(267 days)
No
The 510(k) summary describes a physical barrier membrane made of PTFE and titanium. There is no mention of software, algorithms, image processing, or any terms related to AI or ML. The performance studies focus on material properties, biocompatibility, and sterilization.
Yes.
The device is used in the treatment of alveolar and periodontal bony defect sites and helps to create space for bone-derived cells to repopulate and repair the defect, directly addressing a medical condition.
No.
The device is described as a permanently implantable space-making barrier used in dental procedures, not for diagnostic purposes.
No
The device is a physical implantable membrane made of PTFE and titanium, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to be a "temporarily implantable material" used "in the treatment of alveolar and periodontal bony defect sites." This describes a device used within the body for a therapeutic purpose (space-making barrier for bone grafting).
- Device Description: The description details a physical barrier made of PTFE and titanium, designed to be placed between bone grafts and periosteum. This is a physical implant, not a device that analyzes samples from the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's condition. The device's function is purely mechanical and structural.
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
Cytoplast™ Titanium-Reinforced PTFE Membranes are a temporarily implantable material (nonresorbable) indicated for use as a space-making barrier in the treatment of alveolar and periodontal bony defect sites.
Product codes
NPK
Device Description
Cytoplast™ Titanium-Reinforced PTFE Membranes are placed between bone grafts and the periosteum in dental bone grafting procedures to stabilize and support the bone graft. The PTFE membrane helps create the space needed for bone-derived cells to repopulate and repair the defect.
Cytoplast™ Titanium-Reinforced PTFE Membranes are composed of proprietary 100% polytetrafluoroethylene sheets reinforced with a titanium frame. The titanium frame is embedded between two layers of PTFE. PTFE is biologically nearly inert and a tissue-compatible material. The PTFE membranes are designed to maintain space and conform to tissue contours.
Cytoplast™ Titanium-Reinforced PTFE Membranes are provided in two different thicknesses (approximately 150 µm & 250 µm) and are pre-shaped in a variety of shapes and sizes. Outer dimensions include:
- 12 mm x 20 mm
- . 12 mm x 24 mm
- . 12 mm x 30 mm
- 13 mm x 18 mm
- 13 mm x 19 mm
- 14 mm x 24 mm
- 17 mm x 25 mm
- . 20 mm x 25 mm
- 24 mm x 38 mm
- 25 mm x 36 mm
- 25 mm x 30 mm
- 30 mm x 41 mm
- . 30 mm x 40 mm
- . 38 mm x 38 mm
- . 40 mm x 50 mm
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
alveolar and periodontal 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 Submitted
The substantial equivalence of Cytoplast™ Titanium-Reinforced PTFE Membranes and its primary predicate was demonstrated based on in vitro characterization studies.
Non-clinical testing was performed in accordance with FDA recognized consensus standards and FDA guidelines as applicable.
A complete biocompatibility risk assessment conducted in accordance with ISO series 10993-1 demonstrated biocompatibility risks were able to be mitigated by leveraging biocompatibility testing for the reference device as they are composed of identical materials, manufacturing processes, sterilization and packaging. Biocompatibility of the subject device was confirmed with ISO 10993 testing as follows:
- . Cytotoxicity: ISO MEM Elution Assay with L-929 Mouse Fibroblast Cells
- Irritation (including Intracutaneous reactivity)
- Toxicity (acute, subacute, subchronic, chronic)
- Implantation
Sterilization validation for Ethylene Oxide was performed per ISO 11135-1:2007 to achieve a Sterility Assurance Level of 10 °. Shelf-life testing was performed in compliance with ISO 11607-1.
In vitro product characterization testing was performed to demonstrate substantial equivalence of the subject device to its primary predicate and reference devices. A series of bench tests were conducted to evaluate material and physical properties.
Tensile strength was characterized and compared to the reference device, Bio-Gide® Resorbable Bilayer Membrane, in order to establish a minimum acceptable specification. Lamination was characterized to ensure it is appropriate for the clinical application of the membranes. The comparative bench testing is summarized in the table below.
| Test | Test Method | Results |
|---|---|---|
| Tensile Strength | ASTM D638-14 | Tensile strength ≥ reference device |
| Lamination Strength | Internal | Lamination is acceptable |
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.
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Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Osteogenics Biomedical, Inc. Shane Shuttlesworth President 4620 71st St., Bldg. 78 Lubbock, Texas 79424
Re: K201187
Trade/Device Name: Cytoplast™ Titanium-Reinforced PTFE Membranes Regulation Number: 21 CFR 872.3930 Regulation Name: Bone Grafting Material Regulatory Class: Class II Product Code: NPK Dated: December 28, 2020 Received: December 28, 2020
Dear Shane Shuttlesworth:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976. the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
1
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Andrew Steen Assistant Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K201187
Device Name Cytoplast™ Titanium-Reinforced PTFE Membranes
Indications for Use (Describe)
Cytoplast™ Titanium-Reinforced PTFE Membranes are a temporarily implantable material (non- resorbable) indicated for use as a space-making barrier in the treatment of alveolar and periodontal bony defect sites.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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3
K201187 510(k) Summary
This 510(k) summary is being submitted in accordance with the requirements of 21 CFR 807.92.
