(65 days)
The EVEREST Spinal System may be used in conjunction with the RANGE® (MESA® and DENALI®) Spinal Systems, all of which are cleared for the following indications:
Posterior non-cervical fixation as an adjunct to fusion for the following indications: degenerative disc disease (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, kyphosis); tumor; pseudarthrosis; and/or failed previous fusion.
Except for hooks, when used as an anterolateral thoracic/lumbar system the EVEREST Spinal System may also be used for the same indications as an adjunct to fusion.
When used for posterior non-cervical pediatic patients the EVEREST Spinal System implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. These devices are to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.
The EVEREST Spinal System is a top-loading, multiple component, posterior (thoracic-lumbar) spinal fixation system which consists of pedicle screws, rods, hooks and rod connectors. The subject 510(k) adds sterile packaged implants to the system.
Function: The system functions as an adjunct to fusion to provide immobilization and stabilization of the posterior thoracic and lumbar spine.
This document describes a 510(k) premarket notification for the EVEREST Spinal System. Based on the provided text, the device is a spinal fixation system, and the submission is for adding sterile-packaged implants to the system. The acceptance criteria and supporting study details are primarily related to mechanical performance and material compatibility, not a diagnostic or AI-driven device.
Here's an analysis of the provided information:
Assessment of Acceptance Criteria and Proving Study:
The document describes pre-clinical performance evaluations, not clinical studies in the context of an AI/diagnostic device. The "acceptance criteria" and "study" are focused on the mechanical and material aspects of the spinal implant.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Type of Test) | Reported Device Performance (Summary) |
|---|---|
| Static torsion | Results comparable to previously cleared devices (predicate devices). (Performed per ASTM F1717) |
| Static compression | Results comparable to previously cleared devices (predicate devices). (Performed per ASTM F1717) |
| Dynamic compression bending | Results comparable to previously cleared devices (predicate devices). (Performed per ASTM F1717) |
| Bacterial endotoxin testing | Results provided to support substantial equivalence. (Specific values not given, but implied to meet standards) |
| Accelerated and real-time aging | Results provided to support substantial equivalence. (Performed per AAMI/ANSI/ISO 11607, specific values not given) |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated for each test, but implied to be sufficient for the mechanical and material tests performed according to recognized standards (ASTM F1717, AAMI/ANSI/ISO 11607). For mechanical testing of medical devices, sample sizes are typically determined by statistical methods or industry standards to ensure sufficient power to detect differences or confirm compliance.
- Data Provenance: The tests are non-clinical performance evaluations (i.e., laboratory testing). Therefore, there is no "country of origin of the data" or "retrospective/prospective" in the sense of patient data. The provenance is the results of laboratory tests conducted by the manufacturer or a contracted lab.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable to this type of device submission. Ground truth, in the context of expert consensus, is relevant for diagnostic devices (especially those involving image interpretation or clinical assessment). For a spinal implant, "ground truth" relates to material properties and mechanical performance, which are evaluated through standardized physical testing, not expert interpretation of clinical data.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
This is not applicable. Adjudication methods are used in clinical studies, particularly for diagnostic devices, to resolve discrepancies among multiple expert readers. For mechanical testing, the results are quantitative measurements against predefined standards.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
This is not applicable. An MRMC study is relevant for diagnostic devices that involve human interpretation, particularly when evaluating the impact of AI assistance on reader performance. The EVEREST Spinal System is a physical implant, not a diagnostic or AI-assisted device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This is not applicable. This question refers to the performance of an AI algorithm in isolation. The EVEREST Spinal System is a physical medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for this device's performance evaluation is based on established engineering and material science standards and specifications. For example:
- Mechanical Strength: The "ground truth" is passing the load and fatigue requirements specified in ASTM F1717 (e.g., maintaining structural integrity and specific mechanical properties under defined static and dynamic loads).
- Biocompatibility/Material Safety: The "ground truth" is meeting the bacterial endotoxin limits and aging requirements as per relevant ISO standards (e.g., AAMI/ANSI/ISO 11607 for packaging and sterility).
8. The sample size for the training set:
This is not applicable. The device is not an AI/machine learning device, so there is no training set in this context.
9. How the ground truth for the training set was established:
This is not applicable. As there is no training set (being a physical medical device), the concept of establishing ground truth for it does not apply.
