(127 days)
No
The summary describes a physical intervertebral body fusion device made of PEEK with a porous architecture. There is no mention of software, algorithms, or any computational processing that would suggest the use of AI or ML. The performance studies are based on mechanical testing of the physical implant.
Yes
The device is specifically indicated for spinal fusion procedures to treat conditions like degenerative disc disease and spondylolisthesis, which are medical conditions, and it is designed to facilitate fusion and improve patient outcomes, fitting the definition of a therapeutic device.
No
An intervertebral body fusion device is an implant used in spinal fusion procedures. It is a therapeutic device designed to facilitate fusion, not to diagnose a condition.
No
The device description explicitly states it is comprised of physical components made of PEEK and contains radiolucent markers. It is an intervertebral body fusion device, which is a physical implant.
Based on the provided information, 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, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The NuVasive Cohere ALIF System is an implantable medical device designed for spinal fusion procedures. It is a physical device (a cage made of PEEK) that is surgically placed within the body to facilitate bone fusion.
- Lack of Specimen Analysis: The description and intended use do not mention the analysis of any biological specimens. The device's function is mechanical and biological (promoting fusion), not diagnostic based on in vitro testing.
Therefore, this device falls under the category of a surgical implant or a medical device used in a surgical procedure, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Nu Vasive Cohere ALF System Intervertebral Body Fusion Device is indicated for spinal fusion procedures in skeletally mature patients. The Cohere ALIF System Interverebird Body Fusion Device 10-200 lordotic cages may be used as a standalone system. The System Intervetebral Body Fusion Device 25-30° lordotic cages may be used with supplemental internal spinal fixation systems (e.g., posterior pedicle screw and rod system) that are cleared by the FDA for use in the lumbar spine. The System is designed for use with autogenous bone graft, allogeneis bone graft, intervertebral hody fraise to corticocancellous bone graft, or a bone void filler as cleared by FDA, for use in intervertebral body fusion to facilitate fusion. The devices are to be used in patients who have had alleast sim onths of non-operative treatment.
The NuVasive Cohere ALLF System Intervertebral Body Fusion Device is intended for use in interbody fusions in the lumbar spine from L2 to S1, following discectory in the trestment of symptomatic degenerative disc disease (DD) or degenerative spondylolisthesis, and/or spinal stenosis at one or two adjacent levels. DDD is defined as back pain of discogenic origin with degeneration of the disconfirmed by history and radiographic studies. The Cohere ALFE System Intervertebral Body Fusion Device implants can also be used as an adjunct to fusion in patients diagnosed with multilevel degenerative spondylolisthanis as saind the used in these patients at multiple levels at multiple levels and for patients with degenerative spondylolisthesis or spinal stenosis at one or two adjacent levels, the Cohere ALIF System Intervetebrah Body Fusion Device must be used with a supplemental internal spinal fixation system (e.g., pedicle screw system) cleared by the FDA for use in the lumbar spine in addition to the internal spillal fixal.
From Page 4:
The NuVasive Cohere ALIF System Intervertebral Body Fusion Device is indicated for spinal fusion procedures in skeletally mature patients. The Cohere ALIF System Intervertebral Body Fusion Device 10°-20° lordotic cages may be used as a standalone system. The Cohere ALIF System Intervertebral Body Fusion Device 25°-30° lordotic cages must be used with supplemental internal spinal fixation systems (e.g., posterior pedicle screw and rod system) that are cleared by the FDA for use in the lumbar spine. The System is designed for use with autogenous bone graft, allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft, or a bone void filler as cleared by FDA for use in intervertebral body fusion to facilitate fusion. The devices are to be used in patients who have had at least six months of non-operative treatment.
The NuVasive Cohere ALIF System Intervertebral Body Fusion Device is intended for use in interbody fusions in the lumbar spine from L2 to S1, following discectomy in the treatment of symptomatic degenerative disc disease (DDD) or degenerative spondylolisthesis, and/or spinal stenosis at one or two adjacent levels. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The Cohere ALIF System Intervertebral Body Fusion Device implants can also be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis and sagittal deformity; however, when used in these patients at multiple levels and for patients with degenerative spondylolisthesis or spinal stenosis at one or two adjacent levels, the Cohere ALIF System Intervertebral Body Fusion Device must be used with a supplemental internal spinal fixation system (e.g., pedicle screw system) cleared by the FDA for use in the lumbar spine in addition to the integrated screws.