l. SUBMITTER
| Applicant Name: | Osteogenics Biomedical, Inc. |
|---|---|
| Address: | 4620 71st St, Bldg. 78 |
| Lubbock, Texas 79424 | |
| Phone: | (806) 796-1923 |
| Fax: | (806) 796-0059 |
| Contact Person: | Shane Shuttlesworth |
| President | |
| Date Prepared: | January 22, 2021 |
II. DEVICE
| Trade Name: | Cytoplast™ Titanium-Reinforced PTFE Membranes |
|---|---|
| Common Name: | PTFE Membrane |
| Regulation Name: | Bone Grafting Material |
| Regulation Number: | 21 CFR 872.3930 |
| Regulatory Class: | II |
| Product Code: | NPK (Barrier, Synthetic, Intraoral) |
lll. PRIMARY PREDICATE DEVICE
Cytoplast™ Regentex™ Titanium 250 (Osteogenics Biomedical, Inc.) Primary Predicate K972278 Device:
RPM™ Reinforced PTFE Mesh (K171774) and Bio-Gide® Resorbable Bilayer Membrane (K050466) were used as a reference devices in this submission.
IV. DEVICE DESCRIPTION
Cytoplast™ Titanium-Reinforced PTFE Membranes are placed between bone grafts and the periosteum in dental bone grafting procedures to stabilize and support the bone graft. The PTFE membrane helps create the space needed for bone-derived cells to repopulate and repair the defect.
Cytoplast™ Titanium-Reinforced PTFE Membranes are composed of proprietary 100% polytetrafluoroethylene sheets reinforced with a titanium frame. The titanium frame is embedded between two layers of PTFE. PTFE is biologically nearly inert and a tissue-compatible material.
4
The PTFE membranes are designed to maintain space and conform to tissue contours.
Cytoplast™ Titanium-Reinforced PTFE Membranes are provided in two different thicknesses (approximately 150 µm & 250 µm) and are pre-shaped in a variety of shapes and sizes. Outer dimensions include:
- 12 mm x 20 mm
- . 12 mm x 24 mm
- . 12 mm x 30 mm
- 13 mm x 18 mm
- 13 mm x 19 mm
- 14 mm x 24 mm
- 17 mm x 25 mm
- . 20 mm x 25 mm
- 24 mm x 38 mm
- 25 mm x 36 mm
- 25 mm x 30 mm
- 30 mm x 41 mm
- . 30 mm x 40 mm
- . 38 mm x 38 mm
- . 40 mm x 50 mm
V. INDICATIONS FOR USE
Cytoplast™ Titanium-Reinforced PTFE Membranes are a temporarily implantable material (nonresorbable) indicated for use as a space-making barrier in the treatment of alveolar and periodontal bony defect sites.
VI. COMPARISON OF INDICATIONS FOR USE WITH THE PRIMARY PREDICATE DEVICE
The term "alveolar defects" has been added to the indication for use for the subject device. The term "alveolar defects" includes any bony defect found within the alveolus, both in the mandible and the maxilla. Using the term alveolar defects focuses the indication on the location of the defect rather than the etiology of bone loss and still aligns with how the devices are being used clinically.
VII. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICES
Cytoplast™ Titanium-Reinforced PTFE Membranes are substantially equivalent to the primary predicate device, Cytoplast™ Regentex™ Titanium 250. Cytoplast™ Titanium-Reinforced PTFE Membranes are identical in design, function, composition, biocompatibility, sterilization, sizes, packaging, shelf life, physical properties, and intended use to the legally marketed primary predicate device, Cytoplast™ Regentex™ Titanium 250. See comparison table below:
5
| | Cytoplast™
Titanium-
Reinforced PTFE
Membranes
(K201187)
Osteogenics
Biomedical, Inc. | Cytoplast™
Regentex™
Titanium 250
(K972278)
Osteogenics
Biomedical, Inc. | RPM™ Reinforced
PTFE Mesh
(K171774)
Osteogenics
Biomedical, Inc. | Bio-Gide®
Resorbable Bilayer
Membrane
(K050466)
Geistlich, Pharma |
|----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Code | NPK | LYC | NPK | NPL |
| Indications for
Use | A temporarily
implantable
material (non-
resorbable)
indicated for use as
a space-making
barrier in the
treatment of
alveolar and
periodontal bony
defect sites.
Rx Only | A temporarily
implantable
material (non-
resorbable) for use
as a space-making
barrier in the
treatment of
periodontal
defects.
Rx Only | For stabilization
and support of
bone grafts in
alveolar bony
defect sites.
Rx Only | Simultaneous use
of GBR-membrane
and implants;
augmentation
around
implants placed in
immediate
extraction sockets;
augmentation
around
implants placed in
delayed extraction
sockets; localized
ridge
augmentation for
later implantation;
alveolar ridge
reconstruction for
prosthetic
treatment; filling of
bone defects after
root resection,
cystectomy,
removal of retained
teeth; guided bone
regeneration in
dehiscence defects;
guided tissue
regeneration
procedures in
periodontal
defects.
