(54 days)
No
The document describes a physical implant device and its materials, with no mention of software, algorithms, or AI/ML capabilities.
Yes.
The device is used for intervertebral body fusion of the spine in patients with disc degeneration and/or spinal instability, which is a therapeutic intervention aimed at treating medical conditions.
No
The device is an interbody fusion device designed for use in spinal fusion surgery, not for diagnosing medical conditions. Imaging studies are mentioned as tools to confirm patient conditions, but the device itself is a treatment implant.
No
The device description clearly states it is a physical implant made of PEEK with tantalum marker bands, intended for surgical implantation. It is a hardware device, 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, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description: The Vertera Spine™ Cohere® Cervical Interbody Fusion Device is an implantable medical device designed to be surgically placed in the spine to facilitate bone fusion. It is a physical structure made of PEEK.
- Intended Use: The intended use is for surgical implantation in the spine to treat cervical disc degeneration and instability. It is used in conjunction with imaging studies (radiographs, CT, MRI) to guide the procedure and confirm placement, but the device itself does not analyze these images or bodily specimens.
The information provided clearly describes a surgical implant, not a device used for testing samples outside of the body.
N/A
Intended Use / Indications for Use
The Vertera Spine™ Cohere® Cervical Interbody Fusion Device is indicated for intervertebral body fusion of the spine in skeletally mature patients. The Vertera Spine™ Cervical Interbody Fusion Device is intended for use for anterior cervical interbody fusion in patients with cervical disc degeneration and/or cervical spinal instability, as confirmed by imaging studies (radiographs, CT, MRI), that results in radiculopathy, and/or pain at multiple contiguous levels from C2 - T1. The System is intended to be used with supplemental fixation. The System is designed for use with autogenous and/or allogeneic bone graft comprised of cancellous, corticocancellous bone graft to facilitate fusion
Product codes
ODP
Device Description
The subject Vertera Spine Cohere Cervical Interbody Fusion Device, previously cleared as predicate Vertera Hedgehog Cervical Interbody Fusion Device (K143685), is an interbody fusion device comprised of a single, continuous piece of PEEK Scoria®, which is formed into a final product shape. The subject device remains solid with an extruded porous layer on the superior and inferior surfaces of the implant body. The porous surface is derived directly from the implant body and is not a sintered or otherwise additive coating. The hollow core or graft aperture allows for packing of autograft or allograft to help promote a solid fusion. The PEEK cage contains two marker bands made of tantalum conforming to ASTM F560 R05200, which 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 Vertera Spine Cohere Cervical Interbody Fusion Device comes in a variety of sizes and geometries to suit the individual pathology and anatomical conditions of the patient. The devices are provided sterile, with the accessory surgical instruments packaged as non-sterile to be sterilized by the end user. The Vertera Spine Cohere Cervical Interbody Fusion Device is intended to be used with supplemental fixation.
The purpose of this 510(k) submission is to expand indications for use to include use with allogeneic bone graft comprised of cancellous, cortical, and/or corticocancellous bone graft to facilitate fusion. It also seeks to expand the indications for use to include the treatment of multilevel cervical disc degeneration and/or cervical spinal instability at multiple levels.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
radiographs, CT, MRI
Anatomical Site
cervical spine, 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
Mechanical performance testing data was provided as part of the previous submissions to establish substantial equivalence for their use. Since no design changes are a part of the present submission, additional non clinical testing is not warranted. Therefore, no new mechanical testing was performed for this 510(k) submission.
Key Metrics
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.
0
November 21, 2017
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
NuVasive, Incorporated Michelle Cheung Specialist, Regulatory Affairs 7475 Lusk Boulevard San Diego, California 92121
Re: K173030
Trade/Device Name: Vertera Spine™ Cohere® Cervical Interbody Fusion Device Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: ODP Dated: September 27, 2017 Received: September 28, 2017
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 Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set 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.
