(20 days)
No
The document describes a mechanical spinal implant system and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The device is described as an ISOBAR Spinal System used for immobilization and stabilization of spinal segments, as well as for the treatment of conditions like degenerative disc disease, spondylolisthesis, and fractures, which indicates a therapeutic purpose.
No
The device is described as an implantable spinal system designed to provide immobilization and stabilization of spinal segments as an adjunct to fusion, treating various spinal conditions. Its function is mechanical support and stabilization, not the identification or diagnosis of a disease.
No
The device description explicitly states it consists of physical components made of titanium alloy, such as screws, rods, nuts, hooks, and a transverse connection. It is a hardware-based spinal implant system.
Based on the provided text, 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 clearly states that the EASYS Transverse Connection and the ISOBAR Spinal System are implants used for spinal fixation and stabilization. They are surgically implanted devices, not devices used to analyze samples outside the body.
- Lack of IVD Language: The text does not mention any testing of biological samples, analysis of bodily fluids, or diagnostic purposes related to identifying diseases or conditions through laboratory tests.
The device is a surgical implant used to treat structural issues in the spine.
N/A
Intended Use / Indications for Use
The EASYS Transverse Connection used with the ISOBAR Spinal System is intended for posterior, nonpedicle screw fixation of the noncervical spine/hook and sacral/iliac screw fixation to the noncervical spine/hook and sacral screw fixation to the T1-S1 spine. Indications for use include: - degenerative disc disease (ddd) defined as back pain of discogenic origin with degeneration of the disc ● confirmed by history and radiographic studies - . spondylolisthesis - trauma (i.e., fracture or dislocation) ● - spinal stenosis - deformitics or curvatures (i.e., scoliosis, kyphosis, and/or lordosis) ● - tumor - . pscudoarthrosis - failed previous fusion ● The ISOBAR Spinal System is a pedicle screw system indicated for the treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (1.3 to sacrum) with removal of the implants after the attainment of a solid fusion. The ISOBAR Spinal System is a pedicle scrow system 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: devenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scollosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).
Product codes (comma separated list FDA assigned to the subject device)
MNH, MNI, KWP
Device Description
The ISOBAR Spine System is a pedicle screw system intended to provide immobilization of spinal scentents in skcletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of thoracic, lumbar or sacral spinc: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, spinal turnor, and failed previous fusions. As a podicle screw system the ISOBAR Spinal S ystem is intended for the treatment of severe spondylolisthesis (Grade 3 and 4) of the LS-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 a solid fusion. The ISOBAR Spinal System consists of monoaxial and polyaxial pedicle screws (K990118, K013447 and K020245) rods, nuts and cross link members. It can be used for single or multiple level fixation. It also included single and double hooks (K013444 and K013440) used for posterior, nompedicle screw fixation of the noncervical spine/hook and sacral/illiac screw fixation to the noncervical spine/hook and sacral screw fixation to the T1-S1 spine. All components are manufactured from titanium alloy (Ti-6AI-4V) that conforms to ASTM F136. The additional component that is the subject of this Special 510(k) submission is the EASYS Transverse Connection. Its purpose is to provide rigidity to the spinal construct similar to the crosslink cleared on K990118. It consists of a cross bar and two self locking jumper consists of a clamp and tightening screw.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
noncervical spine, sacral/iliac, T1-S1 spine, L5-S1 vertebra, L3 to sacrum, thoracic, lumbar, sacral spine
Indicated Patient Age Range
skeletally mature patients
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)
Nonclinical Tests: Testing per ASTM 1717 found that the EASYS Transverse Connection is as strong as the predicate device.
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.
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.
K013447, K020245, K013444, K013440
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.
0
MAY 1 3 2003
510(k) Summary
Date April 21, 2003
Submitter Scient'x USA, Inc. 1015 Maitland Center Commons Suite 106A Maitland, FL 32751
Contact person J.D. Webb 1001 Oakwood Blvd Round Rock, TX 78681
512-388-0199
Trade name EASYS Transverse Connection
Common name Posterior spinc system
Classification name
Spinal Interlaminal Fixation Orthosis Spondylolisthesis Spinal Fixation Device System - class II Pedicle Screw Spinal System - class II 888.3050 and 888.3070 (per 21 CFR section)
Indications
The EASYS Transverse Connection used with the ISOBAR Spinal System is intended for posterior, nomedicle screw fixation of the noncervical spine/hook and sacral/iliac screw fixation to the noncervical spine/hook and sacral screw fixation to the T1-S1 spine.
Indications for use include:
- degenerative disc disease (ddd) defined as back pain of discogenic origin with degeneration of the disc ● confirmed by history and radiographic studies
- spondylolisthesis .
- trauma (i.e., fracture or dislocation) ●
- spinal stenosis ●
- deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis) ●
- . tumor
- pseudoarthrosis
- . failed previous fusion
The ISOBAR Spinal System is a pedicle screw system indicated for the treatment of severe spondylolishesis (Grades 3 and 4) of the L5-S1 vertebra 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 a solid fusion.
The ISOBAR Spinal System is a pedicle screw system 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: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, socinal turnor, and failed previous fusion (pseudarthrosis).
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EASYS Transverse Connection 510(k) Summary Page 2
Equivalent Device
This a dditional component is e quivalent to the previous crosslink for the I SODAR Spinal system in indications, usage and materials.
Device Description
The ISOBAR Spine System is a pedicle screw system intended to provide immobilization of spinal scentents in skcletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of thoracic, lumbar or sacral spinc: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, spinal turnor, and failed previous fusions.
As a podicle screw system the ISOBAR Spinal S ystem is intended for the treatment of severe spondylolisthesis (Grade 3 and 4) of the LS-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 a solid fusion.
The ISOBAR Spinal System consists of monoaxial and polyaxial pedicle screws (K990118, K013447 and K020245) rods, nuts and cross link members. It can be used for single or multiple level fixation. It also included single and double hooks (K013444 and K013440) used for posterior, nompedicle screw fixation of the noncervical spine/hook and sacral/illiac screw fixation to the noncervical spine/hook and sacral screw fixation to the T1-S1 spine.
All components are manufactured from titanium alloy (Ti-6AI-4V) that conforms to ASTM F136.
The additional component that is the subject of this Special 510(k) submission is the EASYS Transverse Connection. Its purpose is to provide rigidity to the spinal construct similar to the crosslink cleared on K990118. It consists of a cross bar and two self locking jumper consists of a clamp and tightening screw.
Summary Nonclinical Tests
Tcsting per ASTM 1717 found that the EASYS Transverse Connection is as strong as the predicate device.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird symbol, with three curved lines forming the body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the bird symbol.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 1 3 2003
Scient'x USA, Inc. c/o Mr. J. D. Webb 1001 Oakwood Boulevard Round Rock, Texas 78681
Re: K031290
Trade/Device Name: EASYS Transverse Connection Regulatory Number: 21 CFR 888.3070, 21 CFR 888.3050 Regulation Name: Pedicle screw spinal system, Spinal interlaminal fixation orthosis Regulatory Class: II Product Code: MNH, MNI, KWP Dated: April 21, 2003 Received: April 23, 2003
Dear Mr. Webb:
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.
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Page 2 - Mr. J. D. Webb
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) 594-4639. 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 A. Melleman
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
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510(k) number (if known):