(105 days)
Not Found
No
The device description focuses on the mechanical components (plates and screws) and their materials, with no mention of software, algorithms, or data processing that would indicate AI/ML. The performance studies are mechanical tests, not algorithmic performance evaluations.
Yes
The device is an anterior cervical plate system designed to provide fixation to the spine after surgery, aiding in fusion and treating various spinal conditions like degenerative disc disease, trauma, and deformities, which directly addresses medical conditions.
No
The device description clearly states it is a surgical implant (plates and screws for anterior cervical fixation) used as an adjunct to fusion, not for diagnostic purposes.
No
The device description explicitly states it is comprised of plates and screws made of titanium alloy and nitinol, which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant for stabilizing the anterior cervical spine as an adjunct to fusion. This is a therapeutic intervention, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is comprised of plates and screws made of titanium alloy and nitinol, designed for physical implantation in the spine. This is consistent with a surgical implant, not a diagnostic device.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific markers, or providing diagnostic information about a patient's condition based on in vitro analysis.
- Performance Studies: The performance studies described are mechanical tests (compression, tension, torsion), which are relevant to the structural integrity and function of a surgical implant, not the analytical or clinical performance of a diagnostic test.
In summary, the Sapphire Anterior Cervical Plate System is a surgical implant used for spinal fixation, which falls under the category of medical devices but not In Vitro Diagnostic devices.
N/A
Intended Use / Indications for Use
The Sapphire Anterior Cervical Plate System is intended for anterior cervical fixation (C2 - C7) in skeletally mature patients as an adjunct to fusion for the following indications: degenerative disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (including fracture or dislocation), spinal stenosis, deformities or curvatures (kyphosis, lordosis or scoliosis), tumor, pseudoarthrosis, and failed previous fusion.
Product codes
KWQ
Device Description
The Sapphire Anterior Cervical Plate System is comprised of plates and screws that are used for attachment to the anterior cervical spine. Both plates and screws are available in a variety of sizes to suit the individual pathology and anatomic condition of the patient. Plates are pre-shaped with radial and lordotic curvature and have large windows for graff and end plate visualization. Plates range in length to accommodate one to four levels of fusion.
Screws are available in both fixed and variable angle designs. Fixed angle screws have a predetermined trajectory relative to the plate. Variable angle screws provide freedom in trajectory of the screws into the vertebral body. All screws are equipped with an internal locking mechanism.
Plates and screws are manufactured from titanium alloy (Ti-6A1-4V) conforming to ASTM F 136 or ISO 5832-3, with certain subcomponents manufactured from nitinol conforming to ASTM F 2063.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
anterior cervical spine (C2 - C7)
Indicated Patient Age Range
skeletally mature patients
Intended User / Care Setting
Prescription Use
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 was conducted in accordance with ASTM F 1717, and included:
- A Dynamic compression
- A Static compression
- A Static tension and
- Static torsion.
Mechanical testing indicates that the Sapphire™ Anterior Cervical Plate System is capable of performing in accordance with its intended use and is substantially equivalent to predicate devices.
Key Metrics
Not Found
Predicate Device(s)
K060491, K926453, K100265, K042499
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
Spinal Elements, Inc. Premarket Notification -Sapphire™ Anterior Cervical Plate System
pg 1 of 2
OCT 1 4 2010
510(k) Summary Sapphire™ Anterior Cervical Plate System
510(k) Number K101848
Manufacturer Identification · Submitted by:
Spinal Elements, Inc. 2744 Loker Ave. W., Suite 100 Carlsbad, CA 92010 760-607-0121
Contact Information:
Benjamin A. Kimball Regulatory Affairs Manager Spinal Elements, Inc. 2744 Loker Ave. W., Suite 100 Carlsbad, CA 92010 760-607-1816 Bkimball@spinalelements.com
Date Prepared:
June 29, 2010
Device Indentification Proprietary Name Common Name Device Classification
Proposed Regulatory Class Device Product Code
Sapphire™ Anterior Cervical Plate System Anterior Cervical Plate System 21 CFR 888.3060 (Appliance, Fixation Spinal Intervertebral Body) Class II KWQ
Purpose of this 510(k)
This 510(k) seeks clearance for a new spinal system.
Device Description
The Sapphire Anterior Cervical Plate System is comprised of plates and screws that are used for attachment to the anterior cervical spine. Both plates and screws are available in a variety of sizes to suit the individual pathology and anatomic condition of the patient. Plates are pre-shaped with radial and lordotic curvature and have large windows for graff and end plate visualization. Plates range in length to accommodate one to four levels of fusion.
Screws are available in both fixed and variable angle designs. Fixed angle screws have a predetermined trajectory relative to the plate. Variable angle screws provide freedom in traiectory of the screws into the vertebral body. All screws are equipped with an internal locking mechanism.
1
pg 2 of 2
Plates and screws are manufactured from titanium alloy (Ti-6A1-4V) conforming to ASTM F 136 or ISO 5832-3, with certain subcomponents manufactured from nitinol conforming to ASTM F 2063.
Intended Use of the Device
The Sapphire Anterior Cervical Plate System is intended for anterior cervical fixation ( C2 - C7) in skeletally mature patients as an adjunct to fusion for the following indications: degenerative disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (including fracture or dislocation), spinal stenosis, deformities or curvatures (kyphosis, lordosis or scoliosis), tumor, pseudoarthrosis, and failed previous
fusion.
Substantial Equivalence
The Sapphire™ Anterior Cervical Plate System was shown to be substantially equivalent previously cleared devices in indications for use, design, function, and materials used.
-
Atomic® Anterior Cervical Plate System (K060491).
-
Synthes Anterior Cervical Vertebrae Plate (K926453).
-
Amendia, LLC. Diamond Anterior Cervical Plate System (K100265).
-
Medtronic, Orion Anterior Cervical Plate System (K042499).
Performance Data
Mechanical testing was conducted in accordance with ASTM F 1717, and included:
- A Dynamic compression
- A Static compression
- A Static tension and
-
Static torsion.
Mechanical testing indicates that the Sapphire™ Anterior Cervical Plate System is capable of performing in accordance with its intended use and is substantially equivalent to predicate devices.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the symbol.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
OCT 1 4 2010
Spinal Elements, Inc. % Mr. Benjamin A. Kimball Regulatory Affairs Manager 2744 Loker Avenue West, Suite 100 Carlsbad, California 92010
Re: K101848
Trade/Device Name: Sapphire™ 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: August 18, 2010 Received: September 20, 2010
Dear Mr. Kimball:
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
3
Page 2 - Mr. Benjamin A. Kimball
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 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
For
Mark N. Melkerson
Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known):
510(k) Number (if known):
Device Name: Sapphire™ Anterior Cervical Plate System
Indications for Use:
The Sapphire Anterior Cervical Plate System is intended for anterior cervical fixation (C2 - C7) in skeletally mature patients as an adjunct to fusion for the following indications: degenerative disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (including fracture or dislocation), spinal stenosis, deformities or curvatures (kyphosis, lordosis or scoliosis), tumor, pseudoarthrosis, and failed previous fusion.
Prescription Use X (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
AND/OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
A
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
KIDI898 510(k) Number_
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