RPM Reinforced PTFE Mesh

K171774 · Osteogenics Biomedical, Inc. · NPK · Oct 19, 2017 · Dental

Device Facts

• Record ID: K171774
• Device Name: RPM Reinforced PTFE Mesh
• Applicant: Osteogenics Biomedical, Inc.
• Product Code: NPK · Dental
• Decision Date: Oct 19, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3930
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

RPM™ Reinforced PTFE Mesh is a temporarily implantable material (non-resorbable) indicated for stabilization and support of bone grafts in alveolar bony defect sites.

Device Story

RPM™ Reinforced PTFE Mesh is a temporarily implantable, non-resorbable barrier used in dental bone grafting. It consists of a titanium frame embedded between two layers of polytetrafluoroethylene (PTFE) sheets. The device is placed between the bone graft and the periosteum to stabilize the graft and maintain space for bone-derived cell repopulation and repair. It features circular 0.66 mm diameter macropores to facilitate direct contact between the graft and periosteum, promoting revascularization and cell infiltration. The mesh is provided pre-shaped in various sizes and can be trimmed by the clinician to conform to tissue contours. It is intended for use by dental professionals in clinical settings. By maintaining space and providing structural support, the device aids in the successful regeneration of bone in alveolar defects.

Clinical Evidence

Bench testing only. No clinical data presented. In vitro characterization included tensile strength (ASTM D638-14), lamination strength, and suture retention force, demonstrating performance at least equivalent to reference devices. Biocompatibility testing confirmed the device is non-cytotoxic (ISO 10993-5) and non-irritant (ISO 10993-10).

Technological Characteristics

Materials: 100% polytetrafluoroethylene (PTFE) and titanium frame. Design: Titanium frame embedded between two PTFE layers with 0.66 mm diameter macropores. Form factor: Pre-shaped sheets in various dimensions. Sterilization: Sterile. Biocompatibility: Compliant with ISO 10993-1.

Indications for Use

Indicated for stabilization and support of bone grafts in alveolar 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

• Osteo-Mesh™ TM-300 (K984230)

Reference Devices

• Cytoplast™ Regentex™ Titanium 250 (K972278)
• Bio-Gide® Resorbable Bilayer Membrane (K050466)

Submission Summary (Full Text)

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October 19, 2017

Osteogenics Biomedical, Inc. Shane Shuttlesworth President 4620 71st St. Bldg. 78-79 Lubbock, Texas 79424

Re: K171774

Trade/Device Name: RPM Reinforced PTFE Mesh Regulation Number: 21 CFR 872.3930 Regulation Name: Bone Grafting Material Regulatory Class: Class II Product Code: NPK Dated: June 14, 2017 Received: June 14, 2017

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. 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.

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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education (DICE) at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevicesforYou/Industry/default.htm. 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education (DICE) at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

Mary S. Runner -S

for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K171774

Device Name RPM™ Reinforced PTFE Mesh

Indications for Use (Describe)

RPM™ Reinforced PTFE Mesh is a temporarily implantable material (non-resorbable) indication and support of bone grafts in alveolar 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)

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## 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<br>Lubbock, Texas 79424 |
| Phone: | [phone] |
| Fax: | [phone] |
| Contact Person: | Shane Shuttlesworth<br>President |
| Date Prepared: | May 10, 2017 |

#### II. DEVICE

| Trade Name: | RPM™ Reinforced PTFE Mesh |
|--------------------|-------------------------------------|
| Common Name: | PTFE Mesh |
| Regulation Number: | 21 CFR 872.3930 |
| Regulation Name: | Bone Grafting Material |
| Regulatory Class: | II |
| Product Code: | NPK (Barrier, Synthetic, Intraoral) |

#### lll. PREDICATE DEVICE

| Predicate Device: | Osteo-Mesh™ TM-300 (Osteogenics Biomedical, Inc. |
|-------------------|--------------------------------------------------|
| | K984230 |

Cytoplast™ Regentex™ Titanium 250 (K972278) and Bio-Gide® Resorbable Bilayer Membrane (K050466) were used as a reference devices in this submission.

#### IV. DEVICE DESCRIPTION

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 mesh helps create the space needed for bone-derived cells to repopulate and repair the defect.

RPM™ Reinforced PTFE Mesh is composed of proprietary 100% polytetrafluoroethylene sheets reinforced with a titanium frame. The titanium frame is embedded between two layers of PTFE. PTFE is a biologically inert and tissue-compatible material. RPM™ Reinforced PTFE Mesh is manufactured with circular 0.66 mm diameter macropores to allow direct contact between the

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bone graft and the periosteum. Direct contact between the periosteum and bone graft allows naturally occurring revascularization and infiltration of cells.

The PTFE mesh is designed to maintain space and conform to tissue contours.

RPM™ Reinforced PTFE Mesh is provided pre-shaped in a variety of shapes and sizes. Outer dimensions include:

- 12 mm x 24 mm
- 14 mm x 24 mm
- 17 mm x 25 mm
- 20 mm x 25 mm
- 25 mm x 36 mm
- 25 mm x 30 mm
- 30 mm x 41 mm
- . 24 mm x 38 mm
- 30 mm x 40 mm
- 13 mm x 18 mm
- . 13 mm x 19 mm

### V. INDICATIONS FOR USE

RPM™ Reinforced PTFE Mesh is a temporarily implantable material (non-resorbable) indicated for stabilization and support of bone grafts in alveolar bony defect sites.

### VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

RPM™ Reinforced PTFE Mesh is substantially equivalent to the predicate device, Osteo-Mesh™ TM-300, and the reference device, Cytoplast™ Regentex™ Titanium 250. RPM™ Reinforced PTFE Mesh is identical in design, function, and intended use to the legally marketed predicate device Osteo-Mesh™ TM-300. RPM™ Reinforced PTFE Mesh is identical in composition,

biocompatibility, sterilization, model sizes, packaging, shelf life, physical properties, and intended use to the legally marketed reference device Cytoplast™ Titanium 250. See comparison table below:

| | RPM™ Reinforced<br>PTFE Mesh | Osteo-Mesh™ TM-300<br>(K984230) | Cytoplast™ Regentex™<br>Titanium 250<br>(K972278) |
|------------------------|-------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|
| | Osteogenics Biomedical,<br>Inc. | Osteogenics Biomedical,<br>Inc. | Osteogenics Biomedical,<br>Inc. |
| Product Code | NPK | LEY | LYC |
| Indications for<br>Use | For stabilization and<br>support of bone grafts in<br>alveolar bony defect<br>sites.<br>Rx Only | For stabilization and<br>support of bone grafts in<br>dento-alveolar bony<br>defect sites.<br>Rx Only | A temporarily<br>implantable material<br>(non-resorbable for use<br>as a space-making<br>barrier in the treatment<br>of periodontal defects.<br> |
| | | | Rx Only |
| | | | Rx Only |
| Operational | RPM™ Reinforced PTFE | Osteo-Mesh™ TM-300 is | Cytoplast™ Regentex™ |
| Principles | Mesh is placed between | placed between bone | Titanium 250 is placed |
| | bone grafts and the | grafts and the | between bone grafts and |
| | periosteum in dental | periosteum in dental | the periosteum in dental |
| | bone grafting procedures | bone grafting procedures | bone grafting procedures |
| | to stabilize and support | to stabilize and support | to stabilize and support |
| | the bone graft. The PTFE | the bone graft. The PTFE | the bone graft. The PTFE |
| | mesh helps create the | mesh helps create the | mesh isolates the space |
| | space needed for bone- | space needed for bone- | needed for bone-derived |
| | derived cells to | derived cells to | cells to repopulate and |
| | repopulate and repair | repopulate and repair | repair the defect. |
| | the defect. | the defect. | |
| Design | Titanium frame | Titanium mesh may be | Titanium frame |
| | embedded between two | trimmed and shaped to | embedded between two |
| | layers of PTFE. Titanium | create additional space | layers of PTFE. Titanium |
| | frame may be trimmed | for bone growth. | frame may be trimmed |
| | and shaped to create | Macropores allow direct | and shaped to create |
| | additional space for | contact between the | additional space for |
| | bone growth. | bone graft and the | bone growth. |
| | Macropores allow direct | periosteum. Direct | |
| | contact between the | contact between the | |
| | bone graft and the | periosteum and bone | |
| | periosteum. Direct | graft allows naturally | |
| | contact between the | occurring | |
| | periosteum and bone | revascularization and | |
| | graft allows naturally | infiltration of cells. | |
| | occurring | | |
| | revascularization and | | |
| | infiltration of cells. | | |
| | | | |
| Composition | 100% PTFE, | Titanium | 100% PTFE, |
| | Titanium | | Titanium |
| Pores | Macro | Macro | Micro |
| Use | Single | Single | Single |
| Shelf Life | 4 years | N/A | 4 years |
| Biocompatible | Yes | Yes | Yes |
| Sterilization | Sterile | Non-Sterile | Sterile |
| Model Sizes | Various | Various | Various |
| Maximum | 12 months | Not Stated | Not Stated |
| Duration of | | | |
| Implantation | | | |

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#### PERFORMANCE DATA VII.

## Nonclinical Tests Submitted

The substantial equivalence of RPM™ Reinforced PTFE Mesh and its predicate was demonstrated based on in vitro characterization studies, biocompatibility studies, and clinical history of the reference devices.

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Non-clinical testing was performed in accordance with FDA recognized consensus standards and FDA guidelines as follows:

In vitro product characterization testing was performed to demonstrate substantial equivalence of the subject device to its reference devices. A series of bench tests were conducted to evaluate material properties, biological properties, chemical 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 strength and suture retention force were characterized and compared to the reference device, Cytoplast™ Regentex™ Titanium 250.

| Test | Test Method | Results |
|------------------------|--------------|-------------------------------------------|
| Tensile Strength | ASTM D638-14 | Tensile strength ≥ reference device |
| Lamination Strength | Internal | Lamination strength ≥ reference device |
| Suture Retention Force | Internal | Suture retention force ≥ reference device |

The comparative bench testing is summarized in the table below.

In vitro biocompatibility testing was performed to assess biocompatibility of the RPM™ Reinforced PTFE Mesh as an implantable material.

The subject device passed the following FDA Blue Book Memorandum G95-1 and ISO 10993-1 testing for the biological evaluation of medical devices.

| Test | Test Method/Model | Results |
|--------------|-------------------------------------------------------------------------|---------------|
| Cytotoxicity | ISO MEM Elution Assay with L-929<br>Mouse Fibroblast Cells, ISO 10993-5 | Non-cytotoxic |
| Irritation | Oral Mucosa Irritation, ISO 10993-10 | Non-irritant |

### VIII. CONCLUSION

The results of in vitro device characterization tests show that the subject device, RPM™ Reinforced PTFE Mesh, is substantially equivalent to the predicate device or reference devices. Tensile strength testing shows that the subject device is at least as strong, statistically, as the reference device, Bio-Gide®. Lamination strength and suture retention force tests show that the subject device is at least as strong, statistically, as the reference device, Cytoplast™ Titanium 250. Biocompatibility testing demonstrated that the subject device is non-cytotoxic and a non-irritant.