Rx Only |
| Operational
Principles | Cytoplast™
Titanium-
Reinforced PTFE
Membranes are
placed between
bone grafts and the
periosteum in
dental bone
grafting procedures
to stabilize and
support the bone | Cytoplast™
Regentex™
Titanium 250 is
placed between
bone grafts and the
periosteum in
dental bone
grafting procedures
to stabilize and
support the bone
grafting | RPM™ Reinforced
PTFE Mesh is
placed between
bone grafts and the
periosteum in
dental bone
grafting procedures
to stabilize and
support the bone
graft. The PTFE | BIO-GIDE®
resorbable bilayer
membrane is for
guided tissue and
bone regeneration. |
| | support the bone
graft. The PTFE
membrane isolates
the space needed
for bone-derived
cells to repopulate
and repair the
defect. | graft. The PTFE
membrane isolates
the space needed
for bone-derived
cells to repopulate
and repair the
defect. | mesh helps create
the space needed
for bone-derived
cells to repopulate
and repair the
defect. | |
| Design | Titanium frame
embedded
between two layers
of PTFE. Titanium
frame may be
trimmed and
shaped to create
additional space for
bone growth. | Titanium frame
embedded
between two layers
of PTFE. Titanium
frame may be
trimmed and
shaped to create
additional space for
bone growth. | Titanium frame
embedded
between two layers
of PTFE. Titanium
frame may be
trimmed and
shaped to create
additional space for
bone growth.
Macropores allow
direct contact
between the bone
graft and the
periosteum. Direct
contact between
the periosteum and
bone graft allows
naturally occurring
revascularization
and infiltration of
cells. | Resorbable bilayer
membrane
composed of
collagen type I and
type III without
further cross-
linking or chemical
treatment. The
porous surface -
facing the bone -
allows the ingrowth
of bone forming
cells. The dense
surface - facing
the soft tissue -
prevents the
ingrowth of fibrous
tissue into the
bone defect. |
| Composition | 100% PTFE,
Titanium | 100% PTFE,
Titanium | 100% PTFE,
Titanium | Type I and Type III
Collagen |
| Use | Single | Single | Single | Single |
| Shelf Life | 4 years | 4 years | 4 years | Unknown |
| Biocompatible | Yes | Yes | Yes | Yes |
| Sterilization | Sterile | Sterile | Sterile | Sterile |
| Model Sizes | Various | Various | Various | Various |
| Maximum
Duration of
Implantation | 12 months | Not Stated | 12 months | Unknown |
6
RPM™ Reinforced PTFE Mesh is being used as a reference device to leverage biocompatibility testing performed on this device as applicable to the subject device, Cytoplast™ Titanium-Reinforced PTFE Membranes, since these devices are identical for the purposes of these tests.
The tensile specification for the Cytoplast™ Titanium-Reinforced PTFE Membranes has been selected based off of the reference device, Bio-Guide® Resorbable Bilayer Membrane.
7
VIII. PERFORMANCE DATA
Nonclinical Tests Submitted
The substantial equivalence of Cytoplast™ Titanium-Reinforced PTFE Membranes and its primary predicate was demonstrated based on in vitro characterization studies.
Non-clinical testing was performed in accordance with FDA recognized consensus standards and FDA guidelines as applicable.
A complete biocompatibility risk assessment conducted in accordance with ISO series 10993-1 demonstrated biocompatibility risks were able to be mitigated by leveraging biocompatibility testing for the reference device as they are composed of identical materials, manufacturing processes, sterilization and packaging. Biocompatibility of the subject device was confirmed with ISO 10993 testing as follows:
- . Cytotoxicity: ISO MEM Elution Assay with L-929 Mouse Fibroblast Cells
- Irritation (including Intracutaneous reactivity)
- Toxicity (acute, subacute, subchronic, chronic)
- Implantation
Sterilization validation for Ethylene Oxide was performed per ISO 11135-1:2007 to achieve a Sterility Assurance Level of 10 °. Shelf-life testing was performed in compliance with ISO 11607-1.
In vitro product characterization testing was performed to demonstrate substantial equivalence of the subject device to its primary predicate and reference devices. A series of bench tests were conducted to evaluate material and physical properties.
Tensile strength was characterized and compared to the reference device, Bio-Gide® Resorbable Bilayer Membrane, in order to establish a minimum acceptable specification. Lamination was characterized to ensure it is appropriate for the clinical application of the membranes. The comparative bench testing is summarized in the table below.
| Test | Test Method | Results |
|---|---|---|
| Tensile Strength | ASTM D638-14 | Tensile strength ≥ reference device |
| Lamination Strength | Internal | Lamination is acceptable |
IX. CONCLUSION
The results of in vitro device characterization tests show that the subject device, Cytoplast™ Titanium-Reinforced PTFE Membranes, is substantially equivalent to the primary predicate and reference devices. ISO 10993 testing confirms the biocompatibility of the subject device. Tensile strength testing shows that the subject device is at least as strong as the reference device, Bio-Gide®. Lamination tests show that the subject device is acceptable for its clinical application.