(132 days)
No
The 510(k) summary describes a physical interbody fusion device made of titanium and nickel-cobalt-chromium-molybdenum. There is no mention of software, algorithms, image processing, AI, ML, or any data-driven components. The performance studies are nonclinical mechanical tests.
Yes
The device is intended for intervertebral body fusion of the spine to treat degenerative disc disease, which describes a therapeutic purpose.
No
The device description indicates it is an intervertebral body fusion system, a type of implant used for treatment, not for diagnosing a condition.
No
The device description explicitly states it is manufactured from titanium alloy and nickel-cobalt-chromium-molybdenum, 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, a surgical procedure. IVDs are used to examine specimens from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description: The device is a physical implant made of titanium alloy and nickel-cobalt-chromium-molybdenum, designed to be surgically placed in the spine. This is a medical device, not a diagnostic tool.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze biological samples or provide diagnostic information. Its function is structural support and facilitating fusion.
- Performance Studies: The performance studies focus on mechanical properties and equivalence to other spinal implants, not on diagnostic accuracy or analytical performance.
Therefore, the NuVasive CCX-L Interbody System is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The NuVasive® CCX-L Interbody System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The system is designed for use with autogenous bone graft to facilitate fusion.
The CCX-L Interbody 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. Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the CCX-L Interbody System. The CCX-L Interbody 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 CCX-L Interbody intervertebral fusion device is designed to address lumbar pathologies utilizing interbody placement through a standard posterolateral approach. The NuVasive CCX-L Interbody System is manufactured from titanium alloy (Ti-6A1-4V ELI) conforming to ASTM F136 and ISO 5832-3, and nickel-cobalt-chromium-molybdenum (MP35N) conforming to ASTM F562. 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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Nonclinical testing was performed to demonstrate that the subject CCX-L Interbody System is substantially equivalent to other predicate devices. The following testing was performed:
- Static and dynamic axial compression and compression shear testing per ASTM F2077
- Expulsion Testing
- Subsidence Analysis
The results demonstrate that the subject CCX-L Interbody System presents no new worst-case for performance testing, and the subject device was therefore found to be substantially equivalent to the predicate.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K123231, K140770, K140319, K120918, K141665
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.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 29, 2015
NuVasive, Incorporated Ms. Cynthia Adams Senior Regulatory Affairs Associate 7475 Lusk Boulevard San Diego, California 92121
Re: K143595
Trade/Device Name: NuVasive® CCX-L Interbody System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: April 1, 2015 Received: April 2, 2015
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-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
Page 2 - Ms. Cynthia Adams.
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" (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 vours.
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
510(k) Number (if known)
K143595
Device Name
NuVasive® CCX-L Interbody System
Indications for Use (Describe)
The NuVasive CCX-L Interbody System is intervertebral body fusion of the spine in skeletally mature patients. The system is designed for use with autogenous bone graft to facilitate fusion.
The CCX-L Interbody System is intended for use at either one levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade I spondy|olisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the CCX-L Interbody System. The CCX-L Interbody 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)
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 Regulatory Affairs Specialist NuVasive, Incorporated 7475 Lusk Blvd. San Diego, California 92121 Telephone: (858) 909-1800
Date Prepared: April 27, 2015
B. Device Name
| Trade or Proprietary Name: | NuVasive® CCX-L Interbody System |
|---|---|
| Common or Usual Name: | Intervertebral Body Fusion Device |
| Classification Name: | Intervertebral Body Fusion Device |
| Device Class: | Class II |
|---|---|
| Classification: | 21 CFR § 888.3080 |
| Product Code: | MAX |
C. Predicate Devices
The subject CCX-L Interbody System is substantially equivalent to multiple predicate devices. Globus Medical Caliber® Spacer (K123231) serves as the primary predicate device, while NuVasive® MLX - Medial Lateral Expandable Lumbar Interbody System (K140770), NuVasive® CoRoent® Ti-C System (K140319), NuVasive® CoRoent® Titanium System (K120918) and NuVasive® CoRoent® System (K141665) are additional predicate devices. NuVasive® Brigade® Hyperlordotic System (K123045) is a reference predicate device.
D. Device Description
The CCX-L Interbody intervertebral fusion device is designed to address lumbar pathologies utilizing interbody placement through a standard posterolateral approach. The NuVasive CCX-L Interbody System is manufactured from titanium alloy (Ti-6A1-4V ELI) conforming to ASTM F136 and ISO 5832-3, and nickel-cobalt-chromium-molybdenum (MP35N) conforming to ASTM F562. 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. Indications for Use
The NuVasive CCX-L Interbody System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The system is designed for use with autogenous bone graft to facilitate fusion.
The CCX-L Interbody 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. Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the CCX-L Interbody System. The CCX-L Interbody 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 CCX-L 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 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.
Performance Data G.
Nonclinical testing was performed to demonstrate that the subject CCX-L Interbody System is substantially equivalent to other predicate devices. The following testing was performed:
- Static and dynamic axial compression and compression shear testing per ASTM F2077
- Expulsion Testing
- Subsidence Analysis
The results demonstrate that the subject CCX-L Interbody System presents no new worst-case for performance testing, and the subject device was therefore found to be substantially equivalent to the predicate.
H. Conclusions
Based on the indications for use, technological characteristics, and comparison to predicate devices, the subject CCX-L Interbody System has been shown to be substantially equivalent to legally marketed predicate devices.