(30 days)
The EBI Omega 21™ System is a spinal fixation device for pedicle screw fixation and a non-pedicle hook and sacral/Iliac screw fixation system of the non-cervical spine.
When used as a pedicle screw fixation system, in the non-cervical spine of skeletally mature patients, the System is intended to provide immobilization of spinal segments, as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: Degenerative spondylolisthesis with objective evidence of nuerologic impairment, fracture, dislocations, scoliosis, kyphosis, spinal tumor, and failed previous fusion. (pseudoarthrosis).
In addition, when used as a pedicle screw fixation system in skeletally mature patients, it is intended for patients: (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar - first sacral (L5 - S1) vertebral joint; (b) who are receiving fusions using autogenous bone graft only; (c) who are having the device fixed or attached to the lumbar and sacral spine (1,3 and below); and (d) who are having the device removed after the development of a solid fusion mass.
When used as a posterior hook and sacral/Iliac screw fixation system, the levels of attachment are the lumbar and thoracic spine, and screw fixation limited to the sacrum and ilium. The system is intended for the treatment of degenerative disk disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), pseudoarthrosis, stenosis, scoliosis, spondylolisthesis, fracture, previous failed fusion, or tumor resection.
When used as an anterior fixation system, the levels of attachment are the anterolateral bodies of the lumbar and thoracic spine. The system is intended for the treatment of degenerative disk disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), pseudoarthrosis, scoliosis, spondylolisthesis, fracture, previous failed fusion, or tumor resection.
The EBI Omega 21™ System is a spinal fixation device that uses rods, screws, couplers, and hooks. This submission is for the addition of top loading hooks to supplement the existing system. The components of the system are manufactured from Ti-6AI-4V ELI per ASTM F136.
Here's an analysis of the provided text regarding the EBI Omega21™ System, focusing on acceptance criteria and the supporting study, structured according to your request:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document (510(k) summary) does not explicitly state acceptance criteria or provide quantifiable device performance metrics in the typical sense of a diagnostic study. Instead, it focuses on demonstrating substantial equivalence to previously marketed devices. The "performance" assessment is based on mechanical testing to ensure the new component (top-loading hooks) meets functional requirements and applicable standards, implying that if it functions similarly and meets standards, it is acceptable.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Material Compatibility: Components made from specified, biocompatible material. | Components manufactured from Ti-6Al-4V ELI per ASTM F136. |
| Functional Equivalence: New components (top-loading hooks) perform similarly to existing parts of the system and predicate devices. | "Testing comparing the modifications to the previous system demonstrated that the device complies with applicable standards and meets all of its functional requirements." (Explicitly stated for the modified components) "There are no significant differences between the EBI Omega 21™ System and other currently marketed spinal systems. It is substantially equivalent to the predicate devices in regards to intended use, materials and function." |
| Compliance with Applicable Standards: The device meets relevant industry and regulatory standards for spinal fixation systems. | "Testing comparing the modifications to the previous system demonstrated that the device complies with applicable standards..." |
| Intended Use Equivalence: The modified device can be used for the same clinical indications as predicate devices. | The intended use statement for the EBI Omega 21™ System is provided and is considered substantially equivalent to predicate devices. |
| Safety: The device modification does not introduce new safety concerns compared to predicate devices. (Implied by substantial equivalence and compliance with standards) | Implicitly met by demonstrating functional equivalence, material standards, and "no significant differences" from predicate devices which are already deemed safe. |
2. Sample Size Used for the Test Set and Data Provenance
The provided document does not describe a clinical "test set" in the context of diagnostic performance evaluation with patient data. The "testing" mentioned refers to mechanical and functional testing of the new top-loading hooks. The sample size for such mechanical tests is not specified, nor is the provenance of data as it pertains to patient or clinical outcomes. This is a 510(k) for a medical device (spinal fixation system), not a diagnostic algorithm.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable to this document. The "ground truth" for a mechanical device is its specifications, design, and adherence to engineering principles and standards, not clinical expert consensus on patient data.
4. Adjudication Method for the Test Set
This information is not applicable to this document. Adjudication methods (like 2+1, 3+1) are used in clinical studies with human readers or evaluators, not for mechanical device testing where performance is often measured by objective engineering metrics.
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
This information is not applicable to this document. This is a submission for a spinal fixation device, not an AI or diagnostic imaging tool. There is no mention of AI assistance or human reader studies.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
This information is not applicable to this document. This is a medical device, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance, as implied by the document, is based on:
- Engineering specifications and standards: ASTM F136 for materials.
