(455 days)
The TiBrid™ SC standalone cervical fusion device is indicated for use in anterior cervical interbody procedures in skeletally mature patients with cervical disc disease at one level from the C2-C3 disc to the C7-T1 disc. The implants are to be used with autogenous bone graft and/or allograft comprised of cancellous and/or corticocancellous bone graft and implanted via an anterior approach. The device is to be used is patients who have had six weeks of non-operative treatment. The cervical standalone intervertebral body fusion device is to be used with either two bone screws and a screw locking cover or a connecting plate. If the connecting plate is chosen, the number of screws should correspond to the number of holes in the plate.
The TiBrid™-SC system consists of a standalone hybrid PEEK OPTIMA™ HA Enhanced and titanium alloy cervical interbody device with 3 titanium plate options (two, three, and four screws) that can be connected to the standalone device. The standalone cages are available in multiple footprints and heights, and have a lordotic angle of 6°. The plates are available in multiple heights. The cages feature a hollow center to accommodate autograft or allograft and include anti-migration features. All devices are to be used with autogenous bone graft and/or allograft comprised of cancellous and/or corticocancellous bone graft.
The provided text describes a 510(k) premarket notification for a medical device (Omnia Medical TiBrid™-SC) and does not contain information about the acceptance criteria or a study proving the device meets those criteria for an AI/ML product.
The document is a submission to the FDA for an intervertebral body fusion device, which is a physical implant used in spinal surgery, not a software or AI/ML-based device. The "acceptance criteria" discussed in the document are about demonstrating substantial equivalence to existing predicate devices based on design, materials, dimensions, function, and mechanical testing results (e.g., static and dynamic compression, subsidence, expulsion testing).
Therefore, I cannot extract the requested information regarding an AI/ML device's acceptance criteria and study from this document. The questions posed in your prompt (e.g., sample size for test set, data provenance, number of experts for ground truth, MRMC studies, standalone performance) are relevant to the evaluation of AI/ML products, but not to the type of medical device described in this 510(k) submission.
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November 15, 2022
Omnia Medical, LLC Daniel Johnson Project Engineer 6 Canyon Road, Suite 300 Morgantown, West Virginia 26508
Re: K212612
Trade/Device Name: Omnia Medical TiBridTM-SC Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: OVE Dated: October 14, 2022 Received: October 17, 2022
Dear Daniel Johnson:
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 (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 mediation-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.
Brent Showalter -S
Brent Showalter, Ph.D. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K212612
Device Name Omnia Medical TiBridTM-SC
Indications for Use (Describe)
The TiBrid™ SC standalone cervical fusion device is indicated for use in anterior cervical interbody procedures in skeletally mature patients with cervical disc disease at one level from the C2-C3 disc to the C7-T1 disc. The implants are to be used with autogenous bone graft and/or allograft comprised of cancellous and/or corticocancellous bone graft and implanted via an anterior approach. The device is to be used is patients who have had six weeks of non-operative treatment. The cervical standalone intervertebral body fusion device is to be used with either two bone screws and a screw locking cover or a connecting plate. If the connecting plate is chosen, the number of screws should correspond to the number of holes in the plate.
| 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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Image /page/3/Picture/0 description: The image shows the logo for Omnia Medical. The logo consists of a circular graphic on the left and the words "Omnia Medical" on the right. The top half of the circle is dark blue, and the bottom half is gray. The word "Omnia" is in dark blue, and the word "Medical" is in gray.
510(k) Summary
| Submitted By: | Omnia Medical, LLC6 Canyon Road Suite 300Morgantown, WV 26508 |
|---|---|
| Date: | 08/16/2021 |
| Contact Person:Contact Telephone:Contact Fax: | Daniel Johnson, Project Engineer(440) 333-2127(440) 933-7839 |
| Device Trade Name:Common Name:Device Classification Name: | Omnia Medical TiBrid™-SCIntervertebral Body Fusion DeviceIntervertebral Body Fusion Device with Integrated Fixation, Cervical |
| Device Classification:Reviewing Panel:Product Code: | Class IIOrthopedicOVE |
| Primary Predicate Device: | SeaSpine® Shoreline™ ACS – Anterior Cervical Standalone System(K170569)The primary predicate device has never been subject to a recall. |
| Reference Devices: | Omnia Medical TiBrid™ Cervical Cage (K190363)Omnia Medical TiBrid™-SA (K203207)NuVasive CoRoent Small Interlock System (K192582)The reference predicate device has never been subject to a recall. |
Device Description:
The TiBrid™-SC system consists of a standalone hybrid PEEK OPTIMA™ HA Enhanced and titanium alloy cervical interbody device with 3 titanium plate options (two, three, and four screws) that can be connected to the standalone device. The standalone cages are available in multiple footprints and heights, and have a lordotic angle of 6°. The plates are available in multiple heights. The cages feature a hollow center to accommodate autograft or allograft and include anti-migration features. All devices are to be used with autogenous bone graft and/or allograft comprised of cancellous and/or corticocancellous bone graft.
