(102 days)
No
The device description and performance studies focus on the physical characteristics of the interbody cage and clinical outcomes, with no mention of AI or ML technology.
Yes
The device is a CoRoent Small Interbody System indicated for intervertebral body fusion of the spine in patients with cervical disc degeneration and/or cervical spinal instability, which directly addresses a medical condition and is intended to restore function.
No
Explanation: This device is an interbody fusion system designed for spinal fusion, not for diagnosing medical conditions. Its function is to facilitate the fusion of vertebrae, confirmed by imaging studies, rather than performing the imaging or interpretation for diagnosis itself.
No
The device description clearly states it is a hollow interbody cage manufactured from PEEK-Optima® LT-1 with titanium alloy or tantalum marker pins, which are physical hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description: The NuVasive CoRoent Small Interbody System is a physical implant (an interbody cage) designed to be surgically placed in the spine. It is a medical device used in vivo (within the body), not in vitro (outside the body).
- Intended Use: The intended use is for intervertebral body fusion of the spine, which is a surgical procedure, not a diagnostic test performed on a specimen.
The information provided clearly describes a surgical implant used for structural support and fusion in the spine, which falls under the category of a surgical or orthopedic device, not an IVD.
N/A
Intended Use / Indications for Use
The Nu Vasive CoRoent Small Interbody System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The NuVasive CoRoent Small Interbody System is intended for use for anterior cervical interbody fusion in 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 multiple contiguous levels from C2 - T1. The System is intended to be used with supplemental fixation. The System is designed for use with autogenous and/or allogeneic bone graft comprised of cancellous, cortical, and/or corticocancellous bone graft to facilitate fusion.
Product codes
ODP
Device Description
The NuVasive CoRoent Small Interbody System is a hollow interbody cage manufactured from PEEK-Optima® LT-1 conforming to ASTM F2026. The implant contains a hollow core or graft aperture which allows for packing of autogenous and/or allogeneic bone graft comprised of cancellous, cortical, and/or corticocancellous bone graft material to help promote a solid fusion. Rows of teeth on the surface of each end of the device serve to grip the adjacent vertebrae to resist migration and expulsion of the device includes marker pins composed of titanium alloy conforming to ASTM F136 and ISO 5832-3 or tantalum conforming to ASTM F560 or ISO 13782. The pins serve as radiopaque markers allowing the location and orientation of the device to be seen radiographically during and after the procedure for position confirmation.
The implants are available in flat or contoured endplates, and come in a variety of different shapes and sizes to suit the individual pathology and anatomical conditions of the patient.
The purpose of this 510(k) is to expand the indications for use to include the treatment of multilevel cervical disc degeneration and/or cervical instability at up to four contiguous levels.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
radiographs, CT, MRI
Anatomical Site
C2 - T1
Indicated Patient Age Range
skeletally mature patients
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
A retrospective clinical study of patients with cervical spondylosis including the following additional pathologies (with or without radiculopathy and/or myelopathy) - cervical disc degeneration, herniated nucleus pulposus (HNP), stenosis, deformity, and/or instability - were treated with the subject device. Based on the clinical data, it was determined that the CoRoent Small Interbody System used in the treatment of 3and 4-level cervical disc degeneration has a safety and effectiveness profile similar to the predicate device. Additionally, a clinical literature analysis of multilevel anterior cervical discectomy and fusion (ACDF) was performed to support the use of the subject device at 3 and 4 cervical levels. No other changes have been made to the interbodies since their clearance in the CoRoent Small Interbody System 510(k) K150362. Therefore, no new nonclinical testing was performed for the purpose of this submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 24, 2017
NuVasive, Incorporated Martin Yahiro Director, Medical Affairs 7475 Lusk Boulevard San Diego, California 92121
Re: K163491
Trade/Device Name: NuVasive® CoRoent® Small Interbody System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: ODP Dated: February 24, 2017 Received: February 27, 2017
Dear Dr. Yahiro:
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 devicerelated 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.
1
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/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 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,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K163491
Device Name
NuVasive® CoRoent® Small Interbody System
Indications for Use (Describe)
The Nu Vasive CoRoent Small Interbody System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The NuVasive CoRoent Small Interbody System is intended for use for anterior cervical interbody fusion in 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 multiple contiguous levels from C2 - T1. The System is intended to be used with supplemental fixation. The System is designed for use with autogenous and/or allogeneic bone graft comprised of cancellous, cortical, and/or corticocancellous bone graft to facilitate fusion.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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K163491 Page 1 of 1
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Image /page/3/Picture/1 description: The image shows the logo for Nuvasive. The logo consists of a purple and gray abstract shape on the left, followed by the word "NUVASIVE" in gray. Below the word "NUVASIVE" is the phrase "Speed of Innovation" in a smaller font and purple color.
