(520 days)
Bio-MEM Ti Reinforced membranes are an implantable temporary non-resorbable device (membrane) for use as a spacer creation barrier in the treatment of local defects in the oral cavity in conjunction with tissue regeneration or augmentation. Bio-MEM Ti Reinforced membranes are intended to be submerged and clinically implanted more than 30 days and no longer than 6 months.
Bio-MEM Ti Reinforced membranes are non-resorbable membranes available as Tireinforced configured of a highly shapeable Ti (Reinforced only) enveloped by an embossed polytetrafluoroethylene (PTFE) membrane. Extensive documentation demonstrates tissue compatibility of PTFE. Bio-MEM Ti Reinforced membranes are designed to avoid ingrowth of gingival soft tissue into bony defects, in order to facilitate the neovascularization and bone formation during the repair process of the defect. Bio-MEM Ti Reinforced membranes are provided STERILE and in different anatomical shapes and sizes. The titanium reinforcement is intended for space creating and shapemaintaining which minimize movements and subsequent exposure during the regenerative healing.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Bio-MEM Ti Reinforced Membrane.
Note: The provided text is a 510(k) summary for a medical device (Bio-MEM Ti Reinforced Membrane). 510(k) submissions typically demonstrate substantial equivalence to a predicate device rather than presenting acceptance criteria and studies in the traditional scientific sense for a novel AI/software device. Therefore, the information below will reflect that context. The questions asked are more aligned with AI device studies, and the response will clarify what information is available given the document type.
1. Table of Acceptance Criteria and Reported Device Performance
Strict "acceptance criteria" and "reported device performance" as one might see for a diagnostic AI algorithm are not explicitly stated in this 510(k) summary. Instead, the document focuses on demonstrating that the Bio-MEM Ti Reinforced Membrane is substantially equivalent to its predicate devices based on design, materials, technological characteristics, and performance testing against recognized standards.
The performance testing sections describe the studies undertaken to ensure the device's safety and functionality, which implicitly means the device met the requirements of these tests.
| Aspect Tested | Study Type | Criteria (Implicit) | Performance (Reported) |
|---|---|---|---|
| Strength & Integrity | Bend and Delamination Testing | Device maintains structural integrity and functionality after bending and resists delamination. | Confirmed the strength, integrity, and functionality of the device. (Specific quantitative results not provided, but implies pass) |
| Sterilization | Sterilization Validation (EO Gas) | Device is sterile and maintains sterility over shelf-life. Meets ISO 11135[2014] standards. | Validation conducted to support EO sterilization. (Implies pass) |
| Packaging Shelf-life | Packaging Validation | Packaging maintains sterility and integrity for the specified shelf-life. Meets ISO, ASTM standards. | Validation conducted to support packaging shelf-life of 5 years. (Implies pass) |
| Biocompatibility | Cytotoxicity Testing (ISO 10993-5) | No unacceptable cytotoxic effects. | Cytotoxicity testing conducted. (Implies pass) |
| Biocompatibility | Sensitization Testing (ISO 10993-10) | No unacceptable sensitization. | Sensitization testing conducted. (Implies pass) |
| Biocompatibility | Irritation Testing (ISO 10993-10) | No unacceptable irritation. | Irritation testing conducted. (Implies pass) |
| Biocompatibility | Acute Systemic Toxicity Testing (ISO 10993-11) | No unacceptable acute systemic toxicity. | Acute systemic toxicity testing conducted. (Implies pass) |
| Biocompatibility | Material-Mediated Pyrogenicity (USP 29 <151>) | No pyrogenic response. | Material-mediated pyrogenicity testing conducted. (Implies pass) |
| Biocompatibility | Genotoxicity Testing (AMES, Micronucleus - ISO 10993-3) | Not genotoxic. | Genotoxicity (AMES and micronucleus) testing conducted. (Implies pass) |
| Biocompatibility | Implantation Testing (ISO 10993-6) | Acceptable local effects after implantation. | Implantation testing conducted. (Implies pass) |
| Ethylene Oxide Residuals | Testing against ISO 10993-7 | Ethylene oxide residues below acceptable limits. | Testing conducted against ISO 10993-7. (Implies pass) |
| Material Properties (PTFE) | Testing against ASTM D4895 - 10 | PTFE material meets standard specifications. | Testing conducted against ASTM D4895 - 10. (Implies pass) |
2. Sample Size Used for the Test Set and Data Provenance
The document describes material and mechanical tests, and biocompatibility studies. These types of tests do not typically use "test sets" of patient data in the same way an AI algorithm would.
