(93 days)
No
The device description and performance studies focus on the mechanical properties and clinical outcomes of a PEEK interbody cage, with no mention of AI or ML technology.
Yes
The device is indicated for intervertebral body fusion of the spine in skeletally mature patients to treat cervical degenerative disc disease, which constitutes a therapeutic use.
No
Explanation: The device is an intervertebral body fusion implant used for treatment of degenerative disc disease, not for diagnosing conditions. Its primary function is to facilitate fusion by providing structural support and not to identify or characterize a disease or condition. The radiopaque markers serve to confirm the device's position, not to diagnose a patient's condition.
No
The device description clearly states it is a hollow interbody cage manufactured from PEEK-Optima® LT-1 with titanium or tantalum marker pins, indicating it is a physical implant, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for intervertebral body fusion of the spine, specifically anterior cervical interbody fusion. This is a surgical procedure involving the implantation of a device to facilitate bone fusion.
- Device Description: The device is a physical implant (a hollow interbody cage) made of PEEK with titanium or tantalum markers. It is designed to be surgically placed between vertebrae.
- Lack of Diagnostic Function: The description does not mention any function related to testing samples from the human body (like blood, urine, tissue, etc.) to diagnose a condition, monitor a treatment, or screen for diseases.
- Input: The input is the anatomical site (spine) and the device is used in conjunction with radiographic imaging for position confirmation, not as a diagnostic tool itself.
IVD devices are used in vitro (outside the body) to examine specimens from the human body. This device is used in vivo (inside the body) as a surgical implant.
N/A
Intended Use / Indications for Use
The NuVasive® CoRoent® Small Contoured Interbody System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The CoRoent Small Contoured Interbody System is intended for use for anterior cervical interbody fusion in patients with cervical degenerative disc disease (DDD) at one level from C2 - T1. The System is intended to be used with supplemental fixation. The System is intended for use with autogenous and/or allogeneic bone graft comprised of cancellous, cortical and/or corticocancellous bone graft to facilitate fusion. The cervical devices are to be used in patients who have had at least six weeks of non-operative treatment.
Product codes
ODP
Device Description
The NuVasive CoRoent Small Contoured 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 autograft 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. 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 subject device will be packaged and initially provided non-sterile, and is designed to be sterilized by the user before each use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical spine, 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
Nonclinical testing was performed to demonstrate that the subject CoRoent Small Contoured Interbody System is substantially equivalent to other predicate devices. The following testing and analysis was performed:
- Static and dynamic axial compression per ASTM F2077
- Static and dynamic torsion per ASTM F2077
- Subsidence Analysis per ASTM F2267 ●
- Clinical literature review ●
A systemic literature analysis of published clinical data for cervical interbody fusion devices similar to the CoRoent Small Contoured Interbody System was provided as performance data to support the expanded Indications for Use. For treatment of cervical degenerative pathologies in anterior cervical interbody fusion surgical procedures, the published clinical outcomes demonstrate that the use of allogeneic cancellous, cortical and/or corticocancellous bone graft with the subject device poses no new risks to patients.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
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.
0
Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. To the left of the caduceus, the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 29, 2014
NuVasive, Incorporated Ms. Michelle Cheung Regulatory Affairs Associate 7475 Lusk Boulevard San Diego, California 92121
Re: K142050
Trade/Device Name: NuVasive® CoRoent® Small Contoured Interbody System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: ODP Dated: October 1, 2014 Received: October 2, 2014
Dear Ms. Cheung:
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
1
Page 2 - Ms. Michelle Cheung
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 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/Resourcesfor You/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 yours.
Ronald P. Dean -S for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K142050
Device Name
Nu Vasive® CoRoent® Small Contoured Interbody System
Indications for Use (Describe)
The NuVasive CoRoent Small Contoured Interbody System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The CoRoent Small Contoured Interbody System is intended for use for anterior cervical interbody fusion in patients with cervical degenerative disc disease (DDD) at one level from C2 - TI. The System is intended to be used with supplemental fixation. The System is intended for use with autogenous and/or allogeneic bone graft comprised of cancellous, cortical and/or corticocancellous bone graft to facilitate fusion. The cervical devices are to be used in patients who have had at least six weeks of non-operative treatment.
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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FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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3
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:
Michelle Cheung Regulatory Affairs Associate NuVasive, Incorporated 7475 Lusk Blvd. San Diego, California 92121 Telephone: (858) 909-3360
Date Prepared: October 27, 2014
B. Device Name
| Trade or Proprietary Name: | NuVasive® CoRoent® Small Contoured 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 Contoured Interbody System is substantially equivalent to multiple predicate devices. NuVasive CoRoent Small Interbody System (K140003) serves as the primary predicate device; while NuVasive CoRoent System (K081611) and Medtronic Anatomic PEEK Cervical Fusion System (K130177) are referenced predicates.
D. Device Description
The NuVasive CoRoent Small Contoured 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 autograft 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. 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 subject device will be packaged and initially provided non-sterile, and is designed to be sterilized by the user before each use.
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Image /page/4/Picture/0 description: The image contains the logo for Nuvasive. The logo features a stylized, curved shape in purple and gray on the left side. To the right of the shape is the company name "NUVASIVE" in gray, with the tagline "Speed of Innovation" in purple underneath.
E. Intended Use
The NuVasive CoRoent Small Contoured Interbody System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The CoRoent Small Contoured Interbody System is intended for use for anterior cervical interbody fusion in patients with cervical disc disease (DDD) at one level from C2 - T1. The System is intended to be used with supplemental fixation. The System is intended for use with autogenous and/or allogeneic bone graft comprised of cancellous, corticocancellous bone graft to facilitate fusion. The cervical devices are to be used in patients who have had at least six weeks of non-operative treatment.
F. Technological Characteristics
The subject CoRoent Small Contoured 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
Nonclinical testing was performed to demonstrate that the subject CoRoent Small Contoured Interbody System is substantially equivalent to other predicate devices. The following testing and analysis was performed:
- Static and dynamic axial compression per ASTM F2077
- Static and dynamic torsion per ASTM F2077
- Subsidence Analysis per ASTM F2267 ●
- Clinical literature review ●
A systemic literature analysis of published clinical data for cervical interbody fusion devices similar to the CoRoent Small Contoured Interbody System was provided as performance data to support the expanded Indications for Use. For treatment of cervical degenerative pathologies in anterior cervical interbody fusion surgical procedures, the published clinical outcomes demonstrate that the use of allogeneic cancellous, cortical and/or corticocancellous bone graft with the subject device poses no new risks to patients.
H. Conclusions
Based on the indications for use, technological characteristics, clinical literature analysis, and comparison to predicate devices, the subject CoRoent Small Contoured Interbody System has been shown to be substantially equivalent to legally marketed predicate devices for its intended use.