(288 days)
No
The summary describes a physical dental mesh device and its mechanical and biological testing, with no mention of software, algorithms, or AI/ML capabilities.
No
The device is described as dental membranes intended for permanent fixation to reconstruct and augment alveolar ridges, which are structural and supportive functions, not therapeutic.
No.
Explanation: The device is intended for stabilization and support of bone grafts, reconstruction, and augmentation of alveolar ridges, which are therapeutic and reconstructive functions, not diagnostic.
No
The device description clearly states it is a "system of dental membranes" and mentions physical characteristics like size, shape, and the ability to be contoured. It also describes non-clinical testing related to mechanical properties, biocompatibility, sterilization, and shelf life, all indicative of a physical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The OsteoSync™ Ti Dental Mesh is a physical implantable device (dental mesh) intended for surgical use to stabilize and support bone grafts. It is not used to analyze samples from the body.
- Intended Use: The intended use is for surgical reconstruction and augmentation of bone, not for diagnostic testing.
Therefore, the OsteoSync™ Ti Dental Mesh falls under the category of a surgical implant or device, not an in vitro diagnostic.
N/A
Intended Use / Indications for Use
The OsteoSync™ Ti Dental Mesh is intended for stabilization and support of bone grafts in dento-alveolar bony defect sites.
Product codes
JEY
Device Description
The OsteoSync™ Ti Dental Mesh is a system of dental membranes intended for permanent fixation in adults and designed to aid in the reconstruction and augmentation of the alveolar ridges of the maxilla and mandible. They are available in a variety of sizes and shapes and can be contoured to accommodate the individual anatomic and clinical circumstances of each patient. The implants are sold sterile.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
dento-alveolar bony defect sites, alveolar ridges of the maxilla and mandible
Indicated Patient Age Range
adults
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical Testing: Mechanical testing - worst case devices were evaluated per ASTM F564. Biocompatibility evaluation was leveraged from an FDA authorized master file. Sterilization validation was performed using gamma radiation and Method VDmax, in accordance with ISO 11137-1 and ISO 11137-2. Shelf life validation - sterile integrity was verified by visual, seal strength and seal integrity evaluations in accordance with ASTM F1886, ASTM F88, ASTM F1929 and ASTM F2096. Pyrogenicity - Bacterial endotoxin testing (specifically Limulus amebocyte lysate, LAL) was performed per ANSI/AAMI ST72. Preclinical animal studies in a canine model were relied upon to establish substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Neo Titanium mesh and CTi-mem (neobiotech Co., Ltd – K111761)
Reference Device(s)
SMARTbuilder System (OSSTEM Implant Co., Ltd – K130840), TraumaOne (Biomet Microfixation - the K081067), BoniPlus Dental G-Mesh System (MontJade Engineering Co., Ltd – K182759)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.4760 Bone plate.
(a)
Identification. A bone plate is a metal device intended to stabilize fractured bone structures in the oral cavity. The bone segments are attached to the plate with screws to prevent movement of the segments.(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the agency's name, "U.S. Food & Drug Administration."
Sites Medical, LLC % Karen Warden President BackRoads Consulting Po Box 566 Chesterland, Ohio 44026
July 14, 2021
Re: K202918
Trade/Device Name: OsteoSync™ Ti Dental Mesh Regulation Number: 21 CFR 872.4760 Regulation Name: Bone Plate Regulatory Class: Class II Product Code: JEY Dated: June 15, 2021 Received: June 16, 2021
Dear Karen Warden:
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.