Indications for Use:
The TiBrid™-SC standalone cervical intervertebral fusion device is indicated for use in anterior cervical interbody procedures in skeletally mature patients with cervical disc disease at one level from the C2-C3 disc to the C7-T1 disc. The implants are to be used with autogenous bone graft and/or allograft comprised of cancellous and/or corticocancellous bone graft and implanted via an anterior approach. The device is to be used is patients who have had six weeks of non-operative treatment. The cervical standalone intervertebral body fusion device is to be used with either two bone screws and a screw locking cover or a connecting plate. If the connecting plate is chosen, the number of screws should correspond to the number of holes in the plate.
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Image /page/4/Picture/1 description: The image contains the logo for Omnia Medical. The logo consists of a stylized wave-like graphic on the left, with the text "Omnia" above the text "Medical" on the right. The wave graphic is split into two colors, with the top portion being a dark blue and the bottom portion being a light gray. The text "Omnia" is also in dark blue, while the text "Medical" is in light gray.
Summary of Technological Characteristics:
The Omnia Medical TiBrid™-SC System and the primary predicate have the same intended use and fundamental scientific technology. All devices compare similarly in:
- Design features ●
- Intended use ●
- Materials ●
- Dimensions ●
- . Function
Table 8.1: Dimensions and Technological Characteristics Comparison Cervical Plate Systems
| Table 8.1: Dimensions and Technological Characteristics Comparison Cervical Plate Systems | |||||
|---|---|---|---|---|---|
| Item | Omnia MedicalTiBrid™-SC | SeaSpineShoreline™ ACS -Anterior CervicalStandalone System(K170569) | Omnia MedicalTiBrid™-C(K190363) | NuVasive CoRoentSmall InterlockSystem (K192582) | Comparison |
| ClassificationName | IntervertebralBody FusionDevice withIntegratedFixation, Cervical | Intervertebral BodyFusion Device withIntegrated Fixation,Cervical | Intervertebral FusionDevice with BoneGraft, Cervical | Intervertebral BodyFusion Device withIntegrated Fixation,Cervical | Equivalent |
| Regulation | 21 CFR 888.3080 | 21 CFR 888.3080 | 21 CFR 888.3080 | 21 CFR 888.3080 | Equivalent |
| CommonName | IntervertebralBody FusionDevice | Intervertebral BodyFusion Device | Intervertebral BodyFusion Device | Intervertebral BodyFusion Device | Equivalent |
| Product Code | OVE | OVE | ODP | OVE | Equivalent |
| Indications forUse | The TiBrid™-SCstandalonecervicalintervertebralfusion device isindicated for usein anteriorcervical interbodyprocedures inskeletally maturepatients withcervical discdisease at onelevel from the C2-C3 disc to the C7-T1 disc. Theimplants are to beused withautogenous bone | The SeaSpineShoreline™ ACS isa standalone deviceindicated foranterior cervicalinterbody fusionprocedures inskeletally maturepatients withdegenerative discdisease of thecervical spine at asingle level (C2-T1). TheShoreline™ ACSimplants are to beused with autograftbone graft and/orallogenic bone graft | The TiBrid™Cervical Cage isindicated forintervertebral bodyfusion procedures inskeletally maturepatients withdegenerative discdisease (DDD) at oneor two contiguouslevels within thecervical spine at disclevels from C2 to T1.DDD is defined asneck pain ofdiscogenic originwith degeneration ofthe disc confirmedby patient history | The CoRoent SmallInterlock System is astandalone anteriorcervical interbodyfusionsystem indicated foruse in skeletallymature patients withcervical discdegeneration and/orcervical spinalinstability, asconfirmed by imagingstudies (radiographs,CT, MRI), thatresults inradiculopathy,myelopathy, and/orpain at multiple | Equivalent |
| Table 8.1: Dimensions and Technological Characteristics Comparison Cervical Plate Systems | |||||