- Sample Size for Test Set: Not applicable in the context of human patient data for algorithm evaluation. For the bench and in-vitro/in-vivo biocompatibility tests, specific sample sizes are not detailed in this summary document, but the fact that the tests were conducted according to ISO/ASTM/USP standards implies appropriate sample sizes were used for those specific test methods.
- Data Provenance: Not applicable. These tests were likely performed in a laboratory setting, not with patient data.
3. Number of Experts Used to Establish Ground Truth and Qualifications
Not applicable. The "ground truth" for these types of device performance tests (e.g., sterility, material strength, biocompatibility) is established by adherence to validated international standards and the results of laboratory measurements, not by expert human interpretation of medical images or clinical data.
4. Adjudication Method for the Test Set
Not applicable. This concept belongs to the evaluation of algorithms where human assessment of data needs to be considered. For a physical device like this, performance is measured against established scientific and engineering standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. An MRMC study is a clinical study design used to compare the performance of different diagnostic methods (e.g., human readers with and without AI assistance). This 510(k) summary is for a physical medical implant (a membrane) and focuses on demonstrating its safety and substantial equivalence, not its diagnostic accuracy or the improvement of human performance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No. This device is not an algorithm, so "standalone performance" in that context is not applicable. Its performance is measured by its material properties, biological interactions, and mechanical integrity.
7. The Type of Ground Truth Used
The "ground truth" for the various performance tests is either:
- Physical/Chemical Standards: (e.g., strength measurements in Bend and Delamination testing, density, thickness).
- Biological Standards: (e.g., absence of cytotoxicity, irritation, sensitization, genotoxicity, pyrogenicity as defined by ISO 10993 and USP standards).
- Microbiological Standards: (e.g., sterility per ISO 11135).
Essentially, the ground truth is adherence to internationally recognized and validated scientific and engineering standards.
8. The Sample Size for the Training Set
Not applicable. This device is not an AI algorithm, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no AI algorithm and no training set, this question is not relevant to the Bio-MEM Ti Reinforced Membrane.
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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.
B&Medi Co., Ltd. Taesu Kwon, CEO 56-33, Chukhang-daero 296Beon-gil, Jung-gu Incheon, Incheon 22339 KOREA. SOUTH
8/18/22
Re: K210797
Trade/Device Name: Bio-MEM Ti Reinforced Membrane Regulation Number: 21 CFR 872.3930 Regulation Name: Bone Grafting Material Regulatory Class: Class II Product Code: NPK Dated: March 11, 2021 Received: March 16, 2021
Dear Taesu Kwon:
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.
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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.
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
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Indications for Use
510(k) Number (if known) K210797
Device Name
Bio-MEM Ti Reinforced membrane
Indications for Use (Describe)
Bio-MEM Ti Reinforced membranes are an implantable temporary non-resorbable device (membrane) for use as a spacer creation barrier in the treatment of local defects in the oral cavity in conjunction with tissue regeneration or augmentation. Bio-MEM Ti Reinforced membranes are intended to be submerged and clinically implanted more than 30 days and no longer than 6 months.