for 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)
Device Name OsteoSync™ Ti Dental Mesh
Indications for Use (Describe)
The OsteoSync™ Ti Dental Mesh is intended for stabilization and support of bone grafts in dento-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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
510(k) Summary
| Date: | 14 July 2021 |
|---|---|
| Sponsor: | Sites Medical, LLC |
| 5865 E State Road 14 | |
| Columbia City, IN 46725 | |
| Office: 260.625.3347 | |
| Sponsor Contact: | Greg Stalcup, President/CEO |
| 510(k) Contact: | Karen E. Warden, PhD |
| BackRoads Consulting Inc. | |
| PO Box 566 | |
| Chesterland, OH 44026 | |
| Office: 440.729.8457 | |
| Trade Name: | OsteoSync™ Ti Dental Mesh |
| Common Name: | Bone plate |
| Regulatory Class: | Class II |
| Regulation Name, | |
| Regulation, Product | |
| Code: | Bone plate, 872.4760, JEY |
| Device Description: | The OsteoSync™ Ti Dental Mesh is a system of dental membranes intended |
| for permanent fixation in adults and designed to aid in the reconstruction and | |
| augmentation of the alveolar ridges of the maxilla and mandible. They are | |
| available in a variety of sizes and shapes and can be contoured to | |
| accommodate the individual anatomic and clinical circumstances of each | |
| patient. The implants are sold sterile. | |
| Indications for Use: | The OsteoSync™ Ti Dental Mesh is intended for stabilization and support of |
| bone grafts in dento-alveolar bony defect sites. | |
| Materials: | The OsteoSync™ Ti Dental Mesh implants are manufactured from Grade 2 |
| titanium as described by ASTM F67. | |
| Primary Predicate: | Neo Titanium mesh and CTi-mem (neobiotech Co., Ltd – K111761) |
| Reference Devices: | SMARTbuilder System (OSSTEM Implant Co., Ltd – K130840), TraumaOne |
| (Biomet Microfixation - the K081067), BoniPlus Dental G-Mesh System | |
| (MontJade Engineering Co., Ltd – K182759) | |
| Non-clinical Testing: | Mechanical testing - worst case devices were evaluated per ASTM F564. |
| Biocompatibility evaluation was leveraged from an FDA authorized master file. | |
| Sterilization validation was performed using gamma radiation and Method | |
| VDmax, in accordance with ISO 11137-1 and ISO 11137-2. | |
| Shelf life validation - sterile integrity was verified by visual, seal strength and | |
| seal integrity evaluations in accordance with ASTM F1886, ASTM F88, ASTM | |
| F1929 and ASTM F2096. | |
| Pyrogenicity - Bacterial endotoxin testing (specifically Limulus amebocyte | |
| lysate, LAL) was performed per ANSI/AAMI ST72. | |
| Preclinical animal studies in a canine model were relied upon to establish | |
| substantial equivalence. | |
| Technological | |
| Characteristics: | The OsteoSync™ Ti Dental Mesh has many of the same technological |
| characteristics as the predicate devices. These include anatomic location, | |
| material of manufacture, basic design, method of stabilization, sterile | |
| condition, variety of components offered and their general dimensional | |
| characteristics. The similarities and differences are provided in the following | |
| tables. |
4
| Overall system | Subject Device | Primary
Predicate | Reference Devices | | |
|----------------------------------|-------------------------------------------------------------------------|-------------------------------------------------------------------------|-------------------------------------------------------------------------|-------------------------------------------------------------------------|-------------------------------------------------------------------------|
| Features
System → | OsteoSync™ Ti
Dental Mesh | Neo Titanium
mesh & CTI-
mem | SMARTbuilder
System | BoniPlus Dental
G-Mesh System | TraumaOne |
| 510(k) | K202918 | K111761 | K130840 | K182759 | K081067 |
| Manufacturer: | Sites Medical
LLC | neobiotech Co.,
Ltd. | OSSTEM
Implant Co.,
Ltd. | MontJade
Engineering
Co., Ltd. | Biomet
Microfixation,
Inc. |
| Technological
