(267 days)
No
The 510(k) summary describes a physical medical device (a spinal cage system) and its mechanical properties and testing. There is no mention of software, algorithms, image processing, or any terms related to AI or ML.
Yes
The device is an intervertebral body fusion cage intended for the treatment of degenerative disc disease and spondylolisthesis in the lumbar spine, which are medical conditions, and its purpose is to facilitate fusion, thus making it a therapeutic device.
No
The device is an intervertebral body fusion cage intended for the surgical treatment of degenerative disc disease. It is an implantable medical device used to facilitate fusion, not to diagnose a condition.
No
The device description clearly states it is comprised of physical components like interbody cages, anchoring plates, and associated instrumentation, which are hardware.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "intervertebral body fusion of the lumbar spine." This is a surgical implant used directly in the body.
- Device Description: The description details a physical implant (cage, plates, instrumentation) designed to be placed within the spine.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, tissue) to detect diseases, conditions, or infections. This device does not perform any such testing.
The device is a surgical implant used for structural support and fusion in the spine, not a diagnostic test.
N/A
Intended Use / Indications for Use
The Avenue® T TLIF Cage system is indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use at either one level or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis or retrolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The Avenue T TLIF Cage is designed for use with or without integrated fixation and must be used in conjunction with supplemental fixation cleared by FDA for use in the lumbar spine. The device is implanted via a transforaminal approach and intended for use with autograft to facilitate fusion.
Product codes
OVD, MAX
Device Description
The Avenue T TLIF (Transforaminal Lumbar Interbody Fusion) Cage system is comprised of various size interbody cages, integrated fixation anchoring plates (VerteBRIDGE® Plating), and associated instrumentation. The Avenue T cage is intended for use as an intervertebral body fusion cage in the anterior column of the lumbar spine. The Avenue T cage is designed to be implanted obliquely via a transforaminal approach. The cages feature rows of uni-directional teeth on the superior and inferior surfaces to aid stability and a tapered bullet-shaped tip to ease insertion. The Avenue T cages have a hollow central cavity to contain autogenous bone graft for fusion.
After cage placement, the VerteBRIDGE integrated fixation anchoring plates may be inserted into the cage to provide further stability and fixation. The VerteBRIDGE anchoring plates pass through the cage via slots and lodge firmly into the superior and inferior vertebral endplates. The VerteBRIDGE anchoring plates lock into the Avenue T cages via an integral titanium locking pin.
The Avenue T cage is manufactured from PEEK-OPTIMA® LT1 with embedded ASTM F136 titanium alloy radiographic markers and anchoring plate locking pins. The VerteBRIDGE anchoring plates are manufactured from ASTM F136 titanium alloy.
The Avenue T cages are designed in a variety of length, and lordosis combinations to best fit varying patient anatomies.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lumbar spine, from L2 to S1
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)
Non-clinical performance bench testing conducted to support substantial equivalence for the Avenue T TLIF Cage included:
- Static and dynamic compression testing per ASTM F2077-11
- Static and dynamic compressive shear testing per ASTM F2077-11
- Static and dynamic torsion testing per ASTM F2077-11
- Subsidence testing per ASTM F2267-04
- Static cage expulsion testing
- Static anchoring plate expulsion testing
- Wear testing & debris analysis
Additionally, an implantation study was conducted as part of this 510(k) and assessment of the subject device.
The results of this non-clinical testing demonstrate that the strength of the Avenue T TLIF Cage is sufficient for its intended use and is therefore substantially equivalent to legally marketed predicate devices.
Clinical testing was not required to demonstrate substantial equivalence.
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.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, overlapping to create a sense of depth and connection. The profiles are rendered in a simple, line-art style.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 11, 2015
LDR Spine USA, Incorporated Mr. Bradlev W. Strasser, RAC Regulatory Affairs Project Manager 13785 Research Boulevard, Suite 200 Austin, Texas 78750
Re: K142645
Trade/Device Name: Avenue T® TLIF Cage Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: OVD, MAX Dated: May 11, 2015 Received: May 12, 2015
Dear Mr. Strasser:
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. Bradley W. Strasser, RAC
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 vours.
