(120 days)
Not Found
Not Found
No
The summary describes a physical implant device for spinal fusion and vertebral body replacement. There is no mention of software, algorithms, or any technology that would typically incorporate AI/ML.
Yes.
The device is used for intervertebral body fusion and vertebral body replacement to treat degenerative disc disease, tumor, or trauma/fracture, which are therapeutic interventions.
No
The device is described as an interbody fusion device and a partial vertebral body replacement device, which are therapeutic and reconstructive functions, not diagnostic.
No
The device description clearly states it is comprised of "implants," which are physical hardware components intended for surgical implantation.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Description and Intended Use: The provided text clearly describes a surgical implant (intervertebral body fusion device and vertebral body replacement device) intended to be placed within the body to treat conditions of the spine. It does not involve the analysis of specimens taken from the body.
Therefore, based on the provided information, the ROI Interbody Fusion System is a surgical implant, not an In Vitro Diagnostic device.
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 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 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.
Product codes
MAX, MQP
Device Description
The ROI-A System is part of the ROI Interbody Fusion System family, and is comprised of various sizes and configurations of implants to accommodate individual patient anatomy. The ROI-A is intended to be used for interbody fusion of the lumbar spine, and is also indicated for use as a partial vertebral body replacement of the thoraco-lumbar spine.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Lumbar spine, L2 to S1. Thoracolumbar spine, 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)
Clinical performance data was not required to support this submission.
The results of non-clinical (laboratory) validation testing demonstrate that the proposed design changes provide reasonable assurance of safety and effectiveness.
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
JUN 2 5 2009
LDR Spine ROI Interbody Fusion System ROI-A Implant 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
February 24, 2009
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 ROI-A Implant System
DEVICE DESCRIPTION
The ROI-A System is part of the ROI Interbody Fusion System family, and is comprised of various sizes and configurations of implants to accommodate individual patient anatomy. The ROI-A is intended to be used for interbody fusion of the lumbar spine, and is also indicated for use as a partial vertebral body replacement of the thoraco-lumbar spine.
1
INDICATIONS:
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.
COMPARISON TO THE PREDICATE:
Minor design modifications were made to the Predicate ROI-A System, resulting in the Proposed device design. The Predicate and Proposed devices have the identical intended uses, indications, materials of manufacture, processing, packaging, and surgical technique.
PERFORMANCE DATA:
Clinical performance data was not required to support this submission.
The results of non-clinical (laboratory) validation testing demonstrate that the proposed design changes provide reasonable assurance of safety and effectiveness.
79
page 2 of 2
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with its wings spread, symbolizing protection and service. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", indicating the department's name and national affiliation.
Public Health Service
JUN 25 2009
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
LDR Spine USA % Noah Bartsch, M.S., R.A.C. 4030 W. Braker Lane, Suite 360 Austin, TX 78759
Re: K090507
Trade/Device Name: LDR Spine ROI Interbody Fusion System; ROI-A Implant System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX, MQP Dated: May 22, 2009 Received: May 26, 2009
Dear Mr. Bartsch:
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.
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 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.
3
Page 2 - Mr. Noah Bartsch, M.S., R.A.C.
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 (240) 276-3150 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Mark A. Milliken
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
8
INDICATIONS FOR USE
510(k) Number (if known):
Device Name: LDR Spine RQI Interbody Fusion System - ROI-A Implant System
Indications for Use:
When used as an intervertebral body fusion device, the RO! 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 supplemental fixation and with autograft to facilitate fusion.
When used as a vertebral body replacement device, The RO! 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 implants are intended to be implanted singularly (for ROI-A).
| Prescription Use | AND/OR | Over-The-Counter Use |
|---|---|---|
| X | ||
| (Part 21 CFR 801 Subpart D) | (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)
-バ (EXT for MXM) 6/24109
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number_ K090507