(520 days)
No
The description focuses on the material properties and mechanical function of a physical implantable membrane, with no mention of software, algorithms, or data processing.
Yes
The device is described as an implantable temporary device used in the treatment of local defects in the oral cavity in conjunction with tissue regeneration or augmentation, which aims to facilitate healing and improve tissue function.
No
Explanation: The provided text describes an implantable membrane used as a spacer creation barrier to facilitate tissue regeneration and bone formation. It does not mention any function related to identifying, measuring, or monitoring a disease or condition.
No
The device description clearly states it is an implantable membrane made of PTFE and titanium, which are physical materials, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is 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." This describes a device that is physically implanted into the body to perform a structural function.
- Device Description: The description details the physical composition of the membrane (PTFE and titanium reinforcement) and its mechanism of action (avoiding soft tissue ingrowth to facilitate bone formation). This is consistent with an implantable medical device, not a diagnostic test performed on samples outside the body.
- Lack of IVD Characteristics: There is no mention of the device being used to analyze biological samples (blood, urine, tissue, etc.) to provide diagnostic information about a patient's condition. The device itself is the treatment/support mechanism.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications 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.
Product codes
NPK
Device 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
oral cavity
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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.
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.
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.
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
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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3
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.
4
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.
5
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.
6
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.
8
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.
9
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.
10
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.
12
| 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 | Reference
Predicate Device | Comment |
|------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------|
| Product
Name | Bio-MEM Ti reinforced
Membrane | Neoss Ti-Reinforced
Membrane | Cytoplast Regentex™
Titanium 250 | |
| 510(k) | K210797 | K143327 | K972278 | |
| Manufacturer | B&Medi Co., Ltd. | Neoss, Ltd | Osteogenics
biomedical Co., Ltd | |
| Indications
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. | Ti Reinforced Membrane is 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. Neoss membranes
are intended to be submerged and
clinically implanted more than 30
days with an expected duration of
implantation up of 6 months. | A Temporarily implantable
material (non-resorbable)
for use as a space-making
barrier in the treatment of
periodontal defects. | Wording
is similar
and
principle
of
operation
is the
same |
13
| Code | NPK | NPK | LYC | |
|---|---|---|---|---|
| Design | A variety of configurations. | |||
| May be trimmed and shaped to | ||||
| fit bone defect. For further | ||||
| information, please see 4. | ||||
| Description | 5 configurations. May be | |||
| trimmed and shaped to fit | ||||
| bone defect. | 8 configurations. May be | |||
| trimmed and shaped to fit bone | ||||
| defect | Geometries | |||
| are similar to | ||||
| the predicate | ||||
| and reference | ||||
| devices. | ||||
| Thickness | ||||
| and density | ||||
| are within the | ||||
| range of | ||||
| predicate and | ||||
| reference | ||||
| devices. | ||||
| Usage and | ||||
| sterilization | ||||
| are the same. | ||||
| Material | PTFE | |||
| (Polytetrafluoroethylene) | ||||
| membranes reinforced with a | ||||
| Titanium frame | ePTFE and dense PTFE | |||
| membranes reinforced with a | ||||
| Titanium frame | High density PTFE | |||
| membranes reinforced with a | ||||
| Titanium 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 | |
| Biocompa | ||||
| tibility | Yes | Yes | Yes | |
| Sterilizati | ||||
| on | 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
14
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 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.