(72 days)
No
The device description and performance studies focus on the mechanical properties and structural integrity of the spinal implant system components. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
Yes.
The device components are implants intended to promote fusion and provide stabilization in the spine for various medical conditions, indicating a direct therapeutic action.
No
The device is described as an implant system consisting of screws, hooks, rods, plates, and connectors for promoting fusion and stabilization in the spine, which are therapeutic functions, not diagnostic.
No
The device description explicitly states that the system consists of physical components such as screws, hooks, rods, plates, and connectors, which are manufactured from Titanium alloy. This indicates it is a hardware medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The description clearly states that the Certex OCT Spinal Implant System consists of physical implants (screws, hooks, rods, plates, and connectors) intended to be surgically implanted into the spine to promote fusion and provide stabilization. This is a therapeutic device, not a diagnostic test performed on a sample outside the body.
- Lack of IVD Characteristics: The document does not mention any analysis of biological samples, diagnostic testing, or any of the typical characteristics of an IVD.
Therefore, the Certex OCT Spinal Implant System is a surgical implant device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The intended use of the Certex OCT Spinal Implant System is to promote fusion of the occipito-cervicothoracic regions of the spine (Occiput - T3 inclusive). The indications for use are as follows:
- Degenerative Disc Disease (as identified by neck or back pain of discogenic origin with . degeneration of the disc confirmed by patient history and radiographic studies),
- . Spondylolisthesis,
- Trauma (i.e., fracture or dislocation), .
- . Spinal Stenosis,
- Atlanto-axial fracture with instability, .
- Failed previous fusion, .
- Occipito-cervical dislocation, .
- Revision of previous cervical spine surgery, ●
- Spinal tumors. ●
The occipital bone screws are limited to occipital fixation only.
The hooks and rods are intended to provide stabilization and promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic spine (C1-T3).
The use of the polyaxial screws is limited to placement in the upper thoracic spine (T1-T3) for purposes of anchoring an OCT construct, and are not intended for treatment of thoracic conditions. Screws are not intended to be placed in the cervical spine.
Product codes
KWP
Device Description
The Certex OCT Spinal Implant System consists of screws, hooks, rods, plates and connectors. Various sizes of these implants are available so that adaptations can be made to take into account pathology and individual patient anatomy. The Certex OCT Spinal Implant System components are manufactured from Titanium alloy in accordance with ASTM F136 and will be provided clean but non-sterile.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
occipito-cervicothoracic regions of the spine (Occiput - T3 inclusive), cervical/upper thoracic spine (C1-T3), upper thoracic spine (T1-T3)
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)
The implant components were tested using the following testing standards per FDA Guidance and recommendations:
- ASTM F2706 Standard Test Methods for Occipital-Cervical and Occipital-Cervical-Thoracic . Spinal Implant Constructs in a Vertebrectomy Model
- Static and dynamic compression o
- Static and dynamic torsion o
- ASTM F1798 Standard Guide for Evaluating the Static and Fatigue Properties of . Interconnection Mechanisms and Subassemblies Used in Spinal Arthrodesis Implants
- Axial Slip o
- o Torsional Slip
In summary, results from the biomechanical testing indicate that the Certex OCT Spinal Implant System is substantially equivalent to predicate device performance and is capable of performing in accordance with its intended use.
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
510(k) Summary
ADMINISTRATIVE INFORMATION
Manufacturer Name:
X-spine Systems, Inc. 452 Alexandersville Rd. Miamisburg, OH 45342
DEC 1 1 2013
Telephone (937) 847-8400 FAX (937) 847-8410
Official Contact:
David Kirschman, M.D. Chief Medical Officer
Date Prepared:
December 5, 2013
DEVICE NAME
| Trade/Proprietary Name: | Certex TM OCT Spinal Implant System |
|---|---|
| Common Name: | Spinal Implants |
| Classification Name: | KWP 888.3050 - Appliance, Fixation, Spinal Interlaminal |
ESTABLISHMENT REGISTRATION NUMBER
X-spine Systems, Inc. has submitted an Establishment Registration to FDA. The Establishment Registration number is 3005031160. The owner/operator number for X-spine Systems, Inc. is 9063903.
INTENDED USE
The intended use of the Certex OCT Spinal Implant System is to promote fusion of the occipito-cervicothoracic regions of the spine (Occiput - T3 inclusive). The indications for use are as follows:
- Degenerative Disc Disease (as identified by neck or back pain of discogenic origin with . degeneration of the disc confirmed by patient history and radiographic studies),
- . Spondylolisthesis,
- Trauma (i.e., fracture or dislocation), .
