(31 days)
No
The summary describes a mechanical implant system for spinal stabilization and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The device is indicated for stabilization of the anterior cervical spine in various conditions like trauma, deformity, pseudoarthrosis, tumors, and degenerative disk disease, which are therapeutic interventions.
No
The device description indicates it is an implant system used for stabilization of the anterior cervical spine, not for diagnosis.
No
The device description explicitly states that the device is comprised of implant and instrument components made from Titanium alloy, including a plate, cover plate, set screw, and bone screw components. These are physical hardware components, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body.
- Device Description: The provided text describes a surgical implant (an anterior cervical plate system) that is surgically placed inside the body to stabilize the spine.
- Intended Use: The intended use is for surgical stabilization of the cervical spine, not for testing biological samples.
Therefore, based on the provided information, the Reliance Anterior Cervical Plate System is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Reliance Anterior Cervical Plate System is indicated for stabilization of the anterior cervical spine from C2 to C7 employing unicortical screw fixation at the anterior face of the vertebral bodies. Specific clinical indications for anterior plating include:
- instability caused by trauma or fracture; .
- instability associated with correction of cervical lordosis and kyphosis deformity;
- instability associated with pseudoarthosis as a result of previously failed cervical spine . surgery;
- instability associated with major reconstructive surgery for primary tumors or metastatic . malignant tumors of the cervical spine;
- instability associated with single or multiple level corpectomy in advanced degenerative . disk disease (defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies), spinal canal stenosis and cervical myelopathy.
This device is not approved for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.
Product codes
KWO
Device Description
The Reliance Anterior Cervical Plate System device is intended to be used as an anterior cervical plate device. The Reliance Anterior Cervical Plate System is comprised of implant and instrument components. The Reliance Anterior Cervical Plate implant device is manufactured from Titanium alloy as specified by ASTM F-136. The Reliance Anterior Cervical Plate is a combination of the plate, cover plate, set screw, and bone screw components. The cover plate is attached to the plate by means of the set screw.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
anterior cervical spine from C2 to C7
Indicated Patient Age Range
Not Found
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)
Mechanical testing was performed on the predicate Reliance Anterior Cervical Plate System (K122216) following ASTM F-1717 (static compression bending, static torsion, and dynamic compression bending). The Reliance Anterior Cervical Plate System was found to be substantially equivalent to the predicate devices. Additionally, the Reliance Cervical Plate System is substantially equivalent to the predicate devices in terms of sterilization and biocompatibility. A risk analysis was performed on the subject devices and it was determined that no additional mechanical testing was needed for the subject device.
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
§ 888.3060 Spinal intervertebral body fixation orthosis.
(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.
0
510(k) Summary
APR 2 5 2014
23 April 2014
Reliance Medical Systems, LLC 545 West 500 South, Suite 100 Bountiful, UT 84010 801-295-3280 Telephone: Fax: 801-294-0079
Contact: Bret M. Berry Member-Manager
510(k) Number: Common or Usual Name: Proposed Proprietary or Trade Name: Classification Name: Regulation Number: Product Code: Class:
Anterior Cervical Plate Reliance Anterior Cervical Plate System Spinal Intervertebral Body Fixation Orthosis 21 CFR 888.3060 KWO II
Substantial Equivalence
The Reliance Anterior Cervical Plate is substantially equivalent to itself (K122216). The Reliance Anterior Cervical Plate is equivalent to these commercially available devices in terms of material, intended use, levels of attachment, size range, and strength.
Device Description
The Reliance Anterior Cervical Plate System device is intended to be used as an anterior cervical plate device. The Reliance Anterior Cervical Plate System is comprised of implant and instrument components. The Reliance Anterior Cervical Plate implant device is manufactured from Titanium alloy as specified by ASTM F-136. The Reliance Anterior Cervical Plate is a combination of the plate, cover plate, set screw, and bone screw components. The cover plate is attached to the plate by means of the set screw.
Intended Use/Indications for Use
The Reliance Anterior Cervical Plate System is indicated for stabilization of the anterior cervical spine from C2 to C7 employing unicortical screw fixation at the anterior face of the vertebral bodies. Specific clinical indications for anterior plating include:
- . instability caused by trauma or fracture;
- instability associated with correction of cervical lordosis and kyphosis deformity; ●
- instability associated with pseudoarthosis as a result of previously failed cervical spine . . surgery:
- . instability associated with major reconstructive surgery for primary tumors or metastatic malignant tumors of the cervical spine;
1
- instability associated with single or multiple level corpectomy in advanced degenerative . disk disease (defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies), spinal canal stenosis and cervical myelopathy.
This device is not approved for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.
Performance Data and Substantial Equivalence
Mechanical testing was performed on the predicate Reliance Anterior Cervical Plate System (K122216) following ASTM F-1717 (static compression bending, static torsion, and dynamic compression bending). The Reliance Anterior Cervical Plate System was found to be substantially equivalent to the predicate devices. Additionally, the Reliance Cervical Plate System is substantially equivalent to the predicate devices in terms of sterilization and biocompatibility. A risk analysis was performed on the subject devices and it was determined that no additional mechanical testing was needed for the subject device.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 25, 2014
Reliance Medical Systems, LLC Mr. Bret M. Berry Member-Manager 545 West 500 South, Suite 100 Bountiful, Utah 84010
Re: K140742
Trade/Device Name: Reliance Anterior Cervical Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: KWO Dated: March 26, 2014 Received: March 27, 2014
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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
3
Page 2 - Mr. Bret M. 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 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/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/ReportalProblem/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/Resourcesfor You/Industrv/default.htm.
Sincerely yours.
Ronald P. Jean -S for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K140742
Device Name: Reliance Anterior Cervical Plate System
Indications for Use:
The Reliance Anterior Cervical Plate System is indicated for stabilization of the anterior cervical spine from C2 to C7 employing unicortical screw fixation at the anterior face of the vertebral bodies. Specific clinical indications for anterior plating include:
- instability caused by trauma or fracture; .
- instability associated with correction of cervical lordosis and kyphosis deformity;
- instability associated with pseudoarthosis as a result of previously failed cervical spine . surgery;
- instability associated with major reconstructive surgery for primary tumors or metastatic . malignant tumors of the cervical spine;
- instability associated with single or multiple level corpectomy in advanced degenerative . disk disease (defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies), spinal canal stenosis and cervical myelopathy.
This device is not approved for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
: Concurrence of CDRH, Office of Device Evaluation (ODE)
Anton E. Dmitriev, PhD Division of Orthopedic Devices
: .
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