(56 days)
The LEGEND Spine CORNICE Cervical Spacer System is indicated for use as an intervertebral body fusion device in skeletally mature patients with cervical disc degeneration and/or cervical spinal instability, as confirmed by imaging studies (radiographs, CT, MRI), that results in radiculopathy, myelopathy, and/or pain at one or two contiguous levels from C2 to T1. These patients should have had six weeks of non-operative treatment. The LEGEND Spine CORNICE Cervical Spacer System is also to be used with supplemental fixation system that have been cleared for use in the cervical spine. The LEGEND Spine CORNICE Cervical Spacer System is designed for use with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion.
The LEGEND Spine CORNICE Cervical Spacer System is an Anterior Cervical Interbody Fusion Device that has a hollow chamber to permit packing with bone graft to facilitate fusion. The superior and inferior surfaces of the device have a pattern of teeth to provide increased stability and to help prevent movement of the device. The Legend Spine CORNICE Spacers are made from either PEEK (VESTAKEEP i4 R per ASTM F2026) radiolucent material with embedded tantalum (ASTM F560) x-ray markers or Titanium Alloy conforming to ASTM F136.
The provided document is a 510(k) premarket notification letter and summary for the LEGEND Spine CORNICE Cervical Spacer System. This document describes a medical device, which is a physical implant, not an AI/ML powered device. As such, it does not include information typically sought for AI/ML devices regarding acceptance criteria, performance studies involving AI, human experts, and ground truth establishment in the way an AI/ML product would.
The performance testing described is mechanical testing for the physical implant to ensure its structural integrity and safety. Therefore, I cannot extract the information required for an AI/ML device from this document.
For completeness, I can describe the type of acceptance criteria and performance testing that were included for this physical device:
Acceptance Criteria and Reported Device Performance (Physical Device - Mechanical Testing)
| Acceptance Criteria Type | Performance Test/Standard |
|---|---|
| Structural Integrity | Static and dynamic axial compression |
| Stability/Resistance to Shear | Static and dynamic compression shear |
| Resistance to Dislodgement | Expulsion testing |
| Resistance to Sinkage | Subsidence testing |
| Result | The device meets or exceeds the performance of predicate devices according to ASTM F2077-14, ASTM F2267-04, and the Class II Special Controls Guidance Document. |
Missing Information (as this is not an AI/ML device):
- Sample size used for the test set (no test set in the AI/ML sense)
- Data provenance (not applicable for mechanical testing)
- Number of experts used to establish ground truth (not applicable)
- Qualifications of those experts (not applicable)
- Adjudication method (not applicable)
- Multi-reader multi-case (MRMC) comparative effectiveness study (not applicable)
- Effect size (not applicable)
- Standalone performance (not applicable)
- Type of ground truth (not applicable)
- Sample size for the training set (not applicable)
- How ground truth for the training set was established (not applicable)
The document focuses on demonstrating substantial equivalence to predicate devices through mechanical testing, which is standard for intervertebral body fusion devices. It does not involve any AI/ML components where ground truth and human-in-the-loop performance would be relevant.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". To the right of the seal, there is a blue square with the letters "FDA" in white. Next to the blue square, the words "U.S. FOOD & DRUG ADMINISTRATION" are written in blue.
October 9, 2019
Legend Spine Technologies % Christine Scifert, M.S., M.E.M. Exec. VP MRC-X, LLC 6075 Poplar Ave Memphis, Tennessee 38119
Re: K192208
Trade/Device Name: CORNICE Cervical Spacer System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: ODP Dated: August 8, 2019 Received: August 14, 2019
Dear Christine Scifert:
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.
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
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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 (OS) 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 mediation-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 Ronald P. Jean, Ph.D. Director (Acting) DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K192208
Device Name
LEGEND Spine CORNICE Cervical Spacer System
Indications for Use (Describe)
The LEGEND Spine CORNICE Cervical Spacer System is indicated for use as an intervertebral body fusion device in skeletally mature patients with cervical disc degeneration and/or cervical spinal instability, as confirmed by imaging studies (radiographs, CT, MRI), that results in radiculopathy, and/or pain at one or two contiguous levels from C2 to T1. These patients should have had six weeks of non-operative treatment. The LEGEND Spine CORNICE Cervical Spacer System is also to be used with supplemental fixation system that have been cleared for use in the cervical spine. The LEGEND Spine CORNICE Cervical Spacer System is designed for use with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | |
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary
LEGEND Spine CORNICE Cervical Spacer System October 4, 2019
| Company: | Legend Spine Technologies |
|---|---|
| 1803 Apple Tree Lane | |
| Bethlehem, PA 18015 | |
| Primary Contact: | Christine Scifert |
| Phone: 901-831-8053 | |
| Company Contact: | Steve Marinelli, PE |
| Phone: 267-566-3273 | |
| s.marinelli@legend-spine.com | |
| Trade Name: | LEGEND Spine CORNICE Cervical Spacer System |
| Common Name: | Intervertebral Body Fusion Device |
| Classification: | II |
| Regulation Number: | 888.3080 |
| Panel: | 87-Orthopedic |
| Product Code(s): | ODP |
The LEGEND Spine CORNICE Cervical Spacer System is an Anterior Cervical Device Description: Interbody Fusion Device that has a hollow chamber to permit packing with bone graft to facilitate fusion. The superior and inferior surfaces of the device have a pattern of teeth to provide increased stability and to help prevent movement of the device. The Legend Spine CORNICE Spacers are made from either PEEK (VESTAKEEP i4 R per ASTM F2026) radiolucent material with embedded tantalum (ASTM F560) x-ray markers or Titanium Alloy conforming to ASTM F136.
Indications for Use: The LEGEND Spine CORNICE Cervical Spacer System is indicated for use as an intervertebral body fusion device in skeletally mature patients with cervical disc degeneration and/or cervical spinal instability, as confirmed by imaging studies (radiographs, CT, MRI), that results in radiculopathy, myelopathy, and/or pain at one or two contiguous levels from C2 to T1. These patients should have had six weeks of non-operative treatment. The LEGEND Spine CORNICE Cervical Spacer System is also to be used with supplemental fixation system that have been cleared for use in the cervical spine. The LEGEND Spine CORNICE Cervical Spacer System is designed for use with autogenous
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and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion.
Substantial Equivalence: The subject components were demonstrated to be substantially equivalent to the following systems previously cleared by the FDA:
Primary Predicate: K181140: Axis Chena Cervical PEEK Spacer System
Secondary Predicates: K111983: Zimmer Biomet Vista-S K120275: Depuy Synthes ACIS K160125: K2M Cascadia
Reference Device: K180071: STYLO-T Interbody Cage
The subject components are similar in indications, geometry, and materials to the predicates.
Performance Testing: Static and dynamic axial compression, static and dynamic compression shear, expulsion, and subsidence testing were completed for the CORNICE Spacer according to ASTM F2077-14, ASTM F2267-04, and the Class II Special Controls Guidance Document: Intervertebral Body Fusion Device issued June 12, 2007. Performance testing demonstrates that the subject device meets or exceeds performance of predicate devices demonstrating that the subject devices are substantially equivalent to the predicate devices.
Conclusion
Based on the test results and the comparison to the predicate devices, the subject device is determined to be substantially equivalent to the predicate devices.
§ 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.