(27 days)
No
The document describes a mechanical spinal screw system and its intended use, with no mention of AI or ML technology.
Yes
The device, Polyaxial Hemispherical Spinal Screws, is intended for fixation in the spine to treat various medical conditions like degenerative disc disease, spondylolisthesis, and trauma, which aligns with the definition of a therapeutic device.
No
The device description clearly states it is a spinal screw system, which is an implant used for fixation, not for diagnosis. Its intended use includes treating conditions like degenerative disc disease, spondylolisthesis, and spinal stenosis through fixation, not through diagnosis.
No
The device description explicitly states it consists of physical components like screws, rods, nuts, and cross link members, 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 for spinal fixation. This is a device used in vivo (within the body) to treat structural issues of the spine.
- Device Description: The description details physical components like screws, rods, nuts, and hooks, which are all surgical implants.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is a surgical implant used in vivo.
N/A
Intended Use / Indications for Use
The Polyaxial Hemispherical Spinal Screws are intended for posterior, noncervical pedicle and non-pedicle fixation for the following indications: 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; curvatures (i.e., scoliosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.
As a pedicle screw system the Polyaxial Hemispherical Spinal Screws are 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 (1,3 to sacrum) with removal of the implants after the attainment of a solid fusion.
Product codes
MNI, MNH, KWP
Device Description
The ISOBAR Spinal System consists of monoaxial and polyaxial pedicle screws rods, nuts and cross link members. (K990118, K013447 and K031290) It can be used for single or multiple level fixation. It also includes single and double hooks (K013444 and K013440) used for posterior, nonpedicle screw fixation of the noncervical spine, hook and sacral/iliac screw fixation to the noncervical spine and hook and sacral screw fixation to the T1-S1 spine.
The modification included in this submission is the addition of polyaxial hemispherical screws. These screws function in the same manner as the previously cleared hemispherical screws by insertion into the pedicle then placing an offset clamp over the screw with a rod that has been loaded into the clamp. A nut is them placed on the screw and tightened to secure the assembly. The new polyaxial screw allows the proximal portion of the screw to angulate in order to ease the assembly of the rod loaded clamps onto multiple screws that may not be axially aligned.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
posterior, noncervical pedicle and non-pedicle; lumbar and sacral spine (1,3 to sacrum); L5-S1 vertebrae
Indicated Patient Age Range
skeletally mature patients
Intended User / Care Setting
experienced spinal surgeons with specific training in the use of this pedicle screw spinal system
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 was performed per ATM F1717 and the results are comparable to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
K013447, K031290, K013444, K013440
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
Polyaxial Hemispherical Spinal Screws 510(k) Summary
April 21, 2005
MAY 2 3 2005
| Submitter | Scient'x
Batiment Calypso Parc Ariane 3
78284 Guyancourt
FRANCE |
|---------------------|--------------------------------------------------------------------------|
| Contact person | J.D. Webb
1001 Oakwood Blvd
Round Rock, TX 78681
512-388-0199 |
| Trade Name | Polyaxial Hemispherical Spinal Screws |
| Common name | Posterior pedicle screw system |
| Classification name | Class II per 21 CFR section 888.3070 |
| Product Code | MNI/MNH |
| Equivalent Device | Scient'x ISOBAR Hemispherical Screw system (K990118) |
Device Description
The ISOBAR Spinal System consists of monoaxial and polyaxial pedicle screws rods, nuts and cross link members. (K990118, K013447 and K031290) It can be used for single or multiple level fixation. It also includes single and double hooks (K013444 and K013440) used for posterior, nonpedicle screw fixation of the noncervical spine, hook and sacral/iliac screw fixation to the noncervical spine and hook and sacral screw fixation to the T1-S1 spine.
The modification included in this submission is the addition of polyaxial hemispherical screws. These screws function in the same manner as the previously cleared hemispherical screws by insertion into the pedicle then placing an offset clamp over the screw with a rod that has been loaded into the clamp. A nut is them placed on the screw and tightened to secure the assembly. The new polyaxial screw allows the proximal portion of the screw to angulate in order to ease the assembly of the rod loaded clamps onto multiple screws that may not be axially aligned.
Intended Use
The Polyaxial Hemispherical Spinal Screws are intended for posterior, noncervical pedicle and non-pedicle fixation for the following indications: 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; curvatures (i.e., scoliosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.
As a pedicle screw system the Polyaxial Hemispherical Spinal Screws are 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 (1,3 to sacrum) with removal of the implants after the attainment of a solid fusion.
Summary Nonclinical Tests
Testing was performed per ATM F1717 and the results are comparable to the predicate device.
1
Image /page/1/Picture/1 description: The image shows the seal of the Department of Health and Human Services (DHHS). The seal features the department's name in a circular arrangement around a symbol. The symbol consists of three stylized human profiles facing to the right, representing the department's focus on people and health.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 3 2005
Scient'X C/o Mr. J.D. Webb The Orthomedix Group, Inc. 1001 Oakwood Boulevard Round Rock, Texas 78681
Re: K051063
Trade/Device Name: Polyaxial Hemispherical Spinal Screw Regulation Number: 21 CFR 888.3070, 888.3050 Regulation Name: Pedicle Screw Spinal System, Spinal interlaminal fixation orthosis Regulatory Class: II Product Code: MNI, MNH, KWP Dated: April 21, 2005 Received: April 26, 2005
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.
2
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 (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,
Miriam Provost
Miriam Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known):
Device Name: Polyaxial Hemispherical Spinal Screws
Indications for Use:
The Polyaxial Hemispherical Spinal Screws are intended for posterior, noncervical pedicle and non-pedicle fixation for the following indications: 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; curvatures (i.e., scoliosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.
As a pedicle screw system the Polyaxial Hemispherical Spinal Screws are 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 a solid fusion.
"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 neurological impairment. fracture, dislocation, scollosis, kyphosis, spinal tumor, and failed previous fusion (pseudoarthrosis). 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."
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Muriam C. Provost
יינו ביינו ביינו ביינו בייני שיישו שייש שייש שיישי שיישי שיישי שיישי שיישי יודי יידי יישי ישיי שיישי יודי יישי ישיי שיישי שיישי יודי יידי יידי יידי יידי יידי יידי יידי יידי
(Division Sign-Off) Division of General, Restorative and Neurological Devices
iii 510(k) Number_________________________________________________________________________________________________________________________________________________________________