(113 days)
When intended to promote fusion of the cervical spine and occipito-cervico-thoracic junction (Occiput-T3), the STRYKER Spine Oasys System is intended for:
· Degenerative Disc Disease (as defined by neck and back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies)
- · Spondylolisthesis
- · Spinal Stenosis
- · Fracture/Dislocation
- Atlanto/axial fracture with instability
- · Occipitocervical dislocation
- · Revision of previous cervical spine surgery
- Tumors
When used with the occipital plate, the bone screws are limited to occipital fixation only. The bone screws are not intended to be used in the cervical spine.
The use of the polyaxial screws is limited to placement in the upper thoracic spine (T1 -T3 ). They are not intended to be placed in the cervical spine.
The hooks and rods are also intended to provide stabilization to promote fusion of fracture/dislocation or trauma in the cervical/upper thoracic (C1-T3) spine.
The Stryker Spine OASYS® System can be linked to the Xia® System and Xia® 4.5 Spinal System via the rod-to-rod connectors and transition rods.
The Stryker Spine OASYS® System can also be linked to the polyaxial screws of Xia® II and Xia® 3 System via the saddle connector.
The Stryker Spine OASYS® System is comprised of rods, polyaxial screws, bone screws, hooks, connectors, and occiput plates. The components are available in a variety of lengths in order to accommodate patient anatomy. The components are fabricated from Titanium alloy and CP Titanium and are provided non-sterile. The subject system also offers Vitallium® rods. The Stryker Spine OASYS® System can be linked to the Stryker Spine Xia® family and Xia 4.5 Systems and SR90D System.
The provided text describes a 510(k) premarket notification for the Stryker Spine OASYS® System, a spinal interlaminal fixation orthosis. The submission is for a modification to an already legally marketed predicate device (Stryker Spine OASYS® System: K111719) and therefore does not include a comprehensive study on a new AI device or a detailed acceptance criteria table with reported device performance metrics in the way one might expect for a new diagnostic device.
Instead, the submission focuses on demonstrating that a modification to an existing device (the addition of screws with a modified drive mechanism) does not negatively affect the device's performance compared to the predicate.
Here's an analysis based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria or a table of reported device performance values against those criteria, as it's a 510(k) for a modification to an existing device rather than a de novo submission for a novel device or AI diagnostic.
However, the "Summary of Performance Data" section implies the acceptance criteria for this specific modification:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Addition of screws with modified drive mechanism does not affect the performance of the OASYS® System. | "An engineering analysis was performed to demonstrate that the addition of screws with a modified drive mechanism does not affect the performance of the OASYS® System." |
2. Sample Size for Test Set and Data Provenance
The document states an "engineering analysis was performed." This is typically a mechanical test, not a clinical study involving a "test set" of patients or data in the way an AI diagnostic would require. Therefore, there's no information on a patient-based sample size or data provenance (country of origin, retrospective/prospective). The "test set" would likely refer to the physical screws and system components used in the engineering analysis.
3. Number of Experts and Qualifications for Ground Truth
Not applicable. This is not a study requiring expert readers to establish ground truth for a diagnostic outcome. The "ground truth" here would be the physical integrity and mechanical performance of the modified screws and system components, assessed through engineering principles and testing.
4. Adjudication Method
Not applicable, as this is an engineering analysis, not a study involving expert readers and diagnostic assessments.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not conducted. This is not an AI device, and no human-in-the-loop performance or comparison to human readers is described.
6. Standalone Performance
Not applicable. This is not an AI algorithm but a physical medical device. The "engineering analysis" would represent the standalone evaluation of the modified components' mechanical performance.
7. Type of Ground Truth Used
The ground truth used is based on engineering and mechanical testing standards and performance benchmarks, comparing the modified components to the previously cleared predicate device. This would involve stress tests, fatigue tests, and other mechanical property assessments to ensure the new square drive mechanism does not compromise the device's integrity or function.
8. Sample Size for the Training Set
Not applicable. This is not an AI device that requires a training set.
9. How Ground Truth for the Training Set was Established
Not applicable.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
January 15, 2015
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Stryker Corporation % Garry T. Hayeck, Ph.D. Senior Regulatory Affairs Specialist Stryker Spine 2 Pearl Court Allendale, New Jersey 07401
Re: K142741
Trade/Device Name: OASYS® System Regulation Number: 21 CFR 888.3050 Regulation Name: Spinal interlaminal fixation orthosis Regulatory Class: Class II Product Code: KWP Dated: December 19, 2014 Received: December 22, 2014
Dear Dr. Hayeck:
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. 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 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
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Page 2 - Garry T. Hayeck, Ph.D.
