(205 days)
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 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 autograft 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 autograft to facilitate fusion.
Choice Spine VEO™ Lateral Access & Interbody Fusion System:
The Choice Spine 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 radios. 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 Choice Spine VEO™ Lateral Access & Interbody Fusion System is designed to be used with autogenous graft and supplemental spinal fixation that is cleared for use in the lumbar spine.
Choice Spine Interbody Fusion System:
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 bone graft and a supplemental spinal fixation system that is cleared for use in the lumbar spine.
This submission includes three lumbar implant families. The device description for each family is listed below.
Choice Spine Lumbar Spacer System (Sabre, Shark, Hornet, Harpoon):
The Choice Spine Lumbar Spacer System consists of interbody fusion devices (specifically, SABRE, SHARK™, HORNET™ & HARPOON™ Lumbar Spacers) comprised of polyetheretherketone (PEEK - Optima®) with tantalum markers (ASTM F2026 and ASTM F560) or Ti-6AI-4V ELI (ASTM F136). The spacers have a basic rectangular shape, a hollow center for placement of bone graft and a smooth bullet shaped anterior surface. They are available in an assortment of height, length and anteroposterior angulation combinations to accommodate many different anatomic requirements. These implants are delivered via a posterior or transforaminal approach.
Choice Spine VEO™ Lateral Access & Interbody Fusion System:
The Choice Spine VEO™ Lateral Access & Interbody Fusion System is a multicomponent system including instrumentation made of stainless steel. Aluminum. and Radel R and implants made of tantalum (ASTM F560) and PEEK Optima® (ASTM F2026) or Ti-6Al-4V ELI (ASTM F136). The implants are delivered via lateral approach.
Choice Spine Interbody Fusion System:
The Choice Spine Interbody Fusion System is a family of implants intended to aid in spinal fixation of the lumbar spine. This system includes implants made of Zeniva ZA-500 PEEK (ASTM F2026) with Tantalum markers (ASTM F560) or Ti-6Al-4V ELI (ASTM F136), which are delivered via anterior or anterolateral approach.
The provided document is a 510(k) summary for several intervertebral body fusion devices. This type of document is filed with the FDA to demonstrate substantial equivalence to a legally marketed predicate device, rather than to establish safety and effectiveness through clinical trials with specific acceptance criteria. Therefore, the document does not contain the information requested regarding acceptance criteria, study design, sample sizes, expert ground truth establishment, or multi-reader multi-case studies for a device's performance.
The document primarily focuses on:
- Indications for Use: What conditions the devices are intended to treat.
- Device Description: The materials and general design of the implants.
- Comparison to Predicate Devices: An assertion that the new devices are substantially equivalent to previously cleared devices.
- Non-Clinical Testing: A statement that "no new non-clinical testing is needed" due to the design being the same if manufactured from Titanium instead of PEEK.
In the context of a 510(k) submission for these types of devices, the "acceptance criteria" are typically related to demonstrating substantial equivalence through a comparison of technological characteristics and intended use, often supported by non-clinical performance data (e.g., mechanical testing to ASTM standards), rather than clinical performance metrics like sensitivity, specificity, or reader improvement with AI.
Therefore, I cannot extract the requested information from this document. The document specifically states: "no new non-clinical testing is needed," implying that the performance was considered sufficiently similar to the predicate devices based on design and material changes, and thus no new study specifically proving acceptance criteria for device performance was required or submitted as part of this 510(k).
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized representation of three human profiles facing right, arranged in a way that suggests unity and connection. The profiles are black and are set against a white background. Encircling the profiles are the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 19, 2016
Choice Spine, LP Ms. Kim Finch Manager of Regulatory Affairs 400 Erin Drive Knoxville, Tennessee 37919
Re: K153107
Trade/Device Name: Choice Spine Lumbar Spacer System (Sabre™, Shark™, Hornet™, Harpoon™), Choice Spine VEO™ Lateral Access & Interbody Fusion System, Choice Spine Interbody Fusion System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX, MQP Dated: April 22, 2016 Received: April 25, 2016
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
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(21 CFR Part 807); labeling (21 CFR Parts 801); medical device reporting of medical device-related 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 at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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) K153107
Device Name
Choice Spine Lumbar Spacer System (Sabre™, Shark™, Hornet™, Harpoon™) Choice Spine VEOTM Lateral Access & Interbody Fusion System Choice Spine Interbody Fusion System
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 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 autograft 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 autograft to facilitate fusion.
Choice Spine VEOTM Lateral Access & Interbody Fusion System:
The Choice Spine 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 radios. 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 Choice Spine VEO™ Lateral Access & Interbody Fusion System is designed to be used with autogenous graft and supplemental spinal fixation that is cleared for use in the lumbar spine.
