(76 days)
Not Found
No
The summary describes a physical implant (D-shaped blocks) for vertebral body replacement and mentions no software, algorithms, or data processing that would suggest AI/ML.
Yes
The device is described as a replacement for a vertebral body due to tumor or trauma/fracture in the thoracolumbar spine, which directly indicates a therapeutic purpose.
No
The provided text explicitly states that the ROI-C is intended for use to replace a vertebral body, functioning as a "partial vertebral body replacement." This describes a therapeutic, implantable device, not one used for diagnosis.
No
The device description clearly states that the ROI-C Implants are physical D-shaped blocks manufactured from radiolucent PEEK, indicating it is a hardware medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description and Intended Use: The provided text describes a surgical implant (a vertebral body replacement) used to physically replace a resected or excised vertebral body in the spine. It is a physical device implanted within the body, not a test performed on a sample outside the body.
The description clearly indicates a surgical implant for structural support, not a diagnostic test.
N/A
Intended Use / Indications for Use
The ROI-C is indicated for use to replace a vertebral body that has been resected or excised due to turnor 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. The ROI-C is intended to be implanted in pairs. Supplemental internal fixation is required to properly utilize this system.
Product codes (comma separated list FDA assigned to the subject device)
MQP
Device Description
The ROI-C Implants are D-shaped blocks in a variety of heights and length x width combinations. The ROI-C implants feature a closed graft space and the inferior and superior surface of the devices have a pattern of teeth to provide increased stability. The devices are manufactured from radiolucent PEEK, and are compatible with titanium anchors available for use with the ROI-C system.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
thoracolumbar spine (from T1 to L5)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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)
Results of the non-clinical analysis and verification activities indicate that the ROI-C system is substantially equivalent to the predicate device system.
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
§ 888.3060 Spinal intervertebral body fixation orthosis.
(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.
0
Image /page/0/Picture/1 description: The image shows the logo for "LDR" with the tagline "a passion for innovation" underneath. The logo consists of a stylized eye-like graphic to the left of the letters "LDR", which are in a bold, sans-serif font. The tagline is in a smaller, lighter font and is centered below the "LDR" letters.
MAY 2 9 2008
510(k) Summary
LDR Spine USA ROI-C Partial Vertebral Body Replacement System
1. Owner's Name & Address
LDR Spine USA 4030 West Braker Lane, Suite 360 Austin, TX 78759
Phone: | (512) 344-3333 |
---|---|
Fax: | (512) 344-3350 |
2. Contact Person
Noah Bartsch MS, RAC, Manager, Clinical, Regulatory & Quality Affairs LDR Spine USA 4030 West Braker Lane, Suite 360 Austin, TX 78759
(512) 344-3319 Phone: (512) 344-3350 Fax: noahbartsch@ldrspine.com Email:
3. Date 510(k) Summary Prepared
March 12, 2008
4. Trade Name | LDR Spine ROI-C System |
---|---|
Common Name | Spinal Partial Vertebral Body Replacement Device |
Classification | MQP |
Spinal Intervertebral Body Fixation Orthosis – Class II | |
per 888.3060 |
5. Legally Marketed Equivalent Predicate Device
LDR Spine MC+ Partial Vertebrai Body Replacement System (K043479)
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" in bold, black font. Below the logo, the text "a passion for innovation" is written in a smaller, lighter font. The logo appears to be for a company or organization that values innovation and has a focus on vision or insight, as suggested by the eye graphic.
6. Device Description
The ROI-C Implants are D-shaped blocks in a variety of heights and length x width combinations. The ROI-C implants feature a closed graft space and the inferior and superior surface of the devices have a pattern of teeth to provide increased stability. The devices are manufactured from radiolucent PEEK, and are compatible with titanium anchors available for use with the ROI-C system.
7. Intended Use of the device
The ROI-C is indicated for use to replace a vertebral body that has been resected or excised due to tumor or traumaffracture. 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. The ROI-C is intended to be implanted in pairs. Supplemental internal fixation is required to properly utilize this system.
8. Non-Clinical Performance Data
Results of the non-clinical analysis and verification activities indicate that the ROI-C system is substantially equivalent to the predicate device system.
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). The seal features a stylized eagle with its wings spread, symbolizing protection and service. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" is arranged in a circular pattern around the eagle, indicating the department's name and national affiliation.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
LSR Spine USA, Incoporated % Mr. Noah Bartsch Manager, Clinical, Regulatory & Quality Affairs 4030 West Braker Lane, Suite 360 Austin, Texas 78759
Re: K080728 Trade/Device Name: LDR Spine ROI-C Implant Regulation Number: 21 CFR §888.3060 Regulation Name: Spinal intervertebral body fixation orthosis. Regulatory Class: Class II Product Code: MQP Dated: May 2, 2008 Received: May 5, 2008
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.
MAY 2 9 2008
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark M. Mulhearn
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
K080728
Page 1 of 1
Indications for Use Statement
Page 1 of 1
510(k) Number (if known): K080728
Device Name: LDR Spine ROI-C Implant
Indications for Use:
The ROI-C is indicated for use to replace a vertebral body that has been resected or excised due to turnor 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. The ROI-C is intended to be implanted in pairs. Supplemental internal fixation is required to properly utilize this system.
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)
Neil R. Ogden for mkm
Division of Gener and Neurological Devices
510(k) Number K080728