(155 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and biocompatibility of the implant, with no mention of AI or ML.
Yes
The device is a medical implant designed to treat specific conditions (degenerative disc disease) with the goal of facilitating intervertebral body fusion, which is a therapeutic purpose.
No
Explanation: The device is an implantable intervertebral body fusion cage intended for the treatment of degenerative disc disease, not for diagnosing conditions.
No
The device description clearly states it is comprised of physical components like interbody cages, anchoring plates, and associated instrumentation, manufactured from materials like PEEK and titanium alloy. This indicates it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended to be used in vitro for the examination of specimens derived from the human body in order to provide information for diagnostic, monitoring or compatibility purposes.
- Device Description and Intended Use: The Avenue T TLIF Cage System is a surgical implant designed to be placed within the human body (in the lumbar spine) to facilitate bone fusion. It is a physical device used in a surgical procedure, not a test performed on a sample outside the body.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples, diagnostic information, or laboratory procedures.
Therefore, the Avenue T TLIF Cage System falls under the category of a surgical implant or medical device used in a therapeutic procedure, not an In Vitro Diagnostic.
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 and/or allogenic bone graft composed of cancellous and/or corticocancellous bone graft to facilitate fusion.
Product codes
OVD
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 or allogenic 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 locking pin.
The Avenue T cage is manufactured from PEEK-OPTIMA® LT1 with embedded ASTM F136 titanium alloy radiographic markers and ASTM F2063 wrought nickel-titanium shape memory alloy anchoring plate locking pins. The VerteBRIDGE anchoring plates are manufactured from ASTM F136 titanium alloy.
The Avenue T cages are designed in 30mm and 34mm lengths, 8mm to 19mm heights, and an 11mm width with lordosis angles ranging from 0° to 9°.
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 considered to support substantial equivalence for the Avenue T TLIF Cage included:
- Finite Element Analysis
- Dynamic compressive shear testing per ASTM F2077-11
- Static anchoring plate expulsion testing
- Wear testing & debris analysis
- Corrosion testing
- Limulus Amebocyte Lysate (LAL) endotoxin testing
The results of this non-clinical testing demonstrate that the Avenue T TLIF Cage is sufficient for its intended use in terms of strength and conformance to endotoxin limits 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 is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an image of three faces in profile, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 28, 2016
LDR Spine USA, Inc. Mr. Brad Strasser Manager, U.S. Regulatory Affairs 13785 Research Blvd, Suite 200 Austin, Texas 78750
Re: K161173
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 Dated: September 1, 2016 Received: September 2, 2016
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 Parts 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/ResourcesforYou/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,
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) K161173
Device Name Avenue® T TLIF Cage
Indications for Use (Describe)
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 and/or allogenic bone graft composed of cancellous and/or corticocancellous bone graft to facilitate fusion.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
| ☒ Research Use (Part 21 CFR 312 Subject to Review) |
|---|
| ☐ Care That Is Subject to Health Insurance Portability and Accountability Act (HIPAA) |
X Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/0 description: The image is a logo for LDR. The logo features a stylized eye-shaped graphic in light blue on the left, followed by the letters "LDR" in bold, dark blue font. Below the letters, there is a tagline that reads "a passion for innovation" in a smaller, lighter font.
| 510(k) Summary | |
|---|---|
| Owner's Name & Address: | LDR Spine USA |
| 13785 Research Blvd. Suite 200 | |
| Austin, TX 78750 | |
| Contact Person: | Brad Strasser, RAC |
| Manager, U.S. Regulatory Affairs | |
| Phone: (512) 344-3395 | |
| Fax: (512) 795-8306 | |
| Email: brad.strasser@zimmerbiomet.com | |
| Date: | September 27, 2016 |
| Trade Name: | Avenue® T TLIF Cage |
| Common Name: | Intervertebral body fusion device with integrated fixation |
| lumbar | |
| Panel: | Orthopedic |
| Product Code: | OVD |
| Classification: | Class II, 21 CFR 888.3080 |
| Primary Predicate Device: | K142645 Avenue T TLIF Cage |
| Additional Predicates: | K153495 Avenue T TLIF Cage |
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 or allogenic 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
4
Image /page/4/Picture/1 description: The image contains the logo for LDR. The logo consists of a stylized eye shape in light blue, with a curved figure inside the eye. To the right of the eye is the text "LDR" in bold, dark blue letters. Below the logo is the text "a passion for innovation" in a smaller font size.
inferior vertebral endplates. The VerteBRIDGE anchoring plates lock into the Avenue T cages via an integral locking pin.
The Avenue T cage is manufactured from PEEK-OPTIMA® LT1 with embedded ASTM F136 titanium alloy radiographic markers and ASTM F2063 wrought nickel-titanium shape memory alloy anchoring plate locking pins. The VerteBRIDGE anchoring plates are manufactured from ASTM F136 titanium alloy.
The Avenue T cages are designed in 30mm and 34mm lengths, 8mm to 19mm heights, and an 11mm width with lordosis angles ranging from 0° to 9°.
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 and/or allogenic bone graft composed of cancellous and/or corticocancellous bone graft to facilitate fusion.
Non-Clinical Performance Data:
Non-clinical performance bench testing considered to support substantial equivalence for the Avenue T TLIF Cage included:
- Finite Element Analysis ●
- . Dynamic compressive shear testing per ASTM F2077-11
- Static anchoring plate expulsion testing ●
- . Wear testing & debris analysis
- . Corrosion testing
- . Limulus Amebocyte Lysate (LAL) endotoxin testing
The results of this non-clinical testing demonstrate that the Avenue T TLIF Cage is sufficient for its intended use in terms of strength and conformance to endotoxin limits and is therefore substantially equivalent to legally marketed predicate devices.
5
Image /page/5/Picture/0 description: The image shows the logo for LDR. The logo consists of a stylized eye shape in light blue, with a figure inside the eye. To the right of the eye is the text "LDR" in dark blue, with the letters stacked on top of each other. Below the logo is the text "a passion for innovation" in a smaller font size.
Clinical Performance Data:
Clinical testing was not required to demonstrate substantial equivalence.
Comparison of Technological Characteristics:
The Avenue T TLIF Cage system is substantially equivalent to the predicate devices based on intended use and indications for use. There are no differences in fundamental scientific technology from the predicate device. Minor differences in technological characteristics were assessed via a risk analysis and verification and validation activities. These activities demonstrated that the technological differences between the subject and predicate devices do not raise any new questions of safety and effectiveness, and the Avenue T TLIF Cage is substantially equivalent to the predicate.
Conclusion:
In conclusion, non-clinical testing has demonstrated the subject Avenue T TLIF Cage is equivalent to the predicate device in terms of bench performance and conformance with endotoxin limits. Verification and validation activities performed in conjunction with risk analysis demonstrate the device does not raise any issues of safety and effectiveness. Therefore, the Avenue T TLIF Cage overall is substantially equivalent to the predicate device.