(123 days)
No
The summary describes a mechanical spinal fixation system and its components, with no mention of AI or ML technology. The performance studies focus on mechanical testing.
No
The device, a pedicle screw system, is intended to provide "immobilization and stabilization of spinal segments" and is described as an "adjunct to fusion." These functions are supportive and reparative in nature, rather than directly therapeutic.
No
Explanation: The device is a spinal fixation system, which is a surgical implant used to provide immobilization and stabilization to the spine. It is a treatment device, not a diagnostic one.
No
The device description explicitly states it is composed of pedicle screws and rods, which are 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 provided text describes a spinal fixation system consisting of pedicle screws and rods. These are implanted devices used to stabilize the spine.
- Intended Use: The intended use clearly states that the system is for "immobilization and stabilization of spinal segments" and is an "adjunct to fusion." This is a surgical intervention, not a diagnostic test performed on a sample.
The description focuses on the mechanical function and surgical application of the device within the body, which is characteristic of a surgical implant, not an IVD.
N/A
Intended Use / Indications for Use
The PressON Spinal Fixation System is a posterior, non-cervical pedicle screw system intended to provide immobilization and stabilization of spinal segments that can accept a device construct up to 80mm in length 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 including degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).
In addition, this device is a pedicle screw system indicated for the treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to S1) with removal of the implants after the attainment of a solid fusion.
Product codes
MNI, MNH
Device Description
The PressON Spinal Fixation System is composed of pedicle screws and rods. These components can be assembled and implanted using associated instruments via a posterior approach into the pedicles of the noncervical vertebral bodies. Components are made from Ti-6Al-4V ELI (ASTM F-136).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Thoracic, lumbar, and sacral spine; L5-S1 vertebra; L3 to S1
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Verification activities including static flexion-extension loading and static anterior posterior loading tests per ASTM F1798-97(2008), and static compression bending, static torsion and dynamic compression bending tests per F1717-13 indicate PressON Spinal Fixation System is substantially equivalent to predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K061577, K983583, K081080, K992920, K083028
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
FEB 2 5 2014
| Submitter: | Nexus Spine LLC |
|---|---|
| Contact Person: | Mr. Chris Harmston, Director of Quality and Regulatory Affairs |
| 2825 East Cottonwood Parkway Suite 330 | |
| Salt Lake City, UT 84121 | |
| Telephone: (801) 742-8342 | |
| Fax: (801) 702-8585 | |
| Date Prepared: | February 24, 2014 |
| Trade Name: | PressON Spinal Fixation System |
| Classification, Name | |
| and Number: | Class II |
| Pedicle Screw Spinal System | |
| 21 CFR 888.3070 (b) (1) | |
| Product Code: | MNI and MNH |
| Predicate Device(s): | The subject device is substantially equivalent to the following devices: |
| OvalTwist Pedicle Screw System | |
| Signus Medizintechnik GMBH | |
| 510(k) number K061577 | |
| DePuy AcroMed MOSS Miami Spinal System | |
| DePuy Acromed Inc. | |
| 510(k) number K983583 | |
| TSRH Spinal System | |
| Medtronic Sofamor Danek USA | |
| 510(k) number K081080 | |
| EBI SpineLink System | |
| EBI, L.P. | |
| 510(k) number K992920 | |
| NuVasive SpheRx DBR II System | |
| NuVasive, Inc | |
| 510(k) number K083028 | |
| Device Description: | The PressON Spinal Fixation System is composed of pedicle screws and |
| rods. These components can be assembled and implanted using associated | |
| instruments via a posterior approach into the pedicles of the noncervical | |
| vertebral bodies. Components are made from Ti-6Al-4V ELI (ASTM F- | |
| 136). | |
| Intended Use: | The PressON Spinal Fixation System is a posterior, non-cervical pedicle |
| screw system intended to provide immobilization and stabilization of spinal | |
| segments that can accept a device construct up to 80mm in length 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 including degenerative spondylolisthesis with | |
| objective evidence of neurological impairment, fracture, dislocation, | |
| scoliosis, kyphosis, spinal tumor, and failed previous fusion | |
| (pseudarthrosis). | |
| In addition, this device is a pedicle screw system indicated for the treatment | |
| of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra in | |
| skeletally mature patients receiving fusion by autogenous bone graft having | |
| implants attached to the lumbar and sacral spine (L3 to S1) with removal of | |
| the implants after the attainment of a solid fusion. | |
| Statement of | |
| Technological | |
| Comparison: | The PressON Spinal Fixation System is substantially equivalent to |
| the above listed predicate devices in terms of materials, design, | |
| indications for use and operational principles. | |
| Performance Data: | Verification activities including static flexion-extension loading and static |
| anterior posterior loading tests per ASTM F1798-97(2008), and static | |
| compression bending, static torsion and dynamic compression bending tests | |
| per F1717-13 indicate PressON Spinal Fixation System is substantially | |
| equivalent to predicate devices. | |
| Conclusion: | Documentation provided demonstrates the PressON Spinal Fixation System |
| is substantially equivalent to predicate devices. |
.
510(k) Summary
1
Comments of Children
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 features a stylized caduceus, a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 25, 2014
Nexus Spine, LLC Mr. Chris Harmston Director of Quality and Regulatory Affairs 2825 East Cottonwood Parkway, Suite 330 Salt Lake City, Utah 84121
Re: K133287
Trade/Device Name: PressON Spinal Fixation System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class II Product Code: MNH, MNI Dated: January 27, 2014 Received: January 28, 2014
Dear Mr. Harmston:
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 Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
3
Page 2 - Mr. Chris Harmston
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 Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/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 Small Manufacturers, International and Consumer Assistance 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 yours,
Vincent J. Devlin -S
for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.
510(k) Number (if known)
Device Name PressON Spinal Fixation System
Indications for Use (Describe)
The PressON Spinal Fixation System is a posteried pedicte serew system intended to provide immobilization and stabilization of spinal segments that canstruct up to 80mm in length in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities of the thoracic, lumbar, and sacral spine including degeneralive spondylolises with objective evidencent, fracture, discoving scoliosis, kyphosis, spinal tumor, and failed previous fusion (pscudarthrosis).
In addition, this device is a pedicle sorev system indicated for the treatment of severe spondy holist the 1.5-S i vertebra in skeletally mature patients receiving for anongenous bone graft having implants attached to the lumbar and sacral spine (1.3 to SI) with removal of the implants after the attainment of a solid fusion.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signalure)
FORM FDAY88884 (9/13)
5
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