(34 days)
Not Found
No
The summary describes a physical implant (lumbar cage) and its mechanical testing, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is used to treat degenerative disc disease by providing interbody fusion and requires a period of non-operative treatment to be considered, indicating its therapeutic purpose.
No
This device is an intervertebral fusion device (a lumbar cage system) used for spinal fusion in patients with degenerative disc disease. It is a treatment device, not a diagnostic one.
No
The device description explicitly states it is an intervertebral fusion device made from PEEK with titanium markers, indicating it is a physical implant, not software.
Based on the provided information, the Cortina™ [MAX] Lumbar Cage System is not an IVD (In Vitro Diagnostic) device.
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 about a person's health.
- Device Description and Intended Use: The description clearly states that the Cortina™ [MAX] Lumbar Cage System is an implantable device (a lumbar cage) used for spinal fusion in patients with degenerative disc disease. It is surgically placed within the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, diagnostic testing, or providing information about a patient's health based on in vitro analysis.
The device is a surgical implant used for treatment, not for diagnostic purposes using in vitro methods.
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 lo S 1 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 confim1ed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment.
Product codes (comma separated list FDA assigned to the subject device)
MAX
Device Description
The Cortina™ [MAX] Lumbar Cage System is an intervertebral fusion device made from medical grade PEEK with titanium markers. The subject device is offered in a variety of styles and sizes to accommodate various patient anatomies.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
L2 to S1
Indicated Patient Age Range
skeletally mature
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)
The Cortina™ [MAX] Lumbar Cage System has been tested in the following test modes:
- . Static axial compression per ASTM F2077-11
- Dynamic axial compression per ASTM F2077-11 .
- Static subsidence per ASTM F2267-04 ●
- . Static expulsion per ASTM DRAFT F-04.25.02.02
The results of this non-clinical testing show that the strength of the Cortina™ (MAX) Lumbar Cage System is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices.
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.
Not Found
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
Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
March 22. 2018
NeuroStructures, Inc. Kathleen Wong Director of RA & QA 16 Technology Drive. Suite 165 Irvine, California 92618
Re: K180431
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: February 15, 2018 Received: February 16, 2018
Dear Ms. Wong:
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 Mav 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
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,
Mark N. Melkerson -S
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) K180431
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 lo S 1 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 confim1ed 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) | |
|---|---|
| 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 | Kathleen Wong |
| kw@neurostructures.com | |
| 949.370.4497 | |
| Date Summary was Prepared | 15 February 2018 |
| 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 §888.3050 Device Classification |
| Product Code | MAX |
| Classification Panel | Division of Orthopedic Devices |
K180431 - 510(K)SUMMARY
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 titanium markers. The subject device is offered in a variety of styles and sizes to accommodate various patient anatomies.
This 510(k) is submitted only for the purposes of changing the name of the Cortina™ (K171914) to the Cortina™ MAX). The two devices are otherwise identical, and no changes whatsoever have been made to the Cortina™ (K171914 ).
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.
The indications for use for the Cortina™ [MAX] Lumbar Cage System is identical to that of the primary predicate and similar to that of the additional predicates noted in Table 5-1: Predicate Devices.
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K180431 Page 2 of 2
TECHNOLOGICAL CHARACTERISTICS
The subject and primary predicate device are identical in technological characteristics. The subject and additional 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 primary predicate:
- Principles of Operation
- Indications for Use
- Implant Materials
- Implant Sizes ●
- Surgical Approach
Table 5-1: Predicate Devices
| 510k Number | Trade or Proprietary or Model Name | Manufacturer | Predicate Type |
|---|---|---|---|
| K171914 | Cortina Lumbar Cage System | NeuroStructures | Primary |
PERFORMANCE DATA
The Cortina™ [MAX] Lumbar Cage System has been tested in the following test modes:
- . Static axial compression per ASTM F2077-11
- Dynamic axial compression per ASTM F2077-11 .
- Static subsidence per ASTM F2267-04 ●
- . Static expulsion per ASTM DRAFT F-04.25.02.02
The results of this non-clinical testing show that the strength of the Cortina™ (MAX) Lumbar 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 Cortina™ [MAX] Lumbar Cage System is substantially equivalent to the predicate devices.