(65 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and dimensions of the interbody fusion device, with no mention of AI or ML capabilities.
Yes
The device is indicated for use with autogenous bone graft to stabilize the spinal segment to promote fusion in patients with degenerative disc disease, which is a therapeutic intent.
No
The device description clearly states it is an "interbody fusion device intended to stabilize the spinal segment to promote fusion," and the intended use describes it as being for patients with degenerative disc disease, not for diagnosing it.
No
The device description clearly outlines physical components made of PEEK and titanium, indicating it is a hardware medical device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The Cogent Med-LIF XL is a physical implant (interbody fusion device) made of PEEK and titanium, designed to be surgically inserted into the spine.
- Intended Use: Its purpose is to stabilize the spinal segment and promote fusion, not to analyze biological samples for diagnostic purposes.
The information provided clearly describes a surgical implant used for treatment, not a diagnostic test.
N/A
Intended Use / Indications for Use
The Cogent Mcd-LIF XL is indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. 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 Med-LIF XL includes additional sizes to the Cogent Med-LIF system. The Cogent Med-LIF XL is an interbody fusion device intended to stabilize the spinal segment to promote fusion. The Cogent Med-LIF XL consists of two PEEK spacers with axial voids to contain bone graft material, a titanium linkage that connects the PEEK spacers, angular antimigration teeth, and tantalum x-ray markers.
The Cogent Med-LIF XL is available in various sizes to accommodate varying patient anatomy. The implants come in two lordotic options. 0° (parallel) and 6° (lordotic). The parallel implants are available in heights ranging from 8mm to 16mm and the lordotic implants are available in heights ranging from 10mm to 16mm. All implants are 15mm wide and are available in three lengths; 28, 30 and 32mm. The Cogent Med-LIF XL implants may be inserted via an open or minimally invasive approach and may be placed as a single implant or as two units bilaterally in the same intervertebral space. The Cogent Med-LIF XL 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
one or two contiguous levels from L2 to S1 (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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Cogent Spine conducted the following bench tests:
- ASTM F2077
- . Static Shear Compression
- · Dynamic Shear Compression
In summary, mechanical and non-clinical testing of the Cogent Med-LIF XL device indicated no new risks and demonstrated substantial equivalence in performance compared to a legally marketed predicate.
No clinical studies were performed.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol consists of three stylized human profiles facing right, with flowing lines connecting them. The profiles are rendered in black, and the background is white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 15, 2014
Cogent Spine, LLC % Mr. Jude Paganelli Cor Medical Ventures, LLC 101 North Acacia Avenue, Suite 106 Solana Beach, California 92075
Re: K142193
Trade/Device Name: Cogent Med-LIF XL Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: September 15, 2014 Received: September 16, 2014
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
Page 2 - Mr. Jude Paganelli
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" (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.
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.
RonaldFD/Jean -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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
K142193
Device Name Cogent Med-LIF XL
Indications for Use (Describe)
The Cogent Mcd-LIF XL is indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. 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)
PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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3
510(K) SUMMARY
SUBMITTER:
Submitted By:
| Company Name: | Cogent Spine |
|---|---|
| Address: | 101 N. Acacia, Suite 106 |
| Solana Beach, CA 92075 | |
| Telephone: | (858) 774-7891 |
CONTACT PERSON: Jude Paganelli
DATE PREPARED: July 30, 2014
TRADE NAME: Cogent Med-LIF XL
COMMON NAME: Intervertebral Body Fusion Device
CLASSIFICATION NAME: Intervertebral Body Fusion Device (21 CFR 888.3080)
PRODUCT CODE: MAX
SUBSTANTIALLY EQUIVALENT TO:
The Cogent Med-LIF XL is substantially equivalent to the predicate, Cogent Med-LIF System (K132738) in all facets including: indications, technology, method of use and performance.
DESCRIPTION of the DEVICE:
The Cogent Med-LIF XL includes additional sizes to the Cogent Med-LIF system. The Cogent Med-LIF XL is an interbody fusion device intended to stabilize the spinal segment to promote fusion. The Cogent Med-LIF XL consists of two PEEK spacers with axial voids to contain bone graft material, a titanium linkage that connects the PEEK spacers, angular antimigration teeth, and tantalum x-ray markers.
The Cogent Med-LIF XL is available in various sizes to accommodate varying patient anatomy. The implants come in two lordotic options. 0° (parallel) and 6° (lordotic). The parallel implants are available in heights ranging from 8mm to 16mm and the lordotic implants are available in heights ranging from 10mm to 16mm. All implants are 15mm wide and are available in three lengths; 28, 30 and 32mm.
4
The Cogent Med-LIF XL implants may be inserted via an open or minimally invasive approach and may be placed as a single implant or as two units bilaterally in the same intervertebral space.
The Cogent Med-LIF XL implants are non-sterile and are to be sterilized by the end user.
MATERIALS:
The Cogent Med-LIF XL 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 Med-LIF XL is indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. 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.
NON-CLINICAL TEST SUMMARY:
Cogent Spine conducted the following bench tests:
- ASTM F2077
- . Static Shear Compression
- · Dynamic Shear Compression
In summary, mechanical and non-clinical testing of the Cogent Med-LIF XL device indicated no new risks and demonstrated substantial equivalence in performance compared to a legally marketed predicate.
CLINICAL TEST SUMMARY:
No clinical studies were performed.
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CONCLUSIONS:
The Cogent Med-LIF XL 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.