(349 days)
Not Found
No
The device description focuses on the mechanical components of a spinal system (screws, rods, hooks) and their material composition. There is no mention of software, algorithms, image processing, or terms related to AI/ML.
Yes
The device is described as "intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion in the treatment of instabilities or deformities," which are therapeutic actions.
No
This device is described as a "Spinal System" intended to provide "immobilization and stabilization of spinal segments" and is composed of "pedicle screws, rigid rods and crosslink members, semi-rigid rods and hooks." These are orthopedic implants used for treatment, not for diagnosing conditions.
No
The device description explicitly states it consists of physical components like pedicle screws, rods, and hooks, which are hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant designed to provide immobilization and stabilization of spinal segments. This is a therapeutic device used in vivo (within the body), not a diagnostic device used in vitro (outside the body) to examine specimens like blood or tissue.
- Device Description: The device description details physical components like pedicle screws, rods, and hooks, all of which are surgical implants.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any other typical components or processes associated with in vitro diagnostics.
Therefore, the ISOBAR Spinal System is a surgical implant, not an IVD.
N/A
Intended Use / Indications for Use
The ISOBAR Spinal System is 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 thoracic, lumbar, and sacral degenerative spondylolisthesis with objective evidence of neurological spine: impairment; fracture; dislocation; scoliosis; spinal tumor; and failed previous fusion.
As a pedicle screw system, the ISOBAR Spinal System is intended for the treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebrae in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of solid fusion.
The Semi-Rigid Rod and Dual Dampener Rod should only be used at levels (one and two levels, respectively) that will be fused.
Product codes (comma separated list FDA assigned to the subject device)
KWP, MNH, MNI, NOP
Device Description
The ISOBAR Spinal System consists of pedicle screws, rigid rods and crosslink members (K990118, K013444, K020245, K031290 and K051063), semi-rigid rods (K991326) and hooks (K013440 & 013447). The Isobar Semi-rigid Dual Dampener Rod is an addition to the ISOBAR Spinal System family. The semi-rigid rod allows a very small amount of compression, torsion and bending. The components in this submission are fabricated from Ti6A14V alloy, conforming to ASTM F136 and ISO 5832-3, which is known to be biocompatible.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
thoracic, lumbar, and sacral spine, L5-S1 vertebrae, L3 to sacrum
Indicated Patient Age Range
skeletally mature patients
Intended User / Care Setting
Prescription Use
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)
Testing performed indicates the ISOBAR Spinal System is substantially equivalent to predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
Not Found
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.
K990118, K013444, K020245, K031290, K051063, K991326, K013440 & 013447
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).
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.
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510(k) Summary
APR 1 7 2008
| Contact: | John Sanders
Scient'x USA, Inc.
1015 Maitland Center Commons, Suite 106A
Maitland, FL 32751
407.571.2550 |
|--------------------|----------------------------------------------------------------------------------------------------------------------|
| Device Trade Name: | ISOBAR Spinal System |
| Manufacturer: | Scient'x
Batiment Calypso Parc Ariane 3
78284 Guyancourt, France |
| Classification: | 21 CFR §888.3070; Pedicle screw spinal system
21 CFR §888.3050; Spinal interlaminal fixation orthosis |
| Class: | II |
| Product Code: | KWP, MNH, MNI, NOP |
Indications For Use:
The ISOBAR Spinal System is 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 thoracic, lumbar, and sacral degenerative spondylolisthesis with objective evidence of neurological spine: impairment; fracture; dislocation; scoliosis; spinal tumor; and failed previous fusion.
As a pedicle screw system, the ISOBAR Spinal System is intended for the treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebrae in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of solid fusion.
The Semi-Rigid Rod and Dual Dampener Rod should only be used at levels (one and two levels, respectively) that will be fused.
Device Description:
The ISOBAR Spinal System consists of pedicle screws, rigid rods and crosslink members (K990118, K013444, K020245, K031290 and K051063), semi-rigid rods (K991326) and hooks (K013440 & 013447). The Isobar Semi-rigid Dual Dampener Rod is an addition to the ISOBAR Spinal System family. The semi-rigid rod allows a very small amount of compression, torsion and bending. The components in this submission are fabricated
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Page 2 of 2
from Ti6A14V alloy, conforming to ASTM F136 and ISO 5832-3, which is known to be biocompatible.
Predicate Device(s):
The ISOBAR Spinal System was shown to be substantially equivalent to previously cleared devices and has the same indications for use, design, function, and materials.
Performance Standards:
Testing performed indicates the ISOBAR Spinal System is substantially equivalent to predicate devices.
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 eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the eagle. The eagle is depicted in a simple, black and white design.
APR 17 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Scient'x USA, Inc. % Mr. John Sanders Quality Assurance Regulatory Affairs Manager 1015 Maitland Center Commons Suite 106A Maitland, FL 32751
Re: K071261 Trade/Device Name: ISOBAR Spinal System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: II Product Code: NQP, MNI, MNH, KWP Dated: April 4, 2008 Received: April 7, 2008
Dear Mr. Sanders:
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). You may, therefore, market the device, subject to the general controls provisions of the Act and the limitations described below. 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.
The Office of Device Evaluation has determined that there is a reasonable likelihood that this device will be used for an intended use not identified in the proposed labeling and that such use could cause harm. Therefore, in accordance with Section 513(i)(1)(E) of the Act, the following limitation must appear in the Warnings section of the device's labeling:
The safety and effectiveness of this device for the indication of spinal stabilization without fusion have not been established.
Please note that the above labeling limitations are required by Section 513(i)(1)(E) of the Act. Therefore, a new 510(k) is required before these limitations are modified in any way or removed from the device's labeling.
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Page 2- Mr. John Sanders
The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and permits your device to proceed to the market. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification if the limitation statement described above is added to your labeling.
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.
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.
If you desire specific information about the application of other labeling requirements to your device (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" (21 CFR 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 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.
NocetM
Donna-Bea Tillman, Ph.D., M.P.A. Director Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
K071261
Indications for Use
510(k) Number (if known): K071261
Device Name: ISOBAR Spinal System
Indications for Use: The ISOBAR Spinal System is 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 thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment; fracture; dislocation; scoliosis; spinal tumor; and failed previous fusion.
As a pedicle screw system, the ISOBAR Spinal System is intended for the treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebrae in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of solid fusion.
The Semi-Rigid Rod and Dual Dampener Rod should only be used at levels (one and two levels, respectively) that will be fused.
Prescription Use イ (Part 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 OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Neil R.P. Oglsb for mxn
Division of General, Restorative. and Neurological Devices
510(k) Number K071261