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.

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.

AI/ML Overview

The provided text describes a 510(k) summary for a medical device and does not contain information about an AI/ML powered device, a comparative effectiveness study, or details related to establishing ground truth for a test set in the context of an AI/ML device.

Therefore, I cannot provide the requested information in the format of a table for acceptance criteria and device performance as it pertains to AI/ML or a study that proves a device meets AI/ML specific acceptance criteria. The document describes a traditional medical device (Cytoplast™ Titanium-Reinforced PTFE Membranes) and its substantial equivalence to predicate devices based on non-clinical testing.

Here's a breakdown of what can be extracted in relation to the questions asked, adapted to the context of the provided document:

Acceptance Criteria and Device Performance (Non-AI/ML context)

Acceptance Criteria (Bench Tests)	Reported Device Performance (Cytoplast™ Titanium-Reinforced PTFE Membranes)
Biocompatibility (per ISO 10993)	Confirmed (Cytotoxicity, Irritation, Toxicity, Implantation)
Sterility Assurance Level (per ISO 11135-1:2007)	Achieved 10⁻⁶ SAL
Shelf-life (per ISO 11607-1)	Met (4 years)
Tensile Strength (per ASTM D638-14)	Tensile strength ≥ reference device (Bio-Gide® Resorbable Bilayer Membrane)
Lamination Strength (Internal Test)	Lamination is acceptable

Further Details (where applicable to the provided document):

Sample size used for the test set and the data provenance: Not applicable in the context of AI/ML. The "test set" here refers to the samples of the Cytoplast™ Titanium-Reinforced PTFE Membranes subjected to various non-clinical bench tests (e.g., for tensile strength, lamination). Specific sample sizes for each test are not explicitly stated in the summary, but the tests were performed on the device itself.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth as typically understood for AI/ML models (e.g., expert-labeled images) is not relevant here. The "truth" for these non-clinical tests is determined by standardized protocols (e.g., ASTM D638-14 for tensile strength) and material characterization.
Adjudication method for the test set: Not applicable. This document describes physical and material property testing, not subjective assessment requiring adjudication.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is not an AI/ML device, and no MRMC study was conducted.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is not an AI/ML device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable in the AI/ML sense. The "ground truth" for the non-clinical tests is established by industry standards, physical measurements, and chemical/biological assays. For instance, biocompatibility is evaluated against established ISO 10993 cytotoxicity, irritation, and toxicity standards. Tensile strength is objectively measured.
The sample size for the training set: Not applicable. There is no AI/ML model involved, and therefore no training set.
How the ground truth for the training set was established: Not applicable.

Summary

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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.

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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 (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

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Indications for Use

510(k) Number (if known) K201187

Device Name Cytoplast™ Titanium-Reinforced PTFE Membranes

Indications for Use (Describe)

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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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. 78Lubbock, Texas 79424
Phone:	(806) 796-1923
Fax:	(806) 796-0059
Contact Person:	Shane ShuttlesworthPresident
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

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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:

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	Cytoplast™Titanium-Reinforced PTFEMembranes(K201187)OsteogenicsBiomedical, Inc.	Cytoplast™Regentex™Titanium 250(K972278)OsteogenicsBiomedical, Inc.	RPM™ ReinforcedPTFE Mesh(K171774)OsteogenicsBiomedical, Inc.	Bio-Gide®Resorbable BilayerMembrane(K050466)Geistlich, Pharma
Product Code	NPK	LYC	NPK	NPL
Indications forUse	A temporarilyimplantablematerial (non-resorbable)indicated for use asa space-makingbarrier in thetreatment ofalveolar andperiodontal bonydefect sites.Rx Only	A temporarilyimplantablematerial (non-resorbable) for useas a space-makingbarrier in thetreatment ofperiodontaldefects.Rx Only	For stabilizationand support ofbone grafts inalveolar bonydefect sites.Rx Only	Simultaneous useof GBR-membraneand implants;augmentationaroundimplants placed inimmediateextraction sockets;augmentationaroundimplants placed indelayed extractionsockets; localizedridgeaugmentation forlater implantation;alveolar ridgereconstruction forprosthetictreatment; filling ofbone defects afterroot resection,cystectomy,removal of retainedteeth; guided boneregeneration indehiscence defects;guided tissueregenerationprocedures inperiodontaldefects.Rx Only
OperationalPrinciples	Cytoplast™Titanium-Reinforced PTFEMembranes areplaced betweenbone grafts and theperiosteum indental bonegrafting proceduresto stabilize andsupport the bone	Cytoplast™Regentex™Titanium 250 isplaced betweenbone grafts and theperiosteum indental bonegrafting proceduresto stabilize andsupport the bonegrafting	RPM™ ReinforcedPTFE Mesh isplaced betweenbone grafts and theperiosteum indental bonegrafting proceduresto stabilize andsupport the bonegraft. The PTFE	BIO-GIDE®resorbable bilayermembrane is forguided tissue andbone regeneration.
	support the bonegraft. The PTFEmembrane isolatesthe space neededfor bone-derivedcells to repopulateand repair thedefect.	graft. The PTFEmembrane isolatesthe space neededfor bone-derivedcells to repopulateand repair thedefect.	mesh helps createthe space neededfor bone-derivedcells to repopulateand repair thedefect.
Design	Titanium frameembeddedbetween two layersof PTFE. Titaniumframe may betrimmed andshaped to createadditional space forbone growth.	Titanium frameembeddedbetween two layersof PTFE. Titaniumframe may betrimmed andshaped to createadditional space forbone growth.	Titanium frameembeddedbetween two layersof PTFE. Titaniumframe may betrimmed andshaped to createadditional space forbone growth.Macropores allowdirect contactbetween the bonegraft and theperiosteum. Directcontact betweenthe periosteum andbone graft allowsnaturally occurringrevascularizationand infiltration ofcells.	Resorbable bilayermembranecomposed ofcollagen type I andtype III withoutfurther cross-linking or chemicaltreatment. Theporous surface -facing the bone -allows the ingrowthof bone formingcells. The densesurface - facingthe soft tissue -prevents theingrowth of fibroustissue into thebone defect.
Composition	100% PTFE,Titanium	100% PTFE,Titanium	100% PTFE,Titanium	Type I and Type IIICollagen
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
MaximumDuration ofImplantation	12 months	Not Stated	12 months	Unknown

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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.

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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.

Regulation Number and Section

§ 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.