OMI OCCIPITAL CERVICAL LOOP, MODEL A1089 by OHIO MEDICAL INSTRUMENT CO., INC.

Degenerative disk disease of the cervical vertebrae (neck pain of discogenic origin with degeneration of the disk as confirmed by patient history and radiological studies).
Spondylolisthesis of the cervical vertebrae.
Spinal stenosis of the cervical vertebrae.
Atlanto/axial fracture with instability.
Cervical-occipital dislocation.
Revision of previous cervical fusion surgery.
Tumors.

Device Description

The OMI® Occipital Cervical Loop, Catalog Number A-1089, consists of the following components: Cervical Support Loop, Cross Link, Compression Blocks (2), Cervical Support Nuts (2), and an implantation instrument, the Cervical Support Wrench [11mm].

The OMI® Occipital Cervical Loop is a single-use, permanent device used to assist in stabilization and fusion of the occipital cervical region of the spine. It consists of the Cervical Support Loop [CSL], a contoured rod made of biocompatible titanium having an alloy composition of 6AL-4V ELI, according to ASTM-F136. The CSL is U-shaped, with a circular loop at one end and two free lengths extending lengthwise, parallel to each other, from the loop end. The profile of the CSL resembles that of a normal cervical lordosis from the cervical region of the spine to the occiput of the skull. The Cross Link can be attached to the free end lengths of the CSL for additional rigidity. The Cross Link is flat, with a slot at each end, and can be attached to the CSL with the Compression Blocks and Cervical Support Nuts. The Cross Link, Compression Blocks, and Cervical Support Nuts are also made from 6AL-4V ELI titanium.

These titanium alloy implants are designed for use with multi-filament braided titanium alloy [6Al, 4V] cable, .045 inch [1.1 mm] diameter, 19 inches in length, with a pure, soft titanium mono-filament lead wire 3 inches in length. This wire is Sofamor Danek Catalog # 826-360, the same type of wire cleared for use with Sofamor/Danek spinal devices.

AI/ML Overview

This document describes the 510(k) submission for the OMI® Occipital Cervical Loop, a spinal implant. The primary method for proving substantial equivalence to a predicate device (Ransford Cervical Fixation System™) is through performance testing.

Here's an analysis of the provided information regarding acceptance criteria and the supporting study:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the OMI® Occipital Cervical Loop are implicitly defined by performing "substantially the same" as the predicate device, the Ransford Cervical Fixation System™, in static and fatigue testing. The table below summarizes the comparative performance.

Acceptance Criteria (Implied)	Reported Device Performance (OMI® Occipital Cervical Loop vs. Predicate)
Static Testing
Stiffness	Higher stiffness than the predicate device.
Static Strength	Higher static strength than the predicate device.
Device Failures	No device failures.
Fatigue Testing
Fatigue Performance	Outperformed the predicate device at all load levels tested.
Failure Trend	Rod bending/fracture (Predicate: Rod bending).

2. Sample Size Used for the Test Set and Data Provenance

Sample Size:
- Static Tests: Five (5) tests were run for the OMI® Occipital Cervical Loop and five (5) tests for the predicate device.
- Fatigue Tests: Six (6) tests were run for the OMI® Occipital Cervical Loop and six (6) tests for the predicate device.
Data Provenance: The data is prospective, generated specifically for this 510(k) submission through physical testing of the devices. The country of origin for the testing data is not explicitly stated in the provided text, but the applicant is Ohio Medical Instrument Company, Inc. in Cincinnati, Ohio, USA.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

This section is not applicable. The study involves physical testing of the device, not a diagnostic or AI-based system requiring expert consensus on a test set.

4. Adjudication Method for the Test Set

This section is not applicable, as there is no human-based assessment or diagnostic task requiring adjudication. The results are from mechanical laboratory tests.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done

No, an MRMC comparative effectiveness study was not done. This device is a physical spinal implant, and the study focuses on its mechanical performance compared to a predicate device, not on human reader performance with or without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

No, a standalone algorithm performance study was not done. This device is a physical medical device, not an algorithm or AI system.

7. The Type of Ground Truth Used

The "ground truth" for this study is the objective mechanical performance of the devices under controlled laboratory conditions. This includes measurements of stiffness, static strength, and fatigue life.

8. The Sample Size for the Training Set

This section is not applicable. There is no "training set" as this is not an AI/machine learning model but a physical product undergoing mechanical performance testing.

9. How the Ground Truth for the Training Set Was Established

This section is not applicable, as there is no training set for a physical device undergoing mechanical performance testing.

