(38 days)
Lumbar System Indications: The Aurora Spine Interbody Fusion System devices are indicated for use as intervertebral body fusion devices in skeletally mature patients with degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies) at one or two contiguous levels of the lumbar spine (L2-S1). Patients should have six months of non-operative treatment prior to surgery. These implants are used to facilitate fusion in the lumbar spine and are placed via either a posterior, transforaminal, lateral or anterior approach using autogenous bone. When used as interbody fusion devices these implants are intended for use with supplemental fixation systems cleared for use in the thoracolumbar spine.
Cervical System Indications: The Aurora Spine Interbody Fusion System is indicated for use as an intervertebral body fusion device in skeletally mature patients with degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies) at one level of the cervical spine with accompanying radicular symptoms. Patients should have six weeks of non-operative treatment prior to surgery. Cervical implants are used to facilitate fusion in the cervical spine (C2-T1) and are placed via an anterior approach using autogenous bone. When used as an interbody fusion device, supplemental fixation must be used.
The Aurora Spine Interbody Fusion System, manufactured from PEEK-Optima®, consist of implants available in various foot prints, heights and lordotic configurations with an open architecture to accept packing of autograft materials. The exterior of the device has "teeth" or other generally sharp engagement members on the superior and inferior surfaces to help prevent the device from migrating once it is surgically positioned. The device comes in a PEEK or PEEK with a plasma-sprayed commercially pure titanium coating on the superior and inferior surfaces.
The Aurora Spine Interbody Fusion System is a medical device, and its acceptance criteria are based on mechanical testing to demonstrate substantial equivalence to a predicate device. There is no clinical study involving human patients or AI reported in this document.
1. Table of Acceptance Criteria and Reported Device Performance:
| Test Description | Acceptance Criteria (Standard) | Reported Device Performance (as stated) |
|---|---|---|
| Static Compression | ASTM F2077 | "All data indicates the device is substantial equivalence to the predicate systems" |
| Dynamic Compression | ASTM F2077 | "All data indicates the device is substantial equivalence to the predicate systems" |
| Torsion | ASTM F2077 | "All data indicates the device is substantial equivalence to the predicate systems" |
| Compression-Shear | ASTM F2077 | "All data indicates the device is substantial equivalence to the predicate systems" |
| Subsidence Testing | ASTM F2267 | "All data indicates the device is substantial equivalence to the predicate systems" |
| Expulsion Testing | (Not specified) | "All data indicates the device is substantial equivalence to the predicate systems" |
| Static Shear (Coating) | ASTM F1044 | "All data indicates the device is substantial equivalence to the predicate systems" |
| Static Tension (Coating) | ASTM F1147 | "All data indicates the device is substantial equivalence to the predicate systems" |
| Abrasion (Coating) | ASTM F1978 | "All data indicates the device is substantial equivalence to the predicate systems" |
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not applicable. The document describes non-clinical mechanical testing, not a test set of patient data.
- Data Provenance: Not applicable. The data is from mechanical testing performed on the device components, not from patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This device's acceptance is based on mechanical engineering standards, not expert clinical interpretation of data.
4. Adjudication method for the test set:
- Not applicable. As described, no human adjudication was involved in the mechanical testing for substantial equivalence.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No MRMC comparative effectiveness study was done. This document explicitly states, "Clinical data and conclusions were not needed for this device." There is no mention of AI.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This is a physical medical device (interbody fusion system), not an algorithm or AI.
7. The type of ground truth used:
- The "ground truth" for this device's acceptance is adherence to established ASTM (American Society for Testing and Materials) standards for mechanical properties and the demonstration of substantial equivalence to a legally marketed predicate device (Tyber Medical Interbody System, K130573) based on these mechanical tests.
8. The sample size for the training set:
- Not applicable. There is no training set mentioned or required for this type of device submission, as it involves mechanical testing and not machine learning or AI.
9. How the ground truth for the training set was established:
- Not applicable. As there is no training set, there is no corresponding ground truth establishment process.
