(262 days)
Not Found
No
The document describes a physical interbody fusion device and its materials, without mentioning any software, algorithms, or data processing that would indicate AI/ML.
No.
This device is an intervertebral fusion system designed to physically stabilize the lumbar spine and promote fusion, which is a structural intervention, not a therapeutic treatment.
No
This device is an interbody fusion system designed to facilitate spinal fusion by providing structural support and not for diagnosing a condition.
No
The device description clearly states it is an intervertebral cage manufactured from PEEK with embedded titanium markers and available with titanium alloy anchoring plates, indicating it is a physical implant, not software.
Based on the provided information, 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 (like blood, urine, or tissue) to detect diseases, conditions, or infections.
- Device Function: The Avenue® L Interbody Fusion System is a physical implant designed to be surgically placed in the lumbar spine to facilitate fusion. It is a medical device used in vivo (within the body), not a test performed in vitro (outside the body).
- Intended Use: The intended use clearly describes a surgical procedure for treating degenerative disc disease, not a diagnostic test.
- Device Description: The description details the materials and design of a physical implant, not a diagnostic reagent or instrument.
Therefore, the Avenue® L Interbody Fusion System falls under the category of a surgical implant or medical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Avenue® L Interbody Fusion 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 contiquous levels for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with or without integrated fixation and must be used in conjunction with posterior supplemental fixation (e.g. pedicle screws). The device system is intended to be used with autograft to facilitate fusion.
Product codes (comma separated list FDA assigned to the subject device)
OVD
Device Description
The Avenue L Interbody Fusion System is intended for use as an interbody fusion device in the lumbar spine. The device consists of intervertebral cages manufactured from medical grade PEEK OPTIMA® LT1 (ASTM F2026) with embedded titanium alloy markers (ASTM F136) to facilitate visibility in x-ray imaging. The Avenue L is available with VerteBRIDGE titanium alloy anchoring plates which facilitate fixation to the superior and inferior vertebra, in addition to supplemental fixation. The Avenue L is designed for placement using a lateral surgical approach.
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)
Testing was comprised of subsidence, static axial and shear compression, static torsion, dynamic axial compression and torsion (per ASTM F2077), expulsion (per ASTM F-04.25.02.02), wear debris analysis (per ASTM F1877), and cadaveric evaluations (including flexion/extension and lateral bending fatigue). The results of this testing demonstrate that the performance of the LDR Spine Avenue L system is substantially equivalent to the 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.
K082262, K082262, K090507, K110327, K103382
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
KII3285
Image /page/0/Picture/1 description: The image shows the logo for LDR, which is a company that has "a passion for innovation". The logo consists of a stylized eye with a person inside of it, followed by the letters "LDR" in bold, sans-serif font. The words "a passion for innovation" are written in a smaller, sans-serif font below the letters "LDR".
510(k) Summary Avenue® L Interbody Fusion System
JUL 2 6 2012
Owner's Name & Address: LDR Spine USA 13785 Research Blvd. Suite 200 Austin, TX 78750
Bradley W. Strasser Requlatory Affairs Project Manager Phone: (512) 344-3395 Fax: (512) 795-8306 Email: bradstrasser@ldrspine.com
July 26, 2012
2011
20, 2011
February 02, 2009
Date:
Trade Name:
Common Name:
Contact Person:
Classification:
Predicate Devices:
Device Description
The Avenue L Interbody Fusion System is intended for use as an interbody fusion device in the lumbar spine. The device consists of intervertebral cages manufactured from medical grade PEEK OPTIMA® LT1 (ASTM F2026) with embedded titanium alloy markers (ASTM F136) to facilitate visibility in x-ray imaging. The Avenue L is available with VerteBRIDGE titanium alloy anchoring plates which facilitate fixation to the superior and inferior vertebra, in addition to supplemental fixation. The Avenue L is designed for placement using a lateral surgical approach.
LDR Spine USA Avenue® L Interbody Fusion System
OVD 888.3080- Intervertebral Fusion Device with
LDR Spine ROI-T Implant System; K082262,
LDR Spine ROI-A Implant System; K082262, February 02,
2009; K090507, June 25, 2009; K110327; September 30,
Globus InterContinental® Plate-Spacer; K103382, May
Intervertebral Body Fusion Device
Integrated Fixation, Lumbar
1
Image /page/1/Picture/1 description: The image shows the logo for LDR, which includes a stylized eye graphic to the left of the letters "LDR". Below the letters is the text "a passion for innovation". The logo is black and white.
510(k) Summary Avenue® L Interbody Fusion System
Indications for Use:
The Avenue® L Interbody Fusion 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 contiquous levels for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with or without integrated fixation and must be used in conjunction with posterior supplemental fixation (e.g. pedicle screws). The device system is intended to be used with autograft to facilitate fusion.
Testing was comprised of subsidence, static axial and shear compression, static torsion, dynamic axial compression and torsion (per ASTM F2077), expulsion (per ASTM F-04.25.02.02), wear debris analysis (per ASTM F1877), and cadaveric evaluations (including flexion/extension and lateral bending fatigue). The results of this testing demonstrate that the performance of the LDR Spine Avenue L system is substantially equivalent to the predicate devices.
Clinical testing was not required to demonstrate substantial equivalence.
Clinical Testing:
Non-Clinical Testing:
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three legs, representing service to the nation. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
JUL 2 6 2012
LDR Spine USA, Incorporated % Mr. Bradley W. Strasser Regulatory Affairs Project Manager 13785 Research Boulevard, Suite 200 Austin, Texas 78750
Re: K113285
Trade/Device Name: LDR Spine Avenue® L Interbody Fusion System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: OVD Dated: July 23, 2012 Received: July 24, 2012
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
3
Page 2 – Bradley W. Strasser
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 forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic form in the quint of orovisions (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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 1000 me 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 Small Manufacturers, International and Consumer Assistance 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.
Sincerely yours, .
Sincerely yours,
J. N. Mellecker
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
INDICATIONS FOR USE
510(k) Number (if known): K113285
Device Name:
LDR Spine Avenue® L Interbody Fusion System
Indications for Use:
The Avenue® L Interbody Fusion 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. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with or without integrated fixation and must be used in conjunction with posterior supplemental fixation (e.q. pedicle screws). The device system is intended to be used with autograft to facilitate fusion.
Prescription Use × (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) |
|---|
| -------------------------------------------------------- |
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
| 510(k) Number | K113285 |
|---|---|
| --------------- | --------- |
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