Summary

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K983282

II. 510(k) SUMMARY AND CERTIFICATION

Summary of Safety and Effectiveness: OMI® Occipital Cervical Loop

Pursuant to Section 513(i) of the Federal Food, Drug and Cosmetic Act, as amended by the Safe Medical Devices Act [SMDA] of 1990.

Summary Preparation Date: November 4, 1998

1. General Information:
  Classification Name: Appliance, Fixation, Spinal Interlaminar Common/Usual Name: Cervical spinal implant Proprietary Name: OMI® Occipital Cervical Loop

Applicant's/Submitter's Name and Address & Registration Number:

Ohio Medical Instrument Company, Inc. (OMI) 4900 Charlemar Drive Cincinnati, Ohio 45227

Registration Number: 1525725 Contact Name: Kenneth B. Miller Contact Title: Regulatory Affairs/Quality Assurance Director Contact Phone Number: (513) 561-2705 Contact Fax Number: (513) 561-0195

2. Name of predicate device(s):

Ransford Cervical Fixation System™

3. Classification:

$888.3050 Spinal interlaminar 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.

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4. Performance Standards:

No applicable performance standards have been established by FDA under section 514 of the Food, Drug and Cosmetic Act.

ક. Intended Use and Device Description:

Intended Use:

To assist stabilization and fusion of the cervical spine and cervical occipital junction.

Indications for Use:

Degenerative disk disease of the cervical vertebrae (neck pain of 1. discogenic origin with degeneration of the disc as confirmed by patient history and radiological studies),
Spondylolisthesis of the cervical vertebrae, 2.
Spinal stenosis of the cervical vertebrae, റ്റ്
1. Atlanto/axial fracture with instability,
ട. Cervical-occipital dislocation,
Revision of previous cervical fusion surgery, 6.
Tumors. 7.

Device Description:

The OMI® Occipital Cervical Loop, Catalog Number A-1089, consists of the following components: Cervical Support Loop

Cross Link, Compression Blocks (2), Cervical Support Nuts (2),

and an implantation instrument, the Cervical Support Wrench [11mm].

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Summary of Substantial Equivalence: 6.

The OMI® Occipital Cervical Loop is substantially equivalent to the following device:

·The Ransford Cervical Fixation System™, K965221.

Indications:

·The indications for the OMI® Occipital Cervical Loop are identical to the indications for the predicate device, the Ransford Cervical Fixation System™, currently marketed by Surgicraft, Ltd.

Design:

·Both the OMI® Occipital Cervical Loop and the Ransford Cervical Fixation System™ are posterior attachment surgical approach systems.
•Both systems may be used to treat the same medical or surgical conditions of the cervical spine.
·Both systems have essentially the same cautions and contraindications for use.
·Both are basic spinal rod, crosslink and sublaminar wiring systems.
·Both systems may be attached to the occiput via burr holes and wires.

The concept of sublaminar wires and contoured rods placed posteriorly has been in common use for over 35 years. Most orthopedic and neurosurgery physicians are extensively experienced in these techniques and may be expected to adapt readily to the OMI® Occipital Cervical Loop.

Materials:

·Both the OMI® Occipital Cervical Loop and the predicate device utilize similar titanium implant materials that meet the various BS, ISO and ASTM standards.

Performance:

•Results of comparison static testing and fatique testing demonstrate that the OMI® Occipital Cervical Loop performs substantially the same as the predicate device. Five (5) static tests and six (6) fatigue tests were run of each of the OMI® Occipital Cervical Loop and the predicate device. The static tests results show the OMI® Occipital Cervical Loop to have higher stiffness and static strength than the predicate device. There were no device failures during the static tests. The fatigue tests results show the OMI® Occipital Cervical Loop outperformed the predicate device at all load levels tested. The OMI® Occipital Cervical Loop failure trend was rod bending/fracture, with the predicate device failure trend being rod bending.

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7. Packaging:

All OMI® Occipital Cervical Loops and instruments are supplied in industry standard medical grade packaging suitable for surgical implants and instruments. Shippers and boxes are of suitable design and materials to ensure product identification and protection from damage during shipping and storage.

8. Sterilization:

All OMI® Occipital Cervical Loops and instruments are supplied NON-STERILE. These non-sterile implants are packaged in "clean" condition, after processing to remove manufacturing residue and debris. All OMI® Occipital Cervical Loops and instruments must be removed from their shipping and packing materials, then washed and rinsed thoroughly, and sterilized before they may be used.

