(126 days)
Not Found
No
The description focuses on the materials, sterilization, and intended use of spinal implants, with no mention of AI or ML capabilities.
Yes
The device is indicated for intervertebral body fusion and partial vertebral body replacement to treat degenerative disc disease, restore height, and decompress the spinal cord, which are therapeutic actions to treat or alleviate a disease or injury.
No
The device is an implant system used for intervertebral body fusion and partial vertebral body replacement. It is designed for treatment and structural support, not for diagnosis.
No
The device description explicitly states the implants are manufactured from PEEK-Optima® LT-1 and titanium alloy, which are physical materials, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as an implant system for intervertebral body fusion and partial vertebral body replacement in the spine. These are surgical procedures performed directly on the patient's body.
- Device Description: The device is described as implants made from PEEK and titanium, available in various shapes and sizes for surgical implantation.
- Lack of IVD Characteristics: An IVD device is used in vitro (outside the body) to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The description of the NuVasive CoRoent Sterile Implants System does not involve any of these activities.
Therefore, the NuVasive CoRoent Sterile Implants System is a surgical implant device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The NuVasive CoRoent Sterile Implants System is a device system indicated for the following:
Intervertebral Body Fusion
The NuVasive CoRoent Sterile Implants 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 NuVasive CoRoent Sterile Implants 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 1 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.
Partial Vertebral Body Replacement
The NuVasive CoRoent Sterile Implants System may also be used as a partial vertebral body replacement device indicated for use in the thoracolumbar spine (T1 to L5) to replace a diseased or damaged vertebral body caused by tumor or fracture, to restore height of a collapsed vertebral body, and to achieve decompression of the spinal cord and neural tissues. The System is intended to be used with supplemental internal spinal fixation systems that are cleared by the FDA for use in the thoracic and lumbar spine. Allograft or autograft material may be used at the surgeon's discretion.
Product codes (comma separated list FDA assigned to the subject device)
MAX, MQP
Device Description
NuVasive CoRoent Sterile Implants are manufactured from PEEK-Optima® LT-1 conforming to ASTM F2026 and titanium alloy conforming to ASTM F136 and ISO 5832-3. The implants are offered gamma sterilized. The implants are available in a variety of different shapes and sizes to suit the individual pathology and anatomical conditions of the patient. The device is intended to be used with supplemental internal spinal fixation systems that are cleared by the FDA for use in the lumbar spine.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Lumbar spine (L2 to S1), thoracolumbar spine (T1 to L5)
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
To establish substantial equivalence with predicate devices, test data is provided as evidence that gamma sterilization does not negatively affect mechanical properties of PEEK-Optima LT-1 material. Additionally, gamma sterilization validation, sterile packaging performance validation and the integrity of the sterile barrier over time validation were performed to qualify new packaging and sterilization method for the CoRoent Sterile Implants System.
The results demonstrate that the subject NuVasive CoRoent Sterile Implants System is substantially equivalent to the predicate devices.
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.
NuVasive CoRoent System (K071795), Alphatec Spine Epicage Interbody Fusion Device (K130548)
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.
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Image /page/0/Picture/1 description: The image shows the logo for Nuvasive. The logo consists of a stylized leaf-like shape on the left, followed by the word "NUVASIVE" in capital letters. Below the company name is the tagline "...Speed of Innovation..." in a smaller font. The logo appears to be printed in black on a white background.
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:
Olga Lewis Regulatory Affairs Specialist NuVasive, Incorporated 7475 Lusk Blvd. San Diego, California 92121 Telephone: (858) 909-1800
DEC 2 4 2013
Date Prepared: August 19, 2013
Device Name B.
| Trade or Proprietary Name: | NuVasive® CoRoent® Sterile Implants System |
|---|---|
| Common or Usual Name: | Intervertebral Body Fusion Device; Spinal Intervertebral |
| Body Fixation Orthosis | |
| Classification Name: | Intervertebral Body Fusion Device; Spinal Intervertebral |
| Body Fixation Orthosis |
| Device Class: | Class II |
|---|---|
| Classification: | 21 CFR § 888.3080 and § 888.3060 |
| Product Code: | MAX, MQP |
C. Predicate Devices
The subject NuVasive CoRoent Sterile Implants System is substantially equivalent to the predicate devices, NuVasive CoRoent System (K071795) and Alphatec Spine Epicage Interbody Fusion Device (K130548).
