(58 days)
Not Found
No
The document describes physical spinal implants and their intended use, materials, and dimensions. There is no mention of software, algorithms, or data processing that would indicate the presence of AI or ML.
Yes
The device is a spinal implant intended to treat conditions like collapsed vertebral bodies due to tumor or trauma, and degenerative disc disease, which are therapeutic indications.
No
Explanation: The provided text describes various spinal implants (e.g., Octane, Ascendant, Blackhawk, VEO systems) intended for surgical procedures such as vertebral body replacement and intervertebral body fusion. These devices are used for treatment, not for diagnosing conditions. While some descriptions mention "radiographic studies" or "visualization of the defect site on radiography to assess bone growth," these are references to how the implant's position or the outcome of treatment can be monitored, not that the device itself performs a diagnostic function.
No
The device descriptions clearly indicate that these are physical implants made of materials like PEEK, titanium, and tantalum, intended for surgical implantation in the spine. There is no mention of software as the primary or sole component of the device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The text clearly describes the devices as implants designed for surgical procedures in the spine. Their intended use is to replace vertebral bodies, facilitate spinal fusion, and restore spinal height and biomechanical integrity.
- Lack of Specimen Analysis: There is no mention of the device being used to analyze any biological specimens. Its function is purely mechanical and structural within the body.
Therefore, the described devices fall under the category of implantable medical devices rather than In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
When used as a vertebral body replacement:
The ChoiceSpine Octane-A/T/P Spinal Implant is indicated for use in the thoracolumbar spine (T1 to L5) for partial or total replacement of a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e., fracture), to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The Octane device is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column, even in the absence of fusion for a prolonged period. The device may be used with autogenous bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone graft, and supplemental fixation to facilitate fusion.
When used as an intervertebral body fusion device:
The Octane-A/T/P Spinal Implant is intended for spinal fusion procedures at one or two contiguous levels in the lumbar spine from L2 to S1 in patients with Degenerative Disc Disease (DDD), with up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin, with degeneration of the disc confirmed by history and radiographic studies. Patients should be skeletally mature, and have had at least 6 months of non-operative treatment. The device may be used with autogenous bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone graft, and with supplemental fixation systems cleared for use in the lumbosacral spine.
The Ascendant PC Cervical Spacer System is indicated for anterior cervical interbody fusion procedures in skeletally mature patients with degenerative disc disease at one disc level from C2-T1. Degenerative Disc Disease (DDD) is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six weeks of non-operative treatment. The Ascendant PC Cervical Spacer System is to be used autogenous and/or allogenic bone graft composed of cancellous and /or corticocancellous bone graft, and supplemental fixation (i.e., an anterior cervical plate), and is implanted via an open, anterior approach. Patients with previous non-fusion spinal surgery at involved level may be treated with the device.
The Ascendant Cervical Spacer System is indicated for anterior cervical interbody fusion procedures in skeletally mature patients with degenerative disc disease at one-disc level from C2-T1. Degenerative Disc Disease (DDD) is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six weeks of non-operative treatment.The Ascendant Cervical Spacer System is to be used with autogenous bone and/or allogenic bone graft composed of cancellous and /or corticocancellous bone graft, and supplemental fixation (i.e., an anterior cervical plate), and is implanted via an open, anterior approach. Patients with previous non-fusion spinal surgery at involved level may be treated with the device.
The BLACKHAWK™ Cervical Spacer System is indicated for anterior cervical interbody fusion procedures in skeletally mature patients with degenerative disc disease at one disc level from C2-T1. Degenerative Disc Disease (DDD) is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six weeks of non-operative treatment. The BLACKHAWK™ Cervical Spacer System is to be used autogenous bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone graft, and supplemental fixation (i.e., an anterior cervical plated via an open, anterior approach.
The Octane Straight Intervertebral Fusion Device is intended for spinal fusion procedures at one or two contiguous levels in the lumbar spine from L2 to S1 in patients with Degenerative Disc Disease (DDD) with up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. Patients should be sketally mature and have had at least 6 months of non-operative treatment. The device system is designed for use with autogenous bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone graft, and with supplemental fixation systems cleared for use in the lumbosacral spine.
