(50 days)
No
The summary describes a physical implant (D-shaped blocks) for vertebral body replacement and does not mention any software, algorithms, or data processing that would suggest AI/ML.
Yes
The device is intended to replace a vertebral body due to tumor or trauma/fracture, which is a therapeutic intervention.
No
The device description and intended use indicate it is a surgical implant designed to replace part of a vertebral body, not to diagnose a condition.
No
The device description clearly states it is a physical implant (D-shaped blocks manufactured from radiolucent PEEK) intended for surgical implantation, not a software application.
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 clearly describes a surgical implant designed to replace a 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 device described is a surgical implant used for structural support in the spine.
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 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. The ROI-C is intended to be implanted in pairs. Supplemental internal fixation is required to properly utilize this system.
Product codes
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 patter n of teeth to provide increased stability. The devices are manufactured from radiolucent PEEK, and are compatible with titanium anchor plates available for use with the ROI-C system.
The purpose of this submission is to obtain clearance for a modified design of the ROI-C implants.
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
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)
Results of the non-clinical analysis and verification activities indicate that the proposed ROI-C system is substantially equivalent to the predicate device system.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
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K083857
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FEB 1 2 2009
Image /page/0/Picture/2 description: The image shows the logo for LDR, which includes a stylized eye graphic to the left of the letters "LDR". Below the letters, the text "a passion for innovation" is written in a smaller font. The logo appears to be for a company or organization that values innovation.
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
(512) 344-3333 Phone: 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: Fax: (512) 344-3350 noahbartsch@ldrspine.com Email:
3. Date 510(k) Summary Prepared
December 23, 2008
LDR Spine ROI-C System 4. Trade Name Spinal Partial Vertebral Body Replacement Device Common Name Classification MQP Spinal Intervertebral Body Fixation Orthosis - Class II per 888.3060
5. Legally Marketed Equivalent Predicate Device
LDR Spine ROI-C Partial Vertebral Body Replacement System (K080728) LDR Spine MC+ Partial Vertebral Body Replacement System (K043479)
1
Image /page/1/Picture/1 description: The image shows a logo with an abstract graphic on the left and the letters "LDR" on the right. The graphic on the left appears to be a stylized eye or a circular shape with an opening. The letters "LDR" are in a bold, sans-serif font and are connected to the graphic on the left. The logo has a textured appearance, possibly due to the image being a scan or a low-resolution file.
a passion for innovation
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 patter n of teeth to provide increased stability. The devices are manufactured from radiolucent PEEK, and are compatible with titanium anchor plates available for use with the ROI-C system.
The purpose of this submission is to obtain clearance for a modified design of the ROI-C implants.
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 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.
8. Non-Clinical Performance Data
Results of the non-clinical analysis and verification activities indicate that the proposed 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) of the United States. The seal features a stylized eagle with its wings spread, clutching a caduceus, a symbol of medicine, in its talons. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Public Health Service
LDR Spine USA % Mr. Noah Bartsch, MS. RAC Manager, Clinical, Regulatory & Quality Affairs 4030 West Braker Lane, Suite 360 Austin, Texas 78759
FEB 1 2 2009
Re: K083857
Trade/Device Name: LDR Spine ROI-C Implant Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: MQP Dated: January 23, 2009 Received: January 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 such additional controls. Existing major regulations affecting your device cans 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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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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 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 A. Melkerson
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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K083857
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g
Indications for Use Statement
Page 1 of 1
510(k) Number (if known):
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 tumor or traumalfracture. 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 AND/OR × (Part 21 CFR 801 Subpart D)
OR O
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)
Mark A. Milliken
(Division Sign-Off) Division of General, Restorative, and Neurological Devices 1
510(k) Number