(29 days)
Not Found
Not Found
No
The provided text describes a mechanical spinal implant system and does not mention any software, algorithms, or data processing capabilities that would indicate the use of AI or ML.
Yes.
The device is used for immobilization and stabilization of spinal segments as an adjunct to fusion for a variety of acute and chronic instabilities or deformities, which is a therapeutic purpose.
No
The "Intended Use / Indications for Use" section describes the device as a system for immobilization and stabilization of spinal segments as an adjunct to fusion, treating conditions like spondylolisthesis, fracture, and scoliosis. This indicates a therapeutic or surgical purpose, not a diagnostic one.
No
The device description explicitly states that the ORIA Top Clip System includes physical components made from titanium, such as pedicle screws, set screws, top locking clips, and rods. This indicates it is a hardware-based medical device, not software-only.
Based on the provided information, 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, or tissue) to provide information about a person's health.
- Device Description and Intended Use: The description and intended use clearly indicate that the ORIA Top Clip System is a surgical implant used for spinal fusion and stabilization. It is a physical device implanted into the body, not a test performed on a sample outside the body.
The information provided describes a surgical implant for orthopedic use, not a diagnostic test.
N/A
Intended Use / Indications for Use
ORIA Top 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 Top 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
MNH, MNI
Device Description
The ORIA Top Clip System includes components made from commercially pure titanium and titanium alloy described by ASTM Standards F67 GR2 and ASTM F136, respectively. These components are available in various designs and sizes that allow the surgeon to build an implant construct suited to a patient's anatomical and physiological requirements. The components include: pedicle screws, set screws, top locking clips and rods.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
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
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3070 Thoracolumbosacral pedicle screw system.
(a)
Identification. (1) Rigid pedicle screw systems are comprised of multiple components, made from a variety of materials that allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. Such a spinal implant assembly consists of a combination of screws, longitudinal members (e.g., plates, rods including dual diameter rods, plate/rod combinations), transverse or cross connectors, and interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors).(2) Semi-rigid systems are defined as systems that contain one or more of the following features (including but not limited to): Non-uniform longitudinal elements, or features that allow more motion or flexibility compared to rigid systems.
(b)
Classification. (1) Class II (special controls), when intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). These pedicle screw spinal systems must comply with the following special controls:(i) Compliance with material standards;
(ii) Compliance with mechanical testing standards;
(iii) Compliance with biocompatibility standards; and
(iv) Labeling that contains these two statements in addition to other appropriate labeling information:
“Warning: The safety and effectiveness of pedicle screw spinal systems have been established only for spinal conditions with significant mechanical instability or deformity requiring fusion with instrumentation. These conditions are significant mechanical instability or deformity of the thoracic, lumbar, and sacral spine secondary to severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra, degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). The safety and effectiveness of these devices for any other conditions are unknown.”
“Precaution: The implantation of pedicle screw spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this pedicle screw spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient.”
(2) Class II (special controls), when a rigid pedicle screw system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion in the treatment of degenerative disc disease and spondylolisthesis other than either severe spondylolisthesis (grades 3 and 4) at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment. These pedicle screw systems must comply with the following special controls:
(i) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use.
(ii) Non-clinical performance testing must demonstrate the mechanical function and durability of the implant.
(iii) Device components must be demonstrated to be biocompatible.
(iv) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments.
(v) Labeling must include the following:
(A) A clear description of the technological features of the device including identification of device materials and the principles of device operation;
(B) Intended use and indications for use, including levels of fixation;
(C) Identification of magnetic resonance (MR) compatibility status;
(D) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user; and
(E) Detailed instructions of each surgical step, including device removal.
(3) Class II (special controls), when a semi-rigid system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion for any indication. In addition to complying with the special controls in paragraphs (b)(2)(i) through (v) of this section, these pedicle screw systems must comply with the following special controls:
(i) Demonstration that clinical performance characteristics of the device support the intended use of the product, including assessment of fusion compared to a clinically acceptable fusion rate.
(ii) Semi-rigid systems marketed prior to the effective date of this reclassification must submit an amendment to their previously cleared premarket notification (510(k)) demonstrating compliance with the special controls in paragraphs (b)(2)(i) through (v) and paragraph (b)(3)(i) of this section.
0
· Attachment VII: 510(k) Summary
K040346
page 1 of 1
| Sponsor: | Eurosurgical, SA
B.P.23-18, rue Robespierre
Beaurains, France 62217
Phone: 33-3-21215960, Fax: 33-3-21215970 |
|-----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Official Contact
Person: | Emmanuel Margerit, Regulatory Affairs and Quality Manager |
| Proprietary Trade
Name: | ORIA Top Clip System |
| Device
Description: | The ORIA Top Clip System includes components made from commercially pure
titanium and titanium alloy described by ASTM Standards F67 GR2 and ASTM
F136, respectively. These components are available in various designs and sizes that
allow the surgeon to build an implant construct suited to a patient's anatomical and
physiological requirements. The components include: pedicle screws, set screws, top
locking clips and rods. |
| Intended Use: | ORIA Top 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 Top 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 Top Clip System components are manufactured from implant grade
materials of pure commercial titanium and titanium alloy described by ASTM
Standards F67 GR2 and ASTM F136, respectively. |
| Substantial
Equivalence: | Documentation was provided which demonstrated the ORIA Top Clip System to be
substantially equivalent to a previously cleared system. The substantial equivalence
is based upon equivalence in fundamental scientific technology (manufacturing,
attachment configuration, basic design and materials) and indications/intended use. |
1
Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an image of an eagle with three lines representing its wings.
MAR 1 2 2004
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Eurosurgical, SA C/o Ms. Karen E. Warden, MEBE REO Spine Line 7000 Hampton Center, Suite G1 Morgantown, West Virginia 26505
Re: K040346
Trade/Device Name: ORIA Top Clip System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: II Product Code: MNH, MNI Dated: February 11, 2004 Received: February 12, 2004
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 complics 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 - o Ms. Karen E. Warden, MEBE
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 vours.
Sincerey, yours,
Mark A. Mellema
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
Attachment II: Indications for Use Statement
510(k) Number (if known): Kod 03d
Device Name: ORIA Top Clip System
Indications for Use:
ORIA Top Clip System is indicated for skelctally 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 (1,3 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 OR1A Top 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).
Mark N. Melkerso
(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)
ાર
Over-the-Counter Use_