The Octane Straight PC Intervertebral Fusion Device is intended for spinal fusion procedures at one or two contiguous levels in the lumbar spine from L2 to S1 in patients with Degenerative Disc Disease (DDD,) with up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin, with degeneration of the disc confirmed by history and radiographic studies. Patients should be sketally mature and have had at least 6 months of non-operative treatment. The device system is designed for use with autogenous bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone graft, and with supplemental fixation systems cleared for use in the lumbosacral spine.
The VEO™ Lateral Access & 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 at the involved level(s). These patients should have had six months of non-operative treatment. The VEO™ Lateral Access & Interbody Fusion System is designed to be used with autogenous and/or allogenic bone graft composed of cancellous and / or corticocancellous bone graft, and supplemental spinal fixation that is cleared for use in the lumbar spine.
Product codes (comma separated list FDA assigned to the subject device)
MAX, ODP, OVE, MQP
Device Description
This submission includes 7 subject devices. The device descriptions for each are listed below:
The ChoiceSpine Octane Straight Intervertebral Fusion Device is an implant constructed of medical grade Polyetheretherketone, (PEEK-OPTIMA® LT1) as described by ASTM F2026. The implant incorporates ridges on the superior and inferior surfaces to resist expulsion. The device is open in the transverse plane to allow insertion of bone graft prior to placement, and fenestrated along the sides. The radiolucent PEEK-OPTIMA® material allows visualization of the defect site on radiography to assess bone growth, and incorporates tantalum markers conforming to ASTM F560 to permit verification of position. The Octane Straight Intervertebral Fusion Device is provided sterile for single use.
The ChoiceSpine Octane Straight PC Intervertebral Fusion Device is an implant constructed of medical grade Polyetheretherketone, (PEEK-OPTIMA® LT1) as described by ASTM F2026. The implant incorporates ridges on the superior and inferior surfaces to resist expulsion. The device is open in the transverse plane to allow insertion of bone graft prior to placement, and fenestrated along the sides. The radiolucent PEEK-OPTIMA® material allows visualization of the defect site on radiography to assess bone growth and incorporates tantalum markers conforming to ASTM F560 to permit verification of position. The device is plasma coated with commercial pure titanium (CPTi) per ASTM F1580. The Octane Straight PC Intervertebral Fusion Device is provided sterile for single use.
The BLACKHAWK™ Cervical Spacer System is an anterior cervical interbody device consisting of a PEEK implant cage per ASTM F2026 with tantalum radiographic markers per ASTM F560, nitinol internal locking components per ASTM F2063 and two internal titanium alloy anchors (Ti-6Al-4V ELI) per ASTM F136. They are intended for use as interbody fusion devices and offered in a variety of heights, footprints, and lordotic angles to accommodate varying anatomical conditions. The devices feature a chamber intended to be filled with autogenous bone and or/allogenic bone graft material. They are used with two internal anchors that lock on deployment and provide additional fixation. The BLACKHAWK™ Cervical Spacer System is to be used with autogenous bone and or/allogenic bone graft and supplemental fixation (i.e., an anterior cervical plate), and is implanted via an open, anterior approach.
The Ascendant® Cervical Spacer System is an anterior cervical interbody device consisting of a PEEK Optima® LT1 (polyetheretherkeytone) implant cage with tantalum radiographic markers. It is intended for use as an interbody fusion device and is offered in a variety of heights, footprints and lordotic angles to accommodate varying anatomical conditions. The device features an enclosed chamber intended to be filled with autogenous and or/allogenic bone graft material. The Ascendant® Cervical Spacer System is intended to be used with supplemental fixation (i.e., an anterior cervical plate).
The Ascendant™ PC Cervical Spacer System is an anterior cervical interbody device consisting of a PEEK Optima® LT1 (polyetheretherkeytone) implant cage with CP titanium coating and tantalum radiographic markers. It is intended for use as an interbody fusion device and is offered in a variety of heights, footprints and lordotic angles to accommodate varying anatomical conditions. The device features an enclosed chamber intended to be filled with autogenous and or/allogenic bone graft material.
