(178 days)
OVD, MAX, MQP
Not Found
No
The summary describes a physical interbody fusion device and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The document states that the device is intended for intervertebral body fusion of the lumbar spine and for replacing a vertebral body resected due to tumor or trauma/fracture, which are therapeutic interventions.
No
This device is an intervertebral body fusion device and a vertebral body replacement device, used for treatment (fusion and replacement), not for diagnosing conditions.
No
The device description clearly indicates it is a system of implants, which are physical hardware components intended for surgical implantation.
Based on the provided text, 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 and Intended Use: The description clearly states that the ROI Interbody Fusion System is an implantable device used for spinal fusion and vertebral body replacement. It is a physical device surgically placed within the body.
- Lack of Mention of Biological Samples or Testing: The text does not mention any analysis of biological samples or any diagnostic testing performed outside of the body.
Therefore, the ROI 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
When used as an intervertebral body fusion device, the ROI Interbody Fusion System is indicated for intervertebral body fusion of the lumbar spine, from L2 to St, 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 discodisease (DDD) with up to Grade I spandyklisthesis: DDD is defined es back pain of discogenic origin with degeneration of the disc confirmed by history and rediographic studies. The device system is designed for use with supplemental fixation and with autograft to facilitate fusion.
When used as a vertebral body replacement device, The ROI System of implants is indicated for use to replace a vertebral body that has been resected or excised due to turnor of trauma/fracture: The device is intended for use as a partial vertebral body: replacement in the thoracolumbar spine (from 74 to 15) and is intended for use with supplemental internal fixation. Supplemental internal fixation is required to properly utilize this system. These devices are intended to be used with autograft or allograft bane.
Product codes
OVD, MAX, MQP
Device Description
The proposed ROI: Interbody Fusion System will be offered in two: (2) configurations of various sizes. The configurations are designed based on surgical approach, and consist of: 1) ROI-T, transforaminal approach and-2) ROI-A, antentor approach.
The ROI-A implants are intended to be implanted singularly while the ROF-T implantsmay be implanted singularly or in pairs.
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. Thoracolumbar spine (from T1 to L5).
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)
Mechanicalittest results demonstrate that the proposed RQI: Interbody Fusion System is substantially equivalent to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
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
K82a262
ea
FEB -2 2009
LDR Spine ROI Interbody Fusion System
510(k) Summary of Safety and Effectiveness
| SUBMITTED BY | LDR Spine USA
4030 W. Braker Lane, Suite 360
Austin, TX 78759 |
|-----------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|
| FOREIGN ESTABLISHMENT
REGISTRATION NUMBER | 3004788213 |
| US AGENT ESTABLISHMENT
REGISTRATION NUMBER | 3004903783 |
| CONTACT PERSON | Noah Bartsch
Manager, Clinical, Regulatory and Quality Affairs
Phone: 512-344-3319
Fax: 512-344-3350 |
| DATE PREPARED | December 2, 2008 |
| CLASSIFICATION NAME | MAX 888.3080- Intervertebral Fusion Device with
Bone Graft, Lumbar
MQP 888.3060 - Spinal Intervertebral Body Fixation
Orthosis |
| COMMON NAME | Intervertebral Body Fusion Device (MAX)
Spinal Vertebral Body Replacement Device (MQP) |
| PROPRIETARY NAME | LDR Spine ROI Interbody Fusion System |
DEVICE DESCRIPTION
The proposed ROI: Interbody Fusion System will be offered in two: (2) configurations of various sizes. The configurations are designed based on surgical approach, and consist of: 1) ROI-T, transforaminal approach and-2) ROI-A, antentor approach.
INDICATIONS:
When used as an intervertebral body fusion device, the ROI Interbody Fusion System is indicated for intervertebral body fusion of the tumbar spine, from 1,2 to St, 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 discodisease (DDD) with up to Grade I spandyklisthesis: DDD is defined es back pain of discogenic origin with degeneration of the disc confirmed by history and rediographic studies. The device system is designed for use with supplemental fixation and with autograft to facilitate fusion.
1
When used as a vertebral body replacement device, The ROI System of implants is indicated for use to replace a vertebral body that has been resected or excised due to turnor of trauma/fracture: The device is intended for use as a partial vertebral body: replacement in the thoracolumbar spine (from 74 to 15) and is intended for use with supplemental internal fixation. Supplemental internal fixation is required to properly utilize this system. These devices are intended to be used with autograft or allograft bane.
The ROI-A implants are intended to be implanted singularly while the ROF-T implantsmay be implanted singularly or in pairs.
MECHANICAL TEST DATA
.
.
Mechanicalitest results demonstrate that the proposed RQI: Interbody Fusion System is substantially equivalent to the predicate device ..
. ਕੁਹ
2
Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the bird symbol. The text is in all caps and appears to be in a sans-serif font.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
SEP 12 2011
LDR Spine USA % Mr. Noah Bartsch Manager, Clinical, Regulatory and Quality Affairs 4030 W. Braker Lane, Suite 360 Austin, Texas 78759
Re: K082262
Trade/Device Name: LDR Spine ROI Interbody Fusion System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: OVD, MAX, MQP Dated: December 2, 2008 Received: December 4, 2008
Dear Mr. Bartsch:
This letter corrects our substantially equivalent letter of February 2, 2009.
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 (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.
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
3
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 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.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,
Mark N. Mulkern
Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE
510(k) Number (if known): K082262
Device Name:
LDR Spine RO! Interbody Fusion System
Indications for Use:
When used as an intervertebral body fusion device, the ROI Interbody Fusion System is indicated for intervertebral body fusion of the lumbar spine, from L2 to SI, 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 supplemental fixation and with autograft to facilitate fusion.
When used as a vertebral body replacement device, The ROI System of implants is indicated for use to replace a vertebral body that has been resected or excised due to tumor or trauma/fracture. The device is intended for use as a partial vertebral body replacement in the thoracolumbar spine (from T1 to L5) and is intended for use with supplemental internal fixation. Supplemental internal fixation is required to properly utilize this system. These devices are intended to be used with autograft or allograft bone.
The ROI-A implants are intended to be implanted singularly while the ROI-T implants may be implanted singularly or in pairs.
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
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(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 General, Restorative, | |
| and Neurological Devices | |
| 510(k) Number | K082262 |