(50 days)
The TiBrid™ SA system is indicated for use as an adjunct to fusion in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). Patients should have six months of nonoperative therapy. This device is intended for use with autogenous bone graft and/or allograft compromised of cancellous and/or corticocancellous bone graft and integrated fixation.
The TiBrid™ -SA is a standalone device and must be used with the internal bone screws or TiBrid™. SA plate and bone screws provided.
The Omnia Medical TiBrid™-SA System is a standalone intervertebral body fusion system used in the spine to replace a collapsed, damaged, or unstable disc. The implantable devices are manufactured from PEEK-OPTIMA™ HA Enhanced, titanium alloy, and tantalum for radiographic visualization. Each device is available in multiple footprints, heights, and angles. The implants 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 and integrated fixation.
The provided document is a 510(k) premarket notification from the FDA for a medical device called the "Omnia Medical TiBrid™-SA System." This notification approves the device based on its substantial equivalence to previously cleared predicate devices. It does not describe a study conducted by the applicant to prove the device meets acceptance criteria, but rather summarizes how the device compares to predicate devices based on certain performance data.
Therefore, the requested information, specifically regarding acceptance criteria, reported performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth establishment, and training set details, is not present in the provided text. The document states that "Clinical Studies were not applicable to support a substantial equivalence determination for this device."
However, I can extract the non-clinical performance data type and the conclusion regarding substantial equivalence.
Here's a breakdown of the information that can be extracted or inferred from the provided text, and explicit statements about what is not available:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated in terms of quantitative criteria, but implicitly refers to equivalence with predicate devices under specific ASTM standards. | Non-clinical tests demonstrated compliance with ASTM F2077 Standard Test Methods for Intervertebral Body Fusion Devices by performing static and dynamic compression shear testing. |
| The mechanical testing results, material, indications and intended uses, and device function are comparable to the predicate device. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not applicable/not provided. The document refers to non-clinical (mechanical) testing, not a clinical test set with human or animal subjects.
- Data Provenance: Not applicable/not provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable/not provided. Ground truth establishment by experts is typically associated with clinical studies involving human interpretation or diagnoses, which were not performed for this submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/not provided. This relates to clinical study methodology, which was not performed.
5. 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
- No, an MRMC comparative effectiveness study was not done. The device mentioned (Omnia Medical TiBrid™-SA System) is an intervertebral body fusion device (an implant), not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. The device is an implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For the non-clinical performance data, the "ground truth" would be the engineering specifications and established ASTM standards for implantable devices. Compliance with these standards confirms the device's mechanical integrity.
8. The sample size for the training set
- Not applicable. No training set for an algorithm was used as this is an implant device, not an AI/ML product.
9. How the ground truth for the training set was established
- Not applicable. No training set for an algorithm was used.
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April 24, 2024
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Omnia Medical, LLC % Jennifer Palinchik President JALEX Medical, LLC 27865 Clemens Rd., Suite 3 Westlake, Ohio 44145
Re: K240623
Trade/Device Name: Omnia Medical TiBrid™-SA System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: OVD Dated: March 20, 2024 Received: March 20, 2024
Dear Jennifer Palinchik:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,
Katherine D. Kavlock -S
for
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
Submission Number (if known)
Device Name
Omnia Medical TiBrid TM -SA System
Indications for Use (Describe)
The TiBrid™ SA system is indicated for use as an adjunct to fusion in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). Patients should have six months of nonoperative therapy. This device is intended for use with autogenous bone graft and/or allograft compromised of cancellous and/or corticocancellous bone graft and integrated fixation.
The TiBrid™ -SA is a standalone device and must be used with the internal bone screws or TiBrid™. SA plate and bone screws provided.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
ver-The-Counter Use (21 CFR 801 Subpart C)
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Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.
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Image /page/3/Picture/1 description: The image shows the logo for Omnia Medical. The logo consists of a blue and gray circular graphic on the left, with the words "Omnia Medical" in blue and gray on the right. The word "Omnia" is in blue, and the word "Medical" is in gray.
510(k) Summary
| Submitted By: | Omnia Medical, LLC |
|---|---|
| 6 Canyon Road Suite 300 | |
| Morgantown, WV 26508 | |
| Date: | 04/15/2024 |
| Contact Person: | Jennifer Palinchik, President, JALEX Medical |
| Contact Telephone: | (440) 935-3282 |
| Contact Fax: | (440) 933-7839 |
| Device Trade Name: | Omnia Medical TiBrid™-SA |
| Common Name: | Intervertebral Body Fusion Device |
| Device Classification Name: | Intervertebral Body Fusion Device with Integrated Fixation, Lumbar |
| Device Classification: | Class II |
| Reviewing Panel: | Orthopedic |
| Product Code: | OVD |
| Primary Predicate Device: | Omnia TiBrid™-SA Intervertebral Fusion Device (K203207) |
| Additional Predicate: | SeaSpine Zuma™ System (K082926) |
Device Description:
The Omnia Medical TiBrid™-SA System is a standalone intervertebral body fusion system used in the spine to replace a collapsed, damaged, or unstable disc. The implantable devices are manufactured from PEEK-OPTIMA™ HA Enhanced, titanium alloy, and tantalum for radiographic visualization. Each device is available in multiple footprints, heights, and angles. The implants 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 and integrated fixation.