The VEO® Lateral Access & Interbody Fusion System is a multi-component system including instrumentation made of biocompatible materials such as Stainless Steel, Aluminum, and Radel R and implants made of Tantalum (ASTM F560) and PEEK (ASTM F2026) or Ti-6AI-4V ELI (ASTM F136).
The ChoiceSpine Octane®-A/T/P Spinal Implant is an implant constructed of medical grade Polyetheretherketone, (PEEK-OPTIMA® LT1) as described by ASTM F2026. The implant incorporates ridges on the superior and inferior surfaces to resist expulsion. The device is open in the transverse plain to allow insertion of bone graft prior to placement, and fenestrated along the sides. The radiolucent PEEK-OPTIMA® material allows visualization of the defect site on radiography to assess bone growth, and incorporates tantalum markers conforming to ASTM F560 to permit verification of position. The ChoiceSpine Octane Spinal Implant is provided sterile in three (3) styles:
The Octane-T Spinal Implant, available heights of 7mm to 17mm, in 2mm increments;
The Octane-P Spinal Implant, available in heights of 7mm to 17mm, in 2mm increments; and
The Octane-A Spinal Implant, available in heights of 9mm to 19mm, in 2mm increments, and with a convex superior and inferior surface, angled at either 6° or 12° and in Small, Medium, or Large transverse profile.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Thoracolumbar spine (T1 to L5), Lumbar spine (L2 to S1), Cervical (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)
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.
K171140, K170953, K171489, K141129, K150130, K173260, K150152, K130434, K123997, K082270
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.
0
Image /page/0/Picture/0 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 the FDA logo, which 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.
August 15, 2019
ChoiceSpine, LLC Kim Finch Director of Regulatory Affairs 400 Erin Drive Knoxville, TN 37919
Re: K191621
Trade/Device Name: ChoiceSpine Cervical Spacer System "Blackhawk", ChoiceSpine Cervical Interbody Spacer System "Ascendant", ChoiceSpine Cervical Interbody Spacer System "Ascendant PC", ChoiceSpine Intervertebral Fusion Device "Octane Straight", ChoiceSpine Intervertebral Fusion Device "Octane Straight PC", ChoiceSpine VEO Lateral Access & Interbody Fusion System, ChoiceSpine Octane A/T/P Spinal Implant System
Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX, ODP, OVE, MQP Dated: July 15, 2019 Received: July 16, 2019
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. 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.
1
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 devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
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/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
for Melissa Hall Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K191621
Device Name
ChoiceSpine Octane A/T/P Spinal Implant System
Indications for Use (Describe)
When used as a vertebral body replacement:
The ChoiceSpine Octane-A/T/P Spinal Implant is indicated for use in the thoracolumbar spine (T1 to L5) for partial or total replacement of a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e., fracture), to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The Octane device is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column, even in the absence of fusion for a prolonged period. The device may be used with autogenous bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone graft, and supplemental fixation to facilitate fusion.
When used as an intervertebral body fusion device:
The Octane-A/T/P Spinal Implant is intended for spinal fusion procedures at one or two contiguous levels in the lumbar spine from L2 to S1 in patients with Degenerative Disc Disease (DDD), with up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin, with degeneration of the disc confirmed by history and radiographic studies. Patients should be skeletally mature, and have had at least 6 months of non-operative treatment. The device may be used with autogenous bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone graft, and with supplemental fixation systems cleared for use in the lumbosacral spine.
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995,
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of infonmation unless it displays a currently valid OMB number."
3
Indications for Use
510(k) Number (if known) K191621
Device Name
ChoiceSpine Cervical Interbody Spacer System "Ascendant PC"
Indications for Use (Describe)
The Ascendant PC Cervical Spacer System is indicated for anterior cervical interbody fusion procedures in skeletally mature patients with degenerative disc disease at one disc level from C2-T1. Degenerative Disc Disease (DDD) is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six weeks of non-operative treatment. The Ascendant PC Cervical Spacer System is to be used autogenous and/or allogenic bone graft composed of cancellous and /or corticocancellous bone graft, and supplemental fixation (i.e., an anterior cervical plate), and is implanted via an open, anterior approach. Patients with previous non-fusion spinal surgery at involved level may be treated with the device.
