(117 days)
Not Found
No
The document describes a physical implant system for spinal fusion and vertebral body replacement, made of PEEK or Titanium. There is no mention of software, algorithms, image processing, or any terms related to AI/ML.
Yes
The device is described as an "intervertebral body fusion" system, an "interbody fusion system," and a "vertebral body replacement system" used for treatment of conditions like degenerative disc disease, spondylolisthesis, tumor, or traumatic injury, all of which aim to treat or alleviate a disease or injury.
No
The device description indicates that it is an implantable medical device (lumbar spacer system, interbody fusion system, vertebral body replacement system), not a diagnostic device. Its purpose is to facilitate spinal fusion and replace vertebral bodies, not to diagnose a condition.
No
The device description explicitly states the implant components are made of physical materials (PEEK and Titanium alloy) and are provided as physical implants for surgical procedures. This is a hardware medical device.
Based on the provided information, 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 this device is a system of implants (spacers, cages, vertebral body replacements) made of PEEK or Titanium alloy. Its intended use is for surgical procedures involving the spine (lumbar and thoracolumbar) to facilitate fusion or replace damaged vertebral bodies.
- Lack of Diagnostic Activity: There is no mention of this device being used to analyze biological samples or provide diagnostic information about a patient's health status. It is a physical implant used in a surgical procedure.
Therefore, the Choice Spine Lumbar Spacer System, Interbody Fusion System, and Vertebral Body Replacement System are surgical implants, not in vitro diagnostic devices.
N/A
Intended Use / Indications for Use
Choice Spine Lumbar Spacer System (Sabre™, Shark™, Hornet™, Harpoon™):
The Choice Spine Lumbar Spacer System is indicated for intervertebral body fusion of the lumbar spine, from L2 to S1 in skeletally mature patients who have had six mon-operative treatment. The device is intended for use at either one level or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device is designed for use with supplemental fixation and with autogenous and/or allogeneic bone graft comprised of cancellous, and/or corticocancellous bone graft to facilitate fusion When used as a vertebral body replacement device, the Choice Spine Intervertebral Body Device is intended for use in the thoracic and lumbar spine, from T1 to L5, for the replacement of a collapsed or unstable vertebral body resulting from a tumor or traumatic injury. The device system is designed for use with supplemental fixation and with autogenous and/or allogeneic bone graft comprised of cancellous, and/or corticocancellous bone graft to facilitate fusion. Choice Spine Interbody Fusion System (Harrier™):
The Choice Spine Interbody Fusion System is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These patients should have had six months of non-operative treatment. The Choice Spine Interbody Fusion System is designed to be used with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion and a supplemental spinal fixation system that is cleared for use in the lumbar spine.
Choice Spine Vertebral Body Replacement System (Hawkeye™):
The Choice Spine Vertebral Body Replacement (VBR) System is 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 Vertebral 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 (comma separated list FDA assigned to the subject device)
MAX, MQP
Device Description
The implant components are available in two material varieties, polyetheretherketone (PEEK-OPTIMA® LT1, Invibio® or Zeniva® PEEK, Solvay) as described by ASTM F2026 with integral radiopaque markers manufactured from tantalum as described by ASTM F560. The second implant variety is Titanium alloy (Ti-6Al-4V ELI) which conforms to ASTM F136. All chosen materials are commonly used in medical devices. The implants will be provided non-sterile, but will be steam sterilized before use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
Radiographic studies
Anatomical Site
Lumbar spine, from L2 to S1; thoracic and lumbar spine, from T1 to L5; thoracolumbar spine (T1-L5)
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)
Not Found
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.
K140142, K153107, K120991, K153495
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.
Not Found
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
§ 888.3080 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.
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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is an abstract symbol that resembles a stylized eagle or bird in flight, composed of three overlapping profiles of human faces.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 23, 2016
Choice Spine, LP Kim Finch Manager of Regulatory Affairs 400 Erin Drive Knoxville, Tennessee 37919
Re: K162103
Trade/Device Name: Choice Spine Lumbar Spacer System (Sabre™, Shark™, Hornet™, Harpoon™), Choice Spine Interbody Fusion System (Harrier™), Choice Spine Vertebral Body Replacement System (Hawkeye™) Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX, MQP Dated: October 25, 2016 Received: October 26, 2016
Dear Kim 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 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
1
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/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 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) K162103
Device Name
Choice Spine Lumbar Spacer System (Sabre™, Shark™, Hornet™, Harpoon™) Choice Spine Interbody Fusion System (Harrier™) Choice Spine Vertebral Body Replacement System (Hawkeye™)
Indications for Use (Describe)
Choice Spine Lumbar Spacer System (Sabre™, Shark™, Hornet™, Harpoon™):
The Choice Spine Lumbar Spacer System is indicated for intervertebral body fusion of the lumbar spine, from L2 to S1 in skeletally mature patients who have had six mon-operative treatment. The device is intended for use at either one level or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The designed for use with supplemental fixation and with autogenous and/or
allogeneic bone graft comprised of cancellous, and/or corticocancellous bone graft to facilitate fusion When used as a vertebral body replacement device, the Choice Spine Intervertebral Body Device is intended for use in the thoracic and lumbar spine, from T1 to L5, for the replacement of a collapsed or unstable vertebral body resulting from a tumor or traumatic injury. The device system is designed for use with supplemental fixation and with autogenous and/or allogeneic bone graft comprised of cancellous, and/or corticocancellous bone graft to facilitate fusion. Choice Spine Interbody Fusion System (Harrier™):
The Choice Spine Interbody Fusion System is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These patients should have had six months of non-operative treatment. The Choice Spine Interbody Fusion System is designed to be used with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion and a supplemental spinal fixation system that is cleared for use in the lumbar spine.