| Item | Omnia MedicalTiBrid™-SC | SeaSpineShoreline™ ACS -Anterior CervicalStandalone System(K170569) | Omnia MedicalTiBrid™-C(K190363) | NuVasive CoRoentSmall InterlockSystem (K192582) | Comparison |
| allograftcomprised ofcancellous and/orcorticocancellousbone graft andimplanted via ananterior approach.The device is tobe used is patientswho have had sixweeks of non-operativetreatment. Thecervicalstandaloneintervertebralbody fusiondevice is to beused with either aminimum of twobone screws and ascrew lockingcover or aconnecting plate. | cancellous and/orcorticocancellousbone and implantedvia an anteriorapproach. Thecervical device is tobe used in patientswho have had atleast six (6) weeksof non-operativetreatment. Thecervical device is tobe used withShoreline bonescrew fixation andthe Shorelinelocking cover. | studies. Patientsshould have had atleast six weeks ofnon-operativetreatment prior totreatment withintervertebral cages.This device isintended for use withautogenous bonegraft and/or allograftcomprised ofcancellous and/orcorticocancellousbone graft andsupplementalfixation. | contiguous levelsfrom C2-T1.The System isintended to be usedwith autogenousand/or allogeneic bonegraft comprisedof cancellous, cortical,and/orcorticocancellousbone graft to facilitatefusion. | ||
| Description | The TiBrid™-SCsystem consists ofa standalonehybrid PEEKOPTIMA™ HAEnhanced andtitanium alloycervical interbodydevice with 3titanium plateoptions (two,three, and fourscrews) that canbe connected tothe standalonedevice. Thestandalone cagesare available inmultiplefootprints and | The SeaSpine®Shoreline™ ACS -Anterior CervicalStandalone Systemconsists of theimplant assemblycomposed of asingle use PEEKcervical spacer(ASTM F2026) anda titanium alloy(ASTM F136) platewith titanium alloyvariable angle orfixed bone screws,and a titanium alloylocking cover.Shoreline™ ACS isoffered in a varietyof footprints and | The Omnia MedicalTiBrid™ Systemsare intervertebralbody fusion systemsused in the spine toreplace a collapsed,damaged, or unstabledisc. The implantabledevices aremanufactured fromPEEK-OPTIMA™HA Enhanced,titanium alloy, andtantalum forradiographicvisualization. Eachdevice is available inmultiple footprintsand heights. Theimplant features a | The NuVasiveCoRoent SmallInterlock System is astandalone anteriorcervical interbodydevice consisting of aPEEK(polyetheretherketone)implant cage withtitanium alloy andtantalum radiographicmarkers, titaniumalloy washers, andthree (3) titaniumalloy bone fixationscrews. The devicesare manufacturedfrom PEEK-Optima®LT1 conforming toASTM F2026, | Equivalent |
| Item | Omnia MedicalTiBridTM-SC | SeaSpineShorelineTM ACS -Anterior CervicalStandalone System(K170569) | Omnia MedicalTiBridTM-C(K190363) | NuVasive CoRoentSmall InterlockSystem (K192582) | Comparison |
| heights, and havea lordotic angle of6°. The plates areavailable inmultiple heights.The cages featurea hollow center toaccommodateautograft orallograft andinclude anti-migrationfeatures. Alldevices are to beused withautogenous bonegraft and/orallograftcomprised ofcancellous and/orcorticocancellousbone graft. | heights toaccommodatevariations in patientanatomy and isgenerally box-shaped with surfaceteeth and a centralcanal for receivingautograft bone graftmaterial and/orallogeneic bonegraft composed ofcancellous and/orcorticocancellousbone. The system isimplanted via ananterior approach. | hollow center toaccommodateautograft or allograftand includes anti-migration features.All devices are to beused withautogenous bonegraft and/or allograftcomprised ofcancellous and/orcorticocancellousbone graft andsupplementalfixation. | titanium alloyconforming to ASTMF136, and tantalumconforming to ASTMF560. The implantsare available in avariety of sizes toaccommodateanatomical conditions.The CoRoent SmallInterlock System is astandalone systemintended to be usedwith the bone screwsprovided, and whenused as such requiresno additionalsupplemental fixation. | ||