Indications for Use:
The TiBrid™-SA system is indicated for use as an adjunct to fusion in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). Patients should have six months of nonoperative therapy. This device is intended for use with autogenous bone graft and/or allograft compromised of cancellous and/or corticocancellous bone graft and integrated fixation.
The TiBrid™-SA is a standalone device and must be used with the internal bone screws or TiBrid™-SA plate and bone screws provided.
Summary of Technological Characteristics:
The Omnia Medical TiBrid™-SA System and the predicate devices have the same intended use and fundamental scientific technology. All devices compare similarly in:
- Design features ●
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Image /page/4/Picture/0 description: The image shows the logo for Omnia Medical. The logo consists of a blue and gray wave-like design on the left, with the words "Omnia Medical" in blue and gray on the right. The word "Omnia" is in blue, and the word "Medical" is in gray.
- Intended use .
- Materials ●
- Dimensions ●
- Function ●
| Item | Subject Device:Omnia MedicalTiBrid™-SA | Omnia MedicalTiBrid™-SA(K203207) | Zuma™ System,SeaSpine Inc.(K082926) | Comparison |
|---|---|---|---|---|
| Comparisoncomponent tosubject device | N/A | Interbody, screws,screw covers | Interbody, screws,and platecombination | N/A |
| DeviceClassificationName | Intervertebral FusionDevice withIntegrated Fixation,Lumbar | Intervertebral FusionDevice withIntegrated Fixation,Lumbar | Intervertebral FusionDevice withIntegrated Fixation,Lumbar | Equivalent |
| Regulation | 21 CFR 888.3080 | 21 CFR 888.3080 | 21 CFR 888.3080 | Equivalent |
| Common Name | Intervertebral BodyFusion Device | Intervertebral BodyFusion Device | Intervertebral BodyFusion Device | Equivalent |
| Product Code | OVD | OVD | OVD | Equivalent |
| Indications forUse | The TiBrid™-SAsystem is indicatedfor use as an adjunctto fusion inskeletally maturepatients withdegenerative discdisease (DDD) atone or twocontiguous levelsfrom L2 to S1. DDDis defined as backpain of discogenicorigin withdegeneration of thedisc confirmed byhistory andradiographic studies.The DDD patientsmay also have up toGrade 1spondylolisthesis atthe involved level(s).Patients should havesix months ofnonoperativetherapy. This device | The TiBrid™-SAsystem is indicatedfor use as an adjunctto fusion inskeletally maturepatients withdegenerative discdisease (DDD) atone or twocontiguous levelsfrom L2 to S1. DDDis defined as backpain of discogenicorigin withdegeneration of thedisc confirmed byhistory andradiographic studies.The DDD patientsmay also have up toGrade 1spondylolisthesis atthe involved level(s).Patients should havesix months ofnonoperativetherapy. This device | When used as anintervertebral bodyfusion device, theZuma-L System isintended for spinalfusion procedures atone or twocontiguous levels(L2-S1) in skeletallymature patients withdegenerative discdisease (DDD).DDD is defined asback pain ofdiscogenic originwith degeneration ofthe disc confirmedby history andradiographic studies.DDD patients mayalso have up toGrade 1spondylolisthesis orretrolisthesis at theinvolved level(s).These patients mayhave had a previous | Equivalent |
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Image /page/5/Picture/1 description: The image shows the logo for Omnia Medical. The logo consists of a blue and gray circular graphic on the left, with the word "Omnia" in blue and the word "Medical" in gray on the right. The graphic appears to be a stylized representation of a wave or a mountain range.
| may be packed with | may be packed with | non-fusion spinal |
|---|---|---|
| autogenous bonegraft material. | autogenous bonegraft material. | surgery at the |
| involved spinal | ||
| The TiBridTM-SA is | The TiBridTM-SA is | level(s). These |
| a standalone device | a standalone device | patients should have |
| and must be used | and must be used | had six months of |
| with the internal | with the internal | non-operative |
| bone screws or | bone screws | treatment. The |
| TiBridTM-SA plate | provided. | device is intended to |
| and bone screws | be used with | |
| provided. | autograft. Zuma-L is | |
| a stand-alone system | ||
| intended to be used | ||
| with the bone screws | ||
| provided and | ||
| requires no | ||
| additional | ||
| supplementary | ||
| fixation systems. | ||
| When used as a | ||
| Vertebral Body | ||
| Replacement | ||
| Device, the Zuma-L | ||
| System is intended | ||
| for use in the | ||
| thoracolumbar spine | ||
| (T1 to L5) to replace | ||
| a collapsed, | ||
| diseased, damaged | ||
| or unstable complete | ||
| or partial vertebral | ||
| body due to tumor ortrauma/fracture, to | ||
| achieve anterior | ||
| decompression ofthe spinal cord and | ||
| neural tissues, and to | ||
| restore the height of | ||
| a collapsed vertebral | ||
| body. The Zuma-L | ||
| System is designed | ||
| to restore the | ||
| biomechanical | ||
| integrity of the | ||
| anterior, middle, and | ||
| posterior spinal | ||
| column, even in the |
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Image /page/6/Picture/1 description: The image shows the logo for Omnia Medical. The logo consists of a blue and gray circular design on the left, with the words "Omnia Medical" in blue and gray on the right. The word "Omnia" is in blue, and the word "Medical" is in gray.
