(88 days)
Not Found
No
The document describes a spinal implant system made of standard materials and tested using standard mechanical and biological methods. There is no mention of software, algorithms, image processing, or any terms related to AI/ML.
Yes
The device is indicated for intervertebral body fusion of the spine for the treatment of degenerative disc disease, which constitutes a medical treatment.
No
The device is an intervertebral body fusion system designed to facilitate fusion, not diagnose conditions. Its intended use is for treatment of degenerative disc disease, not diagnosis.
No
The device description explicitly states the device is manufactured from physical materials (PEEK-OPTIMA, titanium, tantalum) and is available in different shapes and sizes, indicating it is a physical implant, not software.
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, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The provided text clearly describes a surgical implant (intervertebral body fusion device) used to treat spinal conditions. It is physically implanted into the patient's body.
- Lack of Specimen Analysis: There is no mention of analyzing any biological specimens from the patient. The device's function is mechanical support and facilitating bone fusion.
Therefore, based on the provided information, the NuVasive CoRoent Ti-C System is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The NuVasive CoRoent Ti-C System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The System is designed for use with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion.
The CoRoent Ti-C System is intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The lumbar devices are to be used in patients who have had at least six months of non-operative treatment. The System is intended to be used with supplemental internal spinal fixation systems that are cleared by the FDA for use in the lumbar spine.
Product codes
MAX
Device Description
The NuVasive® CoRoent Ti-C System is manufactured from PEEK-OPTIMA® (Polyetherether-ketone) conforming to ASTM F2026, commercially pure titanium conforming to ASTM F1580. Ti-6Al-4V ELI conforming to ASTM F136/1472 or Tantalum (Ta) conforming to ASTM F560 or ISO 13782. 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
lumbar spine, from L2 to S1
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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Nonclinical testing was performed to demonstrate that the subject CoRoent Ti-C System is substantially equivalent to other predicate devices. The following testing was performed:
- Static and dynamic axial compression and compression shear 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 Ti-C System presents no new worst-case 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 predicates. No clinical studies were conducted.
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
June 28, 2016
NuVasive, Incorporated Michelle Cheung, Esquire Regulatory Affairs Associate 7475 Lusk Boulevard San Diego, California 92121
Re: K160916
Trade/Device Name: CoRoent® Ti-C System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: April 4, 2016 Received: April 5, 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 yours,
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
510(k) Number (if known) K160916
Device Name CoRoent® Ti-C System
Indications for Use (Describe)
The NuVasive CoRoent Ti-C System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The System is designed for use with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion.
The CoRoent Ti-C System is intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The lumbar devices are to be used in patients who have had at least six months of non-operative treatment. The System is intended to be used with supplemental internal spinal fixation systems that are cleared by the FDA for use in the lumbar spine.
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)
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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 leaf-like shape on the left, followed by the word "NUVASIVE" in gray, and the tagline "Speed of Innovation" in purple below it. The logo is simple and modern, and the colors are eye-catching.
Traditional 510(k) Premarket Notification CoRoent® Ti-C System
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:
Submitted by: A.
Michelle Cheung Specialist. Regulatory Affairs NuVasive, Incorporated 7475 Lusk Blvd. San Diego, California 92121 Telephone: (858) 909-3360
Date Prepared: June 22, 2016
B. Device Name
| Trade or Proprietary Name: | CoRoent® Ti-C System |
|---|---|
| Common or Usual Name: | Intervertebral Body Fusion Device |
| Classification Name: | Intervertebral Body Fusion Device with Bone Graft, Lumbar |
| Device Class: | Class II |
|---|---|
| Classification: | 21 CFR § 888.3080 |
| Product Code: | MAX |
C. Predicate Devices
The subject CoRoent Ti-C System is substantially equivalent to primary predicate device NuVasive CoRoent Ti-C System (K140319), and additional predicates NuVasive CoRoent System (K071795), and NuVasive Lumbar Interbody Implants (K153782).
D. Device Description
The NuVasive® CoRoent Ti-C System is manufactured from PEEK-OPTIMA® (Polyetherether-ketone) conforming to ASTM F2026, commercially pure titanium conforming to ASTM F1580. Ti-6Al-4V ELI conforming to ASTM F136/1472 or Tantalum (Ta) conforming to ASTM F560 or ISO 13782. The implants are available in a variety of different shapes and sizes to suit the individual pathology and anatomical conditions of the patient.
E. Intended Use
The NuVasive CoRoent Ti-C System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The System is designed for use with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion.
The CoRoent Ti-C System is intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with
4
Image /page/4/Picture/1 description: The image shows the logo for Nuvasive. The logo consists of a stylized leaf shape in purple and gray, followed by the word "NUVASIVE" in gray, and the tagline "Speed of Innovation" in purple. The logo is clean and modern, and the colors are eye-catching.
degeneration of the disc confirmed by history and radiographic studies. The lumbar devices are to be used in patients who have had at least six months of non-operative treatment. The System is intended to be used with supplemental internal spinal fixation systems that are cleared by the FDA for use in the lumbar spine.
F. Technological Characteristics
As was established in this submission, the subject CoRoent 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
Nonclinical testing was performed to demonstrate that the subject CoRoent Ti-C System is substantially equivalent to other predicate devices. The following testing was performed:
- Static and dynamic axial compression and compression shear 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 Ti-C System presents no new worst-case 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 predicates. No clinical studies were conducted.
H. Conclusions
Based on the indications for use, technological characteristics, and comparison to predicate devices, the subject CoRoent Ti-C System has been shown to be substantially equivalent to legally marketed predicate devices.