characteristics | | | | | |
| Basic design: | Dental mesh,
various shapes | Dental mesh,
various shapes | Dental mesh,
various shapes | Dental mesh,
various shapes | Dental mesh
and plates,
various shapes |
| Material of
manufacture: | ASTM F67, Gr2 | ASTM F67, Gr2 | ASTM F67, Gr2 | ASTM F67, Gr2 | ASTM F67, Gr2
& Gr4 |
| Method of
stabilization: | Envelopment of
bone graft with
optional
fastener
attachment | Envelopment of
bone graft with
optional
fastener
attachment | Envelopment of
bone graft with
optional
fastener
attachment | Envelopment of
bone graft with
optional
fastener
attachment | Envelopment of
bone graft with
optional
fastener
attachment |
| Condition when
used: | Sterile | Sterile | Sterile | Sterile | Sterile |
| System
characteristics: | | | | | |
| Thickness: | 0.41 to 0.52mm | 0.07 &
0.085mm | 0.1mm | 0.1 to 0.3mm | 0.2 to 0.6mm |
| Surface: | Smooth/smooth
or
smooth/rough
sides | Smooth on both
sides | Smooth on both
sides | Smooth on both
sides | Smooth on both
sides |
| Pore Diameter: | 0.43 to 0.66mm | 0.4 to 0.8mm | 0.6 to 1.0mm | Unknown | Unknown |
Comments:
The thickness of the subject device is greater than that of the Neo Titanium & CT-mem and the . SMARTbuilder systems but only fractionally larger than the largest BoniPlus implants. The thickness of the subject device is within the range offered by TraumaOne.
The pore diameter size of the subject devices lies within those specified by the predicates. .
The surface texture of the subject device and cited predicates is smooth on both sides. However the . subject device additionally offers a smooth gingival side / rough bone side option. The roughened side is intended to assist in securing the mesh to bone. Preclinical animal studies in a canine model provided support for this design. The preclinical animal studies were leveraged from an FDA-authorized master file.
5
| Oval/round
Features↓
| System → | Subject Device | Primary Predicate | Reference Device |
|---|---|---|---|
| 510(k) | K202918 | K111761 | K130840 |
| Manufacturer: | Sites Medical LLC | neobiotech Co., Ltd. | OSSTEM Implant Co., Ltd. |
| Overall dimensions | Image: OsteoSync™ Ti Dental Mesh | Image: Neo Titanium mesh & CTi-mem | Image: SMARTbuilder System |
| Insert diameter | 2 to 6mm | 2.5mm | ~3mm (approximated) |
| Proximal width | 5 to 12mm | 4 to 15mm | 4 to 12mm |
| Buccal width | 4 to 8mm | 8 to 15mm | 7 to 12mm |
| Buccal length | 5 to 8mm | 6 to 20mm | 3 to 9mm |
Comments:
- . The insert diameter of the subject device encompasses the ranqe offered by the Neo Titanium & CTi-mem and the SMARTbuilder systems but extends to a larger range to broaden the system functionality for the end user by minimizing the need for manipulation of generic mesh.
- The buccal width of the subject device overlaps those provided in the Neo Titanium & CTi-. mem and the SMARTbuilder systems but extends narrower to accommodate smaller defects such that the end user does not have to trim a generic mesh to obtain the implant form.
| Posterior Graft | Subject Device | Primary
Predicate | Reference Devices | |
|-----------------------|----------------------------------|------------------------------------|--------------------------------------|-------------------------------|
| Features
System → | OsteoSync™ Ti
Dental Mesh | Neo Titanium
mesh & CTi-mem | BoniPlus Dental
G-Mesh System | TraumaOne |
| 510(k) | K202918 | K111761 | K182759 | K081067 |
| Manufacturer: | Sites Medical
LLC | neobiotech Co.,
Ltd. | MontJade
Engineering Co.,
Ltd. | Biomet
Microfixation, Inc. |
| Overall
dimensions | Image: OsteoSync™ Ti Dental Mesh | Image: Neo Titanium mesh & CTi-mem | Image: BoniPlus Dental G-Mesh System | Image: TraumaOne |
| Insert diameter | 2 to 6mm | NA | NA | NA |
| Proximal width | 15 to 34mm | 12 to 35mm | 25 to 60mm | 80 to 85mm |
| Buccal width | 10 to 20mm | 12 to 35mm | 17 to 60mm | 80 to 85mm |
None of the dimensional differences in the individual mesh shapes raise new questions of substantial equivalence.
