(86 days)
The Omnia Medical VBR is a vertebral body replacement system indicated for use to replace a collapsed, or unstable vertebral body due to tumor or trauma (i.e. fracture). The device is intended for use as a vertebral body replacement in the thoracolumbar spine (from T1 to L5). The device is intended for use with supplemental fixation cleared for use in the thoracolumbar spine and is to be used with autograft and/or allograft.
The Omnia Medical VBR is manufactured from PEEK-OPTIMA™ HA Enhanced conforming to ASTM F2026 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 or allograft to encourage formation of new bone. The device is intended to be used with supplemental fixation.
The FDA 510(k) K172323 submission for the Omnia Medical VBR (Vertebral Body Replacement) provides the following information regarding its acceptance criteria and the study conducted:
1. Table of Acceptance Criteria and Reported Device Performance:
The document summarizes the type of mechanical testing performed, but does not explicitly state numerical acceptance criteria or specific reported performance values. The primary acceptance criterion appears to be demonstrating substantial equivalence to the predicate device (Vu Mesh VBR, K070381) through these mechanical tests.
| Acceptance Criteria Type | Reported Device Performance (as implied by the document) |
|---|---|
| Static Compression | Supports substantial equivalence |
| Dynamic Compression | Supports substantial equivalence |
| Static Torsion | Supports substantial equivalence |
| Dynamic Torsion | Supports substantial equivalence |
| Subsidence | Supports substantial equivalence |
| Expulsion Testing | Supports substantial equivalence |
2. Sample Size Used for the Test Set and Data Provenance:
The document mentions that mechanical testing was performed per ASTM F2077 and ASTM F2267. These standards typically specify the number of samples required for such tests. However, the exact sample sizes used in this specific study are not explicitly stated in the provided text.
Data Provenance: The document does not specify the country of origin of the data or whether the study was retrospective or prospective. Given that it's mechanical testing of a device, the data would have been generated experimentally in a lab setting, likely in the US where Omnia Medical, LLC is located.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This information is not applicable as the study described is a mechanical performance test of a medical device, not a human or animal study requiring expert-established ground truth. The "ground truth" for mechanical testing is based on established engineering principles and ASTM standards.
4. Adjudication Method for the Test Set:
This information is not applicable for mechanical performance testing.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No, an MRMC comparative effectiveness study was not conducted. This type of study is typically performed for diagnostic or AI-assisted interpretation devices involving human readers. The Omnia Medical VBR is a physical implant, and its evaluation focuses on mechanical integrity.
6. If a Standalone Performance Study Was Done:
Yes, a standalone performance study was done in the form of mechanical testing of the device itself (algorithm only without human-in-the loop performance, if we consider the device's inherent mechanical properties as its "algorithm"). The document states: "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 indicates the device's performance was evaluated independently against established standards.
7. The Type of Ground Truth Used:
The "ground truth" for this study was based on established engineering standards and regulatory requirements (ASTM F2077, ASTM F2267) which define acceptable mechanical properties for spinal implants. The device's performance was compared to these standards and to the characteristics of a legally marketed predicate device.
8. The Sample Size for the Training Set:
This information is not applicable. Mechanical testing does not involve a "training set" in the context of machine learning or AI.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable.
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Omnia Medical, LLC % Kevin Majka Quality System/Regulatory Engineer JALEX Medical 30311 Clemens Road Suite 5D Westlake, Ohio 44145
October 26, 2017
Re: K172323
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: MQP Dated: July 28, 2017 Received: August 1, 2017
Dear Mr. Majka:
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. 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 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);
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and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely.
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation 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 to replace a collapsed, or unstable vertebral body due to tumor or trauma (i.e. fracture). The device is intended for use as a vertebral body replacement in the thoracolumbar spine (from T1 to L5). The device is intended for use with supplemental fixation cleared for use in the thoracolumbar spine and is to be used with autograft and/or allograft.
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 the letters "OM" in a blue square on the left, followed by the words "OMNIA MEDICAL" in blue, sans-serif font. The letters "OM" are stylized, with the "O" overlapping the "M".
510(k) Summary
| Submitted By: | Omnia Medical, LLC1000 Hampton Center Suite GMorgantown, WV 26505 |
|---|---|
| Date: | 07/28/2017 |
| Contact Person: | Kevin Majka, Quality System/Regulatory Engineer |
| Contact Telephone: | (440) 541-0060 |
| Contact Fax: | (440) 933-7839 |
| Device Trade Name: | Omnia Medical VBR |
| Device Classification Name: | Spinal intervertebral body fixation orthosis (21 CFR 888.3060) |
| Device Classification: | Class II |
| Reviewing Panel: | Orthopedic |
| Product Code: | MQP |
| Primary Predicate Device: | Vu Mesh VBR (K070381)The predicate device has never been subject to a recall. |
| Reference Devices: | Arena-C® HA PEEK Cervical Intervertebral Body Fusion Device(K142026)Talos®-C (HA) Cervical Intervertebral Body Fusion Devices (K142345) |
Device Description:
The Omnia Medical VBR is manufactured from PEEK-OPTIMA™ HA Enhanced conforming to ASTM F2026 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 or allograft 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 to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e. fracture). The device is intended for use as a vertebral body replacement in the thoracolumbar spine (from T1 to L5). The device is intended for use with supplemental fixation cleared for use in the thoracolumbar spine and is to be used with autograft and/or allograft.
Summary of Technological Characteristics:
The Omnia Medical VBR and the predicate have the same intended use and fundamental scientific technology. Both devices compare similarly in:
- Design features
- Intended use
- Materials
- Dimensions
- Function
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Image /page/4/Picture/0 description: The image is a logo for Omnia Medical. The logo features the letters "OM" in a blue square on the left side of the image. To the right of the square, the word "OMNIA" is written in large, blue letters, with the word "MEDICAL" written in smaller, blue letters below it.
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.
Conclusion:
Based on the indications for use, technological characteristics, and comparison with the predicate device, the subject device has demonstrated substantial equivalence.
§ 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.