510(k) Summary
In accordance with Title 21 of the Code of Federal Regulations, Part 807, and in particular 21 CFR §807.92, the following summary of information is provided:
A. Submitted by:
Martin Yahiro, M.D. Medical Affairs Director NuVasive, Incorporated 7475 Lusk Blvd. San Diego, California 92121 Telephone: 858-638-5589
Date Prepared: March 22, 2017
B. Device Name
| Trade or Proprietary Name: | NuVasive® CoRoent® Small Interbody System |
|---|---|
| Common or Usual Name: | Intervertebral Body Fusion Device |
| Classification Name: | Intervertebral Body Fusion Device with Bone Graft |
| Cervical | |
| Device Class: | Class II |
| Classification: | 21 CFR § 888.3080 |
| Product Code: | ODP |
C. Predicate Devices
The subject CoRoent Small Interbody System is substantially equivalent to the primary predicate device, NuVasive CoRoent Small Interbody System (K150362).
Device Description D.
The NuVasive CoRoent Small Interbody System is a hollow interbody cage manufactured from PEEK-Optima® LT-1 conforming to ASTM F2026. The implant contains a hollow core or graft aperture which allows for packing of autogenous and/or allogeneic bone graft comprised of cancellous, cortical, and/or corticocancellous bone graft material to help promote a solid fusion. Rows of teeth on the surface of each end of the device serve to grip the adjacent vertebrae to resist migration and expulsion of the device includes marker pins composed of titanium alloy conforming to ASTM F136 and ISO 5832-3 or tantalum conforming to ASTM F560 or ISO 13782. The pins serve as radiopaque markers allowing the location and orientation of the device to be seen radiographically during and after the procedure for position confirmation.
The implants are available in flat or contoured endplates, and come in a variety of different shapes and sizes to suit the individual pathology and anatomical conditions of the patient.
The purpose of this 510(k) is to expand the indications for use to include the treatment of multilevel cervical disc degeneration and/or cervical instability at up to four contiguous levels.
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Image /page/4/Picture/1 description: The image shows the logo for Nuvasive. The logo consists of a purple and gray curved shape on the left, followed by the word "NUVASIVE" in gray. Below the word "NUVASIVE" is the phrase "Speed of Innovation" in purple.
E. Indications for Use
The NuVasive CoRoent Small Interbody System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The NuVasive CoRoent Small Interbody System is intended for use for anterior cervical interbody fusion in 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 multiple contiguous levels from C2 - T1. The System is intended to be used with supplemental fixation. The System is designed for use with autogenous and/or allogeneic bone graft comprised of cancellous, cortical, and/or corticocancellous bone graft to facilitate fusion.
F. Technological Characteristics
The subject CoRoent Small Interbody System is substantially equivalent to other predicate devices cleared by the FDA for commercial distribution in the United States. The subject device was shown to have equivalent technological characteristics to its predicate devices through comparison in areas including design, intended use, material composition, and function. This device does not contain software or electrical equipment.
G. Performance Data
The purpose of this 510(k) is to modify the Indications for Use for the subject CoRoent Small Interbody System. A retrospective clinical study of patients with cervical spondylosis including the following additional pathologies (with or without radiculopathy and/or myelopathy) - cervical disc degeneration, herniated nucleus pulposus (HNP), stenosis, deformity, and/or instability - were treated with the subject device. Based on the clinical data, it was determined that the CoRoent Small Interbody System used in the treatment of 3and 4-level cervical disc degeneration has a safety and effectiveness profile similar to the predicate device. Additionally, a clinical literature analysis of multilevel anterior cervical discectomy and fusion (ACDF) was performed to support the use of the subject device at 3 and 4 cervical levels. No other changes have been made to the interbodies since their clearance in the CoRoent Small Interbody System 510(k) K150362. Therefore, no new nonclinical testing was performed for the purpose of this submission.
H. Conclusions
Based on the technological characteristics, clinical literature analysis, retrospective clinical study and comparison to predicate devices, the subject CoRoent Small Interbody System has been shown to be substantially equivalent to legally marketed predicate devices for its intended use.