(41 days)
No
The summary describes a physical intervertebral body fusion device made of PEEK and tantalum markers. There is no mention of software, algorithms, or any computational processing that would suggest the use of AI or ML. The performance studies are based on mechanical testing of the device itself and predicate devices, not on the performance of an AI/ML algorithm.
Yes.
The device is used for intervertebral body fusion procedures to treat degenerative disc disease, which qualifies it as a therapeutic device.
No
This device is a spinal implant (intervertebral body fusion device) used to treat degenerative disc disease, not to diagnose it. Its purpose is mechanical support and fusion, not diagnostic assessment.
No
The device description clearly states it is manufactured from PEEK and tantalum markers, indicating it is a physical implant, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for intervertebral body fusion procedures in patients with degenerative disc disease. This is a surgical implant used in vivo (within the body) to treat a medical condition.
- Device Description: The description details a physical implant made of PEEK and tantalum, designed to be placed between vertebrae.
- Lack of IVD Characteristics: An IVD is a medical device used in vitro (outside the body) to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not perform any such function.
The information provided describes a surgical implant, not a diagnostic test performed on biological samples.
N/A
Intended Use / Indications for Use
The Omnia Medical Rotary PLIF System is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). This device is to be used with autogenous bone graft. The Omnia Medical Rotary PLIF System is to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral body fusion device.
Product codes
MAX
Device Description
The Omnia Medical Rotary PLIF is manufactured from PEEK-OTIMA™ LT1 conforming to ASTM F2026 and tantalum markers conforming to ASTM F560. The Omnia Rotary PLIF is rectangular in shape and available in various sizes with heights ranging from 9mm to 17mm and 0° or 7° of lordosis. The leading end is tapered or bulleted for ease of insertion. All devices are 25mm in length. The device has six tantalum markers for radiographic confirmation of device position and orientation. 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
Radiographic studies
Anatomical Site
L2-S1
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Mechanical Testing:
Engineering rationales were provided to leverage the mechanical testing of the predicates for this submission. Mechanical testing on the predicate included static and dynamic compression per ASTM F2077, static and dynamic torsion per ASTM F2077, subsidence per ASTM F2267, and expulsion testing. These rationales and performance tests support substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Atlas Spine Spacer (K091406)
Reference Device(s)
Atlas Spine Vertebral Body Replacement (K063205)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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February 6, 2018
Omnia Medical, LLC % Mr. Daniel Johnson Regulatory Engineer JALEX Medical 30311 Clemens Road, Suite 5D Westlake, Ohio 44145
Re: K183659
Trade/Device Name: Omnia Medical Rotary PLIF System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX Dated: December 26, 2018 Received: December 27, 2018
Dear Mr. 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
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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/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 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) K183659
Device Name Omnia Medical Rotary PLIF System
Indications for Use (Describe)
The Omnia Medical Rotary PLIF System is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). This device is to be used with autogenous bone graft. The Omnia Medical Rotary PLIF System is to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment with an intervertebral body fusion device.
| 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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510(k) Summary
| Submitted By: | Omnia Medical, LLC
6 Canyon Rd Suite 300
Morgantown, WV 26508 |
|-----------------------------|---------------------------------------------------------------------|
| Date: | 12/26/2018 |
| Contact Person: | Daniel Johnson |
| Contact Telephone: | (440) 541-0060 |
| Contact Fax: | (440) 933-7839 |
| Device Trade Name: | Omnia Medical Rotary PLIF System |
| Device Classification Name: | Intervertebral Body Fusion Device (21 CFR 888.3080) |
| Device Classification: | Class II |
| Reviewing Panel: | Orthopedic |
| Product Code: | MAX |
| Primary Predicate Device: | Atlas Spine Spacer (K091406) |
| | The predicate device has never been subject to a recall |
| Reference Device: | Atlas Spine Vertebral Body Replacement (K063205) |
Device Description:
The Omnia Medical Rotary PLIF is manufactured from PEEK-OTIMA™ LT1 conforming to ASTM F2026 and tantalum markers conforming to ASTM F560. The Omnia Rotary PLIF is rectangular in shape and available in various sizes with heights ranging from 9mm to 17mm and 0° or 7° of lordosis. The leading end is tapered or bulleted for ease of insertion. All devices are 25mm in length. The device has six tantalum markers for radiographic confirmation of device position and orientation. The device is intended to be used with supplemental fixation.
Indications for Use:
The Omnia Medical Rotary PLIF System is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). This device is to be used with autogenous bone graft. The Omnia Medical Rotary PLIF System is to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral body fusion device.
Summary of Technological Characteristics:
The Omnia Medical Stature Spacer and the predicate have the same intended use and fundamental scientific technology. Both devices compare similarly in:
- Design features
- Intended use
- Materials
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- Dimensions
- Function ●
Mechanical Testing:
Engineering rationales were provided to leverage the mechanical testing of the predicates for this submission. Mechanical testing on the predicate included static and dynamic compression per ASTM F2077, static and dynamic torsion per ASTM F2077, subsidence per ASTM F2267, and expulsion testing. These rationales and performance tests support substantial equivalence.
Conclusion:
Based on the indications for use, technological characteristics, and comparison with the predicate device, the subject device has demonstrated substantial equivalence.