(149 days)
The SKYHAWK Lateral Plate System is intended to be used as a non-pedicle lateral or anterolateral fixation system in skeletally mature patients and 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 of the thoracic and lumbar spine. It may be used from levels T1 to L5 with the following indications:
- Degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies);
- Spondylolisthesis;
- Spinal stenosis;
- Spinal deformities (i.e., scoliosis, kyphosis, and/or lordosis);
- Tumor;
- Pseudoarthrosis;
- Failed previous fusion; and
- Trauma (i.e., fracture or dislocation).
The SKYHAWK Lateral Plate System consists of an assortment of non-sterile, single use, titanium alloy (Ti6Al4V ELI per ASTM F136) rigid plates, bone screws, and set screws. The.plates attach by means of screws to the anterolateral or lateral portion of the vertebral body of the thoracolumbar spine (T1-L5). The system includes instrumentation which assists in the surgical implantation of the devices. The SKYHAWK Lateral Plate System implants and instruments are provided non-sterile. They require sterilization prior to use.
The SKYHAWK Lateral Plate System is a medical device for spinal fixation. The provided document details its mechanical testing results but lacks information on performance metrics typically associated with AI/ML-driven devices (like sensitivity, specificity, etc.) or specific acceptance criteria beyond meeting performance benchmarks of predicate devices. Therefore, some sections of your request cannot be fully addressed.
Here's an analysis based on the provided text, focusing on what is available:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Stated Goal) | Reported Device Performance |
|---|---|
| Perform as well as or better than the predicate device in static and dynamic axial compression bending testing and static torsion testing. (Adherence to ASTM F1717-13 "Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model.") | The SKYHAWK Lateral Plate System performs as well or better than the predicate device. |
2. Sample Size Used for the Test Set and Data Provenance
The document describes non-clinical mechanical testing of the device itself, not a test set of data reflecting patient outcomes or imaging. Therefore, concepts like "sample size for the test set" and "data provenance (e.g., country of origin of the data, retrospective or prospective)" as they relate to AI/ML studies are not applicable here. The "sample" in this context refers to the physical devices subjected to mechanical stress tests. The number of devices tested is not specified, but it would align with the requirements of ASTM F1717-13.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This is not applicable as the study involves mechanical testing of a physical device, not an AI/ML diagnostic or prognostic system requiring expert review of data for ground truth establishment. The "ground truth" here is the physical performance of the device under specific, standardized mechanical loads, as measured by testing equipment.
4. Adjudication Method for the Test Set
Not applicable. The "test set" is the physical device and its components, and performance is determined by mechanical measurements against established ASTM standards and predicate device performance, not by expert adjudication.
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
Not applicable. This is a 510(k) submission for a physical medical device (spinal plate system) based on mechanical equivalency, not an AI/ML device involving human readers or comparative effectiveness studies of human performance.
6. 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.
7. The Type of Ground Truth Used
The "ground truth" for this study is the physical performance of the SKYHAWK Lateral Plate System as measured through standardized mechanical testing (static and dynamic axial compression bending, and static torsion testing), compared against the established performance of legally marketed predicate devices and the requirements of ASTM F1717-13.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/ML device.
9. How the Ground Truth for the Training Set Was Established
Not applicable. This is not an AI/ML device.
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OFIX:
5.0
SKYHAWK™ Lateral Plate System
.'
510(k) Summary
2014
K140260 page 1 of 2
| Date Prepared: | May 30, 2014 |
|---|---|
| Purpose for Submission: | New product offering |
| Sponsor: | OrthofixTroy Brooks, RAC3451 Plano ParkwayLewisville, Texas 75056214-937-2047 |
| Device Name: | SKYHAWK™ Lateral Plate System |
| Product Code: | KWQ |
| Classification: | Class II - 21 CFR § 888.3060 - Spinal Intervertebral Body Fixation Orthosis |
| Predicate Device: | Blackstone Medical Spinal Fixation System (SFS) - K080407Blackstone Medical Spinal Fixation System (SFS) - K023498NuVasive Lateral Plate System - K091071NuVasive Lateral Plate System - K061789Globus Medical Plymouth Thoracolumbar Plate System - K120092 |
| Device Description: | The SKYHAWK Lateral Plate System consists of an assortment of non-sterile, single use, titanium alloy (Ti6Al4V ELI per ASTM F136) rigidplates, bone screws, and set screws. The.plates attach by means of screwsto the anterolateral or lateral portion of the vertebral body of thethoracolumbar spine (T1-L5). The system includes instrumentation whichassists in the surgical implantation of the devices. The SKYHAWK LateralPlate System implants and instruments are provided non-sterile. Theyrequire sterilization prior to use. |
| Intended Use: | The SKYHAWK Lateral Plate System is intended to be used as a non-pedicle lateral or anterolateral fixation system in skeletally mature patientsand is intended to provide immobilization and stabilization of spinalsegments, as an adjunct to fusion in the treatment of the following acuteand chronic instabilities of the thoracic and lumbar spine. It may be usedfrom levels T1 to L5 with the following indications:Degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies);Spondylolisthesis;Spinal stenosis;Spinal deformities (i.e., scoliosis, kyphosis, and/or lordosis);Tumor;Pseudoarthrosis;Failed previous fusion; andTrauma (i.e., fracture or dislocation). |
| Non-Clinical Testing: | Mechanical testing of the SKYHAWK Lateral Plate System consisting ofstatic and dynamic axial compression bending testing and static torsiontesting was conducted in accordance with ASTM F1717-13 "Standard TestMethods for Spinal Implant Constructs in a Vertebrectomy Model." Test |
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page 2 of 2
results demonstrate that the SKYHAWK Lateral Plate System performs as well or better than the predicate device and is therefore substantially equivalent to the predicate device.
Conclusion: Based upon similarities in design, materials, intended use, indications for use and the results of mechanical testing, the SKYHAWK Lateral Plate System is substantially equivalent to the predicate devices.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 2, 2014
Orthofix, Incorporated Troy Brooks, RAC Senior Regulatory Affairs Specialist 3451 Plano Parkway Lewisville, Texas 75056
Re: K140260
Trade/Device Name: SKYHAWK™ Lateral Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: KWQ Dated: May 30, 2014 Received: June 2, 2014
Dear Mr. Brooks:
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 (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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Page 2 - Troy Brooks. RAC
forth in the quality 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.
ff 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/ResourcesforYou/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/McdicalDevices/Safctv/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.
Ronald P. Jean -S for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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4.0 Indications for Use Statement
510(k) Number (if known): K 140260
Device Name: SKYHAWKTM Lateral Plate System
Indications for Use:
The SKYHAWK Lateral Plate System is intended to be used as a non-pedicle lateral or anterolateral fixation system in skeletally mature patients and is intended to provide immobilization of spinal segments, as an adjunct to fusion in the treatment of the following acute and chronic instabilities of the thoracic and lumbar spine. It may be used from levels Tl to L5 with the following indications:
- · Degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies);
- · Spondylolisthesis;
- · Spinal stenosis;
- · Spinal deformities (i.e., scoliosis, kyphosis, and/or lordosis);
- · Tumor;
- · Pseudoarthrosis;
- · Failed previous fusion; and
- · Trauma (i.e., fracture or dislocation).
Prescription Use x AND/OR (Per 21 CFR 801.109)
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Anton E. Dmitriev, PhD Division of Orthopedic Devices
§ 888.3060 Spinal intervertebral body fixation orthosis.
(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.