(69 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and biocompatibility of the implant and its components, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is an anterior cervical interbody fusion system used to treat cervical disc disease, facilitating fusion between vertebrae, which directly treats a medical condition.
No
The device description clearly states it is an anterior cervical interbody device used for fusion, not for diagnosing a condition.
No
The device description explicitly states it is an anterior cervical interbody device consisting of physical components made of PEEK, titanium, and tantalum, including an implant cage, washers, and screws. This is clearly a hardware device, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant for spinal fusion, not a test performed on samples taken from the body to diagnose a condition.
- Device Description: The device is described as an implantable system made of various materials, designed to be surgically placed in the spine. This is consistent with a medical device, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any other components typically associated with in vitro diagnostics.
The device is a surgical implant used to treat cervical disc disease.
N/A
Intended Use / Indications for Use
The NuVasive CoRoent Small Interlock II System is an anterior cervical interbody fusion system indicated for use in skeletally mature patients with cervical disc disease (DDD) at one level from C2-T1. The CoRoent Small Interlock II System (lordotic angles of 7° to 15°) is a standalone system. The CoRoent Small Interlock II System (lordotic angles of 20° to 30°) must be used with supplemental fixation cleared by the FDA. The System is intended to be used with autogenous 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.
Product codes
OVE
Device Description
The NuVasive CoRoent Small Interlock II System is an anterior cervical interbody device consisting of a PEEK-OPTIMA® (poly-ether-ether-ketone) implant cage with commercially pure titanium coating, tantalum radiographic markers, titanium allov washers, and three (3) titanium alloy bone fixation screws. The devices are manufactured from PEEK-Optima® LT-1 conforming to ASTM F2026, commercially pure titanium conforming to ASTM F1580, titanium alloy conforming to ASTM F136 and tantalum conforming to ASTM F560 or ISO 13782. The implants are available in a variety of sizes to accommodate anatomical conditions.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical disc disease (DDD) at one level from C2-T1
Indicated Patient Age Range
skeletally mature patients
Intended User / Care Setting
Prescription Use
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 Interlock II System is substantially equivalent to other predicate devices. The following testing and analysis was performed:
- Static and dynamic compression testing per ASTM F2077
- Static and dynamic torsion testing per ASTM F2077
- Wear debris/mass change analysis during ASTM F2077, per ASTM F1877 and ASTM F1714
- Subsidence and push-out analysis
- Bacterial endotoxin testing (BET) per ANSI/AAMI ST72:2011/(R)2016
The results of these studies show that the subject CoRoent Small Interlock II System meets or exceeds the performance of the predicate device and does not introduce any new risks; therefore, the system is substantially equivalent to the predicate devices.
Key Metrics
Not Found
Predicate Device(s)
K161442, K102547, K142299, K163707, K162138, K081611
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.
0
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
NuVasive, Incorporated Cynthia Adams Senior Specialist, Regulatory Affairs 7475 Lusk Blvd. San Diego, California 92121
June 8, 2017
Re: K170961
Trade/Device Name: NuVasive CoRoent Small Interlock II System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: OVE Dated: March 30, 2017 Received: March 31, 2017
Dear Ms. Adams:
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 of medical device
1
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 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
Device Name
NuVasive CoRoent Small Interlock II System
Indications for Use (Describe)
The NuVasive CoRoent Small Interlock II System is an anterior cervical interbody fusion system indicated for use in skeletally mature patients with cervical disc disease (DDD) at one level from C2-T1. The CoRoent Small Interlock II System (lordotic angles of 7° to 15°) is a standalone system. The CoRoent Small Interlock II System (lordotic angles of 20° to 30°) must be used with supplemental fixation cleared by the FDA. The System is intended to be used with autogenous 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.
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
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:
Cynthia Adams Sr. Specialist, Regulatory Affairs NuVasive, Incorporated 7475 Lusk Blvd. San Diego, California 92121 Telephone: (858) 909-1800
Date Prepared: March 30, 2017
B. Device Name
| Trade or Proprietary Name: | NuVasive CoRoent Small Interlock II System |
|---|---|
| Common or Usual Name: | Intervertebral Body Fusion Device |
| Classification Name: | Intervertebral Body Fusion Device with Integrated |
| Fixation, Cervical | |
| Device Class: | Class II |
| Device Class: | Class II |
|---|---|
| Classification: | 21 CFR § 888.3080 |
| Product Code: | OVE |
C. Predicate Devices
The subject CoRoent Small Interlock II System is substantially equivalent to multiple predicate devices. NuVasive CoRoent Small Interlock System (K161442) serves as the primary predicate device, while NuVasive CoRoent Interlock System (K102547), NuVasive CoRoent Interlock System (K142299). NuVasive CoRoent Ti-C System (K163707). NuVasive CoRoent Small Ti-C System (K162138), and NuVasive CoRoent System (K081611) are additional predicate devices.
D. Device Description
The NuVasive CoRoent Small Interlock II System is an anterior cervical interbody device consisting of a PEEK-OPTIMA® (poly-ether-ether-ketone) implant cage with commercially pure titanium coating, tantalum radiographic markers, titanium allov washers, and three (3) titanium alloy bone fixation screws. The devices are manufactured from PEEK-Optima® LT-1 conforming to ASTM F2026, commercially pure titanium conforming to ASTM F1580, titanium alloy conforming to ASTM F136 and tantalum conforming to ASTM F560 or ISO 13782. The implants are available in a variety of sizes to accommodate anatomical conditions.
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E. Indications for Use
The NuVasive CoRoent Small Interlock II System is an anterior cervical interbody fusion system indicated for use in skeletally mature patients with cervical disc disease (DDD) at one level from C2-T1. The CoRoent Small Interlock II System (lordotic angles of 7° to 15°) is a standalone system. The CoRoent Small Interlock II System (lordotic angles of 20° to 30°) must be used with supplemental fixation cleared by the FDA. The System is intended to be used with autogenous 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.
F. Technological Characteristics
As was established in this submission, the subject CoRoent Small Interlock II 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 be substantially equivalent and have the same 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 Interlock II System is substantially equivalent to other predicate devices. The following testing and analysis was performed:
- Static and dynamic compression testing per ASTM F2077 ●
- Static and dynamic torsion testing per ASTM F2077
- Wear debris/mass change analysis during ASTM F2077, per ASTM F1877 and ● ASTM F1714
- Subsidence and push-out analysis
- Bacterial endotoxin testing (BET) per ANSI/AAMI ST72:2011/(R)2016 ●
The results of these studies show that the subject CoRoent Small Interlock II System meets or exceeds the performance of the predicate device and does not introduce any new risks; therefore, the system is substantially equivalent to the predicate devices.
H. Conclusions
Based on the indications for use, technological characteristics, and comparison to predicate devices, the subject CoRoent Small Interlock II System has been shown to be substantially equivalent to legally marketed predicate devices.