(29 days)
Not Found
No
The document describes a mechanical spinal implant component and its intended use, with no mention of software, algorithms, or any technology related to AI or ML.
Yes.
The device is an SCS Spinal System component, indicated for various spinal instabilities and deformities, to provide immobilization and stabilization, and is removed after fusion. This aligns with the definition of a therapeutic device designed to treat or alleviate a medical condition.
No
The device is described as a spinal system component (Omni Axial Connector) used to provide immobilization and stabilization of spinal segments as an adjunct to fusion in the treatment of instabilities or deformities. Its intended uses are therapeutic (fusion, stabilization) rather than diagnostic.
No
The device description explicitly states the device is a "new connector" made from "titanium alloy," indicating it is a physical hardware component, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant system used for spinal fusion and stabilization in patients with various spinal conditions. This is a therapeutic device, not a diagnostic one.
- Device Description: The device is described as a mechanical connector made of titanium alloy, designed to facilitate pedicle screw insertion and attach to spinal rods. This is a physical implant, not a reagent, instrument, or system intended for use in the diagnosis of disease or other conditions.
- Performance Studies: The performance studies described are mechanical and fatigue testing, which are relevant to the structural integrity and durability of a surgical implant, not the analytical or clinical performance of a diagnostic test.
- No Mention of Biological Samples: There is no mention of the device being used with biological samples (blood, urine, tissue, etc.) which is a key characteristic of IVDs.
In summary, the device is a surgical implant intended for therapeutic use in stabilizing the spine, not for diagnosing any condition.
N/A
Intended Use / Indications for Use
When used as a nonpedicle posterior system, the SCS system is indicated for patients with: degenerative disk disease defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies spondylolisthesis fracture spinal stenosls deformities (i.e., scoliosis, kyphosis, lordosis) fumors pseudarthrosis falled previous fusion (pseudarthrosis)
When used as an anterolateral/anterior system the SCS system is indicated for patients with: degenerative disk disease defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies spondylolisthesis fracture spinal stenosis deformities (i.e., scoliosis, kyphosis, lordosis) tumors pseudarthrosis failed previous fusion (pseudanthrosis)
When used as a posterior pedicle system, the device is indicated for use in skeletally mature patients L3 & below who are: having severe spondylolisthesis (Grades 3 and 4) at the L5-S1 joint receiving fusions using autogenous bone graft only having the device fixed or attached to the lumbar and sacral spine having the device removed after the development of a solid fusion mass, Posterior pedicle systems are 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: spondylolisthesis with objective degenerative evidence of neurologic impairment fracture dislocation scoliosis kyphosis spinal tumor falled previous fusion (pseudarthrosis)
Product codes (comma separated list FDA assigned to the subject device)
KWP, KWQ, MNH, MNI
Device Description
This new connector is called the “Omni Axial Connector.” The part number is 7T20-CO04. It is made from titanium alloy as defined by the ASTM and ISO standards indicated below, TA6V ELI ASTM F136-92 ISO 5832-3 The Omniaxial Connector facilitates pedicle screw insertion by providing a range of adaptability of the screw path in the three axist, axial, sagittal and coronal. The OmntAxtal Connector is intended to be a "standard" component of the SCS Spinal System. The OmniAxtal Connector attaches to the spinal rods using the same connecting screw (2TD1-VS53) as used in the existing SCS Spinal System.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Spinal segments of the thoracic, lumbar, and sacral spine, L5-S1 joint
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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Mechanical and fatigue testing were carried out. Samples were tested using the ASTM F-1717-96 guidance document. The maximum and minimum loads, positions and temperatures were recorded. Static testing sufficient to quantify and compare the previously cleared SCS Spiral System connector and the new Omotiaxial Connector clearly demonstrates the substantial equivalence of the two connectors. The product is manufactured in compliance with cGMP regulations.
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.
