(239 days)
Not Found
No
The summary describes a physical implant device and its mechanical testing, with no mention of software, algorithms, or AI/ML capabilities.
Yes
The device is an implant system indicated for intervertebral body fusion of the lumbar spine, used for the treatment of degenerative disc disease. This directly treats or alleviates a medical condition, qualifying it as a therapeutic device.
No
The device is described as an intervertebral body fusion device and is intended for use in spinal fusion procedures. Its function is to facilitate fusion, not to diagnose a condition.
No
The device description explicitly states the device is manufactured from PEEK and has tantalum markers, 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, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states that this device is an "intervertebral body fusion device" intended for surgical implantation in the lumbar spine. It is a physical implant used to facilitate fusion of vertebrae.
- Lack of Biological Sample Analysis: There is no mention of the device analyzing biological samples or providing diagnostic information based on such analysis. Its function is structural and therapeutic.
The device description and intended use clearly place it in the category of a surgical implant, not an in vitro diagnostic.
N/A
Intended Use / Indications for Use
When used as an intervertebral body fusion device, the ROI-A Implant 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 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 supplemental fixation and with autograft to facilitate fusion.
Product codes (comma separated list FDA assigned to the subject device)
OVD
Device Description
The ROI- A Oblique implant is intended for use as an interbody fusion device in the lumbar spine. The device is manufactured from medical grade PEEK OPTIMA® LT1 in accordance with ASTM F2026 and has tantalum markers conforming to ASTM F560 embedded in the implant extremities to facilitate visibility in x-ray imaging. The subject device is designed for placement using an anterolateral approach with an approximate offset angle of 25° from the straight anterior axis.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
x-ray imaging
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 static shear compression, dynamic axial compression and dynamic bending (per ASTM F2077), expulsion (per ASTM F-04.25.02.02), wear debris analysis (per ASTM F1877), low cycle cadaver testing to evaluate clinical stability and device expulsion/pull-out, and high cycle cadaver testing to evaluate device loosening or migration, blade back-out and vertebral body damage. The results of this testing demonstrate that the performance of the LDR Spine ROI-A Oblique implant, when compared with its legally marketed predicate, is substantially equivalent.
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.
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
510(k) Summary of Safety and Effectiveness
SEP 3 0 2011
LDR Spine ROI-A® Implant System
| Owner's Name & Address:
Contact Person: | LDR Spine USA
4030 West Braker Lane, Suite 360
Austin, TX 78759
Phone: (512) 344-3333
Fax: (512) 344-3350
Maritza Elias
Regulatory Affairs Project Manager
LDR Spine USA
4030 West Braker Lane, Suite 360
Austin, TX 78759
Phone: (512) 344-3471
Fax: (512) 344-3350
Email: maritzaelias@ldrspine.com |
|--------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date 510(k) Summary Prepared: | September 29, 2011 |
| Trade Name: | LDR Spine ROI-A® Implant System |
| Common Name: | Intervertebral Body Fusion Device (MAX) |
| Classification: | MAX 888.3080 - Intervertebral Fusion Device with Bone
Graft, Lumbar |
| Legally Marketed Predicate Device: | LDR Spine ROI Implant System (K082262, K090507) |
| Device Description | The ROI- A Oblique implant is intended for use as an interbody
fusion device in the lumbar spine. The device is manufactured
from medical grade PEEK OPTIMA® LT1 in accordance with
ASTM F2026 and has tantalum markers conforming to ASTM
F560 embedded in the implant extremities to facilitate visibility in
x-ray imaging. The subject device is designed for placement
using an anterolateral approach with an approximate offset angle
of 25° from the straight anterior axis. |
| Indications for Use: | When used as an intervertebral body fusion device, the ROI-A
Implant 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 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
supplemental fixation and with autograft to facilitate fusion. |
sheet 1 of 2
1
K110327
510(k) Summary of Safety and Effectiveness
LDR Spine ROI-A® Implant System
Non-Clinical Performance Data:
Testing was comprised of static shear compression, dynamic axial compression and dynamic bending (per ASTM F2077), expulsion (per ASTM F-04.25.02.02), wear debris analysis (per ASTM F1877), low cycle cadaver testing to evaluate clinical stability and device expulsion/pull-out, and high cycle cadaver testing to evaluate device loosening or migration, blade back-out and vertebral body damage. The results of this testing demonstrate that the performance of the LDR Spine ROI-A Oblique implant, when compared with its legally marketed predicate, is substantially equivalent.
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
SEP 30 2011
LDR Spine USA % Ms. Maritza Elias Regulatorv Affairs Project Manager 4030 West Braker Lane. Suite 360 Austin, Texas 78759
Re: K110327
Trade/Device Name: LDR ROI-A Implant System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: II Product Code: OVD Dated: August 31, 2011 Received: September 1, 2011
Dear Ms. Elias:
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 10 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. Insting 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
3
Page 2 – Ms. Maritza Elias
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 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 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 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.him 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.
Eunl Keith
- Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
KI10327
INDICATIONS FOR USE
510(k) Number (if known): K110327
LDR Spine USA ROI-A® Implant System Device Name:
Indications for Use:
When used as an intervertebral body fusion device, the ROI-A Implant 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 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 supplemental fixation and 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)
(Division Sign-Off)
sheet 1 of 1
Division of Surgical, Orthopedic, and Restorative Devices
KII0327 510(k) Number_