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995,
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of infonmation unless it displays a currently valid OMB number."
4
Indications for Use
510(k) Number (if known) K191621
Device Name
ChoiceSpine Cervical Interbody Spacer System "Ascendant"
Indications for Use (Describe)
The Ascendant Cervical Spacer System is indicated for anterior cervical interbody fusion procedures in skeletally mature patients with degenerative disc disease at one-disc level from C2-T1. Degenerative Disc Disease (DDD) is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six weeks of non-operative treatment.The Ascendant Cervical Spacer System is to be used with autogenous bone and/or allogenic bone graft composed of cancellous and /or corticocancellous bone graft, and supplemental fixation (i.e., an anterior cervical plate), and is implanted via an open, anterior approach. Patients with previous non-fusion spinal surgery at involved level may be treated with the device.
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995,
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of infonmation unless it displays a currently valid OMB number."
5
Indications for Use
510(k) Number (if known) K191621
Device Name
ChoiceSpine Cervical Spacer System "Blackhawk'
Indications for Use (Describe)
The BLACKHAWK™ Cervical Spacer System is indicated for anterior cervical interbody fusion procedures in skeletally mature patients with degenerative disc disease at one disc level from C2-T1. Degenerative Disc Disease (DDD) is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six weeks of non-operative treatment. The BLACKHAWK™ Cervical Spacer System is to be used autogenous bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone graft, and supplemental fixation (i.e., an anterior cervical plated via an open, anterior approach.
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995,
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of infonmation unless it displays a currently valid OMB number."
6
Indications for Use
510(k) Number (if known) K191621
Device Name
ChoiceSpine Intervertebral Fusion Device "Octane Straight"
Indications for Use (Describe)
The Octane Straight Intervertebral Fusion Device is intended for spinal fusion procedures at one or two contiguous levels in the lumbar spine from L2 to S1 in patients with Degenerative Disc Disease (DDD) with up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. Patients should be sketally mature and have had at least 6 months of non-operative treatment. The device system is designed for use with autogenous bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone graft, and with supplemental fixation systems cleared for use in the lumbosacral spine.
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995,
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of infonmation unless it displays a currently valid OMB number."
7
Indications for Use
510(k) Number (if known) K191621
Device Name
ChoiceSpine Intervertebral Fusion Device "Octane Straight PC"
Indications for Use (Describe)
The Octane Straight PC Intervertebral Fusion Device is intended for spinal fusion procedures at one or two contiguous levels in the lumbar spine from L2 to S1 in patients with Degenerative Disc Disease (DDD,) with up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin, with degeneration of the disc confirmed by history and radiographic studies. Patients should be sketally mature and have had at least 6 months of non-operative treatment. The device system is designed for use with autogenous bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone graft, and with supplemental fixation systems cleared for use in the lumbosacral spine.
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995,
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of infonmation unless it displays a currently valid OMB number."
8
Indications for Use
510(k) Number (if known) K191621
Device Name
ChoiceSpine VEO Laterial Access & Interbody Fusion System
Indications for Use (Describe)
The VEO™ Lateral Access & 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 at the involved level(s). These patients should have had six months of non-operative treatment. The VEO™ Lateral Access & Interbody Fusion System is designed to be used with autogenous and/or allogenic bone graft composed of cancellous and / or corticocancellous bone graft, and supplemental spinal fixation that is cleared for use in the lumbar spine.
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995,
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of infonmation unless it displays a currently valid OMB number."
