbable bilayer membrane is for guided tissue and bone regeneration. | | | support the bone graft. The PTFE membrane isolates the space needed for bone-derived cells to repopulate and repair the defect. | graft. The PTFE membrane isolates the space needed for bone-derived cells to repopulate and repair the defect. | mesh helps create the space needed for bone-derived cells to repopulate and repair the defect. | | | Design | Titanium frame embedded between two layers of PTFE. Titanium frame may be trimmed and shaped to create additional space for bone growth. | Titanium frame embedded between two layers of PTFE. Titanium frame may be trimmed and shaped to create additional space for bone growth. | Titanium frame embedded between two layers of PTFE. Titanium frame may be trimmed and shaped to create additional space for bone growth. Macropores allow direct contact between the bone graft and the periosteum. Direct contact between the periosteum and bone graft allows naturally occurring revascularization and infiltration of cells. | Resorbable bilayer membrane composed of collagen type I and type III without further cross- linking or chemical treatment. The porous surface - facing the bone - allows the ingrowth of bone forming cells. The dense surface - facing the soft tissue - prevents the ingrowth of fibrous tissue into the bone defect. | | Composition | 100% PTFE, Titanium | 100% PTFE, Titanium | 100% PTFE, Titanium | Type I and Type III Collagen | | Use | Single | Single | Single | Single | | Shelf Life | 4 years | 4 years | 4 years | Unknown | | Biocompatible | Yes | Yes | Yes | Yes | | Sterilization | Sterile | Sterile | Sterile | Sterile | | Model Sizes | Various | Various | Various | Various | | Maximum Duration of Implantation | 12 months | Not Stated | 12 months | Unknown | {6}------------------------------------------------ RPM™ Reinforced PTFE Mesh is being used as a reference device to leverage biocompatibility testing performed on this device as applicable to the subject device, Cytoplast™ Titanium-Reinforced PTFE Membranes, since these devices are identical for the purposes of these tests. The tensile specification for the Cytoplast™ Titanium-Reinforced PTFE Membranes has been selected based off of the reference device, Bio-Guide® Resorbable Bilayer Membrane. {7}------------------------------------------------ #### VIII. PERFORMANCE DATA ## Nonclinical Tests Submitted The substantial equivalence of Cytoplast™ Titanium-Reinforced PTFE Membranes and its primary predicate was demonstrated based on in vitro characterization studies. Non-clinical testing was performed in accordance with FDA recognized consensus standards and FDA guidelines as applicable. A complete biocompatibility risk assessment conducted in accordance with ISO series 10993-1 demonstrated biocompatibility risks were able to be mitigated by leveraging biocompatibility testing for the reference device as they are composed of identical materials, manufacturing processes, sterilization and packaging. Biocompatibility of the subject device was confirmed with ISO 10993 testing as follows: - . Cytotoxicity: ISO MEM Elution Assay with L-929 Mouse Fibroblast Cells - Irritation (including Intracutaneous reactivity) - Toxicity (acute, subacute, subchronic, chronic) - Implantation Sterilization validation for Ethylene Oxide was performed per ISO 11135-1:2007 to achieve a Sterility Assurance Level of 10 °. Shelf-life testing was performed in compliance with ISO 11607-1. In vitro product characterization testing was performed to demonstrate substantial equivalence of the subject device to its primary predicate and reference devices. A series of bench tests were conducted to evaluate material and physical properties. Tensile strength was characterized and compared to the reference device, Bio-Gide® Resorbable Bilayer Membrane, in order to establish a minimum acceptable specification. Lamination was characterized to ensure it is appropriate for the clinical application of the membranes. The comparative bench testing is summarized in the table below. | Test | Test Method | Results | |---------------------|--------------|-------------------------------------| | Tensile Strength | ASTM D638-14 | Tensile strength ≥ reference device | | Lamination Strength | Internal | Lamination is acceptable | #### IX. CONCLUSION The results of in vitro device characterization tests show that the subject device, Cytoplast™ Titanium-Reinforced PTFE Membranes, is substantially equivalent to the primary predicate and reference devices. ISO 10993 testing confirms the biocompatibility of the subject device. Tensile strength testing shows that the subject device is at least as strong as the reference device, Bio-Gide®. Lamination tests show that the subject device is acceptable for its clinical application.