1
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 (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevicesforYou/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 Industry and Consumer Education (DICE) 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
2
Indications for Use
510(k) Number (if known) K173030
Device Name
Vertera Spine™ Cohere® Cervical Interbody Fusion Device
Indications for Use (Describe)
The Vertera Spine™ Cohere® Cervical Interbody Fusion Device is indicated for intervertebral body fusion of the spine in skeletally mature patients. The Vertera Spine Cervical Interbody Fusion Device is intended for use for anterior cervical interbody fusion in patients with cervical disc degeneration and/or cervical spinal instability, as confirmed by imaging studies (radiographs, CT, MRI), that results in radiculopathy, and/or pain at multiple contiguous levels from C2 - T1. The System is intended to be used with supplemental fixation. The System is designed for use with autogenous and/or allogeneic bone graft comprised of cancellous, corticocancellous bone graft to facilitate fusion
| 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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3
Image /page/3/Picture/0 description: The image shows the logo for Vertera Spine. The logo consists of a green graphic on the left and the words "Vertera Spine" on the right. The graphic is a stylized letter V, and the word "Spine" is in a smaller font and is located below the word "Vertera".
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: September 27, 2017
Device Name B.
| Trade or Proprietary Name: | Vertera Spine™ Cohere® Cervical Interbody Fusion
Device |
|----------------------------|-------------------------------------------------------------|
| 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 |
C. Predicate Devices
Product Code:
The subject Vertera Spine™ Cohere® Cervical Interbody Fusion Device is substantially equivalent to the primary predicate device, Vertera Hedgehog Cervical Interbody Fusion Device (K143685), and additional predicate NuVasive CoRoent Small Interbody System (K163491).
ODP
D. Device Description
The subject Vertera Spine Cohere Cervical Interbody Fusion Device, previously cleared as predicate Vertera Hedgehog Cervical Interbody Fusion Device (K143685), is an interbody fusion device comprised of a single, continuous piece of PEEK Scoria®, which is formed into a final product shape. The subject device remains solid with an extruded porous layer on the superior and inferior surfaces of the implant body. The porous surface is derived directly from the implant body and is not a sintered or otherwise additive coating. The hollow core or graft aperture allows for packing of autograft or allograft to help promote a solid fusion. The PEEK cage contains two marker bands made of tantalum conforming to ASTM F560 R05200, which 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 Vertera Spine Cohere Cervical Interbody Fusion Device comes in a variety of sizes and geometries to suit the individual pathology and anatomical conditions of
4
Image /page/4/Picture/1 description: The image shows the logo for Vertera Spine. The logo features a green, stylized leaf-like shape on the left, followed by the word "Vertera" in a thin, sans-serif font. Below "Vertera" is the word "Spine" in a smaller, lighter font with a trademark symbol next to it. The overall design is clean and modern, suggesting a focus on nature and innovation in the field of spinal health.
the patient. The devices are provided sterile, with the accessory surgical instruments packaged as non-sterile to be sterilized by the end user. The Vertera Spine Cohere Cervical Interbody Fusion Device is intended to be used with supplemental fixation.
The purpose of this 510(k) submission is to expand indications for use to include use with allogeneic bone graft comprised of cancellous, cortical, and/or corticocancellous bone graft to facilitate fusion. It also seeks to expand the indications for use to include the treatment of multilevel cervical disc degeneration and/or cervical spinal instability at multiple levels.
E. Indications for Use
The Vertera Spine™ Cohere® Cervical Interbody Fusion Device is indicated for intervertebral body fusion of the spine in skeletally mature patients. The Vertera Spine Cohere Cervical Interbody Fusion Device is intended for use for anterior cervical interbody fusion in patients with cervical disc degeneration and/or cervical spinal instability, as confirmed by imaging studies (radiographs, CT, MRI), that results in radiculopathy, myelopathy, and/or pain at multiple contiguous levels from C2 - T1. The System is intended to be used with supplemental fixation. The System is designed for use with autogenous and/or allogeneic bone graft comprised of cancellous, cortical, and/or corticocancellous bone graft to facilitate fusion
F. Technological Characteristics
As was established in this submission, the subject Vertera Spine Cohere Cervical Interbody Fusion Device 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
Mechanical performance testing data was provided as part of the previous submissions to establish substantial equivalence for their use. Since no design changes are a part of the present submission, additional non clinical testing is not warranted. Therefore, no new mechanical testing was performed for this 510(k) submission.
H. Conclusions
Based on the indications for use, technological characteristics, and comparison to predicate devices, the subject Vertera Spine Cohere Cervical Interbody Fusion Device has been shown to be substantially equivalent to legally marketed predicate devices.