(67 days)
The SKYHAWK Interbody Fusion System is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels in the lumbar spine (L2-S1). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis at the involved levels. These patients may have had a previous non-fusion surgery at the involved level(s). The SKYHAWK Interbody Fusion System is designed for use with autogenous bone graft to facilitate fusion. The system is also intended to be used with supplemental internal spinal fixation systems that are cleared by the FDA for use in the lumbar spine. Patients must have undergone a regimen of at least six (6) months of nonoperative treatment prior to being treated with the SK YHAWK Interbody Fusion System.
The SKYHAWK Interbody Fusion System consists of implants, trials, and instruments. The SKYHAWK Interbody Fusion System is comprised of a variety of implants fabricated and manufactured from polyetheretherketone (PEEK Optima LT1) as described by ASTM F2026 with tantalum markers as described by ASTM F560. PEEK is utilized due to its radiolucent properties, which aids the surgeon in determining if fusion in the operative site has occurred. Since PEEK is transparent in xrays, tantalum marker pins are inserted into the implants in order to give surgeons a visual aid in determining the location of the implants, both intra and postoperatively. The SK YHAWK Interbody Fusion System implants are offered in parallel and lordotic profiles to restore the natural curvature of the spine; the device mav be implanted using a lateral or anterolateral approach. The SKYHAWK Interbody Fusion System implants, trials and instruments are provided non-sterile. They require sterilization prior to use.
This document describes the SKYHAWK™ Interbody Fusion System, a medical device, and its acceptance criteria for regulatory approval. It does not describe an AI/ML powered device, therefore, many of the requested fields are not applicable.
Here's a breakdown of the provided information, focusing on the mechanical testing rather than AI/ML performance:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Static Axial Compression Testing: In accordance with ASTM F2077-11 | "Test results demonstrate that the SKYHAWK Interbody Fusion System is substantially equivalent to the predicate device." |
| Dynamic Axial Compression Testing: In accordance with ASTM F2077-11 | "Test results demonstrate that the SKYHAWK Interbody Fusion System is substantially equivalent to the predicate device." |
| Static Compression Shear Testing: In accordance with ASTM F2077-11 | "Test results demonstrate that the SKYHAWK Interbody Fusion System is substantially equivalent to the predicate device." |
| Dynamic Compression Shear Testing: In accordance with ASTM F2077-11 | "Test results demonstrate that the SKYHAWK Interbody Fusion System is substantially equivalent to the predicate device." |
| Static Subsidence Testing: In accordance with ASTM F2267-04 | "Test results demonstrate that the SKYHAWK Interbody Fusion System is substantially equivalent to the predicate device." |
2. Sample Size for Test Set and Data Provenance
This information is not provided in the document. The document refers to "mechanical testing" but does not specify the number of units tested or any specific test data beyond the general conclusion of substantial equivalence.
3. Number of Experts and Qualifications for Ground Truth
This is not applicable as the study is a mechanical engineering test of a physical device, not an evaluation of an AI system's diagnostic accuracy. Ground truth here refers to the physical properties and performance measured by standardized tests.
4. Adjudication Method for Test Set
This is not applicable as the study involves mechanical testing and compliance with engineering standards, not human interpretation or adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
This is not applicable as this is a mechanical medical device, not an AI/ML diagnostic or assistive tool.
6. Standalone Algorithm Performance
This is not applicable as this is a mechanical medical device, not an algorithm.
7. Type of Ground Truth Used
The ground truth for this device's acceptance is based on established engineering standards and measurement protocols. Specifically, the tests were conducted "in accordance with ASTM F2077-11 'Test Methods for Intervertebral Body Fusion Devices' and ASTM F2267-04 'Standard Test Method for Measuring Load Induced Subsidence of Intervertebral Body Fusion Device under Static Axial Compression'." The "ground truth" is that the device performs within the acceptable parameters defined by these ASTM standards and is demonstrably similar to predicate devices.
8. Sample Size for Training Set
This is not applicable as this is a mechanical medical device, not an AI/ML system that requires a training set.
9. How Ground Truth for Training Set Was Established
This is not applicable as this device does not use a training set in the context of AI/ML. The "ground truth" for the device's design and manufacturing is based on established engineering principles, materials science (PEEK Optima LT1, ASTM F2026, tantalum markers, ASTM F560), and the specified intended use and indications.