{0}------------------------------------------------
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized image of an eagle with three human profiles incorporated into its design. The profiles are stacked on top of each other, creating a sense of depth and unity. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 21, 2016
K2M, Incorporated Ms. Nancy Giezen Manager. Regulatory Affairs 600 Hope Parkway Southeast Leesburg, Virginia 20175
Re: K161369
Trade/Device Name: EVEREST Spinal System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class III Product Code: NKB, OSH, MNH, MNI, KWP, KWQ Dated: June 21, 2016 Received: June 22, 2016
Dear Ms. Giezen:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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 Parts 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
{1}------------------------------------------------
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Lori A. Wiggins -S
for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
Indications for Use
510(k) Number (if known) K161369
Device Name EVEREST Spinal System
Indications for Use (Describe)
The EVEREST Spinal System may be used in conjunction with the RANGE® (MESA® and DENALI®) Spinal Systems, all of which are cleared for the following indications:
Posterior non-cervical fixation as an adjunct to fusion for the following indications: degenerative disc disease (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, kyphosis); tumor; pseudarthrosis; and/or failed previous fusion.
Except for hooks, when used as an anterolateral thoracic/lumbar system the EVEREST Spinal System may also be used for the same indications as an adjunct to fusion.
When used for posterior non-cervical pediatic patients the EVEREST Spinal System implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. These devices are to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.
Type of Use (Select one or both, as applicable)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ---------------------------------------------------------------------------------------------------------------------------------- | --------------------------------------------------------------------------------------------------------------------------------- |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{3}------------------------------------------------
510(k) Summary EVEREST Spinal Svstem
Submitter :
K2M, Inc. 600 Hope Parkway SE Leesburg, VA 20175
Classification
Tradename: Common Name: Regulatory Class: Contact Person: Nancy Giezen Telephone: 571 919 2000 Date Prepared: 6/20/2016
EVEREST Spinal System Spinal Fixation System Class III
Classification Name(s):
Pedicle Screw Spinal System (21 CFR 888.3070, Product Codes NKB, OSH, MNH, MNI) Spinal Intervertebral body fixation Orthosis, (21 CFR 888.3060, Product Code KWO) Spinal Interlaminal fixation Orthosis (21 CFR 888.3050, Product Code KWP)
Predicate Device(s) Primary Predicate EVEREST Spinal System (K151727)
Secondary Predicate RANGE /DENALI/MESA Spinal Systems (K141873)
Device Description
The EVEREST Spinal System is a top-loading, multiple component, posterior (thoracic-lumbar) spinal fixation system which consists of pedicle screws, rods, hooks and rod connectors. The subject 510(k) adds sterile packaged implants to the system.
Function: The system functions as an adjunct to fusion to provide immobilization and stabilization of the posterior thoracic and lumbar spine.
Indications for Use
The EVEREST Spinal System may be used in conjunction with the RANGE® (MESA® and DENALI®) Spinal Systems, all of which are cleared for the following indications:
Posterior non-cervical fixation as an adjunct to fusion for the following indications: degenerative disc disease (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, kyphosis and/or lordosis); tumor; pseudarthrosis; and/or failed previous fusion.
{4}------------------------------------------------
Except for hooks, when used as an anterolateral thoracic/lumbar system the EVEREST Spinal System may also be used for the same indications as an adjunct to fusion.
When used for posterior non-cervical pedicle screw fixation in pediatric patients the EVEREST Spinal System implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. These devices are to be used with autograft and/or allograff. Pediatric pedicle screw fixation is limited to a posterior approach.
Technological Comparison to Predicate(s)
The proposed EVEREST implants were compared to predicate systems and the design features, materials and sizes were found to be substantially the same as these systems.
Non-clinical Performance Evaluation
Mechanical testing was previously performed in accordance with ASTM F1717 (including static torsion, static compression, and dynamic compression bending) and the results were comparable to previously cleared devices. The results of bacterial endotoxin testing and accelerated and real-time aging (per AAMI/ANSI/ISO 11607) were also provided to support substantial equivalence.
Conclusion:
There are no significant differences between the EVEREST Spinal System components and other devices currently being marketed which would adversely affect the use of the product. Therefore the subject devices are substantially equivalent to the predicate devices.
§ 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.