6
| Posterior Graft | Subject Device | Primary
Predicate | Reference Devices |
|--------------------------|------------------------------|--------------------------------|--------------------------------------------|
| Features
System → | OsteoSync™ Ti
Dental Mesh | Neo Titanium
mesh & CTi-mem | BoniPlus Dental
G-Mesh System TraumaOne |
| Buccal length
(total) | 15 to 24mm | 15 to 30mm | NA 50 to 53mm |
Comments:
- None of the predicate devices have a preformed insert diameter slot to accommodate a . dental implant. However, all of the mesh shapes can be trimmed to form and perforated to accommodate a screw. The option broadens the functionality for the end user by minimizing the need for manipulation of generic mesh.
- . The proximal width, buccal width and buccal length dimensions of the subject device lie within the range offered by the Neo Titanium & CTi-mem, BoniPlus G-mesh and the TraumaOne mesh systems.
None of the dimensional differences in the individual mesh shapes raise new questions of substantial equivalence.
| Socket Graft | Subject Device | Primary
Predicate | Reference Devices | |
|-----------------------|---------------------------------|------------------------------------|-----------------------------|--------------------------------------|
| Features
System → | OsteoSync™ Ti
Dental Mesh | Neo Titanium
mesh & CTi-mem | SMARTbuilder
System | BoniPlus Dental
G-Mesh System |
| 510(k) | K202918 | K111761 | K130840 | K182759 |
| Manufacturer: | Sites Medical
LLC | neobiotech Co.,
Ltd. | OSSTEM Implant
Co., Ltd. | MontJade
Engineering Co.,
Ltd. |
| Overall
dimensions | Image: OsteoSync Ti Dental Mesh | Image: Neo Titanium mesh & CTi-mem | Image: SMARTbuilder System | Image: BoniPlus Dental G-Mesh System |
| Insert diameter | 2 to 6mm | 2.5mm | 3.5-4mm | ~3mm
(approximated) |
| Proximal width | 5 to 9.3mm | 4 to 12mm | 4 to 12mm | ~5mm
(approximated) |
| Buccal Length | 10 to 13.5mm | 6 to 10mm | 7 & 9mm | 9.5mm |
| Buccal Width | 7 to 29mm | 8 to 12mm | 8 to 12mm | 9mm |
Comments:
- The insert diameter of the subject device encompasses the range offered by the Neo . Titanium & CTi-mem and the SMARTbuilder systems but extends to a larger range to broaden the system functionality for the end user by minimizing the need for manipulation of generic mesh.
- . The buccal width and length of the subject device overlap but extend longer than the range offered by the cited predicates to accommodate larger defects as necessary.
- . The proximal width of the subject device lies within the range offered by the Neo Titanium & CTi-mem system.
- . None of the dimensional differences in the individual mesh shapes raise new questions of substantial equivalence.
7
| Conclusion: | The OsteoSync™ Ti Dental Mesh possesses the same intended use and
technological characteristics as the predicate devices.
Nonclinical performance testing demonstrated substantial equivalence.
Specifically, |
|-------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| • | A biological risk assessment showed the submitted information and the
preclinical animal studies provided in an FDA authorized master file
mitigated risks with respect to biocompatibility. |
- The sterilization validation achieved the predetermined acceptance . criteria for a sterility assurance level (SAL) of 10-6.
- The shelf-life validation met the predetermined acceptance criteria for a . five year shelf-life.
- The bacterial endotoxin testing results met the predetermined pyrogen ● limit of 20EU/device.
Therefore the OsteoSync™ Ti Dental Mesh is substantially equivalent for its intended use.