| InterbodyFootprints | 16.5 x 14.5mm18 x 15mm | 16 x 14mm18 x 15mm20 x 15mm | 14mm x 12mm16mm x 13.5mm18mm x 15mm | 17mm x 14mm | Equivalent |
| InterbodyHeights | 6 - 12 mm, 1 mmincrements | 5 - 12 mm, 1 mmincrements | 5 - 12 mm, 1 mmincrements | 5 - 12 mm, 1 mmincrements | Equivalent |
| InterbodyLordosis | 6° | 7°, 10°, 15° | 6° | 6° | Equivalent |
| PlateConfigurations | 2,3 and 4 screw | 2,3, and 4 screw | N/A | N/A | Equivalent |
| ScrewDiameters | Ø4.0 or 4.5 mm | Ø3.5 or 4.0 mm | N/A | Ø4.0 or 4.5 mm | Equivalent |
| Screw Lengths | 10 – 18 mm | 10 - 18mm | N/A | 12 – 16 mm | Equivalent |
| Screw Styles | Self-Drilling &Self-Tapping,Fixed & Variable | Self-Drilling &Self-Tapping, Fixed& Variable | N/A | Self-Drilling & Self-Tapping, Fixed &Variable | Equivalent |
| GraftWindows | Yes | Yes | Yes | Yes | Equivalent |
| Bone GraftContact Area | 73 mm² | 65 mm² | 63 mm² | Unknown | Equivalent |
| InsertionFeatures | Threaded hole | Threaded hole | Threaded hole | Unknown | Equivalent |
| Table 8.1: Dimensions and Technological Characteristics Comparison Cervical Plate Systems | |||||
| Item | Omnia MedicalTiBrid™-SC | SeaSpineShoreline™ ACS -Anterior CervicalStandalone System(K170569) | Omnia MedicalTiBrid™-C(K190363) | NuVasive CoRoentSmall InterlockSystem (K192582) | Comparison |
| Anti-MigrationFeatures | Yes | Yes | Yes | Yes | Equivalent |
| InterbodyMaterials | PEEK-OPTIMA™ HAEnhanced perASTM F2026,Titanium Alloyper ASTM F3001,Titanium Alloyper ASTM F136 | PEEK-OPTIMA™per (ASTM 2026),titanium alloy(ASTM F136),Tantalum (ASTMf560), CP TitaniumSurface (ASTMf67) | PEEK-OPTIMA™HA Enhanced (perASTM F2026) andTi-6Al-4V ELI (perASTM F3001),Titanium Alloy perASTM F136 | PEEK-OPTIMA™per (ASTM 2026),titanium alloy (ASTMF136) | Equivalent |
| Plate Materials | Titanium Alloyper ASTM F136 | Titanium Alloy perASTM F136 | N/A | N/A | Equivalent |
| ScrewMaterials | Titanium Alloyper ASTM F136 | Titanium Alloy perASTM F136 | N/A | Titanium Alloy perASTM F136 | Equivalent |
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Image /page/5/Picture/0 description: The image shows the logo for Omnia Medical. The logo consists of a blue and gray wave-like graphic on the left, followed by the words "Omnia" and "Medical" stacked on top of each other on the right. The word "Omnia" is in a bold, dark blue font, while the word "Medical" is in a lighter gray font.
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Image /page/6/Picture/0 description: The image shows the logo for Omnia Medical. The logo consists of a stylized wave-like graphic in blue and gray on the left, followed by the words "Omnia" in a bold, dark blue font and "Medical" in a smaller, gray font below it. The overall design is clean and professional, suggesting a company in the healthcare or medical field.
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Image /page/7/Picture/0 description: The image shows the logo for Omnia Medical. The logo consists of a stylized wave-like graphic in navy blue and gray on the left, followed by the words "Omnia" in a larger, bold, navy blue font and "Medical" in a smaller, gray font below it. The overall design is clean and professional.
Mechanical Testing:
Substantial equivalence is supported by the results of mechanical testing including static and dynamic compression per ASTM F2077, static and dynamic torsion per ASTM F2077, static and dynamic compression shear per ASTM F2077, subsidence per ASTM F2267, and expulsion testing.
Conclusion:
Based on the indications for use, technological characteristics (i.e. design, material, and chemical composition), and comparison with the predicate device, the subject device has demonstrated substantial equivalence.
§ 888.3080 Intervertebral body fusion device.
(a)
Identification. An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion.(b)
Classification. (1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic 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.