| Type of Use (Select one or both, as applicable) |
|---|
| ☑Prescription Use (Part 21 CFR 801 Subpart D) |
| ☐Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary
1. Submitter
| Name: | B&Medi Co., Ltd. |
|---|---|
| Address: | 56-33, Chukhang-daero 296Beong-gil, Jung-gu,Incheon, 22339, Korea |
| Tel/ Fax: | Tel: 82-2-6295-0085, Fax : 82-2-6295-0085 |
| Contact: | Taesu Kwon/CEO, Email : cms@bnmedi.com |
| Date of Submission: | Aug 18, 2022 |
2. Device
| Trade/Device Name: | Bio-MEM Ti Reinforced Membrane |
|---|---|
| Common name: | Non-Resorbable Barrier Membrane |
| Regulation Number: | 21 CFR 872. 3930 |
| Regulation name: | Barrier, Synthetic, Intraoral |
| Regulation Class: | II |
| Product Code : | NPK |
3. Predicate Device
Primary Predicate Device : Neoss Ti Reinforced Membrane (K143327, Neoss, Ltd) Reference Predicate Device : Cytoplast Regentex™ Titanium 250 (K972278 ; Osteogenics Biomedical Co.,Ltd)
4. Description
Bio-MEM Ti Reinforced membranes are non-resorbable membranes available as Tireinforced configured of a highly shapeable Ti (Reinforced only) enveloped by an embossed polytetrafluoroethylene (PTFE) membrane. Extensive documentation demonstrates tissue compatibility of PTFE. Bio-MEM Ti Reinforced membranes are designed to avoid ingrowth of gingival soft tissue into bony defects, in order to facilitate the neovascularization and bone formation during the repair process of the defect. Bio-MEM Ti Reinforced membranes are provided STERILE and in different anatomical shapes and sizes. The titanium reinforcement is intended for space creating and shapemaintaining which minimize movements and subsequent exposure during the regenerative healing.
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Image /page/4/Figure/0 description: The image shows a table with the dimensions of a component labeled PM1224A. The table lists the model number, and then the dimensions A, B, C, and D in millimeters, as well as the thickness E. The dimensions for model PM1224A are: A=24.0 mm, B=12.0 mm, C=11.0 mm, D=2.5 mm, and E=0.25 mm.
Image /page/4/Figure/1 description: The image shows a diagram of a PM1424A model with labeled dimensions. The diagram includes measurements for A, B, C, D, E, and F (thickness). According to the table, the dimensions are as follows: A is 24.0 mm, B is 14.0 mm, C is 14.84 mm, D is 8.89 mm, E is 1.59 mm, and F (thickness) is 0.25 mm.
Image /page/4/Figure/2 description: The image shows a diagram of a PM1725A model with its dimensions labeled. The diagram includes measurements for A, B, C, D, E, and F (Thickness). According to the table, the dimensions are as follows: A is 25.0 mm, B is 17.0 mm, C is 18.36 mm, D is 8.83 mm, E is 2.0 mm, and F (Thickness) is 0.25 mm.
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Image /page/5/Figure/0 description: The image shows a diagram of a PM2025A model with labeled dimensions, accompanied by a table that lists the specifications. The table includes the model number PM2025A, and the dimensions A, B, C, D, and E, with corresponding values of 20.0 mm, 25.0 mm, 15.99 mm, 10.0 mm, and 1.5 mm, respectively. The thickness F is listed as 0.25.
Image /page/5/Figure/1 description: The image shows a diagram of a part with labeled dimensions, accompanied by a table providing specific measurements for two different models. The diagram labels the dimensions as A, B, C, D, E, and F. The table lists the models PM1319A and PM1318A, along with their corresponding measurements in millimeters: A(mm), B(mm), C(mm), D(mm), E(mm), and F(Thickness).
Image /page/5/Figure/2 description: The image shows a diagram of a shape with labeled dimensions, along with a table providing specific measurements for a model. The shape appears to be a rounded square, with dimensions labeled as A, B, C, D, E, and F. The table lists the model PM2530A and provides corresponding measurements: A is 30.0 mm, B is 25.0 mm, C is 17.57 mm, D is 12.65 mm, E is 1.3 mm, and F (thickness) is 0.25 mm.
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Image /page/6/Figure/0 description: The image shows a diagram of a shape with labeled dimensions, accompanied by a table providing specific measurements for two models. The diagram illustrates the shape with dimensions labeled as A, B, C, D, E, and F. The table lists the models PM3040S2 and PM3040SA, along with their corresponding measurements in millimeters: A(mm) is 30.0 for both, B(mm) is 40.0 for both, C(mm) is 22.0 and 19.0, D(mm) is 18.0 and 16.0, E(mm) is 2.0 for both, and F(Thickness) is 0.25 for both.
Image /page/6/Figure/1 description: The image shows a diagram of a PM3040A model with labeled dimensions. The diagram includes measurements for A, B, C, D, E, and F (Thickness). A table below the diagram lists the values for each dimension, with A being 40.0 mm, B being 30.0 mm, C being 26 mm, D being 20.93 mm, E being 2.22 mm, and F (Thickness) being 0.25 mm.
