(210 days)
Not Found
No
The document describes a mechanical spinal implant system and associated instruments, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No
The device is an implantable system designed to promote fusion and provide stabilization in the cervical and cervicothoracic spine, which is a structural aid rather than a therapeutic device that directly treats a medical condition.
No
The provided text describes a surgical implant system used to promote fusion of the spine, not a device used for diagnosis. Its intended use is for treatment, specifically for conditions like spondylolisthesis, spinal stenosis, and fractures.
No
The device description explicitly states it is comprised of "implant and instrument components," which are physical hardware.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The description clearly states that the Reliance Posterior Cervical-Thoracic System is comprised of implant and instrument components used for spinal fusion and stabilization. It is surgically implanted into the body.
- Lack of Specimen Analysis: There is no mention of the device analyzing any biological specimens or providing diagnostic information based on such analysis.
The device is a surgical implant system used to treat specific spinal conditions.
N/A
Intended Use / Indications for Use
The Reliance Posterior Cervical-Thoracic System is intended to promote fusion of the cervical spine and cervicothoracic junction (C1-T3), and is indicated for the following:
- ddd (neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies)
- Spondylolisthesis
- Spinal stenosis
- Fracture/dislocation
- Revision of previous cervical spine surgery
- Tumors
The use of the polyaxial screws is limited to placement in the upper thoracic spine (T1-T3) for anchoring the system only. They are not intended to be placed in the cervical spine.
Hooks and Rods
The rod and hook components are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C1-T3) spine.
WARNING: This device is not approved for screw attachment or fixation to the posterior element(pedicles) of the cervical, thoracic (T4-T12), or lumbar spine. Pedicle screws are intended for placement only in T1-T3 as a means of anchoring the system.
Product codes
KWP
Device Description
The Reliance Posterior Cervical-Thoracic System is comprised of implant and instrument components. The implant component, the Reliance Posterior Cervical-Thoracic device, consists of posterior attachment elements with a set screw and rod. The Posterior Cervical-Thoracic pedicle screw component is offered in a mono-axial configuration. In addition to this components, there are also ancillary components such as hooks, connectors, cross-links, and lateral offset connectors. There are also thoracic poly-axial screw components. Furthermore, the Reliance Posterior Cervical-Thoracic System has a variety of configurations to meet specific patients' needs.
The Reliance Posterior Cervical-Thoracic instrument components include screw drivers, drill guides, plate holders, and drill bits. These instruments are manufactured from stainless steel, high grade plastic, and silicone rubber. There are also instrument trays that house these components.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
cervical spine and cervicothoracic junction (C1-T3), upper thoracic spine (T1-T3), cervical/upper thoracic (C1-T3) spine, cervical, thoracic (T4–T12), or lumbar spine.
Indicated Patient Age Range
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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)
The Reliance Posterior Cervical-Thoracic System has undergone Non-Clinical Testing including Static Compressive, Static Torsion, Dynamic Compressive and Dynamic Torsion in accordance with ASTM F1717. The Reliance Posterior Cervical-Thoracic System is substantially equivalent to the predicate devices. Additionally, the Reliance Posterior Cervical-Thoracic System is also substantially equivalent to the predicate devices in terms of sterilization and biocompatibility.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3050 Spinal interlaminal fixation orthosis.
(a)
Identification. A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.(b)
Classification. Class II.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 29, 2015
Reliance Medical Systems, LLC Mr. Bret Berry Member-Manager P.O. Box 1693 Bountiful, Utah 84010
Re: K142867
Trade/Device Name: Reliance Posterior Cervical-Thoracic System Regulation Number: 21 CFR 888.3050 Regulation Name: Spinal interlaminal fixation orthosis Regulatory Class: Class II Product Code: KWP Dated: February 13, 2015 Received: April 1, 2015
Dear Mr. Berry:
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
1
Page 2 - Mr. Bret Berry
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/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 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 vours.
