(63 days)
No
The 510(k) summary describes a mechanical implant (vertebral body replacement spacer) and its intended use and mechanical testing. There is no mention of AI, ML, image processing, or any software-driven functionality that would suggest the incorporation of these technologies.
Yes
The device is described as a "Vertebral Body Replacement (VBR) System" intended to replace diseased or damaged vertebral bodies, restore spinal column integrity, achieve decompression of the spinal cord, and provide anterior spinal column support. These actions directly address a medical condition or facilitate a therapeutic outcome.
No
Explanation: The device is a vertebral body replacement (VBR) spacer, an implant designed to replace diseased or damaged vertebral bodies and provide spinal column support. It is a treatment device, not a diagnostic one.
No
The device description clearly states it is composed of "implant components" which are physical devices intended for surgical implantation. It is not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The description clearly states that the Choice Spine HAWKEYE™ Vertebral Body Replacement (VBR) Spacers are implantable devices intended to replace damaged vertebral bodies in the spine. They are physical components surgically placed within the body.
- Lack of Diagnostic Activity: There is no mention of this device analyzing biological samples or providing diagnostic information about a patient's health status. Its function is structural support and replacement.
Therefore, the HAWKEYE™ VBR Spacers fall under the category of implantable medical devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The Choice Spine HAWKEYE™ Vertebral Body Replacement (VBR) Spacers are vertebral body replacement devices intended for use in the thoracolumbar spine (TI -L5). Hawkeye (VBR) Spacers are also intended for use in the cervical spine (C2-T1).
When used in the cervical spine (C2-T1), the HAWKEYE™ VBR devices are intended for use in the skeletally mature patients to replace a diseased or damaged vertebral body caused by tumor, fracture, or osteomyelitis, or for reconstruction following corpectomy performed to achieve decompression of the spinal cord and neural tissues in cervical degenerative disorders. These spacers are intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage turnors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion, with bone graft used at the surgeon's discretion.
When used in the thoracolumbar spine (T1-L5), the HAWKEYE ™ VBR Spacers are intended for use to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e., fracture). These spacers are designed to provide anterior spinal column support even in the absence of fusion for a prolonged period.
The interior of the spacers can be packed with autograft or allogenic bone graft comprising cancellous and/or corticocancellous bone graft as an adjunct to fusion.
These devices are intended to be used with FDA-cleared supplemental spinal fixation systems that have been labeled for use in the cervical, thoracic, and/or lumbar spine (i.e.,posterior screw and rod systems, and anterior screw and rod systems). When used at more than two levels, supplemental fixation should include posterior fixation.
Product codes (comma separated list FDA assigned to the subject device)
MQP, PLR
Device Description
The ChoiceSpine HAWKEYE™ Vertebral Body Replacement (VBR) System is composed of implant components which have a basic oval/trapezoidal shape with a hollow center for placement of bone graft. The superior and inferior surfaces have ridges, or “teeth" for resisting migration. The replacement implants, "spacers", are available in an assortment of heights and in multiple angles of lordosis to accommodate different anatomic requirements.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
thoracolumbar spine (T1-L5), cervical spine (C2-T1)
Indicated Patient Age Range
skeletally mature patients
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Mechanical testing (static and dynamic compression and torsion, subsidence and expulsion) was conducted in accordance with the Guidance for Industry & FDA staff Class II Special Controls Guidance Document, Intervertebral Fusion Device per ASTM F2077, and ASTM F2267 and provided in the predicate submissions K171686 to demonstrate substantial equivalence.
A clinical literature review was performed to support the use of subject devices in the cervical spine. The risk of cervical use was identified and mitigated through design and surgical technique. Based on clinical literature, it was determined that the safety profile of subject devices is equivalent to that of the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
February 22, 2019
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Choice Spine Kim Finch Director of Regulatory Affairs 400 Erin Drive Knoxville, Tennessee 37919
Re: K183588
Trade/Device Name: Choice Spine HAWKEYE™ Vertebral Body Replacement (VBR) System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal Intervertebral Body Fixation Orthosis Regulatory Class: Class II Product Code: MOP, PLR Dated: January 25, 2019 Received: January 28, 2019
Dear Ms. Finch:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 of medical device-related adverse events) (21 CFR 803) for
1
devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Melissa Hall -S
For Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K183588
Device Name
Choice Spine HAWKEYE™ Vertebral Body Replacement (VBR) System
Indications for Use (Describe)
The Choice Spine HAWKEYE™ Vertebral Body Replacement (VBR) Spacers are vertebral body replacement devices intended for use in the thoracolumbar spine (TI -L5). Hawkeye (VBR) Spacers are also intended for use in the cervical spine (C2-T1).
When used in the cervical spine (C2-T1), the HAWKEYE™ VBR devices are intended for use in the skeletally mature patients to replace a diseased or damaged vertebral body caused by tumor, fracture, or osteomyelitis, or for reconstruction following corpectomy performed to achieve decompression of the spinal cord and neural tissues in cervical degenerative disorders. These spacers are intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage turnors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion, with bone graft used at the surgeon's discretion.
When used in the thoracolumbar spine (T1-L5), the HAWKEYE ™ VBR Spacers are intended for use to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e., fracture). These spacers are designed to provide anterior spinal column support even in the absence of fusion for a prolonged period.
The interior of the spacers can be packed with autograft or allogenic bone graft comprising cancellous and/or corticocancellous bone graft as an adjunct to fusion.