Image /page/6/Figure/2 description: The image shows a technical drawing of an object with labeled dimensions, accompanied by a table providing specific measurements. The table includes the model number PM2536A, along with dimensions A, B, C, D, E, and F in millimeters. The corresponding measurements are 25.0, 36.0, 15.99, 10.13, 1.5, and 0.25 respectively.
O B&Medi
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Image /page/7/Figure/0 description: The image shows a technical drawing of an object with labeled dimensions, accompanied by a table providing specific measurements. The table includes the model number PM3041A, along with dimensions A, B, C, D, E, and F in millimeters. The corresponding values are 30.0, 41.0, 18.97, 12.92, 1.4, and 0.25 respectively.
Image /page/7/Figure/1 description: The image shows a technical drawing of a part with dimensions labeled A, B, C, and D. A table below the drawing provides specific measurements for a model named PMB2431. The table indicates that for model PMB2431, A is 31.0 mm, B is 24.0 mm, C is 19.0 mm, D is 3.5 mm, and the thickness E is 0.25 mm.
Image /page/7/Figure/2 description: The image shows a technical drawing of a part with dimensions labeled A, B, C, D, and E. A table below the drawing provides specific measurements for the part, identified as model PMB2030. According to the table, dimension A is 30.0 mm, B is 20.0 mm, C is 14.7 mm, D is 8.6 mm, and the thickness (E) is 0.25 mm.
Image /page/7/Picture/3 description: The image shows the logo for B&Medi. The logo consists of a stylized symbol to the left of the text "B&Medi". The symbol appears to be an abstract representation of a medical device or a stylized heart. The text "B&Medi" is written in a sans-serif font and is dark blue.
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Image /page/8/Figure/0 description: The image shows a diagram of a part with labeled dimensions, along with a table providing specific measurements. The table includes the model number PMB2228 and lists the dimensions A, B, C, and D in millimeters, as well as the thickness E. The corresponding values are: A=28.0 mm, B=22.0 mm, C=19.3 mm, D=9.2 mm, and E=0.25.
Image /page/8/Figure/1 description: The image shows a table with the dimensions of a PMB2530S model. The table includes the model number, and the dimensions A, B, C, and D in millimeters. The thickness E is also provided. The dimensions are as follows: A is 30.0 mm, B is 25.0 mm, C is 16.8 mm, D is 10.6 mm, and the thickness E is 0.25.
| C | ||||||
|---|---|---|---|---|---|---|
| No | Model | A(mm) | B(mm) | C(mm) | D(mm) | E(Thickness) |
| 17 | PMB1319 | 19.0 | 13.0 | 14.0 | 9.0 | 0.25 |
| 18 | PMB1318 | 18.0 | 13.0 | 13.4 | 8.5 | 0.25 |
Image /page/8/Picture/3 description: The image shows the logo for B&Medi. The logo consists of a stylized symbol resembling two overlapping hearts or leaves, followed by the text "B&Medi" in a bold, sans-serif font. The color of both the symbol and the text is a dark blue.
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Image /page/9/Figure/0 description: The image shows a technical drawing of a part with dimensions labeled A, B, C, and D. A table below the drawing lists the dimensions for a specific model, PMB3338. The table indicates that for model PMB3338, dimension A is 38.0 mm, B is 33.0 mm, C is 19.8 mm, D is 14.85 mm, and the thickness E is 0.25 mm.
Image /page/9/Figure/1 description: The image shows a diagram of a PMB3040S model. The diagram includes measurements for A, B, C, D, and E. According to the table, the A measurement is 40.0 mm, B is 30.0 mm, C is 28.2 mm, D is 17.1 mm, and E (thickness) is 0.25.
Image /page/9/Figure/2 description: The image shows a diagram of a PMB3040 model with its dimensions labeled. The diagram includes labels A, B, C, D, and E, which correspond to the dimensions listed in the table below the diagram. According to the table, the PMB3040 model has the following dimensions: A(mm) = 40.0, B(mm) = 30.0, C(mm) = 26.8, D(mm) = 25.03, and E(Thickness) = 0.25.
