(13 days)
The NUBIC™ Spinal 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 vertebral body replacement in the thoracolumbar spine (from T1 to LS) and is intended for use with supplemental internal fixation.
The NUBIC™ may be implanted singularly or in pairs.
The supplemental internal fixation systems that may be used with the NUBIC™ Spinal Implant include, but are not limited to, SIGNUS CONKLUSION System, DePuy AcroMed titanium plate or rod systems (Kaneda SR, University Plate, M2, ISOLA, VSP, Moss, TiMX, and Profile).
Not Found
The provided text does not contain information about acceptance criteria, device performance metrics, or study details such as sample sizes, ground truth establishment, expert qualifications, or comparative effectiveness studies.
The document is a 510(k) premarket notification letter from the FDA to Signus Medical, LLC. for the NUBIC™ Spinal Implant. It states that the device is substantially equivalent to a predicate device based on similarities in functional design, indication for use, principles of operation, materials, and performance characteristics.
The letter explicitly mentions:
- Device Name: NUBIC™ Spinal Implant
- Regulation Number: 21 CFR 888.3060 (Spinal intervertebral body fixation orthosis)
- Regulatory Class: II
- Product Code: MQP
- Indications for Use: To replace a vertebral body resected or excised due to tumor or trauma/fracture in the thoracolumbar spine (T1-L5), used with supplemental internal fixation.
- Predicate Device: RABEA™ cleared under K043316.
- Basis for Substantial Equivalence: Similarities in functional design, indication for use, principles of operation, materials, and performance characteristics. It also states the NUBIC™ is "Implanted using the same surgical techniques and equipment; Used in conjunction with the same types of supplemental internal fixation systems; The same manufacturing environment; The same sterilization process; and The same packaging configurations."
However, it does not include:
- A table of acceptance criteria and reported device performance.
- Sample sizes used for test sets or data provenance.
- Number of experts or their qualifications for ground truth.
- Adjudication method for the test set.
- Multi-Reader Multi-Case (MRMC) comparative effectiveness study details.
- Standalone (algorithm only) performance study details.
- Type of ground truth used (e.g., expert consensus, pathology, outcomes data).
- Sample size for the training set.
- How the ground truth for the training set was established.
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AUG 2 5 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Signus Medical, LLC. c/o Ms. Tracy Gray Principal Consultant Alquest, Inc. 4050 Olson Memorial Highway, Suite 350 Minneapolis, Minnesota 55422
Re: K052096
Trade/Device Name: NUBIC™ Spinal Implant Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: MQP Dated: July 29, 2005 Received: August 4, 2005
Dear Ms. Gray:
This letter corrects our substantially equivalent letter of August 16, 2005. The Company title has been changed to reflect the correct owner of the 510(k), Signus Medical. LLC., as indicated in your 510(k) submission.
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.
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Page 2 - Ms. Tracy Gray
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.
This letter will allow you to continue 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 Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark N. Melkerson
Acting Director Division of General, Restorative, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use Page
510(k) Number (if known):
Device Name: NUBIC™ Spinal Implant
Indications for Use:
The NUBIC™ Spinal 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 vertebral body replacement in the thoracolumbar spine (from T1 to LS) and is intended for use with supplemental internal fixation.
GS2046
The NUBIC™ may be implanted singularly or in pairs.
The supplemental internal fixation systems that may be used with the NUBIC™ Spinal Implant include, but are not limited to, SIGNUS CONKLUSION System, DePuy AcroMed titanium plate or rod systems (Kaneda SR, University Plate, M2, ISOLA, VSP, Moss, TiMX, and Profile).
Prescription Use X (Per 21 CFR 801 Subpart D) AND/OR
Over-the-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General, Restorative, and Neurological Devices
| SIGNUS Medical LLC. 510(k) Number | K052096 |
|---|---|
| NUBIC TM Special 510(k) | Appendix B Page 2 |
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510(k) Summary
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| Implanted using the same surgical techniques and equipment; Used in conjunction with the same types of supplemental internal fixation systems; The same manufacturing environment; The same sterilization process; and The same packaging configurations. In summary, the NUBICTM, as described in this submission is, in the opinion of Signus Medical, LLC., substantially equivalent to the predicate device. | |
|---|---|
| Conclusion: | The NUBICTM as modified in this submission, is substantially equivalent to the predicate device, RABEATM cleared under K043316. This conclusion is based upon the similarities of the devices in terms of functional design, indication for use, principles of operation, materials, and performance characteristics. |
§ 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.