These devices are intended to be used with FDA-cleared supplemental spinal fixation systems that have been labeled for use in the cervical, thoracic, and/or lumbar spine (i.e.,posterior screw and rod systems, and anterior screw and rod systems). When used at more than two levels, supplemental fixation should include posterior fixation.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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7. 510(k) Summary
| Date: | February 13, 2019 |
|---|---|
| Sponsor: | ChoiceSpine, LP |
| 400 Erin Drive | |
| Knoxville, TN 37919 | |
| Phone: | 865-246-3333 |
| Fax: | 865-246-3334 |
| Contact Person: | Kim Finch, Director of Regulatory Affairs |
| Proposed Proprietary | |
| Trade Name: | Choice Spine HAWKEYE™ Vertebral Body Replacement (VBR) System |
| Product Class: | Class II |
| Classification Name: | 888.3060 - Spinal Intervertebral Body Fixation Orthosis |
| Device Product Code: | MQP, PLR |
| Purpose of | |
| Submission: | The purpose of this submission is to gain clearance for cervical indications of |
| the ChoiceSpine HAWKEYE™ Vertebral Body Replacement (VBR) System for use | |
| in the thoracolumbar spine (T1-L5) and cervical spine (C2-T1) in Titanium | |
| (K162103), and additive manufactured titanium (K171686). | |
| Device Description: | The ChoiceSpine HAWKEYE™ Vertebral Body Replacement (VBR) System is |
| composed of implant components which have a basic oval/trapezoidal shape | |
| with a hollow center for placement of bone graft. The superior and inferior | |
| surfaces have ridges, or “teeth" for resisting migration. The replacement | |
| implants, "spacers", are available in an assortment of heights and in multiple | |
| angles of lordosis to accommodate different anatomic requirements. | |
| Intended Use: | The ChoiceSpine HAWKEYE™ Vertebral Body Replacement (VBR) System |
| Spacers are vertebral body replacement devices intended for use in the | |
| thoracolumbar spine (T1-L5). Hawkeye (VBR) Spacers are also intended for use | |
| in the cervical spine (C2-T1). | |
| When used in the cervical spine (C2-T1), the HAWKEYE™ VBR devices are | |
| intended for use in the skeletally mature patients to replace a diseased or | |
| damaged vertebral body caused by tumor, fracture, or osteomyelitis, or for | |
| reconstruction following corpectomy performed to achieve decompression of | |
| the spinal cord and neural tissues in cervical degenerative disorders. These | |
| spacers are intended to restore the integrity of the spinal column even in the | |
| absence of fusion for a limited time period in patients with advanced stage | |
| tumors involving the cervical spine in whom life expectancy is of insufficient | |
| duration to permit achievement of fusion, with bone graft used at the surgeon's | |
| discretion. | |
| When used in the thoracolumbar spine (T1-L5), the HAWKEYE ™ VBR Spacers | |
| are intended for use to replace a collapsed, damaged, or unstable vertebral | |
| body due to tumor or trauma (i.e., fracture). These spacers are designed to | |
| provide anterior spinal column support even in the absence of fusion for a | |
| prolonged period. | |
| The interior of the spacers can be packed with autograft or allogenic bone graft | |
| comprising cancellous and/or corticocancellous bone graft as an adjunct to | |
| fusion. | |
| These devices are intended to be used with FDA-cleared supplemental spinal | |
| fixation systems that have been labeled for use in the cervical, thoracic, and/or | |
| lumbar spine (i.e., posterior screw and rod systems, anterior plate systems, and | |
| anterior screw and rod systems). When used at more than two levels, | |
| supplemental fixation should include posterior fixation. | |
| Materials: | The implant components are available in Titanium alloy (Ti-6Al-4V ELI) which |
| conforms to ASTM F136 or ASTM F3001. All chosen materials are commonly | |
| used in medical devices. The implants will be provided non-sterile but will be | |
| steam sterilized before use. | |
| Substantial | |
| Equivalence: | The ChoiceSpine HAWKEYE™ Vertebral Body Replacement (VBR) System with |
| cervical indication is equivalent to the primary predicate (K171686) and | |
| additional predicates Globus Medical Fortify® Corpectomy Spacers (K162315). | |
| The ChoiceSpine Vertebral Body Replacement (VBR) System has been cleared | |
| by the FDA in Titanium (K162103). The predicate devices are equivalent in | |
| principle of operation, indications for use, material, biocompatibility, | |
| sterilization method, stabilization method, anatomic location and approach, | |
| product code and classification, and footprints (length & width). | |
| Performance Data: | Mechanical testing (static and dynamic compression and torsion, subsidence |
| and expulsion) was conducted in accordance with the Guidance for Industry & | |
| FDA staff Class II Special Controls Guidance Document, Intervertebral Fusion | |
| Device per ASTM F2077, and ASTM F2267 and provided in the predicate | |
| submissions K171686 to demonstrate substantial equivalence. | |
| Clinical Literature: | A clinical literature review was performed to support the use of subject devices |
| in the cervical spine. The risk of cervical use was identified and mitigated | |
| through design and surgical technique. Based on clinical literature, it was | |
| determined that the safety profile of subject devices is equivalent to that of the | |
| predicate devices. | |
| Technological | |
| Characteristics: | The ChoiceSpine HAWKEYE™ VBR System implants have the same technological |
| characteristics as the predicate devices through design, intended use, materials, | |
| function, and range of sizes. | |
| Conclusion: | The ChoiceSpine HAWKEYE™ VBR System have the same intended use, same |
| technological characteristics, design, materials, and same principles of | |
| operation as the predicates. |
4