Product codes
OVD
Device Description
The Cohere ALIF System Intervertebral Body Fusion Device is inclusive of sterile, single use interbody implant grade polyetheretherketone (PEEK) devices, available in varied footprints and heights. Each device within the Cohere ALIF System Intervertebral Body Fusion Devce is comprised of a continuous body of PEEK formed into the final product shape with a porous architecture on select faces of the implant. In addition to PEEK, the device assembly contains radiolucent markets to enable visibility under x-ray in vivo. The implants are available in a variety of sizes and lordotic angles to suit the individual pathology and anatomical conditions of the patient. The Cohere ALIF System Intervertebral Body Fusion Device 10°-20° lordotic cages may be used as a standalone system. The Cohere ALIF System Intervertebral Body Fusion Device 25°-30° lordotic cages must be used with supplemental internal spinal fixation systems (e.g. posterior pedicle screw and rod system) 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 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)
Non-clinical testing was performed to demonstrate that the subject Cohere ALIF System Intervertebral Body Fusion Device is substantially equivalent to other predicate devices. The following testing was performed:
- Static and Dynamic Compression (per ASTM F2077)
- Static and Dynamic Compression Shear (per ASTM F2077)
- Gravimetric and Particulate Analysis (ASTM F1714 and F1877)
- Subsidence and screw push-out analysis.
The results demonstrate that the subject Cohere ALIF System Intervertebral Body Fusion Device meets the same criteria as the predicate devices, and the subject device was therefore 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)
NuVasive Thoracolumbar Interbody Systems (K23704), NuVasive Thoracolumbar Interbody Systems (K203201), NuVasive Foundation-LL System (K152943)
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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October 21, 2022
NuVasive, Incorporated Jessica LeBlanc Manager Regulatory Affairs 7475 Lusk Boulevard San Diego, California 92121
Re: K221751
Trade/Device Name: NuVasive® Cohere® ALIF System Intervertebral Body Fusion Device Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: OVD Dated: September 26, 2022 Received: September 29, 2022
Dear Ms. LeBlanc:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
for Brent Showalter, Ph.D. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
510(k) Number (if known) K221751
Device Name
Nu Vasive Cohere ALIF System Intervertebral Body Fusion Device
Indications for Use (Describe)
The Nu Vasive Cohere ALF System Intervertebral Body Fusion Device is indicated for spinal fusion procedures in skeletally mature patients. The Cohere ALIF System Interverebird Body Fusion Device 10-200 lordotic cages may be used as a standalone system. The System Intervetebral Body Fusion Device 25-30° lordotic cages may be used with supplemental internal spinal fixation systems (e.g., posterior pedicle screw and rod system) that are cleared by the FDA for use in the lumbar spine. The System is designed for use with autogenous bone graft, allogeneis bone graft, intervertebral hody fraise to corticocancellous bone graft, or a bone void filler as cleared by FDA, for use in intervertebral body fusion to facilitate fusion. The devices are to be used in patients who have had alleast sim onths of non-operative treatment.
The NuVasive Cohere ALLF System Intervertebral Body Fusion Device is intended for use in interbody fusions in the lumbar spine from L2 to S1, following discectory in the trestment of symptomatic degenerative disc disease (DD) or degenerative spondylolisthesis, and/or spinal stenosis at one or two adjacent levels. DDD is defined as back pain of discogenic origin with degeneration of the disconfirmed by history and radiographic studies. The Cohere ALFE System Intervertebral Body Fusion Device implants can also be used as an adjunct to fusion in patients diagnosed with multilevel degenerative spondylolisthanis as saind the used in these patients at multiple levels at multiple levels and for patients with degenerative spondylolisthesis or spinal stenosis at one or two adjacent levels, the Cohere ALIF System Intervetebrah Body Fusion Device must be used with a supplemental internal spinal fixation system (e.g., pedicle screw system) cleared by the FDA for use in the lumbar spine in addition to the internal spillal fixal.
| Type of Use (Select one or both, as applicable) | X 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 Nuvasive logo. The logo consists of a stylized leaf shape in purple and gray on the left, followed by the word "NUVASIVE" in gray. The leaf shape is divided into two parts, with the top part in purple and the bottom part in gray. The word "NUVASIVE" is in a sans-serif font.
