(127 days)
No
The device description and performance studies focus on the material properties and mechanical characteristics of the PTFE mesh and titanium frame, with no mention of AI or ML algorithms for analysis, diagnosis, or treatment.
No
The device is a temporarily implantable material used to stabilize and support bone grafts, aiding in the natural repair process of alveolar bony defects, rather than directly providing a therapeutic (treatment or cure) action itself.
No
The device is a temporarily implantable material designed to support bone grafts and maintain space for tissue regeneration, not to diagnose medical conditions.
No
The device description clearly states it is a physical mesh made of PTFE and titanium, intended for surgical implantation. It is a hardware device, 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 a "temporarily implantable material" for "support of bone grafts in alveolar bony defect sites." This describes a device used in vivo (within the body) for a structural and supportive purpose during a surgical procedure.
- Device Description: The description details a physical mesh made of PTFE and titanium, designed to be placed between tissues to create space and support bone grafts. This is consistent with an implantable medical device, not a diagnostic test performed in vitro (outside the body) on biological samples.
- Lack of IVD Characteristics: There is no mention of the device being used to analyze biological samples (like blood, urine, tissue), detect specific substances, or provide diagnostic information about a patient's health status.
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
RPM™ Reinforced PTFE Mesh is a temporarily implantable material (non-resorbable) indication and support of bone grafts in alveolar bony defect sites.
Product codes
NPK
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 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
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
alveolar bony defect sites
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
Nonclinical Tests:
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.
Non-clinical testing was performed in accordance with FDA recognized consensus standards and FDA guidelines.
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: Tensile Strength, Test Method: ASTM D638-14, Results: Tensile strength ≥ reference device
Test: Lamination Strength, Test Method: Internal, Results: Lamination strength ≥ reference device
Test: Suture Retention Force, Test Method: Internal, Results: Suture retention force ≥ reference device
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: Cytotoxicity, Test Method/Model: ISO MEM Elution Assay with L-929 Mouse Fibroblast Cells, ISO 10993-5, Results: Non-cytotoxic
Test: Irritation, Test Method/Model: Oral Mucosa Irritation, ISO 10993-10, Results: Non-irritant
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
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.
1
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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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
2
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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3
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: | 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
4
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
PTFE Mesh | Osteo-Mesh™ TM-300
(K984230) | Cytoplast™ Regentex™
Titanium 250
(K972278) |
|------------------------|-------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|
| | Osteogenics Biomedical,
Inc. | Osteogenics Biomedical,
Inc. | Osteogenics Biomedical,
Inc. |
| Product Code | NPK | LEY | LYC |
| Indications for
Use | For stabilization and
support of bone grafts in
alveolar bony defect
sites.
Rx Only | For stabilization and
support of bone grafts in
dento-alveolar 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 |
| | | | 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 | | | |
5
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.
6
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 | |
| 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.