(154 days)
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No
The provided text describes a mechanical spinal implant system and its intended uses. There is no mention of AI or ML technology in the device description, intended use, or any other section.
Yes
The ORIA Spinal Clip System is indicated for treating various spinal conditions like degenerative disc disease, spondylolisthesis, fractures, and deformities, aiming to provide immobilization and stabilization as an adjunct to fusion surgery. These applications clearly align with the definition of a therapeutic device designed to treat or alleviate a medical condition.
No
The ORIA Spinal Clip System is described as an implant system used during spinal fusion surgery to immobilize and stabilize spinal segments. It is a treatment device, not a diagnostic one.
No
The device description explicitly lists physical components such as hooks, screws, rods, connectors, instruments, and sterilizer trays, which are hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections.
- Device Description: The ORIA Spinal Clip System is described as a system of components (hooks, screws, rods, etc.) that are implanted during spinal fusion surgery. These are physical implants used to stabilize the spine.
- Intended Use: The intended use clearly states that the system is used for immobilization and stabilization of spinal segments as an adjunct to fusion in the treatment of various spinal conditions. This is a surgical intervention, not a diagnostic test performed on a sample.
The device is a surgical implant, not a diagnostic tool.
N/A
Intended Use / Indications for Use
When used as a nonpedicle, noncervical posterior system, the ORIA Spinal Clip System is indicated for: (1) degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); (2) spondylolisthesis; (3) fracture; (4) spinal stenosis; (5) deformities (i.e., scoliosis, kyphosis, lordosis), (5) tumor, (6) pseudarthrosis, (7) tumor resection, and/or (8) failed previous fusion.
ORIA Spinal Clip System is indicated for skeletally mature patients: (1) having severe spondylolisthesis (Grades 3 and 4) at L5-S1 joint; (2) who are receiving fusions using autogenous bone graft only; (3) who are having the device fixed or attached to the lumbar and sacral spine (L3 and below); and (4) who are having the device removed after the development of solid fusion mass.
When used as a pedicle screw system in the non-cervical spine of skeletally mature patients, the ORIA Spinal Clip System is indicated for immobilization and stabilization of spinal segments as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: (1) degenerative spondylolisthesis with objective evidence of neurological impairment, (2) fracture, (3) dislocation, (4) scoliosis, (5) kyphosis, (6) spinal tumor, and (7) failed previous fusion (pseudarthrosis).
Product codes (comma separated list FDA assigned to the subject device)
KWP, MNH, MNI
Device Description
The ORIA Spinal Clip System includes components that fit together to form a construct for use during spinal fusion surgery. The system contains components of various designs and sizes that allow the surgeon to build an implant system for each of four defined indications and to fit the patient's anatomical and physiological requirements. The components include: Lumbar, thoracic, and pedicular hooks; Sacral screws; Pedicle screws; Set screws; Locking nuts; Rods in various lengths; Connectors with set screws (sacral, transverse, lateral); Connecting elements; Instruments and Sterilizer trays.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Spinal, L5-S1 joint, lumbar and sacral spine (L3 and below), non-cervical spine, thoracic, lumbar, and sacral spine.
Indicated Patient Age Range
Skeletally mature patients
Intended User / Care Setting
Surgeon, clinical setting
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Documentation was provided which demonstrated the ORIA Spinal Clip System Lateral Intermediate Connector (AL01) to be substantially equivalent to a previously cleared device. The substantial equivalence is based upon equivalence in indications for use, anatomic sites, design, material of manufacture, and function.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
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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).
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§ 888.3050 Spinal interlaminal fixation orthosis.
(a)
Identification. A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.(b)
Classification. Class II.
