(130 days)
The Choice Spine TiGer Shark™ 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 (6) months of non-operative treatment. This device is designed to be used with autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. This device is designed for use with supplemental fixation that is cleared for use in the lumbar spine.
The Choice Spine TiGer Shark™ System consists of implants made of titanium alloy (Ti-6Al-4V ELI per ASTM F3001, Class C). The spacers have a basic rectangular shape, a hollow center for placement of bone graft and a smooth bullet shaped distal surface. They are available in an assortment of height, length and anteroposterior angulation combinations to accommodate many different anatomic requirements. The implants are delivered via a posterior, transforaminal, or lateral approach. The devices are manufactured using the Electron Beam Melting (EBM) additive manufacturing method.
This document is a 510(k) summary for the Choice Spine TiGer Shark™ System, an intervertebral body fusion device. It focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed study that proves the device meets specific acceptance criteria with quantifiable performance metrics.
Therefore, the requested information (acceptance criteria, reported device performance, sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC study details, and standalone performance) is not available within the provided text.
The document discusses the following types of non-clinical testing performed:
- Static Compression - Per ASTM F2077
- Static Compression Shear - Per ASTM F2077
- Dynamic Compression - Per ASTM F2077
- Dynamic Compression Shear - Per ASTM F2077
- Expulsion - N/A
- Subsidence - per ASTM F2267
It states that "Mechanical testing was conducted to prove that the new worst-case design is stronger, and after including all other similarities, shown to be equivalent to the predicate devices in safety, effectiveness, and performance." However, it does not specify the acceptance criteria for "stronger" or "equivalent," nor does it present the numerical results of these tests.
In summary, the provided text does not contain the information necessary to complete the requested table and study details.
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January 26, 2018
Choice Spine, LP Kim Finch Director of Regulatory Affairs 400 Erin Drive Knoxville, Tennessee 37919
Re: K172816
Trade/Device Name: Choice Spine TiGer Shark™ System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX Dated: December 20, 2017 Received: December 21, 2017
Dear Ms. Finch:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 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);
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and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
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) K172816
Device Name Choice Spine TiGer Shark™ System
Indications for Use (Describe)
Choice Spine TiGer Shark™ System:
The Choice Spine TiGer Shark™ 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 (6) months of non-operative treatment. This device is designed to be used with autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. This device is designed for use with supplemental fixation 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)
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510(k) Summary
| Date: | Dec 20, 2017 |
|---|---|
| Sponsor: | Choice Spine, LP |
| 400 Erin Drive | |
| Knoxville, TN 37919 | |
| Phone: | 865-246-3333 |
| Fax: | 865-246-3334 |
| Contact Person: | Kim Finch, Manager of Regulatory Affairs |
| ProposedProprietary TradeName: | Choice Spine TiGer Shark™ System |
| Product Class: | Class II |
| Classification Name: | Choice Spine TiGer Shark™ System: |
| • 888.3080 - Spinal Intervertebral Body Fusion Device | |
| Device ProductCode: | Choice Spine TiGer Shark™ System:• MAX |
| Purpose ofSubmission: | The purpose of this submission is to gain clearance for the new Choice SpineTiGer Shark™ System, which consists of the implants which are made of Ti-6Al-4VELI per ASTM- F3001, Class C. The subject implant devices & instrumentation willbe used with additional previously cleared instrumentation. |
| Device Description: | The Choice Spine TiGer Shark™ System consists of implants made of titaniumalloy (Ti-6Al-4V ELI per ASTM F3001, Class C). The spacers have a basicrectangular shape, a hollow center for placement of bone graft and a smoothbullet shaped distal surface. They are available in an assortment of height,length and anteroposterior angulation combinations to accommodate manydifferent anatomic requirements. The implants are delivered via a posterior,transforaminal, or lateral approach. The devices are manufactured using theElectron Beam Melting (EBM) additive manufacturing method. |
| Indications for Use: | The Choice Spine TiGer Shark™ System is indicated for spinal fusion proceduresin skeletally mature patients with degenerative disc disease (DDD) at one or twocontiguous levels from L2-S1. DDD is defined as discogenic back pain withdegeneration of the disc confirmed by patient history and radiographic studies.These DDD patients may also have up to Grade 1 spondylolisthesis orretrolisthesis at the involved level(s). These patients should have had six (6)months of non-operative treatment. This device is designed to be used withautogenous bone graft and/or allogenic bone graft comprised of cancellousand/or corticocancellous bone graft. This device is designed for use withsupplemental fixation that is cleared for use in the lumbar spine |
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K172816 Page 1 of 2
The implants are made from titanium alloy (Ti-6Al-4V ELI) per ASTM F3001, Class Materials: C and will be provided sterile. Instruments will be provided non-sterile, but will be steam sterilized before use. The instrumentation is made from 455 SS: and 17-4 SS per ASTM F899 and ASTM A564.
Non-Clinical Testing: Static Compression - Per ASTM F2077 Static Compression Shear - Per ASTM F2077 Dynamic Compression - Per ASTM F2077 Dynamic Compression Shear - Per ASTM F2077 Expulsion - N/A Subsidence - per ASTM F2267
Substantial Equivalence: The implants included in this submission are equivalent to the TranS1 Interbody Fusion System (K120991, primary predicate), and Spineart Intervertebral Fusion Device Juliet PO (K142277), Choice Spine Lumbar Spacer System, (K162103), as additional predicates.
Substantial Equivalence
The implants proposed in this submission are identical to the predicate devices Conclusion: in: principle of operation, material, indications for use, biocompatibility, manufacturing and post-processing steps, stabilization method, sterilization method, anatomic location and approach, product code and classification.
The new additive manufacturing method per ASTM F3001, Class C and slight design change introduce a new worst case for design. Mechanical testing was conducted to prove that the new worst-case design is stronger, and after including all other similarities, shown to be equivalent to the predicate devices in safety, effectiveness, and performance.
§ 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.