9
| 510(k) Summary
| Date | August 12, 2019 |
|---|---|
| Sponsor | ChoiceSpine, LLC |
| 400 Erin Drive | |
| Knoxville, TN 37919 | |
| Phone | |
| Fax | 865-246-3333 |
| 865-246-3334 | |
| Contact Person | Kim Finch, Director of Regulatory Affairs |
| Proposed | |
| Proprietary Trade | |
| Name | ChoiceSpine Cervical Spacer System "Blackhawk" |
| ChoiceSpine Cervical Interbody Spacer System "Ascendant" | |
| ChoiceSpine Cervical Interbody Spacer System "Ascendant PC" | |
| ChoiceSpine Intervertebral Fusion Device "Octane Straight" | |
| ChoiceSpine Intervertebral Fusion Device "Octane Straight PC" | |
| ChoiceSpine VEO Lateral Access & Interbody Fusion System | |
| ChoiceSpine Octane A/T/P Spinal Implant System | |
| Product Class | Class II |
| Classification Name | 21 CFR 888.3080 - Intervertebral Body Fusion Device |
| 21 CFR 888.3060 - Intervertebral Body Fixation Orthosis | |
| Device | |
| Product Code | ChoiceSpine Cervical Spacer System "Blackhawk" (OVE) |
| ChoiceSpine Cervical Interbody Spacer System "Ascendant" (ODP) | |
| ChoiceSpine Cervical Interbody Spacer System "Ascendant PC" (ODP) | |
| ChoiceSpine Intervertebral Body Fusion Device "Octane Straight" (MAX) | |
| ChoiceSpine Intervertebral Body Fusion Device "Octane Straight PC" (MAX) | |
| ChoiceSpine Lateral Access Interbody Fusion Device "VEO" (MAX) | |
| ChoiceSine Vertebral Body Implant System "Octane A/T/P" (MAX), (MQP) | |
| Purpose of | |
| Submission | The purpose of this submission is for ChoiceSpine Intervertebral Body Fusion |
| Device Systems to gain clearance for the change in indications for use to allow the | |
| use of autogenous bone and/or allogenic bone graft comprised of cancellous and / | |
| or corticocanellous bone graft material. |
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Device Description This submission includes 7 subject devices. The device descriptions for each are listed below:
The ChoiceSpine Octane Straight Intervertebral Fusion Device is an implant constructed of medical grade Polyetheretherketone, (PEEK-OPTIMA® LT1) as described by ASTM F2026. The implant incorporates ridges on the superior and inferior surfaces to resist expulsion. The device is open in the transverse plane to allow insertion of bone graft prior to placement, and fenestrated along the sides. The radiolucent PEEK-OPTIMA® material allows visualization of the defect site on radiography to assess bone growth, and incorporates tantalum markers conforming to ASTM F560 to permit verification of position. The Octane Straight Intervertebral Fusion Device is provided sterile for single use.
The ChoiceSpine Octane Straight PC Intervertebral Fusion Device is an implant constructed of medical grade Polyetheretherketone, (PEEK-OPTIMA® LT1) as described by ASTM F2026. The implant incorporates ridges on the superior and inferior surfaces to resist expulsion. The device is open in the transverse plane to allow insertion of bone graft prior to placement, and fenestrated along the sides. The radiolucent PEEK-OPTIMA® material allows visualization of the defect site on radiography to assess bone growth and incorporates tantalum markers conforming to ASTM F560 to permit verification of position. The device is plasma coated with commercial pure titanium (CPTi) per ASTM F1580. The Octane Straight PC Intervertebral Fusion Device is provided sterile for single use.
The BLACKHAWK™ Cervical Spacer System is an anterior cervical interbody device consisting of a PEEK implant cage per ASTM F2026 with tantalum radiographic markers per ASTM F560, nitinol internal locking components per ASTM F2063 and two internal titanium alloy anchors (Ti-6Al-4V ELI) per ASTM F136. They are intended for use as interbody fusion devices and offered in a variety of heights, footprints, and lordotic angles to accommodate varying anatomical conditions. The devices feature a chamber intended to be filled with autogenous bone and or/allogenic bone graft material. They are used with two internal anchors that lock on deployment and provide additional fixation. The BLACKHAWK™ Cervical Spacer System is to be used with autogenous bone and or/allogenic bone graft and supplemental fixation (i.e., an anterior cervical plate), and is implanted via an open, anterior approach.
