(100 days)
Not Found
No
The summary describes a mechanical implant for spinal fusion and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes.
The device is intended to replace a collapsed or unstable vertebral body due to tumor or trauma in the thoracolumbar spine (T1-L5), which addresses a pathological condition and restores function.
No
The device is a vertebral body replacement system, an implant used in surgery, not a tool for diagnosing medical conditions. Its purpose is to replace collapsed or unstable vertebral bodies, not to detect or identify a disease or condition.
No
The device description explicitly states it is composed of "implant components" made of PEEK and Ti-6Al-4V ELI, which are physical materials used for surgical implants. This indicates it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to replace a collapsed or unstable vertebral body in the spine due to tumor or trauma. This is a surgical implant used in vivo (within the body).
- Device Description: The device is described as implant components made of PEEK or Ti-6Al-4V ELI, designed to be surgically placed in the spine.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is a surgical implant used in vivo.
N/A
Intended Use / Indications for Use
The Choice Spine HawkeyeTM Vertebral Body Replacement (VBR) System is intended for use in the thoracolumbar spine (T1-L5) to replace a collapsed, or unstable vertebral body due to tumor or trauma (i.e., fracture). The Choice Spine Hawkeye™ Vertebral Body Replacement (VBR) System is intended for use with supplemental fixation and is to be used with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion.
Input: The Choice Spine Hawkeye™ Vertebral Body Replacement (VBR) System is intended for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e., fracture). The Choice Spine Hawkeye™ Vertebral Body Replacement (VBR) System is intended for use with supplemental fixation and is to be used with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion.
Product codes
MOP, MQP
Device Description
The Choice Spine 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. This system includes implants made of PEEK (ASTM F2026) with Tantalum markers (ASTM F560) or Ti-6Al-4V ELI (ASTM F136 or ASTM F3001).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
thoracolumbar spine (T1-L5)
Indicated Patient Age Range
Not Found
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)
Non-clinical The non-clinical testing performed was Static Axial Compression, Static Testing Torsion, Dynamic Torsion, Dynamic Compression per ASTM F2077, Subsidence per ASTM F2267, and Expulsion testing.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Image /page/0/Picture/2 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.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 15, 2017
Choice Spine Kim Finch Manager Regulatory Affairs 400 Erin Drive Knoxville, Tennessee 37924
Re: K171686
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 Dated: August 16, 2017 Received: August 17, 2017
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. 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
1
Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set 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 (DICE) 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/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 (DICE) 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.
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K171686
Device Name
Choice Spine Hawkeye™ Vertebral Body Replacement (VBR) System
Indications for Use (Describe)
The Choice Spine HawkeyeTM Vertebral Body Replacement (VBR) System is intended for use in the thoracolumbar spine (T1-L5) to replace a collapsed, or unstable vertebral body due to tumor or trauma (i.e., fracture). The Choice Spine Hawkeye™ Vertebral Body Replacement (VBR) System is intended for use with supplemental fixation and is to be used with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion.
| 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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3
510(k) Summary
| Date: | September 13, 2017 |
|---|---|
| Sponsor: | Choice Spine, LP |
| 400 Erin Drive | |
| Knoxville, TN 37919 | |
| Phone: | 865-246-3333 |
| Fax: | 865-246-3334 |
| Contact | |
| Person: | Kim Finch, Manager 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 |
| Common | |
| Name: | |
| Device | Spinal Vertebral Body Replacement Device |
| Product Code: | MQP |
| Purpose of | |
| Submission: | The purpose of this submission is to gain clearance for additional sizes of the |
| Choice Spine Hawkeye™ Vertebral Body Replacement (VBR) System implant | |
| family in Titanium using a new method of additive manufacturing. The Choice | |
| Spine Vertebral Body Replacement (VBR) System has been cleared by the FDA | |
| in PEEK (K120570) and in Titanium (K162103). | |
| Device | |
| Description: | The Choice Spine 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. This | |
| system includes implants made of PEEK (ASTM F2026) with Tantalum markers | |
| (ASTM F560) or Ti-6Al-4V ELI (ASTM F136 or ASTM F3001). | |
| Intended Use: | The Choice Spine Hawkeye™ Vertebral Body Replacement (VBR) System is |
| intended for use in the thoracolumbar spine (T1-L5) to replace a collapsed, | |
| damaged, or unstable vertebral body due to tumor or trauma (i.e., fracture). | |
| The Choice Spine Hawkeye™ Vertebral Body Replacement (VBR) System is | |
| intended for use with supplemental fixation and is to be used with autogenous | |
| and/or allogeneic bone graft comprised of cancellous and/or corticocancellous | |
| bone graft to facilitate fusion. |
4
The implant components are available in two material varieties: Materials: polyetheretherketone (PEEK-OPTIMA® LT1, Invibio®) per ASTM F2026 with integral radiopaque markers manufactured from tantalum per ASTM F560, and 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 current subject devices in this submission are equivalent to the Choice Spine Vertebral Body Replacement (VBR) System K120570 (primary) and K162103, Choice Spine Lumbar Spacer System K153107 as additional predicates. The predicate devices are equivalent in principle of operation, indications for use, material, biocompatibility, manufacturing methods/ post processing steps, sterilization method, stabilization method, anatomic location and approach, product code and classification, and footprints (length & width). The additional taller height sizes in this submission, along with the new additive manufacturing method per ASTM F3001 and slight design change of being more trapezoidal and having window cutouts, introduce a new worst case for design. The performance data is substantially equivalent when compared to the primary predicate.
Conclusion: The additional implants proposed in this submission are identical in: Principle of Operation, Indications for Use, Biocompatibility, Sterilization and Stabilization Method, Anatomic Location and Approach, Intended Use, Product Code and Classification, and Footprints (Length & Width) to the previously cleared implants in this family.
The addition of the taller heights (51-60mm) represents a new worst case implant design along with a change in manufacturing method. Therefore, the worst-case size of the additional implants proposed in this submission was subjected to mechanical testing, which is discussed in detail in section 22, and results (along with the comparison in section 14.1) showed that the subject device is substantially equivalent to the predicates listed.
Non-clinical The non-clinical testing performed was Static Axial Compression, Static Testing Torsion, Dynamic Torsion, Dynamic Compression per ASTM F2077, Subsidence per ASTM F2267, and Expulsion testing.