(86 days)
Not Found
No
The 510(k) summary describes a passive interbody fusion device and its mechanical properties. There is no mention of AI, ML, image processing, or any software-driven analytical capabilities.
Yes
The device is an intervertebral body fusion device used to treat cervical disc disease, which involves addressing a medical condition and facilitating a therapeutic outcome (fusion).
No
The device is an intervertebral body fusion device (implant) designed to facilitate fusion in patients with cervical disc disease, not to diagnose a medical condition.
No
The device description clearly details physical implants made of PEEK and titanium, intended for surgical implantation. This is 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 is for intervertebral body fusion of the spine in skeletally mature patients with cervical disc disease. This is a surgical implant used in vivo (within the body) to treat a physical condition.
- Device Description: The device is a physical implant made of PEEK and titanium, designed to be surgically placed between vertebrae. It facilitates bone fusion.
- Lack of IVD Characteristics: IVD devices are used in vitro (outside the body) to examine specimens (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening. This device does not perform any such function. It is a therapeutic device.
Therefore, the NuVasive CoRoent Small Ti-C System is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The NuVasive CoRoent Small Ti-C System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The CoRoent Small Ti-C System is intended for use for anterior cervical interbody fusion in patients with cervical disc disease (DDD) at up to two contiguous levels from C2 - T1. The System is intended to be used with supplemental fixation; the CoRoent Small interbody devices with lordotic angles of 10° or greater are required to be used with an anterior cervical plate as the form of 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 (comma separated list FDA assigned to the subject device)
ODP
Device Description
The NuVasive CoRoent Small Ti-C System is designed to address cervical pathologies utilizing interbody placement through an anterior surgical approach. The subject CoRoent Small Ti-C System implants are hollow devices manufactured from Polyetheretherketone (PEEK) Optima LT-1 conforming to ASTM F2026. A commercially pure titanium (CP Ti) coating is plasma sprayed to the superior and inferior surfaces of the device. 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. Pins made of either titanium alloy (Ti-6Al-4V) conforming to ASTM F136 or ISO 5832-3 or tantalum conforming to ASTM F560 or ISO 13782 serve as radiopaque markers so the location and orientation of the device may be seen radiographically during and after the procedure for position confirmation. The implants are available in a variety of different shapes and sizes to suit the individual pathology and anatomical conditions of the patient.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical spine (from 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)
Non-clinical testing was performed to demonstrate that the subject CoRoent Small Ti-C System is substantially equivalent to other predicate devices. The following testing was performed:
- Static and dynamic axial compression and torsion per ASTM F2077
- Wear debris testing per ASTM F2077, ASTM F1714 and ASTM F1877
- Bacterial endotoxin testing (BET) per ANSI/AAMI ST-72:2011
The results demonstrate that the subject CoRoent Small Ti-C System presents no new worstcase for performance testing, and meets the requirements as outlined in the Agency's guidance, "Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile". No clinical studies were conducted.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K150362, K160916, K140319, K081611
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 26, 2016
NuVasive, Incorporated Ms. Michelle Cheung Regulatory Affairs Specialist 7475 Lusk Boulevard San Diego, California 92121
Re: K162138
Trade/Device Name: NuVasive® CoRoent® Small Ti-C System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: ODP Dated: July 29, 2016 Received: August 1, 2016
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 Parts 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
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" (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 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
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
Page 1 of 1
510(k) Number (if known)
Device Name
NuVasive® CoRoent® Small Ti-C System
Indications for Use (Describe)
The NuVasive CoRoent Small Ti-C System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The CoRoent Small Ti-C System is intended for use for anterior cervical interbody fusion in patients with cervical disc disease (DDD) at up to two contiguous levels from C2 - T1. The System is intended to be used with supplemental fixation; the CoRoent Small interbody devices with lordotic angles of 10° or greater are required to be used with an anterior cervical plate as the form of 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)
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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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
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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:
Michelle Cheung Specialist, Regulatory Affairs NuVasive, Incorporated 7475 Lusk Blvd. San Diego, California 92121 Telephone: (858) 909-3360
Date Prepared: October 24, 2016
B. Device Name
| Trade or Proprietary Name: | NuVasive ® CoRoent® Small Ti-C 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 NuVasive CoRoent Small Ti-C System is substantially equivalent to primary predicate device NuVasive CoRoent Small Interbody System (K150362), and additional predicates CoRoent Ti-C System (K160916), NuVasive CoRoent Ti-C System (K140319) and NuVasive CoRoent System (K081611).
D. Device Description
The NuVasive CoRoent Small Ti-C System is designed to address cervical pathologies utilizing interbody placement through an anterior surgical approach. The subject CoRoent Small Ti-C System implants are hollow devices manufactured from Polyetheretherketone (PEEK) Optima LT-1 conforming to ASTM F2026. A commercially pure titanium (CP Ti) coating is plasma sprayed to the superior and inferior surfaces of the device. 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. Pins made of either titanium alloy (Ti-6Al-4V) conforming to ASTM F136 or ISO 5832-3 or tantalum conforming to ASTM F560 or ISO 13782 serve as radiopaque markers so the location and orientation of the device may be seen radiographically during and after the procedure for position confirmation. The implants are available in a variety of different shapes and sizes to suit the individual pathology and anatomical conditions of the patient.
4
E. Intended Use
The NuVasive CoRoent Small Ti-C System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The CoRoent Small Ti-C System is intended for use for anterior cervical interbody fusion in patients with cervical disc disease (DDD) at up to two contiguous levels from C2 - T1. The System is intended to be used with supplemental fixation; the CoRoent Small interbody devices with lordotic angles of 10° or greater are required to be used with an anterior cervical plate as the form of 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.
F. Technological Characteristics
As was established in this submission, the subject CoRoent Small Ti-C 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
Non-clinical testing was performed to demonstrate that the subject CoRoent Small Ti-C System is substantially equivalent to other predicate devices. The following testing was performed:
- Static and dynamic axial compression and torsion per ASTM F2077
- Wear debris testing per ASTM F2077, ASTM F1714 and ASTM F1877 ●
- Bacterial endotoxin testing (BET) per ANSI/AAMI ST-72:2011 ●
The results demonstrate that the subject CoRoent Small Ti-C System presents no new worstcase for performance testing, and meets the requirements as outlined in the Agency's guidance, "Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile". For the above reasons, the subject device was found to be substantially equivalent to the predicate devices. No clinical studies were conducted.
H. Conclusions
Based on the indications for use, technological characteristics and comparison to predicate devices, the subject CoRoent Small Ti-C System has been shown to be substantially equivalent to legally marketed predicate devices.