(275 days)
No reference devices were used in this submission.
No
The summary describes a physical intervertebral body fusion device and its materials, dimensions, and intended use. There is no mention of software, algorithms, or any technology that would suggest AI or ML capabilities.
Yes
The device is intended to treat symptoms of degenerative disc disease and facilitate fusion by stabilizing the spinal segment.
No
Explanation: This device is described as an intervertebral body fusion device intended to stabilize the spinal segment. Its purpose is mechanical support and to promote fusion, not to diagnose a condition.
No
The device description clearly outlines physical components made of PEEK, Ti-6Al-4V, and tantalum, which are implanted into the body. This indicates a hardware-based medical device, not a software-only one.
Based on the provided text, 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, specifically for treating degenerative disc disease. This is a therapeutic intervention, not a diagnostic test performed on samples from the human body.
- Device Description: The device is described as an intervertebral body fusion device made of materials like PEEK and titanium, designed to be surgically implanted. This aligns with a medical device for treatment, not a diagnostic tool.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing information for diagnosis or monitoring of a disease state through in vitro testing.
Therefore, the Cogent Lateral Interbody System is a medical device intended for surgical implantation, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Cogent Lateral Interbody System is indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to L5. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain 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. These devices are intended for intervertebral body fusion, and are intended to be used with supplemental fixation instrumentation which has been cleared by the FDA for use in the lumbar spine.
Product codes
MAX
Device Description
The Cogent Lateral Interbody System is an intervertebral body fusion device intended to stabilize the spinal segment to promote fusion. The implants are available in a variety of lengths and heights to accommodate varying patient anatomy. The Cogent Lateral Interbody System implants and instruments are supplied non-sterile. The implants in the The Cogent Lateral Interbody System are manufactured from PEEK, Ti-6Al-4V, and tantalum.
The Cogent Lateral Interbody consists of two PEEK spacers with axial voids to contain bone graft material, a titanium linkage that connects the PEEK spacers, angular anti-migration teeth, and tantalum x-ray markers.
The Cogent Lateral Interbody is available in various sizes to accommodate varying patient anatomy. The Cogent Lateral Interbody System is 18 or 22mm wide and includes five available lengths, 40, 45, 50, 55, and 60mm. The Cogent Lateral Interbody System is also available in three lordotic options, 0°, 6°, and 12°. The Cogent Lateral Interbody System is available in heights of 8mm to 16mm.
The Cogent Lateral Interbody System implants may be inserted via an open or minimally invasive approach and may be placed in a lateral or anterolateral orientation.
The Cogent Lateral Interbody System implants are non-sterile and are to be sterilized by the end user.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
from L2 to L5 (lumbar spine)
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
NON-CLINICAL TEST SUMMARY:
Cadaveric Usability Study
CLINICAL TEST SUMMARY:
No clinical studies were performed.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
No reference devices were used in this submission.
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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 25, 2016
Cogent Spine LLC % Mr. Jude Paganelli Cor Medical Ventures LLC 101 North Acacia Avenue, Suite 106 Solana Beach, California 92075
Re: K151406
Trade/Device Name: Cogent Lateral Interbody System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: December 31, 2015 Received: January 4, 2016
Dear Mr. Paganelli:
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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 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 yours,
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) K151406
Device Name Cogent Lateral Interbody System
Indications for Use (Describe)
The Cogent Lateral Interbody System is indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to L5. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain 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. These devices are intended for intervertebral body fusion, and are intended to be used with supplemental fixation instrumentation which has been cleared by the FDA for use in the lumbar spine.
| 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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510(K) SUMMARY
SUBMITTER:
Submitted By:
| Company Name: | Cogent Spine LLC |
|---|---|
| Address: | 101 N. Acacia Ave., Suite 106 |
| Solana Beach, CA 92075 | |
| Telephone: | (858) 774-7891 |
CONTACT PERSON: Jude Paqanelli
DATE PREPARED: February 16, 2016
TRADE NAME: Cogent Lateral Interbody System
COMMON NAME: Intervertebral Body Fusion Device
DEVICE CLASSIFICATION: Class II
CLASSIFICATION NAME: Intervertebral Body Fusion Device (21 CFR 888.3080)
PRODUCT CODE: MAX
SUBSTANTIALLY EQUIVALENT TO:
The Cogent Lateral Interbody System is substantially equivalent to the predicate, Cogent Med-LIF System (K132738) in all facets including: indications, technology, method of use and performance.
Primary Predicate Device: Cogent Med-LIF System (K132738)
Additional Predicate Device: Cogent Med-LIF XL System (K142193)
No reference devices were used in this submission.
The Cogent Lateral Interbody System is similar to the predicate devices in function, technical features, materials, and instrumentation. It differs from the predicate devices in sizing (primarily length and width) as well as intended surgical approach to the spine.
4
DESCRIPTION of the DEVICE:
The Cogent Lateral Interbody System is an intervertebral body fusion device intended to stabilize the spinal segment to promote fusion. The implants are available in a variety of lengths and heights to accommodate varying patient anatomy. The Cogent Lateral Interbody System implants and instruments are supplied non-sterile. The implants in the The Cogent Lateral Interbody System are manufactured from PEEK, Ti-6Al-4V, and tantalum.
The Cogent Lateral Interbody consists of two PEEK spacers with axial voids to contain bone graft material, a titanium linkage that connects the PEEK spacers, angular anti-migration teeth, and tantalum x-ray markers.
The Cogent Lateral Interbody is available in various sizes to accommodate varying patient anatomy. The Cogent Lateral Interbody System is 18 or 22mm wide and includes five available lengths, 40, 45, 50, 55, and 60mm. The Cogent Lateral Interbody System is also available in three lordotic options, 0°, 6°, and 12°. The Cogent Lateral Interbody System is available in heights of 8mm to 16mm.
The Cogent Lateral Interbody System implants may be inserted via an open or minimally invasive approach and may be placed in a lateral or anterolateral orientation.
The Cogent Lateral Interbody System implants are non-sterile and are to be sterilized by the end user.
MATERIALS:
The Cogent Lateral Interbody is manufactured from polyetheretherketone (PEEK) as per ASTM F2026 and contains titanium alloy (Ti-6Al-4V) per ASTM F1472 and tantalum per ASTM F560.
INDICATIONS FOR USE:
The Cogent Lateral Interbody System is indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to L5. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain 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. These devices are intended for intervertebral body fusion, and are intended to be
5
used with supplemental fixation instrumentation which has been cleared by the FDA for use in the lumbar spine.
NON-CLINICAL TEST SUMMARY:
Cadaveric Usability Study
CLINICAL TEST SUMMARY:
No clinical studies were performed.
CONCLUSIONS:
The Cogent Lateral Interbody System device has shown to be substantially equivalent to a legally marketed predicate based on indications for use, technological characteristics, performance testing and comparison to predicate devices.