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
K142645 510(k) Number (if known):
Device Name:
Avenue® T TLIF Cage
Indications for Use:
The Avenue® T TLIF Cage system is indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use at either one level or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis or retrolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The Avenue T TLIF Cage is designed for use with or without integrated fixation and must be used in conjunction with supplemental fixation cleared by FDA for use in the lumbar spine. The device is implanted via a transforaminal approach and intended for use with autograft to facilitate fusion.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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Image /page/3/Picture/0 description: The image is a logo for LDR, a company that is passionate about innovation. The logo features a stylized eye with a person inside of it, followed by the letters "LDR" in bold, dark blue font. Below the logo is the tagline "a passion for innovation" in a smaller font.
| 510(k) Summary | |
|---|---|
| Owner's Name & Address: | LDR Spine USA |
| 13785 Research Blvd. Suite 200 | |
| Austin, TX 78750 | |
| Contact Person: | Bradley W. Strasser, RAC |
| Manager, U.S. Regulatory Affairs | |
| Phone: (512) 344-3395 | |
| Fax: (512) 795-8306 | |
| Email: brad.strasser@ldrspine.com | |
| Date: | June 09, 2015 |
| Trade Name: | Avenue® T TLIF Cage |
| Common Name: | Intervertebral body fusion device with integrated fixation, |
| lumbar | |
| Panel: | Orthopedic |
| Product Code: | OVD, MAX |
| Classification: | Class II, 21 CFR 888.3080 |
| Primary Predicate Device: | CAPSTONE® Spinal System, Medtronic Sofamor Danek USA, Inc. |
| (K133650, cleared December 20, 2013) | |
| Additional Predicate Devices: | Avenue® L Interbody Fusion Cage, LDR Medical SAS (K113285, |
| cleared July 26, 2012) |
Device Description:
The Avenue T TLIF (Transforaminal Lumbar Interbody Fusion) Cage system is comprised of various size interbody cages, integrated fixation anchoring plates (VerteBRIDGE® Plating), and associated instrumentation. The Avenue T cage is intended for use as an intervertebral body fusion cage in the anterior column of the lumbar spine. The Avenue T cage is designed to be implanted obliquely via a transforaminal approach. The cages feature rows of uni-directional teeth on the superior and inferior surfaces to aid stability and a tapered bullet-shaped tip to ease insertion. The Avenue T cages have a hollow central cavity to contain autogenous bone graft for fusion.
After cage placement, the VerteBRIDGE integrated fixation anchoring plates may be inserted into the cage to provide further stability and fixation. The VerteBRIDGE anchoring plates pass
4
Image /page/4/Picture/0 description: The image shows the logo for LDR. The logo consists of a blue oval shape with a stylized human figure inside, followed by the letters "LDR" in bold blue font. Below the letters, there is a tagline that reads "a passion for innovation" in a smaller font.
through the cage via slots and lodge firmly into the superior and inferior vertebral endplates. The VerteBRIDGE anchoring plates lock into the Avenue T cages via an integral titanium locking pin.
The Avenue T cage is manufactured from PEEK-OPTIMA® LT1 with embedded ASTM F136 titanium alloy radiographic markers and anchoring plate locking pins. The VerteBRIDGE anchoring plates are manufactured from ASTM F136 titanium alloy.
The Avenue T cages are designed in a variety of length, and lordosis combinations to best fit varying patient anatomies.
Indications for Use:
The Avenue T TLIF Cage system is indicated for intervertebral body fusion of the lumbar spine. from L2 to S1, in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use at either one level or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis or retrolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The Avenue T TLIF Cage is designed for use with or without integrated fixation and must be used in conjunction with supplemental fixation cleared by FDA for use in the lumbar spine. The device is implanted via a transforaminal approach and intended for use with autograft to facilitate fusion.
Non-Clinical Performance Data:
Non-clinical performance bench testing conducted to support substantial equivalence for the Avenue T TLIF Cage included:
- Static and dynamic compression testing per ASTM F2077-11 ●
- Static and dynamic compressive shear testing per ASTM F2077-11 ●
- Static and dynamic torsion testing per ASTM F2077-11
- Subsidence testing per ASTM F2267-04
- Static cage expulsion testing
- Static anchoring plate expulsion testing ●
- Wear testing & debris analysis ●
Additionally, an implantation study was conducted as part of this 510(k) and assessment of the subject device.
The results of this non-clinical testing demonstrate that the strength of the Avenue T TLIF Cage is sufficient for its intended use and is therefore substantially equivalent to legally marketed predicate devices.
Clinical Performance Data:
Clinical testing was not required to demonstrate substantial equivalence.
Basis of Substantial Equivalence:
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The Avenue T TLIF Cage system is substantially equivalent to the predicate devices based on intended use and indications for use. The differences in technological characteristics do not raise different questions of safety and effectiveness and the scientific data from assessment of these characteristics demonstrate that the subject device is fit for its intended use and comparable to predicate devices. Therefore, the Avenue T TLIF Cage overall is substantially equivalent to the predicate devices.