(91 days)
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Not Found
No
The summary describes a mechanical spinal fixation system and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
No.
A therapeutic device is one that treats a disease or condition. This device is a spinal fixation system, used to stabilize the spine, which is a supportive function, not a direct treatment for disease.
No
The device is described as a spinal fixation system, which is a therapeutic device used in surgical procedures for stabilization, not for diagnosing conditions. It is indicated for various spinal conditions, but its function is to treat, not diagnose.
No
The device description explicitly states it is a "single use spinal fixation device that utilizes rods, screws, and hooks," which are physical hardware components.
No, 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, tissue) to provide information about a person's health.
- Device Description: The EBI® Top Loading MAS Spinal Fixation System is described as a "spinal fixation device that utilizes rods, screws, and hooks." This is a surgical implant used to stabilize the spine.
- Intended Use: The intended use is for spinal fixation in various conditions like degenerative disc disease, trauma, deformities, etc. This involves surgical implantation, not testing of bodily samples.
The description clearly indicates a device used within the body for structural support, not a device used to analyze samples outside the body.
N/A
Intended Use / Indications for Use
The EBI® Top Loading MAS Spinal Fixation System is a non-cervical spinal fixation device intended for use as a pedicle screw fixation system, a posterior hook and sacral/iliac screw fixation system, or as an anterolateral fixation system. Pedicle screw fixation is limited to skeletally mature patients. The device is indicated for all of the following indications regardless of the intended use: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma, (i.e., fracture or dislocation), deformities or curvatures (i.e.. scoliosis, kyphosis, and lordosis), tumor, stenosis, psuedoarthrosis, and failed previous fusion.
Product codes (comma separated list FDA assigned to the subject device)
NKB, MNH, MNI, KWQ, KWP
Device Description
The EBI® Top Loading MAS Spinal Fixation System is a single use spinal fixation device that utilizes rods, screws, and hooks.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Spinal, non-cervical
Indicated Patient Age Range
Pedicle screw fixation is limited to skeletally mature patients.
Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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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)
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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.
Webb-Morley Spine System, EBI Omega21 Spinal Fixation Device, EBI P148 Spinal Fixation Devcie, Zielke VDS System
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.
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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).
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§ 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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JAN 1 3 2004
1.72
510(k) Summary
This 510(k) Summary for the EBI® Top Loading MAS Spinal Fixation System is provided as required per Section 513(3) of the Food, Drug and Cosmetic Act.
- Contact Person: Frederic Testa, RAC 1. Submitter: EBI, L.P. Telephone: (973) 299-9300, ext.2208 100 Interpace Parkway Parsippany, NJ 07054
October 8, 2003 Date prepared:
| 2. Proprietary Name: | EBI® Top Loading MAS Spinal Fixation System |
|---|---|
| Common Name: | Spinal Fixation Device |
| Classification Names: | Spondylolisthesis Spinal Fixation Device System |
| Spinal Intervertebral Body Fixation Orthosis | |
| Spinal Interlaminal Fixation Orthosis |
3. Predicate or legally marketed devices that are substantially equivalent:
- Webb-Morley Spine System .
- EBI Omega21 Spinal Fixation Device .
- EBI P148 Spinal Fixation Devcie .
- Zielke VDS System ●
-
- Description of the device: The EBI® Top Loading MAS Spinal Fixation System is a single use spinal fixation device that utilizes rods, screws, and hooks.
-
- Intended Usc: The EBI® Top Loading MAS Spinal Fixation System is a noncervical spinal fixation device intended for use as a pedicle screw fixation system, a posterior hook and sacral/iliac screw fixation system, or as an anterolateral fixation system. Pedicle screw fixation is limited to skeletally mature patients. The device is
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indicated for all of the following indications regardless of the intended use: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma, (i.e., fracture or dislocation), deformities or curvatures (i.e.. scoliosis, kyphosis, and lordosis), tumor, stenosis, psuedoarthrosis, and failed previous fusion.