- Functional requirements: Demonstrated through "testing comparing the modifications to the previous system."
- Regulatory compliance: Adherence to FDA requirements for spinal fixation devices.
- Substantial equivalence: Comparison to predicate devices already established as safe and effective.
No pathology, expert consensus, or outcomes data is mentioned as a "ground truth" for this specific 510(k) submission.
8. The Sample Size for the Training Set
This information is not applicable to this document. "Training set" refers to data used to train algorithms, which is not relevant here.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable to this document.
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JAN 1 6 2002
510(k) Summary of Safety & Effectiveness
This 510(k) Summary of Safety and Effectiveness for the EBI Omega21™ System is provided as required per Section 513(1)(3) of the Food, Drug and Cosmetic Act.
Contact Person: Frederic Testa Submitter: EBI, L.P. 1. 100 Interpace Parkway Telephone: (973) 299-9300 Parsippany, NJ 07054
Date prepared: December 14, 2001
| 2. Proprietary Name: | EBI Omega 21™ System | |
|---|---|---|
| Common Name: | Spinal Fixation Device | |
| Classification Names: | Spondylolisthesis Spinal Fixation Device System | |
| Spinal Intervertebral Body Fixation Orthosis | ||
| Spinal Interlaminal Fixation Orthosis |
Predicate or legally marketed devices that are substantially equivalent: 3.
" EBI Omega 21™ System (K001357, K992333, K991721, K990303, and K973683)
- Description of the device: The EBI Omega 21™ System is a spinal fixation device that uses rods, 4. screws, couplers, and hooks. This submission is for the addition of top loading hooks to supplement the existing system.
- Intended Use: The EBI Omega 21™ System is a spinal fixation device for pedicle screw fixation and a ಸ. nonpedicle hook and sacral/iliac screw fixation system of the noncervical spine.
When used as a pedicle screw fixation system, in the non-cervical spine of skeletally mature patients, the System is intended to provide immobilization and stabilization of spinal segments, as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine: Degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocations, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).
In addition, when used as a pedicle screw fixation system in skeletally mature patients, it is intended for patients: (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar - first sacral (L5-S1) vertebral joint; (b) who are receiving fusions using autogenous bone graft only; (c) who are having the device fixed or attached to the lumbar and sacral spine (L3 and below); and (d) who are having the device removed after the development of a solid fusion mass.
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K014137 p²/₂
When used as a posterior hook and sacral/iliac screw fixation system, the levels of attachment are the lumbar and thoracic spine, and screw fixation limited to the sacrum and illium. The System is intended for the treatment of degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), pseudarthrosis, scoliosis, spondylolisthesis, fracture, previous failed fusion, or tumor resection.
When used as an anterior fixation system, the levels of attachment are the anterolateral bodies of the lumbar and thoracic spine. The System is intended for the treatment of degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), pseudarthrosis, scoliosis, spondylolisthesis, fracture, previous failed fusion, or tumor resection.
- Materials: The components of the system are manufactured from Ti-6AI-4V ELI per ASTM F136. 6.
- Comparison of the technological characteristics of the device to predicate devices: There are no 7. significant differences between the EBI Omega 21TM System and other currently marketed spinal systems. It is substantially equivalent* to the predicate devices in regards to intended use, materials and function. Testing comparing the modifications to the previous system demonstrated that the device complies with applicable standards and meets all of its functional requirements.
*Any statement made in conjunction with this submission regarding a determination of substantial equivalence to any other product is intended only to relate to whether the product can be lawfully market approval or reclassification and is not intended to be interpreted as an admission or any other in patent infringement litigation. [Establishment Registration and Premarket Notification Procedures, Final Regulation, Preamble, August 23, 1977, FR 42520 (Docket No. 76N-0355.)]
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Image /page/2/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Frederic Testa Regulatory Affairs Specialist EBI, L.P. 100 Interpace Parkway Parsippany, New Jersey 07054
JAN 1 6 2002
K014137 Trade Name: EBI Omega 21™ System Regulatory Number: 21 CFR 888.3070, 21 CFR 888.3070, 21 CFR 888.3050, 21 CFR 888.3060 Regulation Name: Pedicle Screw Spinal System, Spinal Interlaminal Fixation, Orthosis, Spondylolisthesis Spinal Fixation Device System, Spinal Intervertebral Body Fixation Orthosis Regulatory Class: II Product Code: MNH, MNI, KWP, KWQ Dated: December 14, 2001 Received: December 17, 2001
Dear Mr. Testa:
Re:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Mr. Frederic Testa
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its tollfree number (800) 638-2041 or at (301) 443-6597, or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Mark N Millman
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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STATEMENT OF INDICATIONS FOR USE
510(k) Number (if known): K014131
Device Name: EBI Omega 21™ System
Indications For Use:
for Mark A. Miller
Page 1 of 1
(Division Sign-Off)
ad Neurological Devic
510(k) Number _
The EBI Omega 21™ System is a spinal fixation device for pedicle screw fixation and a non-pedicle hook and sacral/Iliac screw fixation system of the non-cervical spine.