The Ascendant® Cervical Spacer System is an anterior cervical interbody device consisting of a PEEK Optima® LT1 (polyetheretherkeytone) implant cage with tantalum radiographic markers. It is intended for use as an interbody fusion device and is offered in a variety of heights, footprints and lordotic angles to accommodate varying anatomical conditions. The device features an enclosed chamber intended to be filled with autogenous and or/allogenic bone graft material. The Ascendant® Cervical Spacer System is intended to be used with supplemental fixation (i.e., an anterior cervical plate).
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The Ascendant™ PC Cervical Spacer System is an anterior cervical interbody device consisting of a PEEK Optima® LT1 (polyetheretherkeytone) implant cage with CP titanium coating and tantalum radiographic markers. It is intended for use as an interbody fusion device and is offered in a variety of heights, footprints and lordotic angles to accommodate varying anatomical conditions. The device features an enclosed chamber intended to be filled with autogenous and or/allogenic bone graft material.
The VEO® Lateral Access & Interbody Fusion System is a multi-component system including instrumentation made of biocompatible materials such as Stainless Steel, Aluminum, and Radel R and implants made of Tantalum (ASTM F560) and PEEK (ASTM F2026) or Ti-6AI-4V ELI (ASTM F136).
The ChoiceSpine Octane®-A/T/P Spinal Implant is an implant constructed of medical grade Polyetheretherketone, (PEEK-OPTIMA® LT1) as described by ASTM F2026. The implant incorporates ridges on the superior and inferior surfaces to resist expulsion. The device is open in the transverse plain to allow insertion of bone graft prior to placement, and fenestrated along the sides. The radiolucent PEEK-OPTIMA® material allows visualization of the defect site on radiography to assess bone growth, and incorporates tantalum markers conforming to ASTM F560 to permit verification of position. The ChoiceSpine Octane Spinal Implant is provided sterile in three (3) styles:
- . The Octane-T Spinal Implant, available heights of 7mm to 17mm, in 2mm increments;
- . The Octane-P Spinal Implant, available in heights of 7mm to 17mm, in 2mm increments; and
- . The Octane-A Spinal Implant, available in heights of 9mm to 19mm, in 2mm increments, and with a convex superior and inferior surface, angled at either 6° or 12° and in Small, Medium, or Large transverse profile.
Proposed The Ascendant PC Cervical Spacer System is indicated for anterior cervical interbody Indications for Use fusion procedures in skeletally mature patients with degenerative disc disease at one disc level from C2-T1. Degenerative Disc Disease (DDD) is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six weeks of non-operative treatment. The Ascendant PC Cervical Spacer System is to be used with autogenous and/or allogenic bone graft composed of cancellous and /or corticocancellous bone graft, and supplemental fixation (i.e., an anterior cervical plate), and is implanted via an open, anterior approach. Patients with previous non-fusion spinal surgery at involved level may be treated with the device.
The Ascendant® Cervical Spacer System is indicated for anterior cervical interbody fusion procedures in skeletally mature patients with degenerative disc disease at onedisc level from C2-T1. Degenerative Disc Disease (DDD) is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six weeks of non-operative treatment.
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The Ascendant Cervical Spacer System is to be used with autogenous bone and/or allogenic bone graft composed of cancellous and /or corticocancellous bone graft, and supplemental fixation (i.e., an anterior cervical plate), and is implanted via an open, anterior approach. Patients with previous non-fusion spinal surgery at involved level may be treated with the device.
The BLACKHAWK™ Cervical Spacer System is indicated for anterior cervical interbody fusion procedures in skeletally mature patients with degenerative disc disease at one disc level from C2-T1. Degenerative Disc Disease (DDD) is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six weeks of non-operative treatment. The BLACKHAWK™ Cervical Spacer System is to be used with autogenous bone and/or allogenic bone graft composed of cancellous and /or corticocancellous bone graft, and supplemental fixation (i.e., an anterior cervical plate), and is implanted via an open, anterior approach.
The Octane Straight Intervertebral Fusion Device is intended for spinal fusion procedures at one or two contiguous levels in the lumbar spine from L2 to S1 in patients with Degenerative Disc Disease (DDD) with up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. Patients should be skeletally mature and have had at least 6 months of nonoperative treatment. The device system is designed for use with autogenous bone and/or allogenic bone graft composed of cancellous and /or corticocancellous bone graft, and with supplemental fixation systems cleared for use in the lumbosacral spine.
