EBI OMEGA 21 SYSTEM by ELECTRO-BIOLOGY, INC.

The EBI Ornega 21™ System is a spinal fixation device for pedicle screw fixation and a nombedicle 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 of neurologic impairment, fracture, dislocations, scoliosis, kyphosis, spinal tumor, and failed previous fusion (psuedarthrosis).

In addition, when used as a pedicle system in skeletally mature patients, it is intended for patients: (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar - first saxral (LS-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 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/iliar screw fixation system, the levels of attachment are the lumbar and thoracc spine, and screw fixation limited to the sacrum and ilium. The System is intended for the treatment of degenerative disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). Psuedarthrosis; stenosis; scollosis; spondylolisthesis, fracture; previous failed fusion; or tumor resection.

When used as an anterior fixation system, the levels of attachment are the anterolateral vertebral 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). Psuedarthrosis; stenosis; spondylolisthesis, fracture; previous failed fusion; or tumor resection.

Device Description

The EBI Omega 21™ System is a spinal fixation device that uses rods, screws, and couplers. This submission is to revise the labeling in accordance with the FDA Final Rule dated July 27, 1998, "Orthopedic Devices: Classification and Reclassification of Pedicle Screw Spinal Systems", and introduce the availability of two shorter length rods.

AI/ML Overview

This document is a 510(k) summary for the EBI Omega 21™ System, a spinal fixation device. It describes the device, its intended use, and its substantial equivalence to previously cleared devices.

Here's an analysis of the document concerning acceptance criteria and supporting studies, based on the provided text:

Acceptance Criteria and Device Performance

The provided document does not explicitly state specific acceptance criteria in terms of discrete performance metrics (e.g., accuracy, sensitivity, specificity, mechanical strength thresholds, etc.) nor does it present a study demonstrating the device meets such criteria with reported performance values.

Instead, the submission focuses on demonstrating substantial equivalence to predicate devices. The "acceptance criteria" are implied by the regulatory requirements for spinal fixation devices and the comparison to established predicate devices.

Implied Acceptance Criteria and Device Characteristics:

Acceptance Criteria (Implied by Regulatory Standards & Predicate Comparison)	Reported Device Performance (from K990303)
Material Composition Compliance: Components meet relevant ASTM standards for biocompatibility and mechanical properties.	Components manufactured from Ti-6Al-4V ELI per ASTM F136. Compliance with biocompatibility standards (stated as a special control).
Mechanical Testing Compliance: Device components withstand mechanical stress relevant to spinal fixation applications (e.g., fatigue, static strength).	Compliance with mechanical testing standards (stated as a special control). No specific performance data (e.g., load capacity, cycles to failure) is provided within this summary.
Intended Use Equivalence: Device indications for use are the same as or very similar to predicate devices, addressing similar spinal conditions.	Intended Use is unchanged from previously cleared EBI Omega 21™ System (K973683). Indications include degenerative spondylolisthesis, fracture, dislocations, scoliosis, kyphosis, spinal tumor, failed previous fusion, severe spondylolisthesis (Grades 3 & 4 L5-S1), degenerative disc disease, pseudarthrosis, stenosis, etc. These match predicate's use.
Technological Characteristics Equivalence: Device technology (design, function) is similar to predicate devices.	"No significant differences between the EBI Omega 21™ System and other currently marketed spinal systems." "Substantially equivalent to the predicate devices in regards to intended use, materials and function."
Labeling Compliance: Adheres to FDA labeling regulations, including specific warnings and precautions for pedicle screw systems.	Revised labeling in accordance with FDA Final Rule (July 27, 1998, "Orthopedic Devices: Classification and Reclassification of Pedicle Screw Spinal Systems"). Includes specific warnings and precautions.

Study Details (Based on available information in the K990303 document):

The document does not describe a clinical study or a standalone performance study with a test set, ground truth, or expert involvement. The primary "study" or evidence presented for this 510(k) submission is a comparison to predicate devices and adherence to recognized standards.

Here's an attempt to address the requested points based solely on the provided text, noting where information is absent:

Sample size used for the test set and the data provenance: Not applicable. No specific test set data is mentioned for performance evaluation in a clinical or standalone study. The substantiation is based on material compliance, mechanical testing standards, and predicate device equivalence.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No specific test set requiring ground truth establishment by experts is described.
Adjudication method for the test set: Not applicable. No test set requiring adjudication is described.
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: Not applicable. This device is a mechanical spinal fixation system, not an AI-assisted diagnostic or analysis tool. Therefore, an MRMC study related to AI assistance is irrelevant and not mentioned.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical medical device, not an algorithm. Standalone performance, in this context, would refer to mechanical testing, which is mentioned as a "special control" that the device "meets", but no specific study results are provided in this summary.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable to a performance study for this device as described in the summary. For a spinal implant, "ground truth" might refer to long-term clinical outcomes or successful fusion, but this document does not present such data for this submission; it relies on the predicate device's established safety and effectiveness.
The sample size for the training set: Not applicable. This is not an algorithm requiring a training set.
How the ground truth for the training set was established: Not applicable. This is not an algorithm requiring a training set.

