(143 days)
No
The summary describes a passive implantable device (cervical cage) and does not mention any software, algorithms, or data processing capabilities that would indicate the use of AI/ML.
Yes
The device is indicated for use in treating degenerative disc disease (DDD) of the cervical spine, which is a medical condition, by aiding in spinal fusion.
No
The device description indicates it is an intervertebral fusion device used with bone graft and supplemental fixation for treatment of degenerative disc disease, not for diagnosis.
No
The device description explicitly states it is an intervertebral fusion device made from medical grade titanium, which is a physical hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a cervical cage system used for spinal fusion in patients with degenerative disc disease. This is a surgical implant used in the body, not a test performed on samples taken from the body.
- Device Description: The description details a physical implant made of titanium, designed to be placed between vertebrae. This is consistent with a surgical device, not a diagnostic test.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information based on laboratory testing.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not fit that description.
N/A
Intended Use / Indications for Use
The Neurostructures Cavetto® [MAX] 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® [MAX] 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® [MAX] Cervical Cage System is intended to be used with supplemental fixation.
Product codes (comma separated list FDA assigned to the subject device)
ODP
Device Description
The Cavetto® [MAX] Cervical Cage System is an intervertebral fusion device made from medical grade titanium per ASTM F136. The subject device is offered in a variety of footprints, styles, and sizes to accommodate various patient anatomies. The Cavetto® [MAX] 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, disc level from 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
An engineering comparison of the material used to manufacture the previously cleared device and the subject device material was completed in lieu of mechanical testing, showing that the subject device is mechanically equivalent to the primary predicate device. Bacterial endotoxin (LAL) testing was conducted and met endotoxin limit specifications.
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.
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.
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.
0
November 8, 2018
Image /page/0/Picture/1 description: The image contains 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 the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath in a smaller font.
NeuroStructures, Inc. % Ms. Meredith May VP. Empirical Consulting Empirical Testing Corp. 4628 Northpark Drive Colorado Springs, Colorado 80918
Re: K181590
Trade/Device Name: Neurostructures Cavetto® [MAX] Cervical Cage System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: ODP Dated: October 10, 2018 Received: October 12, 2018
Dear Ms. May:
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 mav, 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 avare 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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's
1
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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (OS) 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
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.
David Hwang -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
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
Page 1 of 1
510(k) Number (if known) K181590
Device Name
Neurostructures Cavetto® [MAX] Cervical Cage System
Indications for Use (Describe)
The Neurostructures Cavetto® [MAX] 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® [MAX] 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® [MAX] Cervical Cage System is intended to be used with supplemental fixation.
| 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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5.510(K) SUMMARY
| Submitter's Name | Neurostructures, Inc. |
|---|---|
| Submitter's Address | 199 Technology Drive, Suite 110 |
| Irvine, CA 92618 | |
| Company Contact Person | Kathleen Wong |
| kw@neurostructures.com | |
| 949.370.4497 | |
| Contact Person | Meredith L. May MS, RAC |
| Empirical Consulting | |
| 719-337-7579 | |
| MMay@EmpiricalConsulting.com | |
| Date Summary was | |
| Prepared | 30 May 2018 |
| Trade or Proprietary Name | Neurostructures Cavetto® [MAX] 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 |
DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:
The Cavetto® [MAX] Cervical Cage System is an intervertebral fusion device made from medical grade titanium per ASTM F136. The subject device is offered in a variety of footprints, styles, and sizes to accommodate various patient anatomies. The Cavetto® [MAX] 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® [MAX] 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® [MAX] 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® [MAX] Cervical Cage System is intended to be used with supplemental fixation.
The indications for use for the Cavetto® [MAX] Cervical Cage System is similar to that of the predicates in Table 5-1: Predicate Devices.
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TECHNOLOGICAL CHARACTERISTICS
The Cavetto® [MAX] Cervical Cage System and predicate devices have nearly identical technological characteristics and the minor differences do not raise any new issues of safety and effectiveness.
Specifically the following characteristics are similar between the subject and predicates:
- Indications for use
- Principles of operations ●
- Implant material ●
- Sterility ●
- Surgical approach ●
- Structural support mechanism ●
Table 5-1: Predicate Devices
| 510k Number | Trade or Proprietary or Model
Name | Manufacturer | Predicate
Type |
|-------------|------------------------------------------|------------------------------|-------------------|
| K172320 | Cavetto® Cervical Cage System | NeuroStructures | Primary |
| K172064 | Ti-Diagon Oblique TLIF | Camber Spine
Technologies | Reference |
| K142041 | PorOsteon Phusion Metal Cervical
Cage | PorOsteon, Inc. | Reference |
PERFORMANCE DATA
An engineering comparison of the material used to manufacture the previously cleared device and the subject device material was completed in lieu of mechanical testing, showing that the subject device is mechanically equivalent to the primary predicate device. Bacterial endotoxin (LAL) testing was conducted and met endotoxin limit specifications.
CONCLUSION
The overall technology characteristics and mechanical performance data lead to the conclusion that the Cavetto® [MAX] Cervical Cage System is substantially equivalent to the predicate device.