(272 days)
Synthes OC Fusion System is intended to provide stabilization to promote fusion of the occipital-cervical junction. A complete occipital-cervical-thoracic construct can be created by using hooks (C1-T3) that have been previously cleared within the Synthes CerviFix System and the Synthes Axon System.
Synthes OC Fusion System is indicated for the following:
- Degenerative disc disease of the cervical vertebrae (neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies)
- Spondylolisthesis
- Spinal Stenosis
- Fracture/Dislocation
- Atlanto/axial fracture with instability
- Occipital-cervical dislocation
- Revision of previous cervical spine surgery
- Tumors (primary and metastatic)
The use of screws is limited to placement in the occiput. Screws are not intended to be placed in the cervical spine.
The Synthes OC Fusion System consists of occipital plates, occipital screws, occipital clamps, and rods intended to provide stabilization to promote fusion of the occipital-cervical junction. This system allows an occipital-cervical construct of either the occipital plate and rods or occipital clamps and rods. Rods are connected to the occipital plate or occipital clamps using a locking screw. A complete occipital-cervical-thoracic construct can be created by using hooks (C1-T3) that have been previously cleared within the Synthes CerviFix System and the Synthes Axon System.
The occipital bone screws are available in 4.5mm and 5.0mm diameters in lengths from 4mm to 18mm. Variable angle screw insertion is possible.
The occipital clamps are available in either a one-hole or two-hole configuration. The occipital plate is available in two sizes in either a medial or lateral configuration for a total of four available plates.
The plates are manufactured from commercially pure Titanium, grade 4. The rod connection points (rod clamps) in the plate are manufactured from Titanium Aluminum Niobium (Ti-6Al-7Nb) as are the occipital clamps, rods, and occipital screws.
The provided text describes the 510(k) summary for the Synthes OC Fusion System, a medical device. This document focuses on demonstrating substantial equivalence to predicate devices through non-clinical performance data (bench testing), rather than clinical studies or the use of AI. Therefore, many of the requested categories related to AI performance, clinical trials, and ground truth establishment are not applicable.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate Devices (K982322) in design, function, material, and intended use. | Non-Clinical Performance: Bench testing results demonstrated that the Synthes OC Fusion System is substantially equivalent to the predicate devices. |
| (No explicit numerical acceptance criteria for performance metrics were stated in this summary.) |
Study Proving Device Meets Acceptance Criteria:
A non-clinical performance study (bench testing) was conducted to demonstrate substantial equivalence. The document states: "Bench testing results demonstrate that the Synthes OC Fusion System is substantially equivalent to the predicate devices."
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided in the given 510(k) summary. The document focuses on bench testing, not a clinical test set with patient data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts
This information is not applicable/not provided. The device approval is based on non-clinical bench testing, not on clinical data requiring expert-established ground truth.
4. Adjudication Method for the Test Set
This information is not applicable/not provided. Adjudication methods are relevant for clinical studies involving human assessments, which were not part of this submission for substantial equivalence.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and what was the effect size of how much human readers improve with AI vs without AI assistance
No, an MRMC comparative effectiveness study was not done. This device is a physical implant, not an AI-powered diagnostic or assistive tool, and the submission did not include clinical studies.
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 implant, not an AI algorithm.
7. The Type of Ground Truth Used
The "ground truth" for this device's acceptance was established through engineering specifications and performance standards applicable to spinal fixation systems, as evaluated via bench testing against the predicate device. It was not based on expert consensus, pathology, or outcomes data in a clinical trial.
8. The Sample Size for the Training Set
This information is not applicable/not provided. There is no mention of a "training set" as this is not an AI/machine learning device. The design and manufacturing processes follow established engineering principles and quality system regulations.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable/not provided. As there is no AI training set, there is no ground truth established for it. The "ground truth" in the context of this device's development would relate to validated engineering principles and material properties used in its design and manufacturing.
