(38 days)
Not Found
No
The summary describes a physical implant and its mechanical properties, with no mention of software, algorithms, or AI/ML terms.
No.
The device is an implantable vertebral body replacement for structural support, which is often considered a structural device rather than a therapeutic one, as it primarily restores anatomical integrity rather than actively treating a condition.
No
The device description indicates it is an implant designed to replace a vertebral body surgically, not to diagnose a condition.
No
The device description clearly describes a physical implant (cylinder shaped blocks with teeth and an anchoring plate) intended for surgical implantation, not a software product.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the ROI-A Implant is used to replace a vertebral body in the spine. This is a surgical implant used directly in the body.
- Device Description: The description details a physical implant (cylinder-shaped blocks, anchoring plate) designed for surgical implantation.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, tissue, etc.) to provide information for diagnosis, monitoring, or treatment.
IVD devices are used in vitro (outside the body) to analyze samples. This device is used in vivo (inside the body) as a surgical implant.
N/A
Intended Use / Indications for Use
The ROI-A 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-A is intended to be implanted singularly. Supplemental internal fixation is required to properly utilize this system.
Product codes
MQP
Device Description
The ROI-A implants are cylinder shaped blocks in a variety of footprints, heights and lordosis angles.
The ROI-A implants feature a closed graft space. The inferior and superior surfaces of the devices have a pattern of teeth to provide increased stability and inhibit movement of the implants. An anchoring plate in two parts is associated to the device to further enhance its stability.
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)
Mechanical test results demonstrate that the proposed ROI-A Implant is substantially equivalent to the predicate device.
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.
0
K080572
Page 1 of 2
a pession for innovation
APR - 7 2008
510(k) Summary LDR Spine ROI-A Implant
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
Phone: (512) 344-3319 Fax: (512) 344-3350 Email: noahbartsch@ldrspine.com
3. Date 510(k) Summary Prepared: February 27, 2008
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- Trade Name: LDR Spine ROI-A Implant 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 ROI System (K043349) LDR Spine MC+ System (K043479)
6. Device Description
The ROI-A implants are cylinder shaped blocks in a variety of footprints, heights and lordosis angles.
The ROI-A implants feature a closed graft space. The inferior and superior surfaces of the devices have a pattern of teeth to provide increased stability and inhibit movement of the implants. An anchoring plate in two parts is associated to the device to further enhance its stability.
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K080572
Page 2 of 2
7. Intended Use of the device
The ROI-A 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-A is intended to be implanted singularly. Supplemental internal fixation is required to properly utilize this system.
8. Non-Clinical Performance Data
Mechanical test results demonstrate that the proposed ROI-A Implant is substantially equivalent to the predicate device.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular pattern around the symbol. The text is in all caps and is evenly spaced around the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR - 7 2008
LDR Spine USA, Incorporated c/o Mr. Noah Bartsch Manager of Clinical, Regulatory, and Quality Affairs 4030 West Braker Lane, Suite 360 Austin, TX 78759
Re: K080572
Trade/Device Name: ROI-A Partial Vertebral Body Replacement System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: MQP Dated: March 28, 2008 Received: March 31, 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.
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 (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.
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 H. Millman
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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K080572
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Indications for Use Statement
Page 1 of 1
1080592 510(k) Number (if known):
Device Name: LDR Spine ROI-A Implant
Indications for Use:
The ROI-A Implant 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-A is intended to be implanted singularly. Supplemental internal fixation is required to properly utilize this system.
Prescription Use × (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)
Nirl R.S. Qal firmen
Division of General, Restorative, and Neurological Devices
510(k) Number K080572