When used as a pedicle screw fixation system, in the non-cervical spine of skeletally mature patients, the System is intended to provide immobilization of spinal segments, as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: Degenerative spondylolisthesis with objective evidence of nuerologic impairment, fracture, dislocations, scoliosis, kyphosis, spinal tumor, and failed previous fusion. (pseudoarthrosis).
In addition, when used as a pedicle screw fixation system in skeletally mature patients, it is intended for patients: (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar - first sacral (L5 - S1) vertebral joint; (b) who are receiving fusions using autogenous bone graft only; (c) who are having the device fixed or attached to the lumbar and sacral spine (1,3 and below); and (d) who are having the device removed after the development of a solid fusion mass.
When used as a posterior hook and sacral/Iliac screw fixation system, the levels of attachment are the lumbar and thoracic spine, and screw fixation limited to the sacrum and ilium. The system is intended for the treatment of degenerative disk disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), pseudoarthrosis, stenosis, scoliosis, spondylolisthesis, fracture, previous failed fusion, or tumor resection.
When used as an anterior fixation system, the levels of attachment are the anterolateral bodies of the lumbar and thoracic spine. The system is intended for the treatment of degenerative disk disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), pseudoarthrosis, scoliosis, spondylolisthesis, fracture, previous failed fusion, or tumor resection.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
§ 888.3070 Thoracolumbosacral pedicle screw system.
(a)
Identification. (1) Rigid pedicle screw systems are comprised of multiple components, made from a variety of materials that allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. Such a spinal implant assembly consists of a combination of screws, longitudinal members (e.g., plates, rods including dual diameter rods, plate/rod combinations), transverse or cross connectors, and interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors).(2) Semi-rigid systems are defined as systems that contain one or more of the following features (including but not limited to): Non-uniform longitudinal elements, or features that allow more motion or flexibility compared to rigid systems.
(b)
Classification. (1) Class II (special controls), when intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). These pedicle screw spinal systems must comply with the following special controls:(i) Compliance with material standards;
(ii) Compliance with mechanical testing standards;
(iii) Compliance with biocompatibility standards; and
(iv) Labeling that contains these two statements in addition to other appropriate labeling information:
“Warning: The safety and effectiveness of pedicle screw spinal systems have been established only for spinal conditions with significant mechanical instability or deformity requiring fusion with instrumentation. These conditions are significant mechanical instability or deformity of the thoracic, lumbar, and sacral spine secondary to severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra, degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). The safety and effectiveness of these devices for any other conditions are unknown.”
“Precaution: The implantation of pedicle screw spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this pedicle screw spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient.”
(2) Class II (special controls), when a rigid pedicle screw system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion in the treatment of degenerative disc disease and spondylolisthesis other than either severe spondylolisthesis (grades 3 and 4) at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment. These pedicle screw systems must comply with the following special controls:
(i) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use.
(ii) Non-clinical performance testing must demonstrate the mechanical function and durability of the implant.
(iii) Device components must be demonstrated to be biocompatible.
(iv) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments.
(v) Labeling must include the following:
(A) A clear description of the technological features of the device including identification of device materials and the principles of device operation;
(B) Intended use and indications for use, including levels of fixation;
(C) Identification of magnetic resonance (MR) compatibility status;
(D) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user; and
(E) Detailed instructions of each surgical step, including device removal.
(3) Class II (special controls), when a semi-rigid system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion for any indication. In addition to complying with the special controls in paragraphs (b)(2)(i) through (v) of this section, these pedicle screw systems must comply with the following special controls:
(i) Demonstration that clinical performance characteristics of the device support the intended use of the product, including assessment of fusion compared to a clinically acceptable fusion rate.
(ii) Semi-rigid systems marketed prior to the effective date of this reclassification must submit an amendment to their previously cleared premarket notification (510(k)) demonstrating compliance with the special controls in paragraphs (b)(2)(i) through (v) and paragraph (b)(3)(i) of this section.