(98 days)
No
The summary describes a physical implant device and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is a lumbar cage system used for intervertebral fusion to treat degenerative disc disease, which aims to alleviate pain and restore function.
No
The device is an intervertebral fusion device, not intended for diagnosing medical conditions.
No
The device description clearly states it is an intervertebral fusion device made from PEEK or titanium, 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 a surgical implant for spinal fusion in patients with degenerative disc disease. This is a therapeutic device, not a diagnostic one.
- Device Description: The device is described as an intervertebral fusion device made from PEEK or titanium, designed to be implanted in the spine. This is consistent with a surgical implant.
- Lack of Diagnostic Function: There is no mention of the device being used to test samples (blood, tissue, etc.) or to provide diagnostic information about a patient's condition.
- Performance Studies: The performance studies described focus on mechanical testing of the implant's strength and durability, which is relevant for a surgical device, not an IVD.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The Cortina™ [MAX] Lumbar Cage System is indicated for use in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1 whose condition requires the use of interbody fusion combined with supplemental fixation. The interior of the Cortina™ [MAX] Lumbar Cage System should be packed with autogenous bone graft (i.e. autograft). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment.
Product codes
MAX
Device Description
The Cortina™ [MAX] Lumbar Cage System is an intervertebral fusion device made from medical grade PEEK with tantalum markers manufactured from EVONIK PEEK as described in MAF-1922 with the submissions of the predicate Cortina [MAX] (K171914 and K180431) or medical grade titanium per ASTM F136 with a TECOTEX® surface coating. The subject device is offered in a variety of styles and sizes to accommodate various patient anatomies. This submission is intended to add the titanium implants and expand the size offering to include larger footprints.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
from L2 to S1
Indicated Patient Age Range
skeletally mature
Intended User / Care Setting
Prescription Use (Part 21 CFR 801 Subpart D)
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)
The subject devices that are manufactured from titanium require no additional testing, for they are identical in form, shape, and function to the previously cleared devices manufactured from PEEK (K171914/K180431). Titanium material produces implants with a higher yield load and stiffness when the shape is identical, therefore no testing is required.
The subject devices that are manufactured from PEEK present no new worst case to what was to what was previously cleared (K171914/K180431). The addition of the longer (36-42 mm) PLIF implants does not create a new mechanical worst-case for the system as opposed to the 20x9x7mm PLIF tested for the previous clearance , therefore no additional testing is required for the additional length in the line extension.
The DLIF does not need to be tested as a new worst-case for the system, as the design and footprint do not represent a new worst-case for either static or dynamic mechanical testing. The smallest DLIF is significantly larger than what was previously tested for clearance. Additionally, the design of the DLIF is considerably simpler than the tested PLIF and has fewer areas of concern for mechanical integrity.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K171914/K180431, K172064, K173080
Reference Device(s)
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
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, which is 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.
November 25, 2019
NeuroStructures, Inc. % Meredith May Vice President Empirical Testing Corp. 4628 Northpark Drive Colorado Springs, Colorado 80918
Re: K192248
Trade/Device Name: Cortina™ [MAX] Lumbar Cage System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX Dated: October 28, 2019 Received: October 29, 2019
Dear Meredith 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 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 (Acting) DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
4. INDICATIONS FOR USE STATEMENT
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
510(k) Number (if known) K192248
Device Name Cortina™ [MAX] Lumbar Cage System
Indications for Use (Describe)
The Cortina™ [MAX] Lumbar Cage System is indicated for use in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1 whose condition requires the use of interbody fusion combined with supplemental fixation. The interior of the Cortina™ [MAX] Lumbar Cage System should be packed with autogenous bone graft (i.e. autograft). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment.
| 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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per
response, including the time to review instructions, search existing data sources, gather
and maintain the data needed and complete and review the collection of information.