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Image /page/10/Figure/0 description: The image shows a diagram of a part with labeled dimensions. The dimensions are labeled as A, B, C, D, and E. A table below the diagram lists the dimensions for a specific model, PMB2536. The table indicates that A is 25.0 mm, B is 36.0 mm, C is 16.59 mm, D is 10.6 mm, and E (thickness) is 0.25.
Image /page/10/Figure/1 description: The image shows a technical drawing of a part with dimensions labeled A, B, C, D, and E. A table below the drawing provides specific measurements for each dimension. According to the table, for Model PMB3041, A is 30.0 mm, B is 41.0 mm, C is 19.8 mm, D is 14.85 mm, and E (Thickness) is 0.25.
| No | Model | A(mm) | B(mm) | C(mm) | D(mm) | E(Ø) | F(Thickness) |
|---|---|---|---|---|---|---|---|
| 24 | PMB2021 | 19.8 | 20.71 | 10.7 | 13.35 | 2.7 | 0.25 |
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Image /page/11/Figure/0 description: The image shows a diagram of a PMB2325 model with various dimensions labeled A through F. The corresponding table lists the dimensions for the PMB2325 model. Dimension A is 25.16 mm, B is 23.56 mm, C is 9.15 mm, D is 14.02 mm, E is 2.7 mm, and F is 0.25 mm.
Image /page/11/Figure/1 description: The image shows a table with the dimensions of a model. The model number is PMB2029. The table lists the following dimensions: A(mm) is 19.82, B(mm) is 29, C(mm) is 9.85, D(mm) is 17, E(Ø) is 2.7, and F(Thickness) is 0.25.
Image /page/11/Figure/2 description: The image shows a diagram of a PMB2127 model with various dimensions labeled A through F. A(mm) is 21.44, B(mm) is 15.59, C(mm) is 8.91, and D(mm) is 15.59. E(Ø) is 2.7, and F(Thickness) is 0.25. The diagram includes a shape with circular patterns inside.
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| No | Model | A(mm) | B(mm) | C(mm) | D(mm) | E(Ø) | F(Thickness) |
|---|---|---|---|---|---|---|---|
| 28 | PMB2830 | 28.4 | 30 | 18.4 | 20 | 2.7 | 0.25 |
| 29 | PMB2025 | 24.9 | 20 | 14.9 | 10 | 2.7 | 0.25 |
| 30 | PMB2028 | 28.4 | 20 | 18.4 | 10 | 2.7 | 0.25 |
| 31 | PMB2530 | 24.9 | 30 | 14.9 | 20 | 2.7 | 0.25 |
5. Indication for use
Bio-MEM Ti Reinforced membranes are an implantable temporary non-resorbable device (membrane) for use as a spacer creation barrier in the treatment of local defects in the oral cavity in conjunction with tissue regeneration or augmentation. Bio-MEM Ti Reinforced membranes are intended to be submerged and clinically implanted more than 30 days and no longer than 6 months.