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K031471
page 1 of 1
510(k) SUMMARY
| Sponsor: | Eurosurgical, SA
B.P.23-18 rue Robespierre
Beaurains, France 62217
Phone: 33-3-2121 5960, Fax: 33-3-2121 5970 |
|-----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact
Person: | Emmanuel Margerit, Regulatory Affairs and Quality Manager |
| Proprietary
Trade Name: | ORIA Spinal Clip System |
| Device
Description: | The ORIA Spinal Clip System includes components that fit together to form a
construct for use during spinal fusion surgery. The system contains components
of various designs and sizes that allow the surgeon to build an implant system for
each of four defined indications and to fit the patient's anatomical and
physiological requirements. The components include: Lumbar, thoracic, and
pedicular hooks; Sacral screws; Pedicle screws; Set screws; Locking nuts; Rods
in various lengths; Connectors with set screws (sacral, transverse, lateral);
Connecting elements; Instruments and Sterilizer trays. |
| Intended Use: | When used as a nonpedicle, noncervical posterior system, the ORIA Spinal Clip
System is indicated for: (1) degenerative disc disease (defined as back pain of
discogenic origin with degeneration of the disc confirmed by history and
radiographic studies); (2) spondylolisthesis; (3) fracture; (4) spinal stenosis; (5)
deformities (i.e., scoliosis, kyphosis, lordosis), (5) tumor, (6) pseudarthrosis, (7)
tumor resection, and/or (8) failed previous fusion. |
| | ORIA Spinal Clip System is indicated for skeletally mature patients: (1) having
severe spondylolisthesis (Grades 3 and 4) at L5-S1 joint; (2) who are receiving
fusions using autogenous bone graft only; (3) who are having the device fixed or
attached to the lumbar and sacral spine (L3 and below); and (4) who are having
the device removed after the development of solid fusion mass. |
| | When used as a pedicle screw system in the non-cervical spine of skeletally
mature patients, the ORIA Spinal Clip System is indicated for immobilization and
stabilization of spinal segments as an adjunct to fusion in the treatment of the
following acute and chronic instabilities or deformities of the thoracic, lumbar,
and sacral spine: (1) degenerative spondylolisthesis with objective evidence of
neurological impairment, (2) fracture, (3) dislocation, (4) scoliosis, (5) kyphosis,
(6) spinal tumor, and (7) failed previous fusion (pseudarthrosis). |
| Materials: | The ORIA Spinal Clip System Lateral Intermediate Connector (AL01) is
manufactured from titanium and stainless steel. |
| Substantial
Equivalence: | Documentation was provided which demonstrated the ORIA Spinal Clip
System Lateral Intermediate Connector (AL01) to be substantially equivalent
to a previously cleared device. The substantial equivalence is based upon
equivalence in indications for use, anatomic sites, design, material of
manufacture, and function. |
1
Image /page/1/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 features three abstract human figures. The figures are arranged in a way that suggests movement or progress. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 1 0 2003
Eurosurgical, SA c/o Ms. Karen E. Warden Reo Spine Line 7000 Hampton Center, Suite G1 Morgantown, WV 26505
Re: K031471
Trade/Device Name: Oria Spinal Clip System Regulation Number: 21 CFR 888.3050, 888.3070, Regulation Name: Spinal interlaminal fixation orthosis, Pedicle screw spinal system Regulatory Class: II Product Code: KWP, MNH, MNI Dated: 8/20/2003 Received: 8/22/2003
Dear Ms. Warden:
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 (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.
2
Page 2 - Ms. Karen E. Warden
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 Office of Compliance at (301) 594- 4659. 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/dsma/dsmamain.html
Sincerely yours,
Mark N Muller
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use Statement
510(k) Number (if known):
Device Name: ORIA Spinal Clip System
Indications for Use:
When used as a nonpedicle, noncervical posterior system, the ORIA Spinal Clip System is indicated for: (1) degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); (2) spondylolisthesis; (3) fracture; (4) spinal stenosis; (5) deformities (i.e., scoliosis, kyphosis, lordosis), (5) tumor, (6) pseudarthrosis, (7) tumor resection, and/or (8) failed previous fusion.
ORIA Spinal Clip System is indicated for skeletally mature patients: (1) having severe spondylolisthesis (Grades 3 and 4) at L5-S1 joint; (2) who are receiving fusions using autogenous bone graft only; (3) who are having the device fixed or attached to the lumbar and sacral spine (L3 and below); and (4) who are having the device removed after the development of solid fusion mass.
When used as a pedicle screw system in the non-cervical spine of skeletally mature patients, the ORIA Spinal Clip System is indicated for immobilization and stabilization of spinal segments as an adjunct to fusion in the treatment of the following acute and chronic instabilities of the thoracic, lumbar, and sacral spine: (1) degenerative spondylolisthesis with objective evidence of neurological impairment, (2) fracture, (3) dislocation, (4) scoliosis, (5) kyphosis, (6) spinal tumor, and (7) failed previous fusion (pseudarthrosis).
R. Mark N. Millman
1, Restorative
510(k) Number K031471
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109) OR
Over-the-Counter Use
Confidential: ORIA SPINAL CLIP SYSTEM