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- Materials: The components of the System are manufactured from titanium alloy (Ti-6A1-4V ELI) per ASTM F136 and unalloyed titanium per ASTM F 67-00.
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- Comparison of the technological characteristics of the device to predicate devices: There are no significant differences between the proposed EBI® Top Loading MAS Spinal Fixation System and the predicate devices. It is substantially equivalent* to the predicate devices in regards to design, intended use, and materials.
- Any statement made in conjunction with this submission regarding a determination of substantial equivalence to any other product is intended only to relate to whether the product can be lawfully marketed without pre-market approval or reclassification and is not intended to be interpreted as an admission or any other type of evidence in patent infringement litigation. [Establishment Registration and Premarket Notification Procedures, Final Regulation, Preamble, August 23, 1977, FR 42520 (Docket No. 76N-0355.)]
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a stylized human figure.
Public Health Service
JAN 1 3 2004
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Frederic Testa, RAC Senior Regulatory Affairs Specialist EBI, L.P. 100 Interpace Parkway Parsippany, New Jersey 07054
Re: K033312
Trade/Device Name: EBI® Top Loading MAS Spinal Fixation System Trade/Device Name: 277-17-2888.3050,21 CFR 888.3070,21 CFR 888.3060 Regulation Names: 21 CF R 800:5000;27 +60 Corporation orthosis, Pedicle screw spinal system. Spinal intervertebral body fixation orthosis Regulatory Class: II
Product Codes: NKB, MNH, MNI, KWQ, KWP Dated: October 9, 2003 Received: October 15, 2003
Dear Mr. Testa:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave teviewed your Section 310(t) personalially 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 commerce provide to May 20, 7778, as econdance with the provisions of the Federal Food. Drug. devices that have been reclassified in assessman of a premarket approval application (PMA). allo Cosmetic Act (Act) that do not requent to the general controls provisions of the Act. The I ou may, mercere, maniel and tees, coos, coos, coos, coosenents for annual registration, listing of general controls provisions of tactice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMAI. it If your device is classified (500 abs. 1970) with the major regulations affecting your device can Inay be subject to suel additional controller , Title 21, Parts 800 to 898. In addition, FDA may oc found in the Obacements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised hat I DA is issuares of a cevice complies with other requirements of the Act that I DA has made a determinatives administered by other Federal agencies. You must of any I citizal statutes und regations and admited to: registration and fisting ( 12 comply with an the Not 31equirements(01): good manufacturing practice requirements as set CFR Part 807), additing (21 CFR Part 807), good if and if applicable. the electronic forul in the quarts 355tems ($($($($($($($($($($($($($($($($($($($($($($($($($($($($($($($($($($($($($($($($($($($($($($($($($($($($($($($($($($($($($($($($($($($($($($($($($
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Page 2 - Mr. Frederic Testa, RAC
This letter will allow you to begin marketing your device as described in your Section 510(k) This icher with anow you to oegh finding of substantial equivalence of your device to a legally prematics notification: "The Presults 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 if you desire specific as not as (301) 594-4659. Also, please note the regulation entitled. Connect the Ories of Comment of premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general 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 N Millman
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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Statement of Indications for Use
510(k) Number (if known):
Device Name: EBI® Top Loading MAS Spinal Fixation System
Indications For Use:
The EBI® Top Loading MAS Spinal Fixation System is a non-cervical spinal fixation device intended for use as a pedicle screw fixation system, a posterior hook and sacral/iliac screw fixation system, or as an anterolateral fixation system. Pedicle screw fixation is limited to skelctally mature patients. The device is indicated for all of the following indications regardless of the intended use: degencrative disc discase (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma, (i.e., fracture or dislocation), deformitics or curvatures (i.e.. scoliosis, kyphosis, and lordosis), tumor, stenosis, psuedoarthrosis, and failed previous fusion.
(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)
OR
Over-The-Counter Use (Optional Format 1-2-96)
f Mark n Milkemas
Restorative
Devices
K033