(273 days)
Intervertebral Body Fusion Device: The DeRoyal Spine Spacers are intended for use at one or two contiguous levels in the lumbar spine, from L2-S1, in skeletally mature patients who have had six months of non-operative treatment. The device is indicated for the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. Patients with previous non-fusion spinal surgery at the involved level may be treated with the device. The device is intended for use with autogenous bone graft and with supplemental fixation systems cleared for use in the lumbar spine.
Vertebral Body Replacement Device: The DeRoyal Spine Spacer System is indicated for use to replace a vertebral body that has been resected or excised (i.e. partial or total vertebrectomy) due to tumor or trauma/fracture. The device system is intended for use in the thoracolumbar spine from T1 to L5. The devices are intended for use with supplemental fixation and with autograft or allograft bone. The Spine Spacer System is designed to restore biomechanical integrity of the anterior, middle and posterior spinal column even in the absence of fusion for a prolonged period.
The DeRoyal Spine Spacer System consists of PEEK cages having the basic shape of a structural column. The top and bottom surfaces feature teeth to engage the bony endplates. The implants include a large vertical cavity which is packed with bone graft material to promote fusion of the adjacent vertebral bodies. The implants are offered in a variety of heights, widths, lengths and lordotic angles to accommodate varying patient anatomy.
The DeRoyal Spine Spacer System is a medical device and its performance is evaluated through mechanical testing rather than a study involving human subjects or AI algorithms. As such, many of the requested categories (e.g., sample size for test/training sets, expert qualifications, MRMC studies, ground truth types) are not applicable.
Here's an analysis of the provided text based on the nature of the device and its evaluation:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standard) | Reported Device Performance | Comments |
|---|---|---|
| ASTM F2077 (Static and dynamic compression) | "Mechanical testing of the worst case Spine Spacer was performed according to ASTM F2077... The mechanical test results demonstrate that the Spine Spacer device performance is substantially equivalent to the predicate devices." | Specifically, compression testing (both static and dynamic) ensures the device can withstand the forces it will encounter in the spine without failing or deforming excessively. |
| ASTM F2077 (Static and dynamic torsion) | "Mechanical testing of the worst case Spine Spacer was performed according to ASTM F2077... The mechanical test results demonstrate that the Spine Spacer device performance is substantially equivalent to the predicate devices." | Torsion testing (both static and dynamic) assesses the device's ability to resist twisting forces, which are also present in spinal movements. |
| ASTM F2267 (Subsidence properties) | "The subsidence properties were evaluated according to ASTM F2267." | Subsidence testing determines how well the device resists sinking into the surrounding bone under load, which is critical for long-term stability and prevention of complications. The text implies the results met the standard's requirements, leading to substantial equivalence. |
| ASTM Draft Standard (29 August 2000) (Expulsion testing) | "Expulsion testing was performed according to the ASTM Draft Standard (29 August 2000)." | Expulsion testing ensures the device remains securely in place within the intervertebral space and does not migrate out due to forces such as coughing, straining, or spinal movement. The text implies the results met the standard's requirements, leading to substantial equivalence. |
| Substantial Equivalence to Predicate Devices | "The DeRoyal Spine Spacer System devices possess the same intended use and technological characteristics as the predicate devices. Therefore the DeRoyal Spine Spacer System is substantially equivalent for its intended use." | The overall acceptance criterion is demonstrating "substantial equivalence" to legally marketed predicate devices, meaning it is as safe and effective. The mechanical tests contribute to demonstrating this. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated. For mechanical testing, devices are typically tested in batches to ensure consistency and statistical significance, but a specific number is not provided in this summary. It mentions "worst case Spine Spacer," implying representative samples.
- Data Provenance: The mechanical testing was conducted by DeRoyal Industries, Inc. (the manufacturer) and presumably in a controlled laboratory environment. This is prospective testing of manufactured devices.
- Country of Origin of the Data: United States (based on the sponsor's location and FDA submission).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Not Applicable. For mechanical testing of a medical implant, the "ground truth" is defined by established engineering standards (ASTM F2077, ASTM F2267, ASTM Draft Standard). There are no human experts "establishing ground truth" in the way one would for diagnostic imaging. The experts involved would be engineers and quality control personnel performing and interpreting the tests according to the standards.
4. Adjudication Method for the Test Set
- Not Applicable. Adjudication methods like 2+1 or 3+1 are used in studies involving human interpretation or clinical endpoints. Mechanical testing relies on objective measurements against predefined criteria and standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
- No. This is a mechanical device, not a diagnostic or AI-driven system that would involve human readers interpreting cases.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study was Done
- Not Applicable. This is a physical medical device, not an algorithm. Therefore, "standalone performance" in the context of AI does not apply.
7. The Type of Ground Truth Used
- Engineering Standards and Predicate Device Performance. The "ground truth" for the DeRoyal Spine Spacer System's mechanical performance is defined by the requirements outlined in the specified ASTM standards (ASTM F2077, ASTM F2267, ASTM Draft Standard) and the performance characteristics of the legally marketed predicate devices that the DeRoyal system aims to be substantially equivalent to.
8. The Sample Size for the Training Set
- Not Applicable. This device uses mechanical testing for performance evaluation, not machine learning, so there is no "training set."