Choice Spine Vertebral Body Replacement System (Hawkeye™):
The Choice Spine Vertebral Body Replacement (VBR) System is 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 Vertebral 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
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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8. 510(k) Summary
| Date | November 7, 2016 |
|---|---|
| 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 Lumbar Spacer System (Sabre™, Shark™, Hornet™, Harpoon™) |
| Choice Spine Interbody Fusion System (Harrier™) | |
| Choice Spine Vertebral Body Replacement System (Hawkeye™) | |
| Product Class: | Class II |
| Classification | |
| Name: | Choice Spine Lumbar Spacer System (Sabre™, Shark™, Hornet™, Harpoon™): 888.3080- Intervertebral Body Fusion Device 888.3060- Spinal Intervertebral Body Fixation Orthosis Choice Spine Interbody Fusion System (Harrier™): 888.3080- Intervertebral Body Fusion Device Choice Spine Vertebral Body Replacement (Hawkeye™): 888.3060- Spinal Intervertebral Body Fixation Orthosis |
| Device Product | |
| Code: | Choice Spine Lumbar Spacer System (Sabre™, Shark™, Hornet™, Harpoon™): MAX, MQP Choice Spine Interbody Fusion System (Harrier™): MAX Choice Spine Vertebral Body Replacement System (Hawkeye™): MQP |
| Purpose of | |
| Submission: | The purpose of this submission is to gain clearance for additional sizes of the |
| Choice Spine Lumbar Spacer System and Choice Spine Interbody Fusion System | |
| in both PEEK and Titanium and to gain clearance for the Choice Spine Vertebral | |
| Body Replacement System implant family in Titanium. The Choice Spine Lumbar | |
| Spacer System has been cleared by the FDA in PEEK (K140142, K073669) and | |
| Titanium (K153107). The Choice Spine Interbody Fusion System (Formerly Trans- |
Interbody Fusion System) has been cleared in PEEK (K120991) and Titanium (K153107). The Choice Spine Vertebral Body Replacement System has been
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cleared in PEEK (K120570). The indications for these systems have been expanded to include autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion.
Choice Spine Lumbar Spacer System (Sabre™, Shark™, Hornet™, Harpoon™): Intended Use:
The Choice Spine Lumbar Spacer System is indicated for intervertebral body fusion of the lumbar spine, from L2 to S1 in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use at either one level or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with supplemental fixation and with autogenous and/or allogeneic bone graft comprised of cancellous, and/or corticocancellous bone graft to facilitate fusion
When used as a vertebral body replacement device, the Choice Spine Intervertebral Body Device is intended for use in the thoracic and lumbar spine, from T1 to L5, for the replacement of a collapsed or unstable vertebral body resulting from a tumor or traumatic injury. The device system is designed for use with supplemental fixation and with autogenous and/or allogeneic bone graft comprised of cancellous, and/or corticocancellous bone graft to facilitate fusion.
Choice Spine Interbody Fusion System (Harrier™):
The Choice Spine Interbody Fusion System is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These patients should have had six months of nonoperative treatment. The Choice Spine Interbody Fusion System is designed to be used with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion and a supplemental spinal fixation system that is cleared for use in the lumbar spine.
Choice Spine Vertebral Body Replacement System (Hawkeye™):
The Choice Spine 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 Vertebral 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
The implant components are available in two material varieties, Materials: polyetheretherketone (PEEK-OPTIMA® LT1, Invibio® or Zeniva® PEEK, Solvay) as described by ASTM F2026 with integral radiopaque markers manufactured from tantalum as described by ASTM F560. The second implant variety is Titanium alloy (Ti-6Al-4V ELI) which conforms to ASTM F136. All chosen materials are commonly used in medical devices. The implants will be provided non-sterile, but will be steam sterilized before use.
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The subject devices in this submission are equivalent to the following predicates in Substantial intended use, anatomic location, indications, and method of stabilization and the Equivalence: material of manufacture. Choice Spine Lumbar Spacer System (K140142) is the primary predicate. Additional predicates are the Choice Spine Intervertebral Body Device (K153107), The Choice Spine Interbody Fusion System (K120991), and the Avenue® L Lateral Lumbar Cage, Avenue® T TLIF Cage System, ROI-A® ALIF Cage System, ROI-T® Implant System (K153495).
Titanium was chosen as a material option due to its known biocompatibility and its widespread use in spinal and orthopedic implants. Because the designs of the implants are similar between material types (PEEK or Titanitum Alloy) and have been previously cleared, the implants made out of Titanium will be stronger than the implants manufactured from PEEK due to the material properties of Titanium. The ability for an implant to stabilize for fusion is dependent on the geometry of the implant which includes tooth design, surface area, and footprint. The additional sizes in this submission do not introduce a new worst case. The worst case design for each family does not change if the implant was manufactured from Titanium instead of PEEK. Therefore, no new non-clinical testing is needed.