Not Found
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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| Summary of Safety and Effectiveness Information ORTHOTEC, LLC. | ||
|---|---|---|
| Premarket Notification, Section 510(k) | NOVEMBER 1999 | |
| Regulatory Authority: Safe Medical Devices Act of 1990, 21 CFR 807.92 | ||
| 1. | Device Name: | |
| Trade Name: | OmniAxial Connector (SCS Spinal System) | |
| Common Name(s): | pedicle screw spine system | |
| Classification Name(s): | Pedicle Screw Spinal System (Class II Uses) | |
| 2. | Establishment Name & Registration Number: | |
| Name: | ORTHOTEC, LLC. | |
| Number: | 2031734 | |
| 3. | Classification: | |
| § 888.3070 – Spondylolisthesis Spinal Fixation Device System | ||
| § 888.3070 – Pedicle Screw Spinal System (Class II Uses) | ||
| Device Class: | Class II for the requested indications | |
| Classification Panel: | Orthopaedic and Rehabilitation Devices Panel | |
| Product Code(s): | KWP KWQ & MNH, MNI | |
| 4. | Equivalent Predicate Device: | |
| The OmniAxial Connector may be directly contrasted with the earlier screw-rod connector of the | ||
| SCS Spinal System, K983353 . The OmniAxial Connector performs essentially the same function | ||
| as the original connector. The basic design, dimensional tolerances, materials and intended use | ||
| of both devices are identical. | ||
| 5. | Device Description: | |
| This new connector is called the “Omni Axial Connector.” The part number is 7T20-CO04. It is |
made from titanium alloy as defined by the ASTM and ISO standards indicated below,
| TA6V ELI | ASTM F136-92 | ISO 5832-3 |
|---|---|---|
| ---------- | -------------- | ------------ |
The Omniaxial Connector facilitates pedicle screw insertion by providing a range of adaptability of the screw path in the three axist, axial, sagittal and coronal. The OmntAxtal Connector is intended to be a "standard" component of the SCS Spinal System. The OmniAxtal Connector attaches to the spinal rods using the same connecting screw (2TD1-VS53) as used in the existing SCS Spinal System.
Summary of the Testing:
Mechanical and fatigue testing were carried out. Samples were tested using the ASTM F-1717-96 guidance document. The maximum and minimum loads, positions and temperatures were recorded. Static testing sufficient to quantify and compare the previously cleared SCS Spiral System connector and the new Omotiaxial Connector clearly demonstrates the substantial equivalence of the two connectors. The product is manufactured in compliance with cGMP regulations.
6. Applicant Name & Address:
ORTHOTEC, LLC. 546 Hillgreen Drive Beverly Hills, CA 90212-4110 310.557.2000 - 310.843.9500 - fax
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K993926 2 of 3
7. Company Contact:
Regulatory Affairs ORTHOTEC, LLC. 546 Hillareen Drive Beverly Hills, CA 90212-4110 310.557.2000 ~ 310.843.9500 - fax
8. Submission Correspondent:
Mr. David W. Schlerf Buckman Company, LLC. 200 Gregory Lane, Suite C-100 Pleasant Hill, CA 94523-3389 925.356.2640 - 925.356.2654 - fax
9. Performance Standards:
United States Food and Drug Administration mandated performance standards for this device do not exist. Various voluntary performance standards are utilized. Voluntary standards utilized include ASTM, Standard Operating Procedures, vendor & process certification and qualification procedures, Quality Systems Regulations, ISO materials standards and ISO 9000 series quality requlations. ОятноТес, LLC. In addition, meets appropriate general controls authorized under Sections 501, 502, 510, 516, 518, 519, and 520 of the Food, Drug, and Cosmetic Act.
10. Special Controls:
Special controls were published in the Federal Register, Vol. 63, No. 143. July 27, 1998 (Orthopedic Devices: Classification and Reclassification of Pedicie Screw Spinal Systems). The following special controls apply to the marketing of this device when used as a posterior pedicle system:
- Compliance with material standards, (i)
- Compliance with mechanical testing standard, ( ii )
- Compliance with biocompatability standard, and ( iii)
- Compliance with specified labeling requirements. (iv)
11. Special Guidance Document Information:
The 510(k) was prepared in accordance with:
- . "Guidance for Spinal System 510(k)'s," May 7. 1999.
- . "The New 510(k) Paradigm. Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notifications - Final Guidance, March 20, 1998.
12. Storage, Packaging & Sterilization Information:
The Omniaxtal Connector is supplied "NON-STERILE" and must be sterilized before use. The recommended sterilization process is high temperature steam autoclave sterilization. The recommended sterilization cycle will produce a Sterility Assurance Level (SAL) of at least 10°5
The validated cycle is:
Method: Steam Cycle: Gravity Temperature: 250°F (121°C) Exposure Time: 30 minutes
All packages containing implants or instruments should be intact upon receipt. Damaged packaging may indicate the presence of unsafe product. If the package or product is damaged, the product should not be used and should be returned.
2
Product must be handled, stored and opened in such a way that it is protected from inadvertent damage or contamination. When used, the product must be placed into use following cleaning, sterilization and accepted surgical sterile technique.
| 13. | Summary Comparison Table: | |
|---|---|---|
| FEATURE | SCS Spinal System OmniAxial Connector | SCS Spinal System | SE? |
|---|---|---|---|
| Indications for | |||
| Use: | As a Non-pedicle posterior system: spondylolisthesis, fracture, spinal | ||
| stenosis, deformities (i.e., scoliosis, kyphosis, lordosis), tumors, | |||
| pseudarthrosis, failed previous fusion (pseudarthrosis). |
As a Anterolateral/anterior system: spondylolisthesis, fracture, spinal
stenosis, deformities (i.e., scoliosis, kyphosis, lordosis), tumors,
pseudarthrosis, failed previous fusion (pseudarthrosis).