9. How the Ground Truth for the Training Set was Established
- Not Applicable. As there is no training set for a machine learning algorithm, this question is not relevant.
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510(k) Summary FEB - 3 2014 Date: 10 January 2014 Sponsor: DeRoyal Industries, Inc. 200 DeBusk Lane Powell, TN 37849 USA Phone: 888.938.7828 or 865.938.7828 www.deroyal.com Contact Person: Nephi Zufelt, Director of Engineering and Regulatory Affairs Trade Name: DeRoval Spine Spacer System Device Classification Class II Classification Name: Intervertebral body fusion device / Spinal vertebral body replacement device Requlation: 888.3080. 888.3060 Device Product MAX, MQP Code: Device Description: The DeRoyal Spine Spacer System consists of PEEK cages having the basic shape of a structural column. The top and bottom surfaces feature teeth to engage the bony endplates. The implants include a large vertical cavity which is packed with bone graft material to promote fusion of the adjacent vertebral bodies. The implants are offered in a variety of heights, widths, lengths and lordotic angles to accommodate varying patient anatomy. Indications for Use: Intervertebral Body Fusion Device: The DeRoyal Spine Spacers are intended for use at one or two contiguous levels in the lumbar spine. from L2-S1, in skeletally mature patients who have had six months of non-operative treatment. The device is indicated for the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. Patients with previous non-fusion spinal surgery at the involved level may be treated with the device. The device is intended for use with autogenous bone graft and with supplemental fixation systems cleared for use in the lumbar spine. Vertebral Body Replacement Device: The DeRoyal Spine Spacer System is indicated for use to replace a vertebral body that has been resected or excised (i.e. partial or total vertebrectomy) due to tumor or trauma/fracture. The device system is intended for use in the thoracolumbar spine from T1 to L5. The devices are intended for use with supplemental fixation and with autograft or allograft bone. The Spine Spacer System is designed to restore biomechanical integrity of the anterior, middle and posterior spinal column even in the absence of fusion for a prolonged period Materials: DeRoyal Spine Spacer System components are manufactured from polyetheretherketone (PEEK-OPTIMA® LT1, Invibio®) as described by ASTM F2026. Integral marker pins used in the devices are manufactured from tantalum as described by ASTM F560.
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Lumbar I/F Cage® (P960025) Predicate Devices: Lucent® (K050449, K071724 and K081968) Eminent Spine Interbody Fusion System (K090064) MC+ (K043479) Performance Data: Mechanical testing of the worst case Spine Spacer was performed according to ASTM F2077 and included static and dynamic compression and static and dynamic torsion. The subsidence properties were evaluated according to ASTM F2267. Expulsion testing was performed according to the ASTM Draft Standard (29 August 2000). The mechanical test results demonstrate that the Spine Spacer device performance is substantially equivalent to the predicate devices. Technological The DeRoyal Spine Spacer System possesses the same Characteristics: technological characteristics as the predicate devices. These include: . performance (as described above), . basic design (hollow structural column). material (PEEK polymer and tantalum), and . sizes (widths, lengths and heights are within the range(s) . offered by the predicate). Therefore the fundamental scientific technology of the DeRoyal Spine Spacer System devices is the same as previously cleared devices. Conclusion: The DeRoyal Spine Spacer System devices possess the same
intended use and technological characteristics as the predicate devices. Therefore the DeRoyal Spine Spacer System is substantially equivalent for its intended use.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a stylized eagle with three swooping lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring MD 20993-0002
February 3, 2014
DeRoyal Industries, Incorporated % Karen Warden Ph.D. Representative/Consultant BackRoads Consulting, Incorporated P.O. Box 566 Chesterland, Ohio 44026
Re: K131292
Trade/Device Name: DeRoyal Spine Spacer System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX, MQP Dated: January 10, 2014 Received: January 13, 2014
Dear Dr. Warden:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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Page 2 - Karen Warden Ph.D.
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 Small Manufacturers. International and Consumer Assistance at its tollfree 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 Small Manufacturers, International and Consumer Assistance 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.
Sincerely yours,
Vincenting avlin -S
- for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Section 7 - Indications for Use Statement
K131292 510(k) Number:
Device Name: DeRoyal Spine Spacer System
Indications for Use:
Intervertebral Body Fusion Device: The DeRoyal Spine Spacers are intended for use at one or two contiguous levels in the lumbar spine, from L2-S1, in skeletally mature patients who have had six months of non-operative treatment. The device is indicated for the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. Patients with previous non-fusion spinal surgery at the involved level may be treated with the device. The device is intended for use with autogenous bone graft and with supplemental fixation systems cleared for use in the lumbar spine.
Vertebral Body Replacement Device: The DeRoyal Spine Spacer System is indicated for use to replace a vertebral body that has been resected or excised (i.e. partial or total vertebrectorny) due to tumor or trauma/fracture. The device system is intended for use in the thoracolumbar spine from T1 to L5. The devices are intended for use with supplemental fixation and with autograft or allograft bone. The Spine Spacer System is designed to restore biomechanical integrity of the anterior, middle and posterior spinal column even in the absence of fusion for a prolonged period.
OR Prescription Use X Over-the-Counter Use_ (Per 21 CFR 801.109)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Anton E. Dmitriev, PhD Division of Orthopedio 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.