(209 days)
None
No
The summary describes a passive implantable device (cervical cage) and its mechanical testing, with no mention of software, algorithms, or any AI/ML related terms or concepts.
Yes
The device is clearly indicated for treating a specific medical condition (degenerative disc disease of the cervical spine with accompanying radicular symptoms) and is designed to be surgically implanted to facilitate bone fusion, directly impacting the patient's health and function.
No
The device is an intervertebral fusion device (cervical cage system) primarily used for surgical intervention in patients with degenerative disc disease, not for diagnosing conditions.
No
The device description explicitly states it is made from medical grade PEEK and tantalum markers, indicating it is a physical implantable device, not software.
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 (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The description clearly states that the Neurostructures Cavetto® Cervical Cage System is an implantable device used for spinal fusion in the cervical spine. It is surgically placed within the body.
- Lack of Specimen Analysis: There is no mention of this device being used to analyze any biological specimens outside of the body.
Therefore, the Neurostructures Cavetto® Cervical Cage System falls under the category of a surgical implant or medical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Neurostructures Cavetto® Cervical Cage System is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six weeks of non-operative treatment. The Neurostructures Cavetto® Cervical Cage System is to be used with autogenous or allogenic bone graft composed of cancellous bone graft and placed via an open, anterior approach. The Neurostructures Cavetto® Cervical Cage System is intended to be used with supplemental fixation.
Product codes
ODP
Device Description
The Cavetto® Cervical Cage System is an intervertebral fusion device made from medical grade PEEK per ASTM F2026 with tantalum markers per ASTM F560. The subject device is offered in a variety of footprints, styles, and sizes to accommodate various patient anatomies. The Cavetto® Cervical Cage System is offered in parallel and lordotic styles in heights of 4-10mm, widths of 13-19mm, and lengths of 11-16mm.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
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
The Cavetto® Cervical Cage System has been tested in the following test modes:
- Static axial compression per ASTM F2077
- Static torsion per ASTM F2077
- Dynamic axial compression per ASTM F2077
- Dynamic torsion per ASTM F2077
- Static subsidence per ASTM F2267
- Static expulsion per ASTM F04.25.02.02
The results of this non-clinical testing show that the strength of the Cavetto® Cervical Cage System is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices.
Key Metrics
Not Found
Predicate Device(s)
K120275, K150765, K121103, K113559, K090064
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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Image /page/0/Picture/0 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 in blue, with the words "U.S. FOOD & DRUG" stacked on top of the word "ADMINISTRATION".
February 26, 2018
NeuroStructures, Inc. % Mr. Kenneth C. Maxwell II Regulatory and Quality Specialist Empirical Testing Corp. 4628 Northpark Drive Colorado Springs, CO 80918
Re: K172320
Trade/Device Name: Neurostructures Cavetto® Cervical Cage System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: ODP Dated: February 2, 2018 Received: February 5, 2018
Dear Mr. Maxwell:
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 (QS) regulation (21 CFR Part 820);
1
-tronic product radiation control provisions (Sections 531-542 of the Act): 21 CER
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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Vincent J. Devlin -S
for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K172320
Device Name
Neurostructures Cavetto® Cervical Cage System
Indications for Use (Describe)
The Neurostructures Cavetto® Cervical Cage System is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six weeks of non-operative treatment. The Neurostructures Cavetto® Cervical Cage System is to be used with autogenous or allogenic bone graft composed of cancellous bone graft and placed via an open, anterior approach. The Neurostructures Cavetto® Cervical Cage System is intended to be used with supplemental fixation.
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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| Submitter's Name | NeuroStructures, Inc. |
|---|---|
| Submitter's Address | 16 Technology Drive, Suite 165 |
| Irvine, CA 92618 | |
| Company Contact Person | Kathleen Wong |
| kw@neurostructures.com | |
| 949.370.4497 | |
| Contact Person | Kenneth C. Maxwell II |
| Empirical Testing Corp. | |
| 719.291.6874 | |
| kmaxwell@empiricalconsulting.com | |
| Date Summary was | |
| Prepared | 02 February 2018 |
| Trade or Proprietary Name | Neurostructures Cavetto® Cervical Cage System |
| Common or Usual Name | Intervertebral Fusion Device With Bone Graft, Cervical |
| Classification | Class II per 21 CFR §888.3080 |
| Product Code | ODP |
| Classification Panel | Division of Orthopedic Devices |
510(K) SUMMARY
DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:
The Cavetto® Cervical Cage System is an intervertebral fusion device made from medical grade PEEK per ASTM F2026 with tantalum markers per ASTM F560. The subject device is offered in a variety of footprints, styles, and sizes to accommodate various patient anatomies. The Cavetto® Cervical Cage System is offered in parallel and lordotic styles in heights of 4-10mm, widths of 13-19mm, and lengths of 11-16mm.
INDICATIONS FOR USE
The Neurostructures Cavetto® Cervical Cage System is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six weeks of non-operative treatment. The Neurostructures Cavetto® Cervical Cage System is to be used with autogenous or allogenic bone graft composed of cancellous and/or corticocancellous bone graft and placed via an open, anterior approach. The Neurostructures Cavetto® Cervical Cage System is intended to be used with supplemental fixation.
The indications for use for the Cavetto® Cervical Cage System is similar to that of the predicates in Table 5-1: Predicate Devices.
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TECHNOLOGICAL CHARACTERISTICS
The Cavetto® Cervical Cage System and predicate devices have nearly identical technological characteristics and the minor differences do not raise any different questions of safety and effectiveness.
Specifically the following characteristics are similar between the subject and predicates:
- Indications for use
- . Principles of operations
- Implant material PEEK
- Implant material tantalum
- . Sterility
- Implant height ●
- Implant width ●
- Implant length ●
- Implant lordosis ●
- Surgical approach ●
- Structural support mechanism
The following technological differences exist between the subject device and predicate devices:
- o Implant bone graft volume
Table 5-1: Predicate Devices
| 510k Number | Trade or Proprietary
or Model Name | Manufacturer | Predicate
Type |
|-------------|---------------------------------------|--------------|-------------------|
| K120275 | ACIS | Synthes | Primary |
| K150765 | | | |
| K121103 | ROI-C | LDR | Additional |
| K113559 | | | |
| K090064 | Copperhead System | Eminent | Additional |
Performance Data
The Cavetto® Cervical Cage System has been tested in the following test modes:
- Static axial compression per ASTM F2077
- o Static torsion per ASTM F2077
- Dynamic axial compression per ASTM F2077 o
- Dynamic torsion per ASTM F2077 ●
- Static subsidence per ASTM F2267
- Static expulsion per ASTM F04.25.02.02 o
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The results of this non-clinical testing show that the strength of the Cavetto® Cervical Cage System is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices.
CONCLUSION
The overall technology characteristics and mechanical performance data lead to the conclusion that the Cavetto® Cervical Cage System is substantially equivalent to the predicate device.