Choice Spine Interbody Fusion System:
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 bone graft and a supplemental spinal fixation system that is cleared for use in the lumbar spine.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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510(k) Summary
| Date | May 17, 2016 |
|---|---|
| Sponsor: | Choice Spine, LP400 Erin DriveKnoxville, TN 37919 |
| Phone: | 865-246-3333 |
| Fax: | 865-246-3334 |
| Contact Person: | Kim Finch, Manager of Regulatory Affairs |
| ProposedProprietary TradeName: | Choice Spine Lumbar Spacer System (Sabre™, Shark™, Hornet™, Harpoon™)Choice Spine VEO™ Lateral Access & Interbody Fusion SystemChoice Spine Interbody Fusion System |
| Product Class: | Class II |
| ClassificationName: | Choice Spine Lumbar Spacer System (Sabre™, Shark™, Hornet™, Harpoon™):888.3080- Spinal Intervertebral Body Fusion Device 888.3060- Spinal Intervertebral Body Fixation Orthosis Choice Spine VEO™ Lateral Access & Interbody Fusion System:888.3080- Spinal Intervertebral Body Fusion Device Choice Spine Interbody Fusion System:888.3080- Spinal Intervertebral Body Fusion Device |
| Device ProductCode: | Choice Spine Lumbar Spacer System (Sabre™, Shark™, Hornet™, Harpoon™):MAX, MQP Choice Spine VEO™ Lateral Access & Interbody Fusion System:MAX Choice Spine Interbody Fusion System:MAX |
| Purpose ofSubmission: | The purpose of this submission is to gain clearance for additional devicesmanufactured from titanium-alloy. The previously cleared system are ChoiceSpine Lumbar Spacer System, K140142 and K073669, Choice Spine VEO™Lateral Access & Interbody Fusion System (Formerly TranS1 Lateral InterbodyFusion System) K100210 and K123997, and Choice Spine Interbody Fusion |
TranS1 systems were acquired by Choice Spine in 2015.
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Device Description: This submission includes three lumbar implant families. The device description for each family is listed below.
Choice Spine Lumbar Spacer System (Sabre, Shark, Hornet, Harpoon):
The Choice Spine Lumbar Spacer System consists of interbody fusion devices (specifically, SABRE, SHARK™, HORNET™ & HARPOON™ Lumbar Spacers) comprised of polyetheretherketone (PEEK - Optima®) with tantalum markers (ASTM F2026 and ASTM F560) or Ti-6AI-4V ELI (ASTM F136). The spacers have a basic rectangular shape, a hollow center for placement of bone graft and a smooth bullet shaped anterior surface. They are available in an assortment of height, length and anteroposterior angulation combinations to accommodate many different anatomic requirements. These implants are delivered via a posterior or transforaminal approach.
Choice Spine VEO™ Lateral Access & Interbody Fusion System:
The Choice Spine VEO™ Lateral Access & Interbody Fusion System is a multicomponent system including instrumentation made of stainless steel. Aluminum. and Radel R and implants made of tantalum (ASTM F560) and PEEK Optima® (ASTM F2026) or Ti-6Al-4V ELI (ASTM F136). The implants are delivered via lateral approach.
Choice Spine Interbody Fusion System:
The Choice Spine Interbody Fusion System is a family of implants intended to aid in spinal fixation of the lumbar spine. This system includes implants made of Zeniva ZA-500 PEEK (ASTM F2026) with Tantalum markers (ASTM F560) or Ti-6Al-4V ELI (ASTM F136), which are delivered via anterior or anterolateral approach.
Intended 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 months of non-operative treatment. The device is intended for use at either one level or two contiquous 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 autograft 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 autograft to facilitate fusion.
Choice Spine VEO™ Lateral Access & Interbody Fusion System:
The Choice Spine VEO™ Lateral Access & Interbody Fusion System is indicated for spinal fusion procedures in skeletally mature patients with
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degenerative disc disease (DDD) at one or two contiquous 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 spondvlolisthesis or retrolisthesis at the involved level(s). These patients should have had six months of non-operative treatment. The Choice Spine VEO™ Lateral Access & Interbody Fusion System is designed to be used with autogenous graft and supplemental spinal fixation that is cleared for use in the lumbar spine. Choice Spine Interbody Fusion System: 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 bone graft and a supplemental spinal fixation system that is cleared for use in the lumbar spine. Comparison of The implants included in this submission are equivalent to the primary predicate Technological Alphatec Battalion Universal Spacer System (K143740), and additional predicates Characteristics: are Choice Spine Lumbar Spacer System (K140142 and K073669), Choice Spine Interbody Fusion System (K120991), and the Choice Spine VEO™ Lateral Access & Interbody Fusion Device System (K100210 and K123997). Non-Clinical Testing: 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. Conclusion: The subject implants are substantially equivalent in intended use, anatomic location, indications, method of stabilization, and material of manufacture.
§ 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.