As a Posterior pedicle system: degenerative spondylolisthesis with
objective evidence of neurologic impairment, fracture, dislocation, scoliosis,
kyphosis spinal tumor, failed previous fusion (pseudarthrosis), severe
spondylolisthesis (Grades 3 and 4) at the L5-S1 joint, Fusions using
autogenous bone graft only, Device fixed or attached to the lumbar and
sacral spine, device removed after the development of a solid fusion mass. | SAME | YES |
| Design: | OmniAxial pedicle screw | SAME | YES |
| Sterile: | Non-sterile | SAME | YES |
| Sizes: | OmniAxial Pedicle Screws: 6-7mm dia. X 30-55mm length | EQUIVALENT | YES |
| Material: | Stainless steel, titanium alloy, pure titanium | SAME | YES |
| Manufacturer: | OrthoTec, LLC. | OrthoTec, LLC. | YES |
| Product Code: | KWP KWQ & MNH | SAME | YES |
| K - Number: | K993926 | K983355 | YES |
14. Intended Use:
When used as a nonpedicle posterior system, the SCS system is indicated for patients with:
degenerative disk disease defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies spondylolisthesis fracture spinal stenosls deformities (i.e., scoliosis, kyphosis, lordosis) fumors pseudarthrosis falled previous fusion (pseudarthrosis)
When used as an anterolateral/anterior system the SCS system is indicated for patients with:
degenerative disk disease defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies spondylolisthesis fracture spinal stenosis deformities (i.e., scoliosis, kyphosis, lordosis) tumors pseudarthrosis failed previous fusion (pseudanthrosis)
When used as a posterior pedicle system, the device is indicated for use in skeletally mature patients L3 & below who are:
having severe spondylolisthesis (Grades 3 and 4) at the L5-S1 joint
receiving fusions using autogenous bone graft only having the device fixed or attached to the lumbar and sacral spine
having the device removed after the development of a solid fusion mass,
Posterior pedicle systems are 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:
spondylolisthesis with objective degenerative evidence of neurologic impairment fracture dislocation scoliosis kyphosis spinal tumor falled previous fusion (pseudarthrosis
3
Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with its wings spread, with three human profiles incorporated into the design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle symbol.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 7 1999
Mr. David W. Schlerf OrthoTec, LLC c/o Buckman Company, Inc. 200 Gregory Lane. Suite C-100 Pleasant Hill. California 94523-3389
Re: K993926 Trade Name: SCS Spinal System Regulatory Class: II Product Code: MNH. KWO. KWP. and MNI Dated: October 11, 1999 Received: November 18, 1999
Dear Mr. Schlerf:
We have reviewed vour Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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. 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Ouality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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.
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Page 2 - Mr. David W. Schlerf
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or at (301) 443-6597, or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Xennell Hayes
James E. Dillard III
James E. Dillard III Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
રે
510(k) Number : K993926
Device Name(s): Omni-axial Connector (SCS Spinal System)
Intended Use(s) of the Device:
When used as a nonpedicle posterior system, the SCS system is indicated for patients with:
degenerative disk disease defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies spondylolisthesis fracture spinal stenosis deformities (i.e., scoliosis, kyphosis, lordosis) lumors pseudarthrosis failed previous fusion (pseudarthrosis)
When used as an anterolaterallanterior system the SCS system is indicated for patients with:
degenerative disk disease defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studios spondylolisthesis fracture spinal stenosls deformities (i.e., scoliosis, kyphosis, lordosis) tumors pseudarthrosis failed previous fusion (pseudarthrosls)
When used as a posterior pedicle svstem. the device is indicated for use in skeletally mature patients L3 & below who are:
Page 1 of ___ of _____________________________________________________________________________________________________________________________________________________________
having severe spondylollsthesis (Grades 3 and 4) at the L5-S1 joint
receiving fusions using autogenous bone graft only having the device fixed or attached to the lumbar and sacral spine
having the device removed after the development of a solid fusion mass.
Posterior pedicle systems are 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 neurologic impairment fracture dislocation scoliosis kyphosis spinal turnor failed previous fusion (pseudarthrosis)
please do not write below this line - continue on another page if necessary Concurrence of CDRH, Office of Device Evaluation (ODE)
luneh Lager 84 577
Prescription Use __ 1. (Per 21 CFR 801.109)
OR
Over-The-Counter Use_
Over-The-