(21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Mark N. Melkerson -S
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)
Device Name OASYS® System
Indications for Use (Describe)
When intended to promote fusion of the cervical spine and occipito-cervico-thoracic junction (Occiput-T3), the STRYKER Spine Oasys System is intended for:
· Degenerative Disc Disease (as defined by neck and back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies)
- · Spondylolisthesis
- · Spinal Stenosis
- · Fracture/Dislocation
- Atlanto/axial fracture with instability
- · Occipitocervical dislocation
- · Revision of previous cervical spine surgery
- Tumors
When used with the occipital plate, the bone screws are limited to occipital fixation only. The bone screws are not intended to be used in the cervical spine.
The use of the polyaxial screws is limited to placement in the upper thoracic spine (T1 -T3 ). They are not intended to be placed in the cervical spine.
The hooks and rods are also intended to provide stabilization to promote fusion of fracture/dislocation or trauma in the cervical/upper thoracic (C1-T3) spine.
The Stryker Spine OASYS® System can be linked to the Xia® System and Xia® 4.5 Spinal System via the rod-to-rod connectors and transition rods.
The Stryker Spine OASYS® System can also be linked to the polyaxial screws of Xia® II and Xia® 3 System via the saddle connector.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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| 510(k) Summary: OASYS® System | |
|---|---|
| Submitter | Stryker Spine2 Pearl CourtAllendale, NJ 07401 |
| Contact Person | Garry T. Hayeck, Ph.D.Senior Regulatory Affairs SpecialistPhone: 201-760-8043Fax: 201-962-4043E-mail: garry.hayeck@stryker.com |
| Date Prepared | December 16, 2014 |
| Trade Name | OASYS® System |
| Common Name | Spinal Fixation Appliances |
| Proposed Class | Class II |
| Classification Name,Codification | Spinal Interlaminal Fixation Orthosis, 21 CFR § 888.3050 |
| Product Codes | KWP |
| Predicate Devices | Primary Predicate Device:Stryker Spine OASYS® System: K111719 |
| Device Description | The Stryker Spine OASYS® System is comprised of rods, polyaxialscrews, bone screws, hooks, connectors, and occiput plates. Thecomponents are available in a variety of lengths in order toaccommodate patient anatomy. The components are fabricatedfrom Titanium alloy and CP Titanium and are provided non-sterile. Thesubject system also offers Vitallium® rods. The Stryker Spine OASYS®System can be linked to the Stryker Spine Xia® family and Xia 4.5Systems and SR90D System. |
| Indications for Use | When intended to promote fusion of the cervical spine and occipito-cervico-thoracic junction (Occiput-T3), the STRYKER Spine OasysSystem is intended for:Degenerative Disc Disease (as defined by neck and back pain ofdiscogenic origin with degeneration of the disc confirmed by historyand radiographic studies)SpondylolisthesisSpinal StenosisFracture/DislocationAtlanto/axial fracture with instabilityOccipitocervical dislocationRevision of previous cervical spine surgeryTumorsWhen used with the occipital plate, the bone screws are limited tooccipital fixation only. The bone screws are not intended to be used inthe cervical spine.The use of the polyaxial screws is limited to placement in the upperthoracic spine (T1 -T3). They are not intended to be placed in thecervical spine. |
| The hooks and rods are also intended to provide stabilization topromote fusion following reduction of fracture/dislocation or trauma inthe cervical/upper thoracic (C1-T3) spine. | |
| The Stryker Spine OASYS® System can be linked to the Xia® System,SR90D System and Xia® 4.5 Spinal System via the rod-to-rodconnectors and transition rods. | |
| The Stryker Spine OASYS® System can also be linked to the polyaxialscrews of Xia® II and Xia® 3 System via the saddle connector. | |
| Summary ofTechnologicalCharacteristics | The subject OASYS® System shares the same materials, geometries,and fundamental scientific technologies as predicate OASYS®Systems. The proposed new screws are identical to previously clearedOASYS® screws with the exception that they incorporate a squaredrive mechanism. |
| Summary ofPerformance Data | An engineering analysis was performed to demonstrate that theaddition of screws with a modified drive mechanism does not affectthe performance of the OASYS® System. |
| Conclusion | The devices, methodologies, and materials used in this system areequivalent to previously cleared OASYS® Systems. As such, this systemis substantially equivalent to the legally marketed predicate devices. |
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§ 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.