(57 days)
No
The summary describes a physical implant (vertebral body replacement) and its mechanical testing, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The Omnia Medical VBR is a vertebral body replacement system used to treat collapsed, damaged, diseased, or unstable vertebral bodies due to tumor or trauma, or for reconstruction following corpectomy. This directly addresses medical conditions and aims to restore or improve physiological function, classifying it as a therapeutic device.
No
Explanation: The device is a vertebral body replacement system, which is a surgical implant used to replace a damaged vertebral body. Its intended use is for structural support and reconstruction after a corpectomy, not for diagnosing conditions.
No
The device description explicitly states it is manufactured from PEEK-OPTIMA™ HA Enhanced and tantalum markers, indicating it is a physical implant, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Definition of IVD: An In Vitro Diagnostic device is a medical device that is used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. These tests are performed outside of the body (in vitro).
- Description of the Device: The provided text describes a vertebral body replacement system. This is an implantable device used to replace a damaged or diseased part of the spine. It is surgically implanted inside the body.
- Intended Use: The intended use clearly states that the device is used to replace a vertebral body due to tumor, trauma, or for reconstruction following corpectomy. This is a surgical procedure, not a diagnostic test performed on a sample.
The description and intended use of the Omnia Medical VBR align with a surgical implant, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Omnia Medical VBR is a vertebral body replacement system indicated for use in skeletally mature patients to replace a collapsed, damaged, diseased, or unstable vertebral body due to tumor or trauma (i.e. fracture) or for reconstruction following corpectomy performed to achieve decompression of the spinal tissues. The device is intended for use in the cervical spine (from C3 to C7) and in the thoracolumbar spine (from T1-L5). The device is intended for use with supplemental fixation cleared by the FDA for use in the cervical, thoracic, or lumbar spine and is to be used with autogenous bone graft and/or allograft comprised of cancellous and/or corticocancellous bone graft.
Product codes
PLR, MQP
Device Description
The Omnia Medical VBR is manufactured from PEEK-OPTIMA™ HA Enhanced and tantalum markers conforming to ASTM F560. This implant is available in two footprint sizes and offers spacers and endplates which allow for fine adjustments of the height and lordosis to accommodate various patient anatomy. The device features a hollow center and through holes for use with autograft to encourage formation of new bone. The device is intended to be used with supplemental fixation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical spine (from C3 to C7) and in the thoracolumbar spine (from T1-L5)
Indicated Patient Age Range
skeletally mature patients
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
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, subsidence per ASTM F2267, and expulsion testing. This data was presented in the reference predicate submission (K172323) to demonstrate substantial equivalence. No new device designs or worst-case sizes are being introduced. The previously submitted data supports the expanded indications for use.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3060 Spinal intervertebral body fixation orthosis.
(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food & Drug Administration (FDA). On the left, there 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 square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Omnia Medical, LLC % Daniel Johnson Regulatory Engineer JALEX Medical 30311 Clemens Rd Suite 5D Westlake, Ohio 44145
Re: K191778
Trade/Device Name: Omnia Medical VBR Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal Intervertebral Body Fixation Orthosis Regulatory Class: Class II Product Code: PLR, MQP Dated: August 7, 2019 Received: August 8, 2019
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.
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
August 28, 2019
1
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 Melissa Hall 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)
Device Name Omnia Medical VBR
Indications for Use (Describe)
The Omnia Medical VBR is a vertebral body replacement system indicated for use in skeletally mature patients to replace a collapsed, damaged, diseased, or unstable vertebral body due to tumor or trauma (i.e. fracture) or for reconstruction following corpectomy performed to achieve decompression of the spinal tissues. The device is intended for use in the cervical spine (from C3 to C7) and in the thoracolumbar spine (from T1-L5). The device is intended for use with supplemental fixation cleared by the FDA for use in the cervical, thoracic, or lumbar spine and is to be used with autogenous bone graft and/or allograft comprised of cancellous and/or corticocancellous bone graft.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| 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 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 is above the word "Medical", which is in gray.
510(k) Summary
| Submitted By: | Omnia Medical, LLC
6 Canyon Road Suite 300
Morgantown, WV 26508 |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date: | 8/27/19 |
| Contact Person:
Contact Telephone:
Contact Fax: | Daniel Johnson, Regulatory Engineer
(440) 541-0060
(440) 933-7839 |
| Device Trade Name:
Device Classification Name:
Device Classification:
Reviewing Panel:
Product Code:
Primary Predicate Device:
Additional Predicate Device: | Omnia Medical VBR
Spinal intervertebral body fixation orthosis (21 CFR 888.3060)
Class II
Orthopedic
PLR, MQP
NuVasive® Monolith™ Cervical Corpectomy System (K180550)
The predicate device has never been subject to a recall.
Omnia Medical VBR (K172323) |
| | The additional predicate device has never been subject to a recall. |
Device Description:
The Omnia Medical VBR is manufactured from PEEK-OPTIMA™ HA Enhanced and tantalum markers conforming to ASTM F560. This implant is available in two footprint sizes and offers spacers and endplates which allow for fine adjustments of the height and lordosis to accommodate various patient anatomy. The device features a hollow center and through holes for use with autograft to encourage formation of new bone. The device is intended to be used with supplemental fixation.
Indications for Use:
The Omnia Medical VBR is a vertebral body replacement system indicated for use in skeletally mature patients to replace a collapsed, diseased, or unstable vertebral body due to tumor or trauma (i.e. fracture) or for reconstruction following corpectomy performed to achieve decompression of the spinal cord and neural tissues. The device is intended for use in the cervical spine (from C3 to C7) and in the thoracolumbar spine (from T1-L5). The device is intended for use with supplemental fixation cleared by the FDA for use in the cervical, thoracic, or lumbar spine and is to be used with autogenous bone graft and/or allograft comprised of cancellous and/or corticocancellous bone graft.
Summary of Technological Characteristics:
The Omnia Medical VBR and the predicates have the same intended use and fundamental scientific technology. The Omnia Medical VBR and the predicates demonstrate substantial equivalence based on the following characteristics:
- Design features and function ●
- Device components
- . Footprint sizes
4
Image /page/4/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, followed by the words "Omnia Medical" in a serif font. The word "Omnia" is in navy blue, and the word "Medical" is in gray. The logo is clean and professional, suggesting a company in the healthcare or medical field.
- Endplate angles
- Graft openings
- Insertion features
- Materials .
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, subsidence per ASTM F2267, and expulsion testing. This data was presented in the reference predicate submission (K172323) to demonstrate substantial equivalence. No new device designs or worst-case sizes are being introduced. The previously submitted data supports the expanded indications for use.
Conclusion:
Based on the indications for use, technological characteristics, and comparison with the predicate devices, the subject device has demonstrated substantial equivalence.