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K142867
Device Name
Reliance Posterior Cervical-Thoracic System
Indications for Use (Describe)
The Reliance Posterior Cervical-Thoracic System is intended to promote fusion of the cervical spine and cervicothoracic junction (C1-T3), and is indicated for the following:
· ddd (neck pain of discogenic ongin with degeneration of the disc as confirmed by patient history and radiographic studies)
- · Spondylolisthesis
- · Spinal stenosis
- · Fracture/dislocation
- · Revision of previous cervical spine surgery
- · Tumors
The use of the polyaxial screws is limited to placement in the upper thoracic spine (T1-T3) for anchoring the system only. They are not intended to be placed in the cervical spine.
Hooks and Rods
The rod and hook components are also intended to provide stabilization to promote fusion following reduction of fracture/ dislocation or trauma in the cervical/upper thoracic (C1-T3) spine.
WARNING: This device is not approved for screw attachment or fixation to the posterior element(pedicles) of the cervical, thoracic (T4-T12), or lumbar spine. Pedicle screws are intended for placement only in T1-T3 as a means of anchoring the system.
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."
FORM FDA 3881 (8/14)
3
| 510(k) Summary | 10/28/2014 | |
|---|---|---|
| Reliance Medical Systems, LLC | ||
| PO Box 1693 | ||
| Bountiful, UT 84010 | ||
| Telephone: | 801-295-3280 | |
| Fax: | 801-294-0079 | |
| Contact: | Bret Berry | |
| Member-Manager | ||
| Common or Usual Name: | Spinal Fixation Device | |
| Proposed Proprietary or Trade Name: | Reliance Posterior Cervical-Thoracic System | |
| Classification Name: | Spinal Interlaminal Fixation Orthosis (per 21 CFR 888.3050) | |
| Product Code: | KWP |
Substantial Equivalence
The Reliance Posterior Cervical-Thoracic System is substantially equivalent to itself (K122292), primary predicate device and the secondary predicate device, Synthes System & OC Fusion System (K141897), in terms of material, intended use, levels of attachment, size range, and strength.
Device Description
The Reliance Posterior Cervical-Thoracic System is comprised of implant and instrument components. The implant component, the Reliance Posterior Cervical-Thoracic device, consists of posterior attachment elements with a set screw and rod. The Posterior Cervical-Thoracic pedicle screw component is offered in a mono-axial configuration. In addition to this components, there are also ancillary components such as hooks, connectors, cross-links, and lateral offset connectors. There are also thoracic poly-axial screw components. Furthermore, the Reliance Posterior Cervical-Thoracic System has a variety of configurations to meet specific patients' needs.
4
The Reliance Posterior Cervical-Thoracic instrument components include screw drivers, drill guides, plate holders, and drill bits. These instruments are manufactured from stainless steel, high grade plastic, and silicone rubber. There are also instrument trays that house these components.
Intended Use/Indications for Use
The Reliance Posterior Cervical-Thoracic System is intended to promote fusion of the cervical spine and cervicothoracic junction (C1-T3), and is indicated for the following:
- ddd (neck pain of discogenic origin with degeneration of the disc as confirmed by . patient history and radiographic studies)
- Spondylolisthesis .
- Spinal stenosis •
- Fracture/dislocation •
- Revision of previous cervical spine surgery .
- . Tumors
The use of the polyaxial screws is limited to placement in the upper thoracic spine (T1-T3) for anchoring the system only. They are not intended to be placed in the cervical spine.
Hooks and Rods
The rod and hook components are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C1-T3) spine.
WARNING: This device is not approved for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic (T4–T12), or lumbar spine. Pedicle screws are intended for placement only in T1-T3 as a means of anchoring the system.
Performance Data and Substantial Equivalence Discussion
The Reliance Posterior Cervical-Thoracic System has undergone Non-Clinical Testing including Static Compressive, Static Torsion, Dynamic Compressive and Dynamic Torsion in accordance with ASTM F1717. The Reliance Posterior Cervical-Thoracic System is substantially equivalent to the predicate devices. Additionally, the Reliance Posterior Cervical-Thoracic System is also substantially equivalent to the predicate devices in terms of sterilization and biocompatibility.