Summary of the Document's Approach to Demonstrating Safety and Effectiveness:

The K990303 submission for the EBI Omega 21™ System demonstrates safety and effectiveness primarily through substantial equivalence to predicate devices. This means the manufacturer argues that:

The device's materials, design, and function are highly similar to devices already legally marketed.
Its intended use is identical or very similar to the predicate device.
It complies with relevant consensus standards for materials and mechanical testing (though specific results are not detailed in this summary).
Its labeling meets current regulatory requirements.

The mention of "Compliance with mechanical testing standards" indicates that such testing was done, and the device met those standards, serving as the primary technical performance "study" for a device of this type in a 510(k) submission. However, the details of those tests (e.g., number of samples, specific loads, pass/fail criteria, actual performance results) are not included in this high-level summary.

Summary

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4/29/99

K990303

510(k) Summary of Safety & Effectiveness

This 510(k) Summary of Safety and Effectiveness for the EBI Omega 21TM System is provided as required per Section 513(I)(3) of the Federal Food, Drug and Cosmetic Act.

Jon Caparotta, Manager Regulatory Affairs 1. Sponsor: Electro-Biology, Inc. 100 Interpace Parkway Parsippany, NJ 07054

Contact Person: Jonas Wilf Telephone: (973) 299-9300

Date prepared: January 29, 1998

Proprietary Name: Common Name: Classification Names:

EBI Omega 21 TM System Spinal Fixation Device Spondylolisthesis Spinal Fixation Device System Spinal Intervertebral Body Fixation Orthosis Spinal Interlaminal Fixation Orthosis

1. Predicate or legally marketed devices that are substantially equivalent:
  · EBI Omega 21 TM System
Description of the device: The EBI Omega 21™ System is a spinal fixation device 4. that uses rods, screws, and couplers. This submission is to revise the labeling in accordance with the FDA Final Rule dated July 27, 1998, "Orthopedic Devices: Classification and Reclassification of Pedicle Screw Spinal Systems", and introduce the availability of two shorter length rods.
Intended Use: The EBI Omega 21™ System has not changed the Indications for Use or 5. fundamental scientific technology of the previously cleared EBI Omega 21™ System (K973683). The EBI Omega 21™ System is a spinal fixation device for pedicle screw fixation and a 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 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, spunal tumor, and failed previous fusion (psuedarthrosis).

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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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 disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). Psuedarthrosis; stenosis; scoliosis; spondylolisthesis, fracture; previous failed fusion; or tumor resection.

When used as an anterior fixation system, the levels of attachment are the anterolateral vertebral 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). Psuedathrosis; stenosis; scoliosis; spondylolisthesis, fracture; previous failed fusion; or tumor resection.

Materials: The components of the system are manufactured from Ti-6Al-4V ELI per 6. ASTM F136.
1. Comparison of the technological characteristics of the device to predicate devices: 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. The system complicable standards, and meets all of its functional requirements, and meets the required special controls listed below:
- (i) Compliance with material standards.
- Compliance with mechanical testing standards. (ii)
- (iii) Compliance with biocompatibility standards.
- (iv) Labeling which contains the following 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 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."

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 type of evidence in patent infringement itiggition. [Establishing 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 shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines representing the profiles of human faces.

Food and Druq Administration 9200 Corporate Boulevard Rockville MD 20850

APR 2 9 1999

Mr. Jon Caparotta Manager, Regulatory Affairs Electro-Biology, Inc. 100 Interpace Parkway 07054 Parsippany, New Jersey

Re: K990303 Omega 21™ System Trade Name: Requlatory Class: II Product Codes: KWP, KWQ, MNH, and MNI Dated: January 29, 1999 February 1, 1999 Received:

Dear Mr. Caparotta:

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. ਜੋ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Requlation (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 requlation may result in regulatory In addition, FDA may publish further announcements action. 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. Jon Caparotta

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 requlation (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 toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

C. Colin M. Widdison, Ph.D.

ia 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:

The EBI Ornega 21™ System is a spinal fixation device for pedicle screw fixation and a nombedicle hook and sacral| iliac screw fixation system of the noncervical spine.

signature

on of General Restorative Devices K990303 Xk) Number

Prescription Use
(Per 21 CFR 801.109)

Regulation Number and Section

§ 888.3050 Spinal interlaminal fixation orthosis.

(a)
Identification. A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.(b)
Classification. Class II.