Device Description D.
Device Desert Sterile Implants are manufactured from PEEK-Optima® LT-1 conforming to ASTM F2026 and titanium alloy conforming to ASTM F136 and ISO 5832-3. The implants are offered gamma sterilized. The implants are available in a variety of different shapes and sizes to suit the individual pathology and anatomical conditions of the patient. The device is intended to be used with supplemental internal spinal fixation systems that are cleared by the FDA for use in the lumbar spine.
E. Intended Use
The NuVasive® CoRoent Sterile Implants System is a device system indicated for the following: . . . .
Intervertebral Body Fusion
The NuVasive CoRoent Sterile Implants 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.
1
Image /page/1/Picture/1 description: The image shows the logo for Nuvasive. The logo consists of a stylized, abstract shape to the left of the word "NUVASIVE". Below the word "NUVASIVE" is the tagline "...speed of Innovation."
The CoRoent Sterile Implants 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 1 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.
Partial Vertebral Body Replacement
The NuVasive CoRoent Sterile Implants System may also be used as a partial vertebral body replacement device indicated for use in the thoracolumbar spine (T1 to LS) to replace a diseased or damaged vertebral body caused by tumor or fracture, to restore height of a collapsed vertebral body, and to achieve decompression of the spinal cord and neural tissues. The System is intended to be used with supplemental internal spinal fixation systems that are cleared by the FDA for use in the thoracic and lumbar spine. Allograft or autograft material may be used at the surgeon's discretion.
Technological Characteristics F.
As was established in this submission, the subject NuVasive CoRoent Sterile Implants 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 equivalent technological characteristics to its predicate device through comparison in areas including design, labeling/intended use, material composition, and function.
Performance Data G.
To establish substantial equivalence with predicate devices, test data is provided as evidence that gamma sterilization does not negatively affect mechanical properties of PEEK-Optima LT-1 material. Additionally, gamma sterilization validation, sterile packaging performance validation and the integrity of the sterile barrier over time validation were performed to qualify new packaging and sterilization method for the CoRoent Sterile Implants System.
The results demonstrate that the subject NuVasive CoRoent Sterile Implants System is substantially equivalent to the predicate devices.
Conclusions н.
Based on the indications for use, technological characteristics, and comparison to predicate devices, the subject NuVasive CoRoent Sterile Implants System has been shown to be substantially equivalent to legally marketed predicate devices.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features the department's symbol, which is a stylized caduceus, along with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circular fashion around the symbol. The symbol is composed of three abstract shapes that resemble a person embracing a globe. The text is in a sans-serif font and is evenly spaced around the circle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G60 Silver Spring, MD 20993-0002
December 24, 2013
NuVasive, Incorporated Ms. Olga Lewis Regulatory Affairs Specialist 7475 Lusk Boulevard San Diego, California 92121
Re: K132601
Trade/Device Name: NuVasive® CoRoent® Sterile Implants System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX, MQP Dated: November 22, 2013 Received: November 25, 2013
Dear Ms. Lewis:
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
3
Page 2 - Ms. Olga Lewis
forth in the quality systems (OS) 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 Small Manufacturers. International and Consumer Assistance at its tollfree 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 Small Manufacturers, International and Consumer Assistance 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,
Lori A. Wigqins
for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known):__K132601
Device Name: NuVasive® CoRoent® Sterile Implants System
Indications For Use:
. . . ............
The NuVasive CoRoent Sterile Implants System is a device system indicated for the following:
Intervertebral Body Fusion
The NuVasive CoRoent Sterile Implants 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 NuVasive CoRoent Sterile Implants System is intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to SI, for the treatment of degenerative disc disease (DDD) with up to Grade 1 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.
Partial Vertebral Body Replacement
The NuVasive CoRoent Sterlie Implants System may also be used as a partial vertebral body replacement device indicated for use in the thoracolumbar spine (T1 to L5) to replace a diseased or damaged vertebral body caused by turnor or fracture, to restore height of a collapsed vertebrail body, and to achieve decompression of the spinal cord and neural tissues. The System is intended to be used with supplemental internal spinal fixation systems that are cleared by the FDA for use in the thoracic and lumbar spine. Allograft or autograft material may be used at the surgeon's discretion.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF
NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Anton E. Dmitriev, PhD Division of Orthopedic Devices 100 - 1100 3