- . Spinal Stenosis,
- Atlanto-axial fracture with instability, .
- Failed previous fusion, .
- Occipito-cervical dislocation, .
- Revision of previous cervical spine surgery, ●
- Spinal tumors. ●
The occipital bone screws are limited to occipital fixation only.
The hooks and rods are intended to provide stabilization and promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic spine (C1-T3).
The use of the polyaxial screws is limited to placement in the upper thoracic spine (T1-T3) for purposes of anchoring an OCT construct, and are not intended for treatment of thoracic conditions. Screws are not intended to be placed in the cervical spine.
1
DEVICE DESCRIPTION
The Certex OCT Spinal Implant System consists of screws, hooks, rods, plates and connectors. Various sizes of these implants are available so that adaptations can be made to take into account pathology and individual patient anatomy. The Certex OCT Spinal Implant System components are manufactured from Titanium alloy in accordance with ASTM F136 and will be provided clean but non-sterile.
PREDICATE DEVICES
- X-spine Systems, Inc. Certex Spinal Implant System (K122163) .
- Aesculap, LLC S4 Cervical Occipital Plate Spinal System (K062012) .
EQUIVALENCE TO MARKETED PRODUCT
. X-spine Systems, Inc. has submitted information to demonstrate that, for the purposes of FDA's regulation of medical devices, the Certex OCT Spinal Implant System is substantially equivalent to predicate devices based on a comparison including the following characteristics:
- . FDA Product Code
- Intended Uses .
- Surgical Approach .
- Anatomical Region .
- . Implant Materials
- Product Dimensions .
- . Mechanical Performance
PERFORMANCE DATA
The implant components were tested using the following testing standards per FDA Guidance and recommendations:
- ASTM F2706 Standard Test Methods for Occipital-Cervical and Occipital-Cervical-Thoracic . Spinal Implant Constructs in a Vertebrectomy Model
- Static and dynamic compression o
- Static and dynamic torsion o
- ASTM F1798 Standard Guide for Evaluating the Static and Fatigue Properties of . Interconnection Mechanisms and Subassemblies Used in Spinal Arthrodesis Implants
- Axial Slip o
- o Torsional Slip
In summary, results from the biomechanical testing indicate that the Certex OCT Spinal Implant System is substantially equivalent to predicate device performance and is capable of performing in accordance with its intended use.
2
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 symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus.
Food and Drug Administration 10903 New Hamnshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 11, 2013
X-spine Systems, Incorporated David Kirschman, M.D. Chief Medical Officer 452 Alexandersville Road Miamisburg, Ohio 45342
Re: K133094
Trade/Device Name: Certex™ OCT Spinal Implant System Regulation Number: 21 CFR 888.3050 Regulation Name: Spinal interlaminal fixation orthosis Regulatory Class: Class II Product Code: KWP Dated: December 6, 2013 Received: December 9, 2013
Dear Dr. Kirschman:
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 - David Kirschman, M.D.
forth in the quality systems (OS) 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/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 vours.
Ronald#99Jean -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) K133094
Device Name
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Certex™ OCT Spinal Implant System
Indications for Use (Describe)
The intended use of the Certex OCT Spinal Implant System is to promote fusion of the occipito-cervice-thoracic regions of the spine (Occiput - T3 inclusive). The indications for use are as follows:
· Degenerative Disc Disease (as identified by neck or back pain of discogention of the disc confirmed by patient history and radiographic studies),
- · Spondvlolisthesis.
- · Trauma (i.e., fracture or dislocation),
- · Spinal Stenosis,
- · Atlanto-axial fracture with instability,
- · Failed previous fusion,
- · Occipito-cervical dislocation,
- · Revision of previous cervical spine surgery,
- · Spinal tumors.
The occipital bone screws are limited to occipital fixation only.
The hooks and rods are intended to provide stabilization following reduction of fracture/dislocation or trauma in the cervical/upper thoracic spine (C1-T3).
The use of the polyaxial screws is limited to placement in the upper thoracic spine (T1-T3) for purposes of anchoring an OCT construct, and are not intended for treatment of thoracic conditions. Screws are not intended to be placed in the cervical spine.
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)
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) (Signature)