(28 days)
Not Found
No
The document describes a mechanical spinal fixation system and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
Yes
Explanation: The device is intended to treat various spinal conditions such as degenerative disc disease, spondylolisthesis, trauma, deformity, tumor, stenosis, pseudarthrosis, and failed previous fusion, which are conditions that require therapy.
No
The device is described as a "spinal fixation device" and its intended uses are for mechanically stabilizing the spine, not for diagnosing conditions.
No
The device description explicitly states it is a "non-cervical spinal fixation device," which is a hardware implant. The performance studies also focus on mechanical testing, further indicating a physical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use describes a spinal fixation device used for surgical implantation to treat various spinal conditions. This is a therapeutic device, not a diagnostic one.
- Device Description: The description confirms it's a spinal fixation system, which is a physical implant.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, tissue, etc.), providing diagnostic information, or being used in a laboratory setting.
- Performance Studies: The performance studies focus on mechanical testing of the device's strength and conformity to design specifications, which is typical for a surgical implant, not an IVD.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The Array® Spinal System is a non-cervical spinal fixation device intended for use as a pedicle screw fixation system, a posterior hook and sacral/iliac serew fixation system, or as an anterolateral fixation system. Pedicle screw fixation is limited to skeletally mature patiens. 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), deformity or curvature (i.e., scoliosis, kyphosis, and/or lordosis), tumor, stenosis, pseudarthrosis, and failed previous fusion.
Product codes
NKB, MNH, MNI, KWQ, KWP
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
non-cervical spinal
Indicated Patient Age Range
skeletally mature patiens
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
Mechanical testing of the Array® Spinal System was conducted and demonstrates that the proposed line extension conforms to its design specifications. The design requirements were established based on those of the previously cleared predicate devices. The results of testing conducted demonstrate that the worst case of the proposed system adequetely meets the requirements established in design specifications for its mechanical performance.
Key Metrics
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Predicate Device(s)
EBI® Array® Spinal System (Stainless Steel), K061563, EBI® Array® Spinal Fixation System, K033312, EBI® Webb Morley Spine System, K941367
Reference Device(s)
Not Found
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
| | EBI, L.P./Biomet Spine
Array® Spinal System | OCT - 6 2006 | |
|-------------------------|-----------------------------------------------------------------------------------------------------------------------------------|--------------|--|
| SUBMITTER: | EBI, L.P.
100 Interpace Parkway
Parsippany, NJ 07054 | | |
| SUBMISSION PREPARED BY: | Jennifer P. Harakal
Regulatory Affairs Specialist | | |
| CONTACT PERSON: | Debra Bing
Regulatory Affairs Director
Phone: 973-299-9300 x3964
Fax: 973-257-0232 | | |
| DATE PREPARED: | September 7, 2006 | | |
| TRADE NAME: | Array® Spinal System | | |
| COMMON NAME: | Spinal Fixation Device | | |
| CLASSIFICATION NAME: | Spondylolisthesis Spinal Fixation Device
Spinal Intervertebral Body Fixation Orthosis
Spinal Interlaminal Fixation Orthosis | | |
| PRODUCT CODE: | NKB, MNH, MNI, KWQ, KWP | | |
| CLASS: | Class III | | |
| REGULATION NUMBER: | 21 CFR 888.3050, 21 CFR 888.3070,
21 CFR 888.3060 | | |
| PREDICATE DEVICES: | EBI® Array® Spinal System (Stainless Steel), K061563 | | |
| | EBI® Array® Spinal Fixation System, K033312
(formerly referred to as 'Top Loading MAS Spinal
Fixation System') | | |
| | EBI® Webb Morley Spine System, K941367 | | |
INTENDED/INDICATIONS FOR USE:
The Array® Spinal System is a non-cervical spinal fixation device intended for use as a pedicle screw fixation system, a posterior hook and sacral/iliac serew fixation system, or as an anterolateral fixation system. Pedicle screw fixation is limited to skeletally mature patiens. 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), deformity or curvature (i.e., scoliosis, kyphosis, and/or lordosis), tumor, stenosis, pseudarthrosis, and failed previous fusion.
1
TECHNOLOGICAL CHARACTERISTICS:
Performance Testing
Mechanical testing of the Array® Spinal System was conducted and demonstrates that the proposed line extension conforms to its design specifications. The design requirements were established based on those of the previously cleared predicate devices. The results of testing conducted demonstrate that the worst case of the proposed system adequetely meets the requirements established in design specifications for its mechanical performance.
Substantial Equivalence
The Array® Spinal System is substantially equivalent to other legally marketed spinal fixation devices with respect to intended use and indications, technological characterstitiss, and basic principles of operation. This premarket notification is being submitted to address a line extension to the existing Array Spinal System. As demonstrated by mechanical testing, these technological differences do not present any new issues of safety or effectiveness.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle or bird-like figure with outstretched wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 6 - 2006
EBI, L.P. % Ms. Debra Bing Regulatory Affairs Director 100 Interpace Parkway Parsippany, New Jersey 07054
Re: K062685
Trade/Device Name: EBI® ARRAY® Spinal System Regulation Number: 21 CFR 888,3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class III
Product Code: NKB, MNI, MNH, KWP, KWQ Dated: September 7, 2006 Received: September 8, 2006
Dear Ms. Bing:
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.
3
Page 2 – Ms. Debra Bing
This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter will and hyp of substantial equivalence of your device of your device to a legally premainer nodicate 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours,
Salvega Bucland
Tark N. Me kerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement
510(k) Number (if known):
Device Name: EBI® Array® Spinal System
Indications for Use:
The Array Spinal 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, 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), deformity or curvature (i.e., scoliosis, kyphosis, and/or lordosis), turnor, stenosis, pseudarthrosis, and failed previous fusion.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ Use (Part 21 C.F.R. 801 Subpart D)
AND/OR
Over-The-Counter
(21 C.F.R. 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of __ 1_
Oarbare Buchyn
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number K062685