The recommended sterilization method, time and temperature for the OMI® Occipital Cervical Loops and instruments is gravity steam sterilization for 30 minutes at 121° C (250° F). The Sterility Assurance Level (SAL) of the recommended sterilization cycle is 106 (SAL 10°). Validation of the recommended sterilization cycle has been conducted by Surgicraft, Ltd. for the Ransford Cervical Fixation System™, and will be valid for the substantially equivalent OMI® Occipital Cervical Loops and instruments. Independent validation of this sterilization cycle, or an equivalent cycle, using method AAMI-TIR-12-1994, will be completed by OMI for the OMI® Occipital Cervical Loop and instrument prior to offering them for sale.

9. Conclusion:

Static tests and fatigue tests were conducted comparing the OMI® Occipital Cervical Loop to the Ransford Cervical Fixation System™. The results are discussed below.

Five (5) static tests and six (6) fatigue tests were run of each of the OMI® Occipital Cervical Loop and the predicate device. The static tests results show the OMI® Occipital Cervical Loop to have higher stiffness and static strength than the predicate device. There were no device failures during the static tests. The fatigue tests results show the OMI® Occipital Cervical Loop outperformed the predicate device at all load levels tested. The OMI® Occipital Coop failure trend was rod bending/fracture, with the predicate device failure trend being rod bending.

Based on the information provided above, Ohio Medical Instrument Company, Inc. considers the OMI® Occipital Cervical Loop to be equivalent to the predicate device.

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10. Comparison Table

FEATURE	OMI® Occipital CervicalLoop	Ransford Cervical FixationSystem™	SE?
Intended Use:	• Surgical stabilization aloneand surgical stabilization andfusion of the cervical spineand cervical occipital junction.	• Surgical stabilization aloneand surgical stabilization andfusion of the cervical spineand cervical occipital junction.	YES
Indications forUse:	• Degenerative disk disease ofthe cervical vertebrae [neckpain of discogenic origin withdegeneration of the disk asconfirmed by patient historyand radiological studies],• Spondylolisthesis of thecervical vertebrae,• Spinal stenosis of the cervicalvertebrae,• Atlanto/axial fracture withinstability,• Cervical-occipital dislocation,• Revision of previous cervicalfusion surgery,• Tumors.	• Degenerative disk disease ofthe cervical vertebrae [neckpain of discogenic origin withdegeneration of the disk asconfirmed by patient historyand radiographic studies],• Spondylolisthesis of thecervical vertebrae,• Spinal stenosis of the cervicalvertebrae,• Atlanto/axial fracture withinstability,• Cervical-occipital dislocation,• Revision of previous cervicalspine surgery,• Tumors.	YES
Materials:	• Titanium.	• Titanium or stainless steel.	YES
SurgicalApproach:	• Posterior.	• Posterior.	YES
Method ofAttachment:	• Wires to occiput and posteriorarches.	• Wires to occiput and posteriorarches.	YES
K-Number:	• K983282	• K965221	YES
Manufacturer:	Ohio Medical InstrumentCompany, Inc.	Surgicraft, Ltd.	YES

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NOV 1 9 1998

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Kenneth B. Miller Regulatory Affairs and Ouality Assurance Director Ohio Medical Instrument Company, Inc. (OMI) 4900 Charlemar Drive Cincinnati, Ohio 45227

K983282 Re: OMI® Occipital Cervical Loop Regulatory Class: II Product Code: KWP Dated: September 17, 1998 Received: September 18, 1998

Dear Mr. Miller:

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 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). 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 requirements, 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 - Kenneth B. Miller

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" (21CFR 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/dsma/dsmamain.html".

Sincerely yours,

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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K983282 510(k) Number (if known):

Device Name: OMI® Occipital Cervical Loop

Indications For Use:

The OMI® Occipital Cervical Loop is intended to be used to assist stabilization and fusion of the cervical spine and cervical occipital junction.

1. Degenerative disk disease of the cervical vertebrae (neck pain of discogenic origin with degeneration of the disk as confirmed by patient history and radiological studies).
1. Spondylolisthesis of the cervical vertebrae.
1. Spinal stenosis of the cervical vertebrae.
1. Atlanto/axial fracture with instability.
1. Cervical-occipital dislocation.
1. Revision of previous cervical fusion surgery.
1. Tumors.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

cee8

Prescription Use (Per 21 CFR 801.109)

Over-The-Counter Use

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Page A-9

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.