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K053418
Page 1 of 3
510(k) Summary
SEP -6 2006
| 510(k) Summary | |
|---|---|
| Name of Firm: | Synthes Spine1302 Wrights Lane EastWest Chester, PA 19380 |
| 510(k) Contact: | Susan LewandowskiManager, Spine Regulatory AffairsTelephone: 610-719-5712Facsimile: 610-719-5102Email: Lewandowski.susan@synthes.com |
| Date Prepared: | August 28, 2006 |
| Trade Name: | Synthes OC Fusion System |
| Common Name: | Posterior, Cervical, Non-pedicle System |
| Classification: | 21 CFR 888.3050 Spinal Interlaminal Fixation OrthosisClass IIOrthopaedic and Rehabilitation Devices PanelProduct Code KWP |
| Predicate Device(s): | K982322 - Synthes Occipital-Cervical Plate/Rod and HookSystem, cleared November 25, 1998 |
:
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| Device Description: | The Synthes OC Fusion System consists of occipital plates,occipital screws, occipital clamps, and rods intended to providestabilization to promote fusion of the occipital-cervical junction.This system allows an occipital-cervical construct of either theoccipital plate and rods or occipital clamps and rods. Rods areconnected to the occipital plate or occipital clamps using alocking screw. A complete occipital-cervical-thoracic constructcan be created by using hooks (C1-T3) that have been previouslycleared within the Synthes CerviFix System and the Synthes AxonSystem.The occipital bone screws are available in 4.5mm and 5.0mmdiameters in lengths from 4mm to 18mm. Variable angle screwinsertion is possible.The occipital clamps are available in either a one-hole or two-holeconfiguration. The occipital plate is available in two sizes ineither a medial or lateral configuration for a total of four availableplates.The plates are manufactured from commercially pure Titanium,grade 4. The rod connection points (rod clamps) in the plate aremanufactured from Titanium Aluminum Niobium (Ti-6Al-7Nb)as are the occipital clamps, rods, and occipital screws. |
|---|---|
| Intended Use /Indications for Use: | Synthes OC Fusion System is intended to provide stabilization topromote fusion of the occipital-cervical junction. A completeoccipital-cervical-thoracic construct can be created by usinghooks (C1-T3) that have been previously cleared within theSynthes CerviFix System and the Synthes Axon System.Synthes OC Fusion System is indicated for the following: DDD ofthe cervical vertebrae (neck pain of discogenic origin withdegeneration of the disc as confirmed by patient history andradiographic studies), spondylolisthesis, spinal stenosis,atlanto/axial fracture with instability, occipital-cervicaldislocation, revision of previous cervical spine surgery, andtumors (primary and metastatic)The use of screws is limited to placement in the occiput. Screwsare not intended to be placed in the cervical spine. |
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| Comparison of thetechnologicalcharacteristics of thedevice to predicatedevice(s): | The Synthes OC Fusion System is a result of design modificationsto the predicate devices. It is substantially equivalent to thepredicates in design, function, material and intended use. |
|---|---|
| Performance Data(Nonclinical and/orClinical): | Non-Clinical Performance and Conclusions:Bench testing results demonstrate that the Synthes OC FusionSystem is substantially equivalent to the predicate devices.Clinical Performance and Conclusions:Clinical data and conclusions were not needed for this device. |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features the department's name in a circular arrangement around a stylized symbol. The symbol is a representation of a human figure embracing a bird, which is meant to symbolize the department's mission of protecting the health of all Americans and providing essential human services.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP - 6 2006
Synthes Spine c/o Ms. Susan Lewandowski 1302 Wrights Lane East West Chester, PA 19380
Re: K053418
Trade Name: Synthes OC Fusion System Regulation Number: 21 CFR 888.3050 Regulation Name: Spinal Interlaminal Fixation Orthosis Regulatory Class: II Product Code: KWP Dated: August 28, 2006 Received: August 31, 2006
Dear Ms. Lewandowski:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it n your de rise to such 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.
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Page 2 - Ms. Susan Lewandowski :
Please be advised that FDA's issuance of a substantial equivalence determination does not mean I lease be deviloed that I Dr o sation that your device complies with other requirements of the Act that I Dri has Intatutes 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); good manufacturing practice requirements as set Of to rate 077) have systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. product racketing will allow you to begin marketing your device as described in your Section 510(k) rms leter watification. The FDA finding of substantial equivalence of your device to a legally promatics notifications on "cersults 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), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general managemal and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Barbara Inehm
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement
510(k) Number K053418
Synthes OC Fusion System Device Name:
Synthes OC Fusion System is intended to provide stabilization to promote Indications for Use: fusion of the occipital-cervical junction. A complete occipital-cervicalthoracic construct can be created by using hooks (C1-T3) that have been previously cleared within the Synthes CerviFix System and the Synthes Axon System.
Synthes OC Fusion System is indicated for the following:
- Degenerative disc disease of the cervical vertebrae (neck pain of . discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies)
- Spondylolisthesis .
- Spinal Stenosis .
- Fracture/Dislocation .
- . Atlanto/axial fracture with instability
- Occipital-cervical dislocation .
- Revision of previous cervical spine surgery .
- Tumors (primary and metastatic) .
The use of screws is limited to placement in the occiput. Screws are not intended to be placed in the cervical spine.
Prescription Use X (21 CFR 801 Subpart D) AND/OR
Over-the-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) :
510(k) Number Kos 3418
Concurrence of CDRH, Office of Device Evaluation (ODE)
| K053418 | Barbara Buehler |
|---|---|
| (Division Sign-Off) | for MKM |
Division of General, Restorative,
and Neurological DevicesENTIAL
CONFIDENTIAL Synthes OC Fusion System
Page 1 of 1 Traditional 510(k)
§ 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.