The Octane Straight PC Intervertebral Fusion Device is intended for spinal fusion procedures at one or two contiguous levels in the lumbar spine from L2 to S1 in patients with Degenerative Disc Disease (DDD,) with up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin, with degeneration of the disc confirmed by history and radiographic studies. Patients should be skeletally mature and have had at least 6 months of nonoperative treatment. The device system is designed for use with autogenous bone and/or allogenic bone graft composed of cancellous and /or corticocancellous bone graft, and with supplemental fixation systems cleared for use in the lumbosacral spine.
The VEO® Lateral Access & 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 VEO™ Lateral Access & Interbody Fusion System is designed to be used with autogenous and/or allogenic bone graft composed of cancellous and / or corticocancellous bone graft, and supplemental spinal fixation that is cleared for use in the lumbar spine.
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The ChoiceSpine Octane-A/T/P Spinal Implant System:
When used as a vertebral body replacement:
The ChoiceSpine Octane®-A/T/P Spinal Implant is indicated for use in the thoracolumbar spine (T1 to L5) for partial or total replacement of a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e., fracture), to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The Octane device is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column, even in the absence of fusion for a prolonged period. The device may be used with autogenous bone and/or allogenic bone graft composed of cancellous and / or corticocancellous bone graft, and supplemental fixation to facilitate fusion.
The ChoiceSpine Octane-A/T/P Spinal Implant System:
When used as an intervertebral body fusion device: The Octane®-A/T/P Spinal Implant is intended for spinal fusion procedures at one or two contiguous levels in the lumbar spine from L2 to S1 in patients with Degenerative Disc Disease (DDD,) with up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin, with degeneration of the disc confirmed by history and radiographic studies. Patients should be skeletally mature, and have had at least 6 months of nonoperative treatment. The device may be used with autogenous bone and/or allogenic bone graft composed of cancellous and / or corticocancellous bone graft, and with supplemental fixation systems cleared for use in the lumbosacral spine.
- Materials The implants are made from either titanium alloy (Ti-6AI-4V ELI per ASTM F3001 or F1472) or polyetheretherketone (PEEK-Optima) per ASTM F2026 with tantalum markers per ASTM F560.
- Non-Clinical All subject components have been cleared and therefore do not present a new Testing mechanical worst-case and no non-clinical testing is needed.
Predicate Device Primary Predicate: Nexxt Spine, LLC MatrixxTM System (K171140)
Additional Predicate: ChoiceSpine TOMCAT™ Cervical Spacer System (K170953) Additional Predicate: ChoiceSpine Blackhawk™ Cervical Spacer System (K171489)
Additional Predicates: ChoiceSpine Ascendant Cervical Spacer System "Ascendant" (K141129), ChoiceSpine Cervical Spacer System "Ascendant PC" (K150130)
Additional Predicate: SeaSpine Spacer System – Hollywood, Hollywood VI, Ventura, Pacifica (K173260),
Additional Predicates: ChoiceSpine Intervertebral Fusion Device "Octane StraightPC" (K150152), ChoiceSpine Intervertebral Fusion Device "Octane Straight" (K130434), ChoiceSpine VEO™ Lateral Access interbody Fusion Device (K123997), and ChoiceSpine Octane A/T/P™ Vertebral Body Implant System (K082270)
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Substantial Equivalence Nexxt Spine, LLC Matrixx TM System (K171140).
Substantial Equivalence Conclusion
The implants proposed in this submission are similar to the predicates in principle of operation, materials, indications for use, biocompatibility, manufacturing and post processing steps, stabilization methods, sterilizations method, anatomic location and approach, product classification and product codes. The only differences are the indications for use for the subject devices indicate the use of autograft bone and the primary predicates allow with autograft bone and/or allogenic bone graft composed of cancellous and / or corticocancellous bone graft. Both the subject devices and predicate devices require supplemental fixation.
After considering all similarities and differences to the predicate devices, the subject device has shown to be equivalent when compared to the predicate devices in safety, effectiveness, and performance.