{0}------------------------------------------------
K140709 Page 1 of 2
SKYHAWK™M Interbody Fusion System
5.0 510(k) Summary
MAY 2 7 2014 May 22, 2014 Date Prepared: Purpose for Submission: New product offering Sponsor: Orthofix Troy Brooks, RAC 3451 Plano Parkway Lewisville, Texas 75056 214-937-2047 SKYHAWK™ Interbody Fusion System Device Name: MAX Product Code: Classification: Class II - 21 CFR § 888.3080 - Intervertebral Body Fusion Device Predicate Device: Orthofix FORZA Spacer System - K103111 NuVasive CoRoent System - K071795 Medtronic PERIMETER Interbody Fusion Device - K131669 The SKYHAWK Interbody Fusion System consists of implants, trials, and Device Description: instruments. The SKYHAWK Interbody Fusion System is comprised of a variety of implants fabricated and manufactured from polyetheretherketone (PEEK Optima LT1) as described by ASTM F2026 with tantalum markers as described by ASTM F560. PEEK is utilized due to its radiolucent properties, which aids the surgeon in determining if fusion in the operative site has occurred. Since PEEK is transparent in xrays, tantalum marker pins are inserted into the implants in order to give surgeons a visual aid in determining the location of the implants, both intra and postoperatively. The SK YHAWK Interbody Fusion System implants are offered in parallel and lordotic profiles to restore the natural curvature of the spine; the device mav be implanted using a lateral or anterolateral approach. The SKYHAWK Interbody Fusion System implants, trials and instruments are provided non-sterile. They require sterilization prior to use. Intended Use: The SK YHAWK Interbody Fusion System is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels in the lumbar spine (L2-S1). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis at the involved levels. These patients may have had a previous non-fusion surgery at the involved level(s). The SKYHAWK Interbody Fusion System is designed for use with autogenous bone graft to facilitate fusion. The system is also intended to be used with supplemental internal spinal fixation systems that are cleared by the FDA for use in the lumbar spine. Patients must have undergone a regimen of at least six (6) months of nonoperative treatment prior to being treated with the SK YHAWK Interbody Fusion System. .
MAY 2, 2023
{1}------------------------------------------------
K140709 Page 2 of 2
Image /page/1/Picture/1 description: The image shows the word "ORTHOFIX" in bold, black letters. To the left of the word is a black graphic that looks like a stylized letter "O". A small trademark symbol is located to the upper right of the word.
SKYHAWK™ Interbody Fusion System
Non-Clinical Testing: Mechanical testing of the SKYHAWK Interbody Fusion System consisting of static and dynamic axial compression testing, static and dynamic compression shear testing, and static subsidence testing was conducted in accordance with ASTM F2077-11 "Test Methods for Intervertebral Body Fusion Devices" and ASTM F2267-04 "Standard Test Method for Measuring Load Induced Subsidence of Intervertebral Body Fusion Device under Static Axial Compression." Test results demonstrate that the SK YHAWK Interbody Fusion System is 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 Interbody Fusion System is substantially equivalent to the predicate devices.
{2}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/13 description: The image shows the seal of the Department of Health & Human Services-USA. The seal is circular and contains the department's name around the perimeter. In the center of the seal is a stylized image of an eagle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 27, 2014
Orthofix, Incorporated Troy Brooks, RAC Senior Regulatory Affairs Specialist 3451 Plano Parkway Lewisville, Texas 75056
Re: K140709
Trade/Device Name: SKYHAWK™ Interbody Fusion System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: March 31, 2014 Received: April 1, 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
{3}------------------------------------------------
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.
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/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/McdicalDeyices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You mav 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
{4}------------------------------------------------
Image /page/4/Picture/0 description: The image shows the word "ORTHOFIX" in bold, black letters. To the left of the word is a black, abstract shape that resembles a stylized "O". The font is sans-serif and the letters are closely spaced. The overall impression is of a modern and professional logo.
4.0 Indications for Use Statement
510(k) Number (if known): K140709
Device Name: SKYHAWK™ Interbody Fusion System
Indications for Use:
The SKYHAWK Interbody Fusion System is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels in the lumbar spine (L2-S1). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. DDD patients may also have up to Grade I spondylolisthesis at the involved levels. These patients may have had a previous non-fusion surgery at the involved level(s).
The SKYHAWK Interbody Fusion System is designed for use with autogenous bone graft to facilitate fusion. The system is also intended to be used with supplemental internal spinal fixation systems that are cleared by the FDA for use in the lumbar spine. "
Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the SKYHAWK Interbody Fusion System.
AND/OR
Prescription Use X (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 O
§ 888.3080 Intervertebral body fusion device.
(a)
Identification. An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion.(b)
Classification. (1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.