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JAN 3 1 2014
510(k) Summary
Contact: Justin Eggleton Musculoskeletal Clinical & Regulatory Advisers, LLC 1331 H Street NW. 12th Floor Washington, DC 20005 202.552.5800 January 17, 2014 Date Prepared: Device Trade Name: Aurora Spine Interbody Fusion System Sponsor: Aurora Spine, Inc. 1920 Palomar Point Way Carlsbad, CA 92008 Common Name: Lumbar and Cervical Interbody Cage Classification: 21 CFR §888.3080; Intervertebral body fusion device II Class: Product Code: MAX, ODP
Indications For Use:
Lumbar System Indications
The Aurora Spine Interbody Fusion System devices are indicated for use as intervertebral body fusion devices in skeletally mature patients with degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies) at one or two contiguous levels of the lumbar spine (L2-S1). Patients should have six months of non-operative treatment prior to surgery. These implants are used to facilitate fusion in the lumbar spine and are placed via either a posterior, transforaminal, lateral or anterior approach using autogenous bone. When used as interbody fusion devices these implants are intended for use with supplemental fixation systems cleared for use in the thoracolumbar spine.
Cervical System Indications
The Aurora Spine Interbody Fusion System is indicated for use as an intervertebral body fusion device in skeletally mature patients with degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies) at one level of the cervical spine with accompanying radioular symptoms. Patients should have six weeks of non-operative treatment prior to surgery. Cervical implants are used to facilitate fusion in the cervical spine (C2-T1) and are placed
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via an anterior approach using autogenous bone. When used as an interbody fusion device, supplemental fixation must be used.
Device Description:
The Aurora Spine Interbody Fusion System, manufactured from PEEK-Optima®, consist of implants available in various foot prints, heights and lordotic configurations with an open architecture to accept packing of autograft materials. The exterior of the device has "teeth" or other generally sharp engagement members on the superior and inferior surfaces to help prevent the device from migrating once it is surgically positioned. The device comes in a PEEK or PEEK with a plasma-sprayed commercially pure titanium coating on the superior and inferior surfaces.
Predicate Device(s):
The Aurora Spine Interbody Fusion System was shown to be substantially equivalent to previously cleared device and has the same indications for use, design, function, and materials used. This device is the Tyber Medical Interbody System (K130573).
Performance Standards:
Non-clinical mechanical testing was performed consisting of Static and Dynamic Compression, Torsion, Compression-Shear per ASTM F2077. Additionally, Subsidence Testing per ASTM F2267 and Expulsion testing was performed. The coating characterization tests include Static Shear per ASTM F1044, Static Tension per ASTM F1147, and Abrasion per ASTM F1978. All data indicates the device is substantial equivalence to the predicate systems
Clinical data and conclusions were not needed for this device.
Conclusion:
The Aurora Spine Interbody Fusion System is substantially equivalent to predicate devices.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird-like figure.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 31, 2014
Aurora Spine % Mr. Justin Eggleton Director, Spine Regulatory Affairs Musculoskeletal Clinical Regulatory Advisers, LLC 1331 H Street Northwest, 12th Floor Washington, District of Columbia 20005
Re: K133967
Trade/Device Name: Aurora Spine Interbody Fusion System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX, ODP Dated: December 18, 2013 Received: December 24, 2013
Dear Mr. Eggleton:
We have reviewed vour 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
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Page 2 - Mr. Justin Eggleton
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 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/ResourcesforYou/Industry/default.htm. 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.
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,
Vincen Doevlin -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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2. Indications for Use
K133967 510(k) Number (if known):
Device Name: Aurora Spine Interbody Fusion System
Lumbar System Indications
The Aurora Spine Interbody Fusion System devices are indicated for use as intervertebral body fusion devices in skeletally mature patients with degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies) at one or two continuous levels of the lumbar spine (L2-S1). Patients should have six months of non-operative treatment prior to surgery. These implants are used to facilitate fusion in the lumbar spine and are placed via either a posterior, transforaminal, lateral or anterior approach using autogenous bone. When used as interbody fusion devices these implants are intended for use with supplemental fixation systems cleared for use in the thoracolumbar spine.
Cervical System Indications
The Aurora Spine Interbody Fusion System is indicated for use as an intervertebral body fusion device in skeletally manure patients with degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies) at one level of the cervical spine with accompanying radicular symptoms. Patients should have six weeks of non-operative treatment prior to surgery. Cervical implants are used to facilitate fusion in the cervical spine (C2-T1) and are placed via an anterior approach using autogenous bone. When used as an interbody fusion device, supplemental fixation must be used.
Prescription Use V (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH. Office of Device Evaluation (ODE)
Anton E. Dmitriev, PhD Division of Orthopedic 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.