Send comments regarding this burden estimate or any other aspect of this information
collection, including suggestions for reducing this burden, to:
Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
"An agency may not conduct or sponsor, and a person is not required to
respond to, a collection of information unless it displays a currently valid OMB
number."
| FORM FDA 3881 (7/17) | Page 1 of 1 | PSC Publishing Services (301) 443-6740 EF |
|---|---|---|
| ---------------------- | ------------- | ------------------------------------------- |
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020
3
5.510(K) SUMMARY
| Submitter's Name | Neurostructures, Inc. |
|---|---|
| Submitter's Address | 199 Technology Drive, Suite 1110 |
| Irvine, CA 92618 | |
| Submitter's Telephone | 800-352-6103 |
| Company Contact Person | Moti Altarac |
| Contact Person | Meredith Lee May MS, RAC |
| Empirical Consulting | |
| 719-337-7579 | |
| Mmay@EmpiricalConsulting.com | |
| Date Summary was Prepared | 12-Aug-19 |
| Trade or Proprietary Name | Cortina™ [MAX] Lumbar Cage System |
| Common or Usual Name | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Classification | Class II per 21 CFR §888.3080_Device |
| Classification | |
| Product Code | MAX |
| Classification Panel | Division of Orthopedic Devices |
DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION
The Cortina™ [MAX] Lumbar Cage System is an intervertebral fusion device made from medical grade PEEK with tantalum markers manufactured from EVONIK PEEK as described in MAF-1922 with the submissions of the predicate Cortina [MAX] (K171914 and K180431) or medical grade titanium per ASTM F136 with a TECOTEX® surface coating. The subject device is offered in a variety of styles and sizes to accommodate various patient anatomies. This submission is intended to add the titanium implants and expand the size offering to include larger footprints.
INDICATIONS FOR USE
The Cortina™ [MAX] Lumbar Cage System is indicated for use in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1 whose condition requires the use of interbody fusion combined with supplemental fixation. The interior of the Cortina™ [MAX] Lumbar Cage System should be packed with autogenous bone graft (i.e. autograft). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment.
TECHNOLOGICAL CHARACTERISTICS
The subject 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 identical between the subject and predicates:
4
- Principles of Operation ●
- Indications for Use ●
- Implant Materials
- Implant Sizes ●
- Surgical Approach ●
| 510k
Number | Trade or Proprietary or Model
Name | Manufacturer | Predicate
Type |
|---------------------|--------------------------------------------------|---------------------------|-------------------|
| K171914/
K180431 | Cortina™ [MAX] Lumbar Cage
System | NeuroStructures | Primary |
| K172064 | Ti-Diagon Oblique TLIF | Camber Spine Technologies | Additional |
| K173080 | IVA CAGE Ti (ACIF, PLIF,
TLIF, DLIF and ALIF) | HUVEXEL | Additional |
| K172320 | Cavetto® Cervical Cage System | NeuroStructures, Inc. | Reference |
| K142041 | PorOsteon Phusion Metal
Cervical Cage | PorOsteon, Inc. | Reference |
Table 5-1: Predicate Devices
PERFORMANCE DATA
The subject devices that are manufactured from titanium require no additional testing, for they are identical in form, shape, and function to the previously cleared devices manufactured from PEEK (K171914/K180431). Titanium material produces implants with a higher yield load and stiffness when the shape is identical, therefore no testing is required.
The subject devices that are manufactured from PEEK present no new worst case to what was to what was previously cleared (K171914/K180431). The addition of the longer (36-42 mm) PLIF implants does not create a new mechanical worst-case for the system as opposed to the 20x9x7mm PLIF tested for the previous clearance , therefore no additional testing is required for the additional length in the line extension.
The DLIF does not need to be tested as a new worst-case for the system, as the design and footprint do not represent a new worst-case for either static or dynamic mechanical testing. The smallest DLIF is significantly larger than what was previously tested for clearance. Additionally, the design of the DLIF is considerably simpler than the tested PLIF and has fewer areas of concern for mechanical integrity.
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.