Traditional 510(k) Premarket Notification NuVasive® Cohere® ALIF System Intervertebral Body Fusion Device
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:
Jessica LeBlanc Manager, Regulatory Affairs NuVasive, Incorporated 7475 Lusk Blvd. San Diego, California 92121 (951) 816-0973
Date Prepared: June 3, 2022
B. Device Name
| Trade or Proprietary Name: | NuVasive® Cohere® ALIF System
Intervertebral Body Fusion Device |
|----------------------------|--------------------------------------------------------------------|
| 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: | OVD |
C. Predicate Devices
The subject NuVasive Cohere ALIF System Intervertebral Body Fusion Device is substantially equivalent to the primary predicate device NuVasive Thoracolumbar Interbody Systems (K23704) and the additional predicate devices, NuVasive Thoracolumbar Interbody Systems (K203201), and NuVasive Foundation-LL System (K152943).
D. Device Description
The Cohere ALIF System Intervertebral Body Fusion Device is inclusive of sterile, single use interbody implant grade polyetheretherketone (PEEK) devices, available in varied footprints and heights. Each device within the Cohere ALIF System Intervertebral Body Fusion Devce is comprised of a continuous body of PEEK formed into the final product shape with a porous architecture on select faces of the implant. In addition to PEEK, the device assembly contains radiolucent markets to enable visibility under x-ray in vivo. The implants are available in a variety of sizes and lordotic angles to suit the individual pathology and anatomical conditions of the patient. The Cohere ALIF System Intervertebral Body Fusion Device 10°-20° lordotic cages may be used as a standalone system. The Cohere ALIF System Intervertebral Body Fusion Device 25°-30° lordotic cages must be used with supplemental internal spinal fixation systems (e.g. posterior pedicle screw and rod system) that are cleared by the FDA for use in the lumbar spine.
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Image /page/4/Picture/1 description: The image shows the Nuvasive logo. The logo consists of a stylized leaf shape in purple and gray, followed by the word "NUVASIVE" in gray sans-serif font. The leaf shape is split into two parts, with the top part in purple and the bottom part in gray.
E. Indications for Use
The NuVasive Cohere ALIF System Intervertebral Body Fusion Device is indicated for spinal fusion procedures in skeletally mature patients. The Cohere ALIF System Intervertebral Body Fusion Device 10°-20° lordotic cages may be used as a standalone system. The Cohere ALIF System Intervertebral Body Fusion Device 25°-30° lordotic cages must be used with supplemental internal spinal fixation systems (e.g., posterior pedicle screw and rod system) that are cleared by the FDA for use in the lumbar spine. The System is designed for use with autogenous bone graft, allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft, or a bone void filler as cleared by FDA for use in intervertebral body fusion to facilitate fusion. The devices are to be used in patients who have had at least six months of non-operative treatment.
The NuVasive Cohere ALIF System Intervertebral Body Fusion Device is intended for use in interbody fusions in the lumbar spine from L2 to S1, following discectomy in the treatment of symptomatic degenerative disc disease (DDD) or degenerative spondylolisthesis, and/or spinal stenosis at one or two adjacent levels. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The Cohere ALIF System Intervertebral Body Fusion Device implants can also be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis and sagittal deformity; however, when used in these patients at multiple levels and for patients with degenerative spondylolisthesis or spinal stenosis at one or two adjacent levels, the Cohere ALIF System Intervertebral Body Fusion Device must be used with a supplemental internal spinal fixation system (e.g., pedicle screw system) cleared by the FDA for use in the lumbar spine in addition to the integrated screws.
F. Technological Characteristics
As was established in this submission, the subject Cohere ALIF System Intervertebral Body Fusion Device is substantially equivalent to other predicate devices cleared by the FDA for commercial distribution in the United States. The subject devices were 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.
Performance Data G.
Non-clinical testing was performed to demonstrate that the subject Cohere ALIF System Intervertebral Body Fusion Device is substantially equivalent to other predicate devices. The following testing was performed:
- · Static and Dynamic Compression (per ASTM F2077)
- · Static and Dynamic Compression Shear (per ASTM F2077)
- . Gravimetric and Particulate Analysis (ASTM F1714 and F1877)
- Subsidence and screw push-out analysis .
The results demonstrate that the subject Cohere ALIF System Intervertebral Body Fusion Device meets the same criteria as the predicate devices, and the subject device was therefore found to be substantially equivalent to the predicates. No clinical studies were conducted.
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Image /page/5/Picture/1 description: The image shows the Nuvasive logo. The logo consists of a stylized leaf shape in purple and gray, followed by the word "NUVASIVE" in gray sans-serif font. The leaf shape is split into two parts, with the top part in purple and the bottom part in gray.
H. Conclusions
Based on the indications for use, technological characteristics, performance testing, and comparison to predicate devices, the subject Cohere ALIF System Intervertebral Body Fusion Device has been shown to be substantially equivalent to legally marketed predicate devices.