| a prolonged period.Additionally, Zuma-L is intended for usewith bone graft. | ||||
|---|---|---|---|---|
| Description | The Omnia MedicalTiBrid™-SA Systemis a standaloneintervertebral bodyfusion system usedin the spine toreplace a collapsed,damaged, or unstabledisc. Theimplantable devicesare manufacturedfrom PEEK-OPTIMA™ HAEnhanced, titaniumalloy, and tantalumfor radiographicvisualization. Eachdevice is available inmultiple footprintsand heights. Theimplants feature ahollow center toaccommodateautograft or allograftand include anti-migration features.All devices are to beused withautogenous bonegraft and/or allograftcomprised ofcancellous and/orcorticocancellousbone graft andintegrated fixation.32mm x 25mm | The Omnia MedicalTiBrid™-SA Systemis a standaloneintervertebral bodyfusion system usedin the spine toreplace a collapsed,damaged, or unstabledisc. Theimplantable devicesare manufacturedfrom PEEK-OPTIMA™ HAEnhanced, titaniumalloy, and tantalumfor radiographicvisualization. Eachdevice is available inmultiple footprintsand heights. Theimplants feature ahollow center toaccommodateautograft or allograftand include anti-migration features.All devices are to beused withautogenous bonegraft and/or allograftcomprised ofcancellous and/orcorticocancellousbone graft andintegrated fixation.32mm x 25mm | Zuma is animplantable spinaldevice made fromPEEK-OPTIMA®LT1 and titaniumwith tantalummarkers forradiographicvisualization. It issecured to vertebralbodies with titaniumbone screws. Thedevice has opencentral area forreceiving bone graftmaterial and isoffered in a varietyof sizes andgeometries toaccommodatevariations inpathology andpatient anatomy. | Equivalent |
| Footprint Sizes(width x length) | 36mm x 27mm40mm x 29mm | 36mm x 27mm40mm x 29mm | 26mm x 24mm32mm x 25mm38mm x 26mm | Equivalent |
| InterbodyHeights | 10, 12, 14, 16, 18mm | 10, 12, 14, 16, 18mm | 10, 12, 14, 16,18mm | Equivalent |
| InterbodyAngles | 8, 12, 16, 20° | 8, 12, 16, 20° | 8, 12° | Equivalent |
| Graft Window | Yes | Yes | Yes | Equivalent |
| Insertion Feature | Threaded hole | Threaded hole | Threaded hole | Equivalent |
| Anti-MigrationFeatures | Yes | Yes | Yes | Equivalent |
| Use withsupplementalfixation | No | No | Fusion device - noBody replacement -yes | Equivalent |
| InterbodyMaterial &Manufacturing | PEEK-OPTIMA™HA Enhanced (perASTM F2026), Ti-6Al-4V ELI (perASTM F3001),Tantalum (perASTM F560). | PEEK-OPTIMA™HA Enhanced (perASTM F2026), Ti-6Al-4V ELI (perASTM F3001),Tantalum (perASTM F560). | PEEK-OPTIMA®LT1, Titanium alloy,Tantalum marker | Equivalent |
| Screw Diameters | 5.5mm, 6.0mm selftapping and selfdrilling | 5.5mm, 6.0mm selftapping and selfdrilling | 5.5mm, 6mm self-tapping | Equivalent |
| Screw Lengths | 15 - 35mm (5mmincrements) | 15 - 35mm (5mmincrements) | 20, 25, 30, 35mm | Equivalent |
| Screw Material | Medical gradeTi6Al4V ELI perASTM F136 | Medical gradeTi6Al4V ELI perASTM F136 | Medical gradeTi6Al4V ELI | Equivalent |
| Plate Lengths | 30, 32, 34, 36, 38mm | N/A | 43, 44, 45 mm | Equivalent |
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Image /page/7/Picture/1 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 graphic is divided into two sections, with the top section being dark blue and the bottom section being gray. The words "Omnia" and "Medical" are stacked on top of each other, with "Omnia" being in dark blue and "Medical" being in gray.
Performance Data - Non-Clinical:
Non-clinical tests were conducted to verify that the proposed device met all design specifications as Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the subject device complies with ASTM F2077 Standard Test Methods for Intervertebral Body Fusion Devices by performing static and dynamic compression shear testing.
Performance Data - Clinical:
Clinical Studies were not applicable to support a substantial equivalence determination for this device. The mechanical testing results, material, indications and intended uses, and device function are comparable to the predicate device.
Conclusion:
Based on the indications for use, technological characteristics, 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.