6. Comparison with Primary Predicate Device and Reference Predicate Device
| Subject | Subject Device | Primary Predicate Device | ReferencePredicate Device | Comment |
|---|---|---|---|---|
| ProductName | Bio-MEM Ti reinforcedMembrane | Neoss Ti-ReinforcedMembrane | Cytoplast Regentex™Titanium 250 | |
| 510(k) | K210797 | K143327 | K972278 | |
| Manufacturer | B&Medi Co., Ltd. | Neoss, Ltd | Osteogenicsbiomedical Co., Ltd | |
| Indicationsfor use | Bio-MEM Ti Reinforcedmembranes are an implantabletemporary non- resorbabledevice (membrane) for use as aspacer creation barrier in thetreatment of local defects inthe oral cavity in conjunctionwith tissue regeneration oraugmentation. Bio-MEM TiReinforced membranes areintended to be submerged andclinically implanted more than30 days and no longer than 6months. | Ti Reinforced Membrane is animplantable temporary non-resorbable device (membrane) foruse as a spacer creation barrier inthe treatment of local defects inthe oral cavity in conjunction withtissue regeneration oraugmentation. Neoss membranesare intended to be submerged andclinically implanted more than 30days with an expected duration ofimplantation up of 6 months. | A Temporarily implantablematerial (non-resorbable)for use as a space-makingbarrier in the treatment ofperiodontal defects. | Wordingis similarandprincipleofoperationis thesame |
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| Code | NPK | NPK | LYC | |
|---|---|---|---|---|
| Design | A variety of configurations.May be trimmed and shaped tofit bone defect. For furtherinformation, please see 4.Description | 5 configurations. May betrimmed and shaped to fitbone defect. | 8 configurations. May betrimmed and shaped to fit bonedefect | Geometriesare similar tothe predicateand referencedevices.Thicknessand densityare within therange ofpredicate andreferencedevices.Usage andsterilizationare the same. |
| Material | PTFE(Polytetrafluoroethylene)membranes reinforced with aTitanium frame | ePTFE and dense PTFEmembranes reinforced with aTitanium frame | High density PTFEmembranes reinforced with aTitanium frame | |
| Thickness | 0.25mm | 0.3mm | 0.23mm | |
| Density | 3.5g/d m² | 3.5g/d m² | 4.0g/d m² | |
| Usage | Single use only | Single use only | Single use only | |
| Biocompatibility | Yes | Yes | Yes | |
| Sterilization | EO Gas Sterilization | EO Gas Sterilization | EO Gas Sterilization |
7. Technological Characteristics
As summarized in the comparison Table above, the geometries of Bio-MEM Ti Reinforced membranes are similar to the primary predicate device, Neoss Ti-Reinforced Membrane and the reference device, Cytoplast Regentex™ Titanium 250 as featured in the labeling for the predicate and reference devices. The thickness and density are in the range of the predicate and reference devices. Both the subject and predicate devices are comprised of biocompatible nonresorbable PTFE and Titanium and biocompatibility tests (see 8. Performance Testing) support substantially equivalent biocompatibility. The PTFE material of Bio-MEM device is similar in density (mass/area) and thickness to both the predicate and reference devices. The dense material of the Bio-MEM membrane is similar to the Cytoplast membrane. The intended use, principle of operation, and sterilization are the same between the subject and predicate devices.
8. Performance Testing
The Bio-MEM Ti Reinforced Membrane was evaluated for Bend and Delamination Testing in order to confirm the strength, integrity and functionality of the device. Sterilization validation and packaging validation were conducted to support EO sterilization and packaging shelf-life of 5 years. Cytotoxicity, sensitization, irritation, acute systemic toxicity, material-mediated pyrogenicity, genotoxicity (AMES and micronucleus), and implantation testing support biocompatibility of the subject device.
The subject device and processes were tested according to the following standards:
- � ISO 10993-3 (2014) Biological evaluation of medical devices Part3, Test for Genotoxicity, Carcinogenicity and Reproductive Toxicity.
- � ISO 10993-5 Biological Evaluation Of Medical Devices: Test for in vitro
() B&Medi
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cytotoxicity
- � ISO 10993-6(2007) Biological evaluation of medical devices - Part 6: Tests for local effects after implantation.
- � ISO 10993-7[2008] Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals
- � ISO 10993-10 Biological evaluation of medical devices - part 10: tests for irritation and skin sensitization
- � ISO 10993-10 Biological evaluation of medical devices - part 11: tests for systemic toxicity, 5 Acute systemic toxicity
- ISO 11135 [2014] Validation and routine control of ethylene oxide sterilization �
- � ASTM D4895 - 10 Standard Specification for Polytetrafluoroethylene (PTFE) Resin Produced From Dispersion
- � ISO11607, ISO11737, ASTM F1980, ASTM F88, ASTM F1929:2012. Standards which the tests were used in the packaging validation.
- � USP 29 Biological tests <151> Pyrogen Test
9. Clinical Testing
Clinical Data was not required to establish the substantial equivalence of the Bio-MEM Ti Reinforced Membrane.
10. Conclusion
The Bio-MEM Ti Reinforced Membrane is similar to legally marketed devices listed previously in that they share similar indications for use and incorporate similar technological characteristics. All evaluations determined that the Bio-MEM Ti Reinforced Membrane is substantially equivalent to the predicate